U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ventricular (assisst) bypass - Product Code DSQ
Reason
St. jude medical is providing all users of their heartmate ii lvas with pocket controller with new software and updates to hardware to make the exchange to a backup controller easier. this is related to recall z-1227/1230-2014.
Action
Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ventricular (assisst) bypass - Product Code DSQ
Reason
St. jude medical is providing all users of their heartmate ii lvas with pocket controller with new software and updates to hardware to make the exchange to a backup controller easier. this is related to recall z-1227/1230-2014.
Action
Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
St. jude medical is recalling the ellipse icd (implantable cardioverter defibrillator) due to the potential inability to deliver high voltage therapy.
Action
A customer letter dated 4/7/16 was sent to all customers to inform them that St. Jude Medical is recalling the Ellipse ICD (Implantable Cardioverter Defibrillator) due to the potential inability to deliver high voltage therapy. The letter informs the customers that the recall involves information related to 127 units of our Ellipse ICD device distributed worldwide but not implanted in patients. Customers with any questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at 800-722-3774, 24 hours a day, seven days a week.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Ventricular (assisst) bypass - Product Code DSQ
Reason
St. jude medical is providing all users of their heartmate ii lvas with pocket controller with new software and updates to hardware to make the exchange to a backup controller easier. this is related to recall z-1227/1230-2014.
Action
Urgent Medical Device Correction letters, dated March 29, 2017, were sent to customers. The letters provided information on what the current correction will involve to ensure patients are successfully able to exchange their pocket controller in an emergency situation. Patients will receive the updates at scheduled appointment. Questions regarding the notice, should be directed to Abbott HeartLine at 800-456-1477; or, your Abbott Sales Representative.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Transmitter may initiate a software reset resulting in backup operation in some implanted st. jude medical radio frequency (rf) enabled implantable cardioverter assura, unify assura, and quadra assura icds and assurity and allure pacemakers.
Action
The firm, St. Jude Medical, sent an "Important Medical Device Correction" Dear Doctor Letter dated 12/18/14 to customers to inform them that the Merlin@home transmitters may initiate a software reset resulting in backup operation in some implanted St. Jude Medical Radio Frequency (RF) enabled Implantable Cardioverter Defibrillators (ICDs) and Pacemakers. The letter informs the customers of the problems identified and the actions to be taken.
Customers with questions or concerns are instructed to contact their local St. Jude Medical representative or St. Jude Medical's Technical Services Department at 1-800-722-3774.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation - Product Code OAE
Reason
A configuration update needs to be done on tactisys to appropriately recognize all tacticath catheters.
Action
St. Jude Medical sent a Service Bulletin to inform of a TactiSys Configuration File update that needs to be performed. A technical service personnel will visit each consignee and performed the software change on-site. For questions about this Service Bulletin, contact Technical Support
(ETechsupport@sjm.com).
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Leads may have been compromised during the manufacturing process, with cuts in the insulation layer of the svc shock coil.
Action
An Important Medical Device Advisory letter was sent to doctors on 11/3/15 to inform them of the recall by St. Jude Medical. The letter informs the doctors that St. Jude Medical identified that during the manufacturing process of a limited number of Optisure leads, a trim technique to remove excess medical adhesive around the SVC shock coil may have introduced damage to the leads insulation. The letter provides the doctors with the recommendations for patients with a potentially impacted Optisure lead connected to a device with Dynamic TX technology and for patients implanted with a potentially impacted Optisure lead connected to a device without DynamicTx technology. Doctors with questions about the advisory are instructed to contact their local Sales Representative or St. Jude Medical Technical Services at (800) 722-3774.
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
Reason
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
Reason
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and
U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
The Parent Company was added by ICIJ.
The parent company information is based on 2017 public records.
Extra notes in the data
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) - Product Code NKE
Reason
Boston scientific has received reports of intermittent over-sensing of the minute ventilation (mv) sensor signal with certain boston scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers).
Action
On December 19, 2017 the firm sent a letter to all their medical consignees stating the following:
December 2017
Dear Doctor,
Boston Scientific has received reports of intermittent oversensing of the Minute Ventilation (MV) sensor signal with certain Boston Scientific pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). MV sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. This MV behavior may occur with any manufacturers pacing lead system, but Boston Scientific has determined it to be more likely for affected Boston Scientific pacemakers using Medtronic or Abbott/St. Jude
(Abbott) leads implanted in either the right atrium (RA) or right ventricle (RV).
Boston Scientific is actively developing a software update designed to automatically detect and resolve this MV sensor signal oversensing behavior. We anticipate submitting the software update to Regulatory Agencies in
March 2018 and pending approval, will release it as soon as possible thereafter. Until this software update is available, Boston Scientific has additional re commendations to mitigate this risk for affected pacemaker systems.
Root Cause Investigation
The MV sensor in Boston Scientific pacemakers can be used for RightRate" (rate adaptive pacing), Respiratory Rate Trend, or AP Scan"1. When the RA/RV pacing leads and lead terminal connections are operating as
intended, the MV sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (EGMs). However, intermittency related to the lead or pacemaker-lead connection2 has
the potential to create a transient high impedance condition. A high impedance condition may subsequently alter the MV sensor signal such that it becomes visible on EGMs and potentially subject to oversensing on the RA or
RV channels. For a technical description of the Boston Scientifics MV sensor, please refer to Appendix A.
Engineering analysis and