The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Removal from the market of Brio ™ implantable pulse generators, manufactured by St. Jude Medical, USA, due to the possible reduction or loss of therapy, and recommendations for the follow-up of implanted patients.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Temporary cessation of implantation of NanostimTM wireless pacemakers, model S1DLCP, manufactured by St. Jude Medical, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Cessation of the use of the implants of the "Portico ™ transcatheter transcatheter aortic valve transfemoral implantation system", manufactured by St. Jude Medical, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
New temporary cessation of implantation of NanostimTM wireless pacemakers, model S1DLCP, manufactured by St. Jude Medical, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Update of the information about the research carried out by the company for the resumption of implantations of the "Portico ™ transcatheter transcatheter transcatheter aortic valve implantation system", manufactured by St. Jude Medical
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Restart of the Clinical Study of Post-Marketing Tracking of the "NanostimTM Wireless Pacemaker", model S1DLCP, manufactured by St. Jude Medical, USA.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Possibility that certain Defibrillators (ICDs) and implantable pacemakers with radiofrequency (RF) capacity, manufactured by St. Jude Medical CRMD, USA, enter back-up mode when used with the Merlin @ home ™ RF transmitter.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Cessation of implantation, market recall and follow-up of implanted patients with the Fortify ™, FortifyAssura ™, QuadraAssura ™, QuadraAssura MP ™, Unify ™, UnifyAssura ™ and UnifyQuadra ™ defibrillators, manufactured by St. Jude Medical, USA, before May 23, 2015.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
New cessation of implantations and market recall of the NanostimTM wireless pacemaker, model S1DLCP, manufactured by St. Jude Medical, USA, due to the possibility of battery malfunction and recommendations for the follow-up of implanted patients.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Software update of the NanostimTM wireless pacemaker programmer, model S1DLCP, manufactured by St. Jude Medical, USA (company acquired by Abbott, USA).
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Software update of Merlin @ Home ™ remote monitoring transmitters, manufactured by St. Jude Medical, USA (company acquired by Abbott, USA), to version 8.2.2 that includes improvements in cybersecurity.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Possibility that certain EllipseTM Implantable Cardioverter Defibrillators (ICDs), manufactured by St. Jude Medical CRMD, USA, can not administer high voltage therapy, so the device must be replaced to patients carrying them.
The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Spain.
Extra notes in the data
Action
Possibility of a rise in temperature at the implant site during the charging of the implantable pulse generators "Eon", "Eon Mini" and "Brio", manufactured by St. Jude Medical, USA
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Potential insulation damage at the interface of the termination sleeve and svc shock coil in optisure™ dual coil defibrillation leads.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Premature battery depletion with implantable cardioverter defibrillator.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
St. jude medical has received reports of inability to communicate or recharge 78 eon mini ipgs and 1 brio ipg. in the cases reported, the duration between recharges became progressively shorter until the ipg failed to charge or there was a sudden loss of power which resulted in device replacement. after thorough analysis we determined that weld failures within the internal battery of the ipg caused these reports.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=158781
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
Availability of new pacemaker firmware (a type of software) that is intended to address the risk of unauthorized access to st. jude pacemakers that utilize radio frequency (rf) communications (i.E., accent™/ anthem™, accent mri™/ accent st™, assurity™/ allure™ and assurity mri™). this firmware update provides an additional layer of security against unauthorized access to these devices that further reduces the potential for a successful cybersecurity attack.
Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Saudi Arabia.
Extra notes in the data
Report Source: NCMDR
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Reason
St. jude medical received reports of therapy degradation associated with a small number of brio ipgs at a very limited number of hospitals. an analysis of returned devices found that fluid had intruded into the ipg header assembly leading to diminished or loss of therapy. septum damage, which can occur during implant, was found in a majority of the explanted devices and can contribute to fluid intrusion into the ipg header assembly. we are taking a proactive approach by issuing a voluntarily field corrective action for the brio ipg and implementing improvements to the product.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Extra notes in the data
Reason
St. jude medical, a subsidiary of abbott laboratories, has recently received ce approval in the european union for the latest cybersecurity updates for its merlin @ home ™ transmitter for patients and the merlin.Net ™ remote monitoring system.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Extra notes in the data
Reason
With this approval, we will be able to restart nanostim implants within the leadless observational study at selected sites upon approval of the amended protocol by local ethics committees,.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Extra notes in the data
Reason
As part of abbott's post-marketing monitoring and monitoring processes for clinical trials, we pointed to detachment of docking buttons after implantation or during removal attempts of nanostim leadless cardiac pacemakers (lcp), model number s1dlcp.
The data from the Netherlands is current through October 2018. All of the data comes from Inspectie Gezondheidszorg en Jeugd, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the Netherlands.
Extra notes in the data
Reason
Although the probability is small (approximately 1 in 1000) that an error 5 occurs in your system, abbott wants to replace your cardiomems ™ patient system as soon as possible.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.
German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Germany.