Events

Safety Alert Or Field Safety Notices for TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therapy devices (CRT-D)

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by Boston Scientific.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Safety alert / Field Safety Notice
  • Event Number
    MDA/2014/039
  • Date
    2014-10-07
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-teligen-implantable-cardioverter-defibrillators-icd-and-cognis-cardiac-resynchronisation-therapy-devices-crt-d-manufactured-by-boston-scientific-mda-2014-039
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 United Kingdom.
  • Extra notes in the data
    Risk of loss of therapy due to rapid battery depletion. Additional serial numbers of devices are affected since the manufacturer’s original notification in August 2013.In August 2013 Boston Scientific notified users about a subset of COGNIS™ CRT-Ds and TELIGEN™ ICDs that had experienced an increased rate of premature battery depletion due to a problem with a low voltage (LV) capacitor. The manufacturer has now identified a second subset of devices from subsequent clinical experience and analysis, which is expected to be affected by the same capacitor issue. This adds an additional 885 UK patients to the previous total of approximately 1,000 UK patients identified in August 2013.With this FSN the manufacturer has also notified pacing clinics about the recent introduction of updated Safety Architecture software that will improve early detection of diminished LV capacitor performance. In particular this software enhances detection rates for ICDs later in their device life, and provides a new alert indicator on the programmer screen and the LATITUDETM remote patient monitoring system (if used).The manufacturer has confirmed that the current prevalence of failures within the original advisory population has risen from 0.67% in August 2013 to 2% to date, with the newly identified devices expected to perform similarly. The latest FSN provides important additional information on cumulative survival rates* for devices both within and outside the advisory subset population to help with future patient management.*United States data, correct up to 21 July 2014
  • Reason
    (boston scientific) rapid battery depletion leads to risk of loss of therapy. (mda/2014/039).
  • Action
    Identify newly affected patients according to Boston Scientific’s latest Field Safety Notice or look-up tool and schedule them for an in-clinic visit as soon as possible (within 3 months at the latest). Interrogate the device using a programmer which has received the new software provided by Boston Scientific. This will automatically download improved software for detecting a failing capacitor. If a ‘Code 1003’ alert is seen on the programmer screen, contact Boston Scientific Technical Services to help clarify the time to ‘End Of Life’ (EOL) of the device. Note that ‘Approximate time to Explant’ and ‘Time Remaining’ estimates displayed on the programmer are not accurate when this capacitor malfunction has occurred. Schedule device replacement taking into account time to EOL prediction provided by Boston Scientific. Ensure that all audible alerts have been programmed ‘ON’ and remind patients to contact their clinics immediately if they hear beeping. Consider the benefits of monitoring patients at home using the LATITUDE™ Patient Monitoring System. Schedule patients already identified by MDA/2013/072 for follow-up within 3 months to download their ICDs with the improved software for detecting a failing capacitor. This notice replaces MDA/2013/072 issued in September 2013.Note: Prophylactic replacement of these devices is not recommended

Device

TELIGEN implantable cardioverter defibrillators (ICD) and COGNIS cardiac resynchronisation therap...
  • Model / Serial
  • Product Description
    TELIGENTM implantable cardioverter defibrillators (ICD) and COGNISTM cardiac resynchronisation therapy devices (CRT-D) manufactured by Boston Scientific.The manufacturer has issued a Field Safety Notice (400Kb) (FSN) in relation to the second subset of affected devices. This notice has been distributed to clinics that have implanted these devices and conduct routine patient follow-up, and also to clinics equipped with compatible programmers.Device family   Affected model numbers COGNIS CRT-D   N106/N107/N118/N119/P106/P107/P108 TELIGEN DR ICD   E110/F110/F111 TELIGEN VR ICD   E102/F102/F103You can check specific device–serial number combinations to find out if they are affected. This look-up tool differentiates newly identified devices from those already subject to the 2013 advisory notice.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Address
    Lisa Austin Boston Scientific Breakspear Park Breakspear Way Hemel Hemsptead, HP2 4TZ Tel:    01442 411 600Email:    UK-Quality@bsci.com
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    MHRA