Events

Safety Alert Or Field Safety Notices for Teligen and Cognis defibrillators

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/2010/012
  • Date
    2010-02-10
  • 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-and-cognis-defibrillators-risks-for-devices-implanted-subpectorally
  • 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
    For devices implanted subpectorally there are risks of:loss of shock therapy
    inappropriate shock therapy
    loss of pacing therapy
    loss of anti-tachycardia pacingThe manufacturer has established that the bond between the header and case of these specific models can be weakened either from significant forces associated with a subpectoral implant procedure or when a device in a subpectoral position is repeatedly pushed against a rib during contraction of the pectoralis muscle.The following factors may have an impact on the risk of failure if affected devices are implanted subpectorally:exact location of the patient’s ribs relative to the device
    body size and/or muscle mass of the patient (risk increases for larger or muscular patients)
    activity level and/or occupation of the patient (risk increases for more active patients)
    increased implantation duration.The manufacturer issued a Field Safety Notice in December 2009 informing clinicians about this issue.
    The manufacturer has confirmed that approximately 2,500 affected Teligen and Cognis devices have been distributed on the UK market since these models were released in June 2008. They have estimated that approximately 5% of affected devices are implanted subpectorally worldwide. Devices implanted subcutaneously are not included in this advisory.To date the manufacturer has confirmed two (non-UK) reports of device malfunction associated with this issue out of approximately 77,000 devices sold worldwide. Both devices required early replacement (at four and five months post-implant) as they had delivered inappropriate shocks. The manufacturer has not identified a mean time-to-failure for this problem.
  • Reason
    (boston scientific) specific models of defibrillators implanted subpectorally have a risk of loss of shock therapy, inappropriate shock therapy, loss of pacing therapy or loss of anti-tachycardia pacing. (mda/2010/012).
  • Action
    Review records to identify patients with an affected device implanted subpectorally. Recall affected patients for baseline measurements within six weeks, giving priority to those who are pacing-dependent or who have not been followed up within the previous three months. Consider programming ‘Daily Measurement Alerts’ for lead impedance to ‘On’. Consider prophylactic replacement of affected devices in high risk patients. Remind affected patients to contact their clinic if they receive shocks. Follow up affected patients at three-month intervals (as stated in the manufacturer’s instructions for use). Avoid subpectoral implantation of these models. Report device failures and adverse incidents to Boston Scientific and the MHRA.

Device

Teligen and Cognis defibrillators
  • Model / Serial
  • Product Description
    Teligen implantable cardioverter defibrillators (ICDs) and Cognis cardiac resynchronisation therapy defibrillators (CRT-Ds) – specific models. Manufactured by Boston Scientific.Models affected by this alert:Teligen ICDs model numbers E102, E110, E111, F102, F110 and F111. Cognis CRT-Ds model numbers N106, N107, N108, N118, N119, P106, P107 and P108.
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • Manufacturer Address
    Cait Cowley Boston Scientific Breakspear Park Breakspear Way Hemel Hempstead Herts HP2 4TZ Tel: 01442 411 673 Fax: 01442 411 816Email: Cait.Cowley@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