Events

Safety Alert Or Field Safety Notices for GEM® DR and Micro Jewel® II ICDs

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 manufacturer #17429.

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 ID
    MDA/2004/045
  • Event Number
    CON008505
  • Date
    2004-09-09
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON008505
  • 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
  • Reason
    Extended charge times and inability to deliver therapy at battery voltages close to elective replacement indicator (eri) for a subset of the above devices. since 1999 medtronic has issued a series of advisory notices concerning the performance of some gem® dr and micro jewel® ii icds. medtronic's most recent advisory notice is appended to this alert and updates previous follow-up recommendations for affected gem® dr and micro jewel® ii icds. this most recent advisory notice followed receipt of reports in which appropriate therapy had not been delivered during cardiac arrhythmias. medtronic was concerned that these devices may not be capable of delivering adequate high voltage defibrillation therapy at or near the specified eri at 4.91v, or during the following period to end of life (eol), specified at 4.57v. the mhra is publishing this medical device alert to reiterate the recommendations made by medtronic, and to update and replace advice previously issued by the medical devices agency in ptn no. 80.
  • Action
    Note that the recommendations in this update supersede the advice given in Pacemaker Technical Note (PTN No. 80 issued by the Medical Devices Agency in October 1999. Identify patients affected by referring to the serial numbers listed in Appendix 2. Follow the detailed instructions given in Medtronic's Advisory Notice (see Appendix 1). Carry out the following actions for all affected patients (refer to list of serial numbers): battery voltage of 5.16V or less , charge time of 18 seconds or greater . Trust managers should ensure that measures to implement the actions specified above are planned and completed within the following SABS deadlines: ACTION DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM (SABS) Further information about SABS can be found at: www.info.doh.gov.uk/sar/cmopatie.nsf

Device

GEM® DR and Micro Jewel® II ICDs
  • Model / Serial
  • Product Classification
    Cardiovascular Devices
  • Product Description
    Medtronic implantable cardioverter defibrillator (ICD) models GEM® DR 7271 and Micro Jewel® II 7223Cx. Medtronic GEM® DR and Micro Jewel® II ICDs manufactured with suspect capacitors and having serial numbers as indicated in Appendix 2.
  • Manufacturer
    manufacturer #17429

Manufacturer

manufacturer #17429