Events

Alerte Ou Avis De Sécurité sur GEM® DR and Micro Jewel® II ICDs

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par manufacturer #17429.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • ID de l'événement
    MDA/2004/045
  • Numéro de l'événement
    CON008505
  • Date
    2004-09-09
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://webarchive.nationalarchives.gov.uk/20141206095400/http://www.mhra.gov.uk/PrintPreview/PublicationSP/CON008505
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Description du dispositif
    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