Events

Alerte Ou Avis De Sécurité sur Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277

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 Medtronic.

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/2004/019
  • Numéro de l'événement
    CON008561
  • Date
    2004-04-26
  • 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/CON008561
  • 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
    Potential battery defect; possible rapid depletion, prevalence unknown. in september 2003 the mhra received a report from a uk hospital of a model 7274 marquis dr implantable cardioverter defibrillator (icd) that was unresponsive to programmer interrogation at a follow-up four months post-implant (i.E. device status could not be determined). the patient was unaware of any change. at one month post-implant this icd had been functioning normally. initial failure analysis by medtronic indicated the battery voltage to be 0v (zero volts), with no attributable fault in the icd's electronics. battery analysis revealed a defect due to damage incurred during manufacturing. subsequently, medtronic confirmed two similar non-uk incidents in which patients experienced localised tissue heating and pain. in may 2002 a battery in production was first identified with this defect. subsequently in october 2002 two additional batteries used in device production were found to have an identical defect. by march 2003 medtronic had implemented improved manufacturing techniques and quality control testing in order to limit this problem. review of the three explanted icds to date has now shown that some batteries, produced prior to completion of these manufacturing changes and which met original test specifications, may still have a potential to fail. if a defect is present, rapid battery depletion may take place without prior indication at a non-predictable time after implant, possibly occurring even within the advised three-month follow-up period. (this follow-up period is consistent with manufacturer device labelling). within a few hours there will be a complete loss of device function and patients will not receive therapy from the icd. it is also possible that, as the battery rapidly depletes, patients may experience localised pain and/or heat in the tissues surrounding the icd as energy is dissipated within the device. however, although examination of information available to date shows the frequency of occurrence for this problem to be low (1 in 10,000 worldwide), caution is warranted because of the impact that failure could have on the patient. current overall performance of this family of icds is comparable to other icds. approximately 31,000 potentially affected devices have been distributed worldwide, with 805 in the uk. affected batteries were not used in any other medtronic model of icd supplied to the uk. no other icd manufacturer uses this battery. the mhra will continue to monitor this problem through the adverse incident reporting system and will issue further advice as appropriate.
  • Action
    Clinicians are advised to: Identify and return to Medtronic any of the potentially affected devices not yet implanted (see the lists of affected serial numbers under 'Device' section). Ensure that patients implanted with potentially affected devices are followed up at intervals of no more than three months. Inform all patients to immediately contact their ICD centre if they experience: Persistent arrhythmias/resumption of symptoms which remain uncorrected by the ICD and/or Heating sensations or pain in body tissue surrounding the implant. For the MHRA recommended actions see above. DEADLINES FOR THE SAFETY ALERT BROADCAST SYSTEM

Device

Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277
  • Modèle / numéro de série
  • Description du dispositif
    Medtronic implantable defibrillators, models: Marquis VR 7230, Marquis DR 7274, InSync Marquis 7277. There are 805 potentially affected devices manufactured by Medtronic before April 2003 that have been distributed in the UK, 791 of which are believed to be still implanted. These include 289 Marquis VR 7230 devices, 402 Marquis DR 7274 devices and 100 InSync Marquis 7277 devices with serial numbers within the following ranges:
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    MHRA