Events

Alerte Ou Avis De Sécurité sur Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families

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 Boston Scientific Ltd..

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
  • Numéro de l'événement
    MDA/2007/023
  • Date
    2007-03-15
  • Date de publication de l'événement
    2014-12-17
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    https://www.gov.uk//drug-device-alerts/medical-device-alert-vitality-and-assure-implantable-cardioverter-defibrillator-icd-families-and-contak-renewal-cardiac-resynchronisation-therapy-defibrillator-crt-d-families-identify-patients-with-these-implants
  • 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
    Delay in delivery of therapy during device middle-of-life phase due to temporarily extended charge time limits.
    Transition to device end of life (EOL) without prior observation of elective replacement indication (ERI) even though battery capacity remains available.The MHRA has received 31 reports of early explants from four of the above device models (1870, 1871, 1872, A135) during the middle-of-life (MOL) phase. Replacement has been due to observation of premature elective replacement / end of life indicators (ERI/EOL), caused by long capacitor charge times. The MHRA has also become aware of confusion about ERI/EOL indicators throughout implant duration.Incident reports have included devices displaying:extended charge times where no replacement / end of life indicators have been observed
    ERI where charge times have extended beyond 26 seconds giving rise to potentially inappropriate therapy delay for some patients
    EOL indicators with charge times in excess of 30 seconds without ERI being observed in the first instance.Boston Scientific ICDs / CRTDs are designed to regularly monitor both battery voltage and capacitor charge time, and flag ERI when specified limits are exceeded. Charge time ERI is flagged whenever two charges (capacitor reform or therapeutic shock) occur within a 24hr period in which both exceed the specified limit.Increase in charge time (due to a rise in battery impedance) is an expected behaviour of ICDs that have lithium-silver-vanadium-oxide batteries. However, early batteries used in some of the above models have a tendency to exhibit a more exaggerated increase in battery impedance during the MOL phase, due to a battery manufacturing anomaly.Boston Scientific has confirmed that the above models have been programmed with temporarily extended ERI charge time limits during the MOL phase (compared to unaffected models). This is to prevent premature tripping of ERI due to the battery impedance characteristic.In January 2007, Boston Scientific issued a product update about this issue via their website. The company issued a more detailed and informative product update about this problem in March 2007.The MHRA is issuing this Medical Device Alert to ensure that all UK clinicians who implant these devices, or manage patients already implanted with these devices, are aware of Boston Scientific’s communication and can therefore consider the clinical implications of long charge times that may be inappropriate for some patients.
  • Cause
    (boston scientific ltd.) patients may experience extended charge times in the middle-of-life phase of the device, which could lead to a delay in shock delivery; also replacement and end of life indicators may display earlier than expected. (mda/2007/023).
  • Action
    Identify patients implanted with these devices, asses clinical risks associated with the above device problems, and follow the actions on page 2.Be aware of: extended capacitor charge times during device MOL phase, as documented in the most recent Boston Scientific product update (see the MHRA’s website for March 2007 issue) the higher prevalence of long charge times in earlier manufactured devices (see Appendix 2 below) the potential for earlier manufactured devices to pass from ERI to EOL in less than three months. At the next scheduled follow-up, review capacitor charge time history and evaluate the appropriateness of charge time according to patient condition and device dependency, giving priority to those who have not been followed up within the last three months (see Appendix 1 below). Consider the risks (infection etc) and benefits of elective device replacement where capacitor charge time is judged to be inappropriate for an individual patient. Consider scheduling future patient follow-ups at three monthly intervals – where the device is around MOL, to increase the likelihood of detecting longer charge times, early ERI and/or EOL as appropriate. Consider programming the ‘Beep When ERI is Reached’ feature to ‘ON’ (default) for all affected patients. Remind patients to contact their follow-up centre immediately if they hear beeping from their device and/or experience arrhythmias/resumption of symptoms that remain uncorrected by the device. Consult the Boston Scientific website for future related product updates. Report all instances of device failure to the MHRA and Boston Scientific. Report explants to the National Pacing and ICD Database (see contacts on page 3).

Device

Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal card...
  • Modèle / numéro de série
  • Description du dispositif
    Boston Scientific Ltd:Vitality and Assure implantable cardioverter defibrillator (ICD) families and Contak Renewal cardiac resynchronisation therapy defibrillator (CRT-D) families (see Appendix 2 for full details of models affected)
  • Manufacturer
    Boston Scientific Ltd.

Manufacturer

Boston Scientific Ltd.
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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