Events

Alerte De Sécurité sur COGNIS CRT-Ds and TELIGEN ICDs

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2013-08-30
  • Date de publication de l'événement
    2013-08-30
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130830.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medicalmedical device safety alert: boston scientific cognis crt-ds and teligen icds medical device manufacturer, boston scientific, has issued a field safety notice concerning cognis cardiac resynchronization therapy defibrillators (crt-ds) and teligen implantable cardioverter-defibrillators (icds) manufactured prior to december 2009. the affected model numbers are as follows: cognis crt-d: n106, n107, n118, n119, p106, p107 teligen dr icd: e110, f110 teligen vr icd: e012, f102 boston scientific has identified a low voltage (lv) capacitor component that, in some devices, may experience diminished performance after two or more years of implant time. this can increase battery use and eventually trigger one or more safety architecture alerts, accompanied by patient-audible beeping. all cases reported to date have been detected by diagnostic tools within boston scientific’s safety architecture before device function was compromised. “safety architecture” refers to a set of diagnostic monitoring tools in cognis and teligen designed to mitigate potential device performance and clinical risks. these tools periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable. a total of approximately 264,000 cognis and teligen defibrillators have been distributed and implanted since may of 2008. however, a subset of ~38,500 devices (15% of the total) that were manufactured prior to december 2009 has experienced a higher number of lv capacitor malfunctions (approximately 0.67% or 1 in 150). boston scientific advises that there are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring, which are described in device labeling. in addition, the manufacturer recommends physicians to call technical services when investigating a safety architecture alert. following a safety architecture alert or explant indicator due to diminished low voltage capacitor performance, the normal 3-month replacement window may be shortened and increased current drain could deplete the battery and compromise therapy/telemetry. technical services can help estimate how much time is available to replace the device, should a low voltage alert or explant indicator occur. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 30 august 2013.

Device

COGNIS CRT-Ds and TELIGEN ICDs
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific COGNIS CRT-Ds and TELIGEN ICDs
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH