Events

Rappel de COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Boston Scientific Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2013-RN-00906-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2013-08-29
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00906-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    Boston scientific has determined that the performance of a low voltage capacitor in a subset of cognis crt-ds and teligen icds manufactured prior to december 2009 may be compromised over time, causing increased current drain that can lead to premature battery depletion. 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 which 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.
  • Action
    There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring. - Remind patients to contact the clinic if beeping is heard from their device, as instructed in the patient manual. - Physicians should promptly investigate alerts and unanticipated replacement indicator messages. - Following a Safety Architecture alert, contact Boston Scientific Technical Services as directed on programmer screens [24 hours per day / 7 days per week]. Technical Services can facilitate an evaluation of “save-to-disk” information (while the device is still implanted) to help clarify available replacement time. For more details, see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130903.htm .

Device

COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR ...
  • Modèle / numéro de série
    COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)Affected model numbers: COGNIS CRT-D : N106, N107, N118, N119, P106, P107TELIGEN DR ICD: E110, F110TELIGEN VR ICD: E102, F102Manufactured prior to December 2009ARTG Numbers: 154034, 154033, 154039 & 154037
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty 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
    DHTGA