Events

Rappel de Device Recall Lumax Cardiac Resyncronization Therapy Defibrillator (CRTD)

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Biotronik Inc.

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
    46751
  • Classe de risque de l'événement
    Class 3
  • Numéro de l'événement
    Z-1373-2008
  • Date de mise en oeuvre de l'événement
    2007-01-10
  • Date de publication de l'événement
    2008-07-29
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-05-05
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=68220
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Implantable defibrillator - Product Code MRM
  • Cause
    Timing feature error: an implementation error allows the usage of the v-v timing feature, which is not approved for use in the u.S.
  • Action
    Consignees were notified by a letter sent 1/10/07. The letter advised users to stop usage of the affected software. Users were instructed not to implant additional devices until the software program has been corrected. The recalling firm requested that all affected software be scrapped or returned to them. Users were requested update the software with a corrected version as soon as it becomes available.

Device

Device Recall Lumax Cardiac Resyncronization Therapy Defibrillator (CRTD)
  • Modèle / numéro de série
    Software version 603.U, Catalog/Model Number: 359251; ICS 300 programmers Catalog/Model Numbers: 349527, 449530 and 355547; Lumax 340 HF-T Units, Catalog Number: 355263
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution including states of AL, AZ, CA, CO, DE, FL, GA, IL, LA, MI, MO, NC, NJ, NV, NY, OH, OR, PA, SC, TX and WA.
  • Description du dispositif
    Lumax Cardiac Resyncronization Therapy Defibrillator (CRT-D); Implantable, dual-chamber defibrillator; Model Number: HF-T; Catalog Number 355263; Software Version 603.U; Catalog Model Number 359251; ICS 3000 units are composed of three Catalog/Model Numbers: 349527, 349530, and 355547. The model 349530 is the component which is loaded/updated with software.
  • Manufacturer
    Biotronik Inc

Manufacturer

Biotronik Inc
  • Adresse du fabricant
    Biotronik Inc, 6024 Jean Rd, Lake Oswego OR 97035-5308
  • Commentaire du fabricant
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    USFDA