Events

Rappel de Device Recall Renamic and ICS 3000

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
    71658
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2376-2015
  • Date de mise en oeuvre de l'événement
    2015-06-30
  • Date de publication de l'événement
    2015-08-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-24
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=138606
  • 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
    Pacemaker/icd/crt non-implanted components - Product Code rce
  • Cause
    Ventricular packing: lv software programming versions for biotronik crt-p and crt-d devices are recalled because they are not approved for use in the us.
  • Action
    BIOTRONIK sent the Important Product Information letter and the Acknowledgement of Important Product Information Form, dated June 20, 2015, to affected physicians with the following recommendations: -Review programming settings for your patients with CRT-P or CRT-D devices. -If you have a patient with a device programmed to Ventricular pacing: LV, arrange to have the patients device reprogrammed to an appropriate approved mode (i.e. "Ventricular pacing: RV" or "Ventricular pacing: BiV"). -Physicians are requested to sign the Acknowledgement of Important Product Information Form and immediately fax to 800-913-6993 or email to UScompliance@biotronik.com. BIOTRONIK'S representative will update your programmer with approved 1502.U programmer software. Following this update, the Ventricular pacing: LV feature will no longer be available. However, a device previously programmed with "Ventricular pacing: LV will remain programmed in this mode unless and until the pacing mode setting is changed. If you have any questions concerning this Important Product Information, please contact the BIOTRONIK Technical Services Department: Telephone: 1-(800) 284-6689 (24-hour service)

Device

Device Recall Renamic and ICS 3000
  • Modèle / numéro de série
    Affected Product Part Numbers: 394229, 400335, 403222, 406797, 408849
  • Classe de dispositif
    Not Classified
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide Distribution.
  • Description du dispositif
    PSW 1203.U/1, PSW 1301.U, PSW 1307.U, PSW 1403.U, and PSW 1501.U Pacemaker Programmer software. Software approved for use with BIOTRONIK device programmers (trade names: Renamic and ICS 3000). || Allows physicians to program devices to pace exclusively in the left ventricle.
  • Manufacturer
    BIOTRONIK, Inc.

Manufacturer

BIOTRONIK, Inc.
  • Adresse du fabricant
    BIOTRONIK, Inc., 6024 Jean Rd, Lake Oswego OR 97035-5571
  • Société-mère du fabricant (2017)
    Micro Systems International Ag
  • 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