Events

Rappel de Tachos

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
    28982
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0942-04
  • Date de mise en oeuvre de l'événement
    2004-04-29
  • Date de publication de l'événement
    2004-07-20
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2006-04-21
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32911
  • 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 Cardioverter Defibrillator (Non-Crt) - Product Code LWS
  • Cause
    Potential for device to not deliver full amount of energy.
  • Action
    On 4/29/04 the firm issued 'Dear Doctor' letters to the physicians. The letter instructs the physician to schedule an immediate follow-up with all affected patients to determine if their devices are being impacted by the passivation buildup and to determine if device replacement is indicated.

Device

Tachos
  • Modèle / numéro de série
    Model Number 122 499 Serial numbers: 78012522, 78012524, 78012525, 78012548, 78012675, 78012677, 78012681, 78012683, 78012707, 78012709 ¿ 78012712, 78012714, 78012715, 78012718, 78012719, 78012763, 78012767, 78012768, 78012771, 78012791, 78012792, 78012794, 78012804, 78012809, 78012815 ¿ 78012820, 78012968, 78012987 ¿ 78012989, 78013072 ¿ 78013076, 78013092 ¿ 78013094, 78013099, 78013100, 78013165 ¿ 78013185, 78013194, 78013198, 78013200 ¿ 78013204, 78013206, 78013207, 78013210, 78013217 ¿ 78013220, 78013222, 78013224 ¿ 78013227, 78013230 ¿ 78013256, 78013258 ¿ 78013262, 78013278, 78013282, 78013284, 78013285, 78013292, 78013297, 78013299, 78013315, 78013317, 78013321
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Devices were distributed to physicians and medical centers throughout the U.S. The firm does not distribute internationally.
  • Description du dispositif
    Tachos DR - Atrial Tx
  • 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