Events

Rappel de Device Recall Platinium DR DF4 1540

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 Sorin Group Italia SRL - CRF.

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
    77983
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-3232-2017
  • Date de mise en oeuvre de l'événement
    2017-07-24
  • Date de publication de l'événement
    2017-09-28
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158443
  • 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
    Defibrillator, implantable, dual-chamber - Product Code MRM
  • Cause
    There is a possibility of overconsumption of certain platinium implantable cardiac defibrillators (icds) and cardiac resynchronizationtherapy defibrillators (crt-ds) following an electrostatic discharge (esd) during the implant surgery or a magnetic resonance imaging (mri) scan, and what actions to take.
  • Action
    LivaNova issued a communication to physicians treating patients implanted with the products in scope in the form of a customer letter beginning July 24, 2017. The letter instructs users to do the following: 1. In order to mitigate the potential risks associated with both triggering events (ESD at implant or MRI scan), LivaNova recommends physicians follow the patients at the periodicity already stated in the implant manual, especially: " Before the patient is discharged and at each subsequent follow-up, it is advisable to check the battery status and the occurrence of system warnings; " It is recommended that a routine follow-up examination be done one month after discharge, and then every three months until the device nears the replacement date.

Device

Device Recall Platinium DR DF4 1540
  • Modèle / numéro de série
    All Serial Numbers
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    US Nationwide Distribution
  • Description du dispositif
    Platinium DR DF4 1540, Model Number TDF036U, UDI/GTIN 08031527015477, Implantable cardioverter defibrillator, || Biventricular or ventricular antitachycardia pacing, || Dual or single chamber arrhythmia detection || Product Usage: || PLATINIUM VR is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: - Survival of at least one episode of cardiac arrest (manifested by the loss of consciousness) due to ventricular tachyarrhythmia, - Recurrent, poorly tolerated sustained ventricular tachycardia (VT).
  • Manufacturer
    Sorin Group Italia SRL - CRF

Manufacturer

Sorin Group Italia SRL - CRF
  • Adresse du fabricant
    Sorin Group Italia SRL - CRF, Via Crescentino, Saluggia, VC Italy
  • Société-mère du fabricant (2017)
    LivaNova PLC
  • Source
    USFDA