BEUDAMED
    FDA Enforcement Class II Terminated

    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, 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).

    Recall: Z-3231-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3231-2017
    Event ID
    77983
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Sorin Group Italia SRL - CRF
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2017
    Initiation Date
    July 24, 2017
    Classification Date
    September 27, 2017
    Termination Date
    January 29, 2024
    Address
    Via Crescentino, N/A, Saluggia, VC, N/A, N/A, Italy

    Description

    Platinium VR DF4 1240, Model Number TDF035U, UDI/GTIN 08031527015460, 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).

    Reason

    There is a possibility of overconsumption of certain PLATINIUM Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) following an ElectroStatic Discharge (ESD) during the implant surgery or a Magnetic Resonance Imaging (MRI) scan, and what actions to take.

    Code Info

    All Serial Numbers

    Distribution

    US Nationwide Distribution

    Quantity

    72 units