BEUDAMED
    FDA Recall Terminated

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    Recall: Z-2824-2018 · Initiated July 9, 2018

    Recall

    Recall Number
    Z-2824-2018
    Event Number
    80636
    Firm
    Sorin CRM SAS Cvk 4, avenue Reaumur Clamart Cedex France
    FEI Number
    3008159616
    Product Code
    NIK
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    July 9, 2018
    Terminated
    September 6, 2024

    Description

    Sorin Platinium CRT-D 1711 DF-1, Sterile EO. Implantable Cardiac Defibrillator and Resynchronization Therapy Defibrillator

    Reason

    Hardware configuration may lead to overconsumption, followed by loss of pacing and sensing capabilities. The device then cannot identify an arrhythmia that would require defibrillation shock therapy.

    Action

    On 07/09/2018, Urgent Field Safety Notices were mailed via certified postal service to physicians informing them about the removal of the non implanted Platinium devices that may present with this hardware failure and providing recommendations for managing implanted patients, which includes patient follow-up one month after discharge, and then every three months until the device nears the replacement date. Follow-up should include checking for battery status and system warnings. The firm recommends that patients be enrolled in remote monitoring. Physicians were instructed to fill out Customer Reply forms and ensure that all personnel involved in the management of patients implanted with affected devices are aware of the information outlined in the notice. For further assistance the firm provided 877-663-7674.

    Distribution

    US distribution to: NJ, AZ, MS, OK, LA, PA, FL, MI, IL, and MS

    Quantity

    16