BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 7057629 · Received November 24, 2017

    Report

    Report Number
    1000165971-2017-00874
    Event Type
    Malfunction
    Date Received
    November 24, 2017
    Date of Event
    October 27, 2017
    Report Date
    October 28, 2017
    Manufacturer
    SORIN GROUP ITALIA S.R.L. - CRM FACILITY
    Product Code
    MRM
    PMA / PMN Number
    P980049
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT ICD WAS FOUND PROGRAMMED IN NOMINAL MODE DURING A SCHEDULED FOLLOW-UP ON 27 OCTOBER 2017. THE FOLLOWING WARNING WAS DISPLAYED ON THE PROGRAMMER SCREEN: "THE DEVICE WAS REINITIALIZED 1 TIME SINCE THE BEGINNING OF LIFE. LAST RESET DATE (B)(6) 2017 7:16". PRELIMINARY ANALYSIS RESULTS SHOWED THAT THE DEVICE RESET WAS CAUSED BY A CORRUPTION IN DEVICE MEMORY, MOST LIKELY DUE TO A SINGLE EVENT UPSET (SEU). NORMAL DEVICE OPERATION HAS BEEN RESTORED.

    Description of Event or Problem · 1

    REPORTEDLY, THE SUBJECT ICD WAS FOUND PROGRAMMED IN NOMINAL MODE DURING A SCHEDULED FOLLOW-UP ON (B)(6) 2017. THE FOLLOWING WARNING WAS DISPLAYED ON THE PROGRAMMER SCREEN: "THE DEVICE WAS REINITIALIZED 1 TIME SINCE THE BEGINNING OF LIFE. LAST RESET DATE (B)(6) 2017, 7:16". PRELIMINARY ANALYSIS RESULTS SHOWED THAT THE DEVICE RESET WAS CAUSED BY A CORRUPTION IN DEVICE MEMORY, MOST LIKELY DUE TO A SINGLE EVENT UPSET (SEU). NORMAL DEVICE OPERATION HAS BEEN RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    836555 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2736

    Patients

    Seq Age Sex Outcome Treatment
    1