BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PARADYM

    MDR report key: 9326714 · Received November 15, 2019

    Report

    Report Number
    1000165971-2019-00634
    Event Type
    Malfunction
    Date Received
    November 15, 2019
    Date of Event
    October 30, 2019
    Report Date
    January 23, 2020
    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
    GM
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE REFER TO THE ATTACHED ANALYSIS REPORT.

    Description of Event or Problem · 0

    REPORTEDLY, DURING A FOLLOW-UP, MUTIPLE WARNING MESSAGES WERE DISPLAYED, STATING RESPECTIVELY THAT A DEVICE RESET OCCURED ON (B)(6 2019, THE DEVICE WAS OPERATING IN NOMINAL MODE AND THE ATP THERAPIES WERE DEACTIVATED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A CT ON (B)(6) 2019. 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, DURING A FOLLOW-UP, MULTIPLE WARNING MESSAGES WERE DISPLAYED, STATING RESPECTIVELY THAT A DEVICE RESET OCCURED ON (B)(6) 2019, THE DEVICE WAS OPERATING IN NOMINAL MODE AND THE ATP THERAPIES WERE DEACTIVATED. IT WAS REPORTED THAT THE PATIENT UNDERWENT ACT ON (B)(6) 2019. 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
    1120203 PARADYM DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER MRM SORIN GROUP ITALIA S.R.L. - CRM FACILITY PARADYM DR 8550 2454

    Patients

    Seq Age Sex Outcome Treatment
    1