BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIFY ASSURA CRT-D

    MDR report key: 3854641 · Received June 6, 2014

    Report

    Report Number
    2938836-2014-11522
    Event Type
    Malfunction
    Date Received
    June 6, 2014
    Date of Event
    March 4, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKUP VVI WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO A POWER-ON RESET. THE DEVICE WAS TESTED IN THE TEMPERATURE CHAMBER AND LOST ABILITY TO COMMUNICATE VIA TELEMETRY. THE ROOT CAUSE OF THE BACKUP VVI WAS DUE TO A CONNECTION ANOMALY WITH THE CONNECTOR. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT UPON INTERROGATION OF THE DEVICE WAS FOUND TO BE IN BACKUP VVI MODE. THE DEVICE HAD BEEN LEFT IN A CAR AND WAS POSSIBLE THAT THE DEVICE WAS EXPOSED TO COLD TEMPERATURES. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332382 UNIFY ASSURA CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1