BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 2973358 · Received February 21, 2013

    Report

    Report Number
    2938836-2013-00180
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    December 23, 2012
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT, THE DEVICE WAS FOUND TO BE IN BACKUP VVI RESET MODE. NOISE WAS OBSERVED VIA REVIEW OF THE STORED ELECTROGRAMS. THE DEVICE WAS TESTED MANUALLY ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND WAS FOUND TO BE NORMAL. THE ROOT CAUSE OF THE OBSERVATION FROM THE FIELD OF NOISE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IN BVVI MODE. THE PATIENT RECEIVED SEVERAL SHOCKS THE NIGHT BEFORE. REVIEW OF PRINTOUTS SHOWED THE DEVICE EXPERIENCED A POWER ON RESET. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76836 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 3207-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR