BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 4130737 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16156
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    July 15, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION: THE REPORTED FIELD EVENT OF BACKUP VVI WAS CONFIRMED IN THE LABORATORY VIA REVIEW OF THE DEVICE IMAGE AND WAS DUE TO A POWER-ON RESET. THE RESET COULD NOT BE REPRODUCED DURING TESTING. THE CAUSE OF THE POWER-ON RESET COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS FOUND TO BE IN BACKUP VVI UPON INTERROGATION. DEVICE WAS EXPLANTED AFTER PATIENT EXPIRED. PHYSICIAN DID NOT ALLEGE THAT THE DEVICE WAS THE CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    607320 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR