BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE PLUS CRT-D

    MDR report key: 1954745 · Received January 10, 2011

    Report

    Report Number
    2017865-2011-00505
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 22, 2010
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE REPORTED BACKUP VVI MODE WAS VERIFIED. UPON INTERROGATION, THE DEVICE'S DATA SHOWED THAT A POWER-ON- RESET (POR) OCCURRED ON THE DAY OF THE LEAD REVISION. THE POR IS BELIEVED TO HAVE BEEN CAUSED BY THE EXTERNAL DEFIBRILLATION THAT WAS APPLIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEAD REVISION, AFTER TESTING AND EXTERNAL DEFIBRILLATION, THE DEVICE WAS FOUND IN BACKUP VVI MODE WITH NO DEFIB THERAPY AVAILABLE. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMOTE PLUS CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD3211-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention