BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3080194 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00936
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 8, 2013
    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
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED FIELD EVENT OF PREMATURE BATTERY DEPLETION COULD NOT BE CONFIRMED. BASED ON PROGRAMMED SETTINGS AND USAGE DATA, A LONGEVITY CALCULATION WAS PERFORMED AND THE BATTERY WAS WITHIN THE NORMAL LONGEVITY ESTIMATIONS. DEVICE FUNCTION WAS NORMAL WHEN TESTED.

    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 THERE WAS A SHORT MARGIN BETWEEN ERI AND EOL. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180806 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 70 YR Required Intervention