BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMOTE RF CRT-D

    MDR report key: 3903652 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12823
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    February 18, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NIK
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. BASED ON DEVICE SETTINGS, A LONGEVITY CALCULATION WAS PERFORMED AND WAS FOUND TO BE WITHIN EXPECTED LIMITS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PREMATURE BATTERY DEPLETION WAS OBSERVED. THE DEVICE WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381136 PROMOTE RF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD 3213-36 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention