BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EPIC PLUS HF CRT-D

    MDR report key: 4240694 · Received November 10, 2014

    Report

    Report Number
    2938836-2014-17742
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 31, 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 Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS NOT CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE WITHIN THE EXPECTED LIMITS. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT AND NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO PREMATURE BATTERY DEPLETION. THE PATIENTS CONDITION IS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723509 EPIC PLUS HF CRT-D IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC., CRMD V-350 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention