BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 3903744 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12832
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    May 19, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    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

    DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED PREMATURE BATTERY DEPLETION WAS CONFIRMED IN THE LABORATORY. BASED ON ALL AVAILABLE PARAMETER AND USAGE INFORMATION, DEVICE LONGEVITY WAS FOUND TO BE BELOW THE EXPECTED LIMITS. DEVICE LEVEL TESTING WITH AN EXTERNAL POWER SUPPLY INDICATED NORMAL ELECTRICAL PERFORMANCE. THE ORIGINAL BATTERY WAS RETURNED TO THE VENDOR FOR FURTHER EVALUATION AND ANALYSIS COULD NOT CONCLUSIVELY DETERMINE A ROOT CAUSE FOR THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED ERI PREMATURELY. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT CONDITION WAS GOOD BEFORE AND AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380864 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention