BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 3791111 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10423
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    February 25, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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. WITH AN EXTERNAL POWER SUPPLY ATTACHED, THE DEVICE FUNCTIONED NORMALLY. NO HIGH CURRENT WAS DETECTED DURING TESTING AND THE POWER CONSUMPTION WAS NORMAL. 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 PATIENT PRESENTED IN THE ER WITH COMPLAINTS OF DIZZINESS UNRELATED TO THE DEVICE. WHEN THE DEVICE WAS INTERROGATED, A SUDDEN DROP IN BATTERY VOLTAGE WITH NO RECENT SOURCES OF BATTERY DRAIN WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED. THE PATIENT WAS DOING FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268809 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention