BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 3914555 · Received July 3, 2014

    Report

    Report Number
    2938836-2014-13100
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 4, 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 Location
    SE
    Reporter Occupation
    NURSE

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT PRESENTED TO THE CLINIC AFTER RECEIVING A PATIENT NOTIFICATION ALERT. A SUDDEN DROP IN BATTERY VOLTAGE WAS NOTED. THE DEVICE WAS EXPLANTED AND REPLACED DUE TO SUSPECTED PREMATURE BATTERY DEPLETION. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390386 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention