BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 4220992 · Received November 3, 2014

    Report

    Report Number
    2938836-2014-17435
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 3, 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
    NURSE

    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 INABILITY TO COMMUNICATE WAS CONFIRMED IN THE LABORATORY AND WAS DUE TO LOW BATTERY VOLTAGE. 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 MULTIPLE ATTEMPTS TO INTERROGATE THE DEVICE WERE UNSUCCESSFUL. THE PATIENT RECEIVED A VIBRATORY ALERT ONE MONTH PREVIOUS BUT DID NOT CONTACT THE CLINIC. THE DEVICE WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    702583 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