BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF-4 CONNECTOR

    MDR report key: 3901133 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12610
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    March 22, 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
    PR, 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. THE DEVICE WAS TESTED ON THE BENCH AND AN ANOMALOUS COMPONENT ON THE INTEGRATED CIRCUIT WAS FOUND TO BE THE CAUSE OF THE PREMATURE BATTERY DEPLETION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 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
    379615 FORTIFY VR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention