BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3210526 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03381
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 22, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    THE REPORTED BACKUP VVI WAS CONFIRMED IN LABORATORY AND WAS DUE TO TWO SOFTWARE RESETS WITHIN A SHORT PERIOD OF TIME. THE SOFTWARE RESETS WERE CAUSED BY A TRANSIENT DROP IN BATTERY VOLTAGE AS A RESULT OF EXCESSIVE CHARGING.

    Description of Event or Problem · 1

    NEW INFORMATION NOTES THAT DUE TO MULTIPLE SHOCKS RECEIVED, THE DEVICE EXHIBITED ERI CHARACTERISTICS AND WAS EXPLANTED AND REPLACED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER RECEIVING MULTIPLE SHOCKS AND WAS IN ATRIAL FIBRILLATION. THE DEVICE WAS FOUND IN BACK UP VVI MODE. A MAGNET WAS PLACED OVER THE DEVICE TO RELIEVE THE PATIENT FROM THE CONTINUAL THERAPY. THE ARRHYTHMIA WAS TREATED PHARMACEUTICALLY. A ROM DOWNLOAD SUCCESSFULLY RESTORED THE DEVICE. DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311369 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention