BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ST DR

    MDR report key: 3090147 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01187
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 22, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SOFTWARE UPGRADE, AN ERROR MESSAGE WAS OBSERVED. THE DEVICE THEN WENT INTO BACKUP VVI. IT WAS FOUND THAT THE FIRMWARE UPGRADE INTERRUPTED DUE TO AN OVERHEATED PROGRAMMER. AFTER RELOADING THE DEVICE CODE AND REWRITING CHARGE HISTORY, THE DEVICE REVERTED BACK TO NORMAL FUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191219 FORTIFY ST DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2235-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 3650, 14575