BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 4091512 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04801
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 12, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE DEVICE ATTEMPTED TO INDUCE THE PT WITH DC FIBBER SEVERAL TIMES AND WAS UNSUCCESSFUL. CONFIGURATIONS WERE ALTERED AND THE DEVICE SUCCESSFULLY RESCUED THE PT. THE DEVICE REMAINS IMPLANTED AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22504 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR