BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3210614 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03355
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 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
    FL
    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 VIA (B)(4) TRANSMISSION IT WAS REVEALED THE PATIENT RECEIVED INAPPROPRIATE THERAPY. IT WAS SUSPECTED THAT DUE TO PROGRAMMING, THE DEVICE WAS INCORRECTLY DIAGNOSING SVT EPISODES. PROGRAMMING CHANGES WERE RECOMMENDED FOR THE PATIENTS NEXT FOLLOW UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311690 FORTIFY VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention