BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3220131 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04465
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 2, 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 Location
    TX
    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 NON SUSTAINED LEAD NOISE EPISODES WERE OBSERVED DUE TO INTERMITTENT UNDERSENSING. NO LEAD NOISE WAS SEEN ON THE STORED EGM. REPROGRAMMING OF THE DEVICE WAS RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321002 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR