BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3090212 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01193
    Event Type
    Malfunction
    Date Received
    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 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 INTERMITTENT UNDERSENSING WAS OBSERVED. AS A RESULT, NONSUSTAINED LEAD NOISE EPISODES OCCURRED. REPROGRAMMING THE DEVICE WAS RECOMMENDED TO CHANGE THE SENSE/PACE VECTOR. THE DEVICE REMAINS IMPLANTED AND WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191368 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1