BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3090197 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01191
    Event Type
    Malfunction
    Date Received
    May 2, 2013
    Date of Event
    February 15, 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
    PA
    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

    NEW INFORMATION RECEIVED NOTED THAT (B)(4) TRANSMISSION SHOWED LITTLE INFORMATION ON THE CORVUE TREND. IT WAS UNDETERMINED WHY SOME DATA WAS MISSING ON THE TREND. THE PATIENT WILL CONTINUE TO BE FOLLOWED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A NONSUSTAINED LEAD NOISE EVENT WAS TRANSMITTED FROM MERLIN.NET. INTERMITTENT UNDERSENSING WAS OBSERVED. REPROGRAMMING THE DEVICE WAS RECOMMENDED TO CHANGE THE SENSE/PACE VECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191343 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR