BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3220136 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04468
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 24, 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
    CA
    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 THE PATIENT PRESENTED TO CLINIC AFTER RECEIVING A PATIENT NOTIFICATION FOR A NON-SUSTAINED LEAD NOISE EPISODE. NO LEAD NOISE WAS OBSERVED ON THE STORED EGM. A WIDE QRS COMPLEX IS BELIEVED TO HAVE BEEN THE CAUSE. THE DEVICE WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320897 FORTIFY ASSURA DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR