BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR

    MDR report key: 3080155 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01008
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    March 6, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    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 DURING ROUTINE FOLLOW UP, SEVERAL PMT EPISODES WERE OBSERVED. UNDERSENSING WAS NOTED. REPROGRAM- MING WAS PERFORMED TO INCREASE VENTRICULAR SENSITIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182592 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 Required Intervention