BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY DR

    MDR report key: 3210524 · Received July 8, 2013

    Report

    Report Number
    2938836-2013-03379
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 23, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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 FOR A FOLLOW UP. REVIEW OF STORED EGMS NOTED VT THAT APPEARED TO BE SVT WAS OBSERVED. THE PATIENT RECEIVED ATP THERAPY THAT DID NOT BREAK THE RHYTHM. PROGRAMMING CHANGES WERE PERFORMED. DEVICE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309956 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention