BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3220337 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04420
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    May 2, 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 WAS UNDERGOING A TONSILLECTOMY, AND A MAGNET WAS PLACED OVER THE PATIENTS ICD. DURING THE PROCEDURE, THE CAUTERY WAS OVERSENSED AND THE MAGNET REVERSION WAS INTERMITTENT WHICH LED TO INAPPROPRIATE DETECTION AND THERAPY. THE STORED EGM CONFIRMED THE INAPPROPRIATE TACHY DETECTION WAS CAUSED BY EMI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319729 FORTIFY VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention