BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA DR, DF4 CONNECTOR

    MDR report key: 3090214 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01196
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    March 14, 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
    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 NON-SUSTAINED LEAD NOISE WAS TRIGGERED VIA (B)(4) TRANSMISSION, AND SUBSEQUENT FOLLOW-UP NOTED DEVICE DELIVERING INAPPROPRIATE ATP AND SHOCK THERAPY FOR SVT. CLINICIAN PERFORMED PROGRAMMING CHANGES, AND PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192615 FORTIFY ASSURA DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention