BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY ASSURA VR, DF4 CONNECTOR

    MDR report key: 3090211 · Received May 2, 2013

    Report

    Report Number
    2938836-2013-01168
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    November 19, 2012
    Report Date
    December 26, 2012
    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
    MI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, AND MANDATORY MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED DUE TO HIGH DEFIBRILLATION THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192614 FORTIFY ASSURA VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1257-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Required Intervention