BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR, DF4 CONNECTOR

    MDR report key: 3080219 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00996
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    December 30, 2012
    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 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 INAPPROPRIATE THERAPY WAS OBSERVED DUE TO SVT. THE DEVICE WAS REPROGRAMMED SUCCESSFULLY AND REMAINS IMPLANTED. THE PATIENT CONDITION WAS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180864 FORTIFY VR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD1233-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention