BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORTIFY VR

    MDR report key: 2242934 · Received September 11, 2011

    Report

    Report Number
    2017865-2011-06534
    Event Type
    Injury
    Date Received
    September 11, 2011
    Date of Event
    July 15, 2011
    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
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED HIGH IMPEDANCE MEASUREMENTS AND DEVICE HEADER ISSUE WERE NOT CONFIRMED IN THE LABORATORY. ALL IMPEDANCE MEASUREMENTS WERE NORMAL. THE DEVICE WAS TESTED ON THE BENCH WITH TEST LEADS PROPERLY CONNECTED TO THE HEADER. THE DEVICE WAS INTERROGATED AND NORMAL COMMUNICATION WAS SUCCESSFULLY ESTABLISHED. IT IS BELIEVED THAT THE CONNECTION ISSUE RESULTED FROM THE LEAD NOT BEING FULLY INSERTED INTO THE CONNECTOR OR THE SETSCREW NOT BEING FULLY TIGHTENED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE MEASUREMENTS WERE OBSERVED IN THE RV PACING CONFIGURATION. NOISE WAS OBSERVED. NOISE WAS REPRODUCIBLE WITH POCKET MANIPULATION. DEVICE HEADER AND LEAD ISSUE WERE SUSPECTED. THE DEVICE WAS EXPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention (B)(4)