BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, DF-4 CONNECTOR

    MDR report key: 2210928 · Received August 12, 2011

    Report

    Report Number
    2017865-2011-05341
    Event Type
    Death
    Date Received
    August 12, 2011
    Date of Event
    June 26, 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
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND AUTOMATED TEST SYSTEM. ALL DEVICE FUNCTIONS WERE NORMAL.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. NO KNOWN CAUSE WAS REPORTED OR DEVICE ISSUES. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORTIFY DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death 7121Q/58 (B)(4), 4076 (B)(4)