BEUDAMED
    FDA Adverse Event Death Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 3080253 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-01002
    Event Type
    Death
    Date Received
    April 26, 2013
    Date of Event
    March 21, 2013
    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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS TESTED ON THE BENCH AND USING AUTOMATED TEST EQUIPMENT AND MET ALL TEST SPECIFICATIONS. NO ANOMALIES WERE FOUND.

    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 HAD A CARDIAC ARREST AND WAS TRANSPORTED TO AN UNKNOWN HOSPITAL WHERE SHE WAS PRONOUNCED DEAD. IT WAS SUSPECTED THAT THE PATIENT DIDN'T RECEIVE THERAPY. REVIEW OF THE DIAGNOSTICS AND EPISODES DOES NOT APPEAR THE DEVICE MALFUNCTIONED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183033 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death