BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 3230607 · Received July 16, 2013

    Report

    Report Number
    2938836-2013-04703
    Event Type
    Death
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    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 OUT OF RANGE HV LEAD IMPEDANCE AND LOSS OF CAPTURE WERE OBSERVED. DURING THE EXTRACTION PROCEDURE, THE PHYSICIAN NOTED THAT THE LEAD WAS ADHERED ONTO THE MYOCARDIUM AND UPON REMOVAL OF THE LEAD, CARDIAC TAMPONADE WAS OBSERVED. PERICARDIOCENTESIS WAS PERFORMED AND PATIENT REMAINED STABLE THROUGHOUT THE PROCEDURE. THE PATIENT LATER EXPIRED WHILE IN THE RECOVERY ROOM DUE TO COMPLICATIONS FROM EXTRACTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330020 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7170Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| R