BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6057994 · Received October 26, 2016

    Report

    Report Number
    2938836-2016-13277
    Event Type
    Death
    Date Received
    October 26, 2016
    Date of Event
    September 28, 2016
    Report Date
    September 30, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT EXPIRED. THE PATIENT WAS NOT FEELING WELL AND WAS IN COLD SWEATS, EMS WAS CALLED AND PATIENT WAS TAKEN TO ER WHERE HE HAD SHORTNESS OF BREATH AND WAS INTUBATED. CARDIAC ARREST WITH PULSELESS ELECTRICAL ACTIVITY (PEA) WAS NOTED, HE WAS THEN GIVEN CPR WITH ACLS. HE CODED TWICE AND AFTER 26 MINUTES INTO THE CODE, EFFORT WAS TERMINATED AND HE WAS PRONOUNCED DEAD. THERE IS NO KNOWN ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT SUGGESTS THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH WAS UNKNOWN. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED NOTES THAT THE CAUSE OF DEATH WAS UNRELATED TO THE DEVICE OR ITS SETTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710309 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120Q/65 3228933

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death 2088TC/52,CAU250139| CD3365-40Q,7254603