BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6044863 · Received October 20, 2016

    Report

    Report Number
    2938836-2016-12972
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    April 15, 2016
    Report Date
    September 27, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT'S DAUGHTER THAT THE PATIENT EXPIRED. THE CAUSE OF DEATH WAS UNKNOWN. THERE IS NO KNOWN ALLEGATION FROM A HEALTH PROFESSIONAL THAT SUGGESTS THE DEATH WAS RELATED TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694369 DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7170Q/58 3066463

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death (B)(4)