BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6135035 · Received November 30, 2016

    Report

    Report Number
    2938836-2016-14785
    Event Type
    Death
    Date Received
    November 30, 2016
    Date of Event
    August 14, 2016
    Report Date
    October 20, 2021
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LEAD WAS RETURNED FOR EVALUATION AFTER THE PATIENT WAS REPORTED TO HAVE DECEASED. VISUAL INSPECTION DID NOT FIND ANY ANOMALIES ON THE LEAD EXCEPT FOR DAMAGES CONSISTENT WITH THOSE OCCURRING AT THE TIME OF THE PROCEDURE. ELECTRICAL TESTING DID NOT FIND ANY INDICATION OF CONDUCTOR FRACTURES OR INTERNAL SHORTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785158 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120Q/58 3159445

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death 1888TC/52, BCG43389.| CD2231-40Q, 597887.| 1888TC/52, BCG43389| CD2231-40Q, 597887