BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 6105733 · Received November 16, 2016

    Report

    Report Number
    2938836-2016-14193
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    October 17, 2016
    Report Date
    October 19, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 4.4CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED UNEXPECTEDLY. THE CAUSE OF DEATH WAS SUSPECTED TO BE CARDIAC ARREST, BUT IT WAS NOT CONFIRMED. THE DEVICE WAS INTERROGATED AND WAS FOUND TO BE OPERATING NORMALLY. REVIEW OF THE STORED ELECTROGRAMS APPEAR TO INDICATE AN AGONAL RHYTHM AND POSSIBLE EXTERNAL DEFIBRILLATION. 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
    757205 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122/65 2743588

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death (B)(4)| (B)(4)| (B)(4)