BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 6010944 · Received October 7, 2016

    Report

    Report Number
    2938836-2016-11809
    Event Type
    Death
    Date Received
    October 7, 2016
    Date of Event
    November 26, 2015
    Report Date
    September 16, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT DISAPPEARED WHILE WALKING AT THE RIVER SIDE AND HE WAS FOUND IN THE RIVER FOUR WEEKS LATER. IT WAS SUSPECTED THAT THE PATIENT HAD VF EPISODE AND PROBABLY FELL INTO THE RIVER. REVIEW OF PROVIDED SESSION RECORD REVEALED, 10 VF, 1 VT-1, 14 AMS AND 40 NON-SUSTAINED RV OVERSENSING EPISODES SINCE THE PREVIOUS FOLLOW-UP, HOWEVER EGMS ARE AVAILABLE FOR THREE VF AND ONE VT-1 EPISODES. THE PATIENT HAD VT/VF EPISODES, POTENTIALLY AN ELECTRIC STORM. SINCE MANY OF THE VF EPISODES WITH SHOCK DELIVERY ARE OVERWRITTEN, CAN'T SEE IF THE DELIVERED SHOCKS WERE EFFECTIVE OR NOT. THE DEVICE SEEMS TO BEHAVE ACCORDING TO PROGRAMMED SETTINGS AND DESIGN OF ALGORITHMS. NO MALFUNCTION OF THE DEVICE IS SUSPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661877 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7122Q/65 4241732

    Patients

    Seq Age Sex Outcome Treatment
    1 Death 1458Q/86, (B)(4)| 2088TC/52, (B)(4)| CD3371-40Q, 1084842