BEUDAMED
    FDA Adverse Event Death Summary report: N

    RIATA ST OPTIM PASSIVE FIXATION

    MDR report key: 6115156 · Received November 18, 2016

    Report

    Report Number
    2938836-2016-14422
    Event Type
    Death
    Date Received
    November 18, 2016
    Date of Event
    October 22, 2016
    Report Date
    October 22, 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 Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE PATIENT EXPERIENCED EPISODES OF VF, WAS INTUBATED AND NOT DOING WELL. A REVIEW OF THE SESSION RECORDS SHOWED THAT THE PATIENT HAD VF EVENTS AND ALL HV THERAPIES WERE DELIVERED WHICH DID NOT CONVERT THE VF. HIGH OUT OF RANGE HV LEAD IMPEDANCE WAS NOTED. THE EPISODE DURATION WAS LISTED AS 16 MINUTES, 46 SECONDS AND FINALLY ENDED WHEN THE VF IS INTERMITTENTLY UNDERSENSED AND THE DEVICE DECLARED RETURN TO SINUS. IN ADDITION, THERE WAS A VF EVENT ON (B)(6) 2016 WHERE THE DEVICE NEEDED TO DELIVER 3 MAX OUTPUT SHOCKS TO CONVERT THE VF. UPON REVIEW OF THE EMG IT WAS DETERMINED THAT THE UNDERSENSING WAS NOT A DEVICE MALFUNCTION, BUT IT IS DUE TO THE PATIENT'S UNDERLYING CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764466 RIATA ST OPTIM PASSIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7070/65 2739879

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death