BEUDAMED
    FDA Adverse Event Death Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 5081524 · Received September 16, 2015

    Report

    Report Number
    2938836-2015-29588
    Event Type
    Death
    Date Received
    September 16, 2015
    Date of Event
    August 25, 2015
    Report Date
    August 26, 2015
    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
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE ER AND WAS PRONOUNCED DEAD ON ARRIVAL. UPON INTERROGATION OF THE DEVICE SEVERAL EPISODES OF VT, VF AND VENTRICULAR LEAD NOISE WERE OBSERVED. LAB TESTING WAS PERFORMED AND IT WAS DETERMINED THAT THE PATIENT WAS HYPERKALEMIC. UPON POST-MORTEM DEVICE INTERROGATION OF ADDITIONAL EGMS, NON-SUSTAINED VENTRICULAR OVERSENSING, SINGLE QRS COMPLEXES OF VARYING AMPLITUDES, AND SUBSEQUENT NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WERE OBSERVED. INHIBITED THERAPY DUE TO VENTRICULAR LEAD NOISE WAS NOTED. DIAGNOSTICS OF VF EPISODE INDICATED DELIVERY OF 36J DEFIBRILLATION THERAPY, A SUBSEQUENT ACCELERATION OF VENTRICULAR RATE, DEGRADATION OF SIGNAL AMPLITUDE, AND ADDITIONAL DELIVERY OF HV THERAPIES WAS NOT ABLE TO CONVERT THE RHYTHM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613298 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) 7120Q/65 A000004013

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death CD1357-40Q, 7203975