BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3911066 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-12967
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Date of Event
    May 7, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN AN ASYMPTOMATIC PATIENT PRESENTED IN CLINIC FOR NORMAL FOLLOW-UP, HIGH, OUT OF RANGE HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED. THE SVC COIL WAS PROGRAMMED OFF. PATIENT WAS FINE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385946 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7121/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR