BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 4130819 · Received September 30, 2014

    Report

    Report Number
    2938836-2014-16198
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Date of Event
    August 22, 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
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN CLINIC AFTER RECEIVING A VIBRATORY ALERT FOR HIGH, OUT OF RANGE, PACING LEAD IMPEDANCE. IN-CLINIC TESTING YIELDED NORMAL IMPEDANCE MEASUREMENTS. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608493 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST. JUDE MEDICAL, INC., CRMD 7120/60 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR