BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3220010 · Received July 11, 2013

    Report

    Report Number
    2938836-2013-04292
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    May 20, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HIGH, OUT OF RANGE, HV LEAD IMPEDANCE ALERT WAS RECEIVED VIA MERLIN.NET. ISOMETRICS AND DFT TESTING WERE RECOMMENDED. THE PATIENT WILL BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321089 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/52 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR