BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    MDR report key: 3101111 · Received May 9, 2013

    Report

    Report Number
    2938836-2013-01895
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    March 28, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT WHEN ADVANCING AND PULLING BACK THE LEAD THROUGH THE INTRODUCER, RESISTANCE WAS FELT BY PHYSICIAN. VISUAL INSPECTION NOTED POSSIBLE DAMAGE INDUCED BY INTRODUCER. THIS LEAD WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203359 DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7122Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1