BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 1895794 · Received November 10, 2010

    Report

    Report Number
    2017865-2010-04545
    Event Type
    Malfunction
    Date Received
    November 10, 2010
    Date of Event
    September 25, 2010
    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
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NOISE WAS OBSERVED DURING THE HIGH VOLTAGE LEAD CHECK. SUSPECTED CONNECTION ISSUE. ALL OTHER LEAD MEASUREMENTS WERE NORMAL. ON 9/29/10 A NEW ICD WAS IMPLANTED AND THE LEADS WERE RECONNECTED. THE LEADS REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR CD3231-40Q (B)(4)