BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR

    MDR report key: 2984492 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00451
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 30, 2013
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    NVY
    PMA / PMN Number
    P950022
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH HVLI AND NOISE WERE NOTED. WITH THE SVC VECTOR PROGRAMMED OFF, SHOCK IMPEDANCE WAS IN-RANGE. AT TIME OF EXPLANT, A LITTLE AIR BUBBLE WAS NOTED UNDER THE INSULATION BETWEEN THE RV AND SVC COILS. THE LEAD WAS REPLACED. THE PATIENT IS IN GOOD CONDITION AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88574 DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120Q/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR