BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 2984254 · Received February 28, 2013

    Report

    Report Number
    2938836-2013-00421
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    December 4, 2012
    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 Location
    NV
    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

    EXTERNAL INSULATION ABRASION WAS FOUND AT 25.4-26.2CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE SILICONE INSULATION AT THIS LOCATION REMAINED INTACT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO A SUSPECTED LEAD MALFUNCTION. AN ELECTRICAL RESET WAS OBSERVED ON THE COMPETITOR'S DEVICE. IT WAS NOTED THAT THERAPY WAS NOT DELIVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86804 DURATA STS OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD NVY ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7120/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR