BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION

    MDR report key: 3080117 · Received April 26, 2013

    Report

    Report Number
    2938836-2013-00959
    Event Type
    Injury
    Date Received
    April 26, 2013
    Date of Event
    February 22, 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

    EXTERNAL INSULATION ABRASION WAS NOTED AT 21.6-21.7CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNAL INSULATION ABRASION WAS NOTED AT 29.4-29.8CM FROM THE CONNECTOR PIN, CONSISTENT WITH THE LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF HEART. THE SILICON INSULATION WAS INTACT AT THESE LOCATIONS.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH SHOCK IMPEDANCE WERE OBSERVED FOR VECTORS INCLUDING THE CAN. INSULATION ANOMALY ON PROXIMAL PART OF THE LEAD WAS NOTED. THE LEAD WAS EXPLANTED AND REPLACED. ANALYSIS OF THE ASSOCIATED ICD IDENTIFIED THAT THE IMPEDANCE ANOMALY WAS DUE TO A BROKEN CAN WIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180750 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 Required Intervention (B)(4)