BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073144 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02386
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 2, 2008
    Manufacturer
    ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
    Product Code
    LWS
    PMA / PMN Number
    PMA00001
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TIP STIFFNESS TEST WAS PERFORMED DUE TO THE REPORTED PERFORATION AND WAS FOUND TO BE WITHIN SPECIFICATION. AS RECEIVED, THE HELIX WAS IN EXTENDED POSITION AND COULD NOT BE RETRACTED DUE TO DRY BODY FLUID AND TISSUE IN THE HELIX BARREL. AFTER CLEANING, THE HELIX COULD BE ACTUATED AND WAS FOUND TO BE WITHIN MEASURED SPECIFICATION. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO DEFECTS IN MATERIALS OR WORKMANSHIP WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RV LEAD PERFORATED THE DAY OF IMPLANT. THE LEAD WAS REMOVED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention