BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073089 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02336
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 28, 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 Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD TIP STIFFNESS WAS FOUND TO BE WITHIN SPECIFICATION DURING TESTING. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. DRIED BODY FLUID/TISSUE INSIDE THE HEADER AND INNER INSULATION PREVENTED HELIX EXTENSION. AFTER CLEANING AND SECTIONING, NORMAL HELIX MECHANISM WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD PERFORATED THE RIGHT VENTRICULAR APEX. THE PATIENT DEVELOPED MODERATE PERICARDIAL EFFUSION. THE LEAD WAS REPLACED.

    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 7122/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention