BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURATA STS OPTIM ACTIVE FIXATION LEAD

    MDR report key: 1073145 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02387
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 22, 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
    TN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED A TIP STIFFNESS TEST INDICATED NORMAL DEVICE CHARACTERSTICS. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. AS RECEIVED, THE HELIX WOULD NOT EXTEND DUE TO DRIED BLOOD AND OVERTORQUED DISTAL COIL. THE HELIX EXTENSION LENGTH WAS WITHIN PRODUCT SPECIFICATIONS. MULTIPLE CUTS AND BENDS WERE NOTED ON THE LEAD. THE DAMAGES FOUND ARECONSISTENT WITH THAT OCCURRING AT THE TIME OF EXPLANT.

    Description of Event or Problem · 1

    A PERFORATION WAS REPORTED. LOSS OF CAPTURE, LOW R-WAVES AND DECREASED IMPEDANCE WAS ALSO NOTED. THE PATIENT COMPLAINED OF CHEST PAIN. THE LEAD ADVANCED FROM THE ORIGINAL IMPLANT SITE. THE LEAD WAS REPLACED WHEN AN ATTEMPT TO REPOSITION WAS UNSUCCESSFUL.

    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