BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIATA ST OPTIM ACTIVE FIXATION

    MDR report key: 1073538 · Received July 11, 2008

    Report

    Report Number
    2017865-2008-02432
    Event Type
    Injury
    Date Received
    July 11, 2008
    Date of Event
    April 4, 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
    AL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO MEDWATCH FORM WAS RECEIVED. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. BLOOD IN THE HELIX CAUSED INABILITY TO EXTEND THE HELIX. THE DISTAL COIL WIRES WERE TWISTED AS A RESULT OF OVERTORQUE NEAR THE CONNECTOR PIN. AFTER CLEANING, THE HELIX COULD BE EXTENDED AND RETRACTED FROM A SHORT LENGTH OF THE LEAD. NO DEFECTS IN MATERIALS OR WORKMANSHIP WERE NOTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS DISLODGED. THE LEAD WAS REMOVED WHEN AN ATTEMPT TO REPOSITION WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIATA ST OPTIM ACTIVE FIXATION DEFIBRILLATION LEAD LWS ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION 7020/65 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention