BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERCUTANEOUS TRIAL LEAD

    MDR report key: 1822468 · Received August 26, 2010

    Report

    Report Number
    1627487-2010-02458
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 30, 2010
    Report Date
    July 30, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    ON (B)(6)2010, THE PT WAS IMPLANTED WITH AN SCS TRIAL LEAD. TWO DAYS LATER THE MULTI TRAIL STIMULATOR'S (MTS) BATTERY WAS DEPLETED. THE PT BECAME FRUSTRATED, AND TRIED TO PULL THE TRIAL LEAD OUT. THE LEAD SUBSEQUENTLY FRACTURED INTO 2 PIECES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS TRIAL LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3086 3095341

    Patients

    Seq Age Sex Outcome Treatment
    1 Other