BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 3/4 PERCUTANEOUS LEADS

    MDR report key: 1871006 · Received October 8, 2010

    Report

    Report Number
    1627487-2010-02777
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 14, 2010
    Report Date
    September 14, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION 3 OF 3 (MIGRATED LEAD). PLEASE SEE MFR REPORT# 1627487-2010-02757 FOR EVALUATION OF DEVICE 1 AND MFR REPORT# 1627487-2010-02776 FOR EVAL OF DEVICE 2. METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. 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

    DEVICE 3 OF 3 (MIGRATED LEAD). PLEASE SEE MFR REPORT #1627487-2010-02757 FOR DEVICE 1 AND MFR REPORT #1627487-2010-02776 FOR DEVICE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 3/4 PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 84417

    Patients

    Seq Age Sex Outcome Treatment
    1 Other