BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 ELECTRODE LEAD

    MDR report key: 1800744 · Received August 12, 2010

    Report

    Report Number
    1627487-2010-01463
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    July 14, 2010
    Report Date
    July 20, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE 1 OF 2. (SEE MFR REPORT# 1627487-2010-02408 FOR DEVICE 2). THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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 1 OF 2. (SEE MFR REPORT # 1627487-2010-02408 FOR DEVICE 2). ON (B)(6) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT EXPERIENCED LEAD MIGRATION AND LOSS OF STIMULATION. THE LEADS WERE EXPLANTED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 ELECTRODE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS 3186 116489

    Patients

    Seq Age Sex Outcome Treatment
    1 Other