BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 8 PERCUTANEOUS LEAD

    MDR report key: 1884087 · Received October 21, 2010

    Report

    Report Number
    1627487-2010-02846
    Event Type
    Injury
    Date Received
    October 21, 2010
    Date of Event
    September 21, 2010
    Report Date
    September 21, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, 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

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH A SCS SYSTEM. ON (B)(6) 2010, IT WAS REPORTED THAT THE PT'S LEAD MIGRATED. THE DOCTOR PLANS TO REVISE THE LEAD, MOVING IT BACK IT TO ITS ORIGINAL LOCATION. A DATE HAS NOT YET BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 8 PERCUTANEOUS LEAD SPINAL CORD STIMULATION LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3186 3163464

    Patients

    Seq Age Sex Outcome Treatment
    1 Other