BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1852428 · Received September 29, 2010

    Report

    Report Number
    1627487-2010-02584
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 26, 2010
    Report Date
    September 1, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. CONCLUSIONS - 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. PLEASE SEE MFR REPORT #1627487-2010-02677 FOR DEVICE 2. ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYS. SOON AFTER THE PT BEGAN DOING PHYSICAL THERAPY, SHE NO LONGER FELT STIMULATION ON HER LEFT SIDE. X-RAYS SHOWED THAT ONE LEAD MIGRATED. THE DOCTOR DECIDED TO REMOVE BOTH LEADS AND IMPLANT THE PT WITH ONE LEAD. THE PT NOW RECEIVES ADEQUATE STIMULATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATOR LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 2858162

    Patients

    Seq Age Sex Outcome Treatment
    1 Other