BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANS OCTRODE LEAD

    MDR report key: 802375 · Received January 3, 2007

    Report

    Report Number
    1627487-2006-00004
    Event Type
    Injury
    Date Received
    January 3, 2007
    Date of Event
    December 1, 2006
    Report Date
    January 3, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: DEVICE HAS NOT YET BEEN RETURNED FOR EVALUATION AS OF THE DATE OF THIS REPORT. ANS INC. CORP HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS, INC. CORP DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IN 2006, PT WAS IMPLANTED AN EON IPG AND TWO DUAL OCTRODE LEADS FOR SPINAL CORD STIMULATION. POST-OPERATIVELY, THE PT REPORTED FEELING SOME NUMBNESS IN HER RIGHT LEG FROM HER HIP TO HER KNEE. THE PT REPORTED HAVING EXCELLENT STIMULATION COVERAGE AND WAS SENT HOME. DURING A FOLLOW-UP VISIT WITH HER PHYSICIAN THREE DAYS LATER, THE PT SHOWED SOME IMPROVEMENT WITH A DECREASE IN THE WEAKNESS AND NUMBNESS, BUT SHE STILL REQUIRED ASSISTANCE IN WALKING. THE SCS SYSTEM WAS EXPLANTED SIX DAYS LATER, AND THE PT DID NOT RECEIVE ANOTHER SCS SYSTEM. FOLLOW-UP ON THE PT FOUND THAT SHE WAS NEAR TO FULL RECOVERY TO HER BASELINE STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS OCTRODE LEAD SPINAL CORD STIMULATOR ELECTRODE GZB ADVANCED NEUROMODULATION SYSTEMS, INC 3186 57787

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other