BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD, 60 CM

    MDR report key: 1064732 · Received June 23, 2008

    Report

    Report Number
    1627487-2008-00012
    Event Type
    Injury
    Date Received
    June 23, 2008
    Date of Event
    May 22, 2008
    Report Date
    May 23, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOR DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00013 FOR DEVICE 2). METHOD: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. ANS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS, INC. DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2 (REFERENCE TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00013 FOR DEVICE 2) PATIENT IMPLANTED WITH SCS SYSTEM IN 2008. THE PHYSICIAN CONDUCTED A REVISION AT APPROXIMATELY 3 MONTHS LATER, DUE TO LEAD MIGRATION. INTRAOPERATIVELY, THE PATIENT REPORTED SHE COULD NOT FEEL HER TOES, FEET, OR LEGS, AND SUBSEQUENTLY COULD NOT MOVE THEM. IT WAS REPORTED THAT THE PHYSICIAN DISCONTINUED THE PROCEDURE AND EXPLANTED THE SYSTEM. THE EXPLANTED SYSTEM WAS DISCARDED AND NOT RETURNED TO ANS FOR EVALUATION. PATIENT FOLLOW-UP REPORT THAT THE PATIENT WAS IN FULL RECOVERY AND HAS NO MOTOR OR SENSORY LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD, 60 CM SPINAL CORD STIMULATION LEAD GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3186 116236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other