BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS OCTRODE LEAD

    MDR report key: 806635 · Received January 4, 2007

    Report

    Report Number
    1627487-2006-00007
    Event Type
    Other
    Date Received
    January 4, 2007
    Date of Event
    December 8, 2006
    Report Date
    January 3, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION - DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. RESULTS: ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: DEVICE WAS DISCARDED, UNABLE TO FOLLOW-UP. ANS INC. CORPORATION HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS, INC. CORPORATION DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED IN 2006 WITH TWO LEADS AND AN IPG. A FEW WEEKS LATER, ONE OF THE LEAD IMPLANT SITES BECAME INFECTED. THE PHYSICIAN NOTED THE INFECTION WAS CONTAINED ONLY TO THAT ONE LEAD SITE, AND HE STATED HE DID NOT FEEL THE INFECTION WAS DEVICE-RELATED. ONE MONTH LATER, THE PHYSICIAN REMOVED AND DISCARDED THAT LEAD. FOLLOW-UP ON THE PATIENT FOUND THAT THE INFECTION HAS RESOLVED.

    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 56442

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other