BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS QUATTRODE LEAD

    MDR report key: 911024 · Received September 7, 2007

    Report

    Report Number
    1627487-2007-00018
    Event Type
    Other
    Date Received
    September 7, 2007
    Date of Event
    November 1, 2006
    Report Date
    September 6, 2007
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. DEVICE WAS DISCARDED, UNABLE TO FOLLOW-UP. ADVANCED NEUROMODULATION SYSTEMS, INC. HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM A MEDICAL OPINION AS TO THE RELEVANCE OF THE PATIENT'S HISTORY TO THE EVENT REPORTED.

    Description of Event or Problem · 1

    PATIENT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG, 4 LEADS, AND 2 EXTENSIONS IN 2006. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION, AND THE LEADS WERE EXPLANTED THE FOLLOWING MONTH, FOLLOW UP WITH THE PATIENT FOUND THAT SHE HAS RECOVERED FROM THE INFECTION AND WILL BE ABLE TO RECEIVE HER REPLACEMENT LEADS WITHIN A FEW MONTHS. THE ORIGINAL LEADS WERE DISCARDED BY THE HOSPITAL AND NOT RETURNED TO ANS FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS QUATTRODE LEAD SPINAL CORD STIMULATOR LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3146 55831

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other