BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANS LAMITRODE SURGICAL LEAD

    MDR report key: 611102 · Received June 2, 2005

    Report

    Report Number
    1627487-2005-00004
    Event Type
    Other
    Date Received
    June 2, 2005
    Date of Event
    May 2, 2005
    Report Date
    June 1, 2005
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DEVICE WAS IMPLANTED IN 2005. THE PATIENT'S POCKET SITE BEGAN OOZING AND WAS CULTURED 2 MONTHS LATER. THE PRELIMINARY RESULT OF THE CULTURE IS A PSEUDOMONAS INFECTION. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THIS INFECTION. THE RN CALLED TO SEE IF ANS RECOMMENDED REMOVING JUST THE IPG OR THE ENTIRE SYSTEM. ANS RECOMMENDED REMOVAL OF THE ENTIRE SPINAL CORD STIMULATION (SCS) SYSTEM. SYSTEM WAS EXPLANTED 4 DAYS LATER AND PATIENT WS TREATED WITH ANTIBIOTICS. UPON EXAMINATION THE FOLLOWING MONTH, THE INFECTION HAS CLEARED AND PATIENT IS DOING WELL. THE PHYSICIAN'S OFFICE PLANS TO SCHEDULE THE PATIENT'S IMPLANT OF THE NEW SYSTEM SOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANS LAMITRODE SURGICAL LEAD SPINAL CORD STIMULATOR ELECTRODE GZB ADVANCED NEUROMODULATION SYSTEMS, INC. 3240 18942

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other