BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIPOLE 16C LAMITRODE LEAD

    MDR report key: 1048809 · Received May 21, 2008

    Report

    Report Number
    1627487-2008-00009
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 15, 2008
    Report Date
    May 21, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. ADDITIONALLY, DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED. ALL RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS. CONCLUSIONS: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE DEVICE EVALUATION OR FROM REVIEW OF THE DEVICE HISTORY RECORD AND STERILIZATION RECORD. 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

    THE PATIENT WAS IMPLANTED WITH AN IPG AND A LEAD FOR SCS IN 2008, WITH THE LEAD POSITIONED AT MID-T8. IT WAS REPORTED THAT IN THE RECOVERY ROOM THE PATIENT STATED HE WAS UNABLE TO FEEL HIS LEGS. ASSESSMENT OF THE PATIENT FOUND THAT HE HAD POSITIVE TACTILE SENSATION, POSITIVE RANGE OF MOTION OF LOWER EXTREMITIES, BUT PRESENTATION OVERALL WAS WEAK. AFTER A FEW HOURS, THERE WAS NO CHANGE IN THE PATIENT'S STATEMENTS OR ASSESSMENTS, AND THE PHYSICIAN CHOSE TO REMOVE THE LEAD. FOLLOW UP ON THE PATIENT FOUND THAT HE IS GOING THROUGH PHYSICAL THERAPY, HAS TACTILE SENSATION, BUT IS NOT YET STRONG ENOUGH TO HAVE COMPLETE WALKING ABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 16C LAMITRODE LEAD SPINAL CORD STIMULATION SURGICAL LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3214 113671

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R