BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE, NARROW TRIPOLE LEAD, 16 CH, 60CM

    MDR report key: 1195133 · Received October 9, 2008

    Report

    Report Number
    1627487-2008-00031
    Event Type
    Injury
    Date Received
    October 9, 2008
    Date of Event
    September 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORDS WERE REVIEWED, NO ANOMALIES NOTED. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. ANS, INC. HAS LIMITED INFO RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. ANS, INC. DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED PT WAS IMPLANTED WITH A LEAD AT T9-T10 AND IPG FOR LOWER BACK AND LEFT LEG PAIN AND THAT THE DOCTOR HAS MRI'S PERFORMED ON ALL PTS BEFOREHAND TO ASSESS CANAL SIZE. POST IMPLANT PT STATED HE COULD NOT FEEL LEGS BILATERALLY. PT COULD MOVE RIGHT LEG BUT COULD NOT MOVE LEFT LEG. IT WAS REPORTED THAT SYSTEM WAS EXPLANTED LATER THAT NIGHT. THE SYSTEM WAS NOT RETURNED TO ANS FOR EVALUATION. FOLLOW-UP FOUND PT IS DOING FINE AND HAS REGAINED BOTH FEELING AND MOVEMENT IN HIS LEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE, NARROW TRIPOLE LEAD, 16 CH, 60CM SPINAL CORD STIMULATION SURGICAL LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC 3219 171268

    Patients

    Seq Age Sex Outcome Treatment
    1 Other