BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE LEAD

    MDR report key: 1316299 · Received February 18, 2009

    Report

    Report Number
    1627487-2009-00005
    Event Type
    Injury
    Date Received
    February 18, 2009
    Date of Event
    January 19, 2009
    Report Date
    January 26, 2009
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. 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 A MEDICAL 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 HAD A SUCCESSFUL TRIAL AND IN 2009, THE PERMANENT LEAD WAS PLACED. IT WAS REPORTED FOR THE PERMANENT LEAD THE MD USED A LAMITRODE TRIPOLE SURGICAL LEAD, WHICH WAS PLACED AT T9-T11 FOR BILATERAL LEG AND BACK PAIN. IT WAS REPORTED POST-OP THE SYSTEM WAS NEVER TURNED ON AND PT HAD MOVEMENT/FEELING IN ALL EXTREMITIES; HOWEVER, PT COMPLAINED ABOUT SEVERE PAIN AT INCISION SITE. APPROXIMATELY TWO HOURS POST-OP, NURSE REPORTED PT COULD NOT LONGER FEEL HIS LEGS. DOCTOR TOOK PT BACK TO OPERATING ROOM AND EXPLANTED SYSTEM, WHICH WAS DISCARDED. IT WAS REPORTED PT REGAINED FEELING/MOVEMENT AFTER EXPLANT. DEVICE DISCARDED AND NOT RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3214 176059

    Patients

    Seq Age Sex Outcome Treatment
    1 Other