BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE NARROW TRIPOLE LEAD

    MDR report key: 1251288 · Received December 4, 2008

    Report

    Report Number
    1627487-2008-00042
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    October 29, 2008
    Report Date
    November 6, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION FOR DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00043 FOR DEVICE 2). EVALUATION: DEVICE HISTORY RECORD AND STERILIZATION RECORD WERE REVIEWED, NO ANOMALIES WERE FOUND. RESULTS: ALL RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS. CONCLUSION: DEVICE NOT RETURNED. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE 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 A MEDICAL 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

    DEVICE 1 OF 2 (REFER TO MANUFACTURER'S REPORT NUMBER 1627487-2008-00043 FOR DEVICE 2). IT WAS REPORTED DUE TO LEAD MIGRATION, PATIENTS PERCUTANEOUS LEADS WERE REVISED IN 2008, AND A PADDLE LEAD WAS PLACED AT T9-T10 FOR BACK AND LEG PAIN. IN THE RECOVERY ROOM, IT WAS REPORTED THAT PATIENT HAD NO SENSATION OR MOVEMENT FROM THE WAIST DOWN, NO BOWL CONTROL, AND INCONTINENCE. LATER THAT DAY, IT WAS REPORTED THAT PHYSICIAN REMOVED THE SCS SYSTEM AND DISCARDED SYSTEM. PATIENT REPORTED PHYSICIAN FOUND A HEMATOMA UNDER THE LEAD. FOLLOW-UP IN REHAB FOUND PATIENT HAS IMPROVED, AND IS WALKING WITH THE AID OF A WALKER. THE EXPLANTED SYSTEM HAS NOT BEEN RETURNED TO ANS FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE NARROW TRIPOLE LEAD SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3219 174130

    Patients

    Seq Age Sex Outcome Treatment
    1 Other