BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_INS_STIMULATOR

    MDR report key: 2665712 · Received July 23, 2012

    Report

    Report Number
    3007566237-2012-01722
    Event Type
    Injury
    Date Received
    July 23, 2012
    Date of Event
    August 19, 2011
    Report Date
    June 26, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS.

    Description of Event or Problem · 1

    LITERATURE: MAMMIS, A., MOGILNER, A. Y. THE USE OF INTRAOPERATIVE ELECTROPHYSIOLOGY FOR THE PLACEMENT OF SPINAL CORD STIMULATOR PADDLE LEADS UNDER GENERAL ANESTHESIA. NEUROSURGERY. 2012;70(2 SUPPL):230-236. SUMMARY: PLACEMENT OF SPINAL CORD STIMULATING PADDLE LEADS HAS TRADITIONALLY BEEN PERFORMED UNDER LOCAL ANESTHESIA WITH INTRAVENOUS SEDATION TO ALLOW INTRAOPERATIVE CONFIRMATION OF APPROPRIATE PLACEMENT. IT MAY BE DIFFICULT TO MAINTAIN APPROPRIATE SEDATION IN CERTAIN PATIENTS BECAUSE OF MEDICAL COMORBIDITIES. FURTHERMORE, PATIENTS UNDERGOING LEAD REVISION FREQUENTLY HAVE EXTENSIVE EPIDURAL SCARRING, REQUIRING MULTILEVEL LAMINECTOMIES TO PLACE THE ELECTRODE APPROPRIATELY. TO REPORT OUR TECHNIQUE OF NEUROPHYSIOLOGIC MONITORING THAT ALLOWS THESE PROCEDURES TO BE PERFORMED UNDER GENERAL ANESTHESIA. DATA FROM 78 PATIENTS WHO UNDERWENT ELECTROMYOGRAPHY DURING LAMINECTOMY FOR PADDLE LEAD PLACEMENT WERE RETROSPECTIVELY REVIEWED. SEVENTY PATIENTS PRESENTED FOR FIRST-TIME PERMANENT SYSTEM PLACEMENT AFTER A SUCCESSFUL TRIAL, AND 8 WERE REFERRED FOR REVISION OR REPLACEMENT OF PREVIOUSLY FUNCTIONING SYSTEMS. SURGERIES WERE PERFORMED UNDER GENERAL ANESTHESIA WITH FLUOROSCOPIC GUIDANCE. ELECTROMYOGRAPHY WAS USED TO HELP DEFINE THE PHYSIOLOGICAL MIDLINE OF THE SPINAL CORD AND TO GUIDE APPROPRIATE LEAD PLACEMENT. SOMATOSENSORY EVOKED POTENTIALS WERE USED AS AN ADJUNCT TO MINIMIZE THE POSSIBILITY OF NEURAL INJURY. IMMEDIATELY POSTOPERATIVELY, 75 OF 78 PATIENTS REPORTED THAT THE PARESTHESIA COVERAGE WAS AS GOOD AS (OR BETTER THAN) THAT OF THE SPINAL CORD STIMULATION TRIAL. AT THE LONG-TERM FOLLOW-UP, 1 SYSTEM WAS REMOVED FOR INFECTION, AND 6 SYSTEMS WERE EXPLANTED FOR LACK OF EFFICACY. A TOTAL OF 64 OF THE 78 IMPLANTED PATIENTS REPORTED CONTINUED PAIN RELIEF WITH STIMULATOR USE. REVISION SURGERY WAS PERFORMED IN 9 PATIENTS. THE USE OF INTRAOPERATIVE ELECTROPHYSIOLOGY FOR THE PLACEMENT OF SPINAL CORD STIMULATION PADDLE LEADS UNDER GENERAL ANESTHESIA IS A SAFE AND EFFICACIOUS ALTERNATIVE TO AWAKE SURGERY. REPORTED EVENT: AN UNKNOWN NUMBER OF PATIENTS PRESENTED FOR REVISION OR REPLACEMENT OF PREVIOUSLY FUNCTIONING PERMANENT SYSTEMS SECONDARY TO LEAD MIGRATION. AN UNKNOWN NUMBER OF PATIENTS PRESENTED FOR REVISION OR REPLACEMENT OF PREVIOUSLY FUNCTIONING PERMANENT SYSTEMS SECONDARY TO LEAD MALPOSITION. AN UNKNOWN NUMBER OF PATIENTS PRESENTED FOR REVISION OR REPLACEMENT OF PREVIOUSLY FUNCTIONING PERMANENT SYSTEMS SECONDARY TO LEAD FRACTURE. AN UNKNOWN NUMBER OF PATIENTS PRESENTED FOR REVISION OR REPLACEMENT OF PREVIOUSLY FUNCTIONING PERMANENT SYSTEMS SECONDARY TO INFECTION. SIX PATIENTS HAD THEIR DEVICES EXPLANTED DUE TO LACK OF EFFICACY. ONE PATIENT HAD THEIR DEVICE EXPLANTED DUE TO INFECTION. ONE PATIENT SUFFERED A LATERAL LEAD MIGRATION AFTER A FALL, NECESSITATING LEAD REPOSITIONING. THERE WERE FOUR INSTANCES OF LEAD FRACTURES REQUIRING REVISION SURGERY. THERE WAS ONE INSTANCE OF EXTENSION WIRE FRACTURE. THERE WAS ONE INSTANCE OF INS MALFUNCTION REQUIRING REVISION SURGERY. THE DETAILS OF THE MALFUNCTION WERE NOT REPORTED. ONE PATIENT REQUIRED A REVISION LAMINECTOMY AFTER COMPLAINING POSTOPERATIVELY OF SEVERE BAND-LIKE ABDOMINAL PAIN DESPITE APPROPRIATE PARESTHESIA COVERAGE. DEVICE INFECTION (SECONDARY TO (B)(6)) OCCURRED IN 1 PATIENT, NECESSITATING COMPLETE HARDWARE REMOVAL. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEU_INS_STIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR Required Intervention