BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2950586 · Received February 8, 2013

    Report

    Report Number
    3007566237-2013-00429
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    April 4, 2012
    Report Date
    January 16, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD (B)(4).

    Description of Event or Problem · 1

    SHILS, J. L., ARLE, J. E. INTRAOPERATIVE NEUROPHYSIOLOGIC METHODS FOR SPINAL CORD STIMULATOR PLACEMENT UNDER GENERAL ANESTHESIA. NEU ROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2012;15(6):560-572. DOI: 10.1111/J.1525-1403.2012.00460.X. SUMMARY: THE OBJECTIVE OF THE STUDY WAS TO DEMONSTRATE THAT SPINAL CORD STIMULATORS (SCSS) MAY BE PLACED SAFELY AND ACCURATELY UNDER GENERAL ANESTHESIA (GA) AND THAT THE PROPOSED EVALUATION METHOD ACTIVATES STRUCTURES PREDOMINANTLY IN THE DORSAL COLUMNS. DATA WERE RETROSPECTIVELY ANALYZED FROM 172 ELECTRODES IMPLANTED WITH SPINAL CORD SCSS AT THE LAHEY CLINIC BETWEEN SEPTEMBER 2008 AND JULY 2011. ALL PATIENTS HAD THEIR SCS PLACED UNDER GA. ELECTROMYOGRAPHY WAS RECORDED FROM UPPER OR LOWER LIMB MUSCLE GROUPS RELATED TO THE PLACEMENT OF THE STIMULATOR ELECTRODE. LATERALIZATION WAS PERFORMED BASED ON ELECTROMYOGRAPHIC RESPONSES AND ELECTRODE PAIRS STIMULATED. IN A SELECT GROUP OF PATIENTS, STANDARD NEUROPHYSIOLOGIC TESTS, PAIRED PULSE, AND COLLISION STUDIES WERE PERFORMED TO DEMONSTRATE THAT THE PAIN STIMULI WERE ACTIVATING THE DORSAL COLUMNS. ONE HUNDRED FIFTY-FIVE PATIENTS HAD STANDARD THORACIC OR CERVICAL SCS PLACEMENT. PREOPERATIVELY THIS COHORT OF PATIENTS HAD A VISUAL ANALOG SCORE (VAS) OF 7.51_1.93, WHILE POSTOPERATIVELY THE VAS WAS 3.63_2.43 (A REDUCTION OF 52.11%). BASED ON THE ELECTROMYOGRAPHIC RECORDING TECHNIQUE, THE ELECTRODES WERE REPOSITIONED INTRAOPERATIVELY IN 15.9% OF PATIENTS. THE RECOVERY TIME (INITIAL APPROXIMATELY 70 MSEC AND COMPLETE APPROXIMATELY 150-300 MSEC) IN BOTH THE PAIRED-PULSE TESTS AND THE COLLISION STUDIES SHOWED THAT THE STIMULATION USED TO ELICIT THE COMPOUND MUSCLE ACTION POTENTIALS CAME FROM ANTIDROMIC ACTIVATION OF THE DORSAL COLUMNS AND NOT FROM THE CORTICOSPINAL TRACT. GA SCS IS SAFE AND APPEARS TO BE AT LEAST AS ACCURATE AND EFFICACIOUS AS USING THE AWAKE SCS PLACEMENT TECHNIQUE BASED ON A 50% IMPROVEMENT IN THE VAS. IN ADDITION, THE TECHNIQUE PRESENTED HEREIN DEMONSTRATES THAT THE TEST STIMULI ACTIVATE THE SAME FIBER TRACTS AS THAT OF THE THERAPEUTIC STIMULATION. REPORTED EVENTS: TWO PATIENTS HAD THEIR STIMULATORS REMOVED FOR INFECTION. SIX PATIENTS HAD THEIR STIMULATOR REMOVED DUE TO NO SIGNIFICANT PAIN REDUCTION. TWENTY TWO PATIENTS HAD THEIR ELECTRODES REPOSITIONED OR REPLACED. TWO OF THE PATIENTS UNDERWENT MULTIPLE REPOSITIONING. 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
    55068 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention