BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3181731 · Received June 21, 2013

    Report

    Report Number
    3007566237-2013-02049
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    April 17, 2013
    Report Date
    May 29, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. PRODUCT ID: NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_ UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    CHODAKIEWITZ, Y. G., BICALHO, G. V., CHODAKIEWITZ, J. W. MULTI-TARGET NEUROSTIMULATION FOR ADEQUATE LONG-TERM RELIEF OF NEUROPATHIC AND NOCICEPTIVE CHRONIC PAIN COMPONENTS. SURGICAL NEUROLOGY INTERNATIONAL. 2013;4(SUPPL 3):S170-175. DOI: 10.4103/2152-7806.110676. SUMMARY: SUCCESSFUL TREATMENT OF CHRONIC PAIN FOR PATIENTS WITH FAILED BACK SURGERY SYNDROME CAN BE EXTREMELY COMPLICATED. THESE PATIENTS REQUIRE CAREFUL AND INDIVIDUALIZED CLINICAL ASSESSMENT, AS THEY OFTEN PRESENT WITH MIXED PAIN SYNDROMES THAT INVOLVE BOTH NEUROPATHIC AND NOCICEPTIVE COMPONENTS. THE DISTINCT TYPES OF PAIN INVOLVED IN SUCH CASES MAY REQUIRE COMBINED TREATMENTS FROM INDIVIDUAL INTERVENTIONS THAT ARE ANALGESICALLY INDEPENDENT AND SPECIFIC FOR EACH TYPE OF PAIN INVOLVED. NEUROMODULATION BY ELECTRIC STIMULATION AT APPROPRIATELY CHOSE TARGETS AND COMBINATIONS MAY BE AN IMPORTANT OPTION TO CONSIDER FOR SUCH PATIENTS. WE PRESENT A CASE OF COMBINED DEBILITATING AXIAL NOCICEPTIVE SPINAL PAIN AND BILATERAL NEUROPATHIC LEG PAIN IN A PATIENT AFTER 14 FAILED BACK OPERATIONS. A COMBINATION OF SPINAL CORD STIMULATION AND DEEP BRAIN STIMULATION IN THE PERIVENTRICULAR GRAY (PVG) HAVE SUCCESSFULLY PROVIDED THE PATIENT WITH COMPLETE RELIEF OF BOTH COMPONENTS OF HIS CHRONIC PAIN CONDITION, AFTER ALL OTHER PAIN MANAGEMENT OPTIONS HAD BEEN EXHAUSTED. BY ALTERNATING ACTIVATION OF EACH IMPLANTED STIMULATOR SEPARATELY AND IN CONJUNCTION, WE WERE ABLE TO DEMONSTRATE A CLINICALLY INDEPENDENT ANALGESIC CHARACTER FOR EACH STIMULATION SYSTEM, EACH SPECIFIC TO A PARTICULAR TYPE OF PAIN. THE SCS PROVIDED COMPLETE RELIEF OF THE NEUROPATHIC PAIN COMPONENT WITHOUT AFFECTING THE NOCICEPTIVE COMPONENT AT ALL. IN COMBINATION, THERE WAS COMPLETE RELIEF OF THE TOTAL CHRONIC PAIN CONDITION. THERE APPEARED TO BE NO OVERLAPPING OR SYNERGISTIC EFFECT BETWEEN THE TWO NEUROMODULATION SYSTEMS IN THE PATIENT. THE PATIENT HAS HAD PROLONGED COMPLETE RELIEF FROM HIS CHRONIC PAIN CONDITION WITH THE COMBINED NEUROMODULATION INTERVENTION OVER 22 YEARS OF FOLLOW-UP. REPORTED EVENT: PATIENT HAD ELECTRODE PROGRAMMING ADJUSTMENTS AFTER ACCIDENTAL EXPOSURE TO MAGNETIC FIELDS. 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
    283265 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR