BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE DEEP BRAIN STIMULATION NEUROSTIMULATOR

    MDR report key: 3004297 · Received March 14, 2013

    Report

    Report Number
    3007566237-2013-00779
    Event Type
    Injury
    Date Received
    March 14, 2013
    Date of Event
    November 10, 2012
    Report Date
    February 14, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID NEU_ENS_STIMULATOR, SERIAL# UNKNOWN. PRODUCT TYPE: EXTERNAL NEUROSTIMULATOR: PRODUCT ID 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 3387, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    BOCCARD, S. G., PEREIRA, E. A., MOIR, L., AZIZ, T. Z., GREEN, A. L. LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION FOR NEUROPATHIC PAIN. NEUROSURGERY. 2013;72(2):221-231. DOI: 10.1227/NEU.0B013E31827B97D6. SUMMARY: DEEP BRAIN STIMULATION (DBS) TO TREAT NEUROPATHIC PAIN REFRACTORY TO PHARMACOTHERAPY HAS REPORTED VARIABLE OUTCOMES AND HAS GAINED (B)(4) BUT NOT USA REGULATORY APPROVAL. THE OBJECTIVE WAS TO PROSPECTIVELY ASSESS LONG-TERM EFFICACY OF DBS FOR CHRONIC NEUROPATHIC PAIN IN A SINGLE-CENTER CASE SERIES. PATIENT REPORTED OUTCOME MEASURES WERE COLLATED BEFORE AND AFTER SURGERY, USING A VISUAL ANALOG SCORE, SHORT-FORM 36-QUESTION QUALITY-OF-LIFE SURVEY, MCGILL PAIN QUESTIONNAIRE, AND EUROQOL-5D QUESTIONNAIRES (EQ-5D AND HEALTH STATE). ONE HUNDRED NINETY-SEVEN PATIENTS WERE REFERRED OVER 12 YEARS, OF WHOM 85 RECEIVED DBS FOR VARIOUS ETIOLOGIES: 9 AMPUTEES, 7 BRACHIAL PLEXUS INJURIES, 31 AFTER STROKE, 13 WITH SPINAL PATHOLOGY, 15 WITH HEAD AND FACE PAIN, AND 10 MISCELLANEOUS. MEAN AGE AT SURGERY WAS (B)(6), AND MEAN FOLLOW-UP WAS 19.6 MONTHS. CONTRALATERAL DBS TARGETED THE PERIVENTRICULAR GRAY AREA (N = 33), THE VENTRAL POSTERIOR NUCLEI OF THE THALAMUS (N =15), OR BOTH TARGETS (N = 37). ALMOST 70% (69.4%) OF PATIENTS RETAINED IMPLANTS 6 MONTHS AFTER SURGERY. THIRTY-NINE OF 59 (66%) OF THOSE IMPLANTED GAINED BENEFIT AND EFFICACY VARIED BY ETIOLOGY, IMPROVING OUTCOMES IN 89% AFTER AMPUTATION AND 70% AFTER STROKE. IN THIS COHORT, .30% IMPROVEMENTS SUSTAINED IN VISUAL ANALOG SCORE, MCGILL PAIN QUESTIONNAIRE, SHORT-FORM 36-QUESTION QUALITY-OF-LIFE SURVEY, AND EUROQOL-5D QUESTIONNAIRE WERE OBSERVED IN 15 PATIENTS WITH .42 MONTHS OF FOLLOW-UP, WITH SEVERAL OUTCOME MEASURES IMPROVING FROM THOSE ASSESSED AT 1 YEAR. DBS FOR PAIN HAS LONG-TERM EFFICACY FOR SELECT ETIOLOGIES. CLINICAL TRIALS RETAINING PATIENTS IN LONG-TERM FOLLOW-UP ARE DESIRABLE TO CONFIRM FINDINGS FROM PROSPECTIVELY ASSESSED CASE SERIES. REPORTED EVENTS: FIVE PATIENTS EXPERIENCED INFECTION WHICH REQUIRED DEVICE REMOVAL. TWO PATIENTS EXPERIENCED INFECTION WHICH WAS SUCCESSFULLY TREATED WITH ANTIBIOTICS. ONE PATIENT HAD LEAD EROSION REQUIRING REMOVAL. FOUR PATIENTS HAD LEAD REVISIONS DUE TO BREAKAGE FOLLOWING A FALL. SEVEN PATIENTS HAD LEAD REVISIONS DUE TO A LOSS OF THERAPEUTIC EFFECT DESPITE STIMULATION CYCLING OR BREAKS FROM STIMULATION. TWENTY-FIVE PATIENTS REQUIRED INS CHANGES. 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
    107903 UNKNOWN IMPLANTABLE DEEP BRAIN STIMULATION NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention