BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3545089 · Received December 31, 2013

    Report

    Report Number
    3007566237-2013-04216
    Event Type
    Injury
    Date Received
    December 31, 2013
    Date of Event
    August 22, 2013
    Report Date
    December 11, 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
    HEALTH PROFESSIONAL

    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. CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_INS_STIMULATOR, SERIAL # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ZAKARIA, R., VAJRAMANI, G., WESTMORELAND, L., FLETCHER, N., ELDRIDGE, P., ALUSI, S., OSMAN-FARAH, J. TREMOR REDUCTION AND QUALITY OF LIFE AFTER DEEP BRAIN STIMULATION FOR MULTIPLE SCLEROSIS-ASSOCIATED TREMOR. ACTA NEUROCHIRURGICA. 2013;155(12):2359-2364. SUMMARY: TREMOR IS AN IMPORTANT CAUSE OF DISABILITY AND POOR QUALITY OF LIFE AMONGST MULTIPLE SCLEROSIS (MS) PATIENTS. WE ASSESSED THE OUTCOMES OF VENTRAL INTERMEDIATE (VIM) NUCLEUS DEEP BRAIN STIMULATION FOR THE TREATMENT OF MULTIPLE SCLEROSIS (MS)¿ASSOCIATED TREMOR AT A SINGLE CENTRE IN A PROSPECTIVE FASHION. SIXTEEN PATIENTS (9 FEMALE, 7MALE) WITH A MEAN AGE OF 41.7 YEARS (RANGE 24¿59) UNDERWENT SURGERY. THE MEDIAN DURATION OF MS PRIOR TO SURGERY WAS 6.5 YEARS AND MEDIAN DURATION OF TREMOR PRIOR TO SURGERY WAS 4 YEARS. CASE SELECTION WAS BY MULTIDISCIPLINARY ASSESSMENT WITH CARERS, THERAPISTS, NEUROSURGEONS AND MOVEMENT DISORDER NEUROLOGISTS. TREMOR WAS SCORED PRE-OPERATIVELY AND AT 6 TO 12 MONTHS POST OPERATIVELY USING BAIN AND/OR FAHN¿TOLOSA¿MARIN SYSTEMS. THE EURO-QOL 5D TOOL WAS USED TO ASSESS QUALITY OF LIFE BEFORE AND AFTER SURGERY. THE MEAN TREMOR REDUCTION WAS 39 % WITH A RANGE BETWEEN 0 AND 87%. FIVE OF 16 PATIENTS ACHIEVED AT LEAST 50% TREMOR REDUCTION AND 11 OF 16 ACHIEVED AT LEAST 30 % TREMOR REDUCTION AT LAST FOLLOW UP, MEAN 11.6 MONTHS (RANGE 3¿80). TREMOR WAS SIGNIFICANTLY REDUCED AS RATED BY BAIN SCORES (WILCOXON MATCHED PAIRS, Z =3.07, P =.002) AND TENDED TO SIGNIFICANCE AS RATED BY FAHN SCORES (WILCOXON MATCHED PAIRS, Z =1.85, P =0.06). SUB-ANALYSIS OF ACTIVITIES OF DAILY LIVING MEASURES FROM THE FAHN SYSTEM SHOWED POST OPERATIVE IMPROVEMENT IN FEEDING (STATISTICALLY SIGNIFICANT), HYGIENE, DRESSING, WRITING AND WORKING. MEAN VISUAL ANALOGUE SCORES (0¿100) OF PATIENT REPORTED WELL-BEING INCREASED FROM 54.6 TO 57.4 POST OPERATIVELY WITH A TREND TO SIGNIFICANCE (STUDENT¿S T-TEST, T =1.26, P =0.2). EURO-QOL 5D UTILITY VALUES INCREASED FOLLOWING SURGERY WITH A TREND TO SIGNIFICANCE WHICH WAS GREATER IN THE GROUP WITH AT LEAST 50%TREMOR REDUCTION THAN IN THOSE WITH NONE OR AT LEAST 30 % TREMOR REDUCTION. VIM DBS MAY REDUCE SEVERE, DISABLING TREMOR IN PATIENTS WITH MS. THIS TREMOR REDUCTION TENDS TO BE ASSOCIATED WITH IMPROVED QUALITY OF LIFE AND FUNCTION IN THOSE WHO RESPOND. PATIENT REPORTED OUTCOME MEASURES MAY NOT CORRELATE WITH PHYSICIAN RATED CLINICAL OUTCOME SUCH AS TREMOR SCORING SYSTEMS AND MORE SUBTLE ASSESSMENT OF THESE PATIENTS IS REQUIRED. REPORTED EVENTS: ONE PATIENT WAS INITIALLY REFERRED WITH AN INFECTED STIMULATOR IN SITU FOLLOWING SURGERY AT ANOTHER INSTITUTION AND THIS WAS REMOVED IN ITS ENTIRETY BEFORE REINSERTING NEW ELECTRODES AND BATTERY. ONE PATIENT DEVELOPED RECURRENT INFECTIONS OF THE CONNECTOR SITES AND THE SCALP WOUND, SECONDARY TO POOR DENTITION AND EVENTUALLY THE SYSTEM WAS REMOVED AT 1 YEAR POST-OPERATIVELY. THIS PATIENT DID NOT OPT TO HAVE ELECTRODES REIMPLANTED. ONE PATIENT REQUIRED REPLACEMENT OF THE CONNECTING LEADS TO THE BATTERY DUE TO MALFUNCTION WITH HIGH IMPEDANCES AT 6 MONTHS AND THE SYSTEM WAS FUNCTIONING WELL FOLLOWING THIS. 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
    681640 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention