BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6870411 · Received September 15, 2017

    Report

    Report Number
    3007566237-2017-03894
    Event Type
    Malfunction
    Date Received
    September 15, 2017
    Date of Event
    June 30, 2017
    Report Date
    September 15, 2017
    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

    AGE/DATE OF BIRTH. PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED IS NOTED IN THE EVENT AS KNOWN. SEX. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED IS NOTED IN THE EVENT AS KNOWN. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387, PRODUCT TYPE: LEAD. PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR TREATMENT OF CHRONIC PAIN THE REPORTED EVENTS WERE REPORTED IN THE FOLLOWING ARTICLE: BOCCARD SGJ, PRANGNELL SJ, PYCROFT L, CHEERAN B, MOIR L, PEREIRA EAC, FITZGERALD JJ, GREEN AL, AZIZ TZ. LONG-TERM RESULTS OF DEEP BRAIN STIMULATION OF THE ANTERIOR CINGULATE CORTEX FOR NEUROPATHIC PAIN. WORLD NEUROSURGERY (2017) DOI: 10.1016/J.WNEU.2017.06.173 ABSTRACT: DEEP BRAIN STIMULATION OF THE ANTERIOR CINGULATE CORTEX IS A RECENT TECHNIQUE THAT HAS SHOWN SOME PROMISING SHORT-TERM RESULTS IN PATIENTS WITH CHRONIC REFRACTORY NEUROPATHIC PAIN. THREE YEARS AFTER THE FIRST CASE-SERIES, WE ASSESSED ITS EFFICACY ON A LARGER COHORT, WITH LONGER FOLLOW-UP. TWENTY-FOUR (24) PATIENTS (19 MALES; 49.1 YEARS) WITH NEUROPATHIC PAIN UNDERWENT BILATERAL ACC DBS. PATIENT REPORTED OUTCOME MEASURES WERE COLLECTED PRE- AND POST-SURGERY, USING THE NUMERICAL RATING SCALE (NRS), SHORT-FORM 36 QUALITY OF LIFE (SF-36), MCGILL PAIN (MGQ), AND EUROQOL-5D QUESTIONNAIRES. TWENTY-TWO (22) PATIENTS AFTER A TRIAL WEEK WERE FULLY INTERNALIZED AND 12 HAD A MEAN FOLLOW-UP OF 38.9 MONTHS. SIX MONTHS POST-SURGERY, THE MEAN NRS SCORE DROPPED FROM 8.0 TO 4.27. THERE WAS A SIGNIFICANT IMPROVEMENT IN THE MPQ AND EQ-5D SCORE SIGNIFICANTLY DECREASED. THE PF DOMAIN OF SF-36 WAS SIGNIFICANTLY IMPROVED. FURTHERMORE, IN 83% OF THESE PATIENTS: AT 6 MONTHS NRS WAS IMPROVED BY 60% AND MPQ DECREASED BY 47%. AFTER 1 YEAR, NRS DECREASED BY 43%, EQ-5D WAS SIGNIFICANTLY REDUCED AND SIGNIFICANT IMPROVEMENTS WERE ALSO OBSERVED FOR DIFFERENT DOMAINS OF THE SF-36. AT LONGER FOLLOW-UPS, EFFICACY WAS SUSTAINED UP TO 42 MONTHS IN SOME PATIENTS, WITH A NRS AS LOW AS 3. FOLLOW-UP RESULTS CONFIRM THAT ACC DBS ALLEVIATES CHRONIC NEUROPATHIC PAIN REFRACTORY TO PHARMACOTHERAPY AND IMPROVES QUALITY OF LIFE IN A SIGNIFICANT NUMBER OF PATIENTS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE FOLLOWING EVENTS WERE REPORTED IN A LITERATURE ARTICLE: REPORTED EVENTS: PATIENT G: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR CHRONIC RIGHT LEG PAIN DUE TO FAILED BACK SURGERY SYNDROME (FBSS) IN (B)(6) 2010. THE RIGHT WIRE WAS REPORTED AS BROKEN. THERE WAS NO INTERVENTION REPORTED. DBS REMAINED ON AS OF LAST FOLLOW-UP IN (B)(6) 2016. THE PATIENT HAD AN INITIAL DECREASE IN PAIN SCORES BETWEEN THE PREOPERATIVE SCORES AND THE 12-MONTH FOLLOW-UP, BUT THEN EXPERIENCED A SLIGHT INCREASE IN PAIN SCORES BETWEEN THE 12-MONTH AND 24-MONTH FOLLOW-UPS. PATIENT W: ONE (B)(6) FEMALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2014 FOR CHRONIC WHOLE BODY PAIN DUE TO A ROAD TRAFFIC ACCIDENT. THERE WAS ONE LEAD BROKEN DURING STAGE 2. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    649776 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR