BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6870340 · Received September 15, 2017

    Report

    Report Number
    3007566237-2017-03893
    Event Type
    Injury
    Date Received
    September 15, 2017
    Date of Event
    June 30, 2017
    Report Date
    October 31, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    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 EACH 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 EACH 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. 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 THE DEVICE WAS IMPLANTED FOR TREATMENT OF CHRONIC PAIN. THE REPORTED EVENTS ARE FROM 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.

    Additional Manufacturer Narrative · 1

    (B)(4)REMOVED. ADDITIONAL INFORMATION RECEIVED HAS CONFIRMED THAT EVENTS 10 AND 11 INVOLVED NON-MEDTRONIC DEVICES. ADDITIONAL INFORMATION ALSO ALLOWED EVENTS 8 AND 9 TO MATCHED TO PREVIOUSLY REPORTED PRODUCT EVENTS: EVENTS 8 AND 9 WERE PREVIOUSLY REPORTED IN MANUFACTURING REPORT NUMBERS 3004209178-2016-24037 AND 3004209178-2016-24050 RESPECTIVELY. 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 C: ONE (B)(6) MALE PATIENT UNDERWENT LEFT-SIDE ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR POST STROKE CHRONIC RIGHT HEMIBODY PAIN IN (B)(6) 2009. THE PATIENT EXPERIENCED AN INFECTION WHICH REQUIRED DEVICE REMOVAL. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. PATIENT H: ONE (B)(6) MALE PATIENT UNDERWENT RIGHT-SIDE ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2011 FOR CHRONIC LEFT ARM PAIN DUE TO BRACHIAL PLEXUS INJURY. THE PATIENT REQUIRED DEVICE REMOVAL DUE TO AN INFECTION AS OF LAST FOLLOW-UP IN (B)(6) 2011. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. PATIENT F: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR SPINAL CORD INJURY (SCI) ¿ TETRAPLEGIA RELATED PAIN IN BOTH ARMS IN (B)(6) 2010. THE PATIENT EXPERIENCED AN INFECTION AND HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) REMOVED AS OF (B)(6) 2012. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. PATIENT F: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR SPINAL CORD INJURY (SCI) ¿ TETRAPLEGIA RELATED PAIN IN BOTH ARMS IN (B)(6) 2013. THE PATIENT EXPERIENCED AN INFECTION. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. PATIENT M: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2012 FOR CHRONIC RIGHT HAND PAIN POST STROKE. THE PATIENT EXPERIENCED INFECTION AND ECZEMA. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. THE DBS WAS REMOVED AS OF LAST FOLLOW-UP IN (B)(6) 2014. 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. THE PATIENT REQUIRED DEVICE REMOVAL DUE TO AN INFECTION AS OF (B)(6) 2014. THE INFECTION MAY HAVE REQUIRED EXTERNALIZATION OF THE ELECTRODES. AN UNKNOWN NUMBER OF PATIENTS WITH ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR CHRONIC PAIN EXPERIENCED A FURTHER STROKE, RENDERING THE IMPLANT INEFFECTIVE. PATIENT N: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2012 FOR CHRONIC RIGHT HEMIBODY PAIN DUE TO FAILED BACK SURGERY SYNDROME (FBSS). THE PATIENT EXPERIENCED SEIZURES ASSESSED BY DBS NEUROLOGY SERVICE WITH CLINICAL EVALUATION AND EEG VIDEO TELEMETRY IN 2015. IT WAS NOTED THAT THE PATIENT¿S SEIZURES WERE UNRECOGNIZED FOR ¿SOME TIME,¿ AND EVEN AFTER SEIZURES WERE RECOGNIZED, THE PATIENT COULD NOT TOLERATE STIMULATION BEING TURNED DOWN. THE PATIENT HAD PROGRESSIVE INCREASES IN SEIZURE FREQUENCY AND SEVERITY, WHICH EVENTUALLY RESULTED IN GENERALIZED CONVULSIVE SEIZURES, WITH STATUS EPILEPTICUS ON A COUPLE OF OCCASIONS. THIS OCCURRED DESPITE BEING ON ANTI-EPILEPTIC MEDICATION, AND DESPITE STIMULATION BEING TURNED OFF. IT WAS NOTED THAT THE PATIENT HAD DEVELOPED DE NOVO STIMULATION INDUCED EPILEPSY. HOWEVER, IT WAS NOTED THAT DBS WAS ON AS OF LAST FOLLOW-UP IN (B)(6) 2016. PATIENT K: ONE (B)(6) FEMALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2012 FOR CHRONIC WHOLE SPINE PAIN DUE TO FAILED BACK SURGERY SYNDROME (FBSS). THE PATIENT EXPERIENCED SEIZURES ASSESSED BY DBS NEUROLOGY SERVICE WITH CLINICAL EVALUATION AND EEG VIDEO TELEMETRY IN 2015; THE PATIENT SHOWED PROGRESSIVE INCREASES IN SEIZURE FREQUENCY AND SEVERITY. IT WAS REPORTED THAT THE PATIENT COULD NOT TOLERATE PAIN AND INCREASED STIMULATION ON THEIR OWN OR RESISTED TURNING DOWN STIMULATION. IT WAS NOTED THAT THE PATIENT HAD DEVELOPED DE NOVO STIMULATION-INDUCED EPILEPSY. IT WAS NOTED THAT DBS WAS TURNED OFF DESPITE PAIN RELIEF AS OF LAST FOLLOW-UP IN (B)(6) 2016. PATIENT Q: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2013 FOR CHRONIC LEFT ARM AND CHEST PAIN POST STROKE. IN THE IMMEDIATE POSTOPERATIVE PERIOD, THE PATIENT EXPERIENCED CONVULSIVE SEIZURES AT THE VERY HIGH STIMULATION INTENSITIES REQUIRED FOR NEAR-COMPLETE PAIN RELIEF. THESE WERE ASSESSED BY DBS NEUROLOGY SERVICE WITH CLINICAL EVALUATION AND EEG VIDEO TELEMETRY IN 2015. STIMULATION INTENSITIES JUST BELOW THE CONVULSIVE THRESHOLD WERE WELL-TOLERATED FOR NEARLY TWO YEARS BEFORE THE PATIENT REPORTED STEREOTYPED NEUROLOGICAL EVENTS (¿LIP SMACKING¿). THE PATIENT REFUSED TESTING OF STIMULATION THRESHOLDS ABOVE THOSE HE RECOGNIZED AS SAFE DURING VIDEO-TELEMETRY. DBS REMAINED ON AS OF LAST FOLLOW-UP IN (B)(6) 2016. HOWEVER, IT WAS ALSO REPORTED THAT THE PATIENT HAD SWITCHED OFF DBS AS THE THRESHOLD FOR SEIZURES HAD FALLEN BELOW THAT REQUIRED FOR USEFUL PAIN RELIEF. PATIENT S: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2013 FOR CHRONIC LEFT ARM PAIN POST STROKE. THE PATIENT EXPERIENCED ABSENCE SEIZURES ASSESSED BY DBS NEUROLOGY SERVICE WITH CLINICAL EVALUATION AND EEG VIDEO TELEMETRY IN 2015; THE PATIENT DEVELOPED RECURRENT STEREOTYPED NEUROLOGICAL EVENTS (¿DIFFICULTY FINDING WORDS¿) ABOVE A CERTAIN PREVIOUSLY WELL-TOLERATED THRESHOLD OF STIMULATION INTENSITY, 12 MONTH AFTER SURGERY. BY THE TIME HE FIRST REPORTED SYMPTOMS, THE PATIENT HAD REDUCED THE STIMULATION INTENSITY. THE PATIENT SWITCHED OFF THE STIMULATOR AS PAIN RELIEF WAS FELT TO BE MINIMAL AT SAFE STIMULATION INTENSITIES. THE SEIZURES STOPPED OCCURRING ONCE THE STIMULATION WAS SWITCHED OFF, BUT THE PAIN INCREASED TO PRE-OPERATIVE LEVELS WITHIN WEEKS. DBS WAS TURNED OFF DESPITE PAIN RELIEF AS OF LAST FOLLOW-UP IN (B)(6) 2015. ONE (1) PATIENT WITH ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR CHRONIC PAIN SUFFERED RECURRENT STEREOTYPED EVENTS SUGGESTIVE OF SEIZURES. THE EVENTS CEASED FOLLOWING EXPLANTATION. FOLLOW-UP WAS DECLINED BY THE PATIENT. PATIENT A: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) FOR CHRONIC BACK PAIN DUE TO FAILED BACK SURGERY SYNDROME (FBSS) IN (B)(6) 2007. THE PATIENT EXPERIENCED DIMINISHED PAIN RELIEF AFTER THE TRIAL PERIOD. THE DEVICE WAS REMOVED DUE TO NO PAIN RELIEF AS OF (B)(6) 2009. PATIENT I: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2011 FOR CHRONIC LEFT ARM PAIN DUE TO BRACHIAL PLEXUS INJURY. THE PATIENT EXPERIENCED DIMINISHED PAIN RELIEF AFTER THE TRIAL PERIOD. THE DEVICE WAS REMOVED DUE TO INSUFFICIENT PAIN RELIEF AS OF LAST FOLLOW-UP IN (B)(6) 2012. PATIENT J: ONE (B)(6) MALE PATIENT UNDERWENT BILATERAL ANTERIOR CINGULATE CORTEX (ACC) DEEP BRAIN STIMULATION (DBS) IN (B)(6) 2011 FOR CHRONIC CHEST PAIN OF UNKNOWN ORIGIN. THE PATIENT EXPERIENCED DIMINISHED PAIN RELIEF AFTER THE TRIAL PERIOD. THE DEVICE WAS REMOVED DUE TO INSUFFICIENT PAIN RELIEF AS OF LAST FOLLOW-UP IN (B)(6) 2012. THE FOLLOWING DEVICE INFORMATION WAS PROVIDED: LEAD MODEL 3387.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651149 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 Other| R