BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4947368 · Received July 28, 2015

    Report

    Report Number
    3007566237-2015-02115
    Event Type
    Injury
    Date Received
    July 28, 2015
    Date of Event
    April 29, 2015
    Report Date
    July 1, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT P ROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION AS IT WAS IMPLANTED FOR EPILEPSY. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    VOGES, B. R., SCHMITT, F. C., HAMEL, W., HOUSE, P. M., KLUGE, C., MOLL, C. K. E., STODIECK, S. R. DEEP BRAIN STIMULATION OF ANTERIOR NUCLEUS THALAMI DISRUPTS SLEEP IN EPILEPSY PATIENTS. EPILEPSIA. 2015; **(*): 1¿5. DOI: 10.1111/EPI.13045 SUMMARY: IN VIEW OF THE REGULATORY FUNCTION OF THE THALAMUS IN THE SLEEP-WAKE CYCLE, THE IMPACT OF DEEP BRAIN STIMULATION (DBS) OF THE ANTERIOR NUCLEUS THALAMI (ANT) ON SLEEP WAS ASSESSED IN A SMALL CONSECUTIVE COHORT OF EPILEPSY PATIENTS WITH STANDARDIZED POLYSOM NOGRAPHY (PSG). IN NINE PATIENTS TREATED WITH ANT-DBS (VOLTAGE 5 V, FREQUENCY 145 HZ, CYCLIC MODE), THE NUMBER OF AROUSALS DURING STIMULATION AND NONSTIMULATION PERIODS, NEUROPSYCHIATRIC SYMPTOMS (NPS), AND SEIZURE FREQUENCY WERE DETERMINED. ELECTROCLINICAL AROUSALS WERE TRIGGERED IN 14.0 TO 67.0% (MEAN 42.4 _ SD 16.8%) OF ALL DEEP BRAIN STIMULI. SIX PATIENTS REPORTED NPS. NOCTURNAL DBS VOLTAGES WERE REDUCED IN EIGHT PATIENTS (ONE PATIENT WITHOUT NPS REFUSED) AND PSGS WERE REPEATED. ELECTROCLINICAL AROUSALS OCCURRED BETWEEN 1.4 AND 6.7 (MEAN 3.3 _ 1.7) TIMES MORE FREQUENTLY DURING STIMULATION PERIODS COMPARED TO NONSTIMULATION PERIODS; THE NUMBER OF AROUSALS POSITIVELY CORRELATED WITH THE LEVEL OF DBS VOLTAGE (RANGE 1 V TO 5 V) (SPEARMAN0S RANK COEFFICIENT 0.53121; P <(><<)> 0.05). NO PATIENT EXPERIENCED SEIZURE DETERIORATION AND FOUR PATIENTS REPORTED REMISSION OF NPS. THIS CASE-(B)(6) STUDY PROVIDES EVIDENCE THAT ANT-DBS INTERRUPTS SLEEP IN A VOLTAGE-DEPENDENT MANNER, THUS PUTATIVELY RESULTING IN AN INCREASE OF NPS. REDUCTION OF NOCTURNAL DBS VOLTAGE SEEMS TO LEAD TO IMPROVEMENT OF NPS WITHOUT HAMPERING EFFICACY OF ANT-DBS. REPORTED EVENT: PATIENT 6: ONE (B)(6) MALE PATIENT WITH ANTERIOR NUCLEI OF THALAMUS (ANT) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF EPILEPSY COMPLAINED OF ANXIETY, MOOD INSTABILITY, AND DISTURBED SLEEP. A POLYSOMNOGRAPHIC RECORDING OF THE PATIENT¿S SLEEP CYCLE SHOWED DBS STIMULUS LEAD TO AWAKENING OF THE PATIENT, WITHOUT RETURNING TO SLEEP. A HYPNOGRAM BETWEEN 0AM AND 8AM SHOWED EXTENSIVE SLEEP DISRUPTION AT 5V OF ANT-DBS. THE REPORTER STATED THAT THE HYPNOGRAM SHOWED THAT AFTER SHORT SLEEP LATENCY, THE PATIENT PASSED ONE FIRST SLEEP CYCLE FOR 1.5 HOURS WITH SLEEP N2, FOLLOWED BY N3, AND SUBSEQUENTLY BY REM SLEEP. IN THE FOLLOWING THREE HOURS, POLYSOMNOGRAPHY REVEALED REPEATED SLEEP DISRUPTIONS, THEREAFTER TWO PERIODS OF GOOD SLEEP QUALITY, FOLLOWED AGAIN BY SEVERE SLEEP FRAGMENTATION. PERIODIC LIMB MOVEMENT AND MODERATE SLEEP APNEA SYNDROME, BOTH WITH LITTLE IMPACT ON SLEEP QUALITY, WERE DIAGNOSED. AFTER REDUCING THE DBS VOLTAGE TO 2.5V, THE DBS-AROUSAL RATIO DECREASED FROM 5.10 TO 2.00 WITHOUT SIGNIFICANT ALTERATIONS IN NON-DBS RELATED AROUSALS OR IN PERIOD LIMB MOVEMENT OR APNEA INDICES, INDICATING THAT THE VOLTAGE-DEPENDENT REDUCTION OF THE ELECTROCLINICAL AROUSALS IN THE PATIENT WAS INDEPENDENT FROM HIS SOMNOLOGIC COMORBIDITY. THE PATIENT¿S NOCTURNAL DBS VOLTAGE WAS REDUCED TO 2V. THE PATIENT¿S SEIZURE REDUCTION WAS THEN REDUCED GREATER THAN 50% IN COMPARISON TO SEIZURE FREQUENCY BEFORE DBS SURGERY. THE PATIENT ALSO HAD COMPLETE REMISSION OF HIS COMPLAINTS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: IMPLANTABLE NEUROSTIMULATOR ACTIVA (MODEL NUMBER NOT PROVIDED) FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490589 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR Other