BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4947176 · Received July 28, 2015

    Report

    Report Number
    3007566237-2015-02111
    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 PROVIDED 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 TO TREAT EPILEPSY. CONCOMITANT MEDICAL PRODUCT: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, 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-COHORT 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 4: ONE (B)(6)-YEAR-OLD FEMALE PATIENT WITH ANTERIOR NUCLEI OF THALAMUS (ANT) DEEP BRAIN STIMULATION (DBS) FOR TREATMENT OF EPILEPSY EXPERIENCED GREATER THAN 50% REDUCTION IN SEIZURES COMPARED TO PRIOR TO DBS SURGERY. ACCORDING TO POLYSOMNOGRAPHY, THE PATIENT EXPERIENCED 4.0 DBS-RELATED AROUSALS PER HOUR AND 4 APNEAS PER HOUR WITH A NOCTURNAL VOLTAGE OF 5.0. THE PATIENT THEN HAD THE NOCTURNAL DBS VOLTAGE REDUCED TO 2.5V; IT WAS NOTED THAT THIS DECREASE IN NOCTURNAL VOLTAGE DID NOT REDUCE SEIZURE FREQUENCY BY GREATER THAN 50% COMPARED TO BEFORE THE REDUCTION. HOWEVER, THE PATIENT DID NOT EXPERIENCE SEIZURE DETERIORATION AS A RESULT. THE NUMBER OF DBS-RELATED AROUSALS WAS REDUCED TO 3.0 AROUSALS PER HOUR OF SLEEP. THE PATIENT HAD NO COMPLAINTS OF NEUROPSYCHIATRIC SIDE EFFECTS. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488085 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Other