BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3840848 · Received May 30, 2014

    Report

    Report Number
    3007566237-2014-01476
    Event Type
    Injury
    Date Received
    May 30, 2014
    Date of Event
    March 17, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID, NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    CHARLES, D., KONRAD, P.E., NEIMAT, J.S., MOLINARI, A.L., TRAMONTANA, M.G., FINDER, S.G., GILL, C.E., BLITON, M.J., KAO, C., PHIBBS, F.T., HEDERA, P., SALOMON, R.M., CANNARD, K.R., WANG, L., SONG, Y., DAVIS, T.L. SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN EARLYSTAGE PARKINSON¿S DISEASE. PARKINSONISM AND RELATED DISORDERS. 2014, 2014(1-7). HTTP://DX.DOI.ORG/10.1016/J.PARKRELDIS.2014.03.019. SUMMARY: DEEP BRAIN STIMULATION (DBS) IS AN EFFECTIVE AND APPROVED THERAPY FOR ADVANCED PARKINSON¿S DISEASE (PD), AND A RECENT STUDY SUGGESTS EFFICACY IN MID-STAGE DISEASE. THIS MANUSCRIPT REPORTS THE RESULTS OF A PILOT TRIAL INVESTIGATING PRELIMINARY SAFETY AND TOLERABILITY OF DBS IN EARLY PD. THIRTY SUBJECTS WITH IDIOPATHIC PD (HOEHN <(>&<)> YAHR STAGE II OFF MEDICATION), AGE 50-75, ON MEDICATION > 6 MONTHS BUT <(><<)> 4 YEARS, AND WITHOUT MOTOR FLUCTUATIONS OR DYSKINESIAS WERE RANDOMIZED TO OPTIMAL DRUG THERAPY (ODT) (N = 15) OR DBS + ODT (N = 15). CO-PRIMARY ENDPOINTS WERE THE TIME TO REACH A 4-POINT WORSENING FROM BASELINE IN THE UPDRS-III OFF THERAPY AND THE CHANGE IN LEVODOPA EQUIVALENT DAILY DOSE FROM BASELINE TO 24 MONTHS. AS HYPOTHESIZED, THE MEAN UPDRS TOTAL AND PART III SCORES WERE NOT SIGNIFICANTLY DIFFERENT ON OR OFF THERAPY AT 24 MONTHS. MEDICATION REQUIREMENTS IN THE DBS + ODT GROUP WERE LOWER AT ALL TIME POINTS WITH A MAXIMAL DIFFERENCE AT 18 MONTHS. WITH A FEW EXCEPTIONS, DIFFERENCES IN NEUROPSYCHOLOGICAL FUNCTIONING WERE NOT SIGNIFICANT. TWO SUBJECTS IN THE DBS + ODT GROUP SUFFERED SERIOUS ADVERSE EVENTS; REMAINING ADVERSE EVENTS WERE MILD OR TRANSIENT. THIS STUDY DEMONSTRATES THAT SUBJECTS WITH EARLY STAGE PD WILL ENROLL IN AND COMPLETE TRIALS TESTING INVASIVE THERAPIES AND PROVIDES PRELIMINARY EVIDENCE THAT DBS IS WELL TOLERATED IN EARLY PD. THE RESULTS OF THIS TRIAL PROVIDE THE DATA NECESSARY TO DESIGN A LARGE, PHASE III, DOUBLE-BLIND, MULTICENTER TRIAL INVESTIGATING THE SAFETY AND EFFICACY OF DBS IN EARLY PD. REPORTED EVENTS: ONE PATIENT EXPERIENCED A PERIOPERATIVE INFARCTION/STROKE IN THE LEFT BASAL GANGLIA. THE REPORTER STATED THAT THE INFARCTION AFFECTED THE PATIENT¿S MOTOR AND COGNITIVE OUTPUT THROUGHOUT THE DURATION OF THE STUDY. THE REPORTER STATED THAT THIS CAUSED PERMANENT COGNITIVE IMPAIRMENT AND TRANSIENT WEAKNESS IN THE RIGHT FACE AND HAND. ONE PATIENT EXPERIENCED AN INFECTION OF THE DEEP BRAIN STIMULATION (DBS) LEAD 12 MONTHS AFTER IMPLANT. THE REPORTER STATED THAT THE PATIENT HAD ACCIDENTALLY STRUCK THE RIGHT SIDE OF HIS HEAD ON HIS GARAGE DOOR 12 MONTHS POSTOPERATIVELY. IT WAS NOTED THAT A RIGHT SUPERIOR FRONTAL SCALP INFECTION SUBSEQUENTLY DEVELOPED ALONG THE LEAD EXTENSION AND WAS UNSUCCESSFULLY TREATED WITH ORAL ANTIBIOTICS. THE REPORTER STATED THAT THE RIGHT LEAD, EXTENSION, AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE THUS REMOVED 18 MONTHS POSTOPERATIVELY. IT WAS NOTED THAT THE INFECTION RESOLVED, BUT THE SUBJECT DID NOT RECEIVE STIMULATION ON THE RIGHT SIDE FOR THE REMAINDER OF THE STUDY. ONE PATIENT EXPERIENCED AN AUDITORY HALLUCINATION. ONE PATIENT EXPERIENCED HALLUCINATION. TWO PATIENTS EXPERIENCED SLEEP APNEA SYNDROME. SIX PATIENT EXPERIENCED DEAFNESS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3389 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
    318262 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention| S