BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7562827 · Received June 1, 2018

    Report

    Report Number
    3007566237-2018-01664
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    January 29, 2018
    Report Date
    June 1, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BLASBERG, F., WOJTECKI, L., ELBEN, S., SLOTTY, P.J., VESPER, J., SCHNITZLER, A., GROISS, S.J. COMPARISON OF AWAKE VS. ASLEEP SURGERY FOR SUBTHALAMIC DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE. NEUROMODULATION 2018. DOI: 10.1111/NER.12766. 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. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE, NOR WAS THE PUBLISHED DATE. MEDICAL DEVICES: PRODUCT ID NEU_INS_STIMULATOR, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) SURGERY FOR PARKINSON¿S DISEASE (PD) IS USUALLY PERFORMED AS AWAKE SURGERY ALLOWING SUFFICIENT INTRAOPERATIVE TESTING. RECENTLY, OUTCOMES AFTER ASLEEP SURGERY HAVE BEEN ASSUMED COMPARABLE. HOWEVER, DIRECT COMPARISONS BETWEEN AWAKE AND ASLEEP SURGERY ARE SCARCE. TO INVESTIGATE THE DIFFERENCE BETWEEN AWAKE AND ASLEEP SURGERY COMPARING MOTOR AND NONMOTOR OUTCOME AFTER SUBTHALAMIC NUCLEUS (STN)-DBS IN A LARGE SINGLE CENTER PD POPULATION. NINETY-SIX PATIENTS WERE RETROSPECTIVELY MATCHED PAIRWISE (48 ASLEEP AND 48 AWAKE) AND COMPARED REGARDING IMPROVEMENT OF UNIFIED PD RATING SCALE MOTOR SCORE (UPDRS-III), COGNITIVE FUNCTION, LEVODOPA-EQUIVALENT-DAILY-DOSE (LEDD), STIMULATION AMPLITUDES, SIDE EFFECTS, SURGERY DURATION, AND COMPLICATION RATES. ROUTINE TESTING TOOK PLACE AT THREE MONTHS AND ONE YEAR POSTOPERATIVELY. CHRONIC DBS EFFECTS (UPDRS-III WITHOUT MEDICATION AND WITH STIMULATION ON [OFF/ON]) SIGNIFICANTLY IMPROVED UPDRS-III ONLY AFTER AWAKE SURGERY AT THREE MONTHS AND IN BOTH GROUPS ONE YEAR POSTOPERATIVELY. ACUTE EFFECTS (PERCENTAGE UPDRS-III REDUCTION AFTER ACTIVATION OF STIMULATION) WERE ALSO SIGNIFICANTLY BETTER AFTER AWAKE SURGERY AT THREE MONTHS BUT NOT AT ONE YEAR COMPARED TO ASLEEP SURGERY. UPDRS-III SUBITEMS ¿FREEZING¿ AND ¿SPEECH¿ WERE SIGNIFICANTLY WORSE AFTER ASLEEP SURGERY AT THREE MONTHS AND ONE YEAR, RESPECTIVELY. LEDD WAS SIGNIFICANTLY LOWER AFTER AWAKE SURGERY ONLY ONE WEEK POSTOPERATIVELY. THE OTHER MEASURES DID NOT DIFFER BETWEEN GROUPS. OVERALL MOTOR FUNCTION IMPROVED FASTER IN THE AWAKE SURGERY GROUP, BUT THE DIFFERENCE CEASED AFTER ONE YEAR. HOWEVER, AXIAL SUBITEMS WERE WORSE IN THE ASLEEP SURGERY GROUP SUGGESTING THAT WORSENING OF AXIAL SYMPTOMS WAS RISKED IMPROVING OVERALL MOTOR FUNCTION. AWAKE SURGERY STILL SEEMS ADVANTAGEOUS FOR STN-DBS IN PD, ALTHOUGH ASLEEP SURGERY MAY BE CONSIDERED WITH LOWER THRESHOLD IN PATIENTS NOT SUITABLE FOR AWAKE SURGERY. REPORTED EVENTS: (1) THERE WERE THIRTEEN CASES OF POSTOPERATIVE INFECTION OF THE STIMULATOR SYSTEM OVER THE PERIOD OF ONE YEAR. (2) THERE WERE AN UNKNOWN NUMBER OF UNEXPECTED HOSPITALIZATIONS/CLINICAL CONTACTS INCLUDING OUTPATIENT VISITS. THE MEAN NUMBER OF THESE EVENTS WAS 2.22 IN THE AWAKE SURGERY GROUP AND 1.79 IN THE ASLEEP SURGERY GROUP. NO SPECIFIC DEVICE INFORMATION WAS AVAILABLE IN THE LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404938 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R