BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7562061 · Received June 1, 2018

    Report

    Report Number
    3007566237-2018-01661
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    March 3, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENTS. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. TANAKA, M., TANI, N., MARUO, T., OSHINO, S., HOSOMI, K., SAITOH, Y., KISHIMA, H. RISK FACTORS FOR POSTOPERATIVE DELIRIUM AFTER DEEP BRAIN STIMULATION SURGERY FOR PARKINSON DISEASE. WORLD NEUROSURG. 2018. DOI: 10.1016/J.WNEU.2018.03.021. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SUMMARY: OBJECTIVE: THE AIM OF THIS STUDY WAS TO INVESTIGATE THE INCIDENCE OF AND RISK FACTORS FOR POSTOPERATIVE DELIRIUM (POD) AFTER DEEP BRAIN STIMULATION (DBS) SURGERY IN PATIENTS WITH PARKINSON DISEASE. - METHODS: WE ANALYZED THE PREOPERATIVE T1-WEIGHTED MAGNETIC RESONANCE IMAGING DATA OF 71 PATIENTS WITH PARKINSON DISEASE WHO UNDERWENT DBS SURGERY. MULTIPLE REGRESSION ANALYSIS WAS PERFORMED WITH AGE, L-DOPA EQUIVALENT DAILY DOSE, LATERALITY OF THE SURGERY, TARGET REGIONS, NUMBER OF ELECTRODE TRAJECTORIES TRIED, GRAY MATTER VOLUME, AND WHITE MATTER (WM) VOLUME AS EXPLANATORY VARIABLES AND THE DURATION (NUMBER OF DAYS) OF POD AS THE RESPONSE VARIABLE. IN ADDITION, REGIONAL BRAIN ATROPHY ASSOCIATED WITH POD WAS INVESTIGATED BY MEANS OF VOXEL-BASED MORPHOMETRY. RESULTS: EXCLUDING PATIENTS WITH OUTLIERS, 61 PATIENTS WERE INCLUDED IN THE ANALYSES. POD HAD OCCURRED IN 26 OF THE 61 PATIENTS (42.6%). AGE AND TOTAL WM VOLUME WERE SHOWN BY MULTIPLE REGRESSION ANALYSIS TO CORRELATE SIGNIFICANTLY WITH THE DURATION OF POD (P < 0.05 AND < 0.01, RESPECTIVELY). WM WAS SIGNIFICANTLY REDUCED IN THE TEMPORAL STEM, AND THE REDUCTION IN VOLUME CORRELATED SIGNIFICANTLY WITH THE DURATION OF POD (P < 0.001). GRAY MATTER ATROPHY WAS NOT ASSOCIATED WITH POD. - CONCLUSIONS: WE FOUND THAT AGE AND WM ATROPHY IN THE TEMPORAL STEM ARE FACTORS PREDICTIVE OF POD AFTER DBS SURGERY. IN AGED PATIENTS WITH TEMPORAL STEM ATROPHY, SURGICAL PROCEDURES AND POSTOPERATIVE MANAGEMENT SHOULD BE CAREFULLY EXPLORED TO REDUCE THE RISK OF POSTOPERATIVE DELIRIUM. REPORTED EVENTS: 26 PATIENTS WITH DEEP BRAIN STIMULATION (DBS) TO TREAT PARKINSON'S DISEASE (PD) EXPERIENCED POSTOPERATIVE DELIRIUM (POD). POSTOPERATIVE DELIRIUM WAS REPORTEDLY BROADLY DEFINED AS ANY EVENT INVOLVING HALLUCINATIONS, DELUSIONS, OR DISORIENTATION WITHIN 14 DAYS AFTER THE SURGERY, INCLUDING ANY ATTEMPT BY THE PATIENT TO REMOVE THE URINARY CATHETER OR PERIPHERAL VENOUS CATHETER. IT WAS NOTED THAT PATIENTS WHO EXPERIENCED POD HAD SIGNIFICANTLY HIGHER MODIFIED RANKIN SCALE (MRS) SCORES COMPARED TO THOSE WITHOUT, FROM WHICH THE AUTHORS CONCLUDED THEIR ¿OUTCOME WAS WORSE.¿ ALL PATIENTS WERE REPORTEDLY IMPLANTED WITH EITHER 3387 OR 3389 MODEL LEADS. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404859 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other