BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8637093 · Received May 23, 2019

    Report

    Report Number
    3007566237-2019-01150
    Event Type
    Injury
    Date Received
    May 23, 2019
    Date of Event
    February 21, 2019
    Report Date
    May 23, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE OR 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 EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. DESCRIPTION OF PROBLEM OR EVENT: 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. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. KAHN, L., MANSOUR, M., XIAN LEE, S., GOUVEIA, E., HANNA, J., GARCES, J., SCULLEN, T., MCCORMACK, E., RIFFLE, J., GLYNN, R., HOUGHTON, D., LEA, G., BIRO, E., BUI, C., SULAIMAN, O., SMITH, R. "LONG-TERM OUTCOMES OF DEEP BRAIN STIMULATION IN SEVERE PARKINSON¿S DISEASE UTILIZING UPDRS III AND MODIFIED HOEHN AND YAHR AS A SEVERITY SCALE." CLINICAL NEUROLOGY AND NEUROSURGERY 179 (2019) 67¿73. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT: OBJECTIVES: DEEP BRAIN STIMULATION (DBS) IS THE SURGICAL TREATMENT OF CHOICE FOR MODERATE TO SEVERE PARKINSON¿S DISEASE (PD). HOWEVER, FEW STUDIES HAVE ASSESSED ITS EFFICACY IN SEVERE PD AS DEFINED BY THE MODIFIED HOEHN AND YAHR SCALE (HY). THIS STUDY EVALUATES LONG-TERM AND MEDICATION OUTCOMES OF DBS IN SEVERE PD. PATIENTS AND METHODS: WE RETROSPECTIVELY COLLECTED THE DATA OF 15 PATIENTS FROM 2008 TO 2014 WITH SEVERE PD TREATED WITH DBS. RETROSPECTIVE ASSESSMENT WITH THE MODIFIED HOEHN AND YAHR SCALE AND MOTOR SUBSET OF THE UNIFIED PARKINSON¿S DISEASE RATING SCALE (UPDRS III) WERE USED TO OBJECTIVELY TRACK SEVERITY AND MOTOR FUNCTION IMPROVEMENT, RESPECTIVELY. LEVODOPA EQUIVALENCE DAILY DOSES (LEDD), NUMBER OF ANTI-PD MEDICATIONS AND NUMBER OF DAILY MEDICATION DOSES WERE USED TO MEASURE IMPROVEMENTS IN MEDICATION BURDEN. DATA WAS EVALUATED USING UNIVARIATE ANALYSES, ONE SAMPLE PAIRED T-TEST, TWO SAMPLE PAIRED T-TEST, AND WILCOXON SIGNED-RANK TEST. RESULTS: THE MEAN POST-OPERATIVE FOLLOW-UP WAS 44.63 MONTHS, AVERAGE AGE AT DIAGNOSIS AND THE AVERAGE AGE AT TIME OF DBS WAS 51.3 YEARS AND 61.5 YEARS, RESPECTIVELY, AND THE TIME FROM DIAGNOSIS TO TREATMENT WAS 13.2 YEARS. SIGNIFICANT DECREASES WERE SEEN IN UPDRS III SCORES (PRE-OP=44.533; POST-OP=26.13; P=0.0094), LEDD (PRE-OP=1679.34 MG; POST-OP=837.48 MG; P=0.0049), AND NUMBER OF DAILY DOSES (PRE-OP=21.266; POST-OP 12.2; P=0.0046). NO SIGNIFICANT DECREASE WAS SEEN IN THE NUMBER OF ANTI-PD MEDICATIONS (PRE-OP=3.8; POST-OP=3.2; P=0.16). CONCLUSION: FOLLOWING DBS, SEVERE PD PATIENTS DEMONSTRATED SIGNIFICANT IMPROVEMENTS IN MOTOR FUNCTION AND MEDICATION BURDEN DURING LONG-TERM FOLLOW-UP. WE BELIEVE OUR RESULTS PROVE THAT DBS IS EFFICACIOUS IN THE MANAGEMENT OF SEVERE PD, AND THAT FURTHER RESEARCH SHOULD FOLLOW TO EXPAND DBS CRITERIA TO INCLUDE SEVERE DISEASE. 1 PATIENT EXPERIENCED AN INFECTION THAT RESULTED IN REPLACEMENT OF HARDWARE. 1 PATIENT EXPERIENCED AN INFECTION THAT DID NOT RESULT IN THE REPLACEMENT OF HARDWARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431745 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other| R