BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12981909 · Received December 12, 2021

    Report

    Report Number
    2182207-2021-02151
    Event Type
    Injury
    Date Received
    December 12, 2021
    Date of Event
    June 20, 2021
    Report Date
    December 12, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387, LOT#: UNKNOWN, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    SEUNG HYUN LEE, MI SUN KIM, YUN SU HWANG, SUNGYANG JO, KYE WON PARK, SANG RYONG JEON, SUN JU CHUNG. CLINICAL IMPLICATION OF STIMULATION-INDUCED DYSKINAESIA IN GLOBUS PALLIDUS DEEP BRAIN STIMULATION FOR ADVANCED PARKINSON¿S DISEASE. DOI:10.1136/JNNP-2020-326015. INTRODUCTION DEEP BRAIN STIMULATION (DBS) HAS BEEN PROVEN EFFECTIVE IN IMPROVING MOTOR SYMPTOMS AND REDUCING LEVODOPA-INDUCED DYSKINAESIA (LID) OF ADVANCED PARKINSON¿S DISEASE (PD). DBS FOR PD TARGETS EITHER THE SUBTHALAMIC NUCLEUS (STN) OR THE GLOBUS PALLIDUS INTERNA (GPI). THE THERAPEUTIC EFFECTS ON MOTOR SYMPTOMS ARE SIMILAR BETWEEN STN AND GPI DBS. HOWEVER, IT HAS BEEN REPORTED THAT GPI DBS IS MORE EFFECTIVE IN IMPROVING LID. THUS, GPI DBS MAY BE PREFERRED IN PATIENTS WITH SEVERE LID. STIMULATION-INDUCED DYSKINAESIA (SID) CAN BE OBSERVED IN PATIENTS WHO UNDERGO DBS. SID IN PATIENTS WITH PD WHO UNDERGO STN DBS MAY INDICATE PROPER POSITIONING OF THE LEAD, AND IS CONSIDERED TO BE A GOOD PROGNOSTIC FACTOR FOR MOTOR OUTCOME. SID MAY ALSO DEVELOP IN GPI DBS, AND DORSAL GPI OR GLOBUS PALLIDUS EXTERNA (GPE) STIMULATION IN PARTICULAR MAY BE ASSOCIATED WITH SID. HOWEVER, LITTLE IS KNOWN ABOUT THE CLINICAL IMPLICATIONS OF SID IN GPI DBS. THEREFORE, THE AIM OF THIS STUDY WAS TO INVESTIGATE THE EFFECT OF SID ON THE CLINICAL OUTCOMES OF GPI DBS. REPORTED EVENTS: IT WAS REPORTED THAT THERE WAS ONE PATIENT THAT EXPERIENCED BRAIN HEMORRHAGE AND LEAD REVISION OR REMOVAL AFTER THE DBS SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1879684 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female Required Intervention