BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 19762731 · Received July 17, 2024

    Report

    Report Number
    3006630150-2024-04614
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    April 30, 2024
    Report Date
    July 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB220145DC0. MODEL: DB-2201-45-DC. SERIAL: (B)(6). BATCH: 7075156.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED PERIELECTRODE EDEMA AFTER THE IMPLANT PROCEDURE AND HAD SYMPTOMS OF DROWSINESS AND LEFT HEMIPARESIS. THE EDEMA WAS FOUND AROUND THE IMPLANTED ELECTODE. A RIGHT FRONTAL PERIELECTRODE HEMATOMA, MARKED LATERAL VENTRICLE COMPRESSION EDEMA. THE PHYSICIAN SUSPECTED FOREIGN BODY REACTION AND THE PATIENT WAS HOSPITALIZED AND ADMINISTERED DEXAMETASONA AND ANTIBIOTRAPIA. THE PATIENT IS UNDERGOING REHABILITATION AND CONTINUES TO HAVE PHYSICAL SEQUELAE ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362843 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 7074890 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H