BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 19762732 · Received July 17, 2024

    Report

    Report Number
    3006630150-2024-04612
    Event Type
    Injury
    Date Received
    July 17, 2024
    Date of Event
    May 6, 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: 7075150.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT DEVELOPED PERIELECTRODE EDEMA TWENTY-SEVEN DAYS AFTER THE IMPLANT PROCEDURE AND HAD SYMPTOMS OF DIZZINESS, AND POSTERAL INSTABILITY. THE EDEMA WAS FOUND, WITH COMPUTED TOMOGRAPHY (CT), AROUND THE IMPLANTED ELECTRODE. THE PHYSICIAN SUSPECTED FOREIGN BODY REACTION AND WAS ADMINISTERED DEXAMETASONA. THE PATIENT IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362844 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 7074894 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention