BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 17238224 · Received June 30, 2023

    Report

    Report Number
    3006630150-2023-03782
    Event Type
    Injury
    Date Received
    June 30, 2023
    Date of Event
    September 1, 2020
    Report Date
    June 30, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(6); BATCH: 7071793.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE LEAD EXTENSIONS WERE EXPLANTED. THE EXPLANTED DEVICES WERE NOT RETURNED TO BSC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1423058 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7071764 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention