BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23216449 · Received October 4, 2025

    Report

    Report Number
    2124215-2025-70286
    Event Type
    Injury
    Date Received
    October 4, 2025
    Date of Event
    September 12, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    00191506023577
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS.

    Additional Manufacturer Narrative · 0

    D2.B.: PRO CODE (PRODUCT CODE): NHL, PJS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEHISCENCE OF THE LEFT SIDE LEAD EXTENSION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WHICH WAS PROTRUDING THROUGH THE SKIN AT THE LEAD EXTENSION SITE. THE PATIENT UNDER A PROCEDURE IN WHICH THE AREA WAS OPENED, CLEANED OUT, THE LEAD EXTENSION WAS EXPLANTED AND A NEW DEVICE IMPLANTED. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT IS EXPECTED TO FULLY RECOVER AND THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DEHISCENCE OF THE LEFT SIDE LEAD EXTENSION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM WHICH WAS PROTRUDING THROUGH THE SKIN AT THE LEAD EXTENSION SITE. THE PATIENT UNDER A PROCEDURE IN WHICH THE AREA WAS OPENED, CLEANED OUT, THE LEAD EXTENSION WAS EXPLANTED AND A NEW DEVICE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1439020 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-3128-55B 5002265 00191506023577

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Male Required Intervention