BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 22983685 · Received September 5, 2025

    Report

    Report Number
    3006630150-2025-07272
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    July 2, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    NHL
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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: 7093203. UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED HIGH IMPEDANCES. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE IT WAS DISCOVERED THAT THE LEAD EXTENSION WIRES WERE TWISTED UP IN THE POCKET OF THE IMPLANTABLE PULSE GENERATOR (IPG). THE LEAD EXTENSIONS WERE REPLACED AND THE HIGH IMPEDANCES RESOLVED. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE EXPLANTED LEAD EXTENSIONS WERE RETAINED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286260 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR NHL BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7091684 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Required Intervention