BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23348728 · Received October 21, 2025

    Report

    Report Number
    3006630150-2025-09344
    Event Type
    Injury
    Date Received
    October 21, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729896104
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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: 7141829, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7143934, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE IMPLANTATION OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM, THE PHYSICIAN ENCOUNTERED AN ISSUE WHILE TUNNELING THE LEAD. THE TUNNELING TOOL INADVERTENTLY EXITED THE SKIN AND THEN RE-ENTERED BEFORE REACHING THE POCKET SITE IN THE CHEST. DUE TO THE BREACH OF THE STERILE FIELD AND POTENTIAL CONTAMINATION, THE PHYSICIAN ELECTED TO REPLACE BOTH LEAD EXTENSIONS AND SUCCESSFULLY RE-TUNNELED THE NEW EXTENSIONS UNDER STERILE CONDITIONS. THE PATIENT SUBSEQUENTLY EXPERIENCED BLEEDING, PAIN, DISCOMFORT, SWELLING, AND REDNESS ALONG THE TUNNELING PATH. THERE WERE NO OTHER REPORTED COMPLICATIONS POSTOPERATIVELY. THE PHYSICIAN ATTRIBUTED THE TUNNELING COMPLICATION TO THE SHARPNESS AND FLIMSINESS OF THE TUNNELING TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976197 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-4254 35765306 08714729896104

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention