BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NA

    MDR report key: 23751532 · Received December 8, 2025

    Report

    Report Number
    3006630150-2025-11277
    Event Type
    Injury
    Date Received
    December 8, 2025
    Date of Event
    December 17, 2021
    Report Date
    February 16, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN DECEMBER 2021 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-PC UPN: M365DB14080, MODEL: DB-1408, SERIAL: (B)(6), BATCH: 203511, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2021 ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-IPG-PC UPN: M365DB14080 MODEL: DB-1408 SERIAL: (B)(6) BATCH: 203511 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT'S LEAD EXTENSION PROTRUDED THROUGH THE SKIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PHYSICIAN DID NOT WANT TO RISK AN INFECTION THEREFORE; THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE DBS SYSTEM. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THE LOCAL REPRESENTATIVE WAS NOT PRESENT FOR THE PROCEDURE TO RETRIEVE THEM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENTS LEAD EXTENSION PROTRUDED THROUGH THE SKIN AT THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. THE PHYSICIAN DID NOT WANT TO RISK AN INFECTION; THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE DBS SYSTEM. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THE LOCAL REPRESENTATIVE WAS NOT PRESENT FOR THE PROCEDURE TO RETRIEVE THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29136 NA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION NM-3138-55 7092559 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention