BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK?

    MDR report key: 23660816 · Received November 26, 2025

    Report

    Report Number
    3006630150-2025-10871
    Event Type
    Injury
    Date Received
    November 26, 2025
    Date of Event
    September 10, 2025
    Report Date
    December 18, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: DATE OF EVENT - APPROXIMATELY SOMETIME AFTER 23SEP2025 - EXACT EVENT DATE IS UNKNOWN. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002773, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002773, UDI: (B)(4). PRODFUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001669, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001666, UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-PC, UPN: M365DB14320, MODEL: DB-1432, SERIAL: (B)(6), BATCH: 236096, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA , BATCH: 36188567, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITES ON THE HEAD WHERE THE BURR HOLE COVERS WERE IMPLANTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WERE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE INCISION SITES ON THE HEAD WHERE THE BURR HOLE COVERS WERE IMPLANTED. THE PATIENT UNDERWENT A REVISION PROCEDURE WHERE THE FULL DBS SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WERE DISCARDED BY THE MEDICAL FACILITY AND WERE NOT RETURNED. ADDITIONAL INFORMATION WAS RECEIVED THAT INDICATED THE PATIENT EXPERIENCED PURULENT DRAINAGE FROM THE RIGHT FRONTAL WOUND. THE PATIENT UNDERWENT A LEFT FRONTAL WOUND WASHOUT IN ATTEMPT TO PREVENT EXPLANTING THE DBS SYSTEM A FEW DAYS PRIOR TO THE EXPLANT PROCEDURE. THE PATIENT WAS DIAGNOSED WITH CORYNEBACTERIUM BOVIS INFECTION. THE PATIENT WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING WELL POSTOPERATIVELY. THE CORRECT EVENT DATE AND EXPLANT DATE WERE ALSO PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912793 SURETEK? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-4600-C 36150611 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention