BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK?

    MDR report key: 22405252 · Received July 4, 2025

    Report

    Report Number
    3006630150-2025-05181
    Event Type
    Injury
    Date Received
    July 4, 2025
    Date of Event
    June 11, 2025
    Report Date
    November 11, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: (B)(6) UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCK: H6. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7112735, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE RIGHT-SIDED LEAD AND BURR HOLE COVER (BHC) DUE TO INFECTION. THE PATIENT EXPERIENCED FLUID DISCHARGE AT THE AFFECTED SITE. ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION, AND CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT DISCLOSED. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE. ALL EXPLANTED COMPONENTS WERE DISCARDED AND WILL NOT RETURN FOR ANALYSIS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE TO REMOVE THE RIGHT-SIDED LEAD AND BURR HOLE COVER (BHC) DUE TO INFECTION. THE PATIENT EXPERIENCED FLUID DISCHARGE AT THE AFFECTED SITE. ANTIBIOTIC THERAPY WAS INITIATED TO MANAGE THE INFECTION, AND CULTURES WERE OBTAINED; HOWEVER, THE RESULTS WERE NOT DISCLOSED. THE PATIENT IS DOING WELL FOLLOWING THE PROCEDURE. ALL EXPLANTED COMPONENTS WERE DISCARDED AND WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2767719 SURETEK? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-4600-C 32358224 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention