BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK

    MDR report key: 21758782 · Received April 2, 2025

    Report

    Report Number
    3006630150-2025-02087
    Event Type
    Injury
    Date Received
    April 2, 2025
    Date of Event
    December 17, 2024
    Report Date
    April 2, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729820802
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7103404. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7104005.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED EROSION AND POOR WOUND HEALING AT THE BURR-HOLE COVER IMPLANT SITE FROM A PROCEDURE THAT WAS REPORTED IN MDR FORM 3006630150-2024-09432. IT WAS NOTED THAT THE PATIENT WAS NOT HEALING TO SATISFACTION, THERE IS NO MEDICAL CONDITION THAT MAY HAVE CONTRIBUTED TO EVENT, AS A RESULT THE REASON FOR POOR WOUND HEALING AND EROSION IS UNKNOWN PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE BURR-HOLE COVER AND LEADS WERE REMOVED BEFORE COMPLETING THE PROCEDURE. THE PATIENT HAS SINCE THEN RECOVERED AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732017 SURETEK STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-4600-C 31313102 08714729820802

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention