BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURETEK?

    MDR report key: 23000581 · Received September 9, 2025

    Report

    Report Number
    3006630150-2025-07345
    Event Type
    Injury
    Date Received
    September 9, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 35973414. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001858 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550. MODEL: DB-3216-55 SERIAL: (B)(6). BATCH: 5001851. UDI: (B)(4). PRODUCT FAMILY: DBS-IPG-PC. UPN: M365DB14320. MODEL: DB-1432. SERIAL: (B)(6). BATCH: 236086. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5002938. UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2203450. MODEL: DB-2203-45. SERIAL: (B)(6). BATCH: 5002957. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: (B)(6), BATCH: 35973414, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001858, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001851, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001244, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002938, UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2203450, MODEL: DB-2203-45, SERIAL: (B)(6), BATCH: 5002957, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION THAT DEVELOPED AROUND THE BURR HOLE COVERS. THE PATIENT'S SYMPTOMS INCLUDED SCABBING AND FLUID DRAINAGE NEAR THE LEAD EXTENSIONS AND LEAD JUNCTION. THE PATIENT WAS PLACED ON ANTIBIOTICS TO TREAT THE INFECTION AND WAS REFERRED TO INFECTIOUS DISEASE SPECIALISTS FOR CULTURE CONFIRMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCATION OF THE EXPLANTED DEVICES REMAINS UNKNOWN. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE CULTURE RESULTS WERE NOT DISCLOSED. THE EXPLANTED DEVICES WERE RETAINED BY THE FACILITY AND WILL NOT BE RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THE PATIENT IS DOING WELL POSTOPERATIVELY AND IS AWAITING HAVING THE DEVICE REIMPLANTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION THAT DEVELOPED AROUND THE BURR HOLE COVERS. THE PATIENT'S SYMPTOMS INCLUDED SCABBING AND FLUID DRAINAGE NEAR THE LEAD EXTENSIONS AND LEAD JUNCTION. THE PATIENT WAS PLACED ON ANTIBIOTICS TO TREAT THE INFECTION AND WAS REFERRED TO INFECTIOUS DISEASE SPECIALISTS FOR CULTURE CONFIRMATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCATION OF THE EXPLANTED DEVICES REMAINS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258497 SURETEK? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-4600-C 35867128

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention