BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 23669023 · Received November 27, 2025

    Report

    Report Number
    3006630150-2025-10928
    Event Type
    Injury
    Date Received
    November 27, 2025
    Date of Event
    June 30, 2025
    Report Date
    January 6, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985051
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001249. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: 5001880. UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT D2B: ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE - <NHL, PJS>. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365DB3216550. MODEL: DB-3216-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE DEEP BRAIN STIMULATION (DBS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE DBS PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO AN INFECTION. ACCORDING TO THE PHYSICIAN ASSESSMENT, THE INFECTION ORIGINATED AROUND THE LEAD EXTENSIONS AND SUBSEQUENTLY SPREAD TO THE IMPLANTABLE PULSE GENERATOR (IPG) SITE. DUE TO A NON DEVICE RELATED MEDICAL CONDITION, THE PATIENT TENDS TO SCRATCH AND PICK AT WOUNDS; THE PHYSICIAN INDICATED THAT THIS OCCURRED AND THE INFECTION BEGAN TO DEVELOP. ACCORDING TO THE PHYSICIAN, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) WAS CONFIRMED. THE PATIENT WAS PLACED ON ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED FOR ANALYSIS. POSTOPERATIVELY, THE PATIENT WAS DOING VERY WELL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THESE DEEP BRAIN STIMULATION (DBS) DEVICES WERE EXPLANTED DUE TO AN UNKNOWN REASON. THE LOCATION OF THE DEVICE IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199064 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 778096 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male Required Intervention