BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 23577529 · Received November 17, 2025

    Report

    Report Number
    3006630150-2025-10500
    Event Type
    Injury
    Date Received
    November 17, 2025
    Date of Event
    July 9, 2025
    Report Date
    November 17, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7131792 UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7131292 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7133780 UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550 MODEL: NM-3138-55 SERIAL: (B)(6) BATCH: 7131763 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: NA BATCH: 35560178 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600-C SERIAL: NA BATCH: 35448608 UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4605C0 MODEL: DB-4605-C SERIAL: NA BATCH: 34570912 UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A SYSTEM EXPLANT PROCEDURE DUE TO INFECTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE LOCATION OF THE EXPLANTED DEVICES IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2362481 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 775833 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Required Intervention