BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 23785543 · Received December 11, 2025

    Report

    Report Number
    3006630150-2025-11370
    Event Type
    Injury
    Date Received
    December 11, 2025
    Date of Event
    November 13, 2025
    Report Date
    February 27, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK DB2 ADDITIONAL PROCODES: 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: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 24985328. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA . BATCH: 27282905. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 25168210. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    DB2: 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: (B)(6) UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 24985328, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA , BATCH: 27282905, UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: NA, BATCH: 25168210, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: (B)(6), UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    DB2: 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: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 24985328. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 27282905. UDI: (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600-C. SERIAL: NA. BATCH: 25168210. UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: (B)(6). UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD SEVERE TREMORS, AND ALTHOUGH THE SYSTEM HELPED, THEY WANTED TO REVISE THE SYSTEM TO TRY TO OBTAIN MORE SYMPTOM RELIEF. PATIENT DID WELL POSTOPERATIVELY BUT CONTINUES TO EXPERIENCE SEVERE TREMORS. EXPLANTED DEVICES WERE RETAINED BY THE FACILITY; AS SUCH PHYSICAL ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHEREIN THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM WAS REMOVED FOR AN UNKNOWN REASON. NO ADDITIONAL INFORMATION COULD BE OBTAINED AT THIS TIME. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD SEVERE TREMORS, AND ALTHOUGH THE SYSTEM HELPED, THEY WANTED TO REVISE THE SYSTEM TO TRY TO OBTAIN MORE SYMPTOM RELIEF. PATIENT DID WELL POSTOPERATIVELY BUT CONTINUES TO EXPERIENCE SEVERE TREMORS. EXPLANTED DEVICES WERE RETAINED BY THE FACILITY; AS SUCH PHYSICAL ANALYSIS COULD NOT BE CONDUCTED IN OUR LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2624820 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 515317 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Required Intervention