BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 22543458 · Received July 18, 2025

    Report

    Report Number
    3006630150-2025-05630
    Event Type
    Injury
    Date Received
    July 18, 2025
    Date of Event
    June 22, 2025
    Report Date
    May 18, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985051
    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 B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <PJS, NHL>. 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).

    Additional Manufacturer Narrative · 0

    CORRECTION TO THE INITIAL MDR IN BLOCK(S) B5 AND H6. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL PRO CODE SELECTION THAT APPLIES TO THE INDICATION OF THIS DEVICE <PJS, NHL> PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001466, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB3216550, MODEL: DB-3216-55, SERIAL: (B)(6), BATCH: 5001508, 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 INFECTION AT THE POCKET SITE, WHICH WAS NOTED TO BE RED AND SWOLLEN. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PEDIATRIC PATIENT UNDERWENT AN EXPLANT PROCEDURE DUE TO INFECTION AT THE POCKET SITE, WHICH WAS NOTED TO BE RED AND SWOLLEN. THE PATIENT IS DOING WELL POST OPERATIVELY. THE EXPLANTED DEVICE WILL NOT BE RETURNED AS IT WAS DISPOSED PER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165278 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1232 599326 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1