BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23287146 · Received October 15, 2025

    Report

    Report Number
    3006630150-2025-08779
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 4, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2202-45. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7102604. MODEL/CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM. UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: NM-3138-55. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 7110638; 7112840. MODEL/CATALOG DESCRIPTION: 55CM 8 CONTACT EXTENSION. UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-1216. SERIAL NUMBER: (B)(6). BATCH/LOT NUMBER: 566071. MODEL/CATALOG DESCRIPTION: VERCISE GENUS R16 IPG KIT. UNIQUE IDENTIFIER (UDI) # (B)(4).

    Additional Manufacturer Narrative · 0

    BLOCK D2B PRO CODE (PRODUCT CODE): NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL NUMBER/CATALOG NUMBER: DB-2202-45, SERIAL NUMBER:(B)(6), BATCH/LOT NUMBER: 7102604, MODEL/CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 45CM, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: NM-3138-55, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 7110638; 7112840, MODEL/CATALOG DESCRIPTION: 55CM 8 CONTACT EXTENSION, UNIQUE IDENTIFIER (UDI) # (B)(4). MODEL NUMBER/CATALOG NUMBER: DB-1216, SERIAL NUMBER: (B)(6), BATCH/LOT NUMBER: 566071, MODEL/CATALOG DESCRIPTION: VERCISE GENUS R16 IPG KIT, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A WOUND ON THEIR SCALP AT THE LEAD AND LEAD EXTENSION SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM AND UNDERWENT A PROCEDURE IN WHICH ALL THE DEVICES WERE EXPLANTED. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY. IT WAS ADDITIONALLY REPORTED THAT THE PATIENT HAS FULLY RECOVERED POST-OPERATIVELY, IT WAS NOTED THAT HAVING HAD ALL DEVICES EXPLANTED WAS DUE TO THEIR PRE-EXISTING CONDITION OF TREMORS HAVING RETURNED. CULTURES WERE TAKEN, AND WERE NEGATIVE. THE IMPLANTABLE PULSE GENERATOR (IPG) WAS EXPLANTED OUT OF AN ABUNDANCE OF CAUTION AT THE PHYSICIANS' DISCRETION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A WOUND ON THEIR SCALP AT THE LEAD AND LEAD EXTENSION SITE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM AND UNDERWENT A PROCEDURE IN WHICH ALL THE DEVICES WERE EXPLANTED. THE PATIENT IS EXPECTED TO FULLY RECOVER. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2791179 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7116320 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention