BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23101512 · Received September 19, 2025

    Report

    Report Number
    3006630150-2025-07822
    Event Type
    Injury
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 16, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: 7140083 UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCK: B5. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEEP BRAIN STIMULATION (DBS) SYSTEM IMPLANT PROCEDURE. DURING INTRAOPERATIVE TESTING, THE PATIENT'S ARM BEGAN TO HURT, AND HIS FACE DROOPED. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING NO SIGNIFICANT ABNORMALITIES. THE PHYSICIAN DOES NOT BELIEVE THE SYMPTOMS WERE RELATED TO THE PROCEDURE OR THE DEVICE. THE IMPLANT PROCEDURE WAS COMPLETED ONE WEEK AFTER THE DESCRIBED EVENT. THE PATIENT HAS FULLY RECOVERED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEEP BRAIN STIMULATION (DBS) SYSTEM IMPLANT PROCEDURE. DURING INTRAOPERATIVE TESTING, THE PATIENT'S ARM BEGAN TO HURT, AND HIS FACE DROOPED. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING NO SIGNIFICANT ABNORMALITIES. THE PHYSICIAN DOES NOT BELIEVE THE SYMPTOMS WERE RELATED TO THE PROCEDURE OR THE DEVICE. THE IMPLANT PROCEDURE WAS COMPLETED ONE WEEK AFTER THE DESCRIBED EVENT. THE PATIENT HAS FULLY RECOVERED. IT WAS REPORTED THAT THE PATIENT UNDERWENT A DEEP BRAIN STIMULATION (DBS) SYSTEM STAGE 2 PROCEDURE. DURING INTRAOPERATIVE TESTING, THE PATIENT'S ARM BEGAN TO HURT, AND HIS FACE DROOPED. THE PATIENT WAS HOSPITALIZED FOR ONE DAY. A COMPUTED TOMOGRAPHY (CT) SCAN WAS PERFORMED, REVEALING NO SIGNIFICANT ABNORMALITIES. THE PHYSICIAN DOES NOT BELIEVE THE SYMPTOMS WERE RELATED TO THE PROCEDURE OR THE DEVICE. THE IMPLANT PROCEDURE WAS COMPLETED ONE WEEK AFTER THE DESCRIBED EVENT. THE PATIENT HAS FULLY RECOVERED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PHYSICIAN IS UNCERTAIN ABOUT THE CAUSE OF THE SYMPTOMS OBSERVED DURING THE CASE. THE PHYSICIAN DOES NOT BELIEVE THE SYMPTOMS WERE DEVICE RELATED, AS THEY BEGAN PRIOR TO ANY DEVICE IMPLANTATION. THE PATIENT HAS FULLY RECOVERED, AND ALL IMAGING STUDIES RETURNED NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766422 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7140281 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Hospitalization