BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 24103889 · Received January 16, 2026

    Report

    Report Number
    3006630150-2026-00389
    Event Type
    Injury
    Date Received
    January 16, 2026
    Date of Event
    November 17, 2025
    Report Date
    January 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATION - EVENT OCCURRED AFTER STAGE ONE DBS ON 11-17-2025. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7140419, UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    CORRECTION TO BLOCKS: E1, H6. BLOCK B3: APPROXIMATION - EVENT OCCURRED AFTER STAGE ONE DBS ON 11-17-2025. BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODES: PJS, NHL. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS; UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7140419; UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A HEART ATTACK AFTER THEIR STAGE ONE PROCEDURE. THE EXACT TIMING AND CAUSE OF THE HEART ATTACK REMAIN UNKNOWN. STAGE TWO OF THE DBS PROCEDURE WAS POSTPONED DUE TO THIS EVENT. THE PATIENT REQUIRES CLEARANCE FROM A CARDIOLOGIST BEFORE PROCEEDING FURTHER. THE PATIENT'S NEUROSURGEON DOES NOT BELIEVE THAT ANY DEVICE CONTRIBUTED TO THE HEART ATTACK. THE PATIENT HAD NO PRIOR CARDIAC HISTORY; THIS WAS THE FIRST EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED A HEART ATTACK AFTER THEIR STAGE ONE PROCEDURE. THE EXACT TIMING AND CAUSE OF THE HEART ATTACK REMAIN UNKNOWN. STAGE TWO OF THE DBS PROCEDURE WAS POSTPONED DUE TO THIS EVENT. THE PATIENT REQUIRES CLEARANCE FROM A CARDIOLOGIST BEFORE PROCEEDING FURTHER. THE PATIENT'S NEUROSURGEON DOES NOT BELIEVE THAT ANY DEVICE CONTRIBUTED TO THE HEART ATTACK. THE PATIENT HAD NO PRIOR CARDIAC HISTORY; THIS WAS THE FIRST EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE REMAINS IMPLANTED IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED STATED THAT THE PHYSICIAN'S ASSESSMENT OF THE HEART ATTACK EXPERIENCED BY THE PATIENT WAS NOT RELATED TO THE DEVICE OR THE DBS IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237351 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7139813 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other