BEUDAMED
    FDA Adverse Event Death Summary report: N

    VERCISE PC

    MDR report key: 25250433 · Received May 21, 2026

    Report

    Report Number
    3006630150-2026-03369
    Event Type
    Death
    Date Received
    May 21, 2026
    Date of Event
    July 20, 2024
    Report Date
    May 21, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729984467
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: BOLIER E, HOLEWIJN R, DE BIE RMA, ET AL. VALIDATION OF THE HOTSPOT FOR DORSOLATERAL SUBTHALAMIC NUCLEUS TARGETING IN DEEP BRAIN STIMULATION SURGERY FOR PARKINSONS DISEASE: A POST HOC ANALYSIS OF A RANDOMISED CONTROLLED TRIAL. J NEUROL NEUROSURG PSYCHIATRY. MAR 13 2025;96(3):272-279. DOI:10.1136/JNNP-2023-333164. BLOCK D2B: ADDITIONAL PRODUCT CODES NHL, PJS. WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. MODEL NUMBER/CATALOG NUMBER: UNK-P-DBS-LINEAR_LEADS. SERIAL NUMBER: UNKNOWN. BATCH/LOT NUMBER: UNKNOWN. MODEL/CATALOG DESCRIPTION: UNKNOWN. UNIQUE IDENTIFIER (UDI) : WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. MODEL NUMBER/CATALOG NUMBER: UNK-P-DBS-LINEAR_LEADS. SERIAL NUMBER: UNKNOWN. BATCH/LOT NUMBER: UNKNOWN. MODEL/CATALOG DESCRIPTION: UNKNOWN. UNIQUE IDENTIFIER (UDI) : WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. MODEL NUMBER/CATALOG NUMBER: UNK-P-DBS-LINEAR_LEADS. SERIAL NUMBER: UNKNOWN. BATCH/LOT NUMBER: UNKNOWN. MODEL/CATALOG DESCRIPTION: UNKNOWN. UNIQUE IDENTIFIER (UDI) : WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT. MODEL NUMBER/CATALOG NUMBER: UNK-P-DBS-LINEAR_LEADS. SERIAL NUMBER: UNKNOWN. BATCH/LOT NUMBER: UNKNOWN. MODEL/CATALOG DESCRIPTION: UNKNOWN. UNIQUE IDENTIFIER (UDI) : WE ARE UNABLE TO PROVIDE THE UNIQUE IDENTIFIER (UDI) # FOR THIS PRODUCT. ALL AVAILABLE PRODUCT DATA HAS BEEN INCLUDED IN THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE ARTICLE TITLED VALIDATION OF THE HOTSPOT FOR DORSOLATERAL SUBTHALAMIC NUCLEUS TARGETING IN DEEP BRAIN STIMULATION SURGERY FOR PARKINSONS DISEASE: A POST HOC ANALYSIS OF A RANDOMISED CONTROLLED TRIAL THAT A PATIENT DIED. VISUALIZATION OF THE DORSOLATERAL SUBTHALAMIC NUCLEUS (STN) REMAINS CHALLENGING ON 1.5 AND 3TESLA T2 WEIGHTED MRI. OUR PREVIOUSLY DEFINED HOTSPOT, RELATIVE TO THE WELL VISUALIZED MEDIAL STN BORDER, SERVES AS AN MRI LANDMARK FOR DORSOLATERAL STN IDENTIFICATION IN DEEP BRAIN STIMULATION (DBS). WE AIMED TO VALIDATE THIS HOTSPOT IN A SEPARATE TRIAL COHORT OF PARKINSONS DISEASE (PD) PATIENTS AND REFINE ITS LOCATION. PATIENTS WERE SELECTED FROM A SINGLE CENTER RANDOMIZED CONTROLLED TRIAL COMPARING BILATERAL STN DBS SURGERY UNDER GENERAL VERSUS LOCAL ANESTHESIA, THAT INCLUDED PATIENTS WITH PD BETWEEN (B)(6) 2015 AND (B)(6) 2019. PATIENTS UNDERWENT DBS ELECTRODE IMPLANTATION UNDER LOCAL ANESTHESIA (AWAKE) OR GENERAL ANESTHESIA (ASLEEP). FINAL ELECTRODE PLACEMENT WAS DONE USING ELECTRODES WITH FOUR STIMULATION LEVELS VERCISE CARTESIA DIRECTIONAL LEADS, A SUBCUTANEOUS OR SUBPECTORAL, INFRACLAVICULAR PULSE GENERATOR, VERCISE PC WAS IMPLANTED IN THE SAME SURGICAL SESSION. TWO PATIENTS WERE LOST TO FOLLOW UP, ONE RETRACTED PARTICIPATION AND ONE PATIENT DIED DUE TO UNRELATED CAUSE PRIOR TO FOLLOW UP. THE CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509671 VERCISE PC STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1140-S 08714729984467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death