BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 24373147 · Received February 17, 2026

    Report

    Report Number
    3006630150-2026-00949
    Event Type
    Injury
    Date Received
    February 17, 2026
    Date of Event
    January 21, 2026
    Report Date
    April 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    PJS
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THEY REMAIN IMPLANTED IN THE PATIENT; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED. THE REVIEW OF THE DHR IDENTIFIED THAT THERE WERE NO PROCESS RELATED NON-CONFORMANCES, SCRAP, OR REWORK PERFORMED DURING THE PRODUCTION THAT COULD EXPLAIN THE EVENT. THE REVIEWS ENSURE EACH DEVICE MEETS SPECIFICATION PRIOR TO RELEASE FOR USE. THERE IS NO INDICATION THE DEVICE MANUFACTURING PROCESS CONTRIBUTED TO THE REPORTED COMPLAINT. A LABELING REVIEW WAS PERFORMED ON THE DEVICE'S INSTRUCTIONS FOR USE (IFU). THERE IS NO EVIDENCE THAT THE DEVICE WAS USED IN A MANNER INCONSISTENT WITH THE LABELLED INDICATIONS. BASED ON A THOROUGH REVIEW OF THE REPORTED COMPLAINT, BOSTON SCIENTIFIC HAS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF KNOWN INHERENT RISK OF DEVICE.

    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: 7141419, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A BILATERAL STAGE 1 IMPLANT PROCEDURE TARGETING THE VENTRAL INTERMEDIATE NUCLEUS (VIM) FOR ESSENTIAL TREMOR. EVERYTHING WAS NORMAL DURING AND IMMEDIATELY FOLLOWING THE PROCEDURE; HOWEVER, LATER THAT NIGHT THE PATIENT SHOWED SIGNS OF INTRACRANIAL HEMORRHAGE. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED BLEEDS ON BOTH SIDES OF THE BRAIN, ONE SUPERFICIAL AND THE OTHER IN THE THALAMUS, CLOSE TO THE DISTAL TIP OF THE LEAD. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL AND HAS NOT YET BEEN DISCHARGED. THE PATIENT WILL BE OBSERVED UNTIL THEY ARE EITHER CLEARED TO UNDERGO THE SECOND STAGE OF THEIR DBS OR RELEASED FOR OUTPATIENT CARE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A BILATERAL STAGE 1 IMPLANT PROCEDURE TARGETING THE VENTRAL INTERMEDIATE NUCLEUS (VIM) FOR ESSENTIAL TREMOR. EVERYTHING WAS NORMAL DURING AND IMMEDIATELY FOLLOWING THE PROCEDURE; HOWEVER, LATER THAT NIGHT THE PATIENT SHOWED SIGNS OF INTRACRANIAL HEMORRHAGE. A COMPUTED TOMOGRAPHY (CT) SCAN CONFIRMED BLEEDS ON BOTH SIDES OF THE BRAIN, ONE SUPERFICIAL AND THE OTHER IN THE THALAMUS, CLOSE TO THE DISTAL TIP OF THE LEAD. THE PATIENT HAS BEEN ADMITTED TO THE HOSPITAL AND HAS NOT YET BEEN DISCHARGED. THE PATIENT WILL BE OBSERVED UNTIL THEY ARE EITHER CLEARED TO UNDERGO THE SECOND STAGE OF THEIR DBS OR RELEASED FOR OUTPATIENT CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432303 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR PJS BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7139411 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| H