BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 24665772 · Received March 23, 2026

    Report

    Report Number
    3006630150-2026-01723
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    February 24, 2026
    Report Date
    May 14, 2026
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: MODEL: DB-2202-30 SERIAL: (B)(6). BATCH: 7083393 CATALOG DESCRIPTION: DBS DIRECTIONAL LEAD STERILE KIT 30 CM UDI: (B)(4). MODEL: DB-1216 SERIAL: (B)(6). BATCH: 597778 CATALOG DESCRIPTION: VERCISE GENUS R16 IPG KIT UDI: (B)(4).

    Additional Manufacturer Narrative · 0

    DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: MODEL: UNKNOWN. SERIAL: UNKNOWN. BATCH: UNKNOWN. CATALOG DESCRIPTION: UNKNOWN. UDI: UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS FEELING UNUSUALLY LOW AND INACTIVE. UPON ADMITTANCE TO THE HOSPITAL, HIGH IMPEDANCE VALUES WERE IDENTIFIED ON BOTH LEADS. REPROGRAMMING OF THE THERAPY WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THESE ELEVATED IMPEDANCE MEASUREMENTS RESULTED IN INADEQUATE STIMULATION, PREVENTING THE PATIENT FROM RECEIVING THE INTENDED THERAPEUTIC BENEFIT FOR PARKINSONS DISEASE. XRAY IMAGING WAS ORDERED TO ASSESS POTENTIAL DAMAGE TO THE LEADS OR EXTENSIONS, THOUGH RESULTS ARE STILL PENDING. THE PATIENT ALSO NOTED A RECENT FALL ON THE LEFT SIDE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) IS LOCATED BUT REPORTED NO DIRECT IMPACT TO THE BATTERY. THE PATIENT REMAINS HOSPITALIZED AS THE ISSUE CONTINUES TO BE INVESTIGATED. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE SYMPTOMS THAT THE PATIENT EXPERIENCED WAS SLOWNESS IN MOVEMENT, INCREASE IN TREMORS AND PAIN RESULTING IN AN INABILITY TO PERFORM HIS DAILY ACTIVITIES. THE XRAY PERFORMED SHOWED NO DAMAGE TO THE LEADS OR LEAD EXTENSIONS. THE PHYSICIAN ALSO NOTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) MIGHT BE THE CAUSE OF THE HIGH IMPEDANCES BECAUSE IMPEDANCES ARE SHOWING AT THE SAME CONTACT LEVELS ON BOTH LEADS. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL AND WILL BE UNDER A PERIOD OF OBSERVATION TO MONITOR IMPEDANCES AND CLINICAL RESULTS. THE MODEL AND SERIAL NUMBERS OF THE LEADS AND IPG WERE ALSO PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT WAS FEELING UNUSUALLY LOW AND INACTIVE. UPON ADMITTANCE TO THE HOSPITAL, HIGH IMPEDANCE VALUES WERE IDENTIFIED ON BOTH LEADS. REPROGRAMMING OF THE THERAPY WAS ATTEMPTED BUT WAS UNSUCCESSFUL. THESE ELEVATED IMPEDANCE MEASUREMENTS RESULTED IN INADEQUATE STIMULATION, PREVENTING THE PATIENT FROM RECEIVING THE INTENDED THERAPEUTIC BENEFIT FOR PARKINSONS DISEASE. XRAY IMAGING WAS ORDERED TO ASSESS POTENTIAL DAMAGE TO THE LEADS OR EXTENSIONS, THOUGH RESULTS ARE STILL PENDING. THE PATIENT ALSO NOTED A RECENT FALL ON THE LEFT SIDE WHERE THE IMPLANTABLE PULSE GENERATOR (IPG) IS LOCATED BUT REPORTED NO DIRECT IMPACT TO THE BATTERY. THE PATIENT REMAINS HOSPITALIZED AS THE ISSUE CONTINUES TO BE INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272084 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-30 7083293 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1