BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE? CARTESIA?

    MDR report key: 23042898 · Received September 12, 2025

    Report

    Report Number
    3006630150-2025-07570
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    June 19, 2025
    Report Date
    September 12, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL APPLICABLE PRODUCT CODE: 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: 7130725, UDI: (B)(4). PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5003630, UDI: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT RECEIVING DEEP BRAIN STIMULATION (DBS) THERAPY EXPERIENCED A RECURRENCE OF RIGIDITY AND SLOWNESS. A CLINICAL EVALUATION BY THE TREATING PHYSICIAN DETERMINED THAT THE LOSS OF THERAPEUTIC EFFECT ON THE PATIENT'S LEFT SIDE WAS ATTRIBUTABLE TO ELEVATED LEAD IMPEDANCES. SUBSEQUENT SURGICAL INTERVENTION REVEALED THAT THE LEAD TAIL HAD BECOME DISCONNECTED FROM THE LEAD EXTENSION HEADER. THE PHYSICIAN ASSESSED THAT THIS DISCONNECTION WAS DUE TO SLIPPAGE BETWEEN THE LEAD TAIL AND THE LEAD EXTENSION HEADER. DURING THE REVISION PROCEDURE, THE SET SCREW WAS LOOSENED TO ALLOW FOR PROPER REINSERTION OF THE LEAD INTO THE HEADER, AFTER WHICH IT WAS SECURELY RETIGHTENED. POSTOPERATIVELY, THE PATIENT DEMONSTRATED CLINICAL IMPROVEMENT. THE ELEVATED IMPEDANCES WERE RESOLVED, AND THE PREVIOUSLY REPORTED SYMPTOMS SUBSIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2169902 VERCISE? CARTESIA? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-2202-45 7130576 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention