BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19015116 · Received April 1, 2024

    Report

    Report Number
    3006630150-2024-01986
    Event Type
    Injury
    Date Received
    April 1, 2024
    Date of Event
    May 24, 2021
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7078766. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 27123411. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 509293. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7086928. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7086907.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED FOR A FOLLOW UP AND COMPUTED TOMOGRAPHY (CT) SHOWED THAT THE RIGHT LEAD HAD PULLED BACK AND WAS NOT NEAR THE GLOBUS PALLIDUS INTERNUS (GPI). THE CT ALSO SHOWED THAT THE LEFT LEAD HAD NOT BEEN PLACED WELL BUT WAS LOCATED NEAR THE GLOBUS PALLIDUS EXTERNA (GPE). THE PATIENT UNDERWENT A REVISION PROCEDURE TO REPLACE AND REPOSITION THE DBS SYSTEM TO TARGET THE SUBTHALAMIC NUCLEUS (STN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1517495 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7078691 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Female Required Intervention