BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 20463351 · Received October 16, 2024

    Report

    Report Number
    3006630150-2024-07003
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    September 20, 2024
    Report Date
    October 16, 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
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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: 7117286. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: 7122733. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6) BATCH: 7125656.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED AN INFECTION AT THE CONNECTION SITE OF THE LEAD AND LEAD EXTENSION ON THE LEFT SIDE OF THE HEAD WHEREIN SHOWING SIGNS OF REDNESS, SWELLING AND FEELING DISCOMFORT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE INFECTED SITE WAS OPENED AND THOROUGHLY FLUSHED, CLEANED AND DISINFECTED AND ANTIBIOTICS WERE ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2567335 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7117056 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention