BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 15871865 · Received November 28, 2022

    Report

    Report Number
    3006630150-2022-06602
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    September 23, 2022
    Report Date
    November 28, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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)(4). BATCH: 7082657. PRODUCT FAMILY: DBS-IPG-R-MRI. UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(4). BATCH: 521109. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). BATCH: 7088366. PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(4). BATCH: 7088439. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: (B)(4). BATCH: 27889964.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A SCALP INFECTION, THE EXACT LOCATION WAS NOT SPECIFIED. THE PHYSICIAN CONFIRMED THE CAUSE OF THE INFECTION WAS NOT DEVICE RELATED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM AS A PRECAUTION. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED FOR ANALYSIS AS THEY WERE DESTROYED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2053872 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7082641 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention