BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 19977474 · Received August 13, 2024

    Report

    Report Number
    3006630150-2024-05305
    Event Type
    Injury
    Date Received
    August 13, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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: 7123125.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH A SEVERE HEADACHE PRIMARILY ON THE LEFT SIDE OF HIS HEAD 21 DAYS POST IMPLANT PROCEDURE. A COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI) SCANS WERE PERFORMED, AND THEY REVEALED THAT THE PATIENT HAD A SUBDURAL BLEED ON THE LEFT SIDE OF HIS BRAIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL, UNDERWENT A CRANIOTOMY TO ADDRESS THE HEMATOMA, AND WAS ADMINISTERED ROUTINE POSTOPERATIVE ANTIBIOTICS. NO ADDITIONAL INFORMATION WAS AVAILABLE DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619361 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7121695 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male Required Intervention| H