BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 18278662 · Received December 6, 2023

    Report

    Report Number
    3006630150-2023-07677
    Event Type
    Injury
    Date Received
    December 6, 2023
    Date of Event
    November 9, 2023
    Report Date
    December 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7101578; PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB12320, MODEL: DB-1232, SERIAL: (B)(6), BATCH: 546424; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000502; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365DB312855B0, MODEL: DB-3128-55B, SERIAL: (B)(6), BATCH: 5000287; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30853164; PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 30853164.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PATIENT EXPERIENCED POOR WOUND HEALING AT THE LEAD INCISION SITE ON THE TOP OF THEIR HEAD. THE PHYSICIAN ASSESSED THAT THE LEAD INCISION SITE HAD BECOME INFECTED DUE TO THE POOR WOUND HEALING. CULTURES TAKEN WERE POSITIVE FOR MYCOBACTERIUM. THE PATIENT WAS PRESCRIBED ANTIBIOTICS AND UNDERWENT A PROCEDURE TO HAVE THE ENTIRE DEEP BRAIN STIMULATION (DBS) SYSTEM REMOVED. THE PATIENT DID WELL POSTOPERATIVELY. PHYSICAL ANALYSIS OF THE EXPLANTED DEVICES COULD NOT BE CONDUCTED IN OUR LABORATORY AS BOSTON SCIENTIFIC REPRESENTATIVES WERE NOT IN ATTENDANCE AT THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876292 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7101572 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention