BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 13725794 · Received March 10, 2022

    Report

    Report Number
    3006630150-2022-00962
    Event Type
    Injury
    Date Received
    March 10, 2022
    Date of Event
    February 18, 2022
    Report Date
    June 17, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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: 5169286. PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 24287871.

    Additional Manufacturer Narrative · 0

    BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7083451. PRODUCT FAMILY: DBS-IPG-R-MRI UPN: M365DB12160. MODEL: DB-1216. SERIAL: (B)(6). BATCH: 513561. PRODUCT FAMILY: DBS-LEAD FIXATION UPN: M365DB4600C0. MODEL: DB-4600C. SERIAL: N/A. BATCH: 27445857. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: (B)(6). PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550. MODEL: NM-3138-55. SERIAL: (B)(6). BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENTS RIGHT LEAD AND BURR HOLE COVER WERE EXPOSED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED DEVICES WERE SENT FOR CULTURE AND DISPOSED OF BY THE FACILITY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S RIGHT LEAD AND BURR HOLE COVER WERE EXPOSED. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE AND WAS ADMINISTERED ANTIBIOTICS. THE PATIENT WAS DOING FINE POST-OPERATIVELY. THE EXPLANTED DEVICES WERE SENT FOR CULTURE AND DISPOSED OF BY THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT DBS SYSTEM WAS REMOVED DURING THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2269644 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7083276 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention