BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 10664157 · Received October 12, 2020

    Report

    Report Number
    3006630150-2020-04799
    Event Type
    Injury
    Date Received
    October 12, 2020
    Date of Event
    July 15, 2020
    Report Date
    July 10, 2023
    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

    THE DEVICES WERE DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7073171; PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: M365DB1200S0, MODEL: DB-1200-S, SERIAL: (B)(6), BATCH: 742120; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH:7075169; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7075332.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S DBS SYSTEM WAS EXPLANTED DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS NOT KNOWN, BUT THE INFECTION WAS DEEMED TO NOT BE RELATED TO THE DEVICE. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT'S DBS EXTENSIONS WERE ALSO EXPLANTED DURING THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE DISPOSED OF AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A TECHNICAL PRODUCT ANALYSIS OF THE DEVICE COULD NOT BE COMPLETED. (B)(4). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: (B)(4), MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7073171. PRODUCT FAMILY: DBS-IPG-R-MRI, UPN: (B)(4), MODEL: DB-1200-S, SERIAL: (B)(4), BATCH: 742120.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S DBS SYSTEM WAS EXPLANTED DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS NOT KNOWN, BUT THE INFECTION WAS DEEMED TO NOT BE RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126618 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7073020 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention