BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17425328 · Received July 31, 2023

    Report

    Report Number
    3006630150-2023-04463
    Event Type
    Injury
    Date Received
    July 31, 2023
    Date of Event
    June 12, 2023
    Report Date
    November 13, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905271
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE:(B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB2220-30. SERIAL: (B)(6). BATCH: 7080565.

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER PHONE: (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202300. MODEL: DB2220-30. SERIAL: (B)(6). BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT THAT IS ENROLLED IN THE A4080 ESSENTIAL TREMOR REGISTRY CLINICAL STUDY EXPERIENCED AN EVENT OF PERIFOCAL OEDEMA AROUND THE LEAD SITE WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS GIVEN MEDICATION AND HOSPITALIZED AND THE EVENT IS RESOLVING. THE SERIOUS EVENT WAS ASSESSED AS HAVING A PROBABLE RELATIONSHIP TO THE PROCEDURE, DEVICE AND STIMULATION. THE DEVICES WILL NOT BE RETURNED AS THEY REMAIN IMPLANTED. ADDITIONAL INFORMATION WAS RECEIVED THAT THE EVENT RESOLVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT THAT IS ENROLLED IN THE A4080 ESSENTIAL TREMOR REGISTRY CLINICAL STUDY EXPERIENCED AN EVENT OF PERIFOCAL OEDEMA AROUND THE LEAD SITE WHICH WAS MODERATE IN SEVERITY. THE PATIENT WAS GIVEN MEDICATION AND HOSPITALIZED AND THE EVENT IS RESOLVING. THE SERIOUS EVENT WAS ASSESSED AS HAVING A PROBABLE RELATIONSHIP TO THE PROCEDURE, DEVICE AND STIMULATION. THE DEVICES WILL NOT BE RETURNED AS THEY REMAIN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1965172 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-30 7080555 08714729905271

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R