BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 17159878 · Received June 19, 2023

    Report

    Report Number
    3006630150-2023-03502
    Event Type
    Injury
    Date Received
    June 19, 2023
    Date of Event
    April 5, 2023
    Report Date
    August 28, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    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: PHONE NUMBER - (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6).

    Additional Manufacturer Narrative · 0

    E1: PHONE NUMBER - (B)(6). ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: BRAND NAME: VERCISE CARTESIA, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7093420.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT THAT IS ENROLLED IN THE A4080 ESSENTIAL TREMOR REGISTRY CLINICAL TRIAL, EXPERIENCED A NON SERIOUS ADVERSE EVENT OF WOUND INFECTION AT THE LEAD SURGICAL SCAR SITE ON THE HEAD THAT WAS MODERATE IN SEVERITY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, WHICH CAUSED DIARRHEA AND THE EVENT RESOLVED TEN DAYS LATER. IT WAS NOTED THAT THE RELATIONSHIP OF THE EVENT WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE WHICH OCCURRED THREE MONTHS PRIOR, AND NOT RELATED TO THE DEVICE. THE DEVICES REMAIN IMPLANTED AND WILL THEREFORE NOT BE RETURNED FOR ANALYSIS. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT ALSO EXPERIENCED PAIN AND SENSITIVITY TO THE TOUCH IN THE AREA OF THE RIGHT FRONTAL SCAR, AND THERE WAS SECRETION EXPRESSED FROM THE AREA. THE PATIENT WAS PLACED ON A COURSE OF ANTIBIOTICS FOR TEN DAYS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT THAT IS ENROLLED IN THE A4080 ESSENTIAL TREMOR REGISTRY CLINICAL TRIAL, EXPERIENCED A NON SERIOUS ADVERSE EVENT OF WOUND INFECTION AT THE LEAD SURGICAL SCAR SITE ON THE HEAD THAT WAS MODERATE IN SEVERITY. THE PATIENT WAS PRESCRIBED ANTIBIOTICS, WHICH CAUSED DIARRHEA AND THE EVENT RESOLVED TEN DAYS LATER. IT WAS NOTED THAT THE RELATIONSHIP OF THE EVENT WAS REPORTED AS HAVING A CAUSAL RELATIONSHIP TO THE PROCEDURE WHICH OCCURRED THREE MONTHS PRIOR, AND NOT RELATED TO THE DEVICE. THE DEVICES REMAIN IMPLANTED AND WILL THEREFORE NOT BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1014063 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7093666 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention