BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 11952642 · Received June 7, 2021

    Report

    Report Number
    3006630150-2021-02722
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 14, 2021
    Report Date
    June 29, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450; MODEL: DB-2202-45; SERIAL: (B)(6); BATCH: 7075108.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE ADVANCE2 CLINICAL STUDY THAT IS BEING CONDUCTED BY FUNCTIONAL NEUROMODULATION LTD, LIMITED COMPANY, EXPERIENCED A SEIZURE AFTER ONE OF THE LEADS WAS IMPLANTED. THE SEIZURE WAS ASSESSED AS BEING MODERATE IN SEVERITY. THE PATIENTS HOSPITALIZATION WAS PROLONGED AND THEY WERE GIVEN MEDICATION, KEPPRA 1,500 MG LOAD IV X2, AT WHICH TIME THE EVENT RESOLVED. IT WAS INDICATED THAT THE EVENT HAS A PROBABLE RELATIONSHIP TO THE LEAD. ADDITIONALLY, IT WAS STATED THAT NOTHING HAPPENED DURING THE PROCEDURE THAT MAY HAVE CONTRIBUTED TO THE EVENT. IMAGING WAS TAKEN POST IMPLANT AND CONFIRMED THAT THE LEAD WAS PLACED IN THE PROPER LOCATION FOR THE STUDY.

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN:(B)(4). MODEL: DB-2202-45 SERIAL: (B)(4). BATCH: 7075108.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT, WHO IS ENROLLED IN THE ADVANCE2 CLINICAL STUDY THAT IS BEING CONDUCTED BY FUNCTIONAL NEUROMODULATION LTD, LIMITED COMPANY, EXPERIENCED A SEIZURE AFTER ONE OF THE LEADS WAS IMPLANTED. THE SEIZURE WAS ASSESSED AS BEING MODERATE IN SEVERITY. THE PATIENTS HOSPITALIZATION WAS PROLONGED AND THEY WERE GIVEN MEDICATION, KEPPRA 1,500 MG LOAD IV X2, AT WHICH TIME THE EVENT RESOLVED. IT WAS INDICATED THAT THE EVENT HAS A PROBABLE RELATIONSHIP TO THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    845173 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7075089 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R