BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE CARTESIA

    MDR report key: 12252977 · Received July 30, 2021

    Report

    Report Number
    3006630150-2021-04230
    Event Type
    Injury
    Date Received
    July 30, 2021
    Date of Event
    May 26, 2021
    Report Date
    July 30, 2021
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729905288
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN M365DB2202450, MODEL DB-2202-45, SERIAL (B)(4), BATCH 7078243. PRODUCT FAMILY: DBS-EXTENSION: UPN M365NM3138550, MODEL NM-3138-55, SERIAL (B)(4), BATCH 7083051. PRODUCT FAMILY: DBS-EXTENSION: UPN M365NM3138550, MODEL NM-3138-55, SERIAL (B)(4), BATCH 7083982.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT A PROCEDURE IN WHICH HIS LEADS AND LEAD EXTENSIONS WERE EXPLANTED FOR AN UNKNOWN REASON. THE EXPLANTED DEVICES WILL NOT BE RETURNED. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1150867 VERCISE CARTESIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-2202-45 7074368 08714729905288

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention