BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 13205187 · Received January 10, 2022

    Report

    Report Number
    3006630150-2021-07495
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    December 13, 2021
    Report Date
    January 10, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729836544
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB220145DC0, MODEL: DB-2201-45DC, SERIAL: (B)(4), BATCH: 5173197.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT'S LEADS WERE EXPOSED. THE PATIENT UNDERWENT A WOUND TOILETTE AND RE-SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854417 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45DC 7070031 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention