BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 16578030 · Received March 20, 2023

    Report

    Report Number
    3006630150-2023-01402
    Event Type
    Injury
    Date Received
    March 20, 2023
    Date of Event
    August 23, 2022
    Report Date
    March 20, 2023
    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
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: EXACT DATE UNKNOWN, EVENT OCCURRED IN (B)(6) 2022. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB220145DC0, MODEL: DB-2201-45-DC, SERIAL: (B)(4), BATCH: 7070100.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED INADEQUATE STIMULATION AND THE PHYSICIAN ASSESSED THAT THE LEADS MIGRATED. REPROGRAMMINGS WERE ATTEMPTED BUT THEY DID NOT RESOLVE THE EVENT. THEREFORE, THE PATIENT UNDERWENT A LEAD REVISION WHEREIN BOTH LEADS WERE EXPLANTED AND REPLACED. THERE WERE NO PATIENT COMPLICATIONS POSTOPERATIVELY. THE EXPLANTED LEADS WILL NOT BE RETURNED AS THEY WERE DISPOSED OF BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    370755 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION DB-2201-45-DC 5166650 08714729836544

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention