BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE

    MDR report key: 17674385 · Received September 1, 2023

    Report

    Report Number
    3006630150-2023-05251
    Event Type
    Injury
    Date Received
    September 1, 2023
    Date of Event
    August 10, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    MHY
    UDI-DI
    08714729820765
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENT INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7110673. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7103424.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED DISCOMFORT AT THE LEAD EXTENSION SITE. THE PHYSICIAN ASSESSED THERE WAS A POSSIBLE INFECTION AT THE LEAD AND LEAD EXTENSION SITE. THEREFORE, THE PATIENT UNDERWENT A PROCEDURE TO CLEAN OUT THE LEAD AND LEAD EXTENSION SITE. A CULTURE WAS TAKEN HOWEVER, CULTURE RESULTS ARE UNKNOWN. THE PATIENT WAS EXPECTED TO FULLY RECOVER POSTOPERATIVELY. NOTHING WAS IMPLANTED OR EXPLANTED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1455107 VERCISE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION NM-3138-55 7110629 08714729820765

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention