BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 21009089 · Received December 23, 2024

    Report

    Report Number
    3006630150-2024-08963
    Event Type
    Injury
    Date Received
    December 23, 2024
    Date of Event
    August 1, 2024
    Report Date
    December 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRO CODES IN BLOCK D2B NHL, PJS. BLOCK B3: APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7117983. PRODUCT FAMILY: DBS-LINEAR LEADS: UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL:(B)(6). BATCH: 7120722 PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 33781444. PRODUCT FAMILY: DBS-LEAD FIXATION: UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 33825236.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT EXPERIENCED MILD FLUID DISCHARGE AT THEIR IMPLANTABLE PULSE GENERATOR (IPG) AND LEADS IMPLANT SITE. A BIOPSY WAS TAKEN AND CONFIRMED NO ABNORMALITIES WERE FOUND. IT WAS NOTED THAT THE CAUSE OF INFECTION IS UNKNOWN HOWEVER MAY HAVE BEEN AN ALLERGIC REACTION SPECIFIC TO THE PATIENT PER THE PHYSICIANS ASSESSMENT. THE PATIENT UNDERWENT A PROCEDURE WHERE THE DBS SYSTEM WAS REMOVED. PHYSICAL ANALYSIS OF THE DBS SYSTEM WAS NOT PERFORMED AS THEY WERE DISCARDED BY THE FACILITY THE PATIENT DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2513859 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 758394

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention