BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17804083 · Received September 22, 2023

    Report

    Report Number
    3006630150-2023-05788
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 25, 2023
    Report Date
    February 23, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    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 COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450. MODEL: DB-2202-45. SERIAL: (B)(6). BATCH: 7103308 AND 7103323.

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND EROSION AND POOR SKIN HEALING ON THE SCALP. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) AND TWO LEADS WERE EXPLANTED, IT WAS INDICATED THAT THE EVENT WAS NOT DEVICE RELATED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DESTROYED BY THE FACILITY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENTS' INCISION HAS NOT HEALED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED WOUND EROSION AND POOR SKIN HEALING ON THE SCALP. THE PATIENT UNDERWENT A PROCEDURE IN WHICH THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) AND TWO LEADS WERE EXPLANTED, IT WAS INDICATED THAT THE EVENT WAS NOT DEVICE RELATED. THE PATIENT IS DOING WELL POST OPERATIVELY. THE DEVICES WILL NOT BE RETURNED AS THEY WERE DESTROYED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1267766 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 568132 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention