BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17980720 · Received October 20, 2023

    Report

    Report Number
    3006630150-2023-06434
    Event Type
    Injury
    Date Received
    October 20, 2023
    Date of Event
    August 11, 2023
    Report Date
    October 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7113775. PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7113781.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS, SWELLING, AND WARMTH ON HIS CHEST AT THE IMPLANTABLE PULSE GENERATOR (IPG) INCISION SITE. CULTURES WERE TAKEN, BUT THE RESULTS WERE NOT DISCLOSED BY THE PHYSICIAN. INITIALLY, THE PATIENT WAS PRESCRIBED ANTIBIOTICS, BUT ULTIMATELY UNDERWENT AN EXPLANT PROCEDURE WHERE THE IPG AND EXTENSIONS WERE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933622 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 567995 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention