BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 15374919 · Received September 7, 2022

    Report

    Report Number
    3006630150-2022-04602
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 9, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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)(4); BATCH: 7100351. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7100571. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7100788. PRODUCT FAMILY: DBS-EXTENSION; UPN: M365NM3138550; MODEL: NM-3138-55; SERIAL: (B)(4); BATCH: 7101111.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED REDNESS AND DISCHARGE AT THE IMPLANTABLE PULSE GENERATOR (IPG) POCKET SITE. THEREFORE, THE PATIENT UNDERWENT AN EXPLANT PROCEDURE OF THE DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PHYSICIAN ASSESSED THAT THE INFECTION WAS NOT RELATED TO THE DEVICE. A CULTURE WAS TAKEN AND THE RESULTS CONFIRMED THE PRESENCE OF INFECTION. THE PATIENT HAS SINCE BEEN DISCHARGED FROM THE HOSPITAL AND WAS PLACED ON ANTIBIOTICS. THE EXPLANTED DEVICES WILL NOT BE RETURNED AS THEY WERE DISCARDED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255732 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1232 517269 08714729985051

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male Required Intervention