BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 17270559 · Received July 6, 2023

    Report

    Report Number
    3006630150-2023-03945
    Event Type
    Injury
    Date Received
    July 6, 2023
    Date of Event
    June 13, 2023
    Report Date
    July 6, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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: M365DB312855B, MODEL: DB-3128-55B, SERIAL: (B)(6), LOT: 5000296. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), LOT: 7102402. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), LOT: 7104241.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED OOZING AND REDNESS DUE TO AN INFECTION AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) CHEST INCISION SITE. THE PATIENT WAS ADMINISTERED ANTIBIOTICS AND UNDERWENT A PROCEDURE WHERE THE IPG AND LEAD EXTENSION WERE EXPLANTED. CULTURES RETURNED AND DISPLAYED AN INFECTION ON THE LEADS AS WELL, THEREFORE, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE AROUND A WEEK LATER WHERE THE LEADS WERE EXPLANTED. THE DEVICES WILL NOT BE RETURNED AS THEY WERE RETAINED BY THE MEDICAL FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039203 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 561174 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention