BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 19901946 · Received August 3, 2024

    Report

    Report Number
    3006630150-2024-05077
    Event Type
    Injury
    Date Received
    August 3, 2024
    Date of Event
    July 3, 2024
    Report Date
    August 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    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-LEAD FIXATION UPN: M365DB4600C0 MODEL: DB-4600C SERIAL: N/A BATCH: 33133635 PRODUCT FAMILY: DBS-EXTENSION UPN: M365DB312855B0 MODEL: DB-3128-55B SERIAL: (B)(6) BATCH: 5001719. PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450 MODEL: DB-2202-45 SERIAL: (B)(6) BATCH: 7116147.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A FOLLOW UP THE PHYSICIAN SCABBING WAS NOTED THE PATIENTS DEEP BRAIN STIMULATION (DBS) HEAD INCISION SITE. CULTURES TAKEN TESTED POSITIVE FOR PROTEUS. IT WAS NOTED THAT SCABBING WAS RELATED TO THE DEVICE PER THE PHYSICIANS ASSESSMENT, HOWEVER IT IS UNKNOWN HOW IT BECAME INFECTED. THE PATIENT UNDERWENT A PROCEDURE WHERE THE WHOLE DBS SYSTEM WAS REMOVED. PHYSICAL ANALYSIS OF THE DBS SYSTEM WAS NOT PERFORMED AS THE FACILITY DID NOT ALLOW RELEASE OF THE DEVICES. THE PATIENT WAS PRESCRIBED CEFTRIAXONE FOR FOURTEEN DAYS AND DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951611 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 598213 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention