BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 19029609 · Received April 2, 2024

    Report

    Report Number
    3006630150-2024-02031
    Event Type
    Injury
    Date Received
    April 2, 2024
    Date of Event
    December 13, 2023
    Report Date
    April 30, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985044
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, 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: (B)(6). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: (B)(6).

    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: 7096269. PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7094384.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO HAVE THE FULL DBS SYSTEM EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY. ADDITIONAL INFORMATION WAS RECEIVED THAT THE INFECTION ORIGINATED IN THE SUTURE BEHIND THE PATIENTS EAR AND SPREAD TO THE ENTIRE DBS SYSTEM. THE PATIENTS SUTURE WOULD NOT DISSOLVE AND UPON REMOVING THE SUTURE, THE PATIENT EXPRESSED THAT THE SITE BECAME HOT. UPON FURTHER INVESTIGATION, THE ENTIRE DBS SYSTEM WAS COMPROMISED. THE PHYSICIAN CONFIRMED THAT THE INFECTION WAS CAUSED BY THE SUTURE AND OPEN WOUND AT THE SUTURE SITE. THE PATIENT WAS PLACED ON INTRAVENOUS (IV) ANTIBIOTICS FOR ONE MONTH. A CULTURE WAS PERFORMED AND CONFIRMED METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MSSA).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DEEP BRAIN STIMULATION (DBS) PATIENT UNDERWENT A REVISION PROCEDURE TO HAVE THE FULL DBS SYSTEM EXPLANTED DUE TO AN INFECTION. THE PATIENT WAS DOING WELL POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623140 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1216 543213 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention