BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS

    MDR report key: 18460606 · Received January 5, 2024

    Report

    Report Number
    3006630150-2023-08490
    Event Type
    Injury
    Date Received
    January 5, 2024
    Date of Event
    April 29, 2023
    Report Date
    January 5, 2024
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729985020
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK B3: EXACT DATE UNKNOWN, EVENT OCCURRED BETWEEN (B)(6) 2023. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7100140; PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7100192; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7110460; PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7111116.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT EXPERIENCED CELLULITIS AT THE DEEP BRAIN STIMULATION (DBS) IMPLANTABLE PULSE GENERATOR (IPG) SITE AND WAS ADMITTED TO THE HOSPITAL. THE PATIENT UNDERWENT A PROCEDURE WHERE THE IPG WAS REMOVED, CULTURES TAKEN DURING THE PROCEDURE TESTED POSITIVE FOR STAPHYLOCOCCUS AUREUS AS A RESULT, THE REMAINING DBS DEVICES WERE REMOVED FOUR DAYS LATER HOWEVER THE ADDITIONAL CULTURES TAKEN WERE NEGATIVE. THE CELLULITIS WAS A RISK OF THE PROCEDURE HOWEVER IT WAS UNKNOWN WHAT CONTRIBUTED TO THE INFECTION PER THE PHYSICIANS ASSESSMENT. PHYSICAL ANALYSIS COULD NOT BE PERFORMED AS THEY WERE DISPOSED BY THE FACILITY. THE PATIENT WAS PRESCRIBED ANTI-BIOTICS AND DID WELL POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601556 VERCISE GENUS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1416 215172 08714729985020

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R