BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GENUS?

    MDR report key: 21937720 · Received April 30, 2025

    Report

    Report Number
    3006630150-2025-02935
    Event Type
    Injury
    Date Received
    April 30, 2025
    Date of Event
    April 2, 2025
    Report Date
    April 30, 2025
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION
    Product Code
    MHY
    UDI-DI
    08714729985044
    PMA / PMN Number
    P150031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D2B: ADDITIONAL PRO CODES NHL, PJS. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-LINEAR LEADS UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7132877, UNIQUE IDENTIFIER (B)(4). PRODUCT FAMILY: DBS-LINEAR LEADS, UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(6), BATCH: 7131186, UNIQUE IDENTIFIER: (B)(4). PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7130647, UNIQUE IDENTIFIER (UDI) # (B)(4), PRODUCT FAMILY: DBS-EXTENSION, UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(6), BATCH: 7130622, UNIQUE IDENTIFIER (UDI) # (B)(4). PRODUCT FAMILY: DBS-LEAD FIXATION, UPN: M365DB4600C0, MODEL: DB-4600-C, SERIAL: N/A, BATCH: 34433904, UNIQUE IDENTIFIER (UDI) # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 20 DAYS POST DEEP BRAIN STIMULATION (DBS) IMPLANT PROCEDURE THE PATIENT EXPERIENCED A FEVER, HEADACHE, WEAKNESS, EXHIBITED UNCONFIRMED VIRAL SIGNS/SYMPTOMS RESULTING IN ADMISSION TO THE EMERGENCY ROOM (ER). IT WAS NOTED THE IMPLANTABLE PULSE GENERATOR (IPG) IMPLANT SITE WAS INFLAMED AND HAD REDNESS THAT EXTENDED TO THE RIGHT LEAD AND LEAD EXTENSION IMPLANT SITE WHEREIN PATIENT EXPERIENCED PAIN. THE PHYSICIAN'S ASSESSMENT WAS THAT PATIENT EXPERIENCED DEHISCENCE AND EDEMA AT THE LEAD AND LEAD EXTENSION SITE AND BELIEVES THE INFECTION IS NOT DEVICE NOR PROCEDURE RELATED, HOWEVER THE REASON IS UNKNOWN. AN ULTRASOUND TAKEN OF THE IPG SITE REVEALED ACCUMULATION OF FLUID, AND A SPINAL LUMBAR TAP AND CULTURES WERE TAKEN. THE PATIENT WAS PRESCRIBED OXACILLIN AND UNDERWENT A PROCEDURE WHEREIN A LAVAGE WAS COMPLETED, CULTURES TAKEN DURING PROCEDURE TESTED POSITIVE FOR STAPHYLOCOCCUS, AS A RESULT THE PHYSICIAN OPTED TO EXPLANT THE DEVICES 2 DAYS FOLLOWING HOSPITALIZATION. THE PATIENT WAS PRESCRIBED CEFAZOLIN, WAS DISCHARGED FROM THE HOSPITAL AND DID WELL POST-OPERATIVELY. PHYSICAL ANALYSIS OF THE DBS DEVICES WAS NOT PERFORMED AS THEY WERE RETAINED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1182358 VERCISE GENUS? STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY BOSTON SCIENTIFIC NEUROMODULATION CORPORATION DB-1216 782919 08714729985044

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R