BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERCISE GEVIA

    MDR report key: 16685573 · Received April 5, 2023

    Report

    Report Number
    3006630150-2023-01808
    Event Type
    Injury
    Date Received
    April 5, 2023
    Date of Event
    August 23, 2022
    Report Date
    April 5, 2023
    Manufacturer
    BOSTON SCIENTIFIC NEUROMODULATION
    Product Code
    NHL
    UDI-DI
    08714729984443
    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

    APPROXIMATED BASED ON THE DATE THE MANUFACTURER BECAME AWARE OF THE EVENT. ADDITIONAL SUSPECT MEDICAL DEVICE COMPONENTS INVOLVED IN THE EVENT: PRODUCT FAMILY: DBS-EXTENSION UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL: (B)(4), BATCH: 7101363, PRODUCT FAMILY: DBS-EXTENSION. UPN: M365NM3138550, MODEL: NM-3138-55, SERIAL:(B)(4), BATCH: 7100199, PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL:(B)(4), BATCH: 7090070, PRODUCT FAMILY: DBS-LINEAR LEADS. UPN: M365DB2202450, MODEL: DB-2202-45, SERIAL: (B)(4), BATCH: 7092796, PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 28996643. PRODUCT FAMILY: DBS-LEAD FIXATION. UPN: M365DB4600C0, MODEL: DB-4600C, SERIAL: N/A, BATCH: 29077364.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A HEAD INJURY AND DEVELOPED INFLAMMATION AT THEIR DEEP BRAIN STIMULATION (DBS) IMPLANT SITE. THE PHYSICIAN NOTED THAT THE PATIENTS HEAD INJURY EXPOSED THE DBS HARDWARE AND ASSESSED A WOUND DEHISCENCE CAUSED THE INFECTION. CULTURES WERE TAKEN REVEALED STAPHYLOCOCCUS AUREUS. THE PATIENT UNDERWENT AN EXPLANT PROCEDURE WHERE THE ENTIRE DBS SYSTEM WAS REMOVED AND WERE PRESCRIBED ANTI-BIOTICS. THE PATIENT DID WELL POST-OPERATIVELY, THE DEVICES WERE DISCARDED BY THE FACILITY AND WILL NOT RETURN FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009407 VERCISE GEVIA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS NHL BOSTON SCIENTIFIC NEUROMODULATION DB-1200-S 743173 08714729984443

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention