BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VIVISTIM® PAIRED VNS¿ SYSTEM

    MDR report key: 25061185 · Received May 1, 2026

    Report

    Report Number
    3012309950-2026-00022
    Event Type
    Injury
    Date Received
    May 1, 2026
    Date of Event
    April 3, 2026
    Report Date
    May 1, 2026
    Manufacturer
    MOBIA MEDICAL, INC.
    Product Code
    QPY
    UDI-DI
    10810041430028
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS IMPLANTED ON (B)(6) 2026. ON (B)(6) 2026, A REHABILITATION FACILITY REPORTED A SUSPECTED INFECTION AT THE IPG POCKET SITE AFTER THE PATIENT CANCELLED A SCHEDULED APPOINTMENT. THE PATIENT WAS SUBSEQUENTLY EVALUATED ON (B)(6) 2026 AND REMAINED ADMITTED OVER THE WEEKEND FOR OBSERVATION AND TREATMENT. IMPLANTING PHYSICIAN WAS NOTIFIED AND INITIATED INTRAVENOUS ANTIBIOTICS. CLINICAL ASSESSMENT INDICATED THAT THE INFECTION WAS SUPERFICIAL. THE PATIENT WAS DISCHARGED ON (B)(6) 2026 WITH A PRESCRIPTION FOR ORAL ANTIBIOTICS. THE PATIENT IS BEING FOLLOWED BY NURSE NAVIGATION AND INTERNAL TEAMS FOR ONGOING MONITORING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117585 VIVISTIM® PAIRED VNS¿ SYSTEM VIVISTIM QPY MOBIA MEDICAL, INC. 1001 10810041430028

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female Other| H