BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM)

    MDR report key: 17380118 · Received July 24, 2023

    Report

    Report Number
    3012309950-2023-00002
    Event Type
    Injury
    Date Received
    July 24, 2023
    Date of Event
    June 29, 2023
    Report Date
    July 21, 2023
    Manufacturer
    MICROTRANSPONDER INC.
    Product Code
    QPY
    UDI-DI
    10810041430066
    PMA / PMN Number
    P210007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    PATIENT REPORTED COUGHING, HOARSENESS AND DIFFICULTY HAVING CONVERSATIONS POST IMPLANT. THE PATIENT FOLLOWED UP WITH IMPLANTING PHYSICIAN AND CONSULTED A VOICE DISORDER SPECIALIST. PER THE PATIENT, THEY HAD VOCAL CORD FILLER AND SYMPTOMS HAVE IMPROVED. DEVICE HISTORY RECORDS WERE REVIEWED FOR IPG S/N (B)(6) AND LEAD S/N (B)(6). THE DEVICES PASSED ALL FUNCTIONAL SPECIFICATIONS AND QUALITY TESTS AND WERE STERILIZED PRIOR TO DISTRIBUTION. NO OTHER RELEVANT INFORMATION HAS BEEN RECEIVED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271819 MICROTRANSPONDER® VIVISTIM® PAIRED VNS¿ SYSTEM (VIVISTIM® SYSTEM) VIVISTIM® SYSTEM QPY MICROTRANSPONDER INC. MODEL 3000 10810041430066

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female Required Intervention