BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 2093643 · Received May 12, 2011

    Report

    Report Number
    1644487-2011-01042
    Event Type
    Injury
    Date Received
    May 12, 2011
    Date of Event
    March 23, 2011
    Report Date
    April 12, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY A VNS PHYSICIAN THAT HE BELIEVED THE VNS PT TO HAVE PARTIAL VOCAL CORD PARALYSIS. THE PT HAD BEEN RECENTLY IMPLANTED AND HER OUTPUT CURRENT HAD BEEN ENABLED. THE PT REPORTEDLY HAD DIFFICULTY SPEAKING SINCE IMPLANT, WHICH IS A CONSTANT PHENOMENON. FURTHER INFORMATION WAS OBTAINED FROM THE PHYSICIAN. ON (B)(6) 2011, SYSTEM DIAGNOSTICS RESULTED IN OK'S, IMPEDANCE = 3827 OHMS, AND IFI=NO. IT WAS NOTED THAT THE PT'S VOICE WAS HOARSE ON THIS DAY. FURTHERMORE, THE SETTINGS AT THIS TIME WERE STATED TO BE 0.25/20/250/30/5 AND 0.25/60/500. THE PHYSICIAN STATED THAT STIMULATION UP TO 1MA DID NOT EVOKE A CHANGE IN THE PT'S VOICE OR A COUGH. THE PHYSICIAN STATED HE WOULD MAINTAIN THE PT'S LOW SETTINGS AND DISCUSS THE DETAILS WITH THE MANUFACTURER. GOOD FAITH ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PULSE GEN MODEL 103 LYJ CYBERONICS INC 103 201604

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other