BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2050205 · Received April 1, 2011

    Report

    Report Number
    1644487-2011-00696
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    March 2, 2011
    Report Date
    February 16, 2018
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 1

    REPORTER INDICATED THAT HIGH LEAD IMPEDANCE READINGS WERE RECEIVED FOR A VNS PT AT AN OFFICE VISIT. IT WAS UNK WHAT DIAGNOSTICS TEST WAS PERFORMED, BUT THE RESULT WAS OUTPUT STATUS = LIMIT, LEAD IMPEDANCE = HIGH, DCDC CODE = 7, EOS = NO. THE VNS WAS DISABLED AND THE PT WAS REFERRED FOR A SURGICAL CONSULT. THE PT HAD NO KNOWN TRAUMA. IT WAS LATER REPORTED THE VNS WAS FUNCTIONING PROPERLY AT THE SURGICAL CONSULT AND NOW NO SURGERY IS SCHEDULED. ATTEMPTS FOR FURTHER INFO ARE IN PROGRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 200520

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male