BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2211086 · Received August 5, 2011

    Report

    Report Number
    1644487-2011-01800
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    March 2, 2011
    Report Date
    July 7, 2011
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED VIA CLINIC NOTES THAT HIGH IMPEDANCE DURING A NORMAL MODE AND MAGNET MODE DIAGNOSTIC TEST WAS OBSERVED ON (B)(6) 2011 AND THE GENERATOR IS NOW NOT ABLE TO BE INTERROGATED AS OF (B)(6) 2011. ON (B)(6) 2011, THE DEVICE WAS SHOWING ERI = YES, SO THE DEVICE IS LIKELY NOW EXPECTED END OF SERVICE. ATTEMPTS FOR FURTHER INFO HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 008950

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Female