BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2062316 · Received April 12, 2011

    Report

    Report Number
    1644487-2011-00775
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 6, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS REPORTED BY A VNS TREATING PHYSICIAN TO THE MANUFACTURER'S CONSULTANT THAT THE VNS PT WAS PRESENTING WITH HIGH IMPEDANCE DURING A SYSTEM DIAGNOSTIC TEST ON (B)(6) 2011. THE PT WAS THEN REFERRED FOR A BATTERY REPLACEMENT CONSULTATION AND THE PT'S DEVICE WAS PROGRAMMED OFF. THE PT'S PHYSICIAN FURTHER REPORTED THAT NO X-RAYS WERE BEING TAKEN AND THAT NO PT MANIPULATION OR TRAUMA IS THOUGHT TO HAVE OCCURRED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PT'S HIGH IMPEDANCE. THE PT'S PRIOR PROGRAMMED SETTINGS COULD NOT BE PROVIDED. ALTHOUGH, A BATTERY REPLACEMENT SURGERY IS LIKELY, THE PT HAS NOT BEEN SCHEDULED FOR A CONSULTATION DATE OR A SURGERY DATE AT THIS TIME. IF ADDITIONAL INFO IS RECEIVED, IT WILL BE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 1169

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR