BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2101993 · Received May 18, 2011

    Report

    Report Number
    1644487-2011-01100
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 19, 2011
    Report Date
    April 19, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED BY A VNS PHYSICIAN THAT THE PATIENT'S VNS RETURNED HIGH IMPEDANCE ON A SYSTEM DIAGNOSTIC TEST. LAST GOOD DIAGNOSTICS WERE SAID TO BE WITHIN THE LAST 6 MONTHS. NO TRAUMA OR MANIPULATION WAS REPORTED TO HAVE CAUSED THE EVENT, AND THE DEVICE WAS NOT DISABLED AS THE PHYSICIAN ELECTED TO KEEP STIMULATION ENABLED. X-RAYS OF THE PATIENT'S DEVICE HAVE NOT BEEN SENT IN FOR REVIEW BY THE MANUFACTURER. THE PATIENT WAS SUBSEQUENTLY REPLACED WITH A NEW LEAD AND GENERATOR. ATTEMPTS FOR FURTHER INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-30 200668

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR