BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2063868 · Received March 23, 2011

    Report

    Report Number
    1644487-2011-00622
    Event Type
    Malfunction
    Date Received
    March 23, 2011
    Date of Event
    January 25, 2011
    Report Date
    February 21, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE FAILURE IS SUSPECTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING UNCOMFORTABLE AND ERRATIC STIMULATION AND A CHOKING SENSATION WHEN EATING. HOWEVER, SHE HAS HAD GREAT SEIZURE CONTROL WITH VNS. THE GENERATOR ALSO SHOWED ERI = YES, SO IT WAS TO BE REPLACED. WHEN PT WENT FOR GENERATOR REPLACEMENT, DIAGNOSTICS PERFORMED PRIOR TO SURGERY GAVE DC/DC = 0 ON SYSTEM DIAGNOSTICS AND HIGH IMPEDANCE ON NORMAL MODE DIAGNOSTICS. IN THE PAST, SYSTEM DIAGNOSTICS HAD ALWAYS BEEN OK WITH DC/DC = 2. ONCE GENERATOR WAS REPLACED, SYSTEM DIAGNOSTICS WERE OK WITH DC/DC = 1 AND NORMAL MODE DIAGNOSTICS WERE OK WITH DC/DC = 3. THOUGH DIAGNOSTICS ARE WITHIN NORMAL LIMITS WITH NEW GENERATOR, A LEAD ISSUE IS STILL SUSPECTED BASED ON PT ADVERSE EVENTS AND DC/DC CODE FLUCTUATION. THE SURGEON WAS NOT PREPARED TO REVISE THE LEAD, SO THE LEAD WAS NOT REPLACED AT THIS TIME. EXPLANTED GENERATOR WAS RETURNED TO MFR AND ANALYSIS CONFIRMED EXPECTED EOS. NO OTHER ANOMALIES WERE NOTED. 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 011040

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other