BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1781119 · Received July 29, 2010

    Report

    Report Number
    1644487-2010-01760
    Event Type
    Malfunction
    Date Received
    July 29, 2010
    Date of Event
    June 1, 2010
    Report Date
    June 29, 2010
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED FOR THIS VNS PT. REVIEW OF THE NOTES INDICATES THAT AT A FOLLOW UP APPOINTMENT ON (B)(6) 2010, A DIAGNOSTIC TEST REVEALED HIGH LEAD IMPEDANCE. THE PHYSICIAN NOTED THAT THE DEVICE WAS DISABLED. IN ADDITION, THE PT'S CAREGIVER REPORTED AN INCREASE IN SEIZURE FREQUENCY OVER THE PAST 4-5 MONTHS. THE PULSE GENERATOR WAS PROGRAMMED OFF WHEN THE HIGH LEAD IMPEDANCE TEST RESULT OCCURRED. THE PHYSICIAN HAS REFERRED THE PT TO A SURGEON WHERE REVISION SURGERY IS LIKELY TO OCCUR. ADDITIONALLY, A MEDICATION CHANGE WAS MADE TO HELP WITH THE PT'S INCREASING SEIZURE FREQUENCY. GOOD FAITH ATTEMPTS TO OBTAIN ADDITIONAL INFO FROM THE TREATING PHYSICIAN ARE UNDERWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 973

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention