BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3884550 · Received June 19, 2014

    Report

    Report Number
    1644487-2014-01542
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    September 18, 2013
    Report Date
    May 27, 2014
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MANUFACTURING RECORDS WERE REVIEWED. REVIEW OF MANUFACTURING RECORDS CONFIRMED THAT THE LEAD PASSED ALL FUNCTIONAL TESTS PRIOR TO DISTRIBUTION. DEVICE FAILURE IS SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    CLINIC NOTES WERE RECEIVED INDICATING THAT THE VNS PATIENT¿S DEVICE SHOWED HIGH IMPEDANCE DURING AN OFFICE VISIT ON (B)(6) 2013. THE PATIENT¿S LAST SEIZURE WAS A YEAR PRIOR TO THE OFFICE VISIT. THE NOTES INDICATE THAT THE PATIENT¿S DEVICE WAS TESTED DURING AN OFFICE VISIT ON (B)(6) 2013 AND NORMAL MODE DIAGNOSTIC RESULTS SHOWED HIGH IMPEDANCE. DURING THE OFFICE VISIT, THE PATIENT REPORTED THAT SHE WAS EXPERIENCING A STRANGLING FEELING IN HER THROAT SINCE HER LAST VISIT ON (B)(6) 2013. THE PATIENT WAS SEEN ON (B)(6) 2014 AND REPORTED HAVING ONE SEIZURE AND ONE AURA SINCE HER LAST OFFICE VISIT ON (B)(6) 2013. CLINIC NOTES DATED (B)(6) 2014 STATE THAT THE PATIENT¿S SEIZURES HAD NOT CHANGED. FURTHER FOLLOW REVEALED THAT THE PATIENT¿S DEVICE WAS NOT DISABLED FOLLOWING THE HIGH IMPEDANCE OBSERVATION. X-RAYS WERE NOT TAKEN AND PATIENT MANIPULATION OR TRAUMA IS NOT BELIEVED TO HAVE CAUSED OR CONTRIBUTED TO THE HIGH IMPEDANCE. NO KNOWN SURGICAL INTERVENTIONS HAVE OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360714 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1036

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR