BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 2181415 · Received July 6, 2011

    Report

    Report Number
    1644487-2011-01495
    Event Type
    Malfunction
    Date Received
    July 6, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 2011
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE MALFUNCTION SUSPECTED, BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO OUR DISTRIBUTOR IN (B)(4), THAT THERE WAS A VNS PT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM DIAGNOSTIC TESTING. THE PT HAS ALSO EXPERIENCED AN INCREASE IN SEIZURES. IT IS UNK IF THEY ARE ABOVE OR BELOW THEIR PRE VNS SEIZURE RATE. THE PT HAD NO SEIZURES IN (B)(6) AND THEN 19 SEIZURES IN (B)(6). REVISION/EXPLORATION SURGERY IS SCHEDULED FOR (B)(6). THEIR VNS HAS BEEN PROGRAMMED OFF. X-RAYS WERE RECEIVED FOR REVIEW VIA SCREEN SHOTS AND NOT OF A CLARITY TO PERFORM A FULL REVIEW. IT WAS NOTED THE LEAD PIN WAS FULLY INSERTED INTO THE GENERATOR HEADER AND NO OBVIOUS LEAD BREAKS WERE SEEN IN THE PORTIONS OF THE LEAD VISUALIZED. THE GENERATOR APPEARED TO BE IN THE LEFT CHEST, THREE TIES DOWNS WERE NOTED SECURING THE LEAD BODY. THE STRAIN RELIEF BEND AND LOOP WERE NOT PER LABELING. THERE APPEARED TO BE SOME LEAD BEHIND THE GENERATOR, THE FILTER FEEDTHROUGHS APPEARED INTACT. GOOD FAITH ATTEMPTS HAVE BEEN MADE FOR FURTHER DETAILS SURROUNDING THE REPORTED EVENTS AND THUS FAR NO FURTHER INFO HAS BEEN ATTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS, INC. 302-20 201565

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention