BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1191913 · Received October 1, 2008

    Report

    Report Number
    1644487-2008-02388
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    May 9, 2008
    Report Date
    September 5, 2008
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN IMPLANT CARD WAS RECEIVED INDICATING THAT THE PATIENT UNDERWENT GENERATOR REPLACEMENT DUE TO END OF SERVICE WHICH CONFIRMED THAT THE GENERATOR WAS NOT EXPLANTED IN 2008. THIS INFORMATION WAS PREVIOUSLY UNKNOWN AT THE TIME OF THE INITIAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MFR THAT THE VNS PT HAD THEIR LEAD REPLACED DUE TO AN UNK REASON. ADD'L INFO WAS RECEIVED REVEALING THAT THE PT PRESENTED AT A FOLLOW UP VISIT IN 2008 WITH WORSENING SEIZURE ACTIVITY. AN UNK TYPE OF DIAGNOSTIC TEST WAS PERFORMED, REVEALING DCDC CODE = 7 AND HIGH LEAD IMPEDANCE. ADDITIONALLY, THE PHYSICIAN REVIEWED X-RAYS WHICH REVEALED A LEAD BREAK APPROX 3CM FROM THE GENERATOR. THE PT SUBSEQUENTLY HAD SURGERY AND IT WAS REPORTED THAT A NEW LEAD AND GENERATOR WERE REIMPLANTED, HOWEVER, WITH THE INFO RECEIVED TO DATE, IT IS UNCLEAR IF THE GENERATOR WAS ACTUALLY REPLACED. THE PROBLEMATIC LEAD WAS LEFT IMPLANTED. FURTHERMORE, THE PHYSICIAN EXPLAINED THAT THE "PTS' SEIZURES ARE VIGOROUS AND THE PTS' NORMAL MOTION IS VERY UNPREDICTABLE DUE TO SEVERE MYOCLONIA. WITH INCREASING STRENGTH, THERE IS CONSIDERABLE AMOUNT OF EVENTS ALL THE TIME THAT POSSIBLY IS TRAUMATIC ENOUGH TO DAMAGE THE INSTRUMENTS AND IN PARTICULAR THE LEAD. WE ARE CERTAINLY SURPRISED THAT BREAKAGE OF THE LEAD DOESN'T OCCUR MORE OFTEN." THE INCREASE IN SEIZURE ACTIVITY IS BELIEVED TO BE DUE TO THE FAILURE OF THE LEAD AND THE RELATIONSHIP OF THE SEIZURE INCREASE TO PRE-VNS BASELINE IS UNK. ATTEMPTS TO OBTAIN THE X-RAYS FOR REVIEW HAVE BEEN MADE, BUT 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 1368

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other| R