BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 1963862 · Received December 22, 2010

    Report

    Report Number
    1644487-2010-02873
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    July 29, 2009
    Report Date
    November 29, 2010
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER REVIEWED X-RAYS OF IMPLANTED DEVICE. RESULTS: X-RAY REVIEWED BY THE MANUFACTURER, NO GROSS LEAD DISCONTINUITIES VISUALIZED. CONCLUSION: DEVICE MALFUNCTION IS SUSPECTED BUT DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US BY OUR COUNTRY REPRESENTATIVE IN (B)(4) THAT A VNS PROGRAMMING PHYSICIAN'S OFFICE HAS CONTACTED THEM AND REPORTED THAT THEY HAD A VNS PATIENT WITH HIGH LEAD IMPEDANCE ON THEIR SYSTEM DIAGNOSTIC TESTING. IT WAS REPORTED THAT THEIR DIAGNOSTICS WERE NORMAL UNTIL (B)(6) 2009, WHEN FOUND OUT TO HAVE 7/LIMIT/HIGH. THE SITE WAS REPORTED TO HAVE REVIEWED THE PATIENT CHEST X-RAY AND IT WAS REPORTED AS NORMAL WITH NO BREAK. THE PATIENT HAS NOT EXPERIENCED ANY ADVERSE EVENTS RELATED TO THEIR HIGH LEAD IMPEDANCE. THEIR VNS DEVICE HAS BEEN CHECKED 3 TIMES SINCE AND IS STILL DISPLAYING HIGH LEAD IMPEDANCE. THE PATIENT'S PARENT IS UNSURE IF THEY ARE GETTING ANY BENEFIT FROM THE VNS. ADVICE HAS BEEN PROVIDED TO THE SITE TO PROGRAM THEIR VNS OFF RELATED TO THEIR HIGH LEAD IMPEDANCE. NO SURGICAL INTERVENTIONS ARE PLANNED AT THIS TIME. NO INJURY OR FALL WAS REPORTED, BUT THE PATIENT DOES EXPERIENCE FREQUENT SEIZURES, SO A FALL CANNOT BE RULED OUT. X-RAYS WERE RECEIVED AND REVIEWED AT THE MANUFACTURER AND NO OBVIOUS LEAD DISCONTINUITY WAS NOTED IN THE PORTIONS OF THE LEAD THAT COULD BE SEEN. ONLY ONE VIEW WAS AVAILABLE. THE MAJORITY OF THE LEAD COULD NOT BE VISUALIZED. THE ELECTRODES WERE VISIBLE AND IT WAS NOTED THAT THE ELECTRODES WERE IMPLANTED ON THE NERVE INVERTED. THERE WERE TWO TIE DOWNS IN THE ELECTRODE LOCATION SECURING THE LEAD BODY BUT NO STRAIN RELIEF LOOP OR BEND WERE PRESENT. THE LEAD WAS THEN ROUTED DOWN TOWARDS THE GENERATOR. ONLY A SMALL SECTION OF THE LEAD BODY COULD BE VISUALIZED. NO FURTHER PORTIONS OF THE LEAD OR GENERATOR WERE IN THE VIEW. BASED ON THE X-RAY REVIEW NO OBVIOUS LEAD DISCONTINUITIES WERE OBSERVED IN THE X-RAY IMAGES PROVIDED. THE GENERATOR AREA AND MAJORITY OF LEAD BODY COULD NOT BE SEEN. THE PIN BEING FULLY INSERTED COULD NOT BE ASSESSED OR THE PRESENCE OF AN UNPRONOUNCED LEAD DISCONTINUITY CANNOT BE RULED OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEAD MODEL 302 LYJ CYBERONICS INC 302-20 200471

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR