BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD MODEL 302

    MDR report key: 3347530 · Received September 13, 2013

    Report

    Report Number
    1644487-2013-02698
    Event Type
    Malfunction
    Date Received
    September 13, 2013
    Date of Event
    January 1, 2012
    Report Date
    August 16, 2013
    Manufacturer
    CYBERONICS INC
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED VIA THE NURSE THAT THE PATIENT HAD BEEN EXPERIENCING VOICE ALTERATION FOR A YEAR, BUT THAT IT HAD NOT BEEN DISCUSSED SINCE DIAGNOSTICS WERE ALL OK AND THE PATIENT HAD STATED THAT THE VOICE ALTERATION WAS MORE OF A CONSTANT RATHER THAN OCCURRING WITH STIMULATION. THE ISSUE FIRST BEGAN IN (B)(6) 2012. THE PATIENT'S SETTINGS WERE DECREASED FROM OUTPUT CURRENT OF 1.75 TO 1.5MA AND MAGNET OUTPUT CURRENT OF 2 TO 1.75MA. PER THE NOTES, THE SYSTEM TEST RESULTED IN DCDC 2 AND NORMAL MODE WAS A DCDC 3. THE PATIENT WAS ALSO REFERRED TO AN EAR NOSE - THROAT DOCTOR (ENT), DR. (B)(6), WHO DID TESTS AND FOUND THAT THERE WAS EXTRA WEAKNESS IN HER VOICE WHEN THE STIMULATION WAS PRESENT. THE PATIENT WAS SEEN AGAIN (B)(6) 2012, DURING WHICH THE SETTINGS WERE DECREASED AGAIN (OUTPUT CURRENT FROM 1.5 TO 1.25MA, MAGNET FROM 1.75 TO 1.5MA). THE PATIENT REPORTED DOING A BIT BETTER. SYSTEM DIAGNOSTICS RESULTED IN DCDC 2, NORMAL MODE WAS DCDC 3. THE PATIENT WAS SEEN (B)(6) 2012, AND SETTINGS WERE DECREASED AGAIN (OUTPUT CURRENT FROM 1.25 TO 1MA, MAGNET FROM 1.5 TO 1.25MA). SYSTEM DIAGNOSTICS RESULTED IN DCDC 1 AND NORMAL MODE DIAGNOSTICS RESULTED IN DCDC 3. (B)(6) 2013, THE PATIENT WAS SEEN AND SETTINGS WERE NOT CHANGED. THIS TIME, SYSTEM DIAGNOSTICS RESULTED IN DCDC 0. IN (B)(6) 2013, SYSTEM DIAGNOSTICS WERE DCDC 0 AGAIN, AND PATIENT REPORTED THE DYSPHONIA WAS BETTER AND HER ABILITY TO SPEAK WAS OK. THE PATIENT WAS LAST SEEN (B)(6) 2013 AND WAS STILL IMPROVING. SYSTEM DIAGNOSTICS RESULTED IN DCDC 1. THE ENT TOOK X-RAYS AND IT HAD SEEMED THAT EVERYTHING WAS INTACT. HOWEVER, DUE TO THE DCDC OF 0, THE PHYSICIAN STATED SHE WAS CONSIDERING HAVING THE PATIENT'S DEVICE REPLACED. IT WAS NOTED THAT ALONG WITH THE DECREASE IN SETTINGS, THE PATIENT BEGAN HAVING AN INCREASE IN SEIZURES. HOWEVER, THE PHYSICIAN WAS UNSURE IF THE INCREASED SEIZURE FREQUENCY WAS RELATED TO VNS OR NOT. THE INCREASE IN SEIZURES WAS NOT ABOVE PRE-VNS BASELINE LEVES. THE PATIENT'S DEVICE WAS DISABLED AND THE PATIENT IS STILL EXPERIENCING CHEST AND NECK DISCOMFORT. ADDITIONAL FOLLOW UP INDICATED THE PATIENT WAS SEEN AGAIN ON (B)(6) 2013 AND WAS HAVING MORE SEIZURES THAT WERE NOT ABOVE PRE-VNS BASELINE LEVELS. THERE WERE NO CONTRIBUTORY EXTERNAL FACTORS, PHYSICAL STATUS, MEDICATIONS, ETC. NO RECENT CHANGES WERE MADE. THE PATIENT WAS PRESENTED STILL EXPERIENCING VOICE DYPSHONIA. LAST TIME THE PATIENT WAS IN, HER VOICE WAS BETTER FOR ABOUT 2-3 WEEKS, BUT NOW IT IS WORSE AND SHE HAS DISCOMFORT IN THE CHEST AREA UP TO THE ELECTRODES THAT FEELS LIKE IT TRAVELS THROUGHOUT THE VNS SYSTEM. THE PATIENT HAS REPORTEDLY ALWAYS COMPLAINED OF PAIN AROUND THE ELECTRODE SITE THE LAST YEAR OR TWO BUT IT HAS BECOME MORE PRONOUNCED. THE PATIENT HAS BEEN MONITORED FOR A YEAR AND THE SITE HAS BEEN WATCHING THE DCDC CODE DROP FROM 3 TO 0; HOWEVER, THE DIAGNOSTICS NEVER SHOWED LOW OR HIGH. THE PATIENT MENTIONED THAT IT "DOESN'T COME ON AND OF LIKE IT USED TO" IN A WAY THAT THE STIMULATION DOES NOT FEEL THE SAME. THE DYSPHONIA IS WHAT BROUGHT THE SITE TO NOTICE THIS INITIALLY. THE PATIENT WAS FEELING THE DYSPHONIA/STIMULATION IN ONE SPECIFIC AREA IN THE NECK WHICH USED TO MAKE THE PATIENT'S VOICE LOW BUT NOW YESTERDAY, THE PATIENT PRESENTED WITH HER VOICE REALLY HIGH PITCHED. THE PHYSICIAN SAID AT THAT POINT THAT THERE IS "SOMETHING GOING ON" AND QUESTIONED IF THERE COULD BE AN ISSUE WITH THE VNS. INITIALLY, THEY THOUGHT IT COULD HAVE BEEN RELATED TO NON-NEUROLOGICAL EVENTS, CO-MORBID CONDITIONS. HOWEVER, THEY ALL RESOLVED AND NOW THEY HAVE DETERMINED IT'S RELATED TO VNS. THEY DO NOT WANT THE PATIENT TO GO THROUGH THIS ANYMORE, SO THEY HAVE REFERRED HER FOR SURGERY AND SHE WILL LIKELY HAVE A FULL REVISION. THE OFFICE EVENT SENT THE PATIENT FOR PSYCHIATRIC EVALUATIONS TO RULE PSYCHIATRIC REASONS OUT AND RULED THE EVENTS TO BE RELATED TO VNS FOR THE LAST YEAR. ADDITIONALLY DURING A ROUTINE CLINIC VISIT FOR GENERAL FOLLOW-UP WHEN SHE WAS BEING SEEN EVERY 3-6 MONTHS, THE OFFICE SENT THE PATIENT TO AN ENT IMMEDIATELY TO PERFORM SWALLOWING TESTS. THE ENT DETERMINED THERE WAS WEAKENING OF THE VOCAL CORD (NOT PARALYSIS) FROM IMPLANT OF VNS BUT WHEN VNS IS STIMULATION, THEY ATTRIBUTE THE DYSPHONIA TO THE STIMULATION. THE ENT TOLD NEUROLOGY THAT THE DYSPHONIA IS PROBABLY RELATED TO THE STIMULATION. THE PATIENT WAS DIAGNOSED IN THE BEGINNING OF 2012 OR MID-2012. THE PATIENT DID NOT WANT TO STOP VNS BECAUSE SHE HAD SUCH A GOOD BENEFIT WITH VNS. THE DYSPHONIA GOT BETTER FOR 2-3 WEEKS THEN KICKED BACK. THE PATIENT RELIES HEAVILY ON THE MAGNET FOR SEIZURES/AURAS, AND SHE BEGAN FEELING A LOT MORE OF VOICE CHANGE ALONG WITH PAIN/DISCOMFORT ALONG THE VNS SYSTEM (CHEST/NECK AREAS). NO X-RAYS BEING TAKEN AT THIS TIME AS THEY ARE REFERRING THE PATIENT FOR SURGERY IRREGARDLESS. SURGERY IS LIKELY, BUT HAS NOT OCCURRED TO DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461170 LEAD MODEL 302 LEAD LYJ CYBERONICS INC 302-20 1527

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Female