BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE GEN MODEL 103

    MDR report key: 3102380 · Received May 9, 2013

    Report

    Report Number
    1644487-2013-01307
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    July 12, 2012
    Report Date
    April 9, 2013
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    PMA / PMN Number
    P970003
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED ON (B)(6) 2013 VIA A (B)(4) MESSAGE THAT THE PATIENT WAS HAVING BREATHING PROBLEMS DURING DEEP SLEEP SINCE VNS IMPLANTATION. A VIDEO WAS POSTED OF THE PATIENT'S SLEEPING ISSUE. THE PATIENT'S CAREGIVER REPORTS THAT SHE IS CERTAIN THAT THESE PROBLEMS STARTED WITH VNS IMPLANT AND HAVE CONTINUED TO GET WORSE AS SETTINGS INCREASE. LATER ON (B)(6) 2013, THE CAREGIVER REPORTED THAT SHE HAS BROUGHT UP THE SLEEPING ISSUE CONCERN WITH THE PATIENT'S VNS NEUROLOGIST AND PRIMARY CARE PHYSICIAN (PCP), BUT THE PHYSICIAN DID NOT SEEM CONCERNED AND SAID IT WAS "NORMAL," BUT SHE FEELS THAT THIS IS NOT. THE CAREGIVER SAID THAT SHE UNDERSTANDS THAT THERE ARE WARNINGS FOR PATIENTS WITH PRE-EXISTING ISSUES AND BEING EVALUATED PRIOR TO VNS FOR THINGS LIKE THIS, BUT SHE FELT THAT THE PATIENT DOES NOT HAVE ANY PHYSICAL ISSUES THAT WOULD CAUSE HER TO HAVE A PRE-EXISTING CONDITION THAT WOULD BE EXACERBATED BY THE VNS THERAPY. SHE DID CONFIRM THAT THE PATIENT HAS NOT HAD A SLEEP STUDY DONE SINCE SO FAR HER PCP DID NOT THINK IT WAS NEEDED AND ALSO HAS NOT REFERRED HER TO AN ENT. THE CAREGIVER THEN WENT ON TO EXPLAIN THAT DURING THE EPISODES, THE PATIENT'S OXYGEN LEVELS ARE DROPPING INTO THE 80S, ESPECIALLY MORE RECENTLY AND WAS NOT AN ISSUE IN THE PAST. THE ISSUE ONLY OCCURS DURING DEEP SLEEP, IS NOT POSITION DEPENDENT OR DUE TO AN ILLNESS LIKE A COLD, IS PRESENT WHEN BREATHING THROUGH MOUTH OR NOSE, OR IF THE PATIENT IS LYING FLAT OR ELEVATED. THE PATIENT HAD GENERATOR REPLACEMENT ON (B)(6) 2012, AND THE CAREGIVER REPORTED THAT THIS ISSUE WAS PRESENT WITH THE PATIENT'S PREVIOUS GENERATOR IMPLANTED ON (B)(6) 2009. (THE SLEEPING ISSUES WITH THE PREVIOUS GENERATOR ARE CAPTURED IN MFG REPORT NUMBER: 1644487-2013-01308.) HOWEVER, THE ISSUE HAS WORSENED SINCE GENERATOR REPLACEMENT IN 2012. SHE SAID THAT AS FAR AS SHE KNEW THERE HAD NOT BEEN ANY ATTEMPTS TO ALLEVIATE THE ISSUE WITH SETTINGS ADJUSTMENTS, HOWEVER WHEN THE PATIENT'S OUTPUT CURRENT WAS LOWERED (SETTINGS UNKNOWN) FOR A FEW DAYS THE PATIENT HAD INCREASE IN HER SEIZURE FREQUENCY, SO THE PATIENT'S SETTINGS WERE INCREASED AGAIN. THAT PATIENT IS STILLING HAVING ABOUT 20+ SEIZURES EVERY 24-HOURS AND HAS SEVERAL SEIZURE-TYPES DUE TO A TRAUMATIC BRAIN INJURY SEVERAL YEARS AGO, WHICH APPEARS TO HAVE SEVERAL FOCAL POINTS IN HER BRAIN, SO HER TREATMENT OPTIONS ARE LIMITED. THE PATIENT WAS STARTED ON A NEW MEDICATION ABOUT A YEAR AGO. THE CAREGIVER DOES NOT FEEL THAT CPAP IS AN OPTION DUE TO THE PATIENT'S SEIZURES WHICH HAVE BEEN VIOLENT AND WOULD LIKELY CAUSE THE CPAP TO BE DAMAGED WITHIN A FEW DAYS. THE CAREGIVER WAS SUGGESTED TO DISCUSS THESE ISSUES WITH THE PHYSICIAN FOR FURTHER DISCUSSIONS AND SUGGESTIONS. FOLLOW-UP WITH THE TREATING VNS NEUROLOGIST WAS PERFORMED WHICH REVEALED THAT THE PATIENT WAS EVALUATED ON (B)(6) 2013. SHE REPORTED THAT SHE WAS NOT AWARE OF THE PATIENT'S BREATHING TROUBLES AND LOWER OXYGEN LEVELS (BELOW 80) UNTIL THE VNS MANUFACTURER CONTACTED HER OFFICE. THE PATIENT/CAREGIVER HAD NOT REPORTED THIS TO HER UNTIL HER APPOINTMENT ON (B)(6) 2013. THE CAREGIVER BROUGHT IN THE VIDEO OF THE PATIENT SLEEPING TO SHOW THE PHYSICIAN. THE PHYSICIAN REPORTED THAT THE BREATHING TROUBLES APPEAR TO BE RELATED TO STIMULATION, SO SHE LOWERED THE OUTPUT CURRENT AND PULSE WIDTH. SHE FURTHER INDICATED THAT IT IS "CLEAR THAT THE PATIENT GETS GASSY DURING STIMULATION." SHE REPORTED THAT IF THIS DOES NOT RESOLVE THE ISSUE, SHE PLANS ON LOWERING THE STIMULATION FURTHER. SHE STATED THAT WHEN THE PATIENT/CAREGIVER DISABLED THE DEVICE WITH THE VNS MAGNET, THE ISSUES RESOLVED SO IT IS "OBVIOUSLY" RELATED TO VNS. THE PHYSICIAN LOWERED THE OUTPUT CURRENT TO 2.5MA AND PULSE WIDTH TO 250USEC. HOWEVER, THE PATIENT DID NOT WANT THE SETTINGS LOWERED, BUT THE PHYSICIAN ELECTED TO TURN DOWN THE SETTINGS TO SEE IF THIS HELPS THE BREATHING TROUBLES. NO ADDITIONAL INFORMATION WAS PROVIDED BY THE PHYSICIAN AS SHE WAS NOT PREVIOUSLY AWARE OF THE BREATHING ISSUES DURING SLEEP. ATTEMPTS FOR THE PRODUCT INFORMATION HAVE BEEN UNSUCCESSFUL TO DATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE VNS PATIENT WAS REFERRED FOR SURGERY. THE NEUROLOGIST BELIEVED THAT THERE WAS AN ISSUE WITH THE PATIENT¿S LEAD. THE PATIENT¿S DEVICE WAS TESTED AND SYSTEM DIAGNOSTIC RESULTS SHOWED NORMAL DEVICE FUNCTION AT THE TIME. THE NEUROLOGIST STATED THAT THE PATIENT¿S DEVICE SHOWED AN IFI CONDITION AND THAT THE PATIENT WAS NO LONGER FEELING THE SAME INTENSITY FROM STIMULATION. FURTHER FOLLOW-UP REVEALED THAT THE PATIENT HAD A SURGICAL CONSULT ON (B)(6) 2014. THE SURGEON STATED THAT GENERATOR AND LEAD REPLACEMENT WAS NEEDED AND THAT THE PATIENT¿S DEVICE WAS ¿DEAD.¿ THE PATIENT UNDERWENT GENERATOR AND LEAD REPLACEMENT SURGERY ON (B)(6) 2014. THE EXPLANTING FACILITY WILL NOT RETURN EXPLANTED DEVICES TO THE MANUFACTURER FOR ANALYSIS; THEREFORE, NO ANALYSIS CAN BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DIAGNOSTICS WERE NORMAL. A FULL REPLACEMENT OF THE VNS SYSTEM WAS PERFORMED BY THE SURGEON ON (B)(6) 2014. DURING SURGERY, THE SURGEON NOTICED THAT THE LEAD WIRE WAS SUTURED TO THE FASCIA IN THE CHEST, RATHER THAN SUTURING THE GENERATOR TO THE FASCIA AS INDICATED IN LABELING. THERE WAS ALSO A KINK IN THE LEAD WIRE IN THE CHEST AREA, BUT NO SPECIFIC LEAD DAMAGE WAS OBSERVED. THE SURGEON WONDERED IF PERHAPS THE SUTURING OF THE LEAD WIRE TO THE CHEST WAS CAUSING THE PATIENT PAINFUL STIMULATION IN THE CHEST AREA AND CLINICAL SYMPTOMS, OR WHETHER IT WAS DUE TO GENERATOR MIGRATION. IT WAS ALSO NOTED THAT THE NEUROLOGIST THOUGHT THE PATIENT'S DEVICE REACHED IFI = YES QUICKLY, BUT BASED ON THE ESTIMATED BATTERY LIFE PER LABELING AT THE PROVIDED SETTINGS IN (B)(6) 2013, THERE IS NO EVIDENCE TO SUGGEST PREMATURE DEPLETION. THE CAREGIVER REPORTED THAT MANIPULATIONS OR INTENSE MOVEMENTS WAS NOT AN ISSUE WITH THIS PATIENT. THE PATIENT'S PAIN HAS RESOLVED SINCE FULL REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204319 PULSE GEN MODEL 103 GENERATOR LYJ CYBERONICS, INC. 103 3247

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention