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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA INC. VAGUS NERVE STIMULATOR

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LIVANOVA USA INC. VAGUS NERVE STIMULATOR Back to Search Results
Event Date 12/19/2005
Event Type  Injury  
Event Description

In (b)(6) 2005, i had a vagus nerve stimulator implanted for treatment resistant depression by a dr (b)(6) at (b)(6) medical center in (b)(6). (dr (b)(6) subsequently worked at (b)(6) medical center). Afterwards, i felt as if i were fighting off an infection. I informed the surgeon, but blood work revealed no infection. About three weeks later, however, my chest began puffing out like a balloon, and i was rushed to the hosp. According to my medical records, i was treated for an (b)(6) infection. I did not find that out until i requested the medical records some time later. The device was removed, and i was kept at (b)(6) med ctr for several days on iv antibiotics. Then i took iv antibiotics at home for a few more weeks, with a nurse coming over to replace the iv syringe in my hand every few days. Two months later, another vagus nerve stimulator was implanted by the same surgeon, who damaged my recurrent laryngeal nerve, leaving me unable to speak for a year. I will report that incident separately. (i assumed these adverse events were reported by the healthcare providers, and i was too severely depressed for years to even attempt to report these incidents myself. But now, years later, i want to be sure you know about these incidents). And i will file another report concerning severe sleep apnea caused by the second vagus nerve stimulator (which i cured in (b)(6) 2013 by having to demand that the neurologist adjusting the settings on the device turn it off, after suffering significant sleep apnea even on a bipap machine. At that point, i had found the studies revealing higher settings on these devices cause severe sleep apnea, severe depression, and cardiac arrest during sleep. But again, i will file separate reports for each of these incidents that contributed to the destruction of my health, disability, and having to live off ssdi since 2011. Of course, i do not have the first vagus stimulator that was removed in (b)(6) 2005. At the time the device was implanted, i was suffering from severe, unremitting depression because a psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania as a side-effect of sertraline, but not otherwise. Vns had no effect on my depression at the time, but the second vagus nerve stimulator nearly caused me to commit suicide because it was causing sleep apnea with an apnea hypoxia index of 47. On (b)(6) 2006, i had a second vagus nerve stimulator implanted for treatment-resistant depression after the first one had to be removed in (b)(6) 2006, because the surgeon infected me with (b)(6) while the first stimulator was implanted (i have submitted a report concerning that adverse event already). I have also submitted a report concerning damage to my recurrent laryngeal nerve when the second device was implanted, leaving me unable to speak for a year. Over the years, my psychiatrist, and then a neurologist, increased the output of the device. I had no risk factor for sleep apnea. I had been running literally 49 miles per week before i began to experience severe depression, in part as a result of settings for the device. I had a cpap sleep study on (b)(6) 2011, which revealed that i was not breathing between 10 and 30 seconds every minute of the night. My apnea hypoxia index (api) was 47. 4. The doctor who diagnosed me with sleep apnea told me that on a scale of 1 to 10 in severity, with 10 as most severe, he rated my sleep apnea as a 9. The settings on the vagus nerve stimulator as of (b)(6) 2011 were: parameters output current (ma): 1. 5, signal frequency (hz): 2. 0, pulse width (usec): 250, signal on time (sec): 30, signal off time (min): 5, magnet output current (ma): 1. 75, magnet on time (sec): 60, magnet pulse width (usec): 250, lead test/normal mode test output status (ok or limit): ok, lead impedance (ok or high): ok, dc-dc converter code (0-7): 3 eri flag (yes or no): no. Even using a bipap machine, my api fluctuated at scores from 8 to 40 until (b)(6) 2013. On that date, i brought several studies to my neurologist's office that proved indisputably that vagus nerve stimulation causes severe sleep apnea, severe exacerbation of depression and cardiac arrest during sleep. I was waking up for years feeling as though somebody had beaten my body with a baseball bat. The neurologist reluctantly turned the device off. That evening, and every subsequent evening since then, i have experienced no sleep apnea. I still have the product, but it is still implanted, and turned off. I do have the product packaging. Because i have the packaging, i will answer below that i do have the product. I weighed approximately (b)(6) pounds in (b)(6) 2011, as opposed to my weight listed in two other reports related to implantation of this device and a prior implantation of a vagus nerve stimulator. Lyme neuroborreliosis since 1980. Babesia microti infection since 1980, severe, unremitting treatment-resistant major depression from late 2003 to late 2006 because psychiatrist took me off medications i was taking for depression and put me on lamictal, zyprexa, etc. Merely because i experienced mild hypomania five days per month as a side-effect of sertraline; severe-to-extreme treatment-resistant depression from (b)(6) 2008 to present because a doctor caused extreme excitotoxicity by provoking a severe inflammatory immune response for an entire year while treating me far too aggressively for lyme disease, and also caused by vagus nerve stimulation. I was not able to reduce the depression to the moderate range until i discovered that buprenorphine acts synergistically with ketamine to reduce depression, and prevents tolerance to ketamine; i took the same dose of both medications for six years. I was able to get off 300mg intramuscular ketamine daily in six weeks, with no withdrawal symptoms, and with better results treating depression 1. 5 years ago when i began treating the cerebral cortex with a 30 watt, 810 nanometer (near infrared) laser that emits a collimated beam, in continuous wave mode for 50 minutes each evening. My nightly readings on my bipap machine, which i have saved, prove that when the vagus nerve stimulator was turned off, i no longer experienced sleep apnea that severely exacerbated my depression, and which caused extreme physical pain. After a vagus nerve stimulator had been implanted in (b)(6) 2015 and removed on (b)(6) 2015, a second vagus nerve stimulator was implanted by a dr. (b)(6) at (b)(6) medical center in (b)(6), on (b)(6) 2006. During the surgery, my left recurrent laryngeal nerve was damaged. I was unable to speak for an entire year. The surgeon casually told me that he did not know whether i would ever be able to speak again. For an entire year, i had to use as much energy as it takes to scream at the top of one's voice merely to make a rasping sound that was barely intelligible. I have a videotape with audio made about six months after the device was implanted, demonstrating the extent of impairment. I still have that video in digital format. The product itself is still implanted but turned off. Since the surgical procedure, not the product itself, caused the damage, and since the product is still implanted but turned off, i will answer below that i do not have the product so that you can evaluate it. I assumed at the time that the manufacturer or surgeon reported this, and then became too severely depressed as a result of sleep apnea caused by the vagus nerve stimulator (and also as a result of medical incompetence of a doctor treating lyme disease and babesia microti) that i was incapable of reporting it. A psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania five days per month as a side-effect of sertraline, but not otherwise. He took me off of sertraline and adderall, and put me on medications such as lamictal and zyprexa. In (b)(6) 2006, i finally felt capable of going to another doctor and asking to be put back on the medications i had been taking before i began seeing the psychiatrist who caused the three-year episode of severe depression. Within a week of being put back on those medications, i was not suffering from depression or mild hypomania. But the vagus nerve stimulator was implanted while the psychiatrist was causing me to suffer a three-year episode of severe, unremitting depression that was not responsive to ect.

 
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Brand NameVAGUS NERVE STIMULATOR
Type of DeviceVAGUS NERVE STIMULATOR
Manufacturer (Section D)
LIVANOVA USA INC.
MDR Report Key7910123
Report NumberMW5080105
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 09/23/2018
3 DeviceS WERE Involved in the Event: 1   2   3  
1 Patient Was Involved in the Event
Date FDA Received09/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 09/25/2018 Patient Sequence Number: 1
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