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dennis100
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« Reply #630 on: September 07, 2018, 11:19:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/09/2016
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes from (b)(6) 2016 indicated that the patient was having voice alteration with stimulation. On (b)(6) 2017, it was reported that the patient was experiencing discomfort so she wanted to be referred to a surgeon for evaluation. In clinic notes, the pain was noted to be severe and to be "foreign body pain. " the patient was being prescribed percocet then hydrocodone for pain management. In (b)(6) of 2018, the patient reported that she continued to have voice alteration, shortness of breath, and pain, so she wanted to be referred to a surgeon for explant. Information was received from a hospital that the patient had been referred for potential explant. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7768510
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dennis100
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« Reply #631 on: September 11, 2018, 02:36:14 AM »

Model Number 102
Event Date 09/26/2011
Event Type  Injury   
Event Description
It was later reported the patient would like to have her device explanted because the vns isn't helping and hasn't helped in years. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Information was received indicating that the patient had his device disabled. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.
 
Event Description
Additional information was received from the patient stating why he wants the vns removed. He states it is not helping his severe depression, it adversely affects his speech when it¿s cycling, it increases his social anxiety because he is concerned it will start cycling when he speaks, and he states the device makes it difficult to breathe when he exercises. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.
 
Event Description
It was initially reported that the patient had requested that the generator be disabled. The patient had reported to the physician that she felt that her depression has been worse since having vns. The physician that reported the event's to the manufacturer is not familiar with vns and the patient so she was unable to provide any additional information. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
It was reported from the patient's mother that she is looking for a surgeon to explant the device because he never received benefit from the therapy. No additional relevant information has been received to date and no surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301015
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dennis100
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« Reply #632 on: September 11, 2018, 02:39:12 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2008
Event Type  Injury   
Event Description
A patient reported that his vns device had been removed prior due to painful stimulation and voice alteration. The patient's explant had previously been reported and was due to unknown reasons. The generator was returned for product analysis and verified that the generator performed according to all functional specifications and was able to adequately provide the intended therapy while placed in a simulated body environment. A review of the manufacturing records and diagnostic history also indicated proper device functionality. Follow-up was performed with the explanting facility, but no further relevant information was able to be received. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6394773
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dennis100
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« Reply #633 on: October 04, 2018, 04:07:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury   
Event Description
Further information was received that the surgeon intended to perform surgical intervention for the lead when the generator needed to be replaced since at this time, the generator was still functional. No further relevant information has been received to date.
 
Event Description
Incoming information was received indicating the patient's device was to be upgraded and the patient was referred for surgery. Follow up with the patient stated that generator replacement was needed due to low battery. It was stated that the surgeon would also take a look at her lead as she reported that the lead was "all clumped up under her neck" and that when she turns her head to the right, she can see the wiring under the skin. She stated she could see the "clump" without turning her head. The patient also reported that her generator had migrated and the surgeon stated that when the generator was replaced, he would ensure the device was better secured in the pocket. It was further stated that the patient has near constant ear and toothache believed to be with stimulation and attributed to vns as she had seen both a dentist and ent. She reported a scratchy voice that worsens with stimulation and makes her feel like she has to gasp for air to continue conversations. It was noted that the patient otherwise has been doing well with vns and sees decrease in seizures with the device. The replacement surgery occurred. It was stated that the leads were not revised as they tested to be functioning within normal limits. Post-operation diagnostics showed the devices were functioning as intended. No device was expected for return per the hospital policies. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing painful stimulation at her jaw. The patient also had pain in her neck and jaw which made it difficult to move. Therefore the patient was being referred for a possible lead revision due to the pain. Because of these symptoms the patient was experiencing issues with depression. No additional relevant information has been received. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6914216
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dennis100
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« Reply #634 on: October 04, 2018, 04:08:03 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
The patient reported that they were having difficulty swallowing, catching their breath, and felt some tightness in their throat. It was reported to first occur with magnet stimulation, and has been getting worse in the past six months. The patient stated that recently the difficulty swallowing, catching her breath and tightness in her throat is constant, and not only occurring with stimulation. The patient stated that they were hospitalized and an upper gi test was performed that came back negative. The patient has not seen a neurologist in some time and was questioning if her battery needed replacement. The patient does not have a current neurologist she visits. No other relevant information has been received to date.
 
Event Description
Additional information was received from the patient's previous neurologist who stated that the patient has not been seen since (b)(6) 2018, and the doctor no longer sees the patient. The device was not interrogated at this time, and there were not medication changes. The patient never mentioned any difficulty swallowing, shortness of breath or throat tightness to the neurologist. No other relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient¿s primary care provider is concerned that the patient¿s throat cancer is returning as the patient has experienced throat pain and hoarseness. Patient reports symptoms have been worsening recently. Patient reports at first inability to tolerate solids and no difficulty tolerating liquids. Patient reports history of throat cancer 2007 when they were treated with surgery as well as chemotherapy. The notes also report that the patient was a former smoker. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7403911
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dennis100
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« Reply #635 on: October 04, 2018, 04:08:47 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was initially reported that the patient had the generator explanted due to not having seizures anymore. It was later received that the patient had the device removed due to throat irritation which did not allow her to sing. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported via clinic notes that the patient's explant was also done due to problems breathing and talking for the patient. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7110827
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dennis100
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« Reply #636 on: October 05, 2018, 12:47:58 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating the patient had an increase in seizure frequency. The notes indicated the [stimulator] stopped for unclear reason. The patient was reported to have increased lethargy some difficulty in speech and also seizures. He was admitted to the hospital. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910279
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dennis100
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« Reply #637 on: October 05, 2018, 12:49:09 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2016
Event Type  Injury   
Event Description
The patient later reported that when her neck it flexed forward, or her hands are on her chest, the device seems to stimulate. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported by the patient, it took her 5 hours to come out of anesthesia after vns implant surgery and that she had jerking and ataxia along with an increase in seizures. The increase in seizures and ataxia were later possibly attributed to abruptly stopping xanax. The patient was given gabapentin for the jerking. The patient also noted it took her a week to get strong enough to walk without a walker. The patient also stated she has a drop in her gait, abnormal movements, slurred speech, and flailing extremities while she was in the hospital. She stated she had been admitted due to seizures. The patient was later seen by her physician and was doing better and was able to walk in sunlight without sunglasses and without jerking and headaches. The patient also mentioned having swallowing issues. It was also noted the patient was able to tolerate the magnet swipes after the 3rd swipe, but it was unknown what tolerability issues were noted with the first 2 swipes. Lastly, the patient noted she can see the lead protruding (still under the skin) when she wakes up in the morning for a few hours before it goes back to flush with her skin. Attempts for additional information have been made but have been unsuccessful to date.
 
Event Description
Additional information was received from the physician stating the patient's symptoms were related to medications. Additionally, the physician did not believe the patient's pinching sensation was related to vns and no interventions have been taken due to the reported pinching sensation.
 
Event Description
Further information was received that the patient believed she had new issues with vns. Specifically, she complained of having "charlie horses in throat" on the left side vocal cord when she yawned or opened her mouth to sing. She also reported that she has experienced pain in the chest that extends down to her left arm. This pain was reportedly not constant (it "comes and goes"). The patient also reported having continued issues that were previously reported such as dysphagia, erratic stimulation, speech impediment, and ambulatory issues. No additional relevant information has been received to date.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
The patient later reported she has had a lot of pinching around the axilla of the left breast incision, and displacement of the device upon moving around in bed. Attempts for additional information have been unsuccessful to date.
 
Event Description
Further information was received that the patient was experiencing an exacerbation of symptoms with vns including sleeping disturbances, ambulatory difficulties, and dysphagia. It was also reported that these symptoms started after her device was programmed back on in june 2017, indicating it had been previously turned off. No other relevant information was received from the patient's physician.
 
Event Description
The patient later reported that she is having an increased sensitivity with clonic jerks, poor large muscle control upon movement, blurred vision, slurred speech, headaches, and a longer recovery time after seizures. She stated she was also having increased light sensitivity. The patient thinks some of the symptoms may be related to medications, but it is not confirmed. She did note that she had a 5 day veeg. She was taken off of 2 of her medications and had a decrease in symptoms of ataxia and stated the majority of her symptoms were medication induced. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5698649
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dennis100
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« Reply #638 on: October 06, 2018, 05:26:06 AM »

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910123
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dennis100
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« Reply #639 on: October 06, 2018, 05:26:59 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/02/2018
Event Type  Injury   
Event Description
It was reported that a large dog had jumped on the patient and the patient believed the vns had migrated. It was reported that the vns started firing and not stopping, which made the patient's throat feel tight. It was stated that the patient's o2 stats were ok. The patient's grandmother taped the magnet over the vns to magnet disable the device. The patient was admitted to the hospital and seen by neurology. The vns was disabled and the patient was sent home. It was stated that the patient was scheduled for surgery to fix or replace the vns. It was later reported that the patient also felt vibration and experienced hoarseness. Diagnostics were within normal limits. It was stated that the vns was disabled as the patient felt better when the vns was off. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7911408
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dennis100
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« Reply #640 on: October 06, 2018, 05:27:34 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for referral for replacement. Notes mention that the patient seizures have changed in the last 6 months and her brother noted that the patient¿s memory ¿is going crazy¿ and sometimes she is not able to talk correctly on the phone or in conversation. Directly after mentioning these issues, the discussion of vns replacement was noted. It appears they believe these issues may be associated with vns. The patient also noted more coughing recently and wasn¿t sure if this was related to vns stimulation. The physician¿s ma indicated that she suspects the seizures are vns related. The physician also believes that the patient¿s memory issues and inability to speak correctly is vns related but there was mention that the nonsense in conversation is her seizure presentation. No additional or relevant information has occurred to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7853645
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dennis100
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« Reply #641 on: October 07, 2018, 03:19:22 AM »

Model Number 303-20
Device Problem High impedance
Event Date 09/04/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high lead impedance was observed in clinic but impedance was within normal limits previously at the implant surgery. Positional diagnostics were performed and device settings were increased and the impedance fluctuated to normal limits. Patient was comfortable with all of the positions while attempting positional diagnostics and tolerated the stimulation. Patient experienced the stimulation induced voice alteration as expected at a double output increase which could indicate a good connection to the nerve. Ap and lateral x-ray images were received and reviewed. The generator placement appeared to be normal in the left axillary chest area. Complete lead pin insertion into the connector block was confirmed with the images provided. The pulse generator feedthru wires appeared to be intact. The lead wires appeared to be intact at the connector pins. No gross lead fracture or sharp angles were observed in the visible portion of the lead. Based on the images provided, no obvious source of high impedance was identified. A review of device history records for the generator and lead shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7844104
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dennis100
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« Reply #642 on: October 15, 2018, 11:43:15 AM »

Model Number 300-20
Event Date 04/16/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The company representative reported that the surgeon pulled the lead when installing the new generator, making the lead taut. After closing the patient and waking her, the patient was in pain as a result of the tautness when she turned her head to the right. The surgeon opted to take the patient back in to surgery to correct. Surgeon used electrocautery and cut the lead at that time. The surgeon noticed that he had cut the lead immediately and damage was visible. The surgeon noted that no injury to the vagus nerve was observed. He did not opt to perform full revision. Therefore, the patient's device was disabled and was never programmed. The patient was referred to a different facility for full revision. The physician noted that patient was a little hoarse following surgery which is believed to be related to surgery, but there was no paralysis believed to be present. No serious injuries occurred, and no interventions were taken to preclude a serious injury. The hospital discards products in surgery, so attempts for product return of the explanted generator on (b)(6) 2012, were unsuccessful. The patient had generator and lead replacement surgery on (b)(6) 2012. Pre-op system diagnostics indicated high lead impedance. The surgeon displayed the x-ray in the operating room, and a lead discontinuity was visible near the generator area. Two system diagnostics on the newly residing generator (one out-of-pocket and one in-pocket) indicated okay results. The field clinical engineer confirmed that the generator was replaced for compatibility to the single pin lead. The explanted generator and lead on (b)(6) 2012, were received by the manufacturer. Product analysis for the generator and lead was completed. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis of the lead identified a coil discontinuity in the positive coil. Scanning electron microscopy images of the positive coil suspected broken ends show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in both coil ends. The suspected coil break is located at approximately 8. 3cm from the end of the connector bifurcation. This was most likely caused during the implant/explant procedure, as reported by the company representative who attended the surgery. Also, the positive coil has what appears to be wear (flat surfaces) in the vicinity of coil discontinuity. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred on the coil in the vicinity of the identified flat surfaces. The outer silicone tubing has what appears to be an imprint at approximately 8. 3 cm from the end of the connector bifurcation. The exact reason for this imprint is unknown. Also, the inner silicone tubing of the positive coil has what appears to be tearing at this location. The unmarked connector pin has what appears to be pitting in the vicinity of the setscrew marks. The inner silicone tubing of the positive coil is abraded open at approximately 8. 1-8. 4 cm from the end of the connector bifurcation. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies (besides an abraded inner tubing opening) were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2697273
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« Reply #643 on: October 27, 2018, 12:55:57 AM »

Model Number 102
Event Date 04/27/2012
Event Type  Malfunction   
Event Description
A fax received on (b)(6) 2012 from the physician indicated that the increase in seizures was not related to vns. The patient's medication was increased, but the patient continued to have seizures. The increase in seizure frequency was to the patient's pre-vns baseline. The patient had convulsion nos seizures. External factors and medication needing changes preceded the increase in seizures.
 
Manufacturer Narrative

Event Description
On (b)(6) 2102, clinic notes were received regarding this vns patient. All notes stated that the physician's diagnosis was that patient had increasing severe convulsive seizures not otherwise specified not greater than or equal to her non-epileptic seizures. Notes dated (b)(6) 2012 indicated that the patient's condition was worse. The patient had five seizures in the past two days, and the timing was different than before. The patient has a seizure on the school bus that lasted 5 minutes, the patient had on seizure when she got off of the bus that lasted 6 minutes. The patient's mother indicated that the patient had been seeing starting spells more in the last few weeks. The patient was disoriented, had trouble with speech, and slept through the night. The patient settings were provided. Notes dated (b)(6) 2012 indicated that the patient was having two seizures per month. The patient's condition was the same. Notes dated (b)(6) 2012 indicated that the patient had a seizure on (b)(6) 2012 when she was excited but was not swiped with the magnet. On (b)(6) 2012, the patient had another seizure on (b)(6) 2102 and was not swiped due to the sureness of the episode. On (b)(6) 2012, the patient had a seizure around 5 pm that lasted for 30 minutes. The patient was swiped 3 to 4 times and diastat was administered. The patient was disoriented, had trouble with speech, and slept through the night. The patient settings were provided. Attempts for additional information will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2797829
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« Reply #644 on: October 30, 2018, 12:47:17 AM »

Model Number 300-20
Event Date 08/30/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a vns patient had a generalized tonic-clonic seizure the earlier day (date unknown). After the seizure, the patient experienced painful stimulation in her chest. The patient's diagnostics were output status: limit, impedance: high ((b)(4);10000 ohms), eos = no. The last known diagnostics, current settings, device disablement after the event, and product information were unknown. X-rays were going to be taken and would be sent into the manufacturer for review. The patient was being referred for a full revision. On (b)(6) 2012, the patient's nurse indicated that the patient's chest and neck x-rays were available and would be sent into the manufacturer for review. The nurse stated that x-rays were taken because the patient was seen the previous day, and upon running diagnostics, high impedance (b)(4);10,000 ohms) was observed. The nurse also indicated that the patient has had very few seizures since being implanted with vns; however, the patient had a generalized tonic-clonic seizure the previous week. For the past month, the patient experienced discomfort in her chest with stimulation. (this was not a shock-like sensation. ) the nurse stated that high impedance was first seen on (b)(6) 2012. It was stated that the device was not disabled. The patient was still experiencing her normal voice alteration; therefore, the device was not programmed off as it appeared that the patient was still receiving stimulation. When asked about manipulation or trauma, the nurse stated that when the patient first called regarding the discomfort, she indicated that she was dizzy. The nurse was pretty sure, but could not confirm, that the patient had fallen at that time, which could explain the dizziness and the painful stimulation. Additional information was received with the patient's x-rays. On (b)(6) 2012, the patient had a partial complex seizure at 14:10 and had a grand mal seizure at 15:10. The patient felt pretty beat up: the patient bruised up her shoulder and back. The patient was evaluated in urgent care and was told that there were no fractures, only bruise. The patient denied any missed medication and no acute illnesses. On (b)(6) 2012, the patient reported dizziness and her medication was adjusted. On (b)(6) 2012, the patient reported that she had missed medications. Since (b)(6) 2012, the patient did not report dizziness and these were the first seizures since the appointment. The patient reported a "different" feeling regarding the generator. It was not a shock, but just different. The patient had a number of seizures since her last visit. The device was stimulation her voice but she felt a weight in her chest with stimulation. The seizures were possibly secondary to an automobile accident. The patient had significant ecchymosis and pain in the left upper arm and should from the fall on her should with the seizures. It was assessed that the patient had the gtc possibly secondary to a fractured lead on the vns. The x-rays were assessed and it was written that the vns wire appears to have a break or crack based on high impedance. Vns replacement including wires was likely. The device was interrogated and diagnostics were run. X-ray images were reviewed by the manufacturer. The generator was visible and appeared to be normally placed. The connector pins appeared to be fully inserted inside the connector blocks. The feedthru wires also appeared intact. The lead was also visible. Lead was present behind the generator. There were no suspect fractures, discontinuities, or sharp angles visible. The lead wires appeared intact at the connector pins. The patient underwent total revision on (b)(6) 2012. The explanted generator and lead were received on (b)(6) 2012 and are currently undergoing product analysis. The returned product form indicated that the lead was explanted due erosion of the lead and parasthesia in the chest.
 
Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Product analysis on the generator showed that the high impedance noted in the lead section was not duplicated in product analysis. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device x-rays reviewed by manufacturer; no gross lead discontinuities visualized.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Review of programming history.
 
Event Description
Additional programming history was reviewed on (b)(6) 2012. High impedance was first seen on (b)(6) 2012. Impedance values and output status varied with diagnostics.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769777
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« Reply #645 on: November 07, 2018, 01:58:18 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Malfunction   
Manufacturer Narrative
A communication error prevented the correct value from being programmed into the device during both electrical tests which resulted in the pulse not disabled.
 
Event Description
It was initially reported that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. The generator would not communicate in the product analysis lab. The battery was found to be depleted, 1. 532 volts as measured with the can removed and battery still attached to the pcb. Post burn-in electrical test results showed that the pulse generator pcb module performed according to functional specifications except for the c4 out of specification condition. The cause for the out of specification c4 capacitor (v cpu) value is likely associated with component aging. A review of pre-temp and post-burn automated electrical test results (performed during manufacture of the product) revealed that a communication error (e. G. Test results display "9999") prevented the correct value from being programmed into the programmed into the device during both electrical tests which resulted in the parameter's current state. No other issues were identified with the returned generator. During electrical testing of a generator's (model 103-106) printed circuit board (pcb), the generator is calibrated to measure voltage using a two point curve from which the trim values diagvbatb and diagvbatm are assigned as the gain and offset of this calibration curve. Diagvbateos threshold corresponds to the threshold level at which the generator will disable output as an eos response and is set at manufacturing after the establishment of diagvbatm and diagvbatb.
 
Event Description
Clinic notes were received providing that the patient can tell when the battery gets low due to changes in behavior and speech but it has little effect on seizures; they are perhaps less intense.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916322
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« Reply #646 on: November 09, 2018, 02:45:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/05/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing a frequency of seizures which created difficulties focusing and talking. Multiple attempts for information were performed, but ao additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8021761
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« Reply #647 on: November 10, 2018, 04:07:50 AM »

Model Number 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/26/2018
Event Type  Injury   
Event Description
Clinic notes from a surgeon's office were received stating that the patient had lost his voice after lead revision surgery. It was stated that the patient was doing well, except had hoarseness which began after the patient returned home from the procedure. It was reported that the patient saw his ent who was able to do a vocal cord check that found the cords to be dysfunctional. The surgeon stated that at this time, he would allow time for the inflammation to improve and then would be able to better determine recovery after some time. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7922050
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« Reply #648 on: November 10, 2018, 04:08:48 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8004870
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« Reply #649 on: November 10, 2018, 04:09:30 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/16/2018
Event Type  Injury   
Event Description
It was reported from the physician that the patient was admitted to the hospital for symptoms of voice changes and neck pain and tingling. The doctor stated that it started 5 days prior and the patient came to the emergency room for the symptoms. The doctor asked what generator the patient had as he was unable to interrogate the patient. He later stated that everything resolved but it is unclear exactly what this means. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7970413
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« Reply #650 on: November 10, 2018, 04:10:12 AM »

Model Number 304-20
Device Problem High impedance
Event Date 09/14/2018
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen from an implant surgery. Three diagnostic tests were performed in the open chest pocket, showing impedance within normal limits. The surgery was completed with no issues and the patient was closed. Following the surgery, the device was turned on to minimal settings. About 6 hours post-operation, the neurologist found that impedance was high. The same high impedance reading was confirmed with a second programmer and the device was turned off. The following day, impedances were found to be within normal limits and the device was turned back on. The patient tolerated the stimulation well and subsequent impedances were within normal limits. The patient was titrated up and was doing well. It was noted through follow up that the patient was small and had a small nerve. There was no unusual swelling or hematoma noted during surgery. Device history records were reviewed for the implanted generator and lead. Both devices were confirmed to have passed all quality inspections prior to distribution. Programming data was reviewed and confirmed that impedance appeared to have increased from within normal limits to high impedance back to normal impedances within 24 hours. No other anomalies were noted. It was later updated that the patient was admitted to the emergency room because he was not able to speak. It was noted that the patient was well in the morning and was dropped off at school talking normally. The school had later called stating that the patient had no verbal communication. There was no sign of pain or discomfort. The parents taped the magnet over the generator and headed to the emergency room. It was stated that after approximately 30 minutes of having the magnet taped over, the patient's speech returned and was described as "raspy". The device was interrogated and found no issues. An ekg was ordered and noted to be unremarkable. The device was turned off. The patient was doing well. Programming data from the event was received and reviewed. No anomalies were noted from the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7950501
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« Reply #651 on: November 11, 2018, 02:44:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2016
Event Type  Injury   
Event Description
It was reported by the patient through social media that she was experiencing voice alteration, breathing difficulties, and pain in the chest and ear. She stated that she wanted to have her device explanted. The explant surgery occurred. The reason for the explant was stated to be due to lack of efficacy and voice alteration. Programming history was reviewed and indicated that the device was functioning as intended, within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7974765
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« Reply #652 on: November 19, 2018, 07:56:50 AM »

Model Number 302-20
Event Date 02/25/2013
Event Type  Injury   
Event Description
Attempts were made for additional questions regarding the patient's vocal cords. The physician replied by stating that he does not manage vocal cords. The physician referred to another physician who managed the patient's vocal cords to have the questions sent to, but the other physician is deceased.

Manufacturer Narrative

Event Description
It was reported that the patient had increase in depression. After communication with the physician assistant on (b)(6) 2013, the physician stated that the patient had increase in depression and no longer feels the stimulation because her voice alteration went away. It was then determined that the patient had pain in her back and caused her to be depressed more as a result. Depression levels are below pre-vns baseline. The patient used to have voice alteration but no longer experience it because the surgeon injected the patient with collagen into her vocal cords and the voice alterations went away. The physician also stated the possibility that the patient's voice alteration went away because she was implanted for a while with the same settings. Attempts for additional questions are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3056134
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« Reply #653 on: November 26, 2018, 04:40:07 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that she has been having very bad digestion issues and difficulties swallowing since (b)(6) 2010. She stated that both issues started around the same time and said she has been to many specialists and physicians for the issue. The patient described the difficulty swallowing as "her food won't go down"; and confirmed that she was not vomiting her food back up, but was having a difficult time getting it to her stomach. Per the patient, solid foods will not digest at all and only liquids go down, but they go down very slowly. The patient stated that she has had many tests performed and has tried several different diets (e. G. The gluten-free diet, sugar free-diet, and dairy-free diet); however, nothing has worked and there has been no improvement. The patient explained that she has been diagnosed with gastroparesis and stated that several physicians believe her vagus nerve has been damaged. Per the patient, her physicians have stated that the vns device has caused nerve damage to her vagus nerve which has caused her to stop digesting food to her stomach. The patient's device stimulates for 30 seconds every 3 minutes, but the difficulty swallowing and digestion problems occur constantly and not just with stimulation. Per the physician's suggestion, the patient's device was turned off on (b)(6) 2013. Additionally, the patient stated that she has gained weight since (b)(6) 2012 as a result of the various diets she has been placed on. The patient stated that since this time she experiences shortness of breath with exertion that occurs all the time and not just with stimulation. Secondly, the patient began experiencing pain under her right rib which started when she gained weight in (b)(6) 2012. The pain was described as a constant pain that has gotten worse over time. This pain gets worse when the patient tries to eat or drink anything. At the time of this report, the patient stated that she had only had her vns device programmed off for a couple hours, but the pain has already lessened, though it was still present. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
On (b)(6) 2013 the physician reported that the patient had gastroparesis and laryngeal difficulty. Per the physician, the patient¿s entire vns system was removed in (b)(6) 2013 with nothing in the operative note indicating nerve damage.

Manufacturer Narrative
This device was implanted to treat fibromyalgia which is an unapproved indication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3096041
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« Reply #654 on: December 07, 2018, 10:33:51 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/19/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient developed swallowing difficulties following a lead and generator replacement surgery due to the vns surgical procedure. The patient's generator was turned on immediately after their vns replacement surgery. It was indicated that the patient's device had been turned off to allow for wound healing and that the physician prescribed steroids for post-operative healing. The device disablement and steroids were for patient comfort. It was additionally reported that the patient underwent surgery due to "vocal cord issues. " both the swallowing and vocal cord issues were attributed to the vns replacement surgery. No additional relevant surgical intervention has occurred to date. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8120818
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« Reply #655 on: December 07, 2018, 10:34:29 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/30/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing side effects such as voice loss/ alterations, tightening of the neck muscles, the patient¿s jaw moving more, and headaches. The patient wished to have the device removed and was referred for surgery. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8104539
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« Reply #656 on: December 09, 2018, 03:30:52 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2006
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient reported through social media that vns did not work for her and that she also did not like that it made her voice hoarse. It was stated that the generator was disabled. Per the physician's assessment, the patient became seizure free after her second surgery for her brain recurrent brain tumor. It was noted that vns was placed after the patient's first surgery for the brain tumor. The device was disabled for lack of efficacy and because the patient was seizure free after removing her brain tumor. It was also reported that there was pain at the "nonfunctioning vns site". No diagnostics were provided. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8083811
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« Reply #657 on: December 15, 2018, 02:54:21 AM »

Model Number 304-20
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Date: settings [output current (ma)/ frequency (hz)/ pulse width (microseconds)/ on time (seconds)/ off time (minutes)/ magnet output current (ma)/ magnet pulse width (microseconds)/ magnet on time (seconds)]; diagnostics: [(normal mode) output status/ lead impedance; (system mode) output status/ lead impedance/ impedance value/ end of service?] : (b)(6) 2012: 0. 5/30/500/30/5; 0. 75/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2012: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/3200ohms/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/no; (b)(6) 2013: 1. 0/30/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2762ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2712ohms/no; (b)(6) 2013: 1. 0/25/500/30/5; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2887ohms/no; (b)(6) 2013: 1. 0/25/500/21/1. 9; 1. 5/60/500; diagnostics: ok/ok; ok/ok/2867ohms/no.

Event Description
It was reported that the patient was diagnosed with vocal cord problem that the ent attributes to vns therapy. It was reported that the patient experiences some difficulty breathing as a result of the vocal cord problem. Clinic notes dated (b)(6) 2013, note that the ent confirmed that vns discharges appear to be affecting the left vocal cord function, which may be compromising respiration in the context of his right-sided cyst. It was reported that device diagnostics were within normal limits. The physician may try to adjust device settings and then send the patient back to ent for reevaluation. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3418880
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« Reply #658 on: December 20, 2018, 02:05:55 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/24/2018
Event Type  Injury   
Event Description
The patient's mother reported to a company representative that the patient experienced voice issues, swallowing, coughing, and hoarseness as a result of the injuries sustained during surgery. The patient's family was concerned with the potential for choking while drinking and vocal cord paralysis. The surgeon reported that the patient experienced a lot of swelling but expected the patient's voice to heal. An ent referred the patient for a modified barium swallow test to evaluate the patient's condition. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.

Event Description
A patient underwent replacement surgery to resolve high impedance present on her vns device, as reported in mfr. Report # 1644487-2016-01548. The surgery was aborted because the explanting physician accidentally punctured the patient's jugular vein, requiring another physician to repair the patient's vein. Per a company representative, the patient stayed in the icu overnight to recover. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7275417
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« Reply #659 on: December 22, 2018, 11:11:03 AM »

Type of Device:     stimulator, autonomic nerve, implanted for epilepsy - lead
                           stimulator, autonomic nerve, implanted for epilepsy
Device Brand        VNS Pulse
Name:
Device                  Cyberonics
Manufacturer's      Cyberonics Inc.
Name:
Date of this           08/01/2011
Report:
(mm/dd/yyyy)
Describe the          Patient who had vagal nerve stimulator implanted ~3 years ago (pt had history of
Event                    intractable epilepsy). He subsequently moved to out of state and reports establishing
or Problem:           care at a neurology practice, and a physician there changed settings as the device was
                            affecting his voice. After that time, he began to have difficulties which retrospectively
                            he feels were related to his device. He was an avid runner, and would experience
                            shortness of breath when he would run after about 5 minutes, and would then
                            improve after he would stop for a few minutes. At the time he attributed it to the
                            change of climate. He eventually developed severe shortness of breath and it was
                            found that his stimulator was misfiring causing constriction of the vocal cords. After
                            that time, the device was turned off and it subsequently has been off ever since. The
                            patient returned for removal of the stimulator. The lead remains in the patient.
                           
the device(s)
may have              Potential for patient harm
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=26077
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