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dennis100
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« on: March 28, 2019, 07:54:06 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/14/2017
Event Type  Death   
Event Description
A company representative saw through a newspaper obituary that this patient passed away in his home due to an unspecified reason. The patient's neurologist did not know the patient's cause of death as they also found out through the newspaper. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as metabolic encephalopathy is not expected to be related to the vns.
 
Event Description
The patient's last hospital discharge report was received and indicated that the patient was discharged into home hospice care three days prior to death. The patient was reportedly admitted to the hospital for metabolic encephalopathy and worsening dementia. However, the patient had other active problems reportedly, as follows: generalized convulsive epilepsy, hypothyroidism, acute kidney failure, hypernatremia, hypokalemia, osteomyelitis of jaw, weakness, debility. The hospital encounter was reportedly included consultation with palliative care. The patient was discharged in poor condition with none of his problems resolved. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6335581
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dennis100
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« Reply #1 on: March 28, 2019, 07:55:08 AM »

Model Number 303-30
Event Date 11/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2012 it was reported that the patient was to have an initial implant that day, but the hospital only had 2 mm leads in stock and upon opening up the patient, it was found that he has a big vagus nerve. The surgeon attempted to implant the 2 mm lead but it was constricting the patient's nerve so it was removed and the patient was closed up. The patient was asked to stayed overnight at the hospital to have surgery the next day with a 3 mm lead that was being shipped to the hospital. The patient's wife did not want the patient to stay overnight and wasn't sure she wanted to risk him going through another surgery if the new lead does not fit. On (b)(6) 2012, it was reported that the patient underwent surgery again with a 3 mm lead. The surgeon noted that the vagus nerve was swollen from the previous surgery and due to the patient having a very large neck he was not able to get good enough exposure of the nerve to get the electrodes around the nerve. The patient was closed up again and sent home. The surgeon also noted that the two 3 mm leads he tried to use lost their coil form after trying to coil nerve.
 
Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the returned leads. The condition of the returned leads was consistent with conditions that typically exist following manipulation of the leads. The patient stated that his voice is still raspy; he has to yell to be heard. The patient also mentioned that if he has a coughing fit, or laughs in a certain position, he feels like he is being chocked. The surgeon stated that he thinks the patient is too large and the leads will not fit. Although implant surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient was scheduled for an ent evaluation. It was reported that the patient has left vocal cord weakness. Clinic notes dated (b)(6) 2013 were received which indicate that the patient has multiple medical problems including chf, dm, htn, copd, and cva ((b)(6) 2012) who presents to the neurosurgery clinic to be assessed for placement of a vagal nerve stimulator. The patient reported that over the past year, his seizures have progressed in frequency and severity with him now having multiple daily grand mal seizures; when his seizures first occurred, he notes he had one seizure per year. In (b)(6), the patient reports that the surgeon attempted to place a vns on two separate occasions but failed. The patient reports that his vagus nerve was too large which lead to the vns leads breaking each time. The patient has had dense hoarseness since the procedures. Due to the cross reactions between his aeds and cardiac medications, as well as the progressive nature of his seizures, the patient has been urged by his neurologist and cardiologist to have a vns placement attempted once more. Additional clinic notes were received from a visit with another surgeon who indicated that the patient has history of an mri showing evidence of a stroke involving a right artery. The patient is having progressively worsening frequency and severity of seizures refractory to current medications and has 2 failed vns placement attempts. It was stated that an assessment of the patient's vocal cords with an ent is needed as the nerve may be transected or permanently damaged. The patient was seen by an ent specialist on (b)(6) 2013 for evaluation of hoarseness and dysphagia. The patient's quality of voice was raspy and rough and the severity was moderate with a significant impact on voice quality or function. The hoarseness started 11/1/2012 after vns surgery. Associated manifestations are dysphagia, frequent heartburn, sore throat, and tobacco use. The patient feels like foods and liquids don't go down and get stuck, also chokes and coughs at times - all new since surgery. The dysphagia is in the lower throat and the patient feels like food sticks in the throat, has a "lump in throat sensation" and states that even swallowing air can give him a choking sensation. The event is moderately severe. Aggravating factors include swallowing liquids, swallowing saliva only, and swallowing solid food. Associated manifestations include frequent heartburn or indigestion, frequent or chronic hoarseness, frequent or chronic sore throat, neurological problems, and pressure sensation in throat. It was found that there was mobility reduced motion in left cord. The right vocal cord had normal mobility but the left vocal cord was limited. There was good approximation of vocal cord phonation but paresis of left vocal cord was suspected. The patient was referred for a barium swallow to evaluate swallowing issues. The operative notes from the (b)(6) 2012 surgery stated that the vagus nerve was exceptionally large comparative to average anatomy. The 2 mm lead was coiled around the nerve and after coiling it was noticed that the vagus nerve due to the extensive size was being strangulated by the lead placement. Due to the large diameter of the vagus nerve it was felt that the coil could not be kept in contact with the nerve without jeopardizing safety. At that point the procedure was aborted with the incision was copiously irrigated with antibiotic solution. The patient was noted to be morbidly obese. On (b)(6) 2013 it reported that the patient has been going to speech therapy and his voice is improving. The patient started speech therapy about 2 weeks prior and is seen 2 times per week for 2 hours. The patient underwent a modified barium swallow on (b)(6) 2013 and the notes from this visit indicate that the diagnosis was dysphagia and that the patient had left vocal cord weakness. The patient was noted to have a history of coronary heart disease, cva, diabetes, chronic back pain, obesity, and hypertension. The patient had resilient (l) side weakness from cva, gerd. The patient had decreased voice and reports coughing on liquids. Gerd was not observed during evaluation. The patient had aspiration throughout assessment. Oral and pharyneal phases of swallowing are normal. No aspiration with modified barium swallow under fluoroscopy.
 
Event Description
Additional information was received on (b)(6) 2013, when it was reported that a second surgeon told the patient he needed to see an ent (ear, nose, and throat) physician because the nerve might have been severed in the previous surgical attempt. The patient later reported that the second surgeon wants a veeg, ent evaluation, and or notes from the initial surgeon. The patient stated that he is still raspy, struggles to push out air and to be heard, when he touches the skin on the left side of neck to throat area, it feels numb. He also stated that if he laughs real hard or gets excited, he starts choking and may gag while drinking fluid, even on air. The patient stated that he has a history of choking on meat, but he thinks that is because he has no teeth.
 
Event Description
Additional information was received when the two 3. 0mm leads that the surgeon had tried to implant in the patient were returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative
Brand name; corrected data: inadvertently listed "lead model unknown" instead of "lead model 303" on initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744
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dennis100
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« Reply #2 on: March 28, 2019, 07:56:04 AM »

Model Number 102
Event Date 11/21/2006
Event Type  Malfunction   
Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.
 
Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.
 
Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.
 
Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.
 
Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.
 
Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.
 
Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
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dennis100
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« Reply #3 on: March 28, 2019, 07:57:44 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
The patient reported that she was diagnosed with left vocal cord paralysis by an ent in 2012. It was reported that the patient's neurologist has not programmed the device off to assess whether or not the paralysis is related to vns therapy. The patient reported that her neurologist "performed something that shocked her" in 2011 and since then she has had voice changes. The neurologist's office indicated that the patient¿s vocal cord paralysis could be related to vns therapy, but that the device has been very effective in helping to control the patient¿s seizures so they are not changed any device settings at this time. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Follow up with the physician's office confirmed that the patient's left vocal cord paralysis was diagnosed by an ent. The patient's last appointment was in (b)(6) 2012. The patient has a history of myasthenia gravis (neuromuscular disease leading to fluctuating muscle weakness) that is not related to vns. Per clinic notes, the nurse noted that it looks like the patient "is developing increasing hoarseness. She had an ent evaluation which did show left vocal cord paralysis. " she also has eye droop which is from myasthenia, not vns. The nurse noted that they cannot ruled out the myasthenia as the potential cause for the difficulty swallowing and left vocal cord paralysis. The physician notes that they could remove the vns, but he indicates that he has discussed this in length with the patient and he cannot state that the laryngeal nerve would return to function even after vns removal. Per notes, "although it is possible that the vns electrodes have caused corrosion on the left laryngeal nerve, i have never experienced this in my cases" and the physician does not suspect this is the case. The patient understands and does not want surgery. She would rather keep vns because it seems to be controlling her seizures. Between (b)(6) 2013, the patient did not have any seizures. The patient is reportedly at "appropriate" settings (not specifically provided) which are helping her with her seizures so they do not want to change the settings. The physician confirmed that since the patient's seizures are well controlled, they do not want to try and change the patient's settings to see if it affects the vocal cord paralysis. At this time, the patient's voice is not worse but still scratchy. They performed an x-ray which showed the vns system was not broken. Copy of x-rays will not be provided to the manufacturer for review. It was indicated that the patient's medications were adjusted to a dose that would help her with myasthenia, but the patient is kind of self-adjusting on her medications. Diagnostics are within normal limits, and the nurse again indicated that they interrogated the device and "settings are where they need to be. The nurse was unsure of what the patient was referring to when she said she was "shocked" at her last visit, but stated that the vns cannot be ruled out it was in relation to the nerve. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3272783
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dennis100
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« Reply #4 on: March 28, 2019, 07:58:20 AM »

Model Number 101
Event Date 06/11/2012
Event Type  Injury   
Event Description
On (b)(6), 2012 clinic notes dated (b)(6), 2012 were received from a vns treating physician. Review of the clinic notes revealed that the patient¿s mother stated the patient was recently hospitalized from (b)(6), 2012- (b)(6), 2012 due to a stroke and a hole in her heart told to her by cardiology. No outpatient cardiology has been set up at this time per the patient's mother. The patient has residual speech difficulty and right upper and lower extremities weakness. The patient has been provided with speech, occupational, and physical therapy. The patient is currently on asa 81mg per day. No new stroke-like symptoms have been reported since then. The patient's blood pressure was noted to be 124/76. The patient's assessment includes stroke/cerebral thrombosis with cerebral infarction. Attempts for further information have been made to the physician but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2665067
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dennis100
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« Reply #5 on: March 28, 2019, 07:58:51 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that he saw the patient and ran diagnostics which showed everything working within normal limits with the generator not near end of service. Patient was complaining about weakness in her left arm and sporadic stimulation around the generator site. Patient was also having breakthrough seizures. Physician felt that the battery was weaning out and did not have confidence in diagnostics testing. Patient underwent a battery replacement surgery. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1909635
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dennis100
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« Reply #6 on: March 28, 2019, 07:59:53 AM »

Model Number 102
Event Date 08/25/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a vns implanting neurosurgeon reported that the after the patient's generator was replaced in (b)(6) 2009, the patient was experiencing vocal cord paralysis where her left vocal cord did not move and had to have a re-innervation procedure. The patient was seen again as she developed what looked like a burn or fungating mass over the generator site. The surgeon removed the generator on (b)(6) 2011 and he reported that it had appeared to have leaked into the pocket; there was metal and scar tissue on histology and the device looked like a rusted battery. Clinic notes from the surgeon were also received. The notes dated (b)(6) 2011 revealed that the patient was experiencing worsening pain at the generator pocket site and had gone to the hospital and been evaluated for any cardiac disease. No cardiac disease was found. She started using a heating pad over the device and she reported that she developed significant blistering at the incision site of the generator and that this has been slowly improving. The device has become more prominent and more painful over the last few weeks however. The surgeon reported that the patient's skin is black and convoluted over the patient's generator incision scar. The device is easily palpable and somewhat mobile. He stated that the patient has likely a burn with some necrosis of the skin at the generator site. It also seems that she may be developing an infection at the generator site and that it should be removed. The surgeon said the patient's seizure control is now much worse without the vns functioning. The operative report from the date of explant, (b)(6) 2011, was also received by the surgeon. The report reveals that the patient had an existing 5cm linear skin incision from the implant of the generator and that a central area of this had turned black and widened to about 0. 5 cm in size. Therefore, an incision was performed to ellipse out the prior scar. The subcutaneous fat was found to be relatively normal in appearance; however, a capsule was encountered with significant fluid and samples were taken for cultures. The capsule was relatively black in color and there appeared to be a wall of possible hemosiderin-stained tissue, several millimeters thick, all within the generator pocket. The surgeon reported that the color of the titanium close to the header of the generator was altered and pictures were taken of it. The surgeon also stated that there was also a collection of very hard black porous material intimately attached to the device. The generator was explanted and the skin biopsy was sent for pathological evaluation. The generator pocket was then copiously irrigated and all of the black material within the scar capsule was removed mechanically. The wound was then closed. The patient's programming history was reviewed in the manufacturer's database which revealed that high impedance was detected on (b)(6) 2010 with a system diagnostics test and normal mode diagnostics test showing results of output=limit/lead impedance =high/dcdc=7/eri=no. The patient was disabled that day to output =0ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec. The manufacturer's consultant reported that she obtained the explanted generator from the surgeon on (b)(6) 2011 and will be sending it back to the manufacturer for product analysis. It has not yet been received by the manufacturer to date. When additional information is received, it will be reported.
 
Event Description
Additional information was received on (b)(6) 2011 when the explanted generator and lead were returned to the manufacturer for product analysis. Product analysis was completed on the generator on (b)(6) 2011. Bodily fluid remnants were observed in the negative connector block and header cavity. The anomalies in the header area may have been a contributing factor to the adverse events. Corrosion/dried fluids and pitting conditions in the negative connector block and setscrew were observed and are most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. The septum was not cored. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Although initial visual analysis of the lead showed fluid ingress, full product analysis on the lead is still pending.
 
Event Description
Additional information was received on (b)(6) 2011 when product analysis was completed on the explanted lead. A large 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 connector pin quadfilar coil appeared to be broken approximately 213mm from the end of the connector boot. The area was identified as being thin which prevented identification of the coil fracture type with evidence of electro-etching, pitting and residual material on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Discoloration was observed inside the majority of the outer silicone tubing. Discoloration was observed throughout the inside of the connector pin inner silicone tubing and on the quadfilar coil. What appeared to be pieces of inner silicone tubing were observed inside the outer silicone tubing. The tubing discoloration suggests that fluid was present in the tubing at some point in time. Based on the returned lead portion, the initial location of fluid ingress into the tubing cannot be determined. With the exception of the identified discontinuity, pitting, and the discoloration observed, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure; no other obvious issues were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Additional information has been requested from the surgeon but no further information has been received to date.
 
Event Description
On december 6, 2011 additional information was received from the surgeon. The surgeon has no evidence that there was any patient manipulation that could have caused the high impedance or infection. No x-rays were taken. The surgeon stated that cultures were taken during surgery and both aerobic and anaerobic cultures were negative. The surgeon believes that the patient's events are directly related to the vns. He stated that the patient developed an increased seizure frequency in 2009 and a decision was made to replace the vns generator. When the new generator was turned on, the patient experienced significant pain and has had vocal cord paralysis since that point in time, approximately (b)(6) 2009. The lead was then replaced. The patient's vocal cord paralysis had not recovered by (b)(6) 2010 and she underwent operative nerve transposition to help with the vocal weakness. The patient was seen in (b)(6) 2011 with pain at the generator site. The patient had stated that she had been experiencing pain for several months prior and the surgeon stated that there was necrotic-appearing tissue at the incision site itself. The surgeon said he was concerned that there was a possible infection, but there was not purulent material at the time of surgery. The surgeon instead said there was very unusual appearing changes to the tissue surrounding the device, and the device itself had a hard metallic build up around it. The surgeon stated that therefore, the device was removed to prevent further injury. The surgeon did not say whether he was aware that the patient had high impedance since (b)(6) 2010 and whether or not the patient's device had been disabled.
 
Event Description
On (b)(6) 2012, additional information was received when the surgeon requested a copy of the product analysis results for the generator as he said the generator looked like it "might have leaked".
 
Manufacturer Narrative
There were observed corrosion/dried fluids and pitting conditions in the negative connector block and setscrew that were most likely related to the observed fluid ingress of the lead that was returned with this pulse generator. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the visual observation of the header area, there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis on the lead has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2253422
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dennis100
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« Reply #7 on: March 28, 2019, 08:00:35 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/29/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.
 
Manufacturer Narrative
Event description, corrected data: the initial report inadvertently did not state the patient's sore throat and increased mucus production. Patient problem codes, corrected data: the initial report inadvertently did not include pain and discharge as patient problem codes.
 
Event Description
It was reported that this patient presented with a sore throat and increased mucus production when visiting the ent regarding their vocal cord paralysis and leukoplakia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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dennis100
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« Reply #8 on: March 28, 2019, 08:01:15 AM »

Model Number 103
Event Date 06/01/2013
Event Type  Injury   
Event Description
Clinic notes, dated (b)(6) 2013, were received which indicate that over the last six months the patient's seizures had become more severe and more frequent and more prolonged. They are generalized clonic and can last a few minutes. The vns device was interrogated and the battery was found to be very low. The physician stated that the patient's seizures have dramatically worsened and he attributes this to the result of this vns battery failure. Per the mother, the second half of year has been challenging due to the patient's increased seizure activity, severity of the seizures, longer seizures, extensive gagging, jerking, and stiffness. Drop seizures have increased and cause extreme weakness in the ankles. No additional information has been received, as the physician does not wish to provide any further information.
 
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. The explanted generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551833
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dennis100
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« Reply #9 on: March 28, 2019, 08:01:56 AM »

Model Number 304-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was reported that the pt experienced a seizure at the airport (was seizure-free for a few months prior to this). She was then brought to a hospital where they performed an mri. Per pt, her magnet was taped over her vns generator for the mri and during the mri, the magnet moved up her chest along the lead causing bruising. Following the mri, the physician at the hospital turned her settings down to the lowest possible settings against pt request. Pt then experienced 12 seizures in 12 hours and was put into a medically induced coma. Pt indicated she has some left-sided numbness and weakness since event and feels she has "left-sided neuro deficit". Pt also indicated that prior to the event, she was being weaned off her medications, which may have caused the seizure at the airport. Pt was seen by her physician a few weeks after event and the device was found to be functioning fine. The physician is ramping up the pt's settings and the pt is doing well. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662335
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« Reply #10 on: March 28, 2019, 08:02:49 AM »

Model Number 105
Event Date 04/18/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, this patient¿s mother reported that the patient has been diagnosed with horner¿s syndrome by the neurosurgeon who implanted the device and that the left side of her face has been droopy since the day of implant and still is. This has been going on for about six weeks now. It was also stated that, since implant, the patient has not been able to swallow normally and was admitted to the hospital as a result. The patient was also diagnosed with left vocal cord paralysis, but no interventions were being taken. The patient could not burp since implant. The patient¿s mother stated that the neck incision scar looked like a brutal scar; however, the surgeon stated that this occurred because the patient has an unusually thick neck. The device had not yet been programmed on. Attempts for additional information have been unsuccessful.
 
Event Description
Additional information was received that the horner¿s syndrome, vocal cord weakness, and difficulty swallowing were all noted 1-2 days post-operatively. These three events were believed to be related to vns. The patient did not have a pre-vns medical history of vocal cord paralysis, difficult swallowing, or being unable to burp. No causal or contributory programming or medication changes preceded any of the events. The patient¿s vocal cord weakness was evaluated by an ent. The device was programmed on and being managed by the epileptologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3195992
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dennis100
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« Reply #11 on: March 28, 2019, 08:03:26 AM »

Model Number 102
Event Date 02/15/2011
Event Type  Injury   
Event Description
It was initially reported that the pt had been experiencing multiple adverse events. It was reported that when the magnet is swiped the pt begins vomiting. As result the pt has lost weight and his blood pressure increase and heart rate increase (120-130 beats per minute). Pt has also experiencing muscle weakness and sweating. Currently the pt is not using his magnet. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2230485
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« Reply #12 on: March 28, 2019, 08:04:27 AM »

Model Number 102
Event Date 07/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.
 
Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.
 
Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.
 
Manufacturer Narrative
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662
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dennis100
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« Reply #13 on: March 28, 2019, 08:05:07 AM »

Model Number 102
Event Date 04/03/2013
Event Type  Injury   
Event Description
It was reported that the patient's seizures have worsened and that the patient's symptoms such as control of head/neck movement, and drooling have been worsening. The patient underwent surgery on (b)(6) 2013 where the vns generator was replaced. Attempts to return the product to the manufacturer for product analysis are underway. Attempts to contact the physician regarding the events have been unsuccessful to date. A battery life calculation was performed using the available programming history and resulted in 3. 41 years until end of service.
 
Event Description
New information was received from the physician¿s office stating that the increased seizures were noted on (b)(6) 2013, and the reason of the increased seizures was that the vns generator needed to be replaced. On (b)(6) 2013 the patient¿s seizures became better and the seizures were back to normal. The patient¿s muscle weakness and the drooling were not reported to the patient¿s physician. The explanted vns generator will not be returned to the manufacturer due to the site¿s policy.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Initial report inadvertently listed wrong event date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3097519
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dennis100
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« Reply #14 on: March 28, 2019, 08:05:48 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
It was observed in the patient¿s clinic notes dated (b)(6) 2013 that the patient was experiencing a new and unusual seizure type and was referred for a generator replacement. The unusual seizure was followed by left sided weakness that last 1-2 hours with full recovery (most likely todd's paralysis). Work up including head ct, echo and "carotid us" were unremarkable. System diagnostics were performed and the device was not at end of service. However, it is believed that a warning message was observed during interrogation to replace the device as soon as possible. The patient's medication was increased, and no vns programming changes were made. Good faith attempts were made to the physician and it was later reported by the physician that the patient was experiencing an increase in seizures, not new and unusual seizure types. The patient¿s seizures improved since vns implantation initially then her seizures worsened. The physician stated that the patient was experiencing left side weakness in their body with a longer recovery time needed after the seizures took place. This event was first observed (b)(6) 2012. He is unsure at this time if the increase in seizure frequency is due to todd's paralysis or vns therapy. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure type. The patient has been referred for a generator replacement, due to the message noted on the handheld during interrogation stating that the device should be replaced as soon as possible. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2013, the patient underwent generator revision. The explanted generator was destroyed per hospital protocol.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3250578
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« Reply #15 on: March 28, 2019, 08:06:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/25/2018
Event Type  Injury   
Event Description
It was reported that after a patient underwent vns revision surgery, the patient suffered a stroke due to the patient's jugular vein being nicked at the time of surgery. The patient is also experiencing arm weakness which the neurologist attributes to have been caused by the stroke. The patient was reported as undergoing occupational and physical therapy for the arm weakness. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8072513
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« Reply #16 on: March 28, 2019, 08:07:01 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that the patient was admitted to the hospital for right sided weakness and chest pain and the patient reported that he had had chronic problems with the vns. The patient also reported focal seizures, the last of which was in (b)(6) 2018. Upon follow-up with the patient, it was reported that the patient was experiencing shortness of breath, chest pain, and pain in his throat which had reportedly been occurring on and off for the past few weeks. The on-call physician did not seem to think these symptoms were related to the vns. System diagnostics and normal mode diagnostics were ok. The patient's vns output frequency was lowered from 30 to 20 hz at the direction of the neurologist, who thought this would alleviate some of the symptoms. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8153856
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dennis100
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« Reply #17 on: March 28, 2019, 08:07:36 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8380159
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dennis100
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« Reply #18 on: March 28, 2019, 08:08:12 AM »

Model Number 104
Event Date 01/01/2014
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2014 note that the patient reports that the vns wires shock her even when the device is off. The patient indicated that she feels like she has lost all use of her left side. It was noted that the patient suffered a fall on (b)(6) 2014, striking the area near the vns. There was no bruising or edema that resulted from the trauma. The patient begun to complain of weakness in her left arm and occasional tingling in her left leg. It was noted that this has not impacted the patient's activity level. The physician programmed the device off on (b)(6) 2014 and x-rays were performed to check for possible damage or movement of the vns caused by the fall. The physician referred the patient to the surgeon because he believed the device has migrated significantly lower than initially placed. The physician reported that he felt the device had migrated some time ago because an x-ray from (b)(6) 2014 showed the device in the same location as the current x-ray. The patient underwent prophylactic generator replacement. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4348399
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dennis100
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« Reply #19 on: June 27, 2019, 12:09:26 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for patient's generator replacement referral. Per notes , the physician noted tenderness on the chest wall when the vns was interrogated. Case manager contacted the neurologist office for the reason for the referral and mentioned that the surgery may just be repositioning surgery for the pain in the chest. At the surgeon's consult appointment, the surgeon mentioned that the patient was ok. The surgeon has deferred repositioning the device. No known surgical interventions have occurred to date.
 
Event Description
Patient was seen by the surgeon for evaluation of neck symptoms as there was a question as to whether these might be related to an existing vagal nerve stimulation. Patient reported intermittent arm numbness, episodes of shaking and pain that seems to radiate from the shoulder and left arm downward she also intermittently describes left arm weakness. The physician indicated that these events sound a lot more like radiculopathy-cervical disc disease than it does anything to with vns device. The surgeon was pessimistic that removal of the device would change symptoms at all and recommended the patient to see someone who specialized in spine disc disorders. The physician reported that the surgery was not planned for the pain. The pain began in (b)(6) 2018 and the cause is suspected to be musculoskeletal reason. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7318737
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« Reply #20 on: June 28, 2019, 11:26:15 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/06/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a vns patient that since the vns was changed, she is staying exhausted, and is having more noticeable seizures. She reports that she has been swiping the magnet, but gets so weak even the magnet is heavy. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7430989
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dennis100
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« Reply #21 on: July 20, 2019, 10:53:42 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was admitted to the hospital due to issues including dysphagia, ataxia, weight loss of 10 pounds since (b)(6) 2018 (implant month of current vns generator), an increase in general tonic-clonic seizures and changes in neurological status: lethargy and muscle weakness. The patient's device was turned off to see if symptoms improved. The doctor believed that the patient may have an allergy to titanium. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939263
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« Reply #22 on: July 20, 2019, 10:54:27 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/09/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the surgeon at the first follow up since vns implant that the patient had a "weak nerve". The generator is not turned on. Attempts to reach out to the surgeon for additional information have been made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8059545
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