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dennis100
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« on: September 20, 2018, 10:18:42 AM »

Model Number 102
Event Date 07/30/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809
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dennis100
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« Reply #1 on: September 20, 2018, 10:19:21 AM »

Lot Number 686260
Event Date 01/06/2012
Event Type  Injury   
Event Description
On the morning of (b)(6), i woke up with a shocking feeling in my head, accompanied by a migraine. When it didn't subside by monday the (b)(6), i decided to email the company that makes my vns, cyberonics. On tuesday the manager called me back and after telling him everything that was happening, he said to turn the device off and see if i still have the shocking feeling by taping my magnet to my vns for a few hours. After taping the magnet to the device, although the shocking went away, my skin started feeling like it was on fire. After removing the magnet a few hours later, the shocking feeling and migraine came back immediately, and there as a burn mark on my chest where the device is. Then on wednesday the (b)(6) i had to be taken to the hosp by ems for severe chest pains. The feeling still hasn't gone away. Frequency: on 30 sec off 1. 5 min.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2423729
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dennis100
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« Reply #2 on: September 20, 2018, 10:20:18 AM »

Model Number 300-30
Event Date 07/08/2011
Event Type  Malfunction   
Event Description
Additional information was received on (b)(4) 2011, when product analysis was completed on the explanted lead. The green negative electrode, a portion of the white positive and green negative electrode quadfilar coils, and a portion of the anchor tether helical were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 8 mm portion the end of the white positive electrode quadfilar coil appeared to be melted. Scanning electron microscopy was performed and the area was identified as having the appearance of being melted, with re-solidified material. It is unknown exactly what caused the quadfilar coil to melt. Based on the obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portion of the device; however since portions of the lead were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. What appeared to be remnants of dried body fluids were observed inside the inner silicone tubes, in some areas. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress. Puncture marks were observed on the inner silicone tubes, past the electrode bifurcation. The marks penetrated the insulation and the quadfilar coils appeared to be kinked. Tool marks were observed on the marked connector inner silicone tubing. The marks penetrated the insulation and three of the marked quadfilar coil strands appeared to have been cut in half. The gouge and puncture marks appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. The torn appearance of the electrode bifurcation and kinked quadfilar coil most likely occurred due to manipulation of the lead during the explant procedure. Product analysis on the explanted generator was completed on (b)(4) 2011. The device performed according to functional specifications and no eri flags were observed during testing. The device was continuously monitored for 26. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The consultant reported that he would meet with the physician in september 2011 and would find out how the patient is doing since the full revision surgery. When additional information is received, it will be reported.
 
Event Description
On (b)(6) 2011, a vns treating physician reported that he saw the vns pt on (b)(6) 2011 and the pt was complaining of painful stimulation in the chest area, above the clavicle. The physician did evoked potential monitoring and noticed a break down of skin where the pt was complaining of pain. It appeared that stimulation was stopping at the clavicle where the skin was breaking down. The physician had three sets of x-ray taken and fluoroscopy performed all of which will not be sent to the mfr for review. The physician reported that the x-ray did not show any lead breaks. The pt's device was disabled and the painful stimulation resolved. The pt was then scheduled for a full revision surgery. The pt is a swimmer and does do butterfly stroke, but no trauma or manipulation was reported. The physician believes that the lead is frayed and did not want to perform any diagnostics because the pt was in pain. The consultant requested that diagnostics then be performed prior to surgery when the pt is under anesthesia. The consultant was unable to attend the pt's full revision surgery on (b)(6) 2011; therefore, the operating room circulating nurse reported that she would have either the neuro-tech who normally does the vns programming in the operating room to call the consultant once the system and normal mode diagnostics were run prior to the pt's revision surgery. The consultant never received a call so it was unk at this time whether diagnostics were indeed performed. The consultant is scheduled to meet with the surgeon at a later date. The lead impedance was reported to be ok after the surgery. The explanted product was returned for product analysis on (b)(6) 2011, which has not yet been completed. The pt's programming history was reviewed which revealed that the pt's last system diagnostic test was performed on november 10, 2010 which showed output = ok/lead impedance = ok/dcdc = 1/eri = no. The pt's settings on (b)(6) 2010 were output - 2ma/frequency = 20 hz/pulse width = 250 usec/on time - 21 sec/off time = 3 min/magnet output = 2. 75 ma/magnet pulse width = 250 usec/magnet on time = 60 sec. A battery life calculation was performed with the programming history available which revealed 6. 91 years until eri = yes. When add'l info is received, it will be reported.
 
Manufacturer Narrative
Method: analysis of programming history.
 
Event Description
The patient's father wrote a book describing the patient's epilepsy. The book described the painful stimulation that occurred in (b)(6) 2011. The book reported the electrical charge was leaving the stimulator properly. It was stopping right where [the patient] was feeling the shock. There was also a description of a red mark on the shoulder, near where the painful stimulation was occurring. The red mark on his shoulder was described as directly over the path of the wire that was hooked up to his stimulator. The patient's physician reportedly turned the device off due to the painful stimulation.
 
Event Description
On (b)(6) 2011, additional information was received when the physician reported that the patient has been doing well with no painful stimulation since replacement surgery.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201312
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dennis100
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« Reply #3 on: September 20, 2018, 10:21:29 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
Upon further follow up with the nurse, it was revealed that the patient is experiencing pain and a "shocking sensation in chest due to wires being bunched up". The lead appears to be protruding from mid-neck to the collarbone with a "knot" felt at the lead body. The only intervention taken to date is assessment by the surgeon. Both the surgeon and the treating vns physician tested the device, and it was reported to be working okay. The patient's severe body spasms are believed to be the likely cause of the lead protrusion and caused the extreme pain and feeling of being shocked. No other physiological changes are believed to have contributed to the lead protrusion. Since the surgeon is afraid the lead wires may break if not replaced and due to the length of implant, the patient is referred for full revision surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported on (b)(6) 2013, that the patient is experiencing lead wires "bulging" accompanied with tension/pain in the neck that occurred right after she had a severe episode of body spasms about 10 days prior. The patient has a variety of physical illnesses, one of which includes these body spasms. The treating rn believed the body spasms may have been experienced as an extreme case due to stress as the patient was on her way to her brother's funeral. She also thought that the protrusion was due to the spasms that the patient experienced. The rn also mentioned that the patient's depression had been worsening recently, but that she believes that the patient's stress (brother passing away, dog being ill) have contributed to this recent increase in depression. The patient was evaluated again by the treating vns psychiatrist on (b)(6) 2013. Diagnostics on the patient's vns are within normal limits. The psychiatrist reports that the lead "bulging out a little bit like a vein" but was unsure if this bulge has always been there all along. Later, it was reported that the patient has also been experiencing pain and swelling in the tongue due to little cuts on her tongue which occurs with stimulation, and the surgeon believes this is related to vns. The patient has been experiencing this for a while; however, it has worsened lately with the other events. The treating rn did not have further details at that time. Clinic notes from the surgeon dated (b)(6) 2013, indicate that the patient complains of tension/pain in the left neck/leads and had been worsening over the past few years. The surgeon indicated in the notes that he can offer operation for lead revision for severe excess lead tension and generator change for end of life which the patient agreed. The patient was scheduled for surgery for possible generator and lead revision due to pain and swelling with stimulation. The surgeon reportedly believes the patient does not need an x-ray because he can see the wires bunched "where it goes into the vns. " as of (b)(6) 2013, the rn reported the patient indicates that she has a "white line in her skin going along the vagal nerve" and a knot at the electrode site which the patient and physician can feel. The rn also indicated that the patient has a lot of accompanying medical, physical and psychological problems. Although surgery is likely, it has not occurred to date. Attempts for additional information from the treating psychiatrist's office ( rn) have been unsuccessful to date. Follow up with the surgeon's office revealed that per the psychiatrist's notes, the patient "denies any pain or discomfort from vns. She has been diagnosed with major depression disorder and major psychotic disorder which may be a psychotic manifestation of her symptoms. Would like to rule out psychotic or psychological disorder. " the nurse indicated that the surgeon appears to be due to not to preclude a serious injury as the notes indicate that she denies pain or discomfort and the symptoms appear to be thought to be related to her other mental/physician illnesses. However, it remains unclear at this time.
 
Manufacturer Narrative

Manufacturer Narrative
The initial report inadvertently reported the age incorrectly as the date of event was listed incorrectly. The initial report inadvertently reported the event date incorrectly as it was reported that the tension and pain in the neck was worsening over the past couple of years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027374
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dennis100
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« Reply #4 on: September 20, 2018, 10:22:18 AM »

Model Number 103
Event Date 05/23/2013
Event Type  Injury   
Event Description
On (b)(6) 2013 information was received that the physician had had a visit with the patient that morning for follow-up after a recent generator replacement surgery. The physician noted that the patient¿s generator site was exposed by approximately 1 cm, that the generator was visible, but that there appeared to be no signs of infection. The patient¿s mother stated that the patient had been picking at the incision site. The physician stated that the site appeared to be healing and that he would see the patient after another week to monitor the healing process. If the site is not healed by then, the surgeon was considering removing the generator and placing it in another site. The physician did not prescribe any antibiotics during the visit because the site did not appear to be infected. A review of manufacturing records confirmed that both the generator and lead passed all functional tests prior to distribution, as well were properly sterilized prior to distribution. Follow-up with the physician indicated that at the follow-up visit he had observed that the implant, which had been implanted into the axillary incision from prior implant, was visible through the sutures. The physician stated that at the (b)(6) 2013 visit there had been erythema around the generator site and that at the follow-up visit the erythema had decreased considerably so and that the site was beginning to look better and beginning to granulate slowly. The physician stated that if the site does not granulate completely that he would have no choice but to explant the generator and either let the incision heal completely before reimplanting again in that location or placing the generator elsewhere instead. The physician will continue to monitor the situation. Attempts for additional information are still in continuation.
 
Event Description
A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 072 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 2. 826% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a small portion of the lead assembly (body) including the electrode section was not returned for analysis and 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 except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Dried body fluids inside the outer and inner tubing was observed in some areas. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were 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. Note that since a small portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. No other information has been provided.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead and that they passed all functional tests prior to distribution.
 
Event Description
Additional information was received stating that the vns patient was re-implanted with a new generator and lead on (b)(6) 2014.
 
Event Description
On (b)(4) 2013 information was received by the reporter that the patient had been tentatively scheduled for a vns revision surgery on (b)(6) 2013 due to the generator being exposed at the chest incision site. Follow-up determined that the patient instead underwent surgery on (b)(6) 2013. The patient had completely removed the generator from his chest and approximately 5 cm of the lead wire was also exposed. The generator and lead were both explanted by the physician and the physician intends to wait a month to allow the incision sites to fully heal before reimplanting vns in the patient. It was also reported that the patient had a skin condition and will be referred to a dermatologist for diagnosis. The explanted lead and generator have been returned to the manufacturer and will soon undergo product analysis. Attempts for additional information will remain in continuation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3165711
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dennis100
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« Reply #5 on: September 20, 2018, 10:23:04 AM »

Model Number 103
Event Date 01/01/2008
Event Type  Injury   
Event Description
It was reported that pt has several issues with respiratory distress when he sleeps. In the last 2 months off and on, the skin around his collarbone would sink in and he would wheeze. Pt's caregiver attributed this to recent adjustments of the vns and dismissed it as it was infrequent; however, during his nap recently, he had his abdomen sinked under his ribs and had erratic breathing for about one min. It happened again fifteen mins later but much more violently. His heart was reportedly beating rapidly and his breathing was a high pitched wheeze. His entire abdomen was spastic. It took about a min for the pt to get back to normal. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1153329
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dennis100
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« Reply #6 on: September 20, 2018, 10:24:01 AM »

Model Number 302-20
Device Problem Mechanical Problem
Event Date 11/23/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received from the doctor indicating that the exact cause of compromised insulation is unknown. It was stated that there was fibrosis and granulation around the tissues, and the source of the granulation seemed to be the tie down. However it is notable that multiple steroid injections and biopsies were performed over the site. Therefore the doctor cannot be certain at which point, and during which surgeries, the lead insulation was compromised. No other relevant information has been received to date.
 
Event Description
System diagnostics were received for the device and indicate no lead fracture. The explanted products have not been received to date. No other relevant information has been received to date.
 
Event Description
The patient has been referred for a prophylactic generator replacement but before replacement surgery, the surgeon noticed inflammation in the neck area, near the lead placement. Before the patient was referred to surgery, they were being seen by a dermatologist who noticed a mass in the left neck, with no signs of infection. The dermatologist noted it to be a rapidly growing pyle on the left neck, suspect for pyogenic granuloma. A biopsy of specimen was taken and it came back as an "inflamed fibroepithelial polyp with hemosiderin deposition and edema. " at a follow-up appointment the dermatologist mentioned the mass to be an "8 mm flesh colored nodule on left neck - regrowth within three weeks" and the patient was injected with steroid at that time. At yet another follow up appointment, the mass bled with minimal trauma, therefore an excisional biopsy was taken and it returned as a pyogenic granuloma, with 1. 2cm at it's largest dimension. A later follow up revealed that healing occurred. The patient was referred to ent as the regrowth returned. A ct scan was done and it was reported "within skin overlying the surgical site, there is no enhancing contour with irregularity, also stable in size. This may represent a pyogenic granuloma as offered in the indication; also consider keloid/hypertrophic scar. There is no enhancement to suggest abscess". The surgeon mentioned that there was inflammation but no sign of infection where the lead is located. The epicenter of inflammation was located near the tie down. The surgeon was unable to determine whether the cause of inflammation was due to previous injections, incisions, the lead (which showed compromised insulation), or the tie downs. There was no obvious pus, but cultures were taken. Due to the inflammation the generator and a portion of the lead were explanted. The lead was cut and the surgeon left a small stump proximally in case re-implantation was needed. The removal site was washed out and the generator was removed in case no further implant is necessary. The patient was then put on antibiotics. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6868430

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dennis100
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« Reply #7 on: September 20, 2018, 10:25:32 AM »

Model Number 300-20
Event Date 04/01/2013
Event Type  Injury   
Event Description
Additional information was received that the patient had seen the surgeon without a referral from her treating physician. The surgery was cancels and is not currently planned.
 
Event Description
Additional information was received that the patient is going to have her generator and lead explanted. Surgery if likely but has not occurred to date.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient was experiencing painful stimulation. The patient has requested to be explanted due to the painful stimulation and possible lead protrusion in the neck. Information of the surgeon's office was that there did not seem to be anything wrong with the patient's vns and indicated that the patient may not be proceeding with surgery but this was not able to be confirmed. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Additional information was received which changes the product the report is reported on.
 
Event Description
On (b)(4) 2013 clinic notes were received dated (b)(6) 2013. The clinic notes mention that the patient has a ¿lump in her neck that another doctor had said that the wire is wrapped around¿. The patient stated that her pump has not worked since (b)(6) 2013; that it has been ¿two years since the wire broke¿. The clinic notes mention that the patient has visual hallucinations. The patient was referred for x-rays to check her lead. A copy of the ct of the neck soft tissue was received dated (b)(6) 2012 which indicates that ¿at the site where there was previously felt to be some skin thickening close to the site of the neurostimulator leads, there is still some skin thickening but no increase in the size of the vague density. The apparent sebaceous cyst seen more anteriorly is unchanged¿. It was stated that the patient had complained of a left neck lump and dysphagia. It was stated that this palpable lump is just inferior to the parotid gland but there is no identifiable mass at this site. Slightly anterior to this, there is a small skin lesion which was noted to might be a small sebaceous cyst. The ct scan sated that there is no mass in the region of the palpable lump. The patient underwent a generator replacement on (b)(6) 2013. The explanted generator has not been received for product analysis to date.
 
Event Description
It was reported that on (b)(6) 2013 the patient had a tumor removed from her neck.
 
Event Description
It was reported that the explanting facility discarded the explanted generator and it will not be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3116210
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dennis100
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« Reply #8 on: September 20, 2018, 10:26:37 AM »

Model Number 300-20
Event Date 07/15/2011
Event Type  Malfunction  
Event Description
It was reported to the mfr via an implant card that a vns pt underwent both generator and lead replacement due to a lead break. Further info was received from the area representative indicating that the pt had reported pain in the chest area. The surgeon opened the pt to have a look at the pain and saw liquid inside the electrodes. A full revision was then planned and the pt was explanted. Additional info was received from the pt's treating physician indicating that the pt introduced himself in their outpatient department in (b)(6), telling he suffered from increasing pains in the subcutaneous pectoral area. Wounds were non-irritating as well as the wound on his throat and the conduction lines of the stimulator lead. The skin on the subcutaneous pectoral implantation area was hard showing the indication of scarring. After further discussion with other physicians, it was decided to operate on the pt. The physician described "there was a subtle preparation of the lead of the vagus nerve stimulator, showing that the case around the lead was damaged and there is liquid between the silicone case and he lead. " at the moment it was indicated that the lead was discarded but the generator will be returned to the mfr. Good faith attempts to obtain additional info have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245743
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dennis100
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« Reply #9 on: September 20, 2018, 10:28:28 AM »

Model Number 303-30
Event Date 11/01/2012
Event Type  Injury   
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
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 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.
 
Manufacturer Narrative

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 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744

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dennis100
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« Reply #10 on: September 20, 2018, 10:29:02 AM »

Model Number 303-20
Event Date 08/01/2012
Event Type  Injury   
Event Description
Reporter indicated the patient had debridement surgery with washout performed on (b)(6) 2012. The two lead tie-downs were removed, as the tie-downs were felt to possibly be causing an allergic reaction which is believed to have caused the infection. The tie-down areas were purulent and irritated. The lead body (not electrodes) was repositioned in a different area away from the infected area. The vns was left programmed on. The patient had no known trauma, and the patient is healing well. Wound cultures were performed which grew out (b)(6) bacteria.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
The patient's mother reported that the electrode was extruding through the patient's neck. It was reported that the patient was prescribed antibiotics and the patient was scheduled for revision surgery. Clinic notes date (b)(6) 2013 note that the patient forms keloids and has experienced chronic crusting from the site. It was noted that the patient was seen with yellowish discharge from the wound site. It was noted that the wound was not erythematous or swollen. The notes indicate that the wound has a keloid and induration, but is not red. A small area of crusting with no exudate was noted. The patient was sent home with bactrim. Operation notes dated (b)(6) 2012 note that the surgical findings were exposed vagal nerve stimulation tie-down tabs with surrounding inflamed skin and extensive subcutaneous granulation tissue surrounding the deeper tie-down tabs and superficial connecting lead, but no evidence of pus. Clinic notes dated (b)(6) 2013 note that the wound showed a chronic ulceration with exposed connecting lead through the wound. There was no drainage or evidence of infection, although there has been crusting and scabbing along the wound. The patient denies picking at the wound. The patient was seen at the emergency department on (b)(6) 2013 after the wound opened up and was sent home with bactrim. The patient denies any trauma to the area. There is no evidence of drainage. The wound is non erythematous and non tender. The notes indicate that the surgeon is going to try one more time to treat the device in situ with antibiotics solution as well as iv antibiotics. It was noted that if it fails explant will be performed. Operative notes dated (b)(6) 2013 note that the vagal nerve stimulator electrode connecting lead in the anterior cervical region is exposed and there is surrounding inflamed skin and subcutaneous granulation tissue, but no evidence of pus. The wound was debrided and a complex closure was performed. Excision of devitalized granulomatous skin was performed. The notes indicate that the mother reported that the scab had fallen off and the lead wire was exposed; therefore treatment in situ was performed. Multiple antibiotic solutions including vancomycin irrigation, half-strength hydrogen peroxide, lactated ringer's bacitracin solution and also vancomycin crystals were attempted to treat the infection and prevent recurrence. The notes indicate that it is almost as if the patient is rejecting the device. On (b)(6) 2013 it was reported that the patient came in with exposed vns generator and is getting it replaced emergently. The following day it was reported that the surgeon debrided the pocket and that there were no issues with the lead. The surgeon placed prophylactic antibiotics in the pocket and lead area. A new generator pocket was formed and the new generator was placed under the muscle to avoid patient manipulation. The patient was given a picc line for antibiotic. It was reported that if the infection persists the patient may be explanted due to body rejection. The patient's mother believes that the patient's bra underwire may have contributed to the issues initially. Operative notes dated (b)(6) 2013 note that the left anterior chest pocket is infection in the generator area due to skin breakdown and protruding generator. It was noted that the generator pocket had accumulation of purulent fluid likely related to a pinhole sized are of skin breakdown most likely related to rubbing of this area from the patient's underwire bra. It was noted that skin cultures were positive for staphylococcus aureus. The explanted generator was received for analysis. Analysis of the generator was completed on (b)(6) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Reporter indicated a patient developed an infection at the vns lead site in the neck. The patient was given antibiotics. Exploratory surgery of the infection site was planned for (b)(6) 2012, but it is not known if this occurred. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2768901
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« Reply #11 on: September 20, 2018, 10:29:47 AM »

Model Number 100
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was reported that the vns patient had the vns generator explanted as the device was protruding and the skin was beginning to erode. F/u with the surgeon's office revealed that they opted to explant the device to prevent any further worsening of the skin erosion so as to prevent a possible infection at the wound site. The pt's device had been programmed off for some time, as it was noted by the patient's treating neurologist that vns therapy was not providing the patient with much benefit for seizure control. There was no report of any causal or contributory pt manipulation to the device site. The exact cause of the protrusion of the pulse generator was not able to be ascertained when following up with the surgeon's office. Good faith attempts to obtain the explanted device for analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1845929
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« Reply #12 on: September 20, 2018, 10:30:33 AM »

Model Number 102
Event Date 10/03/2013
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2013 it was reported that the patient was diagnosed with stage 3 skin cancer on (b)(6) 2013. It was reported that the patient would have cancer removal surgery on her mid back on (b)(6) ; however, this surgery has not been concerned. Follow up with the medical assistant found that the patient called the office on (b)(6) 2013 to report that she had stage 3 melanoma cancer from two moles she had. The medical assistant stated that the patient had the vns implanted for much longer than this and that the cancer was not related to the vns. However, she stated that she would need to confirm this information with the physician as she did not have the authority to verify that there was no relationship. Per the medical assistant, the device was checked in 2012 and found to be fine. No other information was provided.

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« Reply #13 on: September 20, 2018, 10:31:40 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2013
Event Type  Death   
Event Description
It was reported by a company representative that a vns patient was found to be deceased after an online obituary search. Follow-up to the physician by a company representative provided the treating physician was unaware of the patient¿s death and had not seen her in years and didn't have any further information. The state will not release the death certificate to the manufacturer. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the funeral home where services were performed provided the complicating factors and cause of death as: acute respiratory failure, (onset of 1 day), acute pulmonary emboli, (onset 1 day), acute deep venous thrombosis, (onset 2 months). Direct cause of death was, left leg cellulitis, skin necrosis.

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« Reply #14 on: October 12, 2018, 04:32:24 PM »

Model Number 103
Event Date 07/03/2012
Event Type  Injury   
Event Description
It was reported that after a vns implant, a patient presented with signs of cellulitis in the skin of demipulse pocket. The procedure of implantation was on (b)(6) 2012. Blood cultures were taken and antibiogram and the patient stayed in the hospital for 7 days with vancomycin via iv. They were also taking diclosil an oral medication for 7 days. The patient's implanting surgeon felt the event was related to surgery since occurred less than 10 days after surgery. No patient trauma or manipulation was reported prior to the event. The results of the patient's cultures were negative and their antibiotic treatment was prophylactic. The patient finished their antibiotic treatment and their cellulitis resolved.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2659844
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« Reply #15 on: October 29, 2018, 10:20:21 AM »

Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
 
Manufacturer Narrative
(abst 1. 285. ),2012 :abstract "outcomes of vagus nerve stimulation (vns) in pediatric epilepsy" authors: c. D. Yu, i. Abdelmoumen, s. Ramgopal, c. Powell, k. Remy, m. Libenson, j. Madsen, a. Rotenberg, t. Loddenkemper instit: mcgill university, boston children's hospital.
 
Event Description
An abstract article was received for review. The title was. "outcomes of vagus nerve stimulation (vns) in pediatric epilepsy"authors: c. D. Yu, i. Abdelmoumen, s. Ramgopal, c. Powell, k. Remy, m. Libenson, j. Madsen, a. Rotenberg, t. Loddenkemperinstit: mcgill university, boston children's hospital. The abstract reported charts about all patients implanted with the vns at a single center between (b)(6) 1997 and (b)(6) 2011. 252 patients were identified. Complete follow-up data was available for 69 patients. Of the excluded patients, 6 had treatment discontinued during the 12 month follow-up period. Reasons for discontinuation included infection (n=3), nausea (n=1), skin breakdown (n=1), and perceived lack of efficacy (n=1). Sixteen of the 69 patients experienced adverse effects which did not warrant discontinuation of therapy, including voice changes, coughing, throat tickle, difficulty sleeping, and pain over the vns area. This report is to capture one patient who discontinued treatment for skin breakdown. At this time no further information is available.
 
Event Description
On (b)(6) 2013 the full article was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784335
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« Reply #16 on: December 12, 2018, 01:54:33 AM »

Model Number 103
Event Date 08/15/2013
Event Type  Injury   
Event Description
It was initially reported that after the patient was implanted she began having a reaction and the physician felt the patient was rejecting the device. The patient had an infection and the skin was flaking around the generator. The patient has multiple allergies. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution and sterility was confirmed. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution and sterility was confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3360624
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« Reply #17 on: December 13, 2018, 04:25:09 AM »

Model Number 102
Event Date 08/01/2013
Event Type  Injury   
Event Description
It was reported that the patient experienced inflammation around the generator pocket approximately 6 months after implant. It was reported that the patient informed the physician that she had swelling and pain over the generator site, but denies redness or heat. The patient reported that the swelling had been present for 4-5 days. The patient was seen by the physician on (b)(6) 2013 at which time the generator site was found to have a "boggy"; swelling over it, but no redness. It was reported that the patient reported discomfort and that there was some skin discoloration. The fluid was aspirated and found to be pus. The patient underwent generator and lead explant; however, the exact date of explant is unknown. The pocket was irrigated and the patient was placed on iv antibiotics. It was reported that treatment is ongoing. It was reported that the swelling and infection was localized to the site of the generator and that the wounds from the vns implant were fully healed. The patient denies trauma or manipulation which may have caused or contributed to the infection. Cultures showed isolated staphylococcus aureus. Attempts to obtain additional information have been unsuccessful to date.

Event Description
It was reported that the generator and lead were to be returned for analysis. The generator and a piece of the lead were returned to manufacturer for analysis on (b)(6) 2013. Analysis of the lead was completed on (b)(6) 2013. Note that since a significant portion of the lead (including the electrode) portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis of the generator was completed on (b)(6) 2013. Potential contributing factors to the infection have been considered / evaluated and none were found to exist in this situation.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3339646
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« Reply #18 on: January 22, 2019, 04:55:48 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.
 
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
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« Reply #19 on: January 22, 2019, 04:56:51 AM »

Model Number 103
Device Problem Insufficient Information
Event Date 08/06/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was later reported on (b)(6) 2016 that the patient was scheduled to have her lead explanted that day due to an abscess in the neck area. Operative notes from (b)(6) 2016 report that the patient presented for ¿left cervical surgical skin site ulceration caused by erosion of underlying hardware¿ and plastic surgery for keloid formation around the previous generator site incision site. The indications for operation indicated that the generator was previously removed due to complication through the skin. Subsequently, that area of closure developed keloid and more an area in the center of the cervical incision site began to thin out and there was a palpable piece of hardware beneath that thinned out site. It worsened to the point skin broke through and there was a yellowish drainage that came from the site. This was cultured. The patient was admitted and was on iv antibiotics and brought to the room for the to remove the generator, the ulcerated and then have the plastic surgery service revise both the keloid incision and the lead incision on (b)(6) 2016. During the procedure, it was observed that the ulceration site was through dermis and through platysma. The area of the lead strain relief was eroding through the skin. Once that was excised out, the remaining tissues deeper appeared normal. It was irrigated with antibiotic irrigation and then the majority of lead was removed. For the remaining lead portion, it was assessed that it was not able to be easily extracted from within the carotid sheath. It was determined that this was unacceptably risky and difficult because of the extensive amount of scar tissue there/ what was at that point the only remaining wires with the thin final portions of the lead. It was felt that there was no deep infection. The deep space was verified to be sterile. The area was treated with the 3% hydrogen peroxide and after that irrigated it with bacitracin irrigation. The keloid at generator site was removed and there was additional debridement at the generator site. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.
 
Event Description
The patient later had generator explant surgery on (b)(6) 2015 due to an infected pocket. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date. Review of the generator and lead device history records confirmed sterilization was performed prior to distribution.
 
Manufacturer Narrative

Event Description
Analysis was completed on the generator. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the patient was admitted to the hospital with an infection. The patient had pus around the generator site. The patient had surgery on (b)(6) 2015 due to the superficial wound infection in the chest. The procedure included debridement of the dermis and subcutaneous layer. The operative notes reported that the patient presented in clinic on (b)(6) 2015 with appearance of the incision overlying the vagus nerve stimulator generator with the appearance of thinning as though it was at risk of dehiscing. The next day, the patient was admitted with evidence dehiscence that had started to begun and there was also some superficial spreading redness, which had the appearance of cellulitis. Surgery was performed as an emergency procedure, and during the procedure, the site was debrided and irrigated. The surgeon concluded that the evidence was favorable to suggest that the infection was cellulitis only with skin edge dehiscence. The patient was then closed. The generator was not explanted. Good faith attempts for additional relevant information have been unsuccessful to date.

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« Reply #20 on: January 26, 2019, 03:55:36 AM »

Model Number 102
Event Date 07/01/2005
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient underwent surgery on 10/26/2005 to explant her generator due to an infection. The patient was re-implanted with a new generator on (b)(6) 2006. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Further follow-up revealed that the infection was first observed in (b)(6) 2005 with irritation in the left neck due to tracheostomy ties. The patient then experienced skin break down due to the tracheostomy ties. The physician indicated that the tracheostomy ties caused ulceration of the skin over the vns lead. The physician indicated that cultures were performed on (b)(6) 2005 and were positive.

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« Reply #21 on: January 28, 2019, 06:00:47 AM »

Model Number 105
Event Date 04/10/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient was admitted to the hospital on (b)(6) 2014 to explant her generator due to infection and wound breakdown. The issue was first observed on (b)(6) 2014. The cause of the infection is believed to be possibly due to skin erosion. The patient was given iv antibiotic therapy and has not been re-implanted to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4113918
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« Reply #22 on: February 05, 2019, 03:02:36 AM »

Event Type  Injury   
Manufacturer Narrative

Event Description
A vns presentation was given which included adverse events experienced by vns patients. One event involved a patient with skin necrosis with generator extrusion. One event involved a patient with recurrent laryngeal nerve paralysis. The presentation indicates that (b)(6) of a group of 17019 study patients developed infections. Some of the infection required explant of the device. Attempts for additional relevant information have been unsuccessful to date. This manufacturer report involves the reported skin necrosis event.

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« Reply #23 on: February 12, 2019, 03:15:51 AM »

Model Number 105
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(4) 2015 that a patient¿s device was explanted on (b)(6) 2015 due to infection and erosion. There was nothing suspected to be wrong with the device, just that it had eroded through the skin. The lead and generator were received for analysis on 02/02/2015. Product analysis for the lead 302-20 was completed and approved on 02/19/2015. A portion of the lead assembly 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 except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Product analysis for the generator is underway but has not been completed to date. Attempts for additional information have been made and have been unsuccessful to date.
 
Event Description
It was clarified from the physician that the skin erosion was not a lead issue but skin eroded over the generator with breakdown along the incision line. There was no gross sign of infection although clear contamination was present. The culture taken was positive for propionibacter although it was unable to tell if this was infection or contamination from adjacent skin. Therefore, primary infection was not suspected but contamination/infection after skin erosion may be more likely situation.
 
Event Description
Product analysis for the patient¿s m105 device was completed and approved on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 013 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Attempts have been made for further information but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4542162
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« Reply #24 on: February 15, 2019, 03:46:23 AM »

Model Number 103
Event Date 02/18/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was seen in the emergency room for a rash on his neck four days following initial implant surgery. The patient was given a cream to put on the rash and scheduled to follow-up with his physician. It was reported that the rash was believed to be contact dermatitis possibly due to the iodine used pre-operatively. It was reported that the patient does not have a known history of iodine or shellfish allergies, but that the patient would follow-up with dermatology. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #25 on: May 23, 2019, 11:06:16 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
A vns patient reported that she has a feeling of spiders going up her neck, and that the generator feels floppy in her chest. The device has been disabled, the patient has asked to have the device removed and has been referred to neurosurgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the provider indicated the patient has some psych issues and claimed she had to balance the weight of the generator with her pack of cigarettes. However, the physician noted there was no migration of the device and was fine. The explant occurred for the patient comfort as she simply wanted it removed. It was also reported the patient believes the device was causing her psoriasis. Explant surgery occurred. The explanted devices were received by the manufacturer and analysis is underway, but has not been completed to-date.
 
Event Description
Follow-up to the physician provided that the patient has some psych issues and that the psoriasis is not related to the vns. The provider states the vns was working for the patient. Analysis was completed for the returned generator. Functionality of the generator to provide the programmed output currents was successfully verified. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed for the lead. The negative electrode was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6666114
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« Reply #26 on: June 06, 2019, 02:12:42 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2017
Event Type  Injury   
Event Description
It was reported that a patient¿s generator was removed due to a skin breakdown. The patient was sliding on his chest on the hardwood floor, which is believed to have caused the breakdown. Additional relevant information has not been received to-date.
 
Event Description
Revision surgery occurred. It was provided that the device was also removed due to infection. Review of the manufacturing records for the lead and generator confirmed the devices were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6861729
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« Reply #27 on: June 11, 2019, 01:03:13 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2017
Event Type  Injury   
Event Description
It was reported that the patient's device was explanted due to discomfort follow-up showed that the patient was last seen in (b)(6) and the patient's mother reported to the physician that there was skin breakdown where the generator was sticking out of the skin. The generator was returned and product analysis was completed and approved. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The generator and lead design history records were reviewed for sterilization and both devices were confirmed to have been hp sterilized prior to release. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6973986
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« Reply #28 on: June 13, 2019, 03:11:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2017
Event Type  Injury   
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's father reported that his son experienced an infection and redness around his vns after a recent full revision surgery. The device history records were reviewed for the lead and generator and revealed that the devices were sterilized according to specifications prior to release. No additional relevant information has been received to date.
 
Event Description
The patient's neurologist reported that the implanting surgeon explanted the patient's vns due to the infection. Clinic notes were received and indicated that the patient's primary care physician observed a skin problem and rash. The patient was admitted to the emergency department for worsening swelling and spreading erythema around the vns generator. The patient was noted to be itching at the sites. Antibiotics were administered. The patient underwent lead and generator explant due to the supposed infection. The patient had attended a surgical consult two days prior to surgery and exhibited signs of progressive erythema, when it was recommended that the vns be removed. Operative notes indicated that the patient had a 2-3 cc seroma around the generator without obvious sign of infection. The generator and leads were removed and sent for culture, as well as a culturette of the generator pocket itself. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7061966
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dennis100
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« Reply #29 on: June 21, 2019, 12:39:37 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 11/23/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient's device was causing him discomfort. High lead impedance was observed on the patient's device. The patient also reportedly had an external skin wound that may have been caused by the vns. The patient's device was programmed off in response. X-rays were performed and reviewed by the physician and reportedly did not identify a lead break or other abnormality. A company representative reported that the pain may be a result of stimulation. The physician suspected that the patient's wound had become infected. At a subsequent visit, the patient's wound had improved significantly since the device was disabled. The company representative confirmed this via assessment of updated pictures of the wound. The patient was given antibiotics. Lateral neck x-rays of the patient's device were reviewed by the manufacturer. Only a small portion of the lead was visible in the images, and the generator was not visible in the x-ray images provided. The lead was observed in the neck. The strain relief bend was present, but a strain relief loop did not appear to be completed. Two tie-downs appeared to be securing the lead past the strain relief bend. No sharp angles or discontinuities were observed in the images. Ap neck and chest x-rays and lateral chest x-rays were later reviewed by the manufacturer. Due to the angle of the generator in the image, proper lead pin insertion could not be assessed. The filter feedthru wires appeared intact. The lead was observed in the neck, and the electrodes appeared to be placed per labeling. The strain relief bend was present, but a strain relief loop did not appear to be completed. No sharp angles or discontinuities were observed in the visible portion of the lead. A portion of the lead was routed behind the generator and could not be assessed. The cause of the patient¿s high impedance could not be determined with the x-ray images provided. The device history records were reviewed for the lead and generator and revealed that both devices met all sterilization and functional specifications for release prior to distribution. The physician did not believe that patient manipulation of the device caused the external wound and infection. The patient was referred for surgery to resolve the high impedance, but no surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent exploratory surgery. It was determined that fluid was observed in the lead, causing the surgeon to suspect a lead fracture. High impedance was observed on both system and normal mode diagnostic tests. The patient was referred for lead and generator replacement surgery, but no additional surgical intervention has occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7132107
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