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dennis100
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« Reply #30 on: January 04, 2016, 07:05:48 AM »

Model Number 104
Event Date 12/14/2012
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2012. The cause of death is believed to be due to aspiration. The relationship between the death and vns is unknown. No further information relevant to the patient¿s death has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4163522
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dennis100
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« Reply #31 on: January 04, 2016, 07:06:13 AM »

Model Number 102
Event Date 05/22/2010
Event Type Death
Event Description
It was reported that the treating vns physician's office had not seen the patient since 2010 and had not future appointment. Upon review of the internet, the patient's obituary was found which reported the patient passed on (b)(6) 2010. Review of the company programming history database shows that the treating physician programmed the patient's device on (b)(6) 2010 and increased the output current at that time. Attempts for additional information from the physician have been unsuccessful to date. Follow-up with the funeral home revealed that it is not believed that the vns devices were explanted prior to burial.

Manufacturer Narrative

Event Description
It was reported that the cause of death was due to a subclavian clot and that the patient experienced a swallowing disorder and seizures. The hospital medical records indicated that the patient was hospitalized prior to the patient's death from (b)(6) 2010 and was diagnosed with dvts in the upper arms, respiratory distress, seizure disorder, dyspnea, altered mental status, gastro-esophageal reflux disorder and paranoid schizophrenia. It was reported that the patient was in hospice care at the time of his death, but that there are no records in the medical records office from that time. It was reported that the patient was buried and was most probably buried with the vns still implanted. It was reported that the vns helped the patient's seizures. Additional hospital notes were received from the hospitalization prior to death indicating that the patient was observed to have stopped breathing and was pronounced death on (b)(6) 2010. It was noted that the overall clinical impression was that the patient had respiratory failure and lactic acidosis secondary to recurrent aspiration pneumonia. The death certificate listed seizure disorder as the cause of death due to (or as a consequence of) swallowing disorder with aspiration, due to (or as a consequence of) subclavian vein thrombosis. The manner of death was listed as natural. No autopsy was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232880
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dennis100
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« Reply #32 on: January 05, 2016, 12:48:18 AM »

Model Number 102R
Event Date 03/07/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a vns patient passed away on (b)(6) 2013. Their death was not related to their vns device but sudep is suspected to be the cause of their death. The pt weighed (b)(6), the etiology of their seizures: iatrogenic hypoglycemia secondary to insulin in the nursery. The patient had quadriparesis, cortical blindness dysphagia and gerd. The patient had seizure reduction with the vns. They were receiving vns therapy treatment at the time of death. They were set to 2. 00 ma,20 sf ,250 pw ,7 seconds on time,30 seconds off time ,2. 25 ma ,60 seconds on time ,250 pw. No products were explanted at the time of death. No autopsy performed, their death was not witnessed. The patient was found pulseless in the am, cold, lying in bed and no signs of a struggle. The patient did have a history of nocturnal seizures. The patient does have a history of mild aspiration with no recent pneumonia at time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3035470
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dennis100
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« Reply #33 on: January 14, 2016, 09:53:22 AM »

Model Number 102
Event Date 02/01/2011
Event Type Injury
Event Description
On (b)(6) 2013, the physician reported that the patient's increased seizures, aspiration, and sepsis are not related to vns. The patient has a long history of health problems prior to vns. This was the only information the physician was willing to provide.

Event Description
On (b)(6) 2012, clinic notes were received dated (b)(6) 2012, which indicated that the patient's last bad seizures were in (b)(6) 2011, when the patient aspirated and stayed in the hospital for 77 days. It was noted that the patient has bad breakthrough status due to sepsis. The relationship of these events to vns was not provided in the clinic notes. Attempts for further information from the physician are underway but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2870434
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dennis100
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« Reply #34 on: January 15, 2016, 11:08:15 AM »

Model Number 103
Event Date 01/04/2014
Event Type Death
Event Description
It was reported that the vns patient passed away on (b)(6) 2014 due to respiratory arrest from aspiration of food following a long seizure. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3738587
« Last Edit: October 30, 2017, 02:50:32 AM by dennis100 » Logged
dennis100
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« Reply #35 on: January 17, 2016, 05:49:51 AM »

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

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.

Manufacturer Narrative

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 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2845744
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dennis100
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« Reply #36 on: January 20, 2016, 11:11:35 AM »

Model Number 103
Event Date 10/10/2012
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that the vns patient had a vns replacement surgery on (b)(6) 2012 and the last diagnostics on (b)(6) 2012, were all fine with an impedance value of 2000 ohms and the patient was increased form an output of 1. 25ma to 1. 5ma. Previously in (b)(6) 2012, the patient was at output=1. 25ma/pulse width=250usec/frequency=20hz and the pulse width was increased to 500usec and the frequency increased to 30hz. The patient was tolerating vns well. Currently the patient's settings are output=1. 5ma/pulse width=500usec/frequency=30hz/on time=30sec/off time=5min. On (b)(6) 2012, the patient underwent a routine feeding assessment by his speech and language therapist, who had seen him 4 months previously. The therapist felt that he was aspirating on liquids during the hour that she assessed him. This was constant, and not only during stimulation. The mother had not reported any concerns but the therapist says she definitely noticed a difference since his last assessment. She has referred him for investigation and modified his diet. The patient was seen again by the neurologist on (b)(6) 2012, where the nurse changed the parameters to output=1. 5ma/pulse width=250usec/frequency=25hz/on time=30sec/off time=5min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=500usec. Diagnostics showed the device to be functioning properly with output=ok/lead impedance=ok/impedance value=1986 ohms/neos=no. There has been no trauma or manipulation that might have caused the problem. The nurse reported that at this time they believe the aspiration is constant and there are no concerns noted on observation prior to interrogation or afterwards; patient was observed for an hour after. The patient's parents report that it has always been difficult to get the patient to drink water, the patient holds it in his mouth and it dribbles out and he sometimes coughs on it. The patient drinks milk without any similar concerns. No change in parameters and no subsequent improvement was observed. No other interventions are planned besides reducing the pulse width and signal frequency in case stimulation might have interfered with swallowing. The patient's parents do not think it is likely as there has been no ongoing problem with feeding noted by them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816573
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dennis100
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« Reply #37 on: January 21, 2016, 02:45:04 AM »

Model Number 102
Event Date 09/17/2012
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. The notes indicated that the patient had pneumonia, pediatric and adult obstructive sleep apnea, aspiration pneumonia, and dysphagia causing pulmonary aspiration with swallowing. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2810272
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dennis100
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« Reply #38 on: January 21, 2016, 08:45:29 AM »

Model Number 103
Event Date 07/06/2012
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that this vns patient had a past medical history of (b)(6). The notes also indicated that the patient continued to have breakthrough seizures but that the seizure frequency was significantly improved since vns therapy. The patient had generalized tonic-clonic seizures, complex-partial seizures and frontal lobe seizures. On occasion, the patient needed diastat to treat severe seizure activity. Notes dated (b)(6) 2012 indicated that the patient had a seizure on (b)(6) 2012 for which he was taken to the emergency room. During transport the patient aspirated and stopped breathing. There was no provoking factor for the episode but may have been triggered by fluctuating serum levels of his antiepileptic drugs. During follow-up, the physician stated that he did not know if the (b)(6) was related to vns as the event occurred prior to the patient being in his care, and the patient medical history was filled out by the patient's sister. No additional information was available. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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=2806978
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dennis100
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« Reply #39 on: January 25, 2016, 01:17:32 PM »

Model Number 103
Event Date 02/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, it was reported that this patient underwent surgery in (b)(6) 2012 for another procedure. When the patient was waking up from anesthesia, she began to aspirate. The physician believed the device was on during the procedure. The relation of the aspiration to vns and/or medication was unknown. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773208
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dennis100
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« Reply #40 on: January 26, 2016, 03:26:50 AM »

Event Date 09/04/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012 a nurse reported that they are seeing increased chest infections in some patients. It was discussed that if stimulation was causing swallowing difficulties, than possibly aspiration could be occurring. This report and mfr. Report number 1644487-2012-02468 are addressing these patients. Additional information has been requested but no further information has been received to date.

Event Description
Additional information was received on (b)(6), 2012 when the patient's identity was provided for mfr. Report # 1644487-2012-02468. The nurse also reported that no further information could be obtained from their office, therefore the patient in this report and the relationship of the event to vns is still unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2765460
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dennis100
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« Reply #41 on: January 29, 2016, 05:02:34 AM »

Model Number 102
Event Date 04/04/2009
Event Type Death
Event Description
It was reported that the patient passed away. The date of death was (b)(6) 2009. A sudep evaluation for this patient was performed and it was indicated that the death is possible sudep. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Date of event: the patient passed away on (b)(6) 2009, however it was initially reported that the patient passed away on (b)(6) 2009.

Manufacturer Narrative

Event Description
Follow up was performed and it was indicated that the patient passed away from respiratory failure due to chronic aspiration. The cause of death was not believed to be related to vns. Attempts were made for product return; however the device was not explanted at the time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2669431
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dennis100
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« Reply #42 on: January 30, 2016, 02:24:15 AM »

Model Number 102
Event Date 06/17/2012
Event Type Injury
Event Description
It was reported by a company representative that a vns patient experienced voice alteration and aspiration due to unknown reason. The patient was referred to an ent and at the moment are pending results from evaluation. Moreover, information from the treating neurologist indicated the generator was off at the time of the events. The patient had little dysphonia which has disappeared. Corticosteroid therapy was started and the voice had almost normalized. Aspiration was found by ent physician and a reported swallowing difficulty was present pre-vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2656871
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dennis100
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« Reply #43 on: February 01, 2016, 05:53:12 AM »

Model Number 103
Event Date 04/10/2012
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, a physician's office reported that this vns patient was admitted to the hospital, had been in status epilepticus, and needed vns battery replacement. Clinic notes were received on (b)(6) 2012 for (b)(6) 2012 through (b)(6) 2012. These notes indicated increased seizure duration, increased seizure intensity, and increased seizure frequency. The notes also contained ''"date noted"''; for aspiration pneumonia ((b)(6) 2011), respiratory distress ((b)(6) 2011), respiratory syncytial virus pneumonia (rsv) ((b)(6) 2011), and chronic pulmonary aspiration ((b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's mother reported that the patient occasionally has a few ''smaller'' seizures, but no big seizures. However, for the past three days (beginning (b)(6) 2012), the patient began crying with both arms flexed and stiff with bilateral fisting. These episodes last up to 30 minutes. The patient ceased crying when the mother was present, but began crying again when the mother left. The physician's impressions of the patient indicated that over the past one to two months there has been an increase in seizures again with eyes rolling, stiffening, and respiratory irregularities. The notes also reported that another physician reported that the patient has had several episodes of longer seizures for the past several weeks (approximately (b)(6) 2012). Notes dated (b)(6) 2012 state that the patient's device was interrogated for the first time since (b)(6) 2011. The patient's vns settings indicated that the device was disabled due to end of service. No stimulation was being provided as the normal mode and magnet mode output currents were found to be 0 ma. The device was programmed to a normal mode output current of 0. 25 ma (magnet mode 0. 50 ma), and it was stated that the patient is having increased seizures due to the vns battery dying. Consult for replacement surgery was recommended. Notes dated (b)(6) 2012 indicated that the patient had recurrent respiratory infections; however, at this time, there were no features of an active infection or aspiration. Notes dated (b)(6) 2012 stated that the patient's device was disabled due to it being problematic. Follow up with the physician's office on (b)(6) 2012 revealed that the statement regarding the generator being ""problematic""; was a reference to the generator at end of service. The physician's office stated that the patient's reported increase in seizure duration was an increase in the actual seizure time. They were unable to state the relationship of the increased seizure duration and increased seizure intensity to vns because medication changes and the loss of therapy due to end of service were simultaneous. No details were available regarding the increased seizure intensity: it was only stated that the patient's eeg was worse. No interventions have been planned. When asked about the respiratory difficulties, pneumonia, and aspiration, it was stated that this was the patient's baseline and that these issues remained unchanged with relation to vns. Vns replacement surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2594672
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dennis100
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« Reply #44 on: February 02, 2016, 07:01:41 AM »

Model Number 302-20
Event Date 03/01/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Describe event or problem: corrected data. Omitted x-ray review on initial mdr report. Manufacturer reviewed x-rays of implanted device. X-ray review by the manufacture revealed a sharp angle near the connector pin.

Event Description
Additional information was received that the patient's explanted generator will not be returned for analysis as it went home and was not returned. Their electrode was left in place because the patient had established fibrosis and it would have been too risky for the patient to properly dissect around the vagus nerve. X-rays were reviewed. The generator is placed in a normal arrangement on the upper left chest. In the ap chest x-ray view taken after implant, the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin appeared to be intact. A strain relief bend and loop were present, but not as specified by the labeling. Tie-downs were used to hold the bend and the loop. Portions of the lead appeared to be behind the generator and could not be fully assessed. Neither lead breaks nor acute angles were observed in the assessed portions of the lead. In the ap chest x-ray view taken after the report of "lead pulling sensation", the generator appears in the same placement, but seems to have been turned in an anti-clockwise direction with respect to the first x-rays. The filter feed-through wires still appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin were not intact and presented two sharp angles. The strain relief bend and loop were not present any more, and instead a sharp angle appeared right below the positive electrode, in the lead bifurcation.

Event Description
Additional information from the treating physician indicated the explanted material was provided to another medical professional for vigilance. At the moment attempts have been unsuccessful to date to obtain the explanted devices returned to the manufacturer for analysis.

Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not list type of report. Initial report should have had indicated 30-day report.

Event Description
It was initially reported by a company representative that a vns patient experienced an increase in seizures and the suspicion the patient's lead being detached from the nerve. The patient's device was reported to have been programmed off. Additional information was received from the treating physician indicating the increase in seizures began in (b)(6) 2012 and around (b)(6) 2012, there was a complaint of lead pulling sensation. No patient manipulation or trauma was suspected to have contributed to the event and the system diagnostics from implant were within normal limits. Nonetheless, the physician believed the increase in seizures (below pre-vns level) was related to hardware failure. Moreover, the treating physician indicated the patient had undergone generator and lead removal surgery as the patient presented aspiration and bi-tonal voice. The physician indicated the explanted electrode was twisted on itself and believed this caused the winding tension on the nerve. Some manipulation of the electrode was seen in the generator area as the lead was coiled. At the moment replacement surgery will be planned after the patient ameliorates on the reported aspiration and bi-tone voice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2576889
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dennis100
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« Reply #45 on: February 08, 2016, 07:32:18 AM »

Model Number 106
Event Date 12/28/2015
Event Type Injury
Event Description
During initial vns implant, the patient aspirated while waking up from anesthesia. The patient developed a lung infection in the right lobe and was transferred to another hospital as the implanting hospital did not have a pediatric unit. It was later reported that the patient was discharged home with a feeding tube which was removed the following week. It was reported that the patient has now returned to his normal state.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397100
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dennis100
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« Reply #46 on: March 04, 2016, 08:16:11 AM »

Model Number 103
Event Date 07/31/2012
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away due to aspiration during a severe seizure on (b)(6) 2013. The vns was last checked on (b)(6) 2012 and system diagnostics checked good. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Event Description
On (b)(6) 2013, the physician reported that he did not see how there could be a relationship between vns and the patient¿s death. He stated that he saw the patient recently at a marathon and again at the summer special olympics, and the patient seemed fine. The patient's father stated that the patient had a seizure during the olympics, however, the patient was walking up to him (the physician) within half an hour of this seizure. The physician stated that the patient did not experience any increase in seizures and that the death was not related to vns. The physician stated that the death was probable sudep as there was no underlying event for this, and the patient fit the criteria. He stated that he heard about the death a few weeks after he last saw the patient and that there were no extenuating circumstances that preceded the death, so the death was assumed to be sudep. The physician did not have the patient's programming or diagnostic history. No other information was provided. Follow-up with another physician confirmed that there was no relationship between vns and the patient¿s death except that the patient had refractory epilepsy. He said that the vns was working fine and that the patient's device had been interrogated shortly prior to the death and had normal results. Attempts for product return showed that the device buried with the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3197260
« Last Edit: November 27, 2018, 08:15:15 AM by dennis100 » Logged
dennis100
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« Reply #47 on: March 06, 2016, 04:01:45 AM »

Model Number 103
Event Date 07/13/2011
Event Type Injury
Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient's lead and generator were explanted and not replaced on (b)(6) 2012. Follow up with the site revealed that the device was removed due to lack of efficacy and they did not have any additional information to provide. The lead and generator were received by the manufacturer on (b)(4) 2012 and are currently undergoing product analysis.

Event Description
Additional information was received on (b)(4) 2012, when analysis of the explanted lead was completed. Note that since a portion of the lead (including) the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above typical wear and explant related observations, no anomalies were identified in the returned lead portion. The analysis of the generator was completed on (b)(4) 2012. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6) 2011, a vns treating nurse practitioner reported that the vns patient was in the hospital due to seizures. The patient's parent is concerned because when they tape the magnet over the device during meal time recently to halt voice alteration, the device still provides stimulation. In order to double check this report, the nurse practitioner taped the magnet over the device that day in the hospital for about 20 minutes and the device was still activating while the magnet was in place. System diagnostics and normal mode diagnostics were performed on the generator and results were normal; impedance value of 2621ohms and 2635ohms respectively. The device was interrogated and the magnet activations were examined. The handheld showed that the device recorded multiple magnet activations while the magnet was in place for about 20 minutes. The manufacturer's consultant reported that the magnet was taped securely to the skin and the generator is able to be visualized under the skin. The patient was implanted recently in (b)(6) 2011, so the magnet is fairly new. The nurse practitioner stated that she did not know if there was any trauma to the site. The generator is currently disabled due to the magnet issue and the most recent settings before it was disabled were output=1. 5ma/frequency=20hz/pulse width=250usec/on time=21sec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The nurse practitioner reported later that the patient falls a lot but the parents don't know if he fell on the generator directly. His impedance checked out normally for both system and normal mode diagnostics. The patient's brother did bite him near the generator but did not break the skin. He aspirates during stimulation, so they now have the generator off. The patient has had aspiration pneumonia for a while now, so the magnet was being used to disable the device while eating. The nurse did not know if the patient has a history of aspiration, but did state that they have questioned whether or not the vns has made the aspiration worse. Lately (time frame unknown), the mother has noticed that the magnet is not working as it did to disable the device. The nurse states that the magnet had been helping at one point, though, and had improved the patient's aspiration. She stated that the patient has had worsening focal status and that the mother reports that the vns has not helped. The nurse stated that the generator protrudes from the chest so she is sure that the magnet is properly taped over the device. The patient's mother has tried both magnets that came with the patient kit but neither will work lately and it is unknown which side is being taped facing the generator. The nurse reported that she does not know where the magnets are stored when they are not in use. The nurse then stated that during the 20 minutes that the magnet was taped over the device, the patient experienced voice alteration 3 different times for about 60 seconds (magnet on time is 60 seconds). After the device was disabled, no voice alteration was observed. The physician's nurse reported that they tried new magnets and they also did not work to disable the device. Therefore, the patient's generator is programmed to 0ma at this time. The patient has progressively worsening epilepsy and they do not think that it is related in any way to vns. They did not think the vns was helping even before it malfunctioned. If additional information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2200870
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dennis100
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« Reply #48 on: March 06, 2016, 11:03:20 AM »

Model Number 102
Event Date 07/04/2011
Event Type Injury
Event Description
It was reported by the patient's speech pathologist that the patient had "severe oral dysphagia"; the patient also reportedly coughed what she ate. The patient had been admitted to the hospital for aspiration pneumonia, confirmed with a barium test. The mother believed that some of the issues could coincide with a fall the patient experienced. The mother later indicated that the patient was "seriously ill. " the patient was admitted to the hospital for chest pains, which was later diagnosed as pneumonia with aspiration into the lungs. The patient's muscles in her throat had weakened. Consequently, when she swallows, the matter goes into the wrong pipe, causing aspiration into the lungs. The patient's mother stated she had searched and saw that the vns may be causing some of these issues. The patient may have a tube placed due to the issues she is having. Later information from the patient's speech pathologist indicated that the patient's swallowing problems were the same when the device was on and off. The therapist stated she could not state whether the device was causing the swallowing issues, just that the issues were not made worse with stimulation. The mother again told the manufacturer of her daughter's issues. She stated that she could not say the vns was the cause of the problem, but that it could be a cause. The patient recently was not able to stand, was lethargic, and her head was going to one side. Also, the patient was not able to find objects 6 inches in front of her. Additional information from the patient's parents showed that for the past two years, the patient had had problems with choking, aspiration, fainting, low blood pressure, and pneumonia. They had initially believed these issues were due to ongoing dental issues, but after research on vns, they had conducted on their own, the vns may cause these issues. The father of the patient stated the settings had been decreased by 0. 25 ma every month, but they were afraid to disable the vns. The patient's last known settings and diagnostics show proper device function. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196460
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« Reply #49 on: March 09, 2016, 03:05:48 AM »

Model Number 102
Event Date 03/24/2014
Event Type  Death   
Event Description
Follow-up revealed that the patient died at the hospital due to acute respiratory failure suspected to be secondary to aspiration. The patient was admitted to the hospital with respiratory difficulties thought to be secondary to aspiration with pneumonia. The patient had a do not resuscitate and therefore was given morphine and made comfortable. The patient passed away shortly after being removed from bipap.
 
Manufacturer Narrative

Event Description
It was reported that the patient passed away. It was reported that the cause of death was not related to vns therapy. It was reported that the patient's device has been at end of service for approximately two years. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3765234
« Last Edit: January 11, 2019, 02:58:45 AM by dennis100 » Logged
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« Reply #50 on: March 12, 2016, 08:06:41 AM »

Event Date 01/30/2006
Event Type Injury
Event Description
Our (b)(4) office was contacted by the solicitors office in (b)(6) asking for some information in regards to a vns pt and a road traffic incident. It was reported that they had temporary paralysis of the left vocal cord. Her physician believed that the impact caused her seatbelt to press against her with force causing trauma to her vagal nerve and causing the vagal nerve stimulation device to be moved resulting in throat problems. Additional information was rec'd that the pt had their vns implanted 10 years ago and a generator replacement was done in 2005. The pt had no problems with her vns until she was in a road traffic accident on (b)(6) 2006 when their car was hit by another car. She was a passenger in the back seated in the middle and got severe impact from her safety belt. She developed lower lobe pneumonia in hospital. The day she had the accident she also started to suffer from micro aspiration, choking episodes, reflux, problems swallowing, sore throat, gasping for air when talking and a throat clearing cough. The pt's implanting surgeon reported that the trauma caused the side effects after the accident. It was additionally reported that they checked the device and it is still stimulating. Good faith attempts are underway for further details surrounding this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2083000
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« Reply #51 on: March 21, 2016, 12:45:55 AM »

Model Number 103
Event Date 11/01/2010
Event Type Injury
Event Description
It was initially reported by the nurse that the pt was hospitalized for aspiration problems and she was not sure if this was related to vns. She state that the pt has many issues not related to vns and pt is a very difficult case to handle. The nurse was informed to turn off the device and see if the problem resolves. 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=1938615
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« Reply #52 on: March 30, 2016, 08:02:55 AM »

Model Number 102
Event Date 12/13/2009
Event Type Death
Event Description
It was reported that a pt passed away. F/u with the surgeon revealed that the pt had developed left vocal cord paralysis eight months prior (captured in mdr 1644487-2010-00350) as a result of lead revision surgery. The pt had some ongoing right sided paralysis for unk reasons and this did not appear to be related to the device. The pt required a tracheostomy and was following an otolaryngologist for the right side paralysis and did show some improvement. The pt later died due to aspiration with the vocal cord paralysis listed on the death certificate as a contributory factor. The manner of death was listed as "natural" on the death certificate. No autopsy was performed and the pt was buried with the device still implanted. Good faith attempts to obtain additional info regarding the pt's death from the pt's neurologist have been unsuccessful to date.

Manufacturer Narrative
Pt death believed to be a result of aspiration with vocal cord paralysis listed as a contributory factor. The left vocal cord paralysis is the result of the implant procedure and is captured in mdr 1644487-2010-00350.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614851
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« Reply #53 on: April 01, 2016, 02:42:19 AM »

Event Date 06/08/2009
Event Type Injury
Event Description
It was reported in a scientific article that a vns pt presented via the emergency department following a series of six to eight seizures over 24 hours. The pt remained in an uncharacteristically protracted post-ictal state, and developed intermittent stridor associated with respiration embarrassment and hypoxia. Intercurrent vomiting episodes, coupled with widespread pulmonary crepitations, led to a provisional diagnosis of aspiration with laryngospasms. Treatment with continuous positive airway pressure ventilation, intravenous steroids and nebulised bronchodilators improved oxygen saturation, and normal consciousness returned. The stridor continues and was noted to be intermittent and not associated with desaturations. The pt was also noted to be aspirating on feeding. Furthermore, flexible laryngoscopy at rest revealed both vocal cords to be lying in a paramedian position during quiet respiration. During stridulous episodes, the glottis was noted to narrow further, with adduction of the left vocal and vestibular fold. It was suspected that vagus nerve stimulation was contributing to laryngeal dysfunction so the device was programmed off. Subsequent flexible laryngoscopy revealed a fully mobile left vocal fold but persistent right vocal fold palsy. At the moment, it is known that the vagus nerve stimulator remains programmed off and alternative medical therapy was initiated for seizure control. However, good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Article citation: bhatt, y. M. , and hans belloso. "airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists. " the journal of laryngology & otology 3rd ser. 1 (2009): 1-3. Print.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520362
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« Reply #54 on: April 03, 2016, 02:08:43 AM »

Model Number 103
Event Date 10/01/2011
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was initially reported that the patient began having an increase in seizures 5-7 days after having their vns generator initially turned on. The patient was also experiencing behavior changes. The patient exhibited aggression and weeping. The patient has experiencing weeping with seizure activity but never experienced aggression. The patient was recently confused and forgot to take their medication on schedule. This resulted in the patient aspirating during and seizures have having to be hospitalized. The generator was disabled while in the hospital.
 
Event Description
Additional information was received that indicated that the increase in seizures were not related to vns but were due to the patient missing a dose of medication. No further information was provided.
 
Event Description
Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2331542
« Last Edit: September 14, 2018, 08:09:33 AM by dennis100 » Logged
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« Reply #55 on: April 04, 2016, 02:09:25 AM »

Model Number 102
Event Date 07/28/2009
Event Type Injury
Event Description
It was reported that the patient went to the er and had a pulse rate of 49 bpm. The patient's device was programmed off to rule out vns as a contributing factor. Per the reporter, he does not think the low pulse rate is due to the vns since it did not change much even after he turned off the device. The patient also had an episode of aspiration and was admitted to the hospital and intubated. Per the reporter, the patient has parkinson's disease, so there are a lot of health issues. Attempts for further information have been successful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1456772
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« Reply #56 on: April 04, 2016, 02:09:58 AM »

Model Number 103
Device Problem Device Operates Differently Than Expected
Event Date 05/18/2015
Event Type  Injury   
Event Description
It was reported that the patient had reported to the neurologist and ent physician that he had vocal cord paralysis, which the patient believed may be permanent and was from vns stimulation. The paralysis was reported to be on the left side. Following the initial implant surgery, the patient was set to 0. 25 ma output current, which he tolerated. At the first titration, the patient was moved from 0. 25 ma to 0. 5 ma. At 0. 5ma the patient showed symptoms of hoarseness. The patient was then moved to 0. 25ma and the issue persisted. The vns was then set to no longer deliver therapy and the hoarseness persisted which led to the referral to the ent additional information was received that following the vns implant surgery, the patient was reportedly doing well with no hoarseness at all. When the vns was turned to begin to deliver therapy, the patient became hoarse. Per the surgical report the physician obtained, this issue was not surgical. Per this patient, this issue occurred almost immediately after the vns was turned on. It began 10 days after implant around the time of his first titration. The ent physician did not believe the issue was permanent, however, and believed the issue would resolve with time. It was reported that the patient had already shown improvement between (b)(6) 2015 when he first presented to the ent with full left vocal cord paralysis and his next appointment on (b)(6) 2015. No known surgical interventions have been taken. No additional relevant information has been obtained to date.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
The previously submitted mdr inadvertently omitted the patient's report of aspiration and dysphagia.
 
Event Description
When the patient presented to the ent with vocal cord paralysis, the patient was also experiencing mild aspiration and dysphagia. This information was inadvertently not reported on the previously submitted mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027685
« Last Edit: March 05, 2019, 07:46:43 AM by dennis100 » Logged
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« Reply #57 on: April 08, 2016, 01:18:45 AM »

Model Number 103
Event Date 01/01/2016
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient is aspirating. The physician programmed the device off to see if the patient improves. The mom was not sure exactly when this issue began. The patient's device was then turned back on but he was still aspirating even with it off. The patient was going to undergo more tests to evaluate relationship to vns or other factors including a family history of muscle disorder.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5515506
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« Reply #58 on: April 09, 2016, 07:05:12 AM »

Event Date 05/01/2002
Event Type Injury
Event Description
It was reported in a scientific article that a vns pt experienced severe dysphagia, vocal cord paralysis and aspiration. "on the 15th postoperative day the pt was readmitted in the hospital with sudden onset of hoarseness and dysphagia. According to her caretakers, she was seen twisting the pulse generator under her skin a few days before admission. A check of the device with the programming wand showed that it was functioning normally. The chest x-ray obtained at this admission demonstrated excessive twisting of the leads cranial to the pulse generator. The otolaryngology service was consulted, and flexible laryngoscopy revealed left vocal cord paralysis with loss of sensation to the supraglottic airway" the pulse generator was surgically removed, and although the vagus nerve appeared intact, the leads were tangled, tightly twisted and completely separated from the spiral electrodes at the anchoring site. Because of the severe dysphagia the pt also underwent a percutaneous endoscopic gastrectomy three days after vns implantation surgery. The pt was readmitted to the hospital 10 days later for recurrent aspiration. The pt underwent vocal fold injection of gelfoam into the left periglottic space which ameliorated the aspiration. According to the author, "the pt continues to have complete vocal cord paralysis on long term review". Good faith attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
Article: kalkanis, james, priya krishna, jose espinosa, and dean naritoku. "self-inflicted vocal cord paralysis in pts with vagus nerve stimulators. " (2002): 949-51. See scanned pages.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1408594
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« Reply #59 on: June 09, 2016, 01:10:46 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2011
Event Type Injury
Event Description
It was reported by the physician the patient was unable to tolerate higher vns therapy settings due to excessive salivation and aspiration after the vns was implanted (b)(6) 2011. However, it was also reported the patient did see some disease improvement with vns therapy.

Event Description
It was reported by the physician that no interventions were taken in regards to the reported excessive salivation and aspiration. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5109166
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