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dennis100
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« on: September 01, 2018, 01:34:17 AM »

Model Number 304-20
Event Date 06/22/2012
Event Type  Injury   
Event Description
Reporter indicated a patient developed dysphagia, hoarseness, and difficulty speaking following vns implant surgery on (b)(6) 2012. The patient was seen by an ent physician and was diagnosed with "paresis of the plica vocalis, left recurrent laryngeal nerve paresis, and gastroesophageal disease". The events are felt to be permanent and due to the vns implant surgery. The patient had no pre-vns history of the events. The vns was turned down to low settings, as the patient requested it not be disabled. The patient also received prednisone medication. The patient describes the events as "bearable". Intraoperative vns diagnostics were reported as "ok".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2739617
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dennis100
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« Reply #1 on: September 01, 2018, 01:35:13 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that the vns caused the patient's gastroparesis, and their seizures were still not controlled. It was stated that the device didn't work for the patient and was therefore it was turned off. Scar tissue formed in the patient's neck, which was very painful, even to turn their head just a little bit was reported to be torture. Patient reported undergoing surgery to remove device and scar tissue. Patient also reported that there was damage to the vagus nerve. The patient's neurologist who managed the patient's vns did not know about any of the symptoms or issues. No other relevant information has been received to date.

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dennis100
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« Reply #2 on: September 01, 2018, 01:36:27 AM »

Model Number 105
Event Date 05/10/2012
Event Type  Injury   
Manufacturer Narrative
 
Manufacturer Narrative
 
Event Description
Initially, it was reported that the patient was scheduled for explant due to unknown reasons. It was later reported that the patient experiences multiple side effects which were worsened after generator replacement in 2012. It was noted that the patient experienced dysphonia with device activation and dysphagia to pills. The patient also noted atrial fibrillation with seizures, submandibular tenderness, gastroparesis, left-sided breast pain and left-sided jaw pain. It was noted that the symptoms continued after programming the device off. Attempts to obtain additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
It was reported that the patient underwent vns explant. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5526231
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dennis100
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« Reply #3 on: September 01, 2018, 01:37:55 AM »

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

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.
 
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.
 
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 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) 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.

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dennis100
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« Reply #4 on: September 01, 2018, 01:38:58 AM »

Model Number 302-20
Event Date 04/13/2010
Event Type  Injury   
Event Description
It was reported that the patient had continued neck pain and lead pulling when she turned her head. The patient also had pain/burning in throat and difficulty when swallowing. She said that food seemed to get stuck in her throat. The patient had evaluation by an ent in late 2011 which showed left sided laryngeal paresis and retention of food in the right valleculae with no aspiration. Physician notes that the patient has had improved seizures control with vns, but continued discomfort has distracted from benefit. No patient manipulation of vns has occurred. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician. No x-rays of the patient's vns have been taken. The patient did not experience paresis or difficulty swallowing prior to vns implantation which the physician suggests that there is therefore a relationship of these events to vns implantation. The paresis is reportedly associated with stimulation. However, the dysphagia is apparently not associated with stimulation. The patient has also complained of difficulty breathing when the room temperature is hot or cold since the time of implantation. No patient manipulation or trauma has been reported or has been apparent that may have contributed to the events. No interventions have been taken except examinations by her implant surgeon and by ents.
 
Manufacturer Narrative
The initial report inadvertently reported the incorrect event date. The physician has indicated that the symptoms occurred following implant surgery. The initial report inadvertently did not include the patient's age.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2443233
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dennis100
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« Reply #5 on: September 01, 2018, 01:40:42 AM »

Event Type  Injury   
Manufacturer Narrative
Date of birth, corrected data: initial mdr inadvertently provided the incorrect information. Sex, corrected data: initial mdr inadvertently stated this information was unknown; however, the information was known at the time. If implanted, corrected data: initial mdr inadvertently provided the incorrect information. Describe event or problem, corrected data: the initial mdr inadvertently referenced the related mfr numbers incorrectly. The following manufacturer report numbers are associated with each patient¿s respective events reported in the article: mfr #: 1644487-2014-00031 -- asystole related to vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery and psychotic episodes associated with vns. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 ¿ lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00040 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.
 
Event Description
Follow up with the physician was performed. The physician stated that he had reported these events to the manufacturer in time and he was not willing to support any further dialog regarding these issues. The physician confirmed that there were no critical situations around the vns and that in cases where vns was critical, the device had been disabled and/or explanted. No additional information was provided.
 
Event Description
The abstract of the article ¿vagus nerve stimulation therapy in epilepsy patients. Long-term outcome and adverse effects: a retrospective analysis¿ was received and reviewed by the manufacturer. Please see abstract below: ¿background: vagus nerve stimulation (vns) is one of the numerous stimulation procedures used in the treatment of neurological diseases in which there has been growing interest in recent years. Since 1988 it has been frequently used in the therapy of epilepsies but the mechanism of action is still unknown. It is considered to be low in adverse effects. Topics: decision-making process on vns therapy as well as long-term outcome and adverse effects. Method: retrospective analysis of all 62 patients treated over a long period by vns in the epilepsy center of the university hospital of freiburg (germany) from (b)(6) 2002 through (b)(6) 2011. Results: outcome: the results show that 2 out of 62 patients became seizure-free under vns therapy while maintaining the already existing anti-ictal medication and 4 more patients under vns plus dosage increase of the already existing medication and/or new medication. However, in 34 out of 62 patients vns therapy did not improve the seizure situation. Adverse effects: vns is not as low in adverse effects as is generally considered. Only 9 out of 62 patients did not show any adverse effects and on the other hand severe, even life-threatening adverse effects also occurred. Conclusion: patients undergoing vns therapy have to be carefully checked for possible adverse effects, not only at the beginning of vns therapy but also in the long-term course. These results have to be considered in the cost-benefit analysis of this treatment. ¿ the article, written in german, was later received by the manufacturer. Per the article, thirteen patients experienced adverse events related to the vns surgery or vns. A translation of the chart with patient information and outcomes revealed the following adverse events were observed: necrosis, increase in seizures (that were possibly psychogenic), wound infections, secondary rupture of sutures, recurrent laryngeal nerve paresis, horner¿s syndrome, wound dehiscence, lead break, and asystole. The following manufacturer report numbers are associated with each patient and their respective events: mfr #: 1644487-2014-00031 -- asystole, associated with vns. Mfr #: 1644487-2014-00032 -- recurrent laryngeal nerve paresis associated with complications from surgery. Mfr #: 1644487-2014-00033 -- increase in seizures, which were possibly psychogenic, related to vns. Mfr #: 1644487-2014-00034 -- secondary rupture of sutures, associated with complications from surgery, and dysesthesia with the vns. Mfr #: 1644487-2014-00035 -- wound infection associated with complications from surgery, and psychotic episodes associated with vns. Mfr #: 1644487-2014-00036 -- recurrent laryngeal nerve paresis and horner¿s syndrome associated with complications from surgery. Mfr #: 1644487-2014-00037 -- lead break. Mfr #: 1644487-2014-00038 -- recurrent laryngeal nerve paresis, lead pulling sensation, and lead break associated with complications from surgery. Mfr #: 1644487-2014-00039 -- wound infection and secondary rupture of sutures associated with complications from surgery. Mfr #: 1644487-2014-00040 -- necrosis, associated with complications from surgery. Mfr #: 1644487-2014-00041 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00042 -- wound dehiscence associated with complications from surgery. Mfr #: 1644487-2014-00043 -- necrosis, lead pulling sensation, and lead break associated with complications from surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3549167
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dennis100
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« Reply #6 on: September 01, 2018, 01:41:26 AM »

Model Number 102
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received by the manufacturer, which mention that the patient had traumatic cerebral hemorrhage. The patient has had right hemiparesis. Attempts are being made for additional information; however, no other information has been received.

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dennis100
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« Reply #7 on: September 01, 2018, 01:42:03 AM »

Model Number 102
Event Date 11/30/2009
Event Type  Death   
Event Description
It was reported that the vns patient passed away on (b)(6) 2009. The cause of death is unknown. Review of the available programming and diagnostic history showed normal diagnostic results through 2009.
 
Event Description
Additional information was obtained and it was found that the patient¿s date of death was actually (b)(6) 2009 and the patient passed away at the hospital. The patient was admitted to the hospital on (b)(6) 2009 with acute atrial fibrillation with fast response, hypotension, and probable pneumonia. The history of present illness details that the patient had serial life threatening problems over the last two months which included an intracerebral hemorrhage with resulting hemiparesis and marked cognitive and physical deficits. A feeding tube was placed a week prior to the hospital stay because of dysphagia and recurrent aspiration. The patient had an acute mi, pneumonia, svt, and blood pressure difficulties prior to placement. Tachycardia at a rate of 180 led to him being sent to the er. The svt proved quite difficult to control as he was found to have a large intraventricular clot that they did not anticoagulate because of the intracerebral hemorrhage. The physician wished to move the patient to hospice due to the poor prognosis, but his brother wanted gentle care. In a progress note addendum, the physician convinced the patient¿s family to move the patient to hospice care because ¿his prognosis is essentially zero. ¿ the patient had another mi while in the hospital, but the patient's heart rate and blood pressure somewhat stabilized. The patient was eventually discharged on (b)(6) 2009, the date of death.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Manufacturer Narrative
Outcomes attributed to adverse event: death, corrected data: the initial report indicated the date of death was (b)(6) 2009 however, it was (b)(6) 2009. The information has been corrected in this report. Date of event, corrected data: the initial report indicated that the date of the event was (b)(6) 2009 however it was (b)(6) 2009. The information has been corrected in this report.

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dennis100
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« Reply #8 on: September 01, 2018, 01:42:47 AM »

Model Number 102
Event Date 04/01/2011
Event Type  Injury   
Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: the supplemental report #2 inadvertently did not include the programming/diagnostic history provided by the neurologist.
 
Event Description
The patient's implanting facility health information department provided the patient's product information.
 
Event Description
Additional information was received from the neurologist on (b)(6) 2012 which revealed that the stroke and left hemiparesis were first observed in (b)(6) 2011. The neurologist doubts there is any relationship between vns and the patient's stroke and let hemiparesis. The relationship of the patient's chest pains to vns is unknown. No causal or contributory programming or medication changes preceded the onset of the events. No additional information was provided. The neurologist wants to replace the patient's vns generator due to end of service as reported in manufacturer report #: 1644487-2012-00784.
 
Event Description
Clinic notes dated (b)(6) 2011 were received for a vns patient which revealed that the patient had previously had a stroke. The patient was reportedly "recovering okay from the stroke. " the patient requested on this clinic visit for the vns settings to be increased. In the notes dated (b)(6) 2011, the stroke was mentioned again, and it was also noted that the patient has left hemiparesis. It may be assumed that the patient was hospitalized for the stroke, but it is unknown if any additional interventions were taken. Attempts for additional information regarding these events from the physician have been unsuccessful to date. In addition, attempts to medical records to obtain product information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Device manufacturer date:the initial report did not include the specific device information.
 
Manufacturer Narrative
The initial report inadvertently reported the incorrect event date. Additional information was received from the neurologist.

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dennis100
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« Reply #9 on: September 01, 2018, 01:44:15 AM »

Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Event Description
It was reported that the patient underwent generator replacement surgery on (b)(6) 2011 due to end of service. The explanted product was returned to the manufacturer, but analysis is pending.
 
Event Description
Analysis was completed on the returned generator. Upon analysis, the device was found to be at expected end of service. No other anomalies were noted. The patient's recent seizures were likely a result of loss of therapy due to end of service.
 
Event Description
It was reported that the pt is being referred for generator replacement surgery due to eri = yes. It was also noted that the pt". Continues to have fairly frequent seizures. Seizures are occurring on a daily basis, although often during sleep. The most recent new phenomenon is that on several occasions, he has experienced what appeared to be a mild hemiparesis after seizure; however, this has resolved fully and is not a feature of every seizure that he has. " the physician and the family hope that replacement of the generator will lead to further reduction in seizures. Attempts for further info have been unsuccessful to date.

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dennis100
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« Reply #10 on: September 01, 2018, 01:44:59 AM »

Model Number 102
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient has new small seizures and balance disorders in addition to his usual seizures. No end of service flag was seen during interrogation. A battery life calculation using the available programming history showed approximately 4. 6 years left until near end of service is yes. Additional information was received from the physician with all data regarding the patient's follow-up records since the vns implantation in (b)(6) 2012: on the visit 1 in (b)(6) 2012, the device was programmed at 0. 25ma output current - 250¿sec pulse width - 20hz frequency - 30sec on time and 5min off time. No special adverse event was and everything was ok. On the visit 2 in (b)(6) 2013, the patient was stable. He has spent 1 week without seizure (after vns activation) which is rare. He had some seizures during the (b)(6) period. The output current was increased at 0. 5ma. On the visit 3 in (b)(6) 2013, it was found that the patient's seizures increased a little in 2 months. The parents reported dysphonia and small cough but the patient's mood had improved well. The output current was increased to 0. 75ma without any adverse event. No cough was noted. On the visit 4, it was reported that the patient spent 9 days without seizures. The vns stimulation was well tolerated but some episode of cough was reported. The output current was increased to 1ma. System diagnostics returned impedance results within normal limits. On the visit 5, some episode of fever was reported (but not more than 38°c). The cause was unknown but, as reported by the physician, this is a known event to encephalopathic patients with lennox gastaut syndrome. No infection occurred. The output current was increased at 1. 25ma. On the visit 6 in (b)(6) 2013, it was reported an increases in seizures but not intense. It was reported that this could be related to patient's emotions. The output current was increased at 1. 5ma. On the visit 7 in (b)(6) 2013, frequent seizures were noted but not intense. It was reported by the caregivers that the vns magnet was more used because it stops immediately 80-90% of seizures. The output current was modified to 1. 75ma and the frequency was increased to 30hz. On the visit 8 in (b)(6) 2013, the patient seizures frequency was stable and not intense. No voice alteration and cough were reported. The output current was increased at 2ma and the pulse width to 500¿sec. On the visit 9 in (b)(6) 2013, it was noted that the patient mood and behavior were improved well. But it was reported that the patient had one big seizure and fall. Small tonic seizures were noted too. The output current was changed to 2. 25ma. On the visit 10 in (b)(6) 2014, the physician reported that a positive evolution of the situation was noted. A small cough was reported. System diagnostics returned impedance results within normal limits. The duty cycle was changed by modifying the off time from 5min to 3min. On the visit 11 in (b)(6) 2015, a progressive increase in seizures was noted during the past 7 months. No change in medications was performed. It was reported by the physician that this could probably due to the modification of duty cycle (from 5 to 3min off time). The physician decided to change back the duty cycle to the initial settings. System diagnostics returned impedance results within normal limits. On the visit 12 in (b)(6) 2015, it was reported that since the duty cycle was modified back to initial settings, an improvement was noted; seizure reduction was noted. It was reported that the patient was still sensible to emotions. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. On the visit 13 in (b)(6) 2016, it was reported that since (b)(6) 2015 the patient had more seizures. It was reported that on (b)(6) 2016, the patient had a big seizure and fall. That day, he had pallor, muscle spasms, brief respiratory arrest and wound on eyebrow which was treated by antibiotics. It was reported that the patient had later 2 other big unusual seizures: they were generalized tonic chronic seizures. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. The output current was changed to 2. 75ma. On the visit 14, on (b)(6) 2016, the patient was seen for a follow-up of lennox gastaut syndrome. Eeg was ok with some improvement. It was reported that the patient had ambulation difficulties and fall; he could not stay up for a long time. An increase of hemiparesis was reported. Nevertheless, patient's seizures reduction was noted. The vns stimulation was well tolerated. System diagnostics returned impedance results within normal limits and the near end of service flag was no. It was reported that the last vns parameters were at 2. 5ma output current ¿ 30hz frequency ¿ 500¿sec pulse width ¿ 30sec on time ¿ 5min off time. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

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dennis100
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« Reply #11 on: September 01, 2018, 01:45:42 AM »

Model Number 103
Event Date 04/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient was taken to the hospital on several occasions due to indigestion problems. His condition improved but he still had difficult eating by himself as he was fed via feeding tube due to his handicap and lack of motivation. The patient also experienced other adverse events that occurred after vns implant: the patient's mother believed they were due to vns. Toward (b)(6) 2012, the patient began having fecal vomiting and constipation and an aspiration pneumonia complication. At (b)(6) 2012, the patient had a diaphragmatic hernia with large defect. There was a gastro paresis with gastric retention complication post-operatively. In (b)(6) 2012, the patient had aspiration pneumonia with many epileptic seizures in (b)(6) 2012, there was more footage of epilepsy and a reduction of consciousness medical details were missing and proper narration of the event could not be confirmed due to communication errors between the patient's mother and the physician. The patient's current settings were provided. (output current: 1. ? ma, frequency: 30 hz, pulsewidth: 250 usec. ) attempts for additional information have been unsuccessful.
 
Event Description
Reporter indicated the patient's vomiting, syncope, pneumonia, and gastro-paresis are not felt to be related to the vns. The events are not related to vns stimulation either. The events are due to complications from the patient's illness. The patient is a "very disabled man" with multiple epileptic seizures daily and at night. The vns was temporarily disabled due to fever and illness. "there is no way to measure if he is suffering in any way of the stimulation of vns and he is too weak to suffer from anything else beside the illness. Maybe he will be better and then we will evaluate if the vns therapy should be continued or not". No causal or contributory vns programming or medication changes preceded the onset of the events. The patient does not have a pre-vns history of gastro-paresis. The patient does sometimes vomit with illnesses. It is unknown if the patient has a pre-vns history of syncope.

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dennis100
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« Reply #12 on: September 01, 2018, 01:46:33 AM »

Model
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« Reply #13 on: September 01, 2018, 01:47:20 AM »

Model Number 302-20
Device Problems High impedance; Human-Device Interface Problem
Event Date 04/18/2012
Event Type  Malfunction   
Event Description
X-rays images and the associated reports were received along with clinic notes indicating that the patient's vns was now indicating high lead impedance. Review of the x-rays by the manufacturer found no lead discontinuities however the lead pin did appear to be fully inserted inside the connector block. This indicates that the high impedance is likely related to an unpronounced lead discontinuity. The clinic notes indicate that the patient had recently fallen. Follow-up with the physician found that the high impedance was believed to likely have been related to the fall. Last good diagnostics were taken on (b)(6) 2010. The physician indicated that the patient was not able to feel stimulation when the vns was verified as functioning properly so it is unknown when the stimulation may have ceased due to the high impedance. The patient was also noted as being on "a ton of medication. " it is unknown if the patient will have her vns replaced due to financial concerns.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that the patient¿s depressive symptoms had a dramatic reduction with vns therapy, but after a fall in (b)(6) 2013, depression worsened and the vns system had high lead impedance. The pulse width was programmed up.
 
Event Description
Although surgery is likely, surgical intervention has not occurred to date.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate "30-day. ".
 
Manufacturer Narrative

Event Description
Additional information was received that the patient still has not had surgery. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Event Description
The patient later reported being hospitalized due to an exacerbation of gastroparesis.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2603402
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dennis100
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« Reply #14 on: September 01, 2018, 01:48:29 AM »

Model Number 103
Event Date 01/13/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
The generator analysis was completed on (b)(4) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient suffered from seizures, headaches, and hemiparesis. Clinic notes dated (b)(6) 0213 indicated that the patient experienced increased back pain and that her hips were still sore because of injections. Clinic notes dated (b)(6) 2013 indicates that the patient had increased back pain with a possible event in her hips. The patient had to use her magnet over the last few days. Additional information was received indications that provided recent diagnostics results. The patient was referred for generator replacement. Surgery is likely but has not taken place.
 
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient was having breakthrough seizures and now feels tired all the time. The patient reported that the generator was put in arm pit, a pointy thing sticking out of the armpit that she had to get used to. The patient wasn't sure if the surgery caused nerve damage for she had a problem with her arm for 1 year post operatively and could not move her arm. Surgery is likely but has not taken place.
 
Event Description
Additional information was received that the patient¿s arm paralysis was approximately six years prior. The event had resolved, was no longer an issue, and was not believed to be related to vns.
 
Event Description
On (b)(6) 2013, this vns patient underwent generator revision. The explanted generator was returned on (b)(4) 2013 and is pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3106886
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dennis100
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« Reply #15 on: September 01, 2018, 03:00:10 AM »

Model Number 102
Event Date 03/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The returned generator had analysis completed. The device output signal was monitored for more than 24 hours in a simulated body environment and verified that the generator was able to provide the expected output levels for the entire monitoring period. The device performed according to all functional specifications. A visual analysis of the generator did not show any adverse conditions and was consistent with those typically seen after device removal. Portions of the explanted lead were also returned for analysis. The condition of the returned lead portion was consistent with those that typically exist following explant. No anomalies were noted and no discontinuities were identified. The setscrew marks on the connector pin provided evidence of a good mechanical and electrical connection between the lead and the generator.
 
Manufacturer Narrative
Explant date, correction data: supplemental mdr #1 inadvertently did not include that the device had been explanted.
 
Event Description
A patient reported experiencing nerve damage, chronic gastroparesis, and chronic diarrhea soon after having her vns device implanted on (b)(6) 2012. The patient also reported that she had gastric issues prior to vns, and she had gerd surgery in 2014 but the issues didn't get much better. The patient's treating neurologist stated that she did not believe the patient had experienced nerve damage and also provided clinic notes dated (b)(6) 2016. The clinic notes stated that the patient began intermittently vomiting shortly after vns surgery and had seen multiple gi doctors that suggested vns may be a factor. The vomiting and gastric issues caused the patient to experience weight loss. Clinic notes stated that the patient believed the gastroparesis developed as a result of vns surgery due to the relationship between the vagus nerve and the digestive system. The device was programmed off to help the physician determine if the gastroparesis was related to vns on (b)(6) 2016. The physician recommended waiting at least 3 months before determining if the vns device should be explanted. The physician also stated that she believed the patient's constellation of symptoms could indicate dysautonomia. No surgical intervention has been reported to date. No further relevant information has been received to date.
 
Event Description
Information was received indicating the patient underwent an explant surgery due to the patient's discomfort and because her medical diagnosis had changed. The generator was returned the manufacturer and is currently under analysis. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5753203
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dennis100
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« Reply #16 on: September 01, 2018, 03:01:20 AM »

Model Number 102
Event Date 03/01/2012
Event Type  Injury   
Event Description
Information was received indicating the patient underwent an explant surgery due to the patient's discomfort and because her medical diagnosis had changed. The generator was returned the manufacturer and is currently under analysis. No further relevant information has been received to date.
 
Manufacturer Narrative
Explant date, correction data: supplemental mdr #1 inadvertently did not include that the device had been explanted.
 
Event Description
The returned generator had analysis completed. The device output signal was monitored for more than 24 hours in a simulated body environment and verified that the generator was able to provide the expected output levels for the entire monitoring period. The device performed according to all functional specifications. A visual analysis of the generator did not show any adverse conditions and was consistent with those typically seen after device removal. Portions of the explanted lead were also returned for analysis. The condition of the returned lead portion was consistent with those that typically exist following explant. No anomalies were noted and no discontinuities were identified. The setscrew marks on the connector pin provided evidence of a good mechanical and electrical connection between the lead and the generator.
 
Event Description
A patient reported experiencing nerve damage, chronic gastroparesis, and chronic diarrhea soon after having her vns device implanted on (b)(6) 2012. The patient also reported that she had gastric issues prior to vns, and she had gerd surgery in 2014 but the issues didn't get much better. The patient's treating neurologist stated that she did not believe the patient had experienced nerve damage and also provided clinic notes dated (b)(6) 2016. The clinic notes stated that the patient began intermittently vomiting shortly after vns surgery and had seen multiple gi doctors that suggested vns may be a factor. The vomiting and gastric issues caused the patient to experience weight loss. Clinic notes stated that the patient believed the gastroparesis developed as a result of vns surgery due to the relationship between the vagus nerve and the digestive system. The device was programmed off to help the physician determine if the gastroparesis was related to vns on (b)(6) 2016. The physician recommended waiting at least 3 months before determining if the vns device should be explanted. The physician also stated that she believed the patient's constellation of symptoms could indicate dysautonomia. No surgical intervention has been reported to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5753203
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dennis100
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« Reply #17 on: September 01, 2018, 03:02:02 AM »

Model
« Last Edit: December 21, 2018, 09:20:07 AM by dennis100 » Logged
dennis100
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« Reply #18 on: September 01, 2018, 03:03:02 AM »

Model Number 103
Event Date 01/22/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient continues to complain of vocal issues. She indicated that she was seen by an ent. The patient indicated that the ent believed the wire may have gotten tugged during a neck surgery where a steel plate was placed in the patient's neck that may be causing the patient's issues. The patient also reported that she is experiencing vocal dystonia and gastroparesis. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The patient reported that she has facial droop which she resolves with her magnet. The patient also reported that she taped the magnet over the generator to disable device stimulation and she was no longer experiencing tachycardia. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the facial droop, tachycardia, and voice alteration are not related to vns. The physician reported that voice alteration was not noted. The physician also reported that since the patient relates that when the device is off there are no voice changes, the device was programmed off; however, magnet mode stimulation was left on. The physician indicated it is unclear when and why the patient's complaints originated.
 
Event Description
The physician¿s office indicated that the patient has been treated for dystonia for a while at another clinic and it was not believed to be related to vns. The notes found that the patient was seen on (b)(6) 2016 and the vns was functioning as intended. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5470661
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dennis100
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« Reply #19 on: September 01, 2018, 03:04:03 AM »

Model
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dennis100
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« Reply #20 on: September 01, 2018, 03:04:53 AM »

Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt had been experiencing gastrointestinal issues. The pt alleged that vns was causing gastroparesis and causing his gastrointestinal issues however his physician did not indicate that. The pt is considering having his vns removed although there are currently no plans for that. Good faith attempts for more info have been unsuccessful to date.
 
Event Description
Additional information was received that the physician was turning the patient off temporarily. The patient had a gi tumor not related to vns and had lost a lot a weight due to it. The patient is now having trouble putting the weight back on. Since the vagal nerve goes to the gi tract they are going to try to disable the patient for a short time to see if that will help him gain weight. They do not feel that the vns is causing the lack of weight gain but want to see if disabling vns may help with the weight gain. The gastroparesis reported by the patient was determined to be related to the gi tumor and the resulting weight loss, both of which were not related to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2201793
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dennis100
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« Reply #21 on: September 01, 2018, 03:05:43 AM »

Model Number 302-20
Event Date 11/01/2009
Event Type  Injury   
Event Description
It was reported that a vns pt experienced pain during stimulation at the neck site. The pt had recently had a full system replacement as she was initially implanted in 2009 and shortly after surgery, she developed vocal cord paralysis. The vocal cord paralysis is now resolved, but the pt presented pain. Additional information was received from the treating physician indicating the pt was having muscle spasms with stimulation and the probable cause was vns implantation which topped connective tissue in the sternocleidomastoid muscle. The implantation of vns gave massive tension and spasms in the muscle at each stimulation of vns. Interventions taken were to reduce the pt's settings (decrease pulse width to 130 usec) to ameliorate the event. Moreover, the physician stated the pt reported horner syndrome and recurrence paresis in (b) (6) 2009 directly after initial vns implant. At the moment surgical intervention has not been planned and good faith attempts to obtain additional information have been unsuccessful to date. At the moment the muscle spasms are not present anymore and were related to stimulation as parameters were reduced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1779177
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dennis100
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« Reply #22 on: September 13, 2018, 01:59:27 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 08/11/2011
Event Type  Injury   
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect event date.
 
Event Description
It was reported by a company representative that a patient experienced severe cough and a left sided paresis of the neck along with being very hoarse after the patient underwent generator and lead replacement surgery. The patient was seen at a follow-up appointment and the severe cough had disappeared but the patient was still a little hoarse and his voice went away when he spoke for a longer time. At the moment the treating physician believes the paresis is due to the prolonged surgery for replacing the lead and the generator. No further interventions have been planned so far for the reported paresis due to the fact that the symptoms are getting better over time and the situation with coughing and hoarseness is improving, the physician plans to wait for natural recovery of the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2282315
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