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dennis100
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« Reply #450 on: May 19, 2017, 01:21:12 AM »

Model Number 101
Event Date 12/04/2008
Event Type  Injury   
Event Description 
It was reported in a scientific article that a vns patient, who had been receiving vns therapy for nine years without complaint, was admitted to the hospital for the control of an episode status epilepticus, an event not uncommon for the patient, for which medication was administered. The patient experienced an increase in seizures during the hospital stay and eeg monitoring revealed the occurrence of periodic cardiac changes with bradyarrhythmia and often severe asystolia due to atrium ventricular block, which coincided with stimulation. The patient was admitted to the cardiac intensive care unit and underwent holter monitorization, because the periodicity of the bradyarrhythmias was the same as that of the ncp stimulation (around 30 s every 5. 5 min), the ncp was stopped. Once the device was disabled, the reported arrhythmia event resolved. The reporter states that though there appears to be a clear relationship to vns therapy, other contributing factors were believed to be present. These factors include the addition of levetiracetam, which had a notable arrhythmic effect on the patient. The author also suggests that the patient's status episode may have predisposed the patient to the vns-related cardiac arrhythmia.
 
Manufacturer Narrative 
Article citation: iriarte, jorge, elena urrestarazu, manuel alegre, alfonso macias, asier gomez, paola amaro, julio artieda, and cesar viteri. "late-onset periodic asystolia during vagus nerve stimulation. " epilepsia 49 (2008): 1-5.
 
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dennis100
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« Reply #451 on: May 20, 2017, 08:22:48 AM »

Model Number 102
Event Date 07/01/2008
Event Type  Injury   
Event Description 
The initial reporter indicated "that ever since getting vns, she was on the lowest setting because it caused mania". The initial reporter spent the night in the emergency room and per the emergency doctor, she reported he stated "that it was over stimulating her heart and brain. So, they turned it off. " good faith attempts have been made to the patient's vns treating physician and thus far, no additional information has been attained.
 
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dennis100
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« Reply #452 on: May 23, 2017, 01:51:59 AM »

Model Number 102
Event Date 12/01/2007
Event Type  Injury   
Event Description 
Initial rptr indicated that the pt was seen in the er due to chest pain. Reported "started with persistent chest pain about 2 mos ago, prior to her last study visit in 2008. She also started with more intense localized stomach pain and nausea about the same time - she pointed to an area just below her sternum. " the pt has been prescribed medication for her stomach pain. The pt's "eeg and stress test and other heart-related tests have been within normal limits. " reported she had 2 heart scans the 2nd one "showed something". The pt immediately had an angiogram which was negative. Her chest pain is reported to be worse with stimulation and she also has the sensation of a lump in her throat with stimulation. Additionally reported the sensation of wheezing progressing from throat to her chest, with stimulation and has difficulty swallowing when stimulation is on. Since she has been experiencing these events she has been having difficulty sleeping. The vns was disabled for a week to see if the events would resolve. The pt saw a cardiologist and her heart testing was within normal limits. The cardiologist, therefore, concluded that the pt's symptoms must be caused by the vns stimulation. It was reported the pt did not want to consider an adjustment of parameters at this time, and she is considering having the device explanted. Her symptoms/side effects resolved when the device was turned off. The pt is unstable mentally at this time and she is voluntarily being admitted for psychiatric care. The pt's mental state is not over her pre vns events of depression, but being increased by the vns side effect issues she is having. No date set at this time for the pt to have their vns explanted.
 
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dennis100
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« Reply #453 on: May 24, 2017, 02:28:13 AM »

Event Date 04/27/2008
Event Type  Injury   
Event Description 
Reporter indicated a pt's vns was disabled due to constant voice hoarseness and difficulties swallowing which had not resolved despite programming changes. Four days after the vns was disabled, the pt developed an elevated blood pressure and had dizziness. No pathological reason for the elevated blood pressure or dizziness has been found. Attempts for further information from the attending physician have been unsuccessful to date.
 
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dennis100
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« Reply #454 on: May 27, 2017, 02:07:51 AM »

Model Number 102
Event Date 07/06/2006
Event Type  Injury   
Event Description 
A vns patient indicated that he was experiencing dizzy spells which prompted him to visit the emergency room. In the emergency room, an ekg was performed and the results indicated a normal sinus rhythm without stimulation and sinus arrhythmia with occasional premature ventricular complexes during stimulation. It was also indicated that the patient may have possible left atrial enlargement. The patient's device was subsequently disabled with his magnet reportedly causing him to slip "back into depression again. " the patient did indicate that he has a pre-existing history of bradycardia and that he wears a pulse oximeter monitor to alert him when "it hits 39. " follow-up with the patient's cardiac surgeon, who had performed a cardiac exam a month after the patient's initial report, revealed that the patient showed no evidence of arrhythmia or heart enlargement. The patient indicated that he received surgical consult from another cardiac surgeon who reportedly did not diagnose him with any "major" heart condition. Later the patient indicated that he had failed a stress test and that his condition has "gotten to be severe bradycardia". The patient is now seeking surgical consult for the implant of a pacemaker. Good faith attempts for additional information have been unsuccessful to date.
 
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dennis100
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« Reply #455 on: June 09, 2017, 07:51:26 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type Injury
Event Description
It was reported that the patient was informed by her cardiologist that she did not need vns, so she stopped seeing her neurologist to manage her device. The patient's device reportedly depleted around (b)(6) 2016, and the patient had an increase in seizures. The patient went back to her neurologist and was referred for generator replacement surgery, as the neurologist believed that the vns was necessary. A battery life calculation did not support that the patient's device would have been depleted at that time. Attempts for further information were unsuccessful to date. A blc was performed, which resulted in 3. 8 years until neos=yes. The last known settings were from (b)(6) 2012: 1. 75ma/20hz/250us/30sec/3min.

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dennis100
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« Reply #456 on: June 09, 2017, 07:52:15 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type Injury
Event Description
It was reported by the cardiac physician's assistant that they wanted someone to interrogate and possibly disable the patient's generator to see if it was affecting the patient's heart rate. The pa indicated that the patient was bradycardic, typically with a heart rate in the 40s, but it had dropped down to the 30s with a junctional rhythm. The patient had been bradycardic for the past several months but it had worsened and she had presented at the er with dizziness and lightheadedness. The patient had a history of coronary heart disease and had a heart attack less than a year prior. The patient was described as having a complicated medical history. No further relevant information has been received to date.

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dennis100
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« Reply #457 on: June 10, 2017, 02:00:55 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 06/19/2014
Event Type Death
Manufacturer Narrative

Event Description
It was reported that a patient passed away. The patient's neurologist reported that the patient's death was not believed to be related to vns as the physician believed the patient had a heart condition. The physician did not know of the patient's cause of death as he recently learned of the patient's death. The patient was last seen 3 months prior to his death and was not having any problems with the vns device when he was last in the physician's office. No settings or diagnostics were available from the last time the patient was seen. The patient's death certificate did not indicate a cause of death, but indicated that the patient died at his place of residence. An autopsy was performed, but results of the autopsy have not been received to date. The patient's death is classified as probable sudep. No additional relevant information has been provided to date.

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dennis100
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« Reply #458 on: June 10, 2017, 02:01:56 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/29/2017
Event Type Injury
Event Description
It was reported by that patient underwent a cardioversion procedure. Following the procedure the patient¿s generator pocket appeared infected and the skin around the generator was breaking down which caused the generator to extrude. The physician was concerned that the cardioversion procedure could have contributed to the generator extrusion. The patient was referred for surgery due to the generator extruding from the body. The patient's generator was explanted and no replacement occurred at that time. A manufacturing review was performed which showed the generator and lead were sterilized prior to distribution. No additional relevant information has been received to date.

Manufacturer Narrative
Device evaluation is not necessary because the reported event have been determined as not related to vns therapy, but rather to the presence of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6552915
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dennis100
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« Reply #459 on: July 06, 2017, 02:20:37 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing dizziness, headache, and decreased blood pressure with stimulation. The device was disabled which resolved the events. Per physician, the events are believed to be related to the vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947554
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dennis100
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« Reply #460 on: July 07, 2017, 11:30:36 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 08/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The physician reported that the patient had experienced respiratory arrest and had undergone cardiac massage. During this procedure, it is suspected that the generator had migrated and was no longer in the pocket. The patient has reported about not feeling the stimulation and increasing depression since the chest procedure. However, the physician clarified that the patient reports feeling stimulation every once in a while, but not as much as before. Based on good diagnostic test results, it was explained to the physician that the device is functioning as intended and that the patient could have become acclimatized to the sensation at the current settings. It was recommended that the output current could be increased to the next level. No additional relevant information has been received to date.

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dennis100
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« Reply #461 on: July 13, 2017, 03:59:16 AM »

Model Number 102
Event Date 04/04/2011
Event Type  Injury   
Event Description
It was reported by a vns pt that after she allergic reaction to antibiotics prescribed by neurosurgeon, captured in mdr# 1644487-2011-00975, she was told by hospital physician that she has an abnormal ekg. She was referred to cardiologist but the name of cardiologist was not provided. Good faith attempts to obtain additional information from pt's neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082987
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dennis100
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« Reply #462 on: July 15, 2017, 01:51:00 AM »

Model Number 102
Event Date 03/09/2012
Event Type  Injury   
Event Description
It was reported on (b)(6) 2012 that the vns patient was going to be implanted with a cardiac recorder device. Additionally it was reported that the patient is pre-syncopal likely due to atrial fibrillation. Attempts to obtain additional information have been unsuccessful to date. At this time it is unknown what is the relation of the arrhythmia to vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2512933
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dennis100
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« Reply #463 on: July 15, 2017, 01:51:41 AM »

Model Number 102R
Event Date 09/01/2013
Event Type  Injury   
Event Description
The vns patient inquired whether or not vns therapy could cause an irregular heartbeat after receiving therapy for a while. The patient was informed that verification would be needed by a cardiologist. The patient reported that he was given a stress test and that the cardiologist informed him that he has an irregular heartbeat and that he needed to follow-up with his neurologist regarding this issue. The relationship of the irregular heartbeat to vns is unknown. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3576871
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dennis100
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« Reply #464 on: August 02, 2017, 12:51:16 AM »

Model Number 103
Event Date 06/22/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt reported a "tickle" in her ear with stimulation. Pt underwent cardiac pacemaker implantation and post operatively her neck pain became severe. Consequently, pt's generator settings were lowered from 1. 25ma to 0. 75ma and pt's neck pain was resolved. The physician believed that he may have titrated the pt generator settings too fast.
 
Event Description
Additional information was received on (b)(6) 2011 when it was discovered that the patient's cardiac events were not related to vns. On (b)(6) 2011, the physician reported that the patient has not complained of any neck pain or ear tickle and that they are improved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2190432
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dennis100
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« Reply #465 on: August 04, 2017, 08:46:08 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was having chest pains. It was unclear if the pain was due to the vns. The patient was taken in an ambulance and abnormal ecg was observed. The patient had no past abnormal ecgs. It was recommended to the patient to contact her neurologist to run diagnostics. Follow up with the physician's office revealed that the patient had contact the office. It was reported that they were aware of the event, but did not have information. No additional relevant information has been received to date.

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dennis100
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« Reply #466 on: August 04, 2017, 08:46:44 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/09/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that when a vns patient¿s device is on it had an effect of av node block. Systems diagnostics were reported to be fine. The physician lowered the stimulation on time in the hope of resolving it. The physician then turned the device off and that resolved the symptoms. When the device was turned back on the problem returned. A holter monitor was used and seems to confirm that when vns is on there's a cardiac response. The device was left off to see what happens. Additional relevant information has not been received to-date.

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dennis100
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« Reply #467 on: August 08, 2017, 02:27:42 AM »

Model Number 102
Event Date 07/14/2011
Event Type  Malfunction   
Event Description
Additional information was received indicating that the patient never followed up with the neurosurgeon's office to have his device evaluated and has not been seen by the neurosurgeon since (b)(6) 2010. Follow up with the neurologist was attempted and it was indicated that the neurologist did not feel that the bradycardia was related to vns; however he had no other information on the patient's condition. He also indicated that diagnostics were not performed on the patient's device in over a year. No other information was provided. Attempts for additional information have been unsuccessful to date.
 
Event Description
It was reported by a neurosurgeon that a vns pt wanted his device checked since he was not sure if it was functioning correctly. Also, the pt was getting a pacemaker implant due to bradycardia and wanted the surgeon to evaluate/move the device to accommodate for the pacemaker. Pt has been hospitalized several times over the last few months due to cardiac issues per cardiologist. The pt's cardiologist stated that he was not sure if pt's bradycardia was related to vns or to medication response he received during intubation. Pt will likely have a pacemaker implant.
 
Event Description
Additional information was received from a nurse with the patient's treating cardiologist. It was indicated that the patient was never implanted with a pacemaker, and after evaluation, did not require one. The nurse was unable to say why they were initially considering implanting the patient with a pacemaker, however she indicated that the patient recently underwent a cardiac stress test that came back with normal results. No other information was provided.

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dennis100
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« Reply #468 on: August 21, 2017, 04:56:42 AM »

Model Number 103
Event Date 10/28/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the patient reported that she is having bradycardia episodes when her vns goes off. The patient stated that she has an appointment with her cardiologist that day. She states she has a pacemaker, but in the conversation she says that her heart rate goes down to 20 beats per minute and she starts to feel worse. According to the patient she experience dizziness, nausea and ringing in her ears when her heart rate gets so low.
 
Event Description
On (b)(6) 2011, a vns patient reported that she had a seizure on (b)(6) 2011 and fell on her face and broke her nose. She stated that her vns settings had been increased on (b)(6) 2011. While in the hospital having surgery on her nose, the patient was hooked up to the heart monitor. It was discovered that every five minutes when the vns device stimulated, the heart monitor would alarm and her heart would skip two beats. The patient reported that she is also experiencing some shortness of breath. The patient was scheduled to see her neurologist on (b)(6) 2011. The neurologist later reported that the patient's arrhythmia (heart skipping 2 beats) was first noticed on (b)(6) 2011 and was related to the vns stimulation. The neurologist decreased the patient's settings as the arrhythmia event appeared to have occurred after the programmed settings were increased and a holter monitor was used. The patient does not have a medical history of arrhythmia prior to this event. The neurologist reported that it is unknown if the arrhythmia event has recurred, they are in the process of evaluating this. Good faith attempts were made to the patient's implanting hospital for the lead product information but no further information has been received to date. On (b)(6) 2011, the vns patient reported that she is experiencing a slow heart rate as well as the heart rate skipping with stimulation. The patient reported that after the neurologist increased her settings on (b)(6) 2011, she also experienced coughing and painful stimulation. After 10-14 days the events stopped and the patient said she could tolerate settings. The patient stated that after her seizure on (b)(6) 2011, she had another one on (b)(6) 2011. She stated that she saw a physician on (b)(6) 2011 and was referred to an ear nose and throat surgeon on (b)(6) 2011 to operate and repair her nose. On (b)(6) 2011, she had the surgery and during pre-op, she was hooked up to the heart monitor which revealed a slow heart rate and that every five minutes , her heart skipped two beats. The ear nose and throat surgeon informed her to go back to the neurologist to have the settings decreased. The patient's settings were decreased but the patient's heart was still skipping and at half rate according to the holter monitor. The patient was referred to a cardiologist and stated she is going to have a pacemaker implanted. The patient also reported that prior to vns, she did not have any pre-existing heart conditions. The patient further divulged that she has been now diagnosed with a/v stage 2 heart disease and claimed that her heart is only beating 24 beats/minute. On (b)(6) 2011, the patient had a pacemaker implanted. Prior to surgery the patient's output was decreased to 1. 75ma and the patient's heart rate was in the 50's bpm, at 1. 5ma the patient's heart rate was in the 60 bpm (so within normal limits), then at 2. 25ma, the patient's heart rate was in the 40's bpm, and lastly at 2. 5ma, the patient's heart rate showed 40 bpm. The patient's device was then turned off and the patient did not experience bradycardia. The surgeon implanted the pacemaker with the vns disabled through the entire procedure and the patient did not experience bradycardia. After the pacemaker was implanted, the vns was programmed back on. The patient was set to varying settings and the pacemaker was observed to be pacing indicating a decrease in the patient's heart rate. The pacemaker was able to keep the patient's heart rate within normal limits when the vns stimulated. With the patient turned to an output of 2. 0ma, the patient's heart rate was in the mid 60's-68bpm. System diagnostics were performed which showed output=ok/lead impedance=ok/impedance=2834ohms/ifi=no. The patient was programmed to output=2ma/frequency=20hz/pulse width=130usec/on time=21sec/off time=5min/magnet output=2. 25ma/frequency=60hz/pulse width=130usec. The patient wants her device at a higher output current because this is where she reaches efficacy.
 
Event Description
On (b)(6) 2014 it was discovered that this event was reported in a duplicate report; on mfr. Report # 1644487-2014-01642.
 
Event Description
Additional information was received on november 29, 2011 when the patient provided further information that her heart missed two beats every 5 minutes. The patient said that since she has had the pacemaker implanted everything is fine. The patient said that vns has been great for her and she still wants it implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2347665
« Last Edit: August 21, 2017, 06:17:26 AM by dennis100 » Logged
dennis100
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« Reply #469 on: August 22, 2017, 05:47:34 AM »

Model Number 102
Event Date 01/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

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« Reply #470 on: August 30, 2017, 01:39:32 AM »

Event Date 11/10/2011
Event Type  Injury   
Event Description
An op note from the date of initial implant was received. Product information was not provided, however the note did indicate that the patient had a heart condition prior to vns, including a previous mitral valve replacement.
 
Event Description
It was initially reported that following a mitral valve replacement procedure, the patient was unable to feel his vns stimulation. It was then reported that the patient was experiencing an increase in seizures. The patient was then referred for a generator replacement, which was to be performed during an implant procedure for a pacemaker. The revision surgery took place on (b)(6) 2011, and the generator was replaced due to "battery depletion" with "ok" lead impedance. Information regarding the reason for the pacemaker implant, as well as information on the patient's increase in seizures is currently unknown. Attempts for additional information and product return are underway.
 
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2365121

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« Reply #471 on: August 31, 2017, 02:34:51 AM »

Model Number 102
Event Date 11/06/2011
Event Type  Injury   
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.
 
Event Description
It was initially reported that the patient was being implanted with a pacemaker by another company representative. The other's company representative did not know if the reason the patient was being implanted with a pacemaker was related to vns, but did provided the treating cardiologist name. Follow-up with the cardiologist that the other's company representative provided had no record of the patient seeing or planning on seeing anyone in their practice. It is still unknown if the reason for the patient was being implanted with a pacemaker is related to vns. (b)(4) attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2356182

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« Reply #472 on: September 20, 2017, 01:44:05 AM »

Model Number 101
Event Date 02/05/2012
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient passed away. At the time, the reporter did not know the cause of death or when the patient passed. She did not comment on the relationship between the patient's death and vns. A search of the social security index revealed that the date of death was (b)(6) 2012. Attempts for additional information have been unsuccessful to date.
 
Event Description
The physician indicated (b)(6) 2012, that the cause of death was unknown; however, it was not believed to be related to vns. The physician stated that the patient had a history of cad (coronary artery disease) and cabg (coronary artery bypass graft). Attempts have been made for a copy of the patient's death certificate, and have been unsuccessful to date. The patient's device will not be returned for product analysis as the director of the patient's funeral home stated that the patient had been cremated and the device was disposed of.
 
Event Description
The death certificate was received on (b)(6) 2012. The cause of death was not provided on the death certificate however it did state that the manner of death was natural. Additionally the patient passed away in hospice.
 
Event Description
A sudep evaluation was also performed and indicated that the patient's death was likely not sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662335

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« Reply #473 on: September 22, 2017, 01:29:26 AM »

Model Number 102
Event Date 01/18/2013
Event Type  Injury   
Event Description
It was initially reported that a patient had and ekg done which demonstrated concerns for atrial fibrillation. There was no relationship to vns provided. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156370
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dennis100
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« Reply #474 on: October 01, 2017, 12:43:28 AM »

Model Number 101
Event Date 01/05/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported through clinic notes received on (b)(6) 2012, that the patient had an ekg performed on (b)(6) 2011, which revealed sinus bradycardia, with a rate of 57. The notes also suggest that the patient has a pacemaker. It is unknown at this time if the bradycardia is related to vns, however it was documented that the patient also has a history of coronary artery disease.
 
Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856566
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dennis100
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« Reply #475 on: October 04, 2017, 01:19:59 AM »

Model Number 102
Event Date 01/25/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.
 
Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

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dennis100
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« Reply #476 on: October 04, 2017, 01:21:54 AM »

Model Number 102
Event Date 11/20/2011
Event Type  Death   
Event Description
Additional information was received on (b)(6) 2013 when the patient's death certificate was received. The patient passed away on (b)(6) 2011 and the immediate cause of death was noted to be cardiopulmonary arrest, congestive heart failure, atrial fibrillation, and aortic stenosis. The approximate interval between the onset of these events and death was minutes for the cardiopulmonary arrest and years for the congestive heart failure, atrial fibrillation, and aortic stenosis. An autopsy was not performed and the manner of death was stated to be "natural". Good faith attempts for further information from the physician have been unsuccessful.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 when the physician reported that there is no relationship between the cardiopulmonary arrest, atrial fibrillation, and congestive heart failure to vns. The events did not occur with stimulation. No causal or contributory programming or medication changes preceded the onset of these events. The physician stated that he believes the patient had a pre-vns medical history of atrial fibrillation and congestive heart failure. The patient had a previous risk factor of "l/v smoking and hypertension" which may have predisposed the patient to myocardial infarctions according to the physician.
 
Event Description
Additional information is received on (b)(4) 2013 when the physician reported that it is unknown when the patient passed away and the relationship of the patient's death to vns. A copy of the patient's death certificate was requested from the department of vital records in the state the patient passed away in but it has not been received to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient has passed away on (b)(6) 2011. Additional information has been requested from the patient's physician but no further information has been received to date. Based on the information received to date, the patient's death is possibly sudep at this time.

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dennis100
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« Reply #477 on: October 05, 2017, 12:56:33 AM »

Event Date 01/20/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the vns patient was in the icu due to being shot that day. The physician indicated that they have been unable to get the patient's blood pressure down from (b)(6) despite various medications and was questioning whether it could be due to the vns. She confirmed that the patient was not shot in the left chest, so the device was likely intact. The physician was asked for the patient's information, but she didn't have it since the details were in the er at the time. Good faith attempts for further information from the physician, including the identity of the patient, were unsuccessful.

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dennis100
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« Reply #478 on: October 06, 2017, 10:23:36 AM »

Model Number 105
Device Problem No Known Device Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the patient that she has passed out several times and was found to have an arrhythmia. The patient is getting a holter monitor and having a cardiac workup due to these issues. Information was received that the patient had reported fainting prior to getting the vns device however the relation of the vns device to these issues is unknown at this time. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6860725
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dennis100
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« Reply #479 on: October 06, 2017, 10:24:21 AM »

Model Number 303-20
Device Problem No Known Device Problem
Event Date 08/09/2017
Event Type  Injury   
Event Description
Report was received that a patient started experiencing arrhythmia while under anesthesia. The patient was receiving a full revision surgery. After the new generator and lead were implanted, system diagnostics were run and showed high impedance (reported in mfr. Report #1644487-2017-04401). A second lead was tried but the surgeon had difficulty wrapping the electrodes around the nerve. The surgeon reported this was related to the vagus nerve being too big for the 2 mm lead used. This led to extended time under anesthesia. Due to this duration of surgery and the manipulation of the vagus nerve, the patient experienced arrhythmia. The anesthesiologist reportedly recommended that the surgery be terminated as a result. The generator was reportedly left implanted without any lead attached. Further information was received that the arrhythmia was not occurring with stimulation as it appeared about an hour after the last system diagnostic had been performed. It was also reported that the arrhythmia was benign. The lead passed all quality inspections prior to release for distribution. Device evaluation is not necessary due to the arrhythmia not being related to delivery of therapy. No further information has been received to date.
 
Manufacturer Narrative
Device evaluation not necessary due to the event not being related to delivery of therapy at all.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6844458

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