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dennis100
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« Reply #390 on: February 10, 2019, 03:56:47 AM »

Model Number 102
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported through clinic notes dated (b)(6) 2014 that the vns device has moved and is causing the patient pain. It was noted that this happened when her sister did chest compressions after a seizure. The generator is now down into the left breast tissue. Diagnostics showed the device was fine, with eos=yes. The patient had not had an increase in seizures and the physician felt that the patient having chest compressions was unnecessary and inappropriate and did cause the device migration. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4383816
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dennis100
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« Reply #391 on: February 10, 2019, 03:58:05 AM »

Model Number 102
Event Date 10/06/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient believed something was wrong with her lead during an office visit on (b)(6) 2014. The patient was experiencing neck pain, so the physician subsequently lowered the patient¿s device settings. During an office visit on (b)(6) 2014, the patient¿s device was tested and diagnostic results showed normal device function. The patient had a seizure in the office in which she was unresponsive and leaning her head back and forth with her eyes closed. No shaking or rhythmic movement was noted. The magnet was used and the seizure lasted approximately three minutes. The patient opened her eyes but was unresponsive for several minutes. The patient was unaware of the seizure. Since her last office visit on (b)(6) 2014, the patient had eight gtc seizures and had been to the er twice. The physician was questioning the battery status of the patient¿s device. A battery life calculation using the available programming history showed approximately three years remaining until neos = yes. The patient underwent generator replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s increase in seizures was due to the decrease in device settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377886
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dennis100
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« Reply #392 on: February 10, 2019, 03:59:30 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 12/03/2014
Event Type  Injury   
Event Description
Additional information was received that the patient was referred for vns device explant due to chronic pain since implant, which was not resolved even though the device was disabled. The patient underwent a generator and lead explant surgery on (b)(6) 2015. The explanted devices were received by the manufacturer for analysis. However, analysis has not been completed to date. Additional information was received that the patient's diagnostic results have been within normal limits. Furthermore, the explant surgery was taken for patient comfort, not to preclude a serious injury.
 
Manufacturer Narrative

Event Description
Analysis of the explanted generator and lead was completed. Analysis of the generator showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the return lead was completed as well. Note that a large portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Furthermore, additional information was received that the patient's vocal cord paralysis has resolved since first being reported.
 
Event Description
It was reported on that the vns patient had left vocal cord paralysis following implant surgery on (b)(6) 2014 which required the patient to go to the emergency room. The patient did not have a prior history of vocal cord paralysis. Follow up with the patient's treating physician indicated that the believed cause for the left vocal cord paralysis was surgical trauma. The patient was referred to an ent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392406
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dennis100
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« Reply #393 on: February 11, 2019, 02:28:26 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient reported that her vns vibrated every 3 minutes, and afterwards she then would experience pain and swelling in her throat. The patient requested the device be explanted. No additional relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187534
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dennis100
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« Reply #394 on: February 12, 2019, 03:28:03 AM »

Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2014
Event Type  Injury   
Event Description
It was reported that the vns patient felt her generator moving and flipping in her chest which was causing burning sensations. The patient¿s device was tested and showed normal device function. The patient previously reported that her magnet was not aborting her seizures and that magnet mode stimulation was causing burning sensations in the chest. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was found from the surgeon's office who had originally implanted the generator in 2012 that the generator was secured with a non-absorbable silk suture during implantation.
 
Event Description
The patient's generator was explanted and replaced on (b)(6) 2015. The patient's device was discarded after explant and will therefore not be received for analysis.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent surgery to remove the generator from the chest pocket, and place it in the left shoulder. The patient experienced more discomfort following the repositioning of the generator. Additional surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535345
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dennis100
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« Reply #395 on: February 12, 2019, 03:29:41 AM »

Event Date 01/26/2015
Event Type  Malfunction   
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.
 
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532847
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dennis100
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« Reply #396 on: February 13, 2019, 03:07:06 AM »

Model Number 103
Event Date 12/01/2010
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient was referred for surgery to explant her device due to pain that began in (b)(6) 2010. No known surgical interventions have occurred to date. The device was disabled in (b)(6) 2011 due to pain and the patient¿s preference. Review of the available programming and diagnostic history showed normal diagnostic results the date the device was disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4524641
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dennis100
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« Reply #397 on: February 14, 2019, 02:25:36 AM »

Model Number 304-30
Event Date 11/23/2014
Event Type  Malfunction   
Event Description
Additional information was received that the patient is still experiencing ¿pulling¿ sensation and discomfort in his left neck area. The device is currently off.
 
Event Description
It was reported that, for the past 1. 5 months, the patient has had random episodes of sudden discomfort from the generator site up to the left side of his neck that is progressively worsening and occurs 5 times per day. The nurse practitioner has adjusted vns but the discomfort doesn't seem to reduce and might not be associated with the stimulation. The patient experiences discomfort when he is lying still, sitting, or standing, doesn't seem to have any trigger. Patient was contacted several times to visit the clinic to adjust vns or disable vns if needed. But patient has not been able to visit due to transportation issues. Patient was last seen in (b)(6) 2014 and patient was set to comfortable settings at that time. No issues were reported with the device during this visit. Patient has been provided with medications for the pain meanwhile. X-rays were received with a note stating that the patient has been complaining of severe neck pain that radiates into his left clavicle. The pain was reported to be independent of vns activation and he does have pain when he turns his head. Per the nurse practitioner, there is a possible mircrofracture of the lead and the vns was disabled. The patient¿s next appointment is on (b)(6) 2015. The x-rays were reviewed and there did not appear to be any lead discontinuities in the portion of the lead that could be visualized. It was noted that the strain relief bend did not appear to be present. The lack of strain relief bend could possibly be a factor in the patient¿s pain. However no conclusions can be drawn regarding the exact cause of the pain. Attempts made for the diagnostic test results were unsuccessful to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
Additional information was received that the patient's device diagnostics were checked on (b)(6) 2015 and that the results were within normal limits. It was also reported that the patient's pain was slightly better.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4639353
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dennis100
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« Reply #398 on: February 14, 2019, 02:26:16 AM »

Model Number 102
Event Date 01/07/2015
Event Type  Injury   
Event Description
It was reported from the physician's office that the patient hasn't actually been seen since 2013. The nurse indicated that the reason for replacement is not actually known since the patient has not been seen and the mention of throat pain and shortness of breath was a serious issue. She had no more information to provide about the adverse events mention since these occurred a couple of years ago she is no longer their patient. She did not know the patient's current physician. This was all the information provided.
 
Event Description
It was reported that the vns patient underwent surgery to explant her device due to lack of efficacy. Follow-up indicated that the reason for surgery was throat pain and dyspnea. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4515632
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dennis100
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« Reply #399 on: February 15, 2019, 04:01:52 AM »

Event Date 01/01/2011
Event Type  Injury   
Event Description
An anonymous vns patient reported that she had lost her voice for the past four years and was having worsening seizures and uncontrollable pain. The relationship of the patient¿s events to vns is unknown.
 
Manufacturer Narrative

Manufacturer Narrative
Date of this report; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. This report is being submitted to correct this date. Date received by manufacturer; corrected data: the previously submitted manufacturer report inadvertently provided an incorrect date for this field. The reported date should have been 02/25/2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4623367
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dennis100
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« Reply #400 on: February 15, 2019, 04:02:45 AM »

Model Number 103
Event Date 09/01/2012
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient had been experiencing 3-4 episodes of severe shortness of breath within the last 6 months. These events lasted approximately 30 seconds and she had great difficulty getting a full breath. She cannot reproduce these events and is unsure of any pattern or triggers that could possibly be causing these events. The patient also had a complaint of throat pain in (b)(6) 2012. At that time her settings were lowered. The patient's settings prior to the (b)(6) 2012 complaint of throat pain were output=1. 5ma/pulse width=250usec/frequency=20hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. After the (b)(6) 2012 visit, the patient's settings were changed to the following to alleviate the throat pain: output=1. 5ma/frequency=15hz/pulse width=130usec/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=130usec. The patient was interrogated during the (b)(6) 2013 visit, then a system diagnostics test was performed, and then upon second interrogation, the device showed an error message stating "programmed current is possibly not being delivered at the specified level (possibly limited by battery voltage, lead impedance, or other reason). Reprogram the pulse generator to a lower output current and a wider pulse width. " there was no impedance issues, output current errors, or elevate impedance values when running the diagnostics. The patient was re-programmed to a wider pulse width, from 130 usec to 250 usec, per the instructions of the error message (both normal output and magnet output) and the error seemed to resolve itself. No changes were made to the output current or the rest of the patient's settings. Diagnostics were performed again and all results were within normal limits. A final interrogation was performed without an issue. The patient left the clinical visit at settings of output=1. 5ma/pulse width=250usec/frequency=15hz/on time=30sec/off time=1. 1min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The manufacturing records for the generator were reviewed and the device met all specifications prior to distribution. It was later clarified that the issue has resolved itself. Also, the patient's shortness of breath only happened 3-4 times over a 3-4 month span. It was unclear if the patient's pain and shortness of breath coincided with stimulation and if they had resolved. It was stated that x-rays were taken and would be sent to the manufacturer for review but they have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3079679
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dennis100
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« Reply #401 on: February 16, 2019, 03:07:02 AM »

Model Number 302-30
Event Date 07/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Clinic note dated (b)(6) 2015 note that the patient was undergoing surgery due neck pain at the left side of the neck. Surgical notes indicate that the surgery was unremarkable. It was reported that the patient did not have another vns system placed because the patient was "epilepsy free". The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Clinic notes were received dated (b)(6) 2015 that indicated that a patient implanted with a vns device has been experiencing pain at one of their lead "anchor" sites since he was last seen in (b)(6) 2014. The pain has persisted, the patient takes advil but is still able to complete daily activities. The patient was referred for surgery for "removal of the anchor. " additional information was received that reported they were having their vns removed although unclear if whole device or just the anchor. Their pain is reported to be located in their neck and caused by a disconnected lead. It is unknown whether their was any trauma that caused the event.
 
Event Description
Analysis of the returned generator and lead was completed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. There were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4588059
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« Reply #402 on: February 16, 2019, 03:07:56 AM »

Model Number 102
Event Date 02/18/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2015 the patient¿s generator was explanted. It was reported that the removal was ¿painful¿ but this may be suspected to be just a difficult removal although it is unclear. No other details were provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4613666
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dennis100
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« Reply #403 on: February 16, 2019, 03:08:55 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
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dennis100
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« Reply #404 on: February 17, 2019, 06:26:57 AM »

Model Number 302-30
Event Date 01/01/2015
Event Type  Injury   
Event Description
Analysis of the generator was completed on 03/05/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Manufacturer Narrative

Event Description
Initially it was reported that the patient was scheduled for generator and lead replacement for an unknown reason. It was reported that the generator was replaced due to end of service and that it was believed that the patient experienced an increase in seizures, but the pre-vns baseline frequency is unknown. The patient requested to have the lead replaced due to the lead having become more prominent over the last year and pain in the neck when turning head in different directions for 2 weeks prior to surgery. The reason for the protrusion is unknown. Device diagnostics were within normal limits. It was reported that the lead was replaced to preclude a serious injury and for patient comfort. The pain and protrusion resolved following generator and lead replacement surgery. The explanted lead was discarded during surgery. The explanted generator was returned for analysis on 02/10/2015. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570551
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dennis100
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« Reply #405 on: February 17, 2019, 06:28:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
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