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dennis100
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« Reply #30 on: February 11, 2016, 02:28:29 AM »

Model Number 102
Event Date 09/01/2011
Event Type Injury
Event Description
On (b)(6), 2012 clinic notes were received through case management. Review of the clinic notes dated (b)(6), 2012 revealed that the vns patient has been experiencing daily partial seizures. The vns generator battery was reported to be depleted. The patient was referred for replacement. The patient stated that she has never been able to feel the vns activate but remembered that her previous neurologist told her last year that it was almost time for her to have a generator replacement. The clinic notes also state that the patient has been having some hives on her elbows and knees since (b)(6) 2011 and that in (b)(6) 2012. Her face became swollen and she had to go to the emergency room. She took steroids and it got better but periodically she has eye swelling and hives all over, the patient worried that her medication lamictal may be the cause. The physician later reported that the patient was only seen by him on (b)(6), 2012 but the patient reported increased seizures for the last 6 months. He did not have any diagnostic results as they only saw the patient once. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increased seizures. He said they interrogated her vns at this appointment and saw that the battery was dead. A battery life calculation was performed with the programming history available which showed a remaining time of negative years until the elective replacement indicator showed yes. Although surgery is likely, it has not yet occurred.

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. In the product analysis 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. The battery was confirmed to be depleted at eri (elective replacement indicator)=yes in the product analysis laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications and there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2493133
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dennis100
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« Reply #31 on: February 15, 2016, 03:48:48 AM »

Model Number 102
Event Date 08/29/2011
Event Type Injury
Manufacturer Narrative
Date of birth, corrected data: the initial report inadvertently reported the date incorrectly. Date received by manufacturer, corrected data: the supplemental report #7 inadvertently reported the date incorrectly. It should have reported the date as 10/24/2014.

Event Description
It was reported that a vns pt had swelling in his arms and legs around the time of vns implant on (b)(6) 2011 through (b)(6) 2011. The pt went to the er in (b)(6) 2011, and the physicians found that he had a blood clot in his arm and one in his leg. He was hospitalized at that time. During this hospitalization, the pt was diagnosed with one of his heart valves not opening. The pt indicated that he thinks these events are all related to vns. The pt has reportedly not had his vns checked in a while and probably will not until the blood clots and heart valve problem resolve. Attempts for add'l info from the physician have been unsuccessful to date.

Event Description
Additional information was received from the surgeon who reported that the patient's reported additional health problems are not related to vns. The patient has been referred to a vascular specialist, but the patient has not followed up.

Event Description
The patient reported that the patient wants to the vns device explanted because it caused him to have blood clots. The patient indicated that he has had the device disabled 'for a period of time. ' the patient is reportedly now on coumadin, and continues to report that his health has declined with vns. He plans on reducing coumadin in anticipation of vns explant. Attempts for additional information on the device disablement have been unsuccessful to date.

Event Description
It was reported that the patient had the generator and lead explanted on (b)(6) 2014. The explanted products have not been received by the manufacturer to date.

Event Description
Additional information was received from the epileptologist's office which revealed that they are unable to provide an assessment regarding the relationship of the patient's heart conditions to vns. It was noted that the patient's vns system has been working properly and no changes have been made to the patient's medication or the vns settings. They are unaware if any interventions have been planned or if the patient had a medical history of blood clots or heart problems. The surgeon's office reported that the patient's blood clots, swelling and heart valve problems are not related to vns. The patient has been referred to a vascular specialist regarding these events. No causal or contributory medication changes precede the onset of these events, and the patient does not have a medical history of these events. Patient manipulation or trauma may have occurred to have caused/contributed to the swelling. No additional information was provided by the surgeon. The patient further reported that he has seven blood clots, and has swelling in his legs and left arm, which he didn't have before vns. The patient says that with vns, he is having more health problems than what he wants. Attempts for additional information from the surgeon have been unsuccessful to date.

Manufacturer Narrative
The supplemental report #1 inadvertently did not include that the patient now reportedly has seven blood clots.

Event Description
It was reported that the patient has seven blood clots and has swelling in the legs and left arm, and the patient did not have these blood clots and swelling prior to vns. Attempts for additional information from the surgeon's office have been unsuccessful to date.

Event Description
It was reported by the explant hospital that the explanted products were discarded.

Event Description
Information was received from the neurologist¿s office that in clinic notes dated (b)(6) 2012, it was documented that the device was off. The nurse was unable to find when it was first turned off. An additional attempt for information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465251
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dennis100
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« Reply #32 on: February 16, 2016, 03:04:56 AM »

Model Number 304-20
Event Date 11/02/2011
Event Type Injury
Event Description
It was reported that a patient had numbness on her left and right shoulders, arms, and hands. The patient also reported pain in the same area as well as pain in her neck. Per the patient, she never had these problems prior to being implanted with vns. It was believed that the patient may have some nerve damage or a compressed nerve. It was noted that during initial implant surgery, there was excess blood in the chest due to the tunneling process however no main artery or view as affected. Additionally, x-rays were taken by the surgeon during the implant procedure and everything appeared okay. The patient was initially fine after surgery as during follow up appointments a few days after implant, the patient was okay and everything was said to be normal. Good faith attempts to obtain additional information have been unsuccessful to date.

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. This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, cyberonics, or cyberonics; employees caused or contributed to the event described in the report. In particular, this report does not constitute an admission by anyone that the product described in this report has any defects or malfunctions. These words are incorporated into the fda 3500a medwatch form by the fda, and cyberonics objects to their use.

Event Description
Additional information was received on (b)(4) 2012, when it was reported that the patient is still experiencing the numbness in her left and right arms. The settings were 0. 75/20/250/30/3. Diagnostic results were said to be within normal limits however the specific test results were not provided. The patient was also having difficulty breathing. The plan was to program the patient's device off. Follow up with the physician revealed that the pain (shoulder, arms, hands) was related to vns (stimulation). The patient does have a medical history of shoulder/arm/hand pain prior to being implanted with vns. Systems diagnostics gave acceptable results however the specific test results were not provided. The device was programmed off to prevent a serious injury. The device was programmed off on (b)(6) 2012 and the patient wants the device removed however surgery is not scheduled at this point to his knowledge. He did not have any additional information to provide other than the patient is having anxiety and panic attacks because of the issues with her vns. He could not elaborate further or either of those events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435388
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dennis100
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« Reply #33 on: March 01, 2016, 05:02:24 AM »

Model Number 102
Event Date 08/22/2011
Event Type Injury
Event Description
Attempts for additional information regarding the patient's reported pain and migration have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was initially reported that the patient was complaining of pain and twitching in his arm, occurring with stimulation. Additional information was received indicating that the patient was experiencing electrical stimulations in the chest area. Diagnostics were performed and reported to be within normal limits, however no specifics were provided. X-rays were also performed but it is unclear if they will be sent to the manufacturer for review. The patient's device was not disabled, as the patient's neurologist felt that the vns was successfully controlling the patient's seizures. The patient was however referred to a surgeon for possible full revision. Surgery took place on (b)(6) 2011. During the procedure, the lead wire was found to be intact; however the generator was loose in the chest. The old generator was removed and a new generator was securely implanted. The explanted generator has not yet been returned to the manufacturer for analysis. On (b)(6) 2011, it was reported by the patient's surgeon's office that the patient has developed an infection at his generator site, following the replacement surgery. This will be reported under mdr number: 1644487-2011-02286.

Event Description
Additional information was received on (b)(6) 2011, indicating that the pain that the patient was experiencing was attributed to the generator movement in the chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266994
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dennis100
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« Reply #34 on: March 03, 2016, 04:12:30 AM »

Model Number 103
Event Date 07/12/2006
Event Type No Answer Provided
Event Description
On (b)(6) 2011, a vns pt reported that she was experiencing painful stimulation and that it feels as though her breast is being "shocked". She said that she has had painful stimulation since the original implant on (b)(6) 2006. She had a battery replacement on (b)(6) 2011 and she is still experiencing the painful stimulation. The pt reported that the pain used to radiate down her arm but it is not as bad now. She said that the physician ran diagnostics but did not see any problems. As far as efficacy, she reported that she has not had a seizure in four years with vns. The physician's nurse later reported that the pt is having a breast reductions surgery at this time and after that procedure they are going to look into the pt's painful stimulation. The nurse reported that they were not going to provide any further information. Good faith attempts for product information from the implanting hospital were made but no information has been received to date. If additional information is received, it will be reported.

Manufacturer Narrative
Initial mdr inadvertently listed wrong product.

Event Description
Additional information was received on (b)(6) 2011 when the implanting hospital provided the patient's generator product information. On (b)(6) 2011, the vns patient reported that a surgeon had scheduled her for breast reduction surgery on (b)(6) 2011 but that on (b)(6) 2011, the surgeon backed out of the surgery. The surgeon told the patient that he was worried that he might damage the vns device and had no assurance that insurance would replace it and could not subject the patient to seizures. The patient reported that he did not allow another colleague to review the case and stated that she should seek a university setting. The patient reported that she wants a breast reduction because there is tension on the vns device that is causing pain even after the device was moved in (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2228172
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dennis100
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« Reply #35 on: March 10, 2016, 05:07:23 AM »

Model Number 103
Event Date 01/05/2011
Event Type Injury
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that the vns pt is scheduled for a full revision surgery in (b)(6) 2011. The pt have been experiencing pain to her neck upon stimulation since her battery replacement surgery in (b)(6) 2011. The pt has about 1. 3 years left of battery life and a lead impedance value of 2278 ohms. The pt also said that she was experiencing pain in both arms since the battery replacement surgery in (b)(6) 2011. The physician reported that the pt is at high settings but that diagnostic results are within normal limits. No change in medication or settings and no trauma or manipulation to the device occurred. Clinic notes from the physician were rec'd review of clinic notes dates (b)(6) 2011 report that the pt is complaining of pain in the chest and left arm due to vns. The clinic notes also state that the pt is having more seizures and that the vns magnet is not kicking in. The clinic notes reveal that the pt was being referred to a vns implanting surgeon for a second opinion regarding the vns causing chest and left arm pain. Additional information regarding the pt's pain and seizures has been requested from the pt's physician; however, no further information has been rec'd to date. When additional information is rec'd, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133616
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dennis100
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« Reply #36 on: March 21, 2016, 12:24:11 AM »

Event Date 11/19/2010
Event Type Injury
Event Description
It was reported that the pt had her settings turned down due to pain at the electrode site in her neck, down her back and in her arm and leg. She has also experienced an increase in seizures recently and the magnet has had no effect. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938613
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dennis100
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« Reply #37 on: March 24, 2016, 07:18:27 AM »

Event Date 08/01/2010
Event Type Injury
Event Description
It was reported that the patient's generator rotates up when the patient turns her shoulder a certain way. Diagnostics are all okay and the patient feels stimulation like normal. The patient's seizures are well-controlled, but the patient would like to meet with a surgeon to possibly place the generator in a different location, under the muscle, to keep it from rotating when she moves her arm. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1843802
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dennis100
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« Reply #38 on: March 25, 2016, 02:12:00 AM »

Model Number 102
Event Date 07/30/2010
Event Type Injury
Event Description
It was reported that the pt was in the hosp and was having upper left extremity tremors. The hosp staff and family felt it was happening around pt's vns dosing cycle. Magnet was placed over chest and turned off for 8 hrs and tremors stopped. Pt's settings were decreased to conserve battery life and try to alleviate tremors. Battery replacement surgery is likely, but has not occurred to date. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822534
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dennis100
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« Reply #39 on: March 30, 2016, 07:50:59 AM »

Model Number 103
Event Date 12/16/2009
Event Type Injury
Event Description
It was reported that a patient began to feel stimulation down his arm and was feeling stimulation at different times following a motor vehicle accident in which he was a pedestrian and was struck by a car. The patient's device was set to send stimulation every 10 minutes, however, the patient reported feeling stimulation at 10 minutes, sometimes at 12 minutes, and other times at 14 minutes. The physician indicated that device diagnostics were performed and the results were within normal limits however, the exact results obtained were not provided. X-rays were taken and reviewed by the physician who stated no discontinuities were found. The patient was referred for generator revision surgery however, the erratic stimulation continued after the generator was replaced. The explanted generator has been returned to the manufacturer and device evaluation is in process. Good faith attempts to obtain additional information regarding the patient's events are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1599286
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dennis100
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« Reply #40 on: April 09, 2016, 07:01:53 AM »

Model Number 101
Event Date 01/01/2009
Event Type Injury
Event Description
It was reported that the pt requested to have his device explanted because he did not want the device anymore. The pt indicated that it "limited his arm movement. " requests for further info from the treating physician were denied. Good faith attempts to obtain additional info have been unsuccessful to date. The device has been returned to the mfr for analysis, but it has yet to be performed. It is unclear at this time what the relationship of the pt's event is to that of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1409410
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dennis100
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« Reply #41 on: April 21, 2016, 02:33:56 AM »

Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
Reported indicated that a vns patient would have his vns replaced due to pain under the arm. The pain was believed to be due to the placement of the generator and was not related to device stimulation. There is no suspected malfunction of the device. The explanted generator has been returned to the manufacturer for analysis however, device evaluation has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310979
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dennis100
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« Reply #42 on: April 21, 2016, 02:34:32 AM »

Model Number 102
Event Date 01/12/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was hospitalized due to painful stimulation in the neck, chest, and arm in addition to a choking sensation with stimulation. The vns device was disabled and the pain was still present, but the dysphagia resolved. Diagnostic tests were performed following the onset of the events, and were reported to be within normal limits. There was no report of trauma, manipulation or other believed cause prior to the onset of the event. As intervention, the physician opted to have the entire device replaced. The explanted lead and generator were returned to manufacturer and analysis underway. Attempts to obtain additional information in regards to the patient status following revision surgery from the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1310986
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dennis100
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« Reply #43 on: June 07, 2016, 12:27:34 AM »

Model Number 103
Device Problem No Information
Event Date 04/13/2012
Event Type Injury
Event Description
The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time. No additional relevant information has been received to date.

Event Description
The patient reported that she was scheduled to see the surgeon for consult. She indicated that she needs two procedures at the same time. The patient reported that the other procedure she requires is cardiac related for possible stent placement. The patient reported that she had an abnormal ekg, but it may be related to her vns. The patient underwent surgical consult and was referred to a cardiologist. No known surgical interventions have been performed to date.

Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.

Event Description
The physician reported that device diagnostics were within normal limits. The patient was encouraged to use the magnet more. The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.

Event Description
The patient underwent generator replacement. The explanted generator has not been received for analysis to date. The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality. The physician believes a 3d echo was performed. It was reported that the ekg was ok.
Manufacturer Narrative

Event Description
The patient reported that she is still experiencing issues with her new generator. The patient reported that she is uncomfortable and it still hurts sometimes. The patient reported that she feels like it "jumps" around sometimes. The patient complained to the physician's office regarding erratic stimulation. The patient reported that vns isn't working. The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867
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dennis100
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« Reply #44 on: June 07, 2016, 12:28:08 AM »

Model Number 101
Event Date 08/06/2010
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that before the patient's previous implant on (b)(6) 2011, the patient had some arm posturing and cognitive declines. It was also reported that the patient had a dramatic improvement once that battery was replaced. The explanted generator was received by the manufacturer for analysis. Analysis of the generator concluded that no performance issue or any other type of adverse condition was found. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5228873
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dennis100
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« Reply #45 on: June 08, 2016, 01:54:30 AM »

Model Number 105
Device Problem Migration of device or device component
Event Date 03/23/2015
Event Type Injury
Event Description
Additional information was received form the surgeon's office that the patient was seen and that the surgeon felt that the device was satisfactorily in place and that no surgical interventions are needed. If patient experiences an erythema again, patient was advised to see the surgeon at that time.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient experienced pain when she moves her arm. The physician believes that the generator has migrated laterally and has referred patient for surgical evaluation. Diagnostics were reported to be within normal limits. A non-absorbable suture was used to secure the generator to fascia during implant surgery for this patient on (b)(6) 2015. Additional information was received from the neurologist that the patient experienced pain since approximately early (b)(6) 2015. There was no trauma or other incidents that might have contributed to the migration of the device. The migration is believed to be progressive since implantation or soon after. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5178668
« Last Edit: November 29, 2016, 03:51:24 AM by dennis100 » Logged
dennis100
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« Reply #46 on: June 14, 2016, 09:29:14 AM »

Model Number 102
Event Date 04/25/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled. It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed. It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth. She states that moving her left arm sets it off. The patient was then referred for generator replacement evaluation. Review of available data in the programming and history database revealed no anomalies. A battery life calculation performed with available data indicated the device has 8. 5 years remaining until neos = yes although the last 4 years of programming data is missing. Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing. " the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on. The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure. Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos. The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons. The provider submitted additional clinic notes containing device settings. An updated blc performed based on the newly submitted settings indicated that the device has approximately 8. 1 years remaining longevity. No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown. The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis. The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5689538
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« Reply #47 on: June 17, 2016, 12:50:03 AM »

Model Number 103
Event Date 04/01/2016
Event Type Injury
Event Description
It was reported that the patient and his mother were planning to consult with a surgeon on the prospects of getting his vns removed. Information later received indicated that the patient was experiencing pain around his generator site and under his arm. No known surgical interventions have occurred to date. Attempts for additional pertinent information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5655098
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dennis100
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« Reply #48 on: July 27, 2016, 06:36:07 AM »

Model Number 102
Event Date 07/06/2009
Event Type Injury
Event Description
It was initially reported that a vns patient experienced electrical shocking sensations in the chest area. The treating neurologist evaluated the patient's generator and found it to be working within normal limits. Further interventions were to program the patient's generator off. After the generator was programmed off, the patient continued to experience pain around the generator area along with a burning sensation that radiated to the underarm with swelling in the chest. Information received from the treating neurologist revealed the patient went to the er for intervention to be taken due to the chest pain. At the moment, it is known that the event is not related to stimulation, however, the root cause of the events is still unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464539
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« Reply #49 on: November 29, 2016, 01:37:19 AM »

Model Number 103
Event Date 09/15/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported the patient had gone to the er on (b)(6) 2016 complaining of dyspnea, coughing, and a tingling sensation in her face and upper extremities. The physician tested the vns and found high impedance. The vns was programmed off and the patient was referred for surgery. The patient underwent surgery to correct the high impedance observed, on (b)(6) 2016. It was noted that the lead pin was not fully inserted into the generator. The lead pin was reinserted; the impedance was checked both outside and inside the generator pocket. Both sets of diagnostics were within normal limits and there was no need for a replacement of either the lead of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6019996
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« Reply #50 on: November 29, 2016, 01:38:14 AM »

Model Number 106
Event Date 09/11/2016
Event Type Injury
Manufacturer Narrative
Occupation, corrected data, initial mdr inadvertently reported incorrect initial reporter occupation.

Event Description
On (b)(6) 2016 an email was received regarding a patient who was taken to the er when he was experiencing an increase in jerking movements in his arm. The patient's parents believe that it may be related to vns so they asked for an appointment with the neurologist to increase the settings. The physician is not sure what is causing the jerking movements or if this is actual seizure activity. Programming changes made: increased autostim to 0. 5ma and decreased the threshold from 40% to 30%. Also decreased the off time to 3min. No additional relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6012069
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dennis100
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« Reply #51 on: November 29, 2016, 03:08:42 AM »

Model Number 102
Event Date 08/01/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2014 indicate that the patient was seizure free until (b)(6) 2014 at which time, the patient began to experience 3-4 seizures per day. The seizures are described as jab/jolt on the right arm and the bladder. Possible triggers were mentioned such as associating the patient's seizures to eating foods that are high in sugar content and obstructive sleep apnea. The patient was referred for generator replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4343352
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dennis100
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« Reply #52 on: November 29, 2016, 03:11:28 AM »

Number 102
Event Date 07/01/2012
Event Type Injury
Event Description
The patient¿s explanted generator will not be returned for analysis due to the hospital¿s privacy policy.

Event Description
On (b)(6) 2013 clinic notes dated (b)(6) 2013, were received which indicated that the vns patient was admitted to the emergency room on (b)(6) 2013, due to a new seizures type and a new right arm weakness. On the night prior, the patient felt a sudden jerking of her right leg which came up off the bed, followed by her right arm which was shaking as well. The patient stated that it reminded her of a grand mal seizure which she had at age (b)(6), which was unusual for her. The patient's arm became numb, and this was a different seizure, so they wanted to admit the patient after having a head ct which showed abnormalities, nothing acute. The plan was to admit her, and do a video eeg there, thinking that these may be different seizures. It was decided to transfer her, in order to rule out the possibility of stroke, which was doubtful (as this was thought to be a todd's paralysis based on her (b)(6) hmri) but just to make sure there was nothing else going on. By the morning the patient regained her strength in the right hand, suggesting that this was postictal todd's paralysis as suspected. The clinic notes mention that due to the fact that she has been in the er with seizures lately, the last week, and a few other times in the er for other seizures, it may be that she is having a combination of epilespy but also none-epileptic seizures. Clinic notes dated (b)(6) 2013, indicate that the vns battery is at end of service and that before (b)(6) 2012 the patient seizures were picking up, but since (b)(6) 2012, she has had a lot more seizures that are bigger; averaging 2-6 convulsions per month. It was stated that the vns is giving her a little bit of shortness of breath now and then, although she says the symptoms are tolerable. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. A blc was performed which showed 6. 4 years remaining until eri=yes. Good faith attempts for further information from the physician were unsuccessful.

Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 did not indicate that the device will not be explanted due to the hospital's privacy policy. The information has been included in this report.

Event Description
An implant card was received which indicates that the vns device was explanted on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3065662
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dennis100
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« Reply #53 on: November 29, 2016, 03:14:11 AM »

Model Number 102
Event Date 11/13/2009
Event Type Injury
Event Description
It was reported to the mfr that the vns pt went to the emergency room due to a seizure that paralyzed her right arm and right leg. It is unk if the paralysis was permanent or if the event was related to vns therapy. It is unk if any interventions were taken for the reported event. Diagnostic tests performed on the pt's device at implantation surgery revealed proper device function. Good faith attempts to obtain add'l info regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1559750
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dennis100
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« Reply #54 on: November 29, 2016, 03:17:11 AM »

Model Number 102
Event Date 07/18/2008
Event Type Injury
Event Description
It was reported that the vns pt was hospitalized due to pain in right lower extremity and bumps in the right forearm. The pt was diagnosed with deep vein thrombosis at the level of the popliteal vein and thrombus in the greater saphenous vein. The right upper extremity showed some non-occlusive thrombus in the right cephalic vein. Further follow-up revealed that the pt has a history of thrombosis post surgically, therefore it has been determined by the physician that the event is a result of the implantation procedure, and the event is not related to the vns device.

Manufacturer Narrative
Implantation procedure caused event, no device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1147204
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dennis100
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« Reply #55 on: November 29, 2016, 03:21:22 AM »

Model Number 104
Event Date 12/01/2010
Event Type Injury
Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2013 that indicated in (b)(6) 2010 the patient was admitted to the hospital with new tongue spasms. Psychiatry recommended effexor with improvement noted. The patient had new spells (b)(6) 2010 of raising right arm, faraway look, fall to the floor; multiple per day which resolved. The patient saw a physician on (b)(6) 2011 and thought to be new focal seizure or nes. The physician later reported that the change in seizure pattern was first observed around (b)(6) 2010. There were "no changes" according to the physician and the seizures were thought to be non-epileptic spells. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure pattern.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118534
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dennis100
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« Reply #56 on: November 29, 2016, 03:24:06 AM »

Model Number 102
Event Date 02/17/2010
Event Type Injury
Event Description
A review of clinic notes dated (b)(6) 2012 found that the patient went to the emergency room the prior week with records from the emergency room dated (b)(6) 2012 showing that she had an increased frequency of seizures. The emergency room records also noted that the patient's white blood cell count in the urine was high suggesting a mild infection. The clinic notes continued to state that the patient had continued to have a change in her pattern of seizures as well described by her husband. The patient's husband stated that the patient seems to have a twisting movement with shaking in the right arm. The patient had one of these seizures during the appointment, and the physician noted that she appeared to be able to move to her husband and that it appears that the patient is seeking comfort from her husband. After the patient's vns was interrogated, an attempt was made to increase the pulsewidth from 250usec to 500usec, but the patient had significant changes in her voice and felt as if there was a sharp, stabbing pain in her neck when the stimulator turned on. Because of this, the stimulator was reversed and the settings were adjusted so that only minor change was made. According to the physician, the battery appeared to be satisfactory and the plan for the future was to adjust the patient's medication. Attempts have been made to get more information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2816907
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dennis100
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« Reply #57 on: November 29, 2016, 03:27:07 AM »

Model Number 302-20
Event Date 07/26/2011
Event Type Malfunction
Event Description
Additional information was received stating that vns patient¿s generator was explanted due to lack of efficiency and lead discontinuity on (b)(6) 2014. The explanted generator and lead were returned to the manufacturer on (b)(4) 2014. Analysis of the generator showed that the it performed according to functional specifications. Analysis of the lead is currently underway. Attempts for additional information have been made, but no further details have been received to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
Analysis of the lead was completed on (b)(6) 2014. A coil break was identified in the positive coil. Scanning electron microscopy images of the positive coil break (2nd portion) show that pitting or electro-etching conditions have occurred at the break location. Also, the coil has what appears to be wear (flat surfaces) in the vicinity of the break. Due to metal dissolution the fracture mechanism at this end cannot be determined. Scanning electron microscopy images of the positive coil broken end located at the third portion (mating to second portion) showed what appears to be wear (flat surfaces) on the coil strands, resulting in reduction of the diameter of the quadfilar coil strands up to the point of break. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified in the returned lead portions.

Manufacturer Narrative

Manufacturer Narrative
Review of manufacturing history records performed. Review of lead manufacturing history records confirmed all quality tests were passed prior to distribution.

Event Description
Additional information received on (b)(6) 2013 from a nurse who was calling on behalf of the patient's mother who inquired about vns mri precautions with high lead impedance. Although surgery is likely, it has not occurred to date.

Event Description
Additional information was received indicating that the patient¿s mother felt that vns was very effective.

Event Description
It was initially reported that the patient's mother was able to feel the patient's stimulation through his right arm and back and that the patient had high impedance on a diagnostic test performed on (b)(6) 2011. At that time the nurse reported that she would discuss disabling the device with the physician. No trauma or manipulation was suspected. Additional information was received indicating that the mother was feeling the stimulation every three minutes. There were also no causal or contributory programming changes prior to the reported event. Diagnostic history provided indicated that the high impedance was first observed on a diagnostic test performed on (b)(6) 2011. The patient's device was disabled; however the physician chose to re-enable it as the patient started experiencing an increase in seizures. The patient has since been referred to a surgeon. Revision is likely but has not occurred to date. No additional information has been made available at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2438113
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dennis100
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« Reply #58 on: November 29, 2016, 03:30:06 AM »

Event Date 06/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a physician's office that the pt was complaining of chest pain, coughing, and pain in her right arm that started approx two weeks prior. The pt had been to the er and the physicians ruled out "other issues" and told the pt that the symptoms "must be the vns. " the pt was at very low settings and could not tolerate any higher programming. The pt swiped her magnet and had significant cough and tightening of her chest. Also, the pt was unable to tolerate the system diagnostic testing parameters to test device function. The device was disabled to see if the issue resolved. Also, the pt is not currently taking any different medications than in the past. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2201826
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dennis100
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« Reply #59 on: November 29, 2016, 03:34:48 AM »

Model Number 103
Event Date 01/06/2012
Event Type Injury
Event Description
Additional information was received on january 26, 2012 when the explanted lead and generator were returned to the manufacturer for product analysis. The electrode array portion of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Visual examination of the lead identified what appears to be a cut opening and a puncture in the outer silicone tubing. No obvious damage to the inner silicone tubing of the lead coils was noted at these locations. The conditions are consistent with those observed due to the explant process. The lead assembly has remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. The assessment of the believed leakage path was the cuts or punctures made in the lead during the explant procedure. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 9, 2012. Electrical test results demonstrate that the pulse generator performs according to functional specifications and there are no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6), 2012 additional information was received when the patient further stated that while she was still implanted, she visited the emergency room twice because of burn marks received when using her magnet. The patient stated that both emergency room physicians advised her that she needed the device explanted before she died from it. However clinic notes from the patient's visit from the neurologist on (b)(6), 2012 were obtained which stated the vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The patient said she can't wear her hair down because when it touches her neck she has severe pain. The patient additionally stated that she had traumatic brain injury (tbi) before being implanted and therefore should not have been implanted in the first place.

Manufacturer Narrative

Event Description
On (b)(6) 2012 the vns patient reported that since (b)(6) 2011 she has been experiencing pain in her head that is different from a headache, as well as pain in her right arm and an increase in seizures. The patient stated that the pain usually occurs after she has had a seizure. The patient did not know the relation of her increase in seizures to pre-vns baseline levels. The patient reported to the case manager that she is not currently seeing a neurologist as she has a different insurance now. The patient sated that she is feeling a constant low voltage electrical shock in her brain. The patient taped her magnet over the device and said she experienced a burning feeling from the magnet. She said there was a burn mark on her skin when she removed the magnet. She stated that when the magnet was taped over the device, she did not feel the painful stimulation. The manufacturer's consultant reported that the patient had previously lied about her insurance so finding a neurologist was difficult. They found one the patient could see but the patient's husband refused to drive her there. The patient then showed up at the emergency room where the patient's real insurance information was discovered. The patient was seen by a neurologist and he disabled her device because of her reported pain. He went ahead and referred her to a surgeon because of the pain but she screamed at the neurologist and the staff so he asked her to leave and he will not see her again. The patient stated that she still felt painful stimulation even when the device was off and that the magnet stimulation burned her when she swiped the magnet. The clinic notes from the patient's visit from the neurologist on (b)(6) 2012 were obtained which stated that the patient was tearful and hysterical over the pain due to vns. The patient was angry that vns has not helped her. The pain and burning was reported to have started on (b)(6) 2012. The patient stated that she is currently taking hydrocodone for the pain but asked for more pain medication. The neurologist tried to run diagnostics but the patient would not tolerate it and remained hysterical and belligerent. The vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The manufacturer's consultant reported that the patient had her generator and lead explanted on (b)(6) 2012 due to a device malfunction. The patient's husband did not want the explanted product sent to the manufacturer for product analysis; however the surgeon did want the devices sent to the manufacturer. The husband became verbally abusive and was provided the options of having the manufacturer perform product analysis on the device or have the device sent to him without product analysis if he signed a release form.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434478
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