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dennis100
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« Reply #630 on: March 11, 2019, 08:01:43 AM »

Model Number MODEL 250
Event Date 09/04/2012
Event Type  Malfunction   
Event Description
It was reported that the vns patient was hospitalized due to an increase in seizures. The patient's device was tested and system diagnostic results showed normal device function. The patient's device output current was increased from 1ma to 1. 25ma and the patient subsequently began coughing. The output current was reduced back to 1ma, but it was observed that the device off-time was programmed to 60min which is indicative of an interrupted system diagnostic test. The patient's device settings were later corrected. Based on the available programming history, it appears that the interrupted system diagnostic test occurred during an office visit on (b)(6) 2012. The patient was last programmed to 1/20/500/30/60/0. 75/500/30 on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5088743
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dennis100
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« Reply #631 on: April 01, 2019, 01:04:12 AM »

Model Number 302-20
Event Date 01/19/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing painful stimulation and felt like his vns wires were unconnected. The patient had an appointment on (b)(6) 2016, and high impedance was confirmed to be present. The patient was referred for x-rays. No gross fractures were identified in the visible portion of the lead. The electrode portion of the lead could not be assessed as they were not included in the provided images. The presence of a microfracture could not be ruled out. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to high impedance. The explanting facility does not return product to the manufacturer. Therefore, no analysis could be performed.
 
Event Description
Clinic notes were received with further information regarding the high impedance of the patient's device. The patient experienced pain in the chest and neck and coughing with magnet activation. A chest x-ray was performed, and the physician stated that he could see the lead wire going over the sternum and beyond the left border of the sternum. The physician could not feel the lead wire beyond the left border of the sternum even though the lead wire and generator were very superficial, above the pectoralis muscle on the right side of the chest. The physician believed that the lead wire was disconnected either over the sternum or at the are of connection to the "old wire," which was most likely referencing the electrodes on the vagus nerve. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5687518
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dennis100
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« Reply #632 on: April 02, 2019, 01:51:53 AM »

Model Number 106
Event Date 04/23/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had passed away. The cause of death is unknown. A search for an obituary determined the date of death. The patient's vns system was reportedly explanted post-mortem, but was not available for return. Based on the limited available information about the patient's death to the manufacturer, an internal classification has determined that the death may be possible sudep. However, the patient's death is suspected to be sudep by the involved medical professionals based on circumstances unknown to the manufacturer. The conclusion of their assessment has not been conveyed to date.
 
Event Description
The explanted generator and lead were received by the manufacturer on (b)(6) 2016 for product analysis. Product analysis was completed on the returned lead portion on (b)(6) 2016. A section of the lead assembly was returned for analysis in one piece with the lead connector portion still attached to the pulse generator. Initial testing on the generator as-received showed the lead pin had electrical continuity with the generator. The lead's electrodes were not returned for evaluation. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the returned generator on (b)(6) 2016. Visual examination showed only explant-related observations; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs 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. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 030 volts during the relevant portion of the final electrical test and showed an ifi=no condition. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
The patient's mother reported that the vns messed up the patient¿s throat to where they could not swallow and struggled to breath. By the time these harmful effects were found, it was too late to save the patient. Additional information was received from the neurologist that the patient had catastrophic neurological disorder that couldn't be characterized. Soon before the patient¿s passing, the patient presented with fever, coughing, difficulty swallowing, as well as an undefined genetic disorder, but there was said to be no relation to the vns device. The patient was seen by a nutritionist around the same time who noticed the patient coughing and gagging, and recommended that the patient should not eat anything by mouth, and therefore the patient was started using tube feeds. A gastrostomy tube was placed about a month prior to the patient's passing. The neurologist mentioned that the vns was working correctly the last time he saw the patient. The doctor does not believe there to have been any malfunction with the vns device. He also stated that the patient had swallowing difficulty since birth and does not believe the swallowing issues or difficulty breathing issues to be due to the vns device, as the patient never presented with these issues in relation to the device. The doctor stated that it was noted that the patient passed away in her sleep. The doctor stated he did not know for sure, but did not believe that the patient's passing was related to the vns device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5670049
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dennis100
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« Reply #633 on: April 05, 2019, 10:29:52 PM »

Model Number 302-20
Device Problem High impedance
Event Date 02/20/2019
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Patient underwent generator replacement and impedance was noted to be ok post-operative. Two days later, the patient began to experience a scratchy voice and coughing. The patient was seen by a neurologist and high lead impedance was observed. The patient was seen by the surgeon and x-rays were performed. The surgeon reviewed the x-rays and noted that nothing was wrong with the device. The patient was seen by the neurologist's nurse practitioner. Upon interrogation, lead impedance was ok. The patient was programmed to the same settings prior to device replacement and began to experience coughing, gagging, crying, and dry heaving. The patient's settings were decreased until the patient was stable. By the end of the programming session, high impedance was again observed. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444541
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dennis100
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« Reply #634 on: April 06, 2019, 02:50:41 AM »

Model Number 1000
Device Problem Premature End-of-Life Indicator
Event Date 01/13/2019
Event Type  Malfunction   
Event Description
It was reported that on (b)(6) 2019, interrogation of the patient's device showed a low battery warning and the device was pulse-disabled. The patient's model 1000 generator was placed in (b)(6) 2018, battery life was normal at 75-100%. Impedance was within normal limits. Note that the patient experienced coughing and severe pain upon advanced interrogation, which re-enables the device. Because of this, the device was disabled. It was believed the pain/coughing with stimulation was due to the patient losing tolerance of stimulation after the device was pulse-disabled due to battery depletion. This message occurred with two different programming systems. The generator was reset it was noted that the device was now showing low impedance along with end of service. The low impedance was an expected event due to the magnet being left on after generator reset - no device failure is expected regarding the low impedance. Review of x-rays verified that there were no obvious anomalies in the lead. Review of internal data of the generator found that the generator voltage was lower than expected since implant (prior to low battery/disablement) and did not gradually increase as would be expected in the beginning of an implanted generators life. Instead the generator voltage appeared to decrease from implant. It was noted that the 3 battery status indicators (ifi -intensive follow-up indicator, neos- near end of service, eos - end of service) occurred on the same day in january, which indicates that the voltage dropped suddenly on this day. The device history records of the generator were reviewed. The generator passed final functional and quality tests prior to release. No anomalies in testing were noted. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404859
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dennis100
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« Reply #635 on: April 07, 2019, 03:57:15 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns generator replacement surgery. Clinical notes were received as part of this process which reported the patient was experiencing painful stimulation in the chest as well as coughing with vns magnet stimulation. These began after the patient's vns was adjusted at the previous office visit. The pulse width was lowered due to these events, and then the frequency, pulse width, and magnet output current were lowered and it is indicated the coughing resolved after this further decrease. The neurologist speculated that a lead issue was contributing to these tolerability issues and requested that the lead be replaced if a lead issue is found during the surgery. Lead impedance was measured at the office visit and noted to be within normal limits. Follow up with the patient's neurologist determined that the replacement surgery was being taken to potentially prevent a serious injury. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8403687
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dennis100
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« Reply #636 on: May 03, 2019, 03:34:57 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/25/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that a vns patient was experiencing an increase in seizures. The patient was referred for surgery. The physician stated the generator was interrogated and confirmed the device "is functioning well". Follow-up from the patient on (b)(6) 2017 also provide that she has had issues with different seizure types and frequency since last replacement. She stated seizures now happen every 2 weeks when they were happening every 4-5 weeks, lasting up to 2. 5 minutes and her recovery can be up to a week. Follow-up from the physician provided that the most recent diagnostics were normal with no error and the device was not at end of battery life. The patient¿s husband has reported increasing seizure frequency and severity past 3-6 months. The physician provided it is unclear if the increase in seizures was related to vns and mentioned the device is likely needing replacement. There is high suspicion for non-epileptic seizures co-existing with her epilepsy. Battery status indicator was reported to be normal. The change in seizure pattern and post-ictal duration is unclear if it is related to vns. It is suspected that the patient has pnes (psychogenic non-epileptic seizures) as well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the patient provided that she was still experiencing seizures and that she can no longer feel the magnet swipe.
 
Event Description
Follow-up from the patient provided that the generator has migrated close to her armpit due to her weight loss and is bothersome. The patient reports that she has had increased seizures within the last year and does not feel the vns is working. The patient also stated she had a really rough week as she has had a lot of seizures.
 
Event Description
It was reported by the patient that her device was turning on every 10 seconds, and staying on for about 10 seconds. The stimulation was very strong and painful and making it difficult to swallow. She reported that generator location makes it difficult to access with the magnet to disable the device. It was indicated by the surgeon that the patient's replacement surgery was due to battery depletion and her migration would be fixed at this time. Per the surgeon, the surgery was not to preclude a serious injury. No surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient underwent replacement due to battery depletion. The explanted product was returned. The patient reported that she had been having sleep apnea, buzzing in her neck during sleep since 2011. She also indicated that she had felt stronger stimulation in her neck and that she gagged with magnet swipes which had led to weight-loss in the past. The patient's treating physician indicated that this patient was a high anxiety patient. It was found that the patient had multiple complaints requiring investigations of increased seizures, pain with stimulation, dysphagia with stimulation, and perception of stimulation since 2011 that were previously considered separate events. Three reports regarding seizures of this patient were submitted since 2011. In mfr. Report #1644487-2012-00443, the patient reported that she'd had an increase in seizures in january 2012, a tightness in her neck, a decreased range of motion of her neck, and pain and clicking in her throat with stimulation. The physician said that the patient's increased seizures were not related to vns. The physician stated that he believed that the patient¿s pain and ¿tightness¿ or limited range of movement, were psychiatric in nature and not related to vns. In (b)(6) 2015, mfr. Report #1644487-2015-04964, captures a report from the patient that she had a new type of seizure while having her vns settings adjusted. This seizure was later indicated not to be related by the physician and the physician indicated that the patient's seizures had decreased in severity since having the vns. Mfr. Report #1644487-2015-05446 reported that in (b)(6) 2015 the patient had experienced an increase in seizures due to her "levels being low. " the physician indicated that the patient had an extremely variable seizure pattern and that her history is not reliable. Further relevant information to these reports will be captured in the current manufacturing report as these reports appear to be related. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr 4 inadvertently reported that the generator was returned when it was actually discarded.
 
Event Description
The physician indicated that the relationship of the following symptoms---sleep apnea, buzzing in neck, stronger stimulation in her neck, and gagging with magnet swipes which had led to weight-loss in the past--- was unknown. The patient's explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6434722
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dennis100
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« Reply #637 on: May 06, 2019, 05:27:50 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so her treating physician will determine when vns will be programmed on. Mfr. Report #1644487-2010-02742 was submitted to report on the event of vocal cord paralysis. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919363
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dennis100
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« Reply #638 on: May 08, 2019, 10:49:20 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2016
Event Type  Injury   
Event Description
Information was received indicating that the patient's voice was "extremely" hoarse. The hoarseness was not cyclical but constant. The patient was referred to an ent for injects. The hoarseness was present after the patient's implantation surgery in (b)(6) 2016 where the patient's generator was programed on. The patient's generator was disabled in february to allow the patient to heal. Diagnostics of the patient's device were within normal limits. No additional relevant information has been received to date.
 
Event Description
It was later explained by the physician that the patient's voice was hoarse and getting progressively worse, along with coughing and aspiration of both solids and liquids. It was also explained the patient has left vocal cord paresis as opposed to paralysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6378738
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dennis100
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« Reply #639 on: May 08, 2019, 10:50:09 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2017
Event Type  Injury   
Event Description
A report was received indicating that a patient had a constant nose bleed that began a day after the patient's vns device settings were changed. The patient was also coughing up blood. The patient's device was programmed off after the bloody nose began by the patient's treating physician. After the device was programmed off the patient's nose continued to bleed. A review of the available programming history showed that the device had historically good impedance values. A review of the device history record for the implanted generator confirmed that it had passed all quality inspections prior to release for distribution.
 
Event Description
Additional clarifying information was provided from the patient's nurse regarding the bloody nose. The nose bleed had started about 4 days after the patient was programmed up. The nose reportedly began bleeding when the device stimulated. On the patient's next visit, the vns was turned off and the nose bleed came back a few days later. The patient then decided to try stimulation again and was turned back on. The patient's nose was reportedly only bleeding periodically and did not bleed for an entire week, non-stop. All diagnostic results were within normal limits during the clinic visits. The patient had reportedly fallen right before the nosebleed started and the physician believed it may have been related because the patient hit her neck during the fall. The physician also believed the placement of the vns may have been contributing to the nose bleeds. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6376517
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dennis100
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« Reply #640 on: May 10, 2019, 02:18:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing constant stimulation, pain, and coughing "all the time". The patient was said to be going to the er. Clinic notes and a referral form were received reporting that the patient was referred for surgery due to constant stimulation causing pain, coughing, and shortness of breath. The device was disabled on (b)(6) 2019 for the adverse events. The patient underwent replacement surgery. It was noted pre-operatively that the device was already disabled upon interrogation at surgery. No pre-operative diagnostics were performed. During the surgery, the surgeon looked at the device being explanted and stated seeing some dot marks. At the patient's follow up appointment, it was clarified that the patient's pain, which was in the neck area, had resolved after the device was disabled. Prior to disablement, the patient felt like the pain was constantly going off. No device was returned to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510188
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dennis100
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« Reply #641 on: May 11, 2019, 03:36:19 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that a patient had an infection on his neck incision after a patient's first implant and was given antibiotics. At the patient's dosing appointment, the physician still turned up the patient's generator to 0. 25ma, which the patient was tolerating well. It was stated that the patient had started taking antibiotics since the day after surgery, and that per the physician, the neck incision infection is healing well. It was further noted that the patient had a respiratory infection and still had a cough. Device history records were reviewed and showed that the implanted devices were sterilized prior to distribution. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8485770
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dennis100
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« Reply #642 on: May 11, 2019, 03:37:13 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2016
Event Type  Injury   
Event Description
It was reported by a patient that she will be getting her generator replaced because it keeps shifting. A clinical note from the physician provided that the patient will instead have surgery to move the generator. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the surgeon¿s office provided that the cause of the migration is unknown. Clinic notes received provided that the patient is experiencing discomfort around the generator. The patient had several seizures in the pacu ((b)(6) 2016) and had significant coughing with stimulation and was admitted for observation. Her vns output current and magnet current were turned down on (b)(6) 2016 and patient was discharged home. She reports that she continued to have coughing with stimulation on (b)(6) 2016 but that it decreased significantly on (b)(6) 2016. Her autostim setting was turned down to 0. 375ma on (b)(6) 2016. She reports that she has been doing well since her last visit. However, the vns generator was causing discomfort due to bra strap resting on it and increased subcutaneous mobility. Operative notes from the replacement surgery provided the generator pocket was enlarged to accept the new generator. The existing lead was connected to the cyberonics model 106 generator using the appropriate screwdriver. A lead test was performed and confirmed diagnostics were within normal limits. The generator was turned on the pre-operative settings.
 
Event Description
Clinic notes from a visit on (b)(6)2017 were received which provided that after (b)(6)2016 the patient¿s coughing which occurred post-operatively has no longer occurred. The patient reported no convulsions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6501349
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dennis100
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« Reply #643 on: May 11, 2019, 03:37:59 AM »

Model Number 104
Device Problem Energy Output Problem
Event Date 04/05/2018
Event Type  Malfunction   
Event Description
It was reported that a patient¿s generator was found to be disabled and not delivering current due to a wand reset. The patient experienced coughing when the device was re-enabled. Per the reporter, this had occurred previously with the patient¿s generator and when the device was re-enabled the patient experienced coughing as well. It was reported that an error code 382 was seen which corresponds to the message seen for a variety of disablement causes, and there was no known intentional reset of the patient's device. Reportedly, the patient has had no falls or potential trauma to his chest, there has been no surgery of any kind which could have resulted in the reset, and no one else interrogated his vns device. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. A review of exported programming data confirmed that the patient¿s generator had been reset with an estimated date of (b)(6) 2018. After a system diagnostics test was performed, the device performed as expected. An additional interrogation on (b)(6) 2019 indicated another reset occurred as the estimated restart time was on (b)(6) 2019. There were no issues with lead impedance values or any anomalies with battery voltage in the available data. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8492020&pc=LYJ
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« Reply #644 on: May 11, 2019, 03:39:08 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2019
Event Type  Injury   
Event Description
It was reported by the patient that he had a bad coughing fit after using his magnet and turned blue until he caught his breath. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8546726
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« Reply #645 on: May 11, 2019, 03:40:36 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Event Description
Clinic notes were received for patient referral for replacement. Notes indicated the reason for referral was due to low battery. They also indicated that the mother reports the patient has had a dry cough from vns and the mother wanted the battery checked because of this. The mother also reported that since november about every three weeks the patient has gi upset leading to vomiting or stomach ache. The patient was put on prilosec and this has helped a bit. Notes state he is now having side effects including coughing when the device fires and perhaps some gi issues and painful at times. It is unclear if the patient's referral for replacement is related to the adverse events he has been experiencing. No additional information has been received to date. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8554701
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« Reply #646 on: May 11, 2019, 03:41:13 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2001
Event Type  Injury   
Event Description
The patient was referred for the removal of the vns device as the patient believes the device chokes the them when it stimulates. Programming history was reviewed, and the patient¿s device was disabled on (b)(6) 2002. The last diagnostics showed good impedance. No indications of a device malfunction were identified in the programming history. The patient's device had previously been disabled due to choking and coughing. Per clinic notes, the vns had not helped to decrease the patient¿s frequent seizures of having 1-2 seizures per week. The patient was also said to be having swallowing issues. A second office reported that the patient did not have any discomfort when the device was programmed off. It was reported that the patient was referred for removal in order to allow for mri imaging, however it had previously been reported that the patient was referred for removal due to the feeling of choking so the reason for the patient's removal surgery is unknown. No relevant surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514622
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« Reply #647 on: June 02, 2019, 07:39:39 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/01/2017
Event Type  Injury   
Event Description
An article abstract was received, which indicated that a patient experienced permanent hoarseness and coughing due to left vocal cord paralysis during vns implant surgery. The cause of the vocal cord paralysis was most likely due to manipulation of the vagus nerve during implant, and the patient required further surgery due to the vocal cord paralysis. No further relevant information has been received to date.
 
Event Description
The patient that experienced vocal cord paralysis also experienced dysphagia, which required an otolaryngology consult and lidocaine injection that resulted in some improvement. The patient subsequently had removal of the entire vns system 4 years after placement. The article also mentioned that bradycardia was an adverse event identified in the some of the operative notes of the study patients. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6695060
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« Reply #648 on: June 07, 2019, 05:44:55 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2019
Event Type  Injury   
Event Description
It was reported by the physician that the patient¿s device is causing them to cough with stimulation and is not able to function. The patient was referred for replacement. The physician did not know why the cough is so aggressive. Programming history was received and reviewed for the patient. The device had been disabled. No anomalies were seen. Surgery is likely but has not occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8587882
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« Reply #649 on: June 08, 2019, 06:57:04 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported to a livanova representative by a patient that she was experiencing increased frequency of vns going off, shortness of breath (captured as dyspnea), diminished voice capacity (captured as voice alterations), aspiration, and coughing. The patient notes that there settings were lowered due to these side effects. These events have been captured in mfr report # 1644487-2016-01235. The patient noted that another patient was feeling the exact "similar" symptoms, specifically noting "misfiring of the vns", and reportedly had the device removed and implanted in the patient's brain, reportedly because of "air in the tubing". No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8631276
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dennis100
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« Reply #650 on: June 11, 2019, 01:24:38 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/25/2017
Event Type  Injury   
Event Description
It was reported that the patient is starting to have an abundance of seizures recently. It was stated that system diagnostics were performed and were normal but no value was provided and battery was not near end of service. Her father stated that since the last vns check she is having seizures every 3 days. The patient is recommended to have battery replacement despite the battery not being low. It was noted that it has been 10 years since the last device was implanted and even though the settings have not changed since the last clinic visit she continues to have increased seizure frequency which may be due to weakened battery. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
Additional information was received indicating that this was a very difficult patient. The last time she was seen they tried to increase her settings for efficacy and the patient was very dramatic and coughed with the increase although the nurse thinks that it was not actually brought on by the stim but more for show from the patient who has always been dramatic when changing settings. She said that the mom wanted to see a different provider because they thought that this nurse was causing harm (by increasing settings) so she saw a different nurse in the same facility who turned the vns back down to 0. 25 ma. The device was confirmed to be functioning normally and system diagnostics were normal. It is not known if the increase in the seizures was above, below or back to pre-vns baseline levels. As mentioned the nurse has tried to increase settings but patient won't tolerate, but she thinks the low settings is low efficacy. No additional or relevant information has been received to date.
 
Event Description
The patient underwent prophylactic replacement to replace the 102r generator with a 104 generator. The explanted generator has not been received for analysis. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Describe event, corrected data, supplemental medwatch #2 inadvertently omitted information already known prior to submission. Device available for evaluation?, corrected data, supplemental medwatch #2 inadvertently omitted product received date.
 
Event Description
The explanted generator was received for analysis. Product analysis on the generator was completed and approved. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results of the generator being placed in a simulated body temperature environment 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 device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6959457
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dennis100
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« Reply #651 on: June 13, 2019, 03:32:58 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/18/2014
Event Type  Injury   
Event Description
It was reported that the patient is experiencing vocal cord paralysis. The vocal cord paralysis began right after implant surgery. From the patient¿s outpatient clinic visit two weeks following surgery the patient had hoarseness and coughing and still has this issue. Later on, during several visits, the hoarseness was stated as still being an issue, but mostly related to stimulation. In (b)(6) 2017, the patient was seeing a medical specialist because of hyperventilation: left vocal cord paralysis. No intervention is being taken for the vocal cord paralysis. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7046173
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dennis100
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« Reply #652 on: June 22, 2019, 03:57:57 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/29/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient had vocal cord complications. No additional or relevant information has been received to date.
 
Manufacturer Narrative
(b)(6). (b)(4).
 
Event Description
"vocal cord complications" was clarified by the nurse to be a left vocal cord paresis, and not paralysis. The vocal cords were noted to be inflamed. The patient was also noted to have difficulty swallowing, trouble breathing and coughing, which the physician had also attributed to the vns surgery. The nurse indicated that the patient's condition was improving. No device malfunctions were noted from device interrogation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7173606
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dennis100
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« Reply #653 on: June 27, 2019, 12:16:04 PM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2002
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received indicating that a patient had experienced recurrent laryngeal nerve injury with vns. Per the notes, the patient also experienced a cough with mild pharyngeal pain or dysphagia. Programming history was reviewed for the patient's device, and diagnostics were within the normal limits on the date of implant and one month after implant surgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The physician reported that the patient experienced paresis in the recurrent laryngeal nerve due to initial vns implant surgery, which occurred nearly 14 years prior to the clinic notes. No medical intervention was taken for the nerve injury as it was a one time surgical injury. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7335848
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dennis100
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« Reply #654 on: June 28, 2019, 11:19:20 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/21/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient had a prophylactic full revision surgery and experienced post-operative bradycardia that appeared to be a result of stimulation on times. The surgeon programmed the device off. There were no issues observed during the surgery or intraoperative bradycardia. The impedance during the surgery was within normal limits. No further relevant information has been received to date.
 
Event Description
Further details were received regarding the arrhythmia after vns surgery. The patient did not have a history of cardiac events or any other comorbidities listed. The medications provided to the patient during surgery were not available. The patient did request that she not have general anesthesia, but it was unknown if the patient had a previous reaction to general anesthesia in the past. The surgeon was not comfortable doing the surgery with only local anesthesia, so a full general was performed. The surgeon identified extensive scarring at the electrode site, which was attributed to the implant procedure, and the old electrodes were not removed from the nerve. The new electrodes were implanted above the old electrodes on the vagus nerve. The new device was set to the same settings as the previous generator, per the surgeon's instruction. The surgery was 1. 5 hrs long, which was not considered to be a long surgery due to the full revision. The patient was fine during surgery when system diagnostics were performed. After surgery, the patient experienced asystole during stimulation along with significant coughing. Once the device was programmed off, the asystole and coughing did not occur again. The patient's device was programmed on by the neurologist. The patient did not experience any side effects at these settings, and titration was planned as normal. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7445894
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dennis100
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« Reply #655 on: July 02, 2019, 01:23:18 AM »

Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area ; Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was feeling "electrical jolts" and recurrent pain at the vns site. Clinic notes received for the referral indicate that patient has recurrent left chest pain most likely related to vns placement as well as on occasion "feeling electrical jolts" suggestive of vns dysfunction/malfunction. It was reported that the electrical jolt occurs with stimulation on occasion but not every single time of stimulation. There is no pattern on when it occurs or with certain specific body movements. Surgical exploratory surgery was planned in regard to probable replacement of vagal nerve stimulator in view of chest pain as well as "electrical jolts" to preclude a serious injury but has not occurred to date.
 
Event Description
An implant card was received for the patient's full revision surgery. The implant card indicated that the generator was at intensified follow-up (ifi) = no pre-operation, and that the replacement was for discomfort in the neck. As no malfunctions were noted, and it is known that impedance issues would trigger an error message warning upon interrogation, it is reasonable to assume there was no impedance issue noted. It was stated that at the surgery, the patient was feeling a sharp pain at his electrode site about 4 months prior to the surgery. The pain was associated with stimulation as it seemed to be occurring every 5 minutes, however the neurologist stated that the device was turned off for the past 6-8 weeks. The device diagnostics were checked. Upon running diagnostics, the patient grabbed his neck and began coughing. The neurologist ordered and x-ray of the lead site and had not seen anything abnormal. When settings were increased to 0. 25 ma output current, the patient stated not feeling any stimulation. Output currents were increased to normal mode 0. 5 ma and magnet mode 0. 75 ma; the patient grimaced slightly and said the pain was ok. When the magnet was swiped, the patient began coughing and stated the pain was too much. The device was disabled again, and it was decided the patient would undergo a full revision. The explanted devices were returned for analysis. No abnormalities were noted from the generator. Diagnostics and interrogations were performed with various loads. Communication, impedance, and current delivered were as expected for all tests performed. The output signal was monitored for over 24 hours and placed in a simulated body temperature environment. The generator performed as expected and according to functional specifications. The lead assembly was returned in four portions with one loose tie down. Slice marks were observed in the tubing and the tri-filar coil appeared to be cut in half. The slice mark appeared to have been made by a sharp object which may have occurred during the implant procedure, however this could not be confirmed. The lead assembly had dried remnants of likely body fluids inside the tubing. The slice mark found most likely provided the leakage path to the dried remnants of likely body fluids. With the exception of this slice mark, the conditions of the returned lead portions were consistent with those typically seen from explant procedures. No other obvious anomalies were noted other than a bend connector pin. The set screw marks found on the lead connector pin provided evidence that at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, and except for the cut negative coil, no discontinuities were identified. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7609529
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dennis100
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« Reply #656 on: July 05, 2019, 11:50:44 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by the doctor that the patient was complaining of side effects of coughing and voice alteration and needed an mri of her breast, so they were going to do a full explant. The reason for explant was primarily the mri but the adverse events contributed. No further 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=8745590
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dennis100
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« Reply #657 on: July 05, 2019, 11:51:30 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
The patient's mother reported that the patient is having difficulty with gagging and coughing. The patient's physician sent a surgery referral the day after this report was received. It was noted that after further observation, the patient¿s father noticed that the coughing and gagging were present even without stimulation occurring. The physician believed that the events may be side effects of the epidiolex that the patient was prescribed recently, however the physician did not deny relationship to vns therapy. Additionally, the physician decreased the signal frequency and pulse width parameters of the vns at the patient's appointment to mitigate these complaints. Further follow up with the physician confirmed that the patient also reports pain since vns was taped with the magnet. Additionally, the physician noted that the patient will be seen by neurosurgery for vns battery change to be scheduled. The physician noted that the patient is currently taking vimpat, lamotrigine, and trileptal medications which could be contributing to the reported events. It was noted that they will possibly be weaning the patient off of these medications. The physician refrained from confirming whether or not the reported pain, coughing, and dysphagia were factors to the surgery referral. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8744176
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dennis100
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« Reply #658 on: July 11, 2019, 02:23:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's husband reported that the patient had a psychotic break down and has been inpatient for about the last month. The husband believes vns settings are too high which is causing his wife's problems. He noted that his wife has reacted horribly to magnet swipes, stating that she was having pain in the neck and coughing. The patient's group home later called and reported behavioral changes and frequent urination for this patient. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8667403
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dennis100
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« Reply #659 on: July 11, 2019, 02:26:05 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/21/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported through clinic notes that the patient had a severe coughing fit related to stimulation one day. The parents taped the magnet over the generator and the coughing stopped. The patient went to the er and the device was disabled. The patient's battery status was found to be 11-25% remaining. X-rays showed no problems with the lead. The physician indicated that the patient tolerated the vns on at much lower settings. The physician described the event as the "vns malfunctioning" he then noted that he assumed that the low battery state of the generator is causing variability in function so the next best step would be generator replacement. Note that this patient's generator model should provide therapy until it pulse-disables itself at end of service condition. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8665182
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