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dennis100
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« Reply #90 on: May 09, 2018, 01:42:46 AM »

Model Number 103
Event Date 01/08/2013
Event Type  Injury   
Event Description
Product analysis was completed on the generator on 02/17/2015. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the expected low battery voltage. The battery, 2. 564 volts, shows a neos=yes condition. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 607 volts. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. No anomalies exist and the end-of-service (eos) condition is an expected event. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received stating that the vns patient¿s device showed an end of service condition during an office visit on (b)(6) 2014. The patient is not expected to undergo replacement surgery due to lack of efficacy.
 
Event Description
Clinic notes dated (b)(6) 2014 were received which indicated that the patient is having an increase in seizures, very frequent each day. The patient was referred for a battery replacement and the physician reported that the device has reached end of battery life. The patient underwent generator replacement on (b)(6) 2014. Attempts have been made for the return of the explanted generator but it has not been received to date.
 
Event Description
On (b)(6) 2015 the explanted generator was received for product analysis. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative

Event Description
Clinic notes were received which indicated that the patient's father called the physician's office and stated that the patient is having break through seizures. Per the note, it seems that the patient will have several one day and then go weeks without any activity. The patient's father wanted to know if he could increase the patient's medication and was advised an increased medication dosage amount. The date of this note is unknown. Notes dated (b)(6) 2013 indicate the patient had an increase in seizures and then increase felbamate. The patient's vns was checked and diagnostics indicated that the battery is near end of life. Notes dated (b)(6) 2013 indicate the patient had breakthrough seizures tuesday evening at 5pm that stopped at 6pm. The patient had a lot of facial twitching and fell down once. Otherwise, the patient has done well for months. Clinic notes dated (b)(6) 2013 additionally note the break through seizures, which occurred on (b)(6) 2013. The patient had a breakthrough seizure and fell down the stairs and broke arm. The patient will go for a few days to a week with no seizures, then usually in the morning will see eyes roll back and fall, with some facial twitching. The father noticed an increase in stuttering and stated that the patient is getting worse. Follow up with the physician found that upon interrogating the vns, it was seen to be near end of service. The physician believes the increase in seizures and lack of efficacy was due to the device nearing end of service. Since starting the vns, the patient's seizures have decreased. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the event. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3323028
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dennis100
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« Reply #91 on: July 06, 2018, 10:21:25 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by a physician that a vns patient¿s device was still firing even though the magnet was reportedly used to disable the device. The magnet was placed over the scar on the patient's chest, but the generator could not be felt. The physician reported that he could still see the device firing, which was determined by the patient clenching her teeth. The patient had multiple seizures during this time, which were attributed to the pain caused by the stimulation. It was reported that the seizures got worse and more frequent when the magnet was placed over the generator and that the patient had a neck muscle spasm during stimulations. The patient's device was communicated with the next day, which showed that the device was delivering therapy properly and that there had been no magnet activations during the times that the physician and patient stated that the magnet was used. The magnet was taped over the generator, and then the magnet activation was recorded properly. The physician reported that the generator was placed deep in the patient but could still be palpated, which could have caused the magnet to not activate. Follow-up was then received the next day reporting that, even with the magnet taped in place, the patient had neck and face spasms and tremors in the patient¿s cheeks during vns stimulation. Immediately following the symptoms that lasted up to 20 seconds, the patient went into a tonic seizure lasting 20-40 seconds. The patient's device was then programmed off. The patient was then referred for replacement of the device. Further follow-up indicated that the increase in seizures was not worse than before vns, but the device had been off for a week and the patient's seizures were back to one a day. The increase in seizures was stated not to be caused by vns therapy. The patient felt like the magnet didn't inhibit stimulation. The muscle spams, painful stimulation and increase in seizures resolved after the device was disabled, but the patient was still experiencing a subdermal burning sensation around the generator site. The patient had generator replacement surgery due to the painful stimulation. Diagnostics were within normal limits prior to surgery, and the surgeon found no visible anomalies with the devices prior to explant. The generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594908
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dennis100
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« Reply #92 on: July 06, 2018, 10:22:02 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was indicated that a patient on "normal cycling" stimulation had reduced seizures, and no noted issues with vns. A day after a 0. 5ma increase in output current from 1. 5ma to 2. 0ma, the patient developed secondary generalized clonic seizures on the left side of her face and was hospitalized due to status epilepticus. The vns was suspected to be the cause of the status epilepticus. The vns was turned off, and the patient no longer had generalized tonic clonic seizures. The seizures gradually decreased and subsided after one day. The vns remained off for two days, and then was turned back on and slowly titrated. It was noted that the patient's condition has been stable with medication and vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7573497
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dennis100
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« Reply #93 on: August 10, 2018, 04:01:59 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600
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dennis100
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« Reply #94 on: November 06, 2018, 07:40:38 AM »

Event Date 01/01/2006
Event Type  Malfunction   
Event Description
On (b)(4), 2012 it was reported that the vns patient was initially implanted with vns in the (b)(4) 2002 and began to feel ill with significantly more seizures and absence seizures in 2006. The patient's condition also worsened and he began to cough often and long and coughed until he threw up. The patient was reported to have seen the neurologist on several occasions. In (b)(4) 2009, the patient visited the dentist and the patient's teeth were ground and an ultrasound was performed. The patient 'jumped in the chest' and was hurt by the vns. It was noted that this was pain at the generator site. The patient had severe coughing, felt sick, and had trouble breathing when he left the dentist's office. When the patient came home, the patient's mother suspected that something was not right with the vns. When the settings of the vns could be adjusted by the hospital, the patient coughed hard and long, lost her breath, and turned blue in the face. It was reported that the physician had not been through something like this before. It was noted that this event occurred three times. In the (b)(4) 2010 it was reported that the manufacturer concluded that the vns was broken in the patient's body and the patient underwent revision surgery for a new vns to be implanted. It was reported that the explanted product had been previously been returned for product analysis however as the product information was not provided nor was additional patient identifying information, this could not be verified. Additional information has been requested from the physician but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
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dennis100
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« Reply #95 on: November 10, 2018, 03:56:20 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from the patient¿s mother that her daughter had some serious adverse events over the weekend. She mentioned that the patient started feeling dizzy and nauseous and she had pain and muscle spasms on the left side of her neck. The mother tried to tape the magnet over the patient¿s generator but she stated that it seemed like the vns shocked the patient. The mother then took the patient to the er and was able to successfully tape the magnet over the patient's generator to mitigate the symptoms that the patient was experiencing. She stated they then went to her neurologist but the mother was upset because the neurologist completely ruled out the vns device and did not address their concerns. She did say that the settings were changed and she was informed that the battery was low, so the mother felt that the issue could be occurring due to the low battery of the patient's generator. The mother was asked if there was any recent trauma and she stated that the patient had about 4 seizures from friday to sunday and the patient usually falls down due to her seizures and "runs into things all the time. " it was also reported that the patient also had extreme voice alteration. The mother also alleged that the ¿device misfired and patient is in pain, the device is shocking her. ¿ she stated that her daughter is having dizziness, her heart rate will be up in the 120 or in the low 40s. She stated that she was seen in the er on monday and they said to tape the magnet on it. She then stated that her daughter is weak and tachycardic. The er gave her a beta blocker. They have tried taping the magnet on it, but her chest is getting really hot. There were also changes in her voice. They had never had a problem with the vns before. The mother also alleged complaints of nausea and vomiting. The patient then stated she felt better when the vns was placed over the generator. The patient then said it was getting hot. So uncomfortable that she won¿t go to sleep. The father then said it was comfortable for 10-20 minutes and then goes vibrating and goes into legs and stomach. It also shocks all the way over to the left side of her chest. She stated that she felt bad enough to call the ambulance herself (herself being the patient). The patient was referred for replacement. Notes indicated the same allegations as previously mentioned including, that the patient reports electric shock sensation from the device to patient's neck and whole body, chest pain, magnet held in place over the device after going to the er, magnet made the device feel hot to the patient. Patient reports voice hoarseness of voice twitching on left side of the face, and headache all of which the family thinks is related to vns. The physician states recently she has been having more seizures. She is also having problems with the current device including feeling electric sharp like sensation in her chest and myoclonic movements in her neck and he is recommending a change in the vns device. The physician is recommending prophylactic vns device change so that the patient can have auto stimulation to help reduce her seizures specifically the electric shock-like sensation she is feeling and the cluster of seizures she is having. No surgery 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=8004870
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dennis100
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« Reply #96 on: March 28, 2019, 07:30:16 AM »

Model Number 106
Event Date 01/05/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's mother that there was bruising around the incision site after the vns generator and lead were implanted. An additional phone call was later placed by the patient's mother. The patient's mother explained that the patient initially had a decrease in seizures right after surgery, from about 30 seizures/day down to about 5 seizures/day until (b)(6) 2016. On (b)(6) 2016, the patient had approximately 30 seizures, on (b)(6) 2016 the patient had greater than 50 seizures, and on (b)(6) 2016 the patient had nearly back to back seizures. The patient was taken to the er and the patient's following neurologist came down to the er and programmed the patient's vns on. The patient tolerated the stimulations. It was also reported the patient's mother had used the vns magnet to activate the vns several times on (b)(6) 2016 and noted the patient had done ok with the magnet stimulations. However, it was noted that the patient had some blotchiness on her face, neck, and chest but the cause of the blotchiness was unknown. The blotchiness was noted to come and go with seizures, but not all seizures. The dhrs for both the lead and the generator were reviewed and confirmed the devices passed all testing and were sterilized prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received showing the patient was actually hospitalized for 2 weeks, due to the increased seizures, beginning on (b)(6) 2016. It was also noted the vns magnet was used to temporarily disable to the device; however, it is currently unknown why this disablement occurred. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician who stated the bruising, increase in seizures, and blotchiness were not related to vns, and the office has since made titrations with no recurrence of the issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446622
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dennis100
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« Reply #97 on: April 07, 2019, 02:52:26 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had pain in their left ear all the time, but pain felt stronger during vns stimulation. It was reported that there was a lot of earwax removed, no inflammation, and that the pain is relieved when the patient lays down with a pillow against their ear. It was also reported that the patient experienced dyspnea and pain in left cheek and teeth. The physician decreased the patient's vns settings to prevent chronic nerve pain in the left cheek and teeth area. The patient's diagnostics were reportedly within normal limits. It was additionally reported that the pain occurred only during stimulation and became less severe. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424598
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dennis100
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« Reply #98 on: May 03, 2019, 02:06:30 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2016
Event Type  Injury   
Event Description
It was reported that a patient was having ear, jaw, and neck pain associated with stimulation. It was reported that the issues may also be psychological in nature. Follow-up to the company representative who was at the patient¿s appointment provided the physician attempted to change her duty cycle settings. It was reported she was in the office for over an hour and didn¿t like that cycle as well. She was still having sharp pain that comes from neck up to her ear and into her jaw, cheek and teeth. She has been to the dentist and her teeth are fine. Diagnostics were performed and were reportedly okay. Generator replacement surgery occurred on (b)(6) 2017. The explanted devices were discarded by the explant facility. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the physician provided the full revision was an intervention for the pain reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6296088
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dennis100
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« Reply #99 on: May 10, 2019, 01:56:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing an increase in seizures due to lowered vns settings. The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements. The patient stated that the generator tested ok, but questioned if there could be issues with the generator. The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains. After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke. The patient reported their neck was twitching and was swelling, and there was severe issues with talking. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557527
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dennis100
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« Reply #100 on: July 05, 2019, 11:16:54 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient was experiencing pain and was not tolerating magnet swipes. Clinic notes were provided and mentioned that the patient gets a left-sided pulling of her mouth and body twitching with every magnet swipe, along with headaches. This is said to have been going on for a few months. Clinic notes also mentioned that patient experienced an event where she was shaking, and her left lip was "drawn downward;" she was having difficulty using her left side upper extremities and her arm was painful. This was reported to have occurred after the magnet was used during diagnostics. The physician disabled the vns due to patient¿s episodes after magnet swipes. The patient stated that although the device was turned off, the "pulling" sensation on the left side of her face persisted, and she had tightness on the left side of her upper extremities. The patient was reportedly taken by ambulance to the hospital and admitted for one night. It was also mentioned in the notes that the patient is too afraid to use the magnet to abort seizures because of the mouth "pulling" sensation. The physician informed that the a surgery referral has been placed for patient comfort reasons. Additionally, the physician believes that the reported side effects may be related to the patient's pseudo seizures. The reason for the patient¿s hospitalization was not provided. 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=8676229
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dennis100
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« Reply #101 on: July 16, 2019, 11:26:50 PM »

Model Number 300-30
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 08/21/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A physician reported receiving an error message while interrogating a patient's device stating current could not be delivered. Diagnostics were performed on the patient's device and impedance was found to be high. It was noted that this was high impedance and indicative of a lead fracture. The patient's device was disabled and the patient was referred for surgery. It was noted that the patient was feeling tingling at the check and neck sites. A full revision surgery was performed. No device has been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877449
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