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dennis100
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« on: March 28, 2019, 07:45:11 AM »

Model Number 103
Event Date 03/19/2013
Event Type  Malfunction  
Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002
« Last Edit: June 04, 2019, 08:16:51 AM by dennis100 » Logged
dennis100
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« Reply #1 on: March 28, 2019, 07:46:07 AM »

Model Number 105
Event Date 04/11/2014
Event Type  Injury   
Event Description
Additional information was received. Clinic notes dated (b)(6) 2014 from surgery consult reported that the patient's generator was causing more pain and weakness than her previous device due to the size, which was worse if it was manipulated. The surgeon advised that the device was likely not the source of all of her pain and does not expect all of the pain to resolve after removal. No known surgical intervention has occurred to date.
 
Event Description
Additional information was received indicating that the vns patient¿s pain and rash was noted on (b)(6) 2014. The neurologist stated that the patient was too thin and that the device was bothering her. The patient¿s device was disabled but the patient¿s issues did not resolve. The patient¿s will be explanted for patient comfort but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the patient¿s issues were noted on (b)(6) 2014.
 
Event Description
It was reported that the patient has been complaining of painful stimulation and a rash at the generator site. The patient is going to see surgeon for device explant. Attempts to obtain additional relevant information have been unsuccessful to date. No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3801005
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dennis100
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« Reply #2 on: March 28, 2019, 07:47:15 AM »

Model Number 101
Event Date 12/10/2012
Event Type  Injury   
Event Description
Clinic notes from (b)(6) 2012 reported that the patient was admitted to the hospital with reason for consult as recurrent and exacerbated seizures with a history of intractable seizures. The patient was admitted the day prior to the consult because of weakness and exacerbation of seizures with the vns stimulator "acting up", according to the patient. The patient reported that she had about seven seizures in the prior two weeks. The diagnoses showed the weakness had an unknown etiology. She was admitted for further evaluation and treatment. The physician reported that the patient was no longer his patient, but the trouble standing the patient was experiencing was not related to vns. There were no causal or contributory programming or medication changes precede the onset of the patient's trouble standing. The plan was to check the vns battery operation which the physician reported was functioning properly and to check the level of the patient's anti-seizure medication, eeg and ct scan of the head. Later on (b)(6) 2012, the notes reported that the patient was now not having issues with seizures. The ct scan of the head was unrevealing, and medication levels were pending. When checking the vns generator, the physician indicated in the notes that he was having some "clinical difficulties reading her battery. It is certainly possible that the [vns generator] is down and needs to be replaced". However, the physician provided the patient's settings on (b)(6) 2012. A nurse at the hospital reported that a vns physician came to the facility to interrogate the patient's device. The physician reported that the device was functioning properly which was noted to be impressive as the device had been implanted for about 12 years. Due to insurance reasons, the patient is only evaluated if she is seen in the hospital. However, it was noted that the patient has not been evaluated in some time. The physician reported on (b)(6) 2013 that he does not know how the patient has been since being seen in the hospital in december. Additionally, the nurse indicated on (b)(6) 2012 that the patient's generator was low and inquired. Although surgery is likely, it has not occurred to date. Attempts for additional information regarding the increased seizures from the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967544
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dennis100
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« Reply #3 on: March 28, 2019, 07:48:28 AM »

Model Number 304-20
Event Date 03/15/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that vns patient feels that the generator is no longer working. Patient does not feel the auto stimulation anymore. Information received from patient neurologist visiting the patient that the battery seemed to be ok, and it looked like fibrosis. Additional information was received that vns system was interrogated on (b)(6) 2016 and high lead impedance found. Physician suspects' fibrosis. Further clarification was received from patient that they cannot feel the auto simulation which was every 5 minutes anymore but that could have been also because of body getting used to it. It was reported that patient got worried when they needed to use the magnet and haven't sensed anything after using it. Patient does not have increase in seizures. Additional information was received that when patient used the magnet during the aura they didn't need that longer period to recover and did not need to lie down to stop the seizure. During the last visit when high impedance found, device settings were change to see if patient could feel stimulation which was not the case and patient saw then programmed back to the previous settings. Patient trauma is not believed to have caused or contributed to the high impedance. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received from patient that on (b)(6) 2016 patient had quite a complex seizure in sleep. Type of seizure that patient didn't had for some period in which patient woke up from the bed, pushed himself back in bed with the hands and then started trembling (a normal part of the seizure). Patient reported they don't guarantee that the vns would have stopped the seizure if it would have worked but the chances would have been to be lighter. Patient reported that during the week before had almost daily problems which seems more like vertigos not epileptic seizures in which he doesn't loose conscience or tremble but needs to close the eyes because everything moves and also needs to lay down because of the feeling of loosing all the strength in the muscles. Patient had to call the ambulance and had blood test in the hospital but the vns system wasn't checked.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong suspect device for the event. Device manufacture date; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device manufacture date for the event.
 
Event Description
Additional information was received that patient had a follow up visit with their neurologist who found out that the connection between the vagus nerve and the vns isn't working. Patient was referred for surgery as it was concluded that there is no power in the battery. Patient underwent surgery on (b)(6) 2016. It was reported that during the surgery a lead break was observed and full vns system replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5519604
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dennis100
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« Reply #4 on: March 28, 2019, 07:49:25 AM »

Model Number 103
Event Date 01/08/2013
Event Type  Death   
Event Description
Analysis of the returned generator and lead was completed. An end-of-service (eos) condition was found with pulse generator. There were no performance or any other type of adverse conditions found with the pulse generator. There is no evidence to suggest an anomaly with the returned lead portion. Note that since a large portion of the lead assembly was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
An explanted generator and lead were received for analysis from another medical device manufacturer. The devices had been inadvertently returned to the wrong manufacturer. It was noted that the vns patient had passed away. It was noted that in the last several weeks the patient had been feeling weak and his breathing had stopped. The patient was unresponsive on arrival. No cause of death or relationship of the death to vns was indicated. It was noted that an autopsy was performed. No additional relevant information has been received to date. Analysis of the devices are underway, but have not been completed 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.
 
Event Description
This death information has been reviewed by the medical device manufacturer and with the available information has been determined to be possible sudep. It is not known what state of health the patient was in, or the manner of death, or the cause of death. The physician's office was unable to provide any information as they had no records on the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4167523
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dennis100
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« Reply #5 on: April 11, 2019, 10:13:10 AM »

Model Number 103
Event Date 08/09/2016
Event Type  Injury   
Event Description
It was reported the patient was having a significant drop in heart rate with every stimulation; 90 beats per minute (bpm) to 45 bpm. The patient's off time was temporarily lowered to 1. 1 minutes to see if the drop in heart rate could be timed. The company representative was at the appointment with the cardiologist when this was confirmed. It was unclear how long this has been occurring, but the patient had been reporting he was very tired. The cardiologist informed the patient that he needed to go back and see his neurologist to determine how to proceed. That patient has seen a dramatic improvement in seizure frequency, so they do not want to discontinue therapy. It was suggested that the physician's try to see if the heart rate issues have corresponded with any increased settings or medication changes.
 
Event Description
It was later reported the patient's vns frequency setting was reduced to 25hz and the pulse width was reduced to 130 usec. It was noted the patient's bradycardia improved. Instead of dropping into the 40 beats per minute range, her heart rate dropped to 60 beats per minute. However, the patient did have an increase in seizures due to the reduced settings. Due to the increased seizures, the vns settings were increased again, but the patient was unable to tolerate the increase. The current was reduced to what it was previously, and the patient still could not tolerate and began having chest pains. Clinic notes from the physician were later received, further describing the events and the adjustments listed above. Additionally, it was noted the patient's heart rate actually dropped into the 20-40 beats per minute range. Additionally, clinic notes from the surgeon were received and the surgeon discussed how the electrode array of the vns lead was already placed high on the patient's nerve, and he did not believe he would be able to place the lead any higher. The surgeon did not feel it was in the patient's best interest to undergo surgery at this time, as he felt he could not place the electrodes higher, so he suggested a pacemaker. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Describe event or problem; corrected data: "the surgeon had also noted that the patient had lightheadedness and feels ill when the vns stimulates and causes bradycardia. " this information was inadvertently left off of the supplemental #01 mfr. Report.
 
Event Description
The surgeon had also noted that the patient had lightheadedness and feels ill when the vns stimulates and causes bradycardia. It was noted the vns had impedance values within normal limits and that the neurologist does believe the bradycardia is due to vns as the bradycardia improved slightly when the parameters were adjusted; however, the patient had an increase in seizures due to the decreased vns therapy. The increase in seizures was still noted to be below pre-vns baseline levels. It was explained that the patient was unable to tolerate and increase in output current as she was having pain in her chest and coughing with stimulation. The settings were adjusted due to the reported pain and coughing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5931921
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dennis100
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« Reply #6 on: April 16, 2019, 01:23:39 AM »

Model Number 106
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a nurse that she has a patient, implanted recently with a gvns enerator model 106, who has suffered from vomiting and fatigue. The patient came on 2 visits where they respectively turned on and increased the output. On both visits, the patient suffered from vomiting and fatigue in the next days. After the second visit, the patient even was admitted in hospital. The patient's device was only programmed at 0. 5ma output current at that moment, and she was not coughing or anything during stimulation. It was reported that the nurse continued to increase the output and advised the patient to call if she feels the symptoms again and drink a lot. It was reported by the nurse that she was wondering this might be due dropping blood pressure. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Additional information from the nurse indicated that the patient was implanted on (b)(6) 2016. It was reported that the event started after the device was switched on, on the first visit. It was reported that the patient has no history of those events prior to vns implantation. No recent medication changes that could have contributed to the events. It was reported that the patient did not suffer with low blood pressure prior to implantation. It was reported by the nurse that she saw the patient on (b)(6) 2016 for a follow-up: she has not suffered anything other than fatigue since last visit when the nurse reduced the signal frequency to 20hz. However the patient is unable to tolerate any output higher than 0. 75ma. It was reported that any increase of the output current leads to coughing and gagging throughout the whole stimulation. No additional information was provided to date.
 
Event Description
Additional information was received from the nurse indicating that the patient's device settings were 0. 75ma output current - 20hz frequency - 250c pulse width - 7sec on time - 1. 8min off time 1. 8. It was reported that the device tests were run and system diagnostics returned impedance results within normal limits. It was reported that the patient had not been noted to have low blood pressure (bp) prior to implantation. On admission to the facility with the initial fatigue and vomiting, she was seen to have low bp. The nurse has not checked the patient's bp in clinic and the problem appears to have resolved since the reduction in signal frequency.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5969521
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dennis100
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« Reply #7 on: June 04, 2019, 08:18:10 AM »

Model Number 102
Event Date 08/12/2010
Event Type  Injury   
Event Description
It was initially reported by the (b)(6), that a call was rec'd from the vns pt's mother that her son was having fluid buildup around the vns device. Later, information from the pt's mother indicated that a pocket of fluid was right over top and around the generator. If they touch it, they can definitely feel the fluid, but do not know whether it is blood or fluid. She stated that it covers the whole generator. Her son is implanted with one of the bigger generators and normally they can see the outline of the device under the skin, however now they can't see it at all. The pt was not known to have had any trauma since the pt's sitter/sister are very watchful over the pt. There wasn't any bruising or redness in the area to suggest infection. The pt also had a low-grade temperature over the weekend prior and he was given otc motrin. There was no recurrence of the temperature. There did not appear to be any pain or any discomfort. The pt was also said to have been sleeping longer than before, which started before the site swelling. The surgeon opted to initially monitor the issue. Later it was indicated that the pt was referred for generator explant due to the swelling at the site and to rule out infection as a precaution. Additional information was rec'd from the surgeon's office. It was indicated in the clinic and op notes that the pt's cultures were negative and the wound was benign. The pt was said to be explanted due to the swelling at the site. It was not clear as to what caused the issues reported, but due to the possibility of infection, the pt's device was removed as safety precaution. The physician did not believe the device caused the infection. There was no pus or signs of infection. When asked about the reported fatigue and fever, the notes did not provide any indication of the issue, but was part of the reason he was referred for explant. It was said to have cleared up after explant, but there is no way to determine if it was related to the swelling. The pt was said to have been seen at the emergency room for the low-grade fever and lethargy. The pt was seen on 09/23 for f/u on the recently implanted generator and there was no observable infection. All appeared to be acceptable for the pt. The explanted pulse generator was returned to the manufacturer for analysis, which confirmed there was no device malfunction. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator. The manufacturer dhrs were searched confirming lead and pulse generator sterilization prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1846171
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dennis100
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« Reply #8 on: June 04, 2019, 08:18:49 AM »

Model Number 102R
Event Date 11/08/2010
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2010 were received on may 6, 2012 regarding this vns patient. The clinic notes allege that the patient's recent seizures have been different than those in the past. The patient reports doing things or having conversations after his seizures and then having no recollection of those events. Sometimes, he will wake up or become aware of his surroundings without knowing how he got there. The patient reports having pre-seizure activity one to two times per week. Occasionally, swiping his magnet will stop the seizure. The patient's last generalized tonic-clonic seizure was about one month ago ((b)(6) 2010). The patient's seizures are characterized as generalize tonic, clonic movements, deviation of eyes and head to one side and focal movements followed by generalized clonic movements. The seizures are preceded by an aura and followed by confusion and lethargy. The patient is having more difficulty remembering how he got to places, losing track of time, and his caretaker reports he just seems "out of it at times. " the patient has been incontinent at times but no tongue biting has been reported. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Review of programming/device diagnostic history performed.
 
Event Description
On (b)(6), 2012, a fax was received from the physician with information regarding the patient's change in seizure pattern from (b)(6), 2010. The physician stated that there was no relationship of the event to vns. The change in seizure pattern was not significant. The interventions taken included checking the patient's levels, educating the patient, and checking the vns. 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=2595567
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dennis100
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« Reply #9 on: June 04, 2019, 08:19:29 AM »

Model Number 103
Event Date 07/23/2013
Event Type  Death   
Event Description
It was reported that the vns patient died the month prior. No other information was provided. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the patient¿s immediate cause of death was ventricular fibrillation arrest and aspiration pneumonia with a contributory condition of dvt¿s (deep venous thrombi). No autopsy was performed. The patient¿s body was cremated and the device was not explanted prior to cremation. Approximately one month prior to the patient¿s death, the patient went to the er on (b)(6) 2013 due to increased lethargy and being unaroused. The patient improved during his work-up at the er, and it was the medical opinion that he was ¿most likely suffering from a postictal state that is recovering slowly. ¿ he was not admitted to the hospital and was released to return to his home with continuation of his baseline medications. The clinical impression was ¿altered mental status ¿ resolved¿. On (b)(6) 2013, the patient developed a high fever at the group home facility, seemed lethargic to caregivers, and was having a lot of coughing. The patient was experiencing respiratory failure with low oxygen saturation, a urinary tract infection, and evidence of pneumonia on a ct scan. He was given antibiotics based on his high risk for aspiration due to swallowing difficulty. An endotracheal tube was placed to facilitate oxygenation that markedly improved. The patient was admitted to the icu on mechanical ventilation and was in critical condition at the time of admission. Medical records of the hospitalization indicate that the patient was admitted with fever and subsequently diagnosed with pneumonia (aspiration related). The patient required intubation, he self-extubated , and was then re-intubated. It was decided by a caregiver to avoid extraordinary procedures and to offer comfort only support and he died a few days later due to sudden ventricular fibrillation and cardiac arrest.
 
Manufacturer Narrative
Date received by manufacturer; corrected data: this date on follow-up mfr. Report #01 was inadvertently reported incorrectly. The date should have been 09/15/2014 rather than 09/16/2014. The report was submitted within the 30 day deadline with the date change.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3342878
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dennis100
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« Reply #10 on: June 04, 2019, 08:20:05 AM »

Model Number 102
Event Date 08/31/2012
Event Type  Malfunction   
Event Description
Additional information was received that the patient was seen by a new neurologist who referred the patient for a generator replaced but did not have the reason. When asked it was said that it may be related to the may have been due to the "lithium battery" or the seizures but they had no information about the seizures or lithium poisoning only that they referred the patient to a neurosurgeon for a generator replacement good faith attempts with the patient's former neurologist have been unsuccessful to date.
 
Event Description
It was reported by the patient's mother that her son had been very lethargic recently and had been experiencing an increase in his seizures. She also reported that her son's white blood count was low and he was also diagnosed with lithium poisoning two months prior. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2851687
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dennis100
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« Reply #11 on: June 04, 2019, 08:20:47 AM »

Model Number 106
Event Date 12/22/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported by the by the patient that she was having painful stimulation and increase in seizures, dysphagia, and coughing. It was noted by the physician's office that the patient's increase in seizures were not above pre-vns baseline levels and that simple vns setting adjustments resolved the issues and were not considered as serious injuries. However, the patient called again reported painful stimulation, voice alteration, and the inability to turn vns settings up. Additionally, the patient stated she has a feeling of being hungover for 72 hours after every settings change, which is described as a post-ictal state, including symptoms of blurred vision, headaches, very tired and lethargic. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the physician's assistant that they started the titration really slow, but the patient is still having these dramatic reactions and always coughs every time the device is titrated, but the patient states she wants to continue programming the settings up. The patient is determined to get up to 1. 5ma because she knows these are getting into the therapeutic level, but the patient is currently still at 1. 0ma. The patient's seizures are noted to be about the same as pre-vns baseline levels and the patient is also on multiple medications and medical marijuana. It was noted that some of these issues may be in the patient's head. It was noted system diagnostics are always checked and the device is performing as expected. It was also explained that the patient has these same types of reactions with medication changes, too. It was confirmed the patient has not had any serious injuries and the only interventions which have been taken are setting changes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5889627
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« Reply #12 on: June 04, 2019, 08:21:22 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/18/2017
Event Type  Injury   
Event Description
It was reported that the patient was having an increase in seizure frequency and duration, along with lethargy and having a hard time speaking more than 1 word. The patient's mother reported that the medications were making the patient sleepy, and the physician noted that the patient was taken off of a blood pressure medication but the seizures continued. The patient was referred for prophylactic replacement to receive the newest model devices. No surgery has occurred to date.
 
Event Description
The patient underwent surgery on (b)(6) 2017. The lead and generator were replaced and the explanted products are not available for return and analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6790861
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« Reply #13 on: June 04, 2019, 08:22:12 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2017
Event Type  Injury   
Event Description
Report received that a patient experienced hypersomnolence and fatigue shortly after initial vns implant. The patient was reportedly very active prior to vns, but after therapy, he became unlike himself and chose to sleep if there were no activities to do. The patient's physician also reported that the patient might have a defect in his serotonin pathway which caused the vns to affect his sleep. The patient was later seen to be in a catatonic state. The physician reportedly disabled normal mode stimulation but kept the magnet mode feature on. She speculated that the change in behavior could be due to forced normalization. Further information was received from the physician that the patient presented with delirium and rigidity while appearing catatonic. She reported that she was looking into the possibility of a neuromuscular problem related to the general anesthetic used in vns surgery. The normal mode remained off. System diagnostics were not provided and no other relevant information has been received to date.
 
Event Description
Further information was received that the vns was turned back on. The patient returned to the clinic and was reportedly hallucinating and presented with a slight elevation of cpk. The physician reported that this might have been due to forced normalization which was previously speculated to be contributing to the patient's earlier behavior. The device was turned back off and the patient was prescribed a low dose antipsychotic. No further information has been received to date.
 
Event Description
Further information was received that the patient has continued to experience psychosis issues while the vns remained off. It was reported that the patient was seizure-free with vns and remained seizure-free with the vns turned off. Because of this, the physician no longer believed the psychosis was vns-related, although it was not known what caused the psychotic issues. No further relevant information has been received to date.
 
Event Description
Further information was received that the physician was unable to draw a conclusion between the patient's presentation of muscle spasms and fatigue/hypersomnolence and the finding of the patient's underlying psychotic issues. The physician indicated they were likely separate events. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6805431
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« Reply #14 on: June 04, 2019, 08:22:51 AM »

Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 11/01/2015
Event Type  Injury   
Event Description
It was reported that the vns patient has had adverse events ever since she was implanted. It was reported that patient has had earache and inflamed tonsils, especially on the left side, as well as terrible lethargy. It was reported that the device output current was gradually increased but the patient then complained of severe earache and pain in her tonsil, the output current was then decreased to 0. 50ma which relieved patient's pain tremendously. It was reported that the patient was treated for tonsillitis with earache, which treatment was inefficacious. Patient is planned for a week long in hospital tests at the beginning of march 2016. Additional information was received that patient has had episode of tonsillitis before vns implant, but not tinnitus. The pain started when the stimulation was switched on. The earache occurs when the device stimulates and continues. The patient was treated for tonsillitis because the tonsil was inflamed, but it was not necessarily diagnosed as tonsillitis. When the stimulation was switched on, the doctor could actually see it affecting the tonsil on the left. It was reported that device diagnostic test gave normal results.
 
Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data : the previously submitted mdr inadvertently did not provide the udi# of the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446723
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dennis100
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« Reply #15 on: June 04, 2019, 08:23:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/31/2018
Event Type  Injury   
Event Description
Clinic notes were received indicating the patient had an increase in seizure frequency. The notes indicated the [stimulator] stopped for unclear reason. The patient was reported to have increased lethargy some difficulty in speech and also seizures. He was admitted to the hospital. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910279
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dennis100
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« Reply #16 on: June 04, 2019, 08:24:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was admitted to the hospital due to issues including dysphagia, ataxia, weight loss of 10 pounds since (b)(6) 2018 (implant month of current vns generator), an increase in general tonic-clonic seizures and changes in neurological status: lethargy and muscle weakness. The patient's device was turned off to see if symptoms improved. The doctor believed that the patient may have an allergy to titanium. 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=7939263
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dennis100
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« Reply #17 on: June 04, 2019, 08:24:52 AM »

Model Number 102
Event Date 07/04/2011
Event Type  Injury   
Event Description
It was reported by the patient's speech pathologist that the patient had "severe oral dysphagia"; the patient also reportedly coughed what she ate. The patient had been admitted to the hospital for aspiration pneumonia, confirmed with a barium test. The mother believed that some of the issues could coincide with a fall the patient experienced. The mother later indicated that the patient was "seriously ill. " the patient was admitted to the hospital for chest pains, which was later diagnosed as pneumonia with aspiration into the lungs. The patient's muscles in her throat had weakened. Consequently, when she swallows, the matter goes into the wrong pipe, causing aspiration into the lungs. The patient's mother stated she had searched and saw that the vns may be causing some of these issues. The patient may have a tube placed due to the issues she is having. Later information from the patient's speech pathologist indicated that the patient's swallowing problems were the same when the device was on and off. The therapist stated she could not state whether the device was causing the swallowing issues, just that the issues were not made worse with stimulation. The mother again told the manufacturer of her daughter's issues. She stated that she could not say the vns was the cause of the problem, but that it could be a cause. The patient recently was not able to stand, was lethargic, and her head was going to one side. Also, the patient was not able to find objects 6 inches in front of her. Additional information from the patient's parents showed that for the past two years, the patient had had problems with choking, aspiration, fainting, low blood pressure, and pneumonia. They had initially believed these issues were due to ongoing dental issues, but after research on vns, they had conducted on their own, the vns may cause these issues. The father of the patient stated the settings had been decreased by 0. 25 ma every month, but they were afraid to disable the vns. The patient's last known settings and diagnostics show proper device function. Attempts for further information have been unsuccessful to date.
 
Event Description
It was noted by the patient's family that they had declined to replace the vns, once it had reached normal end of service, due to the dysphagia the patient experienced in 2011. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196460
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dennis100
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« Reply #18 on: June 04, 2019, 08:25:23 AM »

Model Number 103
Event Date 02/09/2010
Event Type  Injury   
Event Description
It was reported by the vns pt's mother, that the vns pt, who was implanted with the device on (b) (6) 2010, had experienced a syncope event, was very pale, not stable on his legs, and appeared lethargic. The device had not been programmed on at the time of the report of the events. Follow up with the treating physician revealed that the relationship of the syncope event to surgery/vns is unk, however, it was noted that the pt does not have a pre-existing history of syncope events. Additionally, it was noted that the pt "has autism and every change in his life is very difficult for him" and that the pallor, a lethargy were "probably not related to vns". No interventions have been taken for the events, the device has been programmed on, and the physician is in the process of titrating the settings up to therapeutic settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631437
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dennis100
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« Reply #19 on: June 04, 2019, 08:26:07 AM »

Event Date 09/25/2013
Event Type  Injury   
Event Description
It was reported that the patient experienced vomiting and lethargy on (b)(6) 2013, the same day the patient's vns device was replaced. It was stated that the patient would be seen in the emergency room on (b)(6), 2013. Follow up indicated that there was a possible relationship between these events and vns; however, nothing was directly noted. Additional follow up indicated that the patient has very low blood pressure and would be reaching out to the neurologist. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3438450
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dennis100
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« Reply #20 on: June 11, 2019, 01:23:01 AM »

Model Number 304-20
Device Problem High impedance
Event Date 07/19/2017
Event Type  Malfunction   
Event Description
Report received that a patient presented with high impedance. The patient's generator was replaced about two months prior to the high impedance being found. A system diagnostic test was taken after this replacement and showed normal functionality. Since that surgery, the patient had experienced an increase in seizures and fatigue. The patient reportedly had a seizure which caused her to fall at a time between the replacement and high impedance being found. The patient reportedly suffered a black eye from this fall, but it was not known whether this trauma damaged the device. Further information received that the lead pin was thought to be fully inserted although the pin being passed the connector block was not verified. Further information was received that the fatigue was related to the increased seizures. The assessment by the patient's nurse was that since there was a device issue, the patient had an increase in seizures. These additional seizures caused the patient to experience more fatigue. A review of the device history record indicated the lead had passed all quality inspections prior to release for distribution. No surgical intervention has occurred to date and no further relevant information has been obtained.
 
Event Description
Further information was received that the vns was turned off. This likely occurred about two weeks after the high impedance was seen per a reported scheduled appointment. The patient's mother reportedly wanted the vns to be explanted. However, it was reported that the desire for an explant was not related to the high impedance but instead related to the perception of lack of efficacy and the desire for the patient to try a new treatment. This explant was not related to the high impedance as the physician reportedly believed the patient always had efficacy from vns. No known surgical intervention has occurred to date and no additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6953886
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dennis100
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« Reply #21 on: June 13, 2019, 03:31:26 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2017
Event Type  Malfunction   
Event Description
Report received that a patient has felt his vns auto-stimulations more frequently than expected. The patient had reportedly been working with a robot in school and since then, the number of auto-stimulations have increased and the patient had felt more fatigued. The physician reportedly indicated that the auto-stimulation activations did not align with the patient's increase in heart rate. The physician decreased the vns heart rate detection sensitivity which reportedly decreased the number of activations. Further information was received that after the heart detection sensitivity was decreased, the patient presented with an increase in seizures. Diagnostics were reportedly okay, but results were not provided. The patient's mother was concerned that the robot had damaged the vns. No further relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7077344
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dennis100
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« Reply #22 on: June 19, 2019, 04:21:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported having an increase in seizures in the following months after implant (implanted (b)(6) 2016). The information received suggested the device was programed on shortly after implant and the neurologist made no changes at a follow up visit one month later but suggested the patient visit again in one year. Since then the patient visited a new neurologist who reprogrammed the device's settings. The patient reported improvement in focal seizures since the change as well as fatigue and some cognitive changes. No diagnostics or additional settings have been received to date. No additional or relevant information has been received to date.
 
Event Description
Information was received stating the patient's neurologist assessed the increase in seizures was due to the need for titration of settings and did not believe there was an issue with the patient's vns system. Autostim diagnostics were provided and indicated normal function. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7109367
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dennis100
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« Reply #23 on: June 19, 2019, 04:23:35 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/19/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported originally that the patient was having throat discomfort after his last replacement which he believed to be due to vns stimulation. Later on (b)(6) 2017 the patient was experiencing vocal cord paralysis and was having difficulty managing his airway after consulting an ent. With the magnet in place, the ent could see some movement in the left vocal cord only and the patient was better able to maintain his airway. With the magnet removed and vns back on, the vocal cord stopped moving and his oxygen saturations declined. The device was programmed off. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Later information from the physician provided on 10/25/2017 that the patient was experiencing urine retention, lethargy, difficulty eating and drinking, and needed oxygen support. He had been taken to the hospital for difficulty breathing and maintaining oxygen levels. On (b)(6) 2017 a lot of swelling was found in the throat and was admitted to the hospital a day later. On (b)(6) 2017 the patient was taken to the icu and was put on a ventilator and the airway was almost completely swollen shut. On (b)(6) 2017 the vocal cord paralysis was identified and showed improvement after using the magnet to disable vns. On (b)(6) 2017 movement was seen in both the left and right vocal cord although still partially paralyzed, the patient's stats were normalizing well. The device was turned off at that time. On (b)(6) 2017 follow-up with an ent showed a lot of movement was seen in vocal cord but still had partial paralysis. It was reported that the seizure frequency has actually decreased since turning off the vns device. Diagnostics performed by the company representative on (b)(6) 2017 were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7099705
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dennis100
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« Reply #24 on: June 28, 2019, 11:24:45 PM »

Model Number 106
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 03/19/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A company representative attended a clinic visit of a patient experiencing increased seizures and fatigue. The patient informed the nurse during the visit that he could no longer feel stimulation. Upon interrogation of the patient's device, a warning message was observed indicating that the output current was low and the 3ma output current could not be delivered as programmed. Impedance was within the normal limits during the clinic visit. A review of programming history revealed that the patient's generator had been programmed to high settings for nearly 1 year prior to the observance of the warning message. The nurse reported that the physician believed that the increased seizures and fatigue were related to the output current warning message. Clinic notes suggested that the warning message indicated that no current was detected. Due to the warning message, the physician reduced the programmed output current to 2ma. The patient then began to cough uncontrollably with stimulation, which he had not done since implant. The patient's settings were adjusted again. At a follow-up visit nearly one month later, the patient reported that he only had one short seizure since the initial visit. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7431519
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dennis100
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« Reply #25 on: July 20, 2019, 10:56:20 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/29/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the patient was experiencing fatigue symptoms and had been in and out of the hospital. The hospital has given them no answers as to what is causing this episode. The patient's medications have not changed, and the only thing different with his treatment is the new vns implant. The lethargic episode begins after oral medication is taken. The mother confirmed that the generator should be set to the same settings as patient's previous generator. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7944907
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