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dennis100
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« on: September 04, 2014, 11:01:59 PM »

Model Number 102
Event Date 10/24/2012
Event Type Injury
Event Description
On (b)(6) 2012, clinic notes from a vns treating physician were received. Clinic notes dated (b)(6) 2012, revealed that the patient was experiencing tachycardia with bpm in the 120's. The physician referred the patient to a local hospital for general peds evaluation and treatment of dehydration. If the patient failed to respond, the physician noted that cardiac evaluation and monitoring for autonomic instability may be warranted. 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=2862473
« Last Edit: February 11, 2018, 08:34:37 AM by dennis100 » Logged
dennis100
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« Reply #1 on: September 20, 2017, 01:10:07 AM »

Model Number 103
Event Date 03/01/2012
Event Type  Injury   
Event Description
It was reported by the patient that she was being evaluated by a physician and was to undergo a gi capsule enteroscopy because she had been experiencing constant diarrhea, starting in march. The patient reported loosing 15 lbs and being hospitalized due to dehydration because of this issue. It is unknown at this time if these events are related to vns and attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2662002
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dennis100
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« Reply #2 on: September 22, 2017, 01:04:13 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. 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 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 of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
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dennis100
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« Reply #3 on: September 22, 2017, 01:04:56 AM »

Model Number 102
Event Date 08/19/2011
Event Type  Injury  
Event Description
Additional information was received that the patient's cardiac issues were not related to vns, and that the patient did not really have any cardiac issues. No comment was made on the syncope. The physician will not be providing any additional information as he is very hipaa sensitive.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient had syncope and general arrhythmia. The physician feels that both events were related to dehydration but the role vns played in the event was not addressed. When the patient experienced the suspected syncope the patient had not eaten or kept himself hydrated. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2460592
« Last Edit: February 11, 2018, 08:35:21 AM by dennis100 » Logged
dennis100
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« Reply #4 on: February 11, 2018, 03:44:20 AM »

Model Number 102
Event Date 08/26/2011
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2012, this patient's settings were adjusted to reach more efficacious levels. Diagnostics on this day were within normal limits. On (b)(6) 2012, the patient was reportedly having an increase in seizures, lack of efficacy, voice alteration, and an increase in depression. The patient reported potentially having the explanted due to the adverse events.

Event Description
Clinic notes regarding this vns patient were received on (b)(6) 2012. Notes dated (b)(6) 2012 indicated that the patient presented with a major complaint of frequent migraines. These were occurring so often that the patient became dehydrated and was hospitalized numerous times in the past year. The patient had to have iv fluids and narcotics in order to control them. The patient and her husband both felt that the patient was having more migraines since vns implant. The patient came in to request that the device was turned down or off to see if this may have some effect on her migraine frequency. The patient's headaches were now almost daily and severe two or three times a week. The patient was largely in the right side of her head and was associated with an inability to stand noise, light, movement, nausea, and vomiting. The patient was seeing a physician for the migraine treatment at least one per month (or every other month). It was also noted that the vns had not seemed to help the patient's seizures. The exact seizure frequency was not known but that patient averaged, at least, anywhere from two to five generalized tonic-clonic seizures per month and six complex partial seizures per month. The patient believed these were less now than before although the previous frequency estimate was somewhere between four and five per month. The patient's settings were altered at this appointment. The physician noted that the changes would be turning the device to less than therapeutic levels. The physician also seriously doubted that it would cause any migraines. It was noted that the patient's medications were all associated with increase seizures in patients predisposed; however, the patient had more of a problem with the pain from migraines. The patient's settings from (b)(6) 2011 were provided. It was also noted that patient wanted her vns turned down or off. The patient's migraines seemed worse with vns. Notes dated (b)(6) 2011 indicated that the patient's severe migraines were worse and more frequent and that the patient had been hospitalized with migraines with dehydration. The patient's seizure and headache frequencies were also noted. Notes dated (b)(6) 2010 also provided seizure and headache frequencies and stated that the migraines may last up to four days. The patient felt that the partial seizure frequency had decreased. Notes dated (b)(6) 2010 indicated the patient's seizure frequency, but the text was illegible. It was written that the patient felt that the partial seizure frequency decreased. The patient's migraines may last up to four days.

Event Description
(b)(4). Attempts for additional information have been unsuccessful.

Event Description
Per the return product form, the device was explanted because the patient did not want it. Product analysis of the explanted generator found that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿pain with stimulation¿). The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. Based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Since a portion of the lead assembly (body) including the electrodes array section was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.

Event Description
On (b)(6) 2012, it was reported that the patient's settings were changed. The patient's neurologist felt that the patient had pseudoseizures and anxiety. The patient was requesting explant. Surgery is likely but has not taken place. Attempts for additional information have been unsuccessful.

Manufacturer Narrative
Analysis of programming history.

Event Description
Clinic notes dated (b)(6) 2013 were received indicating that the patient was referred for removal of her vns. The patient had three grand mal seizures per month on average. The device was disabled in (b)(6) 2012. The patient was currently having one grand mal seizure and one partial complex seizure per week. The patient had significant a significant medical condition of depression. The patient also presented with headaches. The headaches occurred daily. Associated signs and symptoms included phonophobia, photophobia, and scalp soreness. The headaches were incapacitating. Stress, phonophobia, and photophobia were possible exacerbating factors. The patient is continues to have migraines which she takes morphine for. The physician would like to find a different non-opioid medication to control the patient¿s headaches. Per the physician morphine had the tendency to lower seizure threshold in some patient and can cause rebound headaches.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2773585
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dennis100
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« Reply #5 on: February 11, 2018, 03:45:24 AM »

Model Number 101
Event Date 07/14/2011
Event Type Injury
Event Description
It was reported that the patient had been hospitalized, originally for dehydration. However, it was also indicated that the patient was being medicated for an increase in seizures as well. They are unsure if the patient's generator is at eos, however, the device has not been checked since (b)(6) of 2010. No additional information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2212584
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dennis100
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« Reply #6 on: February 11, 2018, 03:46:19 AM »

Model Number 101
Event Date 10/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information received from the patient's treating neurologist revealed that while he did not see the patient, he does feel that the any of the patient's issues were related to vns however further follow up is being performed with the patient's cardiologist. Good faith attempt to obtain additional information from the cardiologist have been unsuccessful to date.

Event Description
It was initially reported that a vns patient was in the hospital due to cardiac issues. The patient's heart rate was slow with several pauses and was hovering around 50 bpm. Later it was reported that the patient is experiencing issues with vomiting and nausea. The patient's caregiver is wondering if this is gastroparesis however this has not been officially diagnosed. Per the caregiver, the physician did not feel these events were related to stimulation as they began in (b)(6) 2011 and the patient has been implanted since (b)(6) 2002. The caregiver stated the issue could also be due to the group home where the patient resides. The patient started vomiting and had nausea since the first week of (b)(6) and would occur randomly throughout the day. Some days it would occur all day and others it would be occasional. The patient was taken to the hospital on (b)(6) 2011 due to dehydration from the nausea and vomiting. She was discharged on 10/14/2011 and prescribed zofran for nausea, and protonix, which appeared to help her, but by a few days later, it appeared to stop being effective. On (b)(6) 2011, she again went to the er due to dehydration and was then discharged that same day. On (b)(6) 2011, the patient was taken to the hospital due to nausea, vomiting and dehydration. At that time she was noted as having heart issues (bradycardia and tachycardia) so she was transferred to the heart hospital for treatment. She is currently stable with medication, but a pacemaker may needed. The cardiologist doesn't appear to want to implant a pacemaker due to the potential for infection given the location of the vns and does not want to implant on the right side due to a mastectomy 17 years prior (pre-vns), which also required radiation treatment. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2349080
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dennis100
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« Reply #7 on: February 12, 2018, 01:50:47 AM »

Model Number 302
Event Date 06/01/2007
Event Type Injury
Event Description
Since i was implanted with cyberonics, inc vagus nerve stimulator in 2007, i have suffered a series of adverse reactions. These included: weight loss over a 2 month period- requiring 2 hospitalizations for dehydration -due to anorexia and abdominal pain-; severe left ear pain requiring visits to my ent and subsequent lowering of the strength of stimulation; severe shortness of breath accompanied by airway constriction, and low blood oxygen levels requiring evaluation by a pulmonologist, pulmonary function studies, and a cat scan; sleep hypopnea demonstrated by polysomnogram and a choking sensation. I must use the magnet provided by cyberonics inc at least 75% of the time. The stimulator, which was implanted for trd, never seemed to relieve my depression. Dates of use: 2007 - 2008. Diagnosis or reason for use: trd. Event abated after use stopped or dose reduced: yes. Event reappeared after reintroduction: yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1033973
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dennis100
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« Reply #8 on: February 12, 2018, 01:51:46 AM »

Model Number 102
Device Problem No Information
Event Date 07/23/2015
Event Type Injury
Manufacturer Narrative
Supplemental report #1 inadvertently does not state the aware date. The aware date of the previous mdr is (b)(4) 2015.

Manufacturer Narrative

Event Description
It was reported that the patient's device was programmed on initially on wednesday (b)(6) 2015. On (b)(6) 2015, patient experienced nausea, vomiting and seizures. Patient visited the er and was found to have e-lye imbalance as well as low bp with systolic 80. Patient was given if fluids and mg++ and k+ and was sent home. Patient has not had further seizures but had vomiting again. Clinic notes form the er visit indicate that the patient's last seizure prior to vns implant was in (b)(6). Patient experienced two seizures on (b)(6) 2015 and two on (b)(6) 2015. Tests indicate that the patient has slightly elevated creatinine, secondary to dehydration. Patient had received almost two liters of fluid with improvement in her blood pressure. On (b)(6) 2015, it was stated that the patient is feeling better. Attempts for additional relevant information were unsuccessful to date.

Manufacturer Narrative
Suspect device udi: (b)(4). Additional manufacturer narrative and/or corrected data, corrected data: suspect device udi: (b)(4). The suspect device udi was inadvertently not provided in the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5016968
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« Reply #9 on: February 12, 2018, 01:52:36 AM »

Model Number 102
Event Date 01/24/2014
Event Type Death
Event Description
Additional information was received stating that the vns patient¿s death was not related to vns. Analysis of the returned generator and lead was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The generator was confirmed to be at end of service due to normal battery depletion. The depletion was an expected event as determined by the blc and battery voltage measurement. The module performed according to functional specifications. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Note that since a significant portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative

Event Description
The patient's explanted generator and lead were received for analysis from another device manufacturer. Analysis is underway, but has not been completed to date. During investigation of the reason for explant, a search of the patient's name on the internet identified that the patient passed away. The funeral home provided the patient's death certificate which indicated that the immediate cause of death was respiratory failure resulting from dehydration. Seizures disorder was listed as a significant condition that may have contributed to death, but did not result in the underlying cause. The relationship of the vns to the death is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3973684
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« Reply #10 on: February 12, 2018, 01:53:43 AM »

Model Number 102
Event Date 08/19/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the patient's cardiac issues were not related to vns, and that the patient did not really have any cardiac issues. No comment was made on the syncope. The physician will not be providing any additional information as he is very hipaa sensitive.

Event Description
It was initially reported that the patient had syncope and general arrhythmia. The physician feels that both events were related to dehydration but the role vns played in the event was not addressed. When the patient experienced the suspected syncope the patient had not eaten or kept himself hydrated. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2460592
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« Reply #11 on: March 01, 2018, 04:20:07 AM »

Model Number 102
Event Date 04/02/2012
Event Type Injury
Event Description
Product analysis was completed on the returned generator. 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 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 of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator.

Manufacturer Narrative
Suspect medical device corrected data; updated to patient.

Manufacturer Narrative

Event Description
Clinic notes were received for review in regards to a patient's pending generator replacement surgery. It was reported on (b)(6) 2012 that the patient was seen for follow up because he had a seizure two nights ago. He went to (b)(6). He is not on any seizure medications. The hospital gave him ativan. In the emergency room he actually did not have a seizure but came close to one. The patient was dehydrated and was fluid resuscitated and felt better and was discharged. He could not get his vns magnet to work. His vns device was interrogated and a diagnostic test is run, the impedance is ok and his settings are kept the same at current of 3. 00 and magnet of 3. 00. The site planned on sending the patient for a prophylactic generator replacement. The patient had their generator replaced and it is pending being received at the manufacturer for analysis. Good faith attempts are underway for further information about their reported seizure event.

Event Description
Good faith attempts have been made and no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2546141
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« Reply #12 on: March 22, 2018, 12:39:16 AM »

Model Number 103
Event Date 08/20/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 when it was reported that the patient had a follow-up visit with her nurse practitioner that day. The first interrogation of the device indicated that the device was "off, the output current was 0. 0ma, however the magnet output current was at 0. 25ma. The vomiting has "slowed up some" since (b)(6) 2012 and the patient has lost 40 pounds and has little appetite. There were 3,746 magnet activations captured on the device. The device was then programmed "on" to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec. System diagnostics were "ok" and the ohms was noted to be 3,580ohms.

Event Description
It was reported that shortly after the patient's vns stimulation was enabled immediately following initial vns implant surgery, the patient began vomiting. The physician indicated that he was unsure if the vomiting was occurring with stimulation, but he indicated it was likely. The patient was noted as not vomiting when the family swipes the magnet over the generator to activate extra stimulation to abort a seizure. The patient's family believes the patient is having a sensation in his stomach however the patient is nonverbal. The patient's vns was disabled for 3-4 days however when the stimulation was re-enabled, the patient was vomiting so much he became dehydrated and had an increase in seizures requiring hospitalization as a result. Vns diagnostics had not been run since surgery which were noted as within normal limits at that time. The patient's vns has been turned back off for the time being. Follow-up with the patient's neurologist found the patient has a dental abscess which she and the surgeon believe may be contributing to the vomiting with stimulation. They have asked the patient to have resolved and then they will resume vns stimulation. No medication changes were believed to have caused or contributed to the events. Attempts for the missing product information are in progress.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vns patient has lost 40 pounds and is vomiting. The patient's device was shut off except for the magnet settings. The physician questioned whether the leads could possibly be placed upside down. The patient was stated to have profuse vomiting when the device is on. It was reported that the patient's device has sporadically been on and off based on the patient's vomiting events. Currently the physician is thinking about turning the magnet mode off as well.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that the patient had the vns device turned off over a month ago by the surgeon because of vomiting. There are no plans to turn it on until the patient sees a gastro physician.

Event Description
It was again reported that since his vns implant, the patient has had serious stomach issues and has lost a considerable amount of weight. The patient, however, has had an improvement in seizure reduction. The patient was noted to have had persistent vomiting, changes in appetite, and weight loss.

Event Description
On (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time.

Manufacturer Narrative
Describe event or problem; corrected data: inadvertently stated "on (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time" instead of "on (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time" on supplemental report #1.

Event Description
On (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766219
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« Reply #13 on: April 12, 2018, 12:38:40 AM »

Model Number 102
Event Date 08/06/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, the physician's nurse reported that what the patient meant by "heart rate irregularities" was that the patient had a mitral valve prolapse which she has had for over 15 years. The nurse then sent a form which stated that the patient had tachycardia (part of the mitral valve prolapse event). The patient's heart rate prior to the event was 80-90 bpm and the blood pressure was 120/80. The mitral valve prolapse was found during an ekg and started 15 years go. The patient does not have any symptoms of an arrhythmia. The patient experienced increased depression prior to the arrhythmia and had caffeine intake prior to the arrhythmia. The arrhythmia did not correlate with the on time of the programmed device. The physician does not believe the arrhythmia is related to vns and he feels that it is anxiety related. The patient has had such episodes in the past. No interventions have been taken and the arrhythmia event has not recurred. The physician reported that the patient is unsure when the syncope first started. The physician feels it is related to dehydration and he had the patient hydrate. The syncope is not associated with stimulation and no causal or contributory programming or medication changes preceded the onset of the syncope. The patient has a medical history of syncope prior to vns. No further information was provided regarding the nerve damage.
 
Manufacturer Narrative

Event Description
On (b)(6) 2012, a medical status form for the patient was received dated (b)(6) 2012. It reported that the vns patient suffers from some neuropathy that is ongoing. It was also noted that the patient has ongoing heart rate irregularities and syncope. The syncope was stated to be sometimes in response to vns. The patient was also experiencing ongoing mitral valve prolapse (mvp), major depression, gastrointestinal disorder sometimes, gad (generalized anxiety disorder) with panic disorder, and a new onset of chronic pain/pain syndromes. Attempts for additional information have been made to the physician but no further information has been received to date. A battery life calculation was performed which showed 7. 38 years remaining until eri=yes.
 
Event Description
On (b)(6) 2012, the physician reported that the nerve damage was not related to vns stimulation or surgery. It was also clarified that the syncope was related to dehydration and not vns. No further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2722352
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« Reply #14 on: May 02, 2018, 01:57:18 AM »

Model Number 102R
Event Date 01/01/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 note that the patient was recently hospitalized for sepsis. It was noted that the patient presented dehydrated and in septic shock and has probably had a respiratory source. It was noted that the patient had quite a bit of cough and "chest rattling" with progressive shortness of breath prior to the hospitalization. The notes indicate that there is concern regarding dysphagia and possible aspiration pneumonia contributing to her respiratory tract infection and possible sepsis. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667641
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« Reply #15 on: May 10, 2018, 12:59:15 AM »

Event Date 08/11/2013
Event Type  Malfunction   
Event Description
It was reported that the patient was having extremely painful stimulation every five minutes when his generator turned on. This began on (b)(6) 2013, when the physician first turned on the generator. The patient was initially implanted on (b)(6) 2013. The patient stated that the pain occurred every on time after the 5 minute period and has not changed since (b)(6) 2013. The patient stated he would try to disable the stimulation with the magnet, but the pain was severe and his follow up appointment with the physician had been cancelled. Follow up with the patient's caregiver found that the patient had sever nausea and vomiting that weekend, for which the physician requested the patient go to the emergency room. The patient was severely dehydrated and the patient and caregiver believed that the vns may be causing these issues, so the device was disabled with magnet. It was stated that the magnet did not turn off the vns and only lessened the output current. Afterwards, it was stated that the patient and caregiver now believe that the nausea and vomiting are due to dental work that was performed two weeks prior as the patient has been sick ever since. The patient had several teeth pulled and was getting ready for dentures when he started getting sick. Attempts have been made for additional information; however, they have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3390838
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dennis100
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« Reply #16 on: July 18, 2018, 03:28:02 AM »

Model Number 106
Event Date 02/24/2016
Event Type  Injury   
Event Description
It was reported on (b)(6) 2016 that the patient has swelling at the chest incision. The patient was implanted on (b)(6) 2016. The swelling was described as raised and warm to touch. The vns device is not on. There is no neck swelling. Of note, the patient does cpt (chest percussion therapy) vest therapy. He did cpt the 1st day postop and there was some bleeding of the chest incision site, so since then the cpt therapy has been discontinued. Follow-up with the surgeon's office showed that the patient was seen on the 10th. It was determined that the patient had a seroma above the chest incision and antibiotics were prescribed as a precaution for any infection that may develop and the seroma was drained at the appointment. No infection was confirmed but the precautionary medicines were provided. The patient's home was instructed to give the antibiotics. No explant of the device is planned. On (b)(6) 2016, it was reported that the patient's lead wire is poking through the incision.
 
Event Description
The generator and the lead were explanted on (b)(6) 2016.
 
Event Description
Clinic notes received (b)(4) 2016 and dated (b)(6) 2016 states that patient has problems with lead. It was stated it was complicated by a small seroma which was evacuated 2 weeks ago. The patient returns today with a small portion of the vns lead extruding through the skin. This is in the area where the seroma had thinned out the wound. There is no sign of infection or drainage. The surgeon recommends revising the pocket in such a way that his leads will be placed back in the tissue deeper. Due to the patient's mental status, this will have to be done in the or. The patient's surgical intervention has not occurred to date due to the patient being hospitalized for pneumonia and dehydration.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient was taken to the hospital due to a hemotoma. The surgeon performed surgery that day to clean out the generator site due to the lead being exposed. System diagnostics performed at this surgery showed the device was working within specifications. It was reported on (b)(6) 2016 that the patient underwent a surgery that morning. It was stated that the patient had a hemotoma at the chest incision and the lead wire was still poking through the skin. The surgeon cleaned out the hematoma, covered the area in antibiotic powder and put a wound vac in place that he planned to keep in through the weekend. Per the nurse, the patient thrashed around a lot, picked at his incision site and they felt that was contributing to the problems.
 
Event Description
It was reported on (b)(6) 2016 that the patient is referred for explant as it appears that his body is rejecting the lead/generator. The patient now has an open incision. No confirmation of the explant surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529930
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dennis100
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« Reply #17 on: August 11, 2018, 12:52:33 AM »

Model Number 106
Event Date 06/23/2018
Event Type  Injury   
Event Description
Due to excessive throat irritation, my daughter was taken to the emergency room after not eating for over a week. She was diagnosed with dehydration through blood work at the hospital. Required two large iv bags of fluid. My daughter was unable to eat for about two weeks total and lost a lot of weight.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7681233
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dennis100
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« Reply #18 on: September 08, 2018, 12:47:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/27/2018
Event Type  Injury   
Event Description
A voluntary medwatch was received. Within the medwatch it was explained due to excessive throat irritation, her daughter was taken to the emergency room after not eating for over a week. She was diagnosed with dehydration through blood work at the hospital and required two large bags of intravenous fluid. Her daughter was unable to eat for about two weeks total and lost a lot of weight. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7791132
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dennis100
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« Reply #19 on: December 16, 2018, 04:09:13 AM »

Model Number 303-20
Event Date 09/12/2016
Event Type  Injury   
Event Description
It was reported on 09/20/2016 that the patient is experiencing a sore throat and has been choking on his food. Other side effects since his implantation surgery include his voice altering. When he drinks he feels like it is going down his left lung. On 09/14/2016 he stated he got a fever of 103. 9. He went to hospital, and found he had aspiration pneumonia and was dehydrated. No fever now. Was taught how to swallow to prevent aspiration but still doesn't help him. He states voice is still scratchy and vibrating. No redness or heat. Full neck swelling is better but incision swallow and lump is still there. He feels like someone is squeezing his esophagus. When trying to speak, he has to push really hard and use a lot of effort to get sound out. He feels like the lead is super tight. It was reported on 10/04/2016 that the patient cannot talk due to his vns surgery. He said his voice is slightly better, best in morning and gets worse throughout the day. Has to push air very hard to get sounds out. He states that he feels that the wire is too tight. If turns head to right and can feel it pulling. Had swallow study - any liquid gets stuck in back of throat and has hard time getting down to stomach. He states sometimes it goes down in lungs and coughs it out. Immediately post op he says he was dehydrated because he couldn't swallow. And he had aspiration pneumonia. He did state a x-ray was done by neurosurgeon who told him it was placed correctly. Patient thinks the surgery damaged one of the nerves coming off the vagus nerve. That he cut too far toward the front of the neck and nicked a nerve. Ent said that he has left vocal cord paralyzed and could take 6mo to 3 years to recover, but may not improve. He also recommended that vns be taken out. The vns is currently not programmed on. No known surgical intervention has occurred to date.

Manufacturer Narrative

Event Description
It was reported that the patient had a few problems since implant. The patient reported that his leads were hurting and causing a shocking pain in the neck area. As a result of the shocking pain, he experienced headaches. He also described a soreness in the neck area that he believed to be due to the shocking vns stimulation and the lead wire being too tight. No further relevant information has been received to date. No known relevant intervention has occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
The patient's surgeon has not seen them since surgery therefore no further information is known about the adverse events. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6028201
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dennis100
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« Reply #20 on: February 14, 2019, 02:14:28 AM »

Lot Number 202138
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that the patient's symptoms started when she presented to the emergency room in (b)(6) 2014 and was hydrated for dehydration. The patient was eating but not drinking, which then led to a feeding tube being placed in (b)(6). The patient was seen in (b)(6) 2015, and the patient's caregiver had no complaint of issues with stomach pains.
 
Manufacturer Narrative

Manufacturer Narrative
Patient identifier, corrected data: the initial report inadvertently reported this data incorrectly.
 
Event Description
It was reported that a vns patient with a j-tube placed recently, and her gastroenterologist physician thinks she developed gastroparesis from use of vns. Good faith attempts for additional relevant information have been unsuccessful to date. The reporter indicated that he has not verified that the gastroenterologist physician actually reported this, but the family interpreted it as such.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4513683
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