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Author Topic: Misc. Respiratory  (Read 309120 times)
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dennis100
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« Reply #810 on: January 06, 2018, 04:59:18 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/12/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a physician (b)(6) 2017 that they were disabling a patient¿s device as the patient has chronic airway obstruction, and it has been getting much worse lately. She does not think that vns is a part of it, but the patient will be getting a tracheostomy, which is also independent of the vns, but she would like to turn the vns off for this procedure, and will titrate the patient back up afterwards. The doctor then mentioned that this patient has been having some vocal cord swelling recently within the past few weeks, which might also be contributing to the intermittent airway problems. It was mentioned that this patient has had airway problems before having his vns implanted, but believes the vns is aggravating the vocal cords, causing them to swell, which may be exacerbating the airway issues for this patient. It was also mentioned that this was the opinion of the patient¿s ent. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140324
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dennis100
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« Reply #811 on: January 06, 2018, 05:00:21 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 11/20/2017
Event Type Injury
Event Description
It was reported that the patient had been hospitalized due to apneic events. When the vns device output current was disabled the issue resolved. The patient's neurologist assessed that the apneic events were caused by the output current being too high. The device has since been programmed back on to a reduced output current and the apnea stopped. Device diagnostics were reported to be ok. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7131928
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dennis100
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« Reply #812 on: January 08, 2018, 02:55:05 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/01/2013
Event Type Death
Manufacturer Narrative

Event Description
It was reported by a company representative that a vns patient was found to be deceased after an online obituary search. Follow-up to the physician by a company representative provided the treating physician was unaware of the patient¿s death and had not seen her in years and didn't have any further information. The state will not release the death certificate to the manufacturer. Additional relevant information has not been received to-date.

Event Description
Follow-up to the funeral home where services were performed provided the complicating factors and cause of death as: acute respiratory failure, (onset of 1 day), acute pulmonary emboli, (onset 1 day), acute deep venous thrombosis, (onset 2 months). Direct cause of death was, left leg cellulitis, skin necrosis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309339
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dennis100
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« Reply #813 on: January 08, 2018, 02:56:20 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/29/2016
Event Type Death
Manufacturer Narrative

Event Description
An online obituary search revealed that they passed away. The patient reportedly died in a hospital. The generator and lead device history records were reviewed and showed that all specifications were met prior to distribution. No additional pertinent information has been unsuccessful to date.

Event Description
The patient¿s discharge summary was received by the manufacture for review. The cause of death appears to have been respiratory failure following a previous admission and treatment for pneumonia. The patient was admitted in a hypoxic condition with minimal improvement. He was listed as do not resuscitate/do not intervene, so palliative measures were taken before the patient passed away. No additional pertinent information has been received to date.

Event Description
Communication from the servicing funeral showed that the patient's vns was not removed at the time of preparation. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6321985
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dennis100
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« Reply #814 on: January 12, 2018, 02:34:37 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/04/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was hospitalized due to bronchitis. While in the hospital it was noted that the patient also had bradycardia that was associated with vns stimulation. Additional information as received that the bradycardia was confirmed to have been associated with the vns stimulation based on timing and that it was asymptomatic. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7155480
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dennis100
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« Reply #815 on: January 14, 2018, 01:56:30 AM »

Model Number 105
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient had presented several adverse events: hoarse voice, inability to talk during stimulation, gasps for breath at the end of each stimulation, poor quality of life, reclusive, no social life/relationship/job. It was reported that the events started in 2014 after replacement surgery. Additional information was received indicating that those events were considered as serious because they impacted the patient's quality of life. It was reported that the events were solved after the modification of the device settings; now there is a better seizure control and better quality of life. It was reported that no patient history of the events prior to vns implantation, and no medication changes occurred that could cause or contribute to the event. System diagnostics were reported to return normal impedance results with impedance value of 2907 ohms. The output current was programmed at 1. 75ma. Review of manufacturing records confirmed that both, the generator and the lead passed, all functional tests prior to distribution. No additional relevant information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5636447
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dennis100
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« Reply #816 on: January 14, 2018, 01:57:09 AM »

Model Number 102
Event Date 09/24/2009
Event Type Injury
Event Description
It was initially reported that the patient recently had a seizure, which was uncommon for him as he has been more controlled recently. It is unclear what his current seizure frequency is to that of his pre-vns levels. The patient was said to have been admitted to the er and hospitalized for 24-hours, due to "breathing and cardiac issues. " the patient's settings were said have been changed. 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=1514065
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dennis100
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« Reply #817 on: January 20, 2018, 02:47:44 AM »

Model Number 103
Device Problem No Known Device Problem
Event Type Death
Event Description
Information was received from the physician indicating that the patient passed away (b)(6) 2016. The patient had respiratory issues earlier on the day of death and passed away later in their sleep. A battery life calculation was performed and indicated that 0. 1 year were remaining on the patient's generator as of 06/01/2016. The last known diagnostics were within normal limits. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6322386
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dennis100
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« Reply #818 on: February 02, 2018, 03:19:34 AM »

Model Number 103
Device Problems Energy output to patient tissue incorrect; No Known Device Problem
Event Date 12/02/2014
Event Type Injury
Event Description
The patient's neurologist stated that the patient was a very sick child and he did not believe that vns caused the aspiration pneumonia however he was not the treating physician at that time. No other relevant information has been received to date. The explanted product has not been received to date.

Event Description
Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. An electrical load was attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 999 volts during functional testing and showed an ifi=no battery status. The internal device data showed that 5. 725% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portion. Note that the majority of the lead body - including the electrodes - was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. There is no evidence to suggest an anomaly with the returned portion of the device.

Manufacturer Narrative

Manufacturer Narrative

Event Description
The patient's explanted lead and generator were received by the manufacturer. Product analysis is currently underway. No additional pertinent information has been received to date.

Event Description
The patient's device was disabled due to the worsening of the patient's sleep apnea and breathing issues. A programming history review was performed and identified that the patient's device had been disabled on (b)(6) 2014. The most recent diagnostics from (b)(6) 2016 were normal. No further information has been obtained to date.

Manufacturer Narrative
(b)(4).

Event Description
The father of the patient reported also reported that the patient developed aspiration pneumonia which required having a feeding tube placed after the patient's vns was implanted. During the phone call the father reported that the patient's more recent breathing issues started 6 months ago when the family purchased a medical bed. The father believed that the vns and the medical bed were interacting causing the vns to fire resulting in the breathing issues. To mitigate the breathing issues the patient's the father placed a yoga mat between the patient and the bed in case there was any interaction between the devices causing the issue. The temporarily resolved the patient's breathing issues. The father based his conclusion that the vns was delivering current on the fact that the patient reached to their neck when the breathing issues occurred and an electrical tester that the father bought which indicated current was flowing when the father placed the tester on the patient's neck. The father also indicated the bed is putting out an electrical field/ magnetic field and the house has ¿tp links¿, which runs internet signal through electrical system which the father believes this may be a contributing factor. Settings from (b)(6) 2016 show that the patient¿s device was set to an output current of 0ma. The manufacturer of the medical bed was contacted and it was determined that the medical beds wireless remote operated in the frequency range of 315 hz which is well below the threshold where vns operates, 30khz to 100 khz. The father expressed desire to have the vns removed. The patient¿s vns was explanted on (b)(6) 2017. The explanted device has not been received to date. The surgeon who performed the explant indicated that he believed that the vns was not causing the patient¿s issues but he did not have definitive proof. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6240508
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dennis100
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« Reply #819 on: February 06, 2018, 02:36:27 AM »

Event Date 01/30/2006
Event Type Injury
Event Description
Our (b)(4) office was contacted by the solicitors office in (b)(6) asking for some information in regards to a vns pt and a road traffic incident. It was reported that they had temporary paralysis of the left vocal cord. Her physician believed that the impact caused her seatbelt to press against her with force causing trauma to her vagal nerve and causing the vagal nerve stimulation device to be moved resulting in throat problems. Additional information was rec'd that the pt had their vns implanted 10 years ago and a generator replacement was done in 2005. The pt had no problems with her vns until she was in a road traffic accident on (b)(6) 2006 when their car was hit by another car. She was a passenger in the back seated in the middle and got severe impact from her safety belt. She developed lower lobe pneumonia in hospital. The day she had the accident she also started to suffer from micro aspiration, choking episodes, reflux, problems swallowing, sore throat, gasping for air when talking and a throat clearing cough. The pt's implanting surgeon reported that the trauma caused the side effects after the accident. It was additionally reported that they checked the device and it is still stimulating. Good faith attempts are underway for further details surrounding this event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2083000
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dennis100
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« Reply #820 on: February 09, 2018, 03:21:25 AM »

Model Number 103
Event Date 05/15/2011
Event Type Death
Event Description
On (b)(6), 2011 the patient's death certificate was received by the manufacturer. The patient's immediate cause of death was listed to be respiratory failure, chronic respiratory failure, asthma, and cerebral palsy. The death certificate said there was 9 years between the onset of the patient's chronic respiratory failure and the patient's death, there was 8 years between the onset of the patient's asthma and the death, and there was 9 years between the onset of the patient's cerebral palsy and the patient's death. The patient's death was listed as natural. Good faith attempts for additional information regarding the relationship of the patient's death to vns were to no avail; no further information was received from the patient's nurse practitioner.

Event Description
On (b)(6) 2011, a vns treating nurse practitioner reported that a vns pt passed away. No other info was provided. It was discovered that the pt died on (b)(6) 2011, at her home through her obituary. Good faith attempts for additional info have been to no avail thus far as the nurse practitioner has been unable to get further info about the pt's death from the pt's mother. The pt could have possibly died from sudden unexplained death in epilepsy. If additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2155718
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dennis100
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« Reply #821 on: February 09, 2018, 03:22:18 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 01/04/2018
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that during a new patient implant the patient became tachycardic with heart rate 145 bpm and that the generator intermittently sensed the patient's heart rate. After the procedure information was received indicating the anesthesiologist had difficulties maintaining oxygen saturation levels during the surgery and the patient continued to have issues after the surgery. An x-ray was performed and indicated the patient's lungs had collapsed. No x-ray was taken pre-operatively with which to compare the patient's lungs; however, the surgeon indicated this may be related to a pre-existing condition for one of the lungs. The patient's father stated that the patient had a history of low oxygen saturation at night. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7205750
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dennis100
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« Reply #822 on: February 09, 2018, 12:10:21 PM »

Model Number 102
Device Problem No Known Device Problem
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported via social media comment by the patient that the vns would make it harder for the patient to breathe when stimulating, which would cause the patient to have a seizure. The patient's vns generator was explanted when the patient underwent brain surgery. The explanted generator has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7192108
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dennis100
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« Reply #823 on: February 09, 2018, 12:11:25 PM »

Model Number 106
Device Problem No Known Device Problem
Event Date 12/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
The surgeon's office reported that patient is being referred for replacement or explant because the patient is having "issues with her device. " additional information was received that the patient has upper respiratory issues that she thinks are related to vns. The issue was reported to be long standing. The patient's neurologist does not feel it is related to vns and did not refer the patient to see the surgeon. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7170155
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dennis100
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« Reply #824 on: February 21, 2018, 02:23:42 AM »

Event Date 01/01/2002
Event Type Injury
Event Description
From the november 2011 issue of neurology reviews, an article written by jack baney titled "vagus nerve stimulation may reduce seizures in young children" indicated that three patients reported adverse events including "cough, gag, hypopnea, dystonia, and delayed surgical site infection. " all patients involved with the study were implanted between (b)(6) 2002 and (b)(6) 2009 and were younger than 12 years old at the time of implant. Follow-up with the study co-author noted in the file found that he "not able" to provide any information. It is unknown how many of the three patients experienced each event noted due to the wording by the author. No patient or product information is known for any of the patients. This report is to address the third of the three patients.

Manufacturer Narrative
Baney, jack vagus nerve stimulation may reduce seizures in young children. Neurology reviews 19. 11 (2011): 12. Print.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2416004
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dennis100
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« Reply #825 on: March 04, 2018, 01:39:40 AM »

Model Number 300-20
Event Date 04/24/2001
Event Type Injury
Event Description
The patient had generator and lead explant surgery on (b)(6) 2014 to undergo other indication treatment. The explanted products were discarded.

Event Description
Clinic notes dated (b)(6) 2014 reported that by the patient¿s report, she had occasions of unilateral vocal cord paralysis following vns procedure. Subsequently, she seemed to stabilized after undergoing a vocal fold injection procedure. The vocal folds were evaluated to be bilaterally mobile with exhibition of mild edema. The patient presented with report of progressively worsening breathing difficulties. The vns generator was programmed off to 0ma which the physician evaluated may provide some immediate relief with respect to the breathing issues. It was previously reported that the patient had vns programming changes made due to tolerability issues including with subtle hoarseness during stimulation but was tolerated. A note from (b)(6) 2007 indicated the patient had increasing breathing problems and was unknown if related to a recent increase in settings. Later in (b)(6) 2008, the patient felt the breathing issues were related to vns and as a result did not want to increased settings. In (b)(6) 2008, the treating physician indicated the patient¿s asthma was worse and unknown if related to vns at that time. The patient's previously treating physician who managed the vns treatment has retired.

Event Description
Operative notes from explant surgery on (b)(6) 2014 were received and indicated that the pre- and post-operative diagnoses was dyspnea and chronic laryngitis. The indication for procedure detailed that the patient developed chronic laryngitis with symptoms of constriction of the larynx after vns implant, which may be related to the vagal nerve stimulator lead. The surgeon noted that they had concerns that the vagal nerve stimulator may be ¿inappropriately activating the recurrent laryngeal nerve. Because of this, the device will need to be removed. " the generator (including surrounding scar tissue) and majority of lead were explanted; all of the electrodes were not explanted, ¿recognizing the risk of additional dissection was certainly not warranted by any benefit of harvesting additional nerve lead wire. ¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102898
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dennis100
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« Reply #826 on: March 06, 2018, 03:53:08 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 05/07/2016
Event Type Death
Event Description
It was reported that a patient passed away due to unknown causes. It was later reported that the patient's official cause of death was respiratory failure. The patient's devices were not explanted prior to funeral services. The patient's implanting surgeon did not know if the patient's death was related to vns. No programming anomalies were observed in the patient's available programming history. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6483212
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dennis100
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« Reply #827 on: March 09, 2018, 04:00:42 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/12/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was having issues with the vns. It was stated that the patient was experiencing asthma, tightness, and a tight throat while attempting to eat during stimulation on times. The vns was previously disabled due to these events, but then was programmed back on. Follow up with the physician's office revealed that the patient stated that she previously had asthma when she was younger and was diagnosed with mild seasonal asthma, but that it had increased. It was unclear if the increase coincided with the implantation of the vns. It was reported that the patient was on oxygen and had a pre-existing pulmonary dysfunction and that the patient's test results were very abnormal. It was stated that the patient may have chronic obstructive pulmonary disease, or copd. The patient stated that she had difficulty swallowing with vns stimulation due to the tightness, but the patient also experienced difficulty breathing through her nose previously, which was why the patient was on oxygen. The patient stated that she was on oxygen immediately following the vns implantation surgery due the pulse ox readings being so bad. The patient was forced to discontinue oxygen use previously due to insurance issues, but upon recently getting back on oxygen, stated that she felt better. The patient had previously been on steroid inhalers and then an asthma disk. The patient reported that she sometimes anticipated the stimulation, would tense up, and then have difficulty swallowing or drinking. However, it was stated that when she was sitting, the patient was fine and did not even perceive stimulation. The patient felt that she anticipated the previous vns on time and that it was too long. The patient was referred for a swallowing study and would also have a ct scan. The patient's stimulation on and off times were reduced to shorter periods and the output currents were increased. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7299811
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dennis100
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« Reply #828 on: March 09, 2018, 04:01:24 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 07/06/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported through a study adverse event form that a patient's vns was disabled due to laryngospasms. The severity of the laryngospasms was marked as severe and life-threatening. No clarification as to why the event was considered life-threatening has been received to date. As a result of this event, the patient discontinued the study. After the vns was disabled, the problem resolved. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7290396
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« Reply #829 on: March 09, 2018, 04:02:07 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 07/25/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns explantation surgery due to a lack of efficacy. However, clinic notes were received by the manufacturer that indicated that the patient experienced pain and difficulty breathing and would like to have the vns removed. The patient's settings were reduced until the vns was disabled. The patient has experienced no significant interval worsening in seizure control or mood since the settings began to be reduced. It was reported that the patient's seizures were slightly improved with the same aed regimen and the decrease in output currents. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7293758
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« Reply #830 on: March 13, 2018, 01:42:46 AM »

Model Number 304-20
Event Date 07/20/2012
Event Type Injury
Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental emdr #1 indicated that the new information was received on (b)(4) 2012; however, the information was received on (b)(4) 2012. This report is being submitted to correct this information.

Manufacturer Narrative

Event Description
On (b)(6) 2012, additional information was received that the patient had reported vocal cord paralysis and an increase in seizures to the physician on (b)(6) 2012. The patient was scheduled for follow-up in (b)(6), but did not attend the appointment. No additional appointments were scheduled to date. No information was available regarding the increase in seizures or the alleged vocal cord paralysis. Programming history was reviewed. Settings and diagnostic results were available for (b)(6) 2012.

Event Description
On (b)(6) 2012, it was reported that the patient could not feel stimulation since the device settings were reduced. It was also stated that there may have been some sort of vocal cord paralysis; however, it was unknown if it was temporary or permanent but was related to the adverse events the patient was experiencing. The patient's physician believed that the patient could not feel stimulation as the patient had become acclimated to stimulation and no device malfunction was suspected. The patient could not feel normal mode stimulation; however, it was unknown if the patient could feel magnet mode stimulation. Additional follow up on (b)(6) 2012 showed that the patient was doing a lot better. Diagnostics were okay (no values were provided), and the patient still did not feel stimulation. The patient underwent revision surgery on (b)(6) 2012. After the surgery, the patient was unable to tolerate the previous settings. The patient complained of pain in the throat and some difficulty breathing. The patient's normal mode output current and magnet mode output current were lowered to 1. 25ma and 1. 50ma, respectively, and then again to 1. 00 ma and 1. 25 ma. The patient was reported to be tolerating these settings well.

Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Operator of device, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the generator; however, this is actually the lead. This report is being submitted to correct the aforementioned fields. Review of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2722223
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« Reply #831 on: March 16, 2018, 01:55:44 AM »

Model Number MODEL 250
Event Date 08/20/2012
Event Type Malfunction
Event Description
On (b)(6), 2012 it was reported that on (b)(6), 2012 the patient had his vns checked and when the wand was against the device and diagnostics were performed, it transmitted two times of the programmed output. The patient stated that he doubled over, stopped breathing, and his heart stopped for about a minute. While driving home the patient stated that it did it again and at home one other time before he returned to the physician who had it fixed and re-programmed the patient to the correct settings. The patient noted that he had his magnet taped over his device until he was able to see his physician again to get the settings corrected. The physician later clarified that the patient is very sensitive to parameter changes and when the physician performed the system diagnostics, which runs at higher settings than the patient is used to, the patient immediately had painful stimulation and reacted badly so the physician aborted the test. Instead of stopping the test by pressing cancel on the screen, he removed the wand from the patient's generator. The physician did not do a final interrogation prior to the patient leaving the clinic visit. Later that day the patient returned reporting that his vns wasn't set to the correct settings and when the physician interrogate the patient, the patient was set to output=1ma/frequency=20hz/pulse width=500usec/on time=30sec/off time=60min which are the settings that the system diagnostics test runs at. The physician then corrected the patient's settings by programming the patient back down to an output of 0. 5ma and adjusted the other settings appropriately, settings not provided. The physician also stated that the patient only felt painful stimulation, there was no asystole or syncope experienced by the patient during the visit and the physician feels that the reports were likely exaggerated by the patient.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2746524
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dennis100
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« Reply #832 on: March 19, 2018, 02:16:29 AM »

Model Number 103
Event Date 09/17/2012
Event Type Injury
Manufacturer Narrative

Event Description
A nurse practitioner reported to our field representative that they had a vns patient who had their device implanted in (b)(6). The patient was doing fine with vns, up until 2 days ago, when the patient started complaining of excessive stimulation which then made the patient experience nausea and vomiting. The physician recommended to tape the magnet over the device. The patient did that, which was fine for about an hour, but then started experiencing excessive stimulation again after that. The patient had their vns disabled on (b)(6) 2012. The patient described that when she first started to experience this, she initially taped the magnet over the device and for about 1. 5 hours the device was completely off and she did not experience this. But after that 1. 5 hours, she started to feel nauseous again and vomited. Since disabling the device, the patient has had none of the same problems. The patient just has some minor soreness in her throat which appears to be residual. Diagnostics (normal, system, and magnet) and all the diagnostic results were ok, and within normal limits. The normal mode diagnostic showed communication ok/ lead impedance ok/ 3453 ohms /no. The patient's device is currently disabled, and prior to the disablement the settings were at: 0. 75 output current / 30 hz /500 pw / 30 seconds on time/5, minutes off time ,1. 0 ma / 60 seconds on time / 500 pw. The patient additionally reported that she is supposed to swipe her magnet every day, and after she did so yesterday ((b)(6) 2012) she began experiencing irregular stimulation that was going off anywhere from every 20 seconds to every 1. 5 hours. She was clear that the problems only occurred after she swiped the magnet. She stated that her stimulation is supposed to go off every 5 minutes for 30 seconds so she knew this was not right. The patient explained that with the erratic stimulation, she was experiencing pain at the back left side of her throat, and along with the pain she was vomiting, couldn't breathe, and her heart rate would increase to 150. As she was explaining this, she confirmed that the events were occurring with stimulation, aside from the vomiting that was a result of the pain. The patient reported that she had not had any medication or any external factors changes recently. She also confirmed that no trauma or manipulation had occurred prior to these events. The patient additionally reported on (b)(6) that after having vns implanted she was seizure-free for 4. 5 months, but last week had 2 tonic-clonic episodes. It is likely their device was disabled at this time. Therefore the patient was not receiving vns therapy. The patient's device may be kept off for a couple of weeks and the patient reevaluated to turn it program it back on at a later date.

Event Description
On (b)(6) 2012, additional information was received indicating that the patient had been seen three weeks prior and none of the previously reported symptoms had been observed. Per the patient they had all resolved. Follow up with the physician's office indicated that the patient's seizures were well controlled with vns. It was indicated that the pain was believed to be caused by stimulation as it correlated with on times. This pain then caused the patient to vomit. The patient went to the er on (b)(6) 2012 for these symptoms. They met her in the er and turned the device off. When the device was disabled everything resolved. It was indicated that the device may have been stimulating irregularly. The last programming and medication changes occurred in (b)(6). It was also indicated that the patient had no medical history of any of the events and that everything was fine from (b)(6). The physician's office was uncertain if there had been any manipulation or trauma to the device. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was obtained on (b)(6) 2012. It was indicated by the patient's neurologist that the anatomical location of the painful stimulation was left neck and the patient had no manipulation or trauma that could have caused or contributed to the painful stimulation. The physician indicated that he was unaware of the arrhythmia occurring and the patient was seen at an emergency for the arrhythmia. The patient had no prior history or family history of any cardiac events. Per the physician the patient did not experience any traumatic events or triggers prior to the onset of arrhythmia. The physician believes that patient's arrhythmia is not due to medication changes and has no information if the arrhythmia is related to vns therapy. On (b)(6) 2012, the patient's vns was irregularly going off as reported by the physician. The patient had a shocking sensation with very high intensity. The patient's device was turned off to preclude a serious injury. On (b)(6) 2012, the patient's device was turned back on and the programmed settings and diagnostic results appeared to be normal however the diagnostic test results were not provided. On (b)(6) 2012, the patient's device was reevaluated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2788235
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dennis100
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« Reply #833 on: March 21, 2018, 03:21:18 AM »

Model Number 102
Event Date 09/02/2012
Event Type Injury
Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.

Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2769409
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dennis100
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« Reply #834 on: April 07, 2018, 01:32:56 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 02/22/2018
Event Type  Injury   
Event Description
It was reported that the patient stopped breathing for a second when a system diagnostics test was performed during a new patient implantation surgery. A system diagnostic test was performed again with a lower output current and the event did not occur again. There was no reported issue with the device. There was no associated change in heart rate during the event. The patient's neurologist stated the patient did not have a history of apnea and that there was no obvious etiology of the apneic event. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7342790
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dennis100
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« Reply #835 on: April 08, 2018, 01:17:54 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 02/13/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes indicated that a patient was referred for generator replacement surgery after experiencing an increase in seizures. The patient's generator showed a 25% battery life remaining indicator. Follow-up with the nurse indicated that the patient's seizure increase was above her pre-vns levels. The cause of the seizures was unknown. The patient later reported experiencing breathing problems that she believed were related to depletion of the battery. Programming history was reviewed for the patient's generator. Diagnostics from a clinic visit 6 months prior to the reported increased seizures were within the normal limits. The patient underwent lead and generator replacement surgery. The company representative attending the surgery indicated that the generator battery was low, but she could not remember the battery status indicator she observed. The explanted devices have not been received by the manufacturer for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7345047
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dennis100
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« Reply #836 on: April 15, 2018, 12:45:44 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 03/22/2010
Event Type  Death   
Manufacturer Narrative
No conclusion can be drawn.
 
Event Description
The patient's death event has been reviewed and with the available information has been determined to be possible sudep.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was "all other causes, bronchopneumonia (unspecified), hypothalamic dysfunction (not elsewhere classified), other and unspecified abnormalities of breathing, coma (unspecified). " a sudep (sudden unexpected death in epilepsy) evaluation was performed which determined that the death had no sudep indicators. There is no allegation or other information indicating that the death is related to vns. Based on the cause of death, there is no suspected relationship between cause of death and vns.
 
Event Description
It was reported on (b)(6) 2013 that the patient passed away on (b)(6) 2010 from unknown causes. The programming history database was searched and the patient was last programmed on (b)(6) 2010 to: output - 1. 75ma/frequency - 30hz/pulse width - 500 microseconds/on-time - 30seconds/off-time - 3 minutes/magnet output - 2 ma/pulse width - 500 microseconds/on-time - 60 seconds. On (b)(6) 2010 system diagnostics were performed which showed output status - ok/ lead impedance - ok/dcdc - 1/eri - no. According to the department of vital records in the state the patient passed away in, the manufacturer of the patient's medical device is not eligible to obtain a copy of the patient's death certificate. Good faith attempts were made for further information but it was later reported by the physician that no records were obtainable or available in their system for this patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3086325
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« Reply #837 on: April 15, 2018, 12:46:28 AM »

Model Number 103
Event Date 04/04/2013
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that this vns patient died on (b)(6) 2013. The patient was implanted on (b)(6) 2013, and surgery went well. The next day, the patient had a fever and breathing issues. The family called an ambulance, and the emts attempted to resuscitate the patient but were not able to. The cause of death was unknown. The device was not explanted. The device was not programmed on at the time of surgery. The surgeon and neurologist did not think that the death was related to vns. The physician stated that the patient was declining in health for over a year. Follow-up with the patient's neurologist showed that the cause of death was cardiopulmonary arrest and probably sudep. The relationship of the patient's death to vns therapy or surgery was undetermined. The patient did exhibit risk factors that would make him more susceptible to sudep. A death form from the physician indicated that the patient's concurrent illness was a chromosome 2 deletion and encephalopathy with global delay/regression. No autopsy was performed. The death was witnessed by the patient's mother and did not result from trauma. The patient was found pulseless, not breathing, and unresponsive. Cpr was attempted but was unsuccessful. The patient was age one at the onset of epilepsy. The patient had a history of nocturnal and febrile seizures. The patient's seizure types and frequency (per month) were provided: simple partial: 30+, 2nd generalized: 50+, complex partial: 30+, gtc: 15. The patient had a history of respiratory suppression with illness/increased seizures. Follow-up with the surgeon showed that the patient tolerated the procedure well with no complications and that intraoperative impedance was within normal limits an in-house sudep evaluation concluded the death was possible sudep. The patient was found pulseless and unresponsive. The patient has sudep risk factors of febrile and nocturnal seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3082508
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« Reply #838 on: April 22, 2018, 01:17:22 AM »

Model Number 103
Event Date 04/25/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that during initial implant surgery the patient experienced asystole when system diagnostics were performed once the generator was placed in the subcutaneous pocket. The surgeon programmed the generator to 0. 25ma and 14 seconds on and the asystole occurred again. The generator was programmed to 7 seconds on and the asystole occurred again. It was reported that the asystole occurred on with device stimulation. Approximately 5-7 minutes later the generator on time was increase and the asystole did not occur. The output current was increased gradually from 0. 25ma to 0. 5ma to 0. 75ma to 1. 0ma and each time the asystole did not occur. The patient was closed up and the surgery was completed. Further follow-up revealed that the patient did not experience asystole but rather a respiratory pause. The neurologist indicated that information from the surgeon and operative notes indicated that the event was a respiratory pause and that no arrhythmia had occurred. The operative notes indicate that during system diagnostics the patient¿s heart rate remained stable, but there was a respiratory pause that lasted approximately 15 seconds. The device was then tested at an output current of 0. 25ma for 7 seconds which again resulted in a second respiratory pause of shorter duration than the previous. After approximately 5-10 minutes the device was tested again at 0. 25ma for 14 seconds which did not result in a heart rate change or respiratory pause. The device was tested again at different settings as initially reported with no adverse reaction. The system diagnostics were all within normal limits. The patient was monitored in the pacu for postoperative stabilization. The patient was kept hospitalized an additional day for urinary retention and difficulty swallowing post-op both of which resolved within 24 hours. The operative notes indicated that the patient tolerated the surgery well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122396
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« Reply #839 on: April 23, 2018, 01:23:46 AM »

Model Number 102R
Event Date 04/01/2013
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently did not include the explant date even though it was known at that time.
 
Event Description
Additional information was received that product analysis was completed on the 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. The increase in seizures was believed to be related to the generator being at end of service.
 
Event Description
It was initially reported that the patient was experiencing an increase in seizures. There was some discussion that the generator many be depleted based on how long it had been implanted but this was not able to be confirmed. The patient did have monopolarcautery shortly before the report of the increase in seizures and that was thought it could have possible damaged the generator also. The patient the patient was having a pulmonary condition, not related to vns, which could be affecting the patient's seizures. A battery life calculation was performed and showed that the patient was at or near end of service. The patient had a generator replacement and the generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3111419
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