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dennis100
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« on: May 21, 2017, 10:47:29 AM »

Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description 
It was initially reported the pt had lack of efficacy with the vns so it was decided to keep their therapy disabled. Additional information was received from the pt's treating physician that their vns therapy was disabled in 2006 due to swelling around the nerve and possible interference with his pseudobulbar palsy. Good faith attempts are being made for additional details surrounding the nerve swelling. Thus far no further information has been received.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1292037
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dennis100
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« Reply #1 on: May 21, 2017, 10:49:24 AM »

Model Number 102
Event Date 12/11/2012
Event Type  Injury   
Event Description 
On (b)(6) 2013, it was reported that the patient had her generator explanted due to pain and the patient not gaining any seizure benefits from vns therapy. Product analysis on the explanted generator found that it was not at end of service. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Product analysis on the explanted lead found no performance issues. Inspection of the connector pin and ring connector identified what appears to be remnants of silicone adhesive on the exposed surface of the pin within 0. 022in from the o-ring and on the exposed surface of the ring at 0. 020in from the small o-ring and 0. 022in from the large o-ring. This is out of tolerance (max: 0. 015in); however, no adverse effect in the device performance was identified as a result of this condition. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. Note that since the electrode array portion was not returned for analysis an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations typical and wear and explant related observations, no anomalies were identified in the returned lead portion. A review of the patient's programming history found that the patient had been programmed off and had periods of long off time durations originally implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description 
Follow up with the physician's office found that the pain was first observed on (b)(6) 2009. It was stated that the patient complains of pian with sleep and that these symptoms were due to the physical presence of the device and not from stimulation. The exact location of the pain was described as in the left anterior chest region. The explant surgery was for patient comfort and the patient's pain was relieved with removal. No programming or diagnostic history was provided. No causal or contributory programming or medication changes preceded the onset of the pain, and no patient manipulation or trauma occurred which is believed to have caused or contributed to the pain. In regards to the lack of efficacy, it was stated that this was per the patient and neurologist. No other information was provided.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3008992
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dennis100
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« Reply #2 on: May 21, 2017, 10:50:34 AM »

Model Number 302-20
Event Date 10/29/2014
Event Type  Injury   
Manufacturer Narrative 

Event Description 
On 12/01/2014, it was reported that the patient had an injury at his lead site at the collarbone and a subsequent infection. The patient was working on his home and left his caulking removal tool at the top of the ladder and when he climbed back up the ladder his tool fell and struck him in the chest. The patient made an appointment with his physician, and during his appointment on (b)(6) 2014, the patient was put on antibiotics. He returned for follow-up one week later and was told it was getting moderately better. A week after that appointment ((b)(6) 2014), he was told it was improving but he was not doing as well as expected. The physician stated the infection had attached itself to the lead wires. On a 3rd visit a week later ((b)(6) 2014), the general chest infection had cleared up but remained on the lead wire. The patient was then referred to an infectious diseases doctor who recommended that the vns therapy system be removed. It was also reported that the patient¿s leads were fractured and the ¿wire is sticking out of the skin¿. The patient declined to be re-implanted as he had not had efficacy with vns. He stated that he knows the vns is no longer working because he no longer feels hoarseness in his throat or voice alteration and there was usually a ¿tickle on the vocal cord¿ during stimulation. Although surgery is likely, it has not occurred to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4334606
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dennis100
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« Reply #3 on: May 21, 2017, 10:52:20 AM »

Model
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« Reply #4 on: May 21, 2017, 10:54:09 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Malfunction   
Event Description 
Reporter indicated that a patient has not experienced efficacy from vns therapy. It is unknown if the settings have been changed in effort to increase efficacy, and the patient stated that vns settings have not been increased due to patient's coughing, voice alteration, and pain during stimulation. The patient reported that she may have the vns devices explanted due to the lack of efficacy. The patient also reported that she has experienced depression for 40 years and no treatment has been effective.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=969151
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dennis100
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« Reply #5 on: May 21, 2017, 10:55:41 AM »

Model Number 302-20
Event Date 10/01/2008
Event Type  Malfunction   
Event Description 
It was reported to the manufacturer that the patient's lead has been explanted due to fibrosis. The patient was unable to perceive normal mode or magnet mode stimulation. Diagnostics performed on the patient's device showed high lead impedance. There was no patient manipulation or trauma at the device site. The patient observed loss of efficacy and no increase in seizures with therapy two weeks prior to the surgery. X-rays were taken and reviewed. No gross discontinuities were observed on the x-rays. The replacement surgery was successful with diagnostic results within normal limits. The explanted lead has been returned to the manufacturer for product analysis.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1248354
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dennis100
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« Reply #6 on: May 21, 2017, 10:57:21 AM »

Model Number 102
Event Date 05/19/2016
Event Type  Death   
Event Description 
It was reported that a patient who was implanted with a vns device had passed away due to reported sudep. The patient's parents reported a lack of efficacy with the device. Additionally, the patient's primary physician stated that his death was unrelated to vns. The device was explanted by the funeral home and left with the family. No product analysis will be performed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5707514
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dennis100
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« Reply #7 on: May 21, 2017, 10:58:47 AM »

Event Date 08/18/2008
Event Type  Injury   
Event Description 
Reporter indicated a vns patient experienced lack of efficacy and that the vns generator was sticking out at the patient's bra. 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=1176176
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dennis100
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« Reply #8 on: May 21, 2017, 11:00:53 AM »

Model Number 302-20
Event Date 03/12/2008
Event Type  Injury   
Event Description 
Reporter indicated a pt had developed left vocal cord paresis that was diagnosed by an ent physician. The pt's vns system was previously explanted for pt lack of efficacy. Reporter indicated the cause of the left vocal cord paresis was unk, but that the pt was experiencing dysphagia, dyspnea, and voice alteration prior to vns explant surgery. The reporter stated the pt has had vocal cord injection and speech therapy interventions for the left vocal cord paresis. The pt continues to have difficulty with hyperfunction of larynx and poor voice. The explanted devices were returned for product analysis. The lead and generator performed per specifications and no anomalies were noted.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1155248
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dennis100
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« Reply #9 on: May 21, 2017, 11:03:44 AM »

Model Number 201
Event Date 05/08/2013
Event Type  Malfunction   
Manufacturer Narrative 

Manufacturer Narrative 

Event Description 
The explanted generator and lead were received by the manufacturer for analysis. However, product analysis has not been completed to date. The return product form indicated the reason for generator and lead explant on (b)(6) 2013 was due to eri=unknown. No other explantation was provided. The devices were not replaced.
 
Event Description 
It was initially reported that he patient was scheduled for explant surgery due to lack of efficacy. Clinic notes dated (b)(6) 2013 indicated the patient never demonstrated significant efficacy. The patient¿s device turned off in 2012 on a trial basis with no ill effects. The patient and family wanted the device explanted and the physician concurred. The patient was implanted in (b)(6) 2003 and the physician noted in the notes that it ¿has not been working well. ¿ the family never noticed any change in frequency of seizures. The patient had generator and lead explant on (b)(6) 2013. The company representative who attended the surgery reported that the hospital staff was unable to interrogate the device prior to surgery believed to be due to normal end of service. The hospital staff is trained to interrogate and proper troubleshooting steps were reportedly taken to try and resolve the inability to interrogate the device. The programming system used is functioning properly, and the hospital has two backup programming systems as well. The company representative reported that the device was not believed to be turned back on since (b)(6) 2011. Attempts for product return and additional information have been unsuccessful to date.
 
Manufacturer Narrative 
Review of the manufacturing history records performed. Review of the generator manufacturing history records confirmed all quality tests were passed prior to distribution.
 
Event Description 
Product analysis for the generator was completed. The reported failure to program reported was duplicated in the laboratory at two orientations (not due to end of service). This is addressed in the manufacturer¿s physicians manual by instructing the user to reposition the wand. Since product labeling addresses these situations and provides instructions to easily remedy the events (wand position) and (system operation), it is not considered a device malfunction. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was also completed on the lead. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the lead device which may have contributed to the stated complaint. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The company representative attempted to acquire programming/diagnostic data from the physician¿s handheld device, but was unsuccessful.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3127144
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dennis100
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« Reply #10 on: May 21, 2017, 11:05:51 AM »

Model Number 303-30
Event Date 09/15/2011
Event Type  Malfunction   
Manufacturer Narrative 

Event Description 
All attempts for further information have been unsuccessful to date.
 
Event Description 
Reporter indicated a patient had their vns generator and lead removed due to "shocking" sensations, lack of efficacy, and suspected damage to the vns lead due to a mri being performed. No new vns devices were implanted. The explanted devices will not be returned per hospital policy. Attempts for further information are in progress.
 
Event Description 
Reporter indicated the patient's painful vns stimulation was experienced at the chest wall location. The patient had no known trauma and did not manipulate the vns. Vns diagnostics tests prior to explant of the device were within normal limits per the reporter. In addition, x-rays of the vns did not indicate any adverse findings or fractures. The reason for the explant of the vns was due to lack of efficacy per the reporter.
 
Manufacturer Narrative 
Suspect medical device, corrected data: the incorrect lot number was inadvertently reported on the initial mdr report. The correct lot number is provided.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2317767
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dennis100
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« Reply #11 on: May 21, 2017, 11:08:11 AM »

Model Number 102R
Event Date 08/30/2013
Event Type  Injury   
Event Description 
On (b)(6) 2013, it was reported that this vns patient was referred for explant due to upcoming radiation therapy for breast cancer. The lead and generator were explanted on (b)(6) 2013, reportedly due to lack of efficacy. The lead and generator were returned on (b)(6) 2013. 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 in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Lead analysis was approved on (b)(6) 2013 and is captured in mfr report # 1644487-2013-02920. Attempts for additional information have been unsuccessful. Review of programming history shows that the patient¿s device was disabled on (b)(6) 2006. There is no record of the device being programmed back on.
 
Manufacturer Narrative 

Event Description 
This report is a duplicate of mfr. Report #: 1644487-2013-01956. Any additional information obtained will be capture in mfr. Report #: 1644487-2013-01956.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3368862
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dennis100
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« Reply #12 on: May 21, 2017, 11:10:21 AM »

Model Number 102
Event Date 09/27/2012
Event Type  Injury   
Manufacturer Narrative 

Event Description 
It was initially reported that the patient was scheduled for explant due to lack of efficacy. It was later reported that the patient was explanted on (b)(6) 2013 due to discomfort and pain during stimulation and hoarseness. Clinic notes reportedly indicated that the patient was referred for explant due to his hands shaking, dizziness and being tired all of the time. Additionally, it was previously reported that the patient was experiencing difficulty swallowing and choking. Attempts to obtain additional information have been unsuccessful to date. The explanted devices have not been received for analysis to date.
 
Event Description 
The vns explanting facility does not return explanted products to the manufacturer, therefore the product will not be returned and product analysis cannot be performed.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3314185
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dennis100
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« Reply #13 on: May 21, 2017, 11:12:22 AM »

Model Number 103
Event Date 07/13/2011
Event Type  Injury   
Event Description 
Additional information was received on (b)(4) 2012, when analysis of the explanted lead was completed. Note that since a portion of the lead (including) the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above typical wear and explant related observations, no anomalies were identified in the returned lead portion. The analysis of the generator was completed on (b)(4) 2012. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description 
On (b)(6) 2011, a vns treating nurse practitioner reported that the vns patient was in the hospital due to seizures. The patient's parent is concerned because when they tape the magnet over the device during meal time recently to halt voice alteration, the device still provides stimulation. In order to double check this report, the nurse practitioner taped the magnet over the device that day in the hospital for about 20 minutes and the device was still activating while the magnet was in place. System diagnostics and normal mode diagnostics were performed on the generator and results were normal; impedance value of 2621ohms and 2635ohms respectively. The device was interrogated and the magnet activations were examined. The handheld showed that the device recorded multiple magnet activations while the magnet was in place for about 20 minutes. The manufacturer's consultant reported that the magnet was taped securely to the skin and the generator is able to be visualized under the skin. The patient was implanted recently in (b)(6) 2011, so the magnet is fairly new. The nurse practitioner stated that she did not know if there was any trauma to the site. The generator is currently disabled due to the magnet issue and the most recent settings before it was disabled were output=1. 5ma/frequency=20hz/pulse width=250usec/on time=21sec/off time=3min/magnet output=1. 75ma/magnet on time=60sec/magnet pulse width=250usec. The nurse practitioner reported later that the patient falls a lot but the parents don't know if he fell on the generator directly. His impedance checked out normally for both system and normal mode diagnostics. The patient's brother did bite him near the generator but did not break the skin. He aspirates during stimulation, so they now have the generator off. The patient has had aspiration pneumonia for a while now, so the magnet was being used to disable the device while eating. The nurse did not know if the patient has a history of aspiration, but did state that they have questioned whether or not the vns has made the aspiration worse. Lately (time frame unknown), the mother has noticed that the magnet is not working as it did to disable the device. The nurse states that the magnet had been helping at one point, though, and had improved the patient's aspiration. She stated that the patient has had worsening focal status and that the mother reports that the vns has not helped. The nurse stated that the generator protrudes from the chest so she is sure that the magnet is properly taped over the device. The patient's mother has tried both magnets that came with the patient kit but neither will work lately and it is unknown which side is being taped facing the generator. The nurse reported that she does not know where the magnets are stored when they are not in use. The nurse then stated that during the 20 minutes that the magnet was taped over the device, the patient experienced voice alteration 3 different times for about 60 seconds (magnet on time is 60 seconds). After the device was disabled, no voice alteration was observed. The physician's nurse reported that they tried new magnets and they also did not work to disable the device. Therefore, the patient's generator is programmed to 0ma at this time. The patient has progressively worsening epilepsy and they do not think that it is related in any way to vns. They did not think the vns was helping even before it malfunctioned. If additional information is received it will be reported.
 
Event Description 
Additional information was received on (b)(4) 2012, when it was reported that the patient's lead and generator were explanted and not replaced on (b)(6) 2012. Follow up with the site revealed that the device was removed due to lack of efficacy and they did not have any additional information to provide. The lead and generator were received by the manufacturer on (b)(4) 2012 and are currently undergoing product analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2200870
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dennis100
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« Reply #14 on: May 21, 2017, 11:15:48 AM »

Model Number 104
Event Date 05/08/2012
Event Type  Malfunction   
Manufacturer Narrative 

Event Description 
It was initially reported that a vns patient underwent a full revision surgery due to an unknown reason. During the surgery, the surgeon elected to not remove the patient's previously implanted m302 lead and implant a new m304 lead on the right vagus nerve. Instead of utilizing a generator model that was compatible with the new lead, the surgeon opted to implant a dual pin m104 generator (on the left side of the chest) by inserting the single lead pin into one of the two connector blocks. As expected, subsequent diagnostic testing resulted in high impedance results and the patient has reportedly received no efficacy from therapy since the surgery. Additionally, the patient has expressed the presence of neck pain as a result of the lead extending from the left chest to the right side of the neck. The reported high impedance issue is a result of the incorrect implantation technique which has created an open circuit in the system, and not the result of a device malfunction. This is not an unexpected performance of the device, given the implant circumstances. Additionally, product compatibility is clearly listed in product labeling. Additional information from the area representative indicated the patient underwent generator replacement surgery for a single pin generator. Impedance value after replacement was ok. The explanted device will not be returned to the manufacturer for analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592674
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dennis100
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« Reply #15 on: May 21, 2017, 11:16:54 AM »

Model Number 100
Event Date 04/21/2011
Event Type  Injury   
Event Description 
It was reported to the manufacture from explanting physician in (b)(6) that he had a patient with lack of efficacy with their vns therapy and who was having pain at their generator site, left infraclavicular. In the last 2 years, the patient had experienced pain in the area of the generator in the left infraclavicular and axillary regions. The generator had been turned off for 3 years due to battery exhaustion. The patient insisted on having their vns system explanted related to their pain events. It is unknown if this surgery was for patient comfort or to preclude a serious injury to the patient. During the explant procedure at a depth of about 1. 5 cm, the first securing clip was found. The suture was detached and the clip dissected from the fibrin sheath. The cable was followed in the proximal direction and the next securing clip found after 1 cm at the level of the carotid. Here, the suture of the securing clip had pierced the adventitia of the carotid artery. The fibrin sheath surrounded the securing clip, forming a cuff on the carotid. Since the stimulator cable ran through a scar between the jugular and carotid arteries into the depths, dissection was attempted here as well. The project had to be aborted, however, because it was too risky, and both the carotid and the jugular could have been injured. Their explanted generator was returned for analysis. In the product analysis laboratory, it was determined that the device was at and end of service condition; an open can measurement of the battery voltage confirmed that the battery was depleted. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to an end of service condition. No programming history records were found; consequently, a battery life calculation could not be performed. The device performed according to functional specification. Therefore, the electrical performance of the generator, as measured in the product analysis laboratory, will be used to conclude that no performance or any other type of adverse condition was found with the generator.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133608
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dennis100
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« Reply #16 on: May 21, 2017, 11:19:39 AM »

Model Number 101
Event Date 01/01/2010
Event Type  Injury   
Event Description 
It was reported that the patient's device has been turned off for about a year as the patient was not receiving efficacy. Reporter also noted that in the past, the patient had been to the er twice due to hiccups and severe vomiting. The patient was now admitted to the hospital again due to these issues. Reporter states the er physician suggested that the leads were causing irritation to the nerve and causing the hiccups and vomiting. Attempts for further information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1828527
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« Reply #17 on: May 21, 2017, 11:21:13 AM »

Model Number 102
Event Date 12/26/2006
Event Type  Malfunction   
Event Description 
Reporter indicated that a deceased vns patient had lack of efficacy. The patient's death in 2007 was a suicide per the family and was not related to the vns per the reporter. It is not known if the patient was buried with the vns. Review of the programming history revealed the vns settings were not titrated above 0. 5ma/20hz/250pulsewidth/30 seconds on/120 minutes off as at about 5 months prior to the death. These settings are extremely low and were likely not therapeutic.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1014333
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« Reply #18 on: May 21, 2017, 11:23:32 AM »

Event Type  Injury   
Event Description 
Additional information was received that vns simply made the patient's condition worse. The device has been disabled since (b)(6) 2014. It was reported again that the patient does not talk anymore, maybe just one word a day now, though she used to sing a lot. No additional relevant information has been obtained to date.
 
Event Description 
It was reported that the vns patient had experienced hypoxia, coma, voice alteration, and other unspecified adverse events. It was noted that the patient did not receive efficacy from the device and that the patient¿s caregiver wanted to have the device explanted. No known surgical interventions have occurred to date. No further information relevant to the events has been received to date.
 
Event Description 
Additional information was received from the patient's caregiver that the patient has stopped talking little by little and the vns is programmed off. No additional relevant information has been obtained to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4724926
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dennis100
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« Reply #19 on: May 21, 2017, 11:25:14 AM »

Device Problem Unknown (for use when the device problem is not known) 
Event Type  Malfunction   
Manufacturer Narrative 
Murray, diana & yerby, m. "efficacy of vagal nerve stimulation on selected patients with intractable epilepsy".
 
Event Description 
It was reported a vns therapy pt did not receive any benefit from vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810642
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dennis100
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« Reply #20 on: May 21, 2017, 11:28:07 AM »

Model Number 102
Event Date 11/08/2007
Event Type  Injury   
Event Description 
On (b)(6) 2013 the physician¿s nurse stated that the vns was not working for this patient, the patient just never got better. The patient had severe side effects and just had a really rough time with vns. The patient¿s depression didn¿t get better. The nurse stated that she thinks it is related to his underlying illness, being treatment resistant. She also mentioned that he has a history of suicidal thoughts ongoing and some suicidal gestures. She mentioned that he started or continued to have suicidal thoughts very shortly after he was implanted and the vns was turned on. She said she thinks it was because he thought the vns was going to work for him and it didn¿t. The nurse stated that she looked over the patient¿s progress reports and she saw where the device was turned on at 5. 5 weeks and the patient didn¿t feel that his mood had changed. The patient was still feeling depressed and having a lot of side effects.
 
Event Description 
On (b)(6) 2013, it was reported that the vns patient had to have the vns turned off due to severe side effects and he was still depressed. It was previously reported on (b)(6) 2007 that the patient has made suicidal gestures. Further follow up with the physician revealed that the gestures were not related to vns therapy. Additionally, the patient's treating medical professional indicated that patient was experiencing vomiting, nausea, dyspepsia and headache on (b)(6) 2008. The medical professional has stated that all these events can be related to vns. Even though the patient has had medical history of these problems, they appeared to be worsened with vns stimulation. An additional event of cognitive changes where the patient was entering dream states was reported. Follow up with the treating medical professional revealed that the event is believed not to be related to vns therapy, but likely related to the patient's underlying psychiatric condition. The patient is reportedly doing better with emotional freedom exercises and they are considering putting the patient on an anti-psychotic. An additional report was received that this patient is experiencing side effects from vns including difficulty breathing, migraine, photophobia, nausea, indigestion, and reflux. Good faith attempts were made for additional information, but were unsuccessful. Even though a response was not received regarding diagnostics results, investigation of a report of cognitive changes showed the device to be functioning properly on (b)(6) 2008. No additional information was received regarding the dyspnea and visual disturbances events. Additional information from the site indicated that diagnostics on (b)(6) 2008 showed the device to be functioning properly. The physician indicated that all events except migraines were present from the first stimulation. The migraines and photophobia events began after the output current was increased. The dyspnea and dyspepsia events are associated with stimulation on times. It appears the patient had reflux 10 years ago, and the gi symptoms reappeared with vns therapy. It appears that the cognitive changes had disappeared, and then recurred about 2-3 times in one week. An additional contributing factor to the migraines and photophobia is the patient's hypertension. Decreasing the pulsewidth has seemed to help these events. Medication is being administered for the dyspepsia and migraine events. The patient is still undergoing relaxation techniques and therapy. The programming history database was searched. The patient was last programmed to output=1. 75ma/frequency=30hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=0ma/magnet pulse width=500usec/magnet on time=60sec on (b)(6) 2010. The last system diagnostics test was from (b)(6) 2009 which showed output=ok/lead impedance=ok/dcdc=3/eri=no. On (b)(6) 2012 a nurse stated that the patient's output current was increased from 1. 75 to 2. 25, signal frequency decreased from 30 to 25, and off time was increased on (b)(6) 2011. The patient's side effects then became intolerable. On (b)(6) 2011, they turned the device completely off after the patient had turned it off with his magnet for a trial period from (b)(6) 2011. The patient still has the device turned off at present and the patient has since felt better. Additional information was received on when a form dated (b)(6) 2011 from the physician stated that the patient's reflux/indigestion and migraines resolved after turning off the vns. The physician later reported that the lack of efficacy was first observed on (b)(6) 2007. The patient was noted to have severe refractory depression that has been and continues to be non-responsive to therapy, medications, and vns.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118167
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dennis100
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« Reply #21 on: May 21, 2017, 11:30:12 AM »

Model Number 103
Event Date 06/12/2014
Event Type  Injury   
Manufacturer Narrative 

Event Description 
It was reported that the vns patient¿s seizures had increased in intensity. The patient stated that his magnet was no longer aborting his seizures but was able to feel stimulation. The patient¿s device had not been tested for some time. The patient noted that he did not receive efficacy with vns. Follow-up with the neurologist revealed that the patient was swiping his magnet incorrectly. The neurologist stated that patient¿s seizures had improved with vns. The neurologist adjusted the patient¿s medications and indicated that no external factors contributed to the change in seizure intensity.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3918628
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« Reply #22 on: May 21, 2017, 11:31:35 AM »

Model
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« Reply #23 on: May 21, 2017, 11:34:49 AM »

Model Number 105
Device Problems Improper or incorrect procedure or method; No Known Device Problem 
Event Date 09/11/2012
Event Type  Malfunction   
Event Description 
Follow-up was performed with the patient¿s neurologist. He was informed that product analysis found lead fractures and high impedance. He was not aware of any high impedance. System diagnostics were always within normal limits to his knowledge. The patient¿s mother was adamant that the device was not helping, but he did not agree. He programmed the device off in november 2014 and left the magnet on. At that time the impedance was 3980 ohms. The patient had a lower seizure frequency about a year after implant. He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient¿s mother. His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient. Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before. The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off. He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.
 
Manufacturer Narrative 
 
Event Description 
It was reported that the vns patient underwent explant surgery on (b)(6) 2015 due to lack of efficacy. It was noted that the patient was developmental delayed and was hitting himself in the chest. The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from high lead impedance to a normal limits range. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. Analysis of the lead found that that the lead had not been fully inserted into the cavity of the generator. Complete analysis of the lead was reported in manufacturer report # 1644487-2015-05614.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032067
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dennis100
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« Reply #24 on: May 21, 2017, 12:55:43 PM »

Device Problem Malfunction 
Event Date 01/01/2007
Event Type  Malfunction   
Event Description 
Manufacturer received study article noting that 41. 4% of 116 patients (48 patients) treated at two specific medical centers did not receive efficacy from the vns therapy system. Diagnostic results are not available for any of these patients' pulse generators, thus device malfunctions cannot be ruled out. This medwatch represents one patient out of that 48.
 
Manufacturer Narrative 
Device malfunction is suspected, but did not cause or contribute to a death or serious injury. Article citation: "efficacy of vagus nerve stimulation for refractory epilepsy: a re-analysis using the engel classification"; wheeler, markus, et al. 2007.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810632
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dennis100
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« Reply #25 on: May 21, 2017, 01:02:07 PM »

Device Problem Unknown (for use when the device problem is not known)
Event Date 01/01/2007
Event Type Malfunction
Event Description
Article was received that described the following incident regarding a study pt that was implanted with the vns therapy system: pt did not experience any efficacy as a result of being implanted with the vns therapy system.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury. Article citation: "vagus nerve stimulation for intractable epilepsy: outcome in two series combining 90 pts"; sakas, d. E. , et al; springer-verlag 2007.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810665
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dennis100
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« Reply #26 on: May 21, 2017, 01:13:56 PM »

Device Problem Unknown (for use when the device problem is not known) 
Event Date 12/01/2005
Event Type  Malfunction   
Manufacturer Narrative 
Khurana, divya s. Et al (2005) vagus nerve stimulation in children with refractory epilepsy: unusual complications and relationship to sleep-disordered breathing. American epilepsy society meetings in washington, dc, 2-6.
 
Event Description 
It was reported a vns pt "had no change in seizure frequency". Good faith attempts to obtain additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810641
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dennis100
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« Reply #27 on: May 21, 2017, 01:15:22 PM »

Device Problem Unknown (for use when the device problem is not known) 
Event Type  Malfunction   
Manufacturer Narrative 
Murray, diana & yerby, m. "efficacy of vagal nerve stimulation on selected patients with intractable epilepsy".
 
Event Description 
It was reported a vns therapy pt did not receive any benefit from vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810644
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« Reply #28 on: May 21, 2017, 01:16:26 PM »

Device Problem Explanted
Event Date 01/01/2007
Event Type Malfunction
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury. Article citation: "vagus nerve stimulation for intractable epilepsy: outcome in two series combining 90 pts"; sakas, d. E. , et al; springer-verlag 2007.

Event Description
Article was received that described the following incident regarding a study pt that was implanted with the vns therapy system: pt did not have a change in seizure frequency or severity and subsequently had vns explanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1810667
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« Reply #29 on: May 21, 2017, 01:18:17 PM »

Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description 
The pt reported that she had lost 18 pounds in last month or so and was still losing, had no appetite and had to force food down. She additionally reported that she had been receiving ect treatments because her depression was "so bad. " reported "i felt pretty good for a couple of weeks, but as soon as my period arrived, it all went downhill. I'm, perimenopausal and am on hormone therapy. I'm working with my ob/gyn to adjust them, as now i'm having about 2 periods a month - and like clockwork as soon as they hit, i go downhill into serious depression. So i'm averaging about 1 good week per month. " the pt's treating physician did not know if the pt's weight loss was vns related and possibly related to the pt's depression. The pt reported that they were thinking of getting the vns taken out due to throat tightness with stimulation and lack of efficacy, no malfunction suspected. The treating physician did not think that pt was a good candidate for vns therapy. Good faith attempts will be made for product return for analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1199909
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