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dennis100
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« Reply #660 on: July 22, 2018, 03:10:10 AM »

Model Number 102
Event Date 01/20/2014
Event Type  Injury   
Event Description
It was reported that the recently implanted vns patient was seen for their first follow up appointment with the neurologist on (b)(6) 2014 where the device was programmed on for the first time. The patient returned home and subsequently began experiencing chest pain and went to the emergency room where the patient was diagnosed with heart block. A cardiologist referred the patient for pacemaker implant surgery. Although the cardiologist stated that the patient¿s heart block diagnosis was not related to vns, the neurologist continued to inquiry about a possible relationship between heart block and vns. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3679922
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dennis100
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« Reply #661 on: July 31, 2018, 03:48:53 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/06/2017
Event Type  Injury   
Event Description
It was reported to a company representative by a vns patient¿s mother that the patient was having an increase in seizure frequency and intensity. The mother believes the battery is no longer functioning, possibly since (b)(6), and said the patient has pain in the chest and at the side of her neck and in her abdomen. The patient had 3 grandmal seizures in a 12 hour period about a week or 2 ago and as-of (b)(6) 2017 she was having a grand mal seizure every day or every other day. Generator replacement surgery occurred (b)(6) 2017. The explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6491260
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dennis100
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« Reply #662 on: August 07, 2018, 01:18:03 AM »

Model Number 102
Event Date 01/01/2007
Event Type  Injury   
Event Description
Additional info was received from the pt indicating she continued to have a hurting sensation in the neck area where the electrodes were. The pt indicated that the event had been occurring ever since vns implant and her implanting physician would not remove her electrodes. Further info from a company rep indicated the pt was scheduled to see a surgeon for explant consult. F/u was made with the surgeon's office and indicated the pt is scheduled to undergo vns generator removal surgery as the pt complains of pain at the generator site. The pt's device is off and pt wants it out. The surgeon's office indicated the surgery was to preclude a serious injury and had no additional info regarding the pt's treating neurologist. Additional info from the surgeon's office indicated the pt underwent generator removal surgery as scheduled. Good faith attempts to obtain the explanted generator have been unsuccessful to date.
 
Event Description
Additional information was received from the patient on 12/21/2017 that the vns would constantly hurt her in the chest and where the wires were in the neck. She stated it started shorting out years prior. After the battery died it was still hurting her until she had it removed. She stated there was too much scar tissue in the neck on the electrodes and could not be completely removed. Additional relevant information has not been received to-date.
 
Event Description
Follow-up from the physician provided that the vns had served the patient well but that the patient had other underlying issues and offered to remove her vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1959461
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dennis100
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« Reply #663 on: August 07, 2018, 01:31:43 PM »

Model Number 302-20
Device Problems Corrosion; Fracture; Mechanical issue
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
It was reported that a pediatric patient suffered from an increase in number of epileptic seizures and pain in the chest region. Physicians expected a problem and ordered an x-ray on which no breakage or other abnormality could be diagnosed. The neurosurgeon decided to surgically explore during which they could visually see a breakage. The lead was replaced. High impedance was reported to be observed before the surgery and the physician mentioned that no trauma or fall happened to the patient. The explanted lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569971
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dennis100
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« Reply #664 on: August 11, 2018, 01:39:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Report received that a patient had experienced left chest pain. Since the pain began, the patient also experienced 7 seizures which was reportedly more than he typically experienced. It was not known if this was above pre-vns seizure frequency. The patient reported these symptoms to his implanting surgeon who was able to check the functionality of the vns system and found that it was operating as expected. The manufacturer representative was also present at this time he reportedly swiped the magnet to a activate magnet mode stimulation and the patient did not report feeling any pain at that time. Blood-work and x-rays were taken to rule out other causes of the issues. The patient reportedly did not recall any event that would have caused strain or trauma to the left shoulder/chest area. The surgeon reportedly did not believe the pain had anything to do with the vns, but the patient was to follow-up with his neurologist. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7705975
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dennis100
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« Reply #665 on: August 26, 2018, 01:55:34 AM »

Model Number 102
Event Date 07/27/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing chest pain and underwent device explant. It was also reported that the patient did not experience efficacy with vns therapy. It was reported that the patient's device was programmed off on (b)(6) 2013. Device diagnostics were within normal limits. It was reported that the patient had complained of chest pain that had been occurring for 3 days. The patient noted significant relief from the chest pain when the device was programmed off. It was also reported that clinic notes dated (b)(6) 2013 noted migration of the device and because of the patient's chest pain the patient was referred for surgery because the neurologist thought there may be an issue with the device. It was noted that the patient was seizure free since the device was programmed off so the patient's family asked for device explant with no plans to reimplant. The explanted generator and lead were received for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the majority of the lead assembly (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, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4055314
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dennis100
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« Reply #666 on: September 03, 2018, 01:47:07 PM »

Model Number 102
Event Date 06/18/2011
Event Type  Injury   
Manufacturer Narrative
Device mfg records were reviewed. Review of mfg records confirmed sterilization for both the lead and generator prior to distribution.
 
Event Description
On (b)(6), 2011, the vns implanting surgeon reported that the vns pt had his vns explanted on (b)(6), 2011 due to an (b)(6) infection. They were unaware of any plans to replace it. The surgeon's nurse reported that the vns pt went to the er on (b)(6), 2011 for swelling and pain of the incision sites on the neck and chest. The pt was then placed on oral antibiotics. On (b)(6), 2011, the pt saw their surgeon and the infection has not gotten any better since their er visit two days prior. The surgeon prescribed stronger antibiotics and explained to the pt that if they don't feel better in 12-24 hrs, to visit the surgeon again. The pt was hospitalized on (b)(6), 2011 for the infection and placed on iv antibiotics of vancomycin and aosyn. Cultures of both sites were taken at that time and the infection was discovered to be (b)(6). The pt was explanted on (b)(6), 2011 because of the infection. The surgeon's nurse reported that it is unclear at this time if the infection is related to the vns device or a problem with the surgery. The pt is very alert and did not touch or scratch the site and no trauma was noted that could have caused/contributed to the infection. Review of the mfg records confirmed sterilization for both the generator and lead prior to distribution. If further info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180925
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dennis100
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« Reply #667 on: September 07, 2018, 11:37:36 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/17/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a company representative a vns patient reported erratic stimulation in the past that caused chest and neck discomfort. The patient wants her vns explanted. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7774105
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dennis100
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« Reply #668 on: September 07, 2018, 11:38:06 AM »

Model Number 304-20
Device Problem Fracture
Event Date 08/09/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient¿s device is showing high impedance. It was reported the patient's seizure activity has increased and she sometimes feels a "zap" in her neck or chest. It was reported that her (b)(6) head-butted her in the chest. The patient was sent for an x-ray of the neck and chest however there were no lead breaks observed. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7826426
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dennis100
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« Reply #669 on: September 07, 2018, 11:38:37 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/27/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing pain in the neck and chest when swiping the magnet. The device's settings were lowered due to the painful stimulation. It was reported that this did not resolve the pain which persisted after adjustment, and the patient was referred for surgery for the painful stimulation and discomfort. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7832642
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dennis100
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« Reply #670 on: September 07, 2018, 11:39:11 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2018
Event Type  Injury   
Event Description
A patient reported side effects of extreme pain in the sternum/chest, nausea, difficulty swallowing, and any gas belching can¿t come up. He also reported sharps pains and happens when trying to eat. He also mentioned that he can¿t swallow as if there is a blockage in the middle. He also stated that there is a jolting nerve type of pain going through the left shoulder and biceps where the muscle meets the collar bone. He stated that it doesn¿t happen all that much. A couple of years ago, he also mentioned pain with hiccups, that happened when eating. It used to be hit or miss, but is getting to where can¿t breathe when trying to eat. He stated that the issue was lasting longer than 5 minutes. He stated that there are sometimes when looking to the left, can feel it, but not that often. The patient later reported on (b)(6) 2018 that he had shortness of breath, pain in chest and neck, and has difficulty swallowing. These symptoms started 2 months prior but have gotten worse and the pain was so bad that he went to the er. He reports that he wants the device removed. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7827569
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dennis100
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« Reply #671 on: September 08, 2018, 01:13:26 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 10/17/2013
Event Type  Malfunction   
Event Description
It was reported from the patient that since his replacement in 2013 he has had severe pain and discomfort. He states that the physician initially said it might be nerve damage. The patient noted he was in and out of the hospital due to chest pains and burning in his chest and neck, so he states the vns was tested and found to be malfunctioning. The patient stated the device has been programmed off since 2015. The patient would like to have the device removed but no known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7784814
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dennis100
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« Reply #672 on: September 12, 2018, 02:50:29 AM »

Model Number 105
Event Date 09/09/2014
Event Type  Injury   
Event Description
On (b)(6) 2015, it was reported that the patient was scheduled for explant surgery as part of the incision site had opened and some of the generator is visible and exposed. The patient underwent removal of the vns on (b)(6) 2015. The explanted generator has not been returned for product analysis to date.
 
Manufacturer Narrative

Event Description
Clinic notes were received stating that the patient was hospitalized due to reaction to the vns device. The patient¿s symptoms were reported to have been stable.
 
Event Description
It was reported that the patient has been referred for surgery. The physician does not believe the events are related to vns therapy. No surgical interventions have been performed to date.
 
Event Description
It was reported that the recently implanted vns patient was hospitalized on (b)(6) 2014. The patient was experiencing coughing, breathing issues, nausea, vomiting, and chest pain at the generator site. Patient also stopped eating and had lost weight. The patient¿s caregiver wanted the patient¿s device explanted as the events began when the device was programmed on a week after vns surgery. The patient¿s seizures had increased and patient was on more seizure medications than prior to vns therapy. However, the surgeon and neurologist stated that the patient is fine. The patient is diabetic and was admitted with a very high blood sugar level. The patient¿s physician believed the events were due to the patient¿s high blood sugar levels as well as vns stimulation. Following revealed that the patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the hospital discards explanted devices and therefore the explanted generator cannot be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4194303

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dennis100
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« Reply #673 on: September 14, 2018, 08:28:27 AM »

Model Number 103
Event Date 03/01/2011
Event Type  Injury   
Event Description
Reporter indicated a patient vns generator repositioning surgery on (b)(6) 2011 due to pain at the generator site. The pain was due to sub-pectoral placement of the vns. The generator was repositioned under the skin and the pain resolved. No devices were explanted, and the generator was reported to be performing as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2327033
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dennis100
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« Reply #674 on: September 26, 2018, 06:14:50 AM »

Model Number 102
Event Date 01/25/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.
 
Event Description
Reporter indicated that the patient was experiencing painful and erratic stimulation across her chest where the lead is located and also across her neck and down the left side of her chest and arm. It was also reported to also occur at times when she turns her neck too far in certain positions. It was reported that the patient's painful stimulation was a gradual increase over time and did not start immediately. The physician indicated in notes that the vns may be broken. The patient's device was programmed off and the pain resolved. The magnet mode stimulation was left on and the patient indicated that the pain still occurred when the magnet was used. It was reported that the patient was to follow-up with physician to see if lowering device settings would resolve the pain or if surgery was required. Device diagnostics were performed and were within normal limits. X-rays were taken and sent to device manufacturer for review. There were no gross lead fractures that were visualized; however, the presence of an unpronounced lead discontinuity cannot be ruled out. Further follow-up revealed that the patient has been scheduled for system replacement; however, surgery has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2013. It was reported that the surgeon did not proceed with a full generator and lead revision and that the generator was replaced prophylactically. The new generator was placed back on the patient's right side due to the patient's pacemaker on the left side; however, a new pocket was created. The surgeon coiled and placed the lead in a pocket near the generator. It was reported that the surgeon feels that the patient's pain will no longer be an issue now that the lead has more flexibility, with less pulling across the patient's chest. The generator was programmed back to on at lower settings than previous and the patient did not experience any pain from the device stimulation. An implant card was received confirming that the generator was replaced prophylactically on (b)(6) 2013. The lead impedance with the new generator and old lead was "ok". Attempts to have the generator returned to device manufacturer are underway; however, the device has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2972914
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dennis100
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« Reply #675 on: September 29, 2018, 04:51:18 AM »

Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was initially reported by the treating nurse practitioner that the pt was recently diagnosed with sleep apnea. The nurse believed that they were going to attempt to disable the device in the evenings during sleep to see if that would help resolve the issue as he was not having seizures at night, so the therapy was not needed at that time. The pt later reported that he believed the device was going to be disabled. He said that he was having difficulties breathing, had sinus issues, couldn't breathe through the nose, tightness in his chest and was not getting any sleep. He was said to have had a sleep study which did not provide any further info on the issues. He reported that when the magnet was taped to his chest, the issues resolved. The pt also reported the physician did not believe there was anything wrong with his heart. The pt claimed that since his lead and generator repositioning in 2008 (at the pt's request), he has lost seizure control since the seizures have returned to pre-vns baseline levels and the magnet activations have no longer become affective. The pt is requesting removal of the device. Programming history reviewed in manufacturer's programming history database indicating that the last known diagnostics performed were within normal limits. 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=1889162
« Last Edit: September 30, 2018, 12:21:06 PM by dennis100 » Logged
dennis100
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« Reply #676 on: October 05, 2018, 01:12:59 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2018
Event Type  Injury   
Event Description
Additional information was received that the patient was seen by the surgeon who stated the pain was most likely related to a muscle strain so no surgery was scheduled and the patient was referred back to the neurologist.
 
Manufacturer Narrative

Event Description
It was reported that the patient presented in the er with painful stimulation. The pain was stated to be at the neck site for the patient. The patient's device showed that diagnostics were fine. The patient seems to have pain that is associated with magnet stimulation. The device was turned off until the patient can see the neurologist. The patient was then referred for replacement due to battery depletion and because of the new pain at left chest and left neck as the physician was worrisome for lead dysfunction. No known surgical intervention has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7842396
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« Reply #677 on: October 06, 2018, 06:31:22 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/02/2017
Event Type  Injury   
Event Description
The patient then later provided that before the repositioning surgery it felt like she was being strangled over 2-3 minutes apart and she was in excruciating pain. The patient repeated that she was in pain from the generator migration and that when trying to use her arm the generator would turn over 180 degrees.
 
Event Description
Follow-up from the patient was received providing that he says she had her device adjusted about a year ago and stated the physician had to turn it down because it was too high, and increased her seizure medications.
 
Manufacturer Narrative
 
Event Description
It was reported by a physician on (b)(6) 2017 that a patient¿s device was ¿poking out¿ and the patient presented to the er the week before. He reviewed the patient's device via ultrasound and discovered that the generator had been flipping and had migrated. The surgeon stated that he always sutures the generator in place but that he would have to perform a revision to re-suture the generator in place. The patient then stated she had a lot of chest pain and was going for revision of her pocket because her surgeon told her that it was moving too much. Surgery to secure the generator occurred. The patient later provided on (b)(6) 2017 that the generator was flipping over from 4 months prior, and was moving to her arm. The patient reported this caused tremendous pain, but it was flipped surgically, and re-stitched. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960601
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« Reply #678 on: October 10, 2018, 03:35:54 AM »

Model Number 303-30
Event Date 09/15/2011
Event Type  Malfunction   
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.
 
Event Description
All attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2317767
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« Reply #679 on: October 26, 2018, 01:53:56 AM »

Model Number 101
Event Date 01/01/2007
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for vns explant due to an unknown reason. Upon further follow-up, the nurse at the treating physician's office reported on (b)(6) 2012 that the patient's device is being scheduled for explant because it was turned off some time ago for an unclear reason. She thought it may have been due to a low heart rate. Follow-up with the nurse revealed the patient had generator replacement on (b)(6) 2001, and on (b)(6) 2001, the patient was admitted to the hospital with low sodium of 120 on carbamazepine and levetiracetam. She was taken off carbamazepine, and was readmitted on (b)(6) 2001, with cognitive abnormalities on levetiracetam and phenytoin. She has a history of episodic tachycardia and is on betablocker since 2007. Patient was started on ltg in 2008, and the vns was turned off on (b)(6) 2008, due to tachycardia without underlying cause. Per the nurse, after having her device turned off for several years, the "episodic tachycardia remains unexplained, but she is taking a beta blocker". A note from the cardiologist dated (b)(6) 2008, stated that the patient's seizure medications were reduced and she had one significant seizure episode. Since then, she had more palpitations and some vague chest pain. Patient returned on this day for a follow-up due to recent increase frequency of palpitations. Patient had episodes of seizures about every two to three weeks, and it was noted that the patient had a vagal nerve stimulator placed. After the seizure episodes, the patient had palpitations usually at night and lasted for less than minutes, most consistent with probable premature beat feelings. The metoprolol sode was increased to "25 mg daily for pac or inappropriate sinus tachycardia suppression. She also had some vague chest pain and was initiated for cad evaluations. She also has some exertional fatigue. Otherwise, she denied any other cardiac-related complaints". Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the supplemental report #1 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2012.
 
Event Description
Additional follow up with the nurse was performed who reported that the details regarding the events are not remembered. The patient was complaining and being treated for tachycardia. The vns was turned off for an mri on (b)(6) 2008, and the patient had it turned back on (b)(6) 2008 reportedly. When trying to turn the output current on, the nurse reportedly "could not get the output past 0. 75ma" due to extreme coughing. Although the previous output current was 2. 0ma, the site attempted to turn the current to 1. 75ma but the patient experienced violent coughing. Current decreased to 1. 5ma with on time every 3 minutes and off time at 1. 8 minutes. The settings were not tolerated, and continued to not be tolerated at 1. 25ma. Current was therefore decreased. Due to the tachycardia, the vns was turned off soon after per the nurse (which was observed on (b)(6) 2008). Later on (b)(6) 2009, the notes indicated that the device had been turned off with no exacerbation of seizures over 6 months. Patient requested to have the device removed for reasons of pain and discomfort at night. Patient was referred for surgical consult for vns explant. Notes dated (b)(6) 2009 revealed that the patient requested to have vns removed, "as it has not been helping and is somewhat uncomfortable moving around in the pocket".
 
Event Description
Follow-up with the implanting surgeon revealed that from the generator replacement in 2008 there was no mention of a suture being used in the operative note of use of suture to secure the generator to the fascia. Training was provided to the surgeon's office regarding labeling recommendations that a non-absorbable suture be used to secure the generator to prevent such occurrences of generator migration.
 
Manufacturer Narrative
 
Manufacturer Narrative
Suspect medical device, lot number, expiration date, corrected data: the initial report did not report this product information at that time. Device manufacture date, corrected data: the initial report did not report the manufacturer date at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2883274
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dennis100
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« Reply #680 on: November 06, 2018, 07:51:13 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
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dennis100
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« Reply #681 on: November 10, 2018, 04:34:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient did not think the vns was helping with seizure control and therefore the device was turned off in (b)(6) 2018. Now the patient is having pain on the left side of their neck and chest and therefore would like the device removed. Multiple attempts for relevant information were made, but no information has been received to date. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7921839
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dennis100
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« Reply #682 on: November 10, 2018, 04:35:50 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2018
Event Type  Injury   
Event Description
Clinic notes were received for the patient's planned generator replacement due to battery depletion. In the notes, it was reported that the patient previously ascribed intermittent chest pain to the vns, and now the physician believes it may be in part due to the patient's gerd. Per the physician, the generator is likely contributing to the patient's pain, though it is uncertain if it is due to stimulation or the presence of the device. The patient underwent generator replacement. No additional relevant information has been received to date. The generator has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8002204
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dennis100
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« Reply #683 on: November 10, 2018, 04:36:30 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8004870
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dennis100
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« Reply #684 on: November 10, 2018, 04:37:06 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2016
Event Type  Injury   
Event Description
It was reported by the patient through social media that she was experiencing voice alteration, breathing difficulties, and pain in the chest and ear. She stated that she wanted to have her device explanted. The explant surgery occurred. The reason for the explant was stated to be due to lack of efficacy and voice alteration. Programming history was reviewed and indicated that the device was functioning as intended, within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7974765
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dennis100
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« Reply #685 on: November 18, 2018, 09:22:13 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Event Description
It was reported that the patient was having chest pains. It was unclear if the pain was due to the vns. The patient was taken in an ambulance and abnormal ecg was observed. The patient had no past abnormal ecgs. It was recommended to the patient to contact her neurologist to run diagnostics. Follow up with the physician's office revealed that the patient had contact the office. It was reported that they were aware of the event, but did not have information. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6684184
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dennis100
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« Reply #686 on: November 19, 2018, 08:41:36 AM »

Model Number 103
Event Date 07/01/2010
Event Type  Injury   
Event Description
It was reported that the vns patient had experienced a stabbing pain in his left and right chest walls and was admitted to the hospital. The pt had a cardiology consult during which his vns was disabled. When stimulation was re-enabled, the pt's heart rate increased to 120 bpm. The physician stated that these symptoms were intermittent and not consistent with stimulation. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039453
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dennis100
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« Reply #687 on: November 29, 2018, 03:18:30 AM »

Model Number 303-20
Device Problem Insufficient Information
Event Date 04/13/2012
Event Type  Injury   
Event Description
The physician's office reported that the patient will be undergoing a stress test and ekg and the physician is unsure of the relationship to vns at this time. No additional relevant information has been received to date.

Event Description
It was reported that the patient experienced choking, increased blood pressure, increased heart rate and voice alteration with stimulation. Patient had gone to the er due to chest pain suspecting a heart issue but was told that the heart was fine. At the er it was found that patient's dilantin level was high and the er staff immediately tried to get her dilantin level down. Additional information was received that the patient's increased blood pressure and heart rate started since (b)(6) 2015. The neurologist referred patient to the surgeon to assess patient's chest pain, increased heart rate and blood pressure. The relationship of these events to vns therapy is unknown to the neurologist. Clinic notes were later received for the generator replacement, which noted that the patient experienced dysphagia, pain in the left upper extremity and burning around the site of vns, which does not radiate in to the neck. Patient's vns was also reported to have moved due to loss of weight. The surgeon did not recommend any changes due to the migration. Notes also indicated that the patient's vagus nerve was impaired with hoarseness. No known surgical interventions have occurred to date.

Event Description
The patient called and provided additional information that she had undergone surgery due to the previously reported vocal cord paralysis. Her surgery involved removing one of her vocal cords, reportedly. She stated that she was continuing to have an increase in seizures as previously reported. The patient's diagnostics with the new model 106 generator were all within normal limits. No further relevant information has been received to date.

Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental mdr #7 inadvertently had the wrong date under. The date should have been 02/14/2017.

Event Description
The physician reported that device diagnostics were within normal limits. The patient was encouraged to use the magnet more. The physician indicated that the device is working fine and that the seizures are at the patient's pre-vns baseline and that the patient feels she is still having seizures.

Event Description
The patient reported that she is still experiencing issues with her new generator. The patient reported that she is uncomfortable and it still hurts sometimes. The patient reported that she feels like it "jumps" around sometimes. The patient complained to the physician's office regarding erratic stimulation. The patient reported that vns isn't working. The patient reported that she is experiencing an increase in seizures and is concerned that something bad is going to happen to her. Attempts to obtain additional relevant information have been unsuccessful to date.

Event Description
The patient reported that she was scheduled to see the surgeon for consult. She indicated that she needs two procedures at the same time. The patient reported that the other procedure she requires is cardiac related for possible stent placement. The patient reported that she had an abnormal ekg, but it may be related to her vns. The patient underwent surgical consult and was referred to a cardiologist. No known surgical interventions have been performed to date.

Event Description
A patient reported that she had experienced a weight loss of approximately 150 pounds since being implanted with her vns device in (b)(6) 2012. Follow-up with the patient's physician showed that the weight loss was related to vns and was due to experiencing left vocal cord paresis following the implant in (b)(6) 2012. Per the neurologist, the vocal cord paresis may have caused aspiration and thus diminished oral intake, resulting in weight loss. The family was reportedly well compensated as of (b)(6) 2016. The majority of the clinical symptoms reported are related to bodily structures near the lead site ( voice alteration, dysphagia, nerve damage, and vocal cord paresis ). Additionally, the reported events were not alleviated after generator replacement occurred on (b)(6) 2016. Diagnostics have reportedly been within normal limits with both generators. No additional relevant information has been received to date.
Manufacturer Narrative

Event Description
The patient underwent generator replacement. The explanted generator has not been received for analysis to date. The physician reported that the patient underwent cardiology consult and a stress test and there was no evidence of abnormality. The physician believes a 3d echo was performed. It was reported that the ekg was ok.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225867
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dennis100
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« Reply #688 on: December 06, 2018, 01:44:08 AM »

Model Number 105
Event Date 07/13/2014
Event Type  Injury   
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Event Description
Clinic notes were received indicating that the vns patient was scheduled to undergo surgery on (b)(6) 2014 to explant her device. The patient had been hospitalized due to vomiting, diarrhea, sinus bradycardia, and voice hoarseness. The patient was given new medication and her device was disabled. It was noted that the patient¿s voice issues continued despite device disablement. The patient¿s device was tested and showed normal device function. The patient was seen by a cardiologist who determined that the patient had a history of nighttime bradycardia. The patient stated that she also had recently experienced bradycardia during the daytime. The patient had a history of chronic chest pain and was unable to tolerate stimulation at high settings due to the chest pain. The patient wanted her device explanted because it was uncomfortable and reportedly did not help with her seizures. Follow-up revealed that the patient¿s anxiety, nausea, voice alteration, vomiting and diarrhea were all related to vns stimulation. As the patient¿s device settings were increased, the patient¿s bradycardia had worsened and the patient was a non-responder to vns. The neurosurgeon stated that the patient did not have a prior history of cardiac events nor any pre-existing conditions susceptible to cardiac events. Additionally, the neurosurgeon indicated that the patient developed bradycardia following implant surgery. The patient underwent surgery on (b)(6) 2014 to explant her device. The explanted device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013497
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dennis100
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« Reply #689 on: December 07, 2018, 11:34:35 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury   
Event Description
It was reported by a patient's mother that the nurse at her daughter's day program mentioned to her that there was another patient with vns who had to have their vns moved to the other side due to chest pain and hiccups. There was no further information available. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8032941
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