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dennis100
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« Reply #600 on: May 07, 2019, 07:42:00 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2017
Event Type  Injury   
Event Description
The patient was experiencing a painful shocking feeling in his neck at the lead site that occurred with every stimulation. The device was disabled using the magnet. The next day, the painful stimulation returned and the patient was also experiencing an increase in seizures and his neck appeared to be pulsing at the site of the lead. The patient¿s school nurse attempted to disable the generator with the vns magnet however this did not inhibit stimulation. Due to the pain, the patient was taken to the surgeon to have the device programmed off. The surgeon performed diagnostic testing and x-rays and it was reported that everything seemed ok. Further follow-up found that a week prior to the pain and muscle spasm events, the generator¿s settings were increased as a part of normal titration. The physician later reported that the seizure rate was the same as pre-vns baseline and that the settings were still being titrated so the patient had not yet reached efficacious settings. The physician also confirmed that the magnet placement was appropriate to disable the device. The patient underwent surgery where the generator was replaced. The explanted device has not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
The initial report inadvertently did not include information that the device had been received by the manufacturer. ¿no, 02¿ the initial report inadvertently stated the device had not been received to the manufacturer. However the device had been received and was pending analysis. (b)(4). The initial report inadvertently did not include information that the device had been received to the manufacturer and was pending analysis. (b)(4).
 
Event Description
The device was received by the manufacturer and the device underwent product analysis has been completed. The internal data of the generator was reviewed and it indicated that the generator had 172 successful magnet swipes since the manufacture date, including 15 magnet mode activations that occurred around the time that it was reported that the magnet did not inhibit vns stimulation. During functional analysis magnet activations were performed normally. Product analysis found that the device operated within specifications.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: follow up report # 1 had the wrong date for the information received by the manufacturer. The correct date should have been 03/16/2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6381018
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dennis100
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« Reply #601 on: May 08, 2019, 10:40:18 AM »

Model Number 106
Device Problem High impedance
Event Date 03/22/2017
Event Type  Malfunction   
Event Description
It was reported the patient's vns was programmed off due to high impedance. The patient was scheduled for a full revision. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The patient underwent a vns generator replacement due to the reported high impedance. The device was tested in pre-op and still showed high impedance. The physician noted the old generator "felt loose" during the explant. When the new generator was implanted on the same lead, the impedance was within normal limits. It was noted the surgeon attempted to re-insert the lead pin into the original generator, but he still received high impedance. The device is not expected to re returned for analysis as the explanting facility is a no return site. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The date the patient's vns device was evaluated and programmed off was clarified by the physician's nurse. She also stated that the patient's husband had called about it the day before as she was having some painful stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6533121
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dennis100
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« Reply #602 on: May 08, 2019, 10:40:57 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2016
Event Type  Injury   
Event Description
It was reported to a company representative that a vns patient was experiencing painful stimulation with the device. Clinic notes were received from a visit on (b)(6) 2017. The notes described that the patient was experiencing irritation with vagus nerve stimulation cycles. The battery was reported to be at full capacity and there was no ¿weak¿ impedance. During the clinic visit on (b)(6) 2017, it was decided to tape the magnet in place to stop stimulation and assess if the painful stimulation resolves. The patient also wanted to continue referral for surgery in the meantime. The provider stated that they had wrapped the magnet in place themselves during the visit. Follow-up from the physician provided that the painful stimulation did not resolve after the magnet had been taped in place. The patient was scheduled for surgical consult, but no known surgery has occurred to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6376264
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dennis100
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« Reply #603 on: May 09, 2019, 07:45:02 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).
 
Event Description
It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.
 
Event Description
It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503540
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dennis100
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« Reply #604 on: May 09, 2019, 07:46:01 AM »

Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6509179
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dennis100
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« Reply #605 on: May 10, 2019, 02:13:19 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing constant stimulation, pain, and coughing "all the time". The patient was said to be going to the er. Clinic notes and a referral form were received reporting that the patient was referred for surgery due to constant stimulation causing pain, coughing, and shortness of breath. The device was disabled on (b)(6) 2019 for the adverse events. The patient underwent replacement surgery. It was noted pre-operatively that the device was already disabled upon interrogation at surgery. No pre-operative diagnostics were performed. During the surgery, the surgeon looked at the device being explanted and stated seeing some dot marks. At the patient's follow up appointment, it was clarified that the patient's pain, which was in the neck area, had resolved after the device was disabled. Prior to disablement, the patient felt like the pain was constantly going off. No device was returned to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510188
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dennis100
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« Reply #606 on: May 11, 2019, 03:05:13 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a neurologist reported that he visibly could see and feel stimulation on a patient¿s neck. The neck was seen to be vibrating. Diagnostics were ok. The neck would vibrate a couple times during the day, and did not occur with every stimulation. The patient had noted it to be annoying and uncomfortable. The physician was not sure if it was muscle spasms. Additional information was received that the patient had an allergic reaction to a medication in december and was intubated for four days. Since that time she has had painful stimulation that is palpable through the skin of her neck. She also reports shortness of breath. She indicated that the settings were re-adjusted 8 weeks ago, but she is continuing to experience uncomfortable stimulations, stimulations that are palpable through the skin, shortness of breath, and palpitations. Clinic notes were received that the is referred for lead replacement. Notes state patient is still having 30 or more painful stimulations a day and they have discussed replacing leads. Notes state that they need to check the lead as it hasn¿t been the same since she was intubated. Regarding shortness of breath notes state doing well currently. Regarding dysphagia notes indicated stable related to vns and post intubation, discussed with her local ent and will refer for lead replacement. Complains of hoarseness due to vns. Cardiology notes state the patient denies chest pain, shortness of breath and palpitations. Notes again mention the palpable muscle spasm over the left anterior neck during stimulation. Surgery referral for the lead revision is to diagnose and or rule out vns as the cause. While surgery is likely it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552815
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dennis100
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« Reply #607 on: May 11, 2019, 03:06:15 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
It was reported that low lead impedance of less than 600 ohms resulted from multiple system diagnostics tests although output current was ok and was successfully delivered at 1. 5ma. Additionally, the patient does have painful stimulation sometimes as well. The patient was referred for surgery. Follow up was performed with the patient's physician regarding the low impedance. It was reported that there is known trauma or manipulation of the vns area, the patient does not manipulate the lead themselves, and there is no change in stimulation perception reported by the patient. No known 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=8515263
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dennis100
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« Reply #608 on: May 11, 2019, 03:07:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/22/2016
Event Type  Injury   
Event Description
It was reported that the patient is no longer having auras, experiencing painful stimulation and more severe seizures since being implanted with vns. Additional relevant information has not been received.
 
Manufacturer Narrative
The initial report inadvertently omitted information regarding surgical intervention for the reported events.
 
Event Description
No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6499100
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dennis100
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« Reply #609 on: May 14, 2019, 01:24:51 AM »

Device Problems High impedance; Adverse Event Without Identified Device or Use Problem
Event Date 03/10/2017
Event Type  Injury   
Event Description
It was reported by the physician that the patient was uncomfortable with stimulation and he had requested how to perform diagnostic testing. It was later explained the patient was experiencing a shocking sensation with stimulation and the physician had decreased the pulse width and the frequency due to the shocking sensation. The patient was also sent for z-rays. One x-ray ap image, which included the neck and chest, was reviewed. The vns generator was in the left chest, the feedthru wires appeared intact, and the lead wires connector pin could not be fully assessed due to the image quality. A strain relief bend was present, but the presence of a strain relief loop could not be determined. While no sharp angles or gross lead fractures could be visualized due to image quality, there was a potential suspect location near the neck. An additional suspect area was noted above the generator and slightly above an additional lead for a device not associated with vns. However, it should be stated that it is unclear if the suspect areas actually show an issue with the lead, or if the suspect areas are just artifact. Additionally, proper electrode placement could not be determined due to image quality. The cause of the reported painful stimulation could not be conclusively determined. While there were no gross fractures or sharp angles conclusively observed in the image, a portion of the lead behind the generator could not be assessed; therefore, a lead fracture in that portion cannot be ruled out. The presence of a micro-fracture in the lead also cannot be ruled out.
 
Event Description
It was further explained by the physician that the patient¿s pain stopped when the device was programmed off; however, the patient experienced an increase in seizures due to the device disablement, so the device was programmed back on. The physician also mentioned high impedance was observed. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6459382
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dennis100
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« Reply #610 on: May 14, 2019, 01:25:36 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/16/2017
Event Type  Injury   
Event Description
It was reported by a physician that a patient was experiencing painful stimulation. Diagnostics were reportedly okay. The patient currently had placed the magnet over the device to disable stimulation. It was stated the pain began suddenly. From what the patient told him, it was not associated with increase in settings. The plan was to turn off the generator and perform revision surgery. Follow-up from the case manager provided the patient may have had trauma to the neck. Clinic notes were received from a visit on (b)(6) 2017. Within the notes it was provided that the patient has been experiencing shortness of breath and numbness and tingling in the left side of her throat where the leads run through. She feels as if the stimulator is going off all the time. The patient stated she never had similar problems with her previous vns. Diagnostics were provided as ok and battery life was stated as ¿green¿. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6484561
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dennis100
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« Reply #611 on: May 20, 2019, 09:44:32 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing painful stimulation to her face lasting 3-4 seconds 2 times per week at random time periods. The patient was referred for battery replacement. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative
The information for the event description for follow-up report #1 was inadvertently not provided. The information for the device settings were inadvertently not provided in follow-up report #1.
 
Event Description
Follow-up from the physician provided that the results of the most recent diagnostics were normal. The replacement was provided to have been to prevent a serious injury and for patient comfort reasons. Generator replacement surgery occurred. The explanted generator was received (b)(6) 2017. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. Analysis showed the battery was not depleted. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6566111
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dennis100
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« Reply #612 on: May 23, 2019, 11:30:30 PM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2017
Event Type  Injury   
Event Description
It was reported that the patient's vns was bothering her in her neck and shoulder. The physician referred the patient for generator replacement surgery due to the pain and for better seizure control. It was later reported that the patient's vns generator was completely depleted, which indicated that the issue that the patient was experiencing in the neck and shoulder were most likely not related to stimulation. Attempts for further information were unsuccessful to date. No known surgical intervention has occurred to date.
 
Event Description
The patient's mother reported that the patient also felt an electrical shock throughout her body when the device went off, and the physician told her that this was normal. The patient also reportedly experienced lead protrusion and discomfort. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6682630
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dennis100
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« Reply #613 on: May 23, 2019, 11:31:06 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2017
Event Type  Injury   
Event Description
A patient reported that while getting a head mri, the battery had not been turned off and she stated it got hot at the battery and at the attachment to the vagus nerve. The department was aware that she has a vns and was given her id (implant) card. The patient reported having passed out from pain. Follow-up by the company representative provided that the patient was last seen on (b)(6) 2017 and systems diagnostics were normal. The patient's generator was turned off. Additional relevant information has not been received to-date.
 
Event Description
X-ray images were received and reviewed. Based on the x-rays received, the cause for the painful stimulation could not be determined. There was no visual indication of damage to the generator or lead. However, the presence of an abrasion or a micro-fracture in the lead could not be ruled out.
 
Event Description
Follow-up from the physician has provided that the patient may have psych issues involved as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6676919
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dennis100
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« Reply #614 on: May 23, 2019, 11:32:00 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/27/2016
Event Type  Injury   
Event Description
It was reported that the patient was experiencing discomfort with stimulation in her throat. This was not ameliorated with attempts to lower settings. The physician expressed wanting to get the patient¿s vns explanted. Lead impedance was within normal limits, and review of x-rays by the physician did not show any obvious problems that could be causing or contributing to the painful stimulation. X-ray images taken after the onset of the painful stimulation were reviewed by the manufacturer. Ap and lateral x-rays of the neck and an odontoid view were included in the reviewed images. The generator was placed normally per labeling. The connector pin of the lead could not be fully assessed to be inserted inside the connector block due to the viewing angle and quality of the image. The feedthru wires appeared intact. The electrode placement appeared to be per device labeling. A small portion of the lead was behind the generator, making the lead difficult to assess in this area. There were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. The wires at the lead connector pin appeared to be intact. No additional pertinent information has been received to date.
 
Event Description
Communication with the patient¿s treating physician showed that surgery was not to preclude a serious injury and was simply in relation to discomfort. Surgical intervention has not occurred to date, and no additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6548498
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dennis100
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« Reply #615 on: May 23, 2019, 11:32:55 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/16/2015
Event Type  Injury   
Event Description
It was reported that a patient was experiencing painful stimulation. At the patient's request, the neurologist referred the patient to a surgeon for lead revision surgery; however, the functionality of the lead is unclear. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The neurologist reported that the patient's painful stimulation began around 1. 5 years prior to the report. The patient reportedly felt the pain in her neck and all the way up into her ear. The neurologist did not believe the painful stimulation was caused by a lead fracture. The lead revision surgery that was planned as intervention for the painful stimulation was for patient comfort at the time of referral. Diagnostic test results from the date that the painful stimulation began were within the normal limits. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546060
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dennis100
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« Reply #616 on: May 23, 2019, 11:33:32 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury   
Event Description
Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.
 
Event Description
Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551029
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dennis100
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« Reply #617 on: May 23, 2019, 11:34:18 PM »

Model Number 302-20
Device Problem Fracture
Event Date 02/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient had been feeling shocks that caused the patient to be unable to talk and barely breathe. The patient experienced such painful shocks that he had to be restrained at the emergency department. The written notes from the physician stated that he thought the "ground pulled off the nerve" without any clarification. The patient had full revision surgery due to the painful stimulation, and the physician later reported that there was an observed lead break during the surgery. However, diagnostics were within normal limits immediately prior to the surgery. The explanted product has not been received to date.
 
Event Description
The generator was received into analysis. The lead was not received from the explanting hospital. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551020
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dennis100
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« Reply #618 on: May 23, 2019, 11:35:04 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/26/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having pain due to upgrading from a 103 to a 106 due to the increase in size of generator. Clinic notes indicated that the patient had had some pain at the generator site since the procedure. She also had felt a continuous electric shock in her chest wall since her replacement that radiated to her left arm and left upper abdomen as well as numbness down her left arm. After she turned her generator off, her symptoms improved. She continued to have daily auras and seizures and had the worst period of seizures that she's had in years. For these reasons the surgeon recommended replacement of her generator with a m103 due to previous good results. The surgeon's office indicated that they believed that the continuous shocking may be caused by autostimulation. The issues resolved when the device was turned off, but the patient's seizure rate increased because of this. The surgery was indicated to be due to medical necessity. The patient was replaced due to painful stimulation. Lead impedance issues were not detected prior to the replacement. Per the surgeon, he did not observe any lead defects on the visible portion of lead during surgery. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
The explanted generator was received and underwent product analysis. The generator was monitored for 24 hours in a simulated body temperature environment and was able to provide the intended therapy for the entirety of the monitoring period. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Per a comprehensive electrical evaluation, the generator performed according to functional specifications with no anomalies found. The generator's internal data was reviewed. It was found that while the patient's generator was on, the patient received 21 autostimulations per day. Different autostimulation sensitivities and thresholds were not tried outside of the appointment. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6668568
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« Reply #619 on: May 27, 2019, 11:26:54 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2017
Event Type  Injury   
Event Description
It was reported by the patient's husband that the patient presented to an er due to increased seizures. The patient had also felt sporadic stimulations the previous night. The patient was admitted for observation. The patient's neurologist and surgeon were contacted and asked for the company representative to come check the vns. Follow up with the representative revealed that diagnostics were within normal limits. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was scheduled for a full vns replacement. The patient's neurologist requested that a company representative meet with the patient to lower the vns settings due to the reported sporadic stimulation. No surgery is known to have occurred to date.
 
Event Description
The patient underwent full vns replacement surgery. It was stated that no visual problems were found with the lead upon explant. Follow up with the company representative revealed that the patient experienced pain as well. The explanted products have not been received by the manufacturer to date.
 
Event Description
The explanted vns products were received by the manufacturer and are pending product analysis.
 
Event Description
Follow up with the patient by the company representative revealed that the patient's painful stimulation had resolved with the full vns replacement. Generator product analysis was completed. The allegations of increased seizures, and erratic and painful stimulation could not be evaluated in the product analysis, or pa, lab. However, proper functionality of the generator was verified in the pa lab. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The diagnostics were as expected for the programmed parameters. The generator was placed in a simulated body temperature environment and monitored for more than 24 hours. No signs of variation in the output signal were observed and the device provided the expected level of output current. The battery measured 3. 027 v at the completed of the fet, indicating an intensified follow-up indicator, or ifi, = no condition. The generator performed according to functional specifications. There were no performance or other adverse conditions found with the generator. Lead product analysis was completed. Verification of the increased seizures, and erratic and painful stimulation allegations were beyond the scope of activities performed in the pa lab. The portion of the lead containing the electrode array was not returned and, therefore, an evaluation could not be made as to that portion of the lead. Other than typical wear/explant related observations, no other anomalies were identified with the return lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6664754
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dennis100
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« Reply #620 on: June 01, 2019, 03:54:49 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/22/2017
Event Type  Injury   
Event Description
It was reported to a company representative that a patient has requested to have her device removed due to pain at the generator site. She is diagnosed with mental health problems and the patient¿s physician believes the pain is mostly psychological. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Follow-up from the company representative who spoke to the provider indicated that the patient also had pain in the neck from when her grandson had slapped her on the neck. The device was turned off for a couple of weeks and was turned back on with no discomfort and the problem was considered resolved.
 
Event Description
Follow-up from the provider indicated that the neck pain had resolved and the most recent diagnostics were okay.
 
Event Description
Further follow-up from the provider indicated that trauma to the neck has partially dislodged, damaged the electrode and was causing pain. Lead revision surgery occurred, and the explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on follow-up report #3 that the device had been received by the manufacturer.
 
Event Description
The explanted device was received by the manufacturer. Documentation received indicated that the patient felt a lead pulling sensation and then painful stimulation. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Event description, corrected data: the results of product analysis for the returned generator were inadvertently not provided in follow-up report #4.
 
Event Description
Analysis was completed for the returned lead. The electrode array portion was not returned for analysis, and evaluation could not be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727567
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dennis100
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« Reply #621 on: June 01, 2019, 03:55:33 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/22/2017
Event Type  Injury   
Event Description
It was reported that a vns patient was experiencing painful stimulation. The physician first wanted to lower the output settings, but was trying not to have major surgery. It was later provided that the patient was scheduled for a full revision due to painful stimulation and voice alteration. Full revision surgery occurred. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Follow-up to the provider revealed that the device was explanted due to the patient¿s response to the stimulation, and that diagnostics performed at patient checkup were within normal limits. Analysis was completed for the returned lead and generator. A portion of the lead including the electrode array was not returned for analysis. Other than the typical wear and explant related observations, no anomalies were identified in the returned lead portion. The generator output signal was monitored for more than 24 hours in a simulated body temperature environment. The device provided the expected level of output current. Diagnostics were as expected for the programmed parameters. Electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage showed the device was not depleted. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6730458
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« Reply #622 on: June 01, 2019, 03:56:17 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/03/2017
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient experienced painful stimulation at the throat and chest sites with magnet stimulation. She did not feel the pain during normal stimulations. The physician adjusted the magnet mode output current. System diagnostics were within normal limits. The patient's device was at ifi=no, but the physician believed that the battery was low and referred the patient for generator replacement surgery due to the painful stimulation and low battery. The physician reported that the patient did not specify when the painful stimulation started, but she had been having the tolerability issues since the physician started seeing the patient. The physician reported that the surgery was being done due to low battery, as system diagnostics were done and impedance was within normal limits. However, the physician stated that the surgery was also being done to preclude a serious injury. No surgery has occurred to date.
 
Event Description
The patient had generator replacement surgery due to battery depletion (ifi=yes). The explanted generator has not been received to date.
 
Event Description
The explant generator was received for analysis on 08/31/2017. Product analysis on was completed and approved on 09/21/2017. The design history record showed that the pulse generator passed all specifications prior to its release. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The generator battery showed ifi-yes condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6727266
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« Reply #623 on: June 03, 2019, 05:08:10 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/17/2011
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that when she was last titrated up she began to wake up and feel like she had stopped breathing in her sleep. She said that had never happened to her before, she wasn't a snorer, and that her family didn't have a history of this symptom. In addition, she began to hum very loudly in her sleep, she began to hear tapping sounds in her throat every few seconds and she felt like she could feel someone lightly tapping in her throat. She also felt that her throat was tightening during stimulation. She described these sensations as having some pain associated. She indicated that her device was turned back down but that this hadn't helped her much. No further relevant information has been received to date.
 
Event Description
When follow up was performed regarding the patient's potential sleep apnea and her hoarseness, the physician's office indicated that they hadn't been aware of these issues previously. No further relevant information has been received to date,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6820533
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« Reply #624 on: June 03, 2019, 05:09:22 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2015
Event Type  Injury   
Event Description
It was reported that the patient experiences a sharp pain in her left neck during stimulation every 2 months. Usually, the severity of the pain diminished over the course of the day. However, more recently, the pain was not easing over the course of the day. The doctor decreased the frequency, and the pain also decreased. In (b)(6) 2015 the patient had severe pain associated with her vns, and the pain resolved with a decrease in pulse width. Because of the painful stimulation, the patient was referred to see a surgeon for replacement. The patient reported that the vns is causing her excruciating pain, and she wants to claw it out of her neck. When this happens, it occurs just 3 or 4 times, or an entire day. No known surgical interventions for vns have occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent surgery and had their generator replaced. The explanted generator has been received by the manufacturer. Analysis is underway but has not been completed to date.
 
Event Description
The generator underwent product analysis and exhibited proper functionality in its ability to provide appropriate programmed output currents. The device output signal was monitored for more than 24 hours where 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no additional performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6821496
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dennis100
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« Reply #625 on: June 04, 2019, 08:34:56 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
Report was received that a patient had experienced painful stimulation during magnet activation. The magnet output current was reduced and the painful stimulation subsided temporarily. About 7 months later, the patient began feeling painful stimulation on the side of the head and ear with normal and magnet mode stimulation. No adjustments in therapy or trauma occurred prior to the reoccurrence of the painful stimulation. System diagnostics were performed and returned within normal limits. A review of the programing history did not show a presence of high impedance. A review of chest x-rays did not indicate there was any malfunction present. The patient was referred for a generator replacement because adjusting settings did not resolve the painful stimulation and the physician indicated he believed the generator was malfunctioning. No surgical intervention has occurred and no further relevant information has been received to date.
 
Event Description
It was reported that the patient still has left ear pain with stimulation. The setting was decreased to 0. 5 ma but the issue still occurs. A review of additional x-rays received did not indicate any malfunction. No surgical intervention has occurred to date and no further relevant information has been received to date.
 
Event Description
The patient¿s generator was replaced on due to painful stimulation. The explanted generator was received and analysis is underway but has not been completed to date. No additional or relevant information has been received to date.
 
Event Description
Product analysis on the generator model 103 was completed and approved. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿ and ¿painful stimulation¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6801108
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« Reply #626 on: June 07, 2019, 05:34:22 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2019
Event Type  Injury   
Event Description
During a surgery consult appointment for "battery depletion," the patient reported a shocking sensation with the vns stimulation. The neurosurgeon has referred the patient for an x-ray prior to scheduling the patient for a replacement of their generator. 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=8578296
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« Reply #627 on: June 07, 2019, 05:35:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Event Description
It was reported that a patient was in surgery for replacement and during the case it was decided to cancel the case. Her pre-operative generator interrogation showed battery life of 75%-100%. The lead impedance was 3236. The patient was on a very low current output of 0. 125 ma because she said she could not tolerate any higher output. Per information received, the reason for the replacement was due to the tolerability issues. Per programming history, 2016 the patient was set to. 25ma; however there was no further titration history. Procedure was completed and both the generator and lead were replaced. The reason for this new replacement was due to the patient having persistent pain when the generator provided stimulation. The explanted devices have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8578732
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« Reply #628 on: June 08, 2019, 06:48:09 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Event Description
It was reported that the patient's vns was "misfiring" and had fired 36 times in one day. The er physician indicated that the vns kept going off every minute per the patient and would not stop. Magnet disablement was recommended, but the patient and facility requested a company representative program the vns off. A second call was received from the facility. Magnet disablement resolved the issue, but it was still requested to have the vns programmed off. It was believed by the medical professional that the patient experienced painful stimulation since they requested the vns programmed off. The patient was discharged from the facility. Information was later received indicating that the ¿misfiring¿ meant the patient experienced a shocking sensation and that the medical professionals did not wish to disable the vns as they did not want the patient to have seizures. The diagnostics from the latest clinic visit after the admission were reported as within normal limits. The patient was referred for a vns lead replacement surgery due to the painful stimulation. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8654203
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« Reply #629 on: June 08, 2019, 06:49:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/15/2010
Event Type  Injury   
Event Description
It was reported that a vns patient was having trouble with their device and wanted it removed. The patient reports that the device was causing discomfort and pain from stimulation and presence of the device in both neck and chest area. Further follow up with the patient's nurse practitioner confirmed that the generator was turned off prior to (b)(6) 2018. It was confirmed that the patient has been referred to surgery, both for patient comfort reasons and to preclude serious injury. 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=8638725
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