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dennis100
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« Reply #90 on: November 25, 2017, 08:04:33 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/28/2015
Event Type Malfunction
Event Description
An additional x-ray image was received and reviewed. The 103 generator was seen in the left chest. The filter feedthru wires were intact. The connector pin was inserted into the connector block, but it cannot be determined if it had been inserted to the fullest extent. The lead wire was intact at the location of the connector pin; however, there was a portion of the lead located behind the generator that could not be assessed. The electrode placement was done per labeling. The strain relief bend was present but the strain relief loop was not present. Instead, another bend was in place of the loop. Two tie-downs appear to be present holding the strain relief bend. A possible twist in the lead was noted at the top of the left rib. Between the top left rib and the second left rib, there was a suspect area. It is unknown if this is artifact or if one of the lead wires had been bent. There is an additional suspect area over the left clavicle where the lead appears to have been pinched. It is unclear if a fracture has occurred at this point. The cause of the reported high impedance could not be determined based on the x-ray image received. It was also reported the patient had lead revision surgery on (b)(6) 2016. The lead replacement was due to the high impedance observed and the generator was replaced without any problems. It was noted there were two surgeons present and they had both agreed it was too dangerous to remove the electrodes from the left vagus nerved and decided to implant the new lead on the right vagus nerve. The surgeons had tried for several hours to see if there was a possibility to implant the lead on the left vagus nerve, but were unable to do so. A portion of the lead was removed, but the electrodes remained implanted. After re-implant of the new vns system, impedance values were noted to be fine. No patient adverse events were noted during surgery. The explanted devices are expected to be returned to the manufacturer for analysis; however, they have not been received to date.

Manufacturer Narrative

Event Description
Both the lead and the generator were received by the manufacturer for analysis. Analysis on the generator was completed and a review of the ram/flash data download from the generator shows an indication of increased impedance from 2412 ohms to 13902 ohms on (b)(6) 2015. Various electrical loads were attached to the generator and the results of the diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Product analysis of the returned lead is expected but has not been completed to date.

Event Description
A/p and lateral images of the chest and neck of the vns patient dated (b)(6) 2015 were reviewed. The generator was seen in the chest. The filter feedthru wires were intact. The connector pin inside the connector block was confirmed to be completely inserted. The lead wire was intact at the location of the connector pin; however there was a portion of the lead located behind the generator that could not be assessed. No gross fractures or sharp angles were noted. The radiologist suspected a possible fracture on one of the lead wires at the level of the 2nd posterior rib on the ap view. This was not confirmed on the lateral view per the radiologist. It was noted that the two lead wires intertwine at the 2nd posterior rib but an obvious fracture is not noted. A suspect area was identified in the a/p image taken on (b)(6) 2015. In the lead portion on the clavicle, the lead wires appear to be intertwining again. However, a kink on one of the lead wires is suspected. There did not appear to be any other lead discontinuities in the portion of the lead that could be visualized. However, the presence of a micro-fracture in the lead cannot be ruled out.

Event Description
The product analysis for the lead was completed and it was found that the high impedance reported was verified. A break was identified in both the positive and the negative lead coils. Scanning electrode microscopy images of the positive and negative lead coils showed that pitting or electro-etching conditions have occurred at the break locations. Also, the positive lead coil showed minor appearance suggesting that a stress-induced fracture occurred in at least one strand of the positive quadfilar coil. However, due to metal dissolution, mechanical distortion, and/or surface contamination, the fracture mechanism of the broken strands cannot be ascertained. Note that since the electrode array portion was not returned for analysis, an evaluation with resulting commentary could not be made on that portion. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
It was reported that the vns patient's device showed a high impedance condition during an office visit on (b)(6) 2015. The device subsequently disabled. No known surgical interventions have occurred to date.

Manufacturer Narrative
This information was inadvertently reported incorrectly on supplemental #03 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5041455
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dennis100
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« Reply #91 on: November 30, 2017, 01:47:35 AM »

Model Number 103
Device Problem No Information
Event Date 08/25/2015
Event Type Injury
Event Description
Product analysis was completed on the generator on 12/10/15. In the product analysis lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2016 the physician reported that there is no relationship between the patient's cancer and vns. The physician declined to provide the date the cancer was first observed.

Event Description
On 10/23/2015 it was reported that the patient underwent prophylactic generator replacement and the new generator was moved to the right chest wall due to the patient's left breast cancer. Pre-operative diagnostics showed results within normal limits. The explanted generator was returned for product analysis on 11/12/2015. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5079025
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dennis100
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« Reply #92 on: December 01, 2017, 01:39:02 AM »

Model Number 304-20
Device Problem High impedance
Event Date 08/10/2015
Event Type Malfunction
Event Description
Additional information was received that the patient underwent vns generator and lead implant surgery on (b)(6) 2015 due to prophylactic generator replacement and high lead impedance. Pre-op interrogation indicated that the device outputs were programmed off. Pre-op system diagnostic on the patient' device indicated impedance > 10,000 ohms. It was decided to implant this patient's new system on the right side, without removal of the original left side implants. Impedance results were within normal limits on the new device after implant. No additional relevant information ahs been received to date,.

Manufacturer Narrative

Event Description
It was reported that the patient had high impedance detected on his vns system per interrogation from the neurologist's programming system. Device manufacturing records were reviewed and confirmed that the lead passed all functional tests prior to distribution. It appears the vns device has been disabled. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5050090
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dennis100
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« Reply #93 on: December 11, 2017, 01:30:18 AM »

Model Number 102
Event Date 01/28/2016
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(6) 2016 the patient had a prophylactic generator replacement. The surgery was done in conjunction with a left breast biopsy. The lead was tunneled and relocated to the right breast.

Event Description
The patient was being referred for possible revision because she is getting ready to do radiation for breast cancer. She had previously had a tumor removed on her left breast. No additional relevant information has been received to date.

Event Description
It was reported that the patient is scheduled for a prophylactic generator change and lead reposition. She has a left breast tumor that is also being removed at the same time. Good faith attempts to the physician for additional information regarding the tumor have been unsuccessful. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Follow-up #, corrected data: supplemental #1 inadvertently had the follow-up # as blank and not selected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5450833
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dennis100
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« Reply #94 on: December 12, 2017, 01:35:41 AM »

Model Number 302-20
Event Date 01/12/2016
Event Type Malfunction
Event Description
Further information was received indicating that the patient underwent a full replacement surgery on (b)(6) 2016. The lead was replaced due to high impedance. The generator was replaced due battery depletion. It was reported that the vns new system was implanted in the right side of the patient's body. The explanted lead will not be returned to the manufacturer as it was discarded by the facility. Therefore, no analysis could be performed. The explanted generator was returned to the manufacturer on (b)(6) 2016. Analysis of the returned generator was completed. The reported battery depletion was not duplicated in the product analysis laboratory. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that high impedance (dcdc-7) was observed on vns patient's system. The device was then switched off. X-rays were taken and sent to manufacturer for review. Review of the x-rays identified that the lead pin was fully inserted into the generator header. The filter feed-through wires appeared to be intact. Part of the lead appeared to be behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the part of the lead that could be assessed. A micro-fracture could not be ruled out. Further information from the physician was received indicating that the patient had a big fall with chest impact on a door, in early (b)(6) 2016, due to seizure. Since, the magnet is no longer effective. It was reported that the patient has an increase in seizures at pre-vns level. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. It was reported that an intervention is planned. No known surgical interventions have been performed to date. No additional relevant information has been received to date.

Event Description
Further information was received indicating that the patient is subject to a vns study. It was reported that the patient had status epilepticus from (b)(6) 2016. It was reported that the severity of the event was mild. The event was not related to implant but possibly related to vns stimulation. It was reported that the treatment was modified and as other action taken: a lead replacement. It was reported that the event was a serious adverse event since it resulted in an initial or prolonged hospitalization. But it did not cause the subject to discontinue from the study. Additional information indicated that the patient had status epilepticus in the period when high impedance was observed. Therefore, the physician concluded that there was a relationship between both events. Both events are now solved.

Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong conclusion codes for the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5406587
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dennis100
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« Reply #95 on: December 17, 2017, 01:42:40 AM »

Model Number 102
Event Date 05/13/2013
Event Type Injury
Event Description
Medwatch report mw5061274 was received by the manufacturer. The patient reported the following: "the last surgery i had was to insert a vagus nerve stimulator, vns made by cyberonics, this also became infected and i had yet another surgery and infection. They had to redo the surgery on my right chest instead of my left. The specific company for the vns was made by cyberonics with generator (b)(4). After this surgery i had to stay one night in the hospital. " mfr. Report# 1644487-2013-01470 reports an infection that occurred for the patient in (b)(6) 2012 on her right chest. The patient had generator replacement surgery on (b)(6) 2013 and it is unclear if she is stating in this report that replacement surgery led to infection. Attempts for additional information have been made, but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685677
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dennis100
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« Reply #96 on: December 18, 2017, 01:06:43 AM »

Model Number 103
Event Date 02/10/2016
Event Type Injury
Manufacturer Narrative
Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. This information was inadvertently left off of the initial mfr. Report.

Event Description
Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution. It was reported the physician wanted to re-implant the generator on the patient's right side and tunnel the lead to the left vagus nerve as to avoid compromising the original pocket on the left side that had been treated with antibiotics. Product analysis for both the lead and the generator were completed and no anomalies were noted.

Manufacturer Narrative

Event Description
It was reported the patient's neurologist believed there was an infection at the generator site. The patient was then referred to the surgeon for confirmation. The surgeon referred the patient for explant due to the infection. Clinic notes were later received and it was found the patient stated there was a blister, wires were exposed, and still brown drainage. It was also noted the surgeon was going to perform a vocal cord evaluation due to vns placement on the left, and possible place the new vns on the right. The surgeon stated he wants to evaluate the recurrent laryngeal nerve to verify the nerve is stable on both sides. The patient had his generator and lead explanted on (b)(6) 2016. It was noted the generator was completely out of the pocket upon arriving to the hospital. The lead and generator were returned to the manufacturer. Analysis is expected but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5670914
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dennis100
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« Reply #97 on: December 31, 2017, 01:38:43 AM »

Model Number 106
Event Date 07/01/2016
Event Type Injury
Event Description
It was reported that the patient was experiencing a lead pulling sensation which appeared related to the previously migration of the generator. Therefore the physician intended to perform another repositioning surgery where the generator pocket would be moved to the right side of the patient's chest. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.

Event Description
It was reported that the patient was planned for a generator revision and that the placement of the generator would be moved. Additional information from the physician's office indicated that the reason for the revision was the generator had migrated medially and inferiorly and was causing pain and discomfort to the patient's sternum. The surgery was being done to preclude patient injury. The migration began spontaneously, and the physician had used tichron 30 non-absorbable sutures to anchor the generator in the initial surgery before the migration. Additional relevant information has not been received to date.

Manufacturer Narrative
(b)(4).

Event Description
Additional information was received on 10/28/2016. Per the physician, the repositioning was being done because the generator was rubbing against the patient's manubrium and not being done to preclude serious injury. Information was also received from a company representative on 11/01/2016. He stated that the patient felt that stimulation was being triggered when raising her left arm due to the device migration and has shortness of breath and coughs because of this. Before the revision surgery, the patient saw her physician and the physician lowered the output current to 1. 0ma. The change was noted as to have been done for the shortness of breath and cough. The frequency was noted as 15hz, the pulse width as 250 micro seconds, and the off time as 1. 1 min. The patient only had 5 autostimulations in the last 102 days prior to the visit. System diagnostics were noted as normal. It is known that stimulation cannot be triggered by the patient's hand or arm movement unless the patient is using a magnet to trigger magnet activation. The device was repositioned on (b)(6) 2016. No additional relevant information has been received to date.

Event Description
It was found out that the patient was in a car crash which is suspected to be the cause of the migration of the device. The adverse events previously reported are stated to have been occurring for some time which predated the accident. Therefore those events appear to be unrelated to the accident and migration of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6063772
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dennis100
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« Reply #98 on: January 01, 2018, 01:28:14 AM »

Model Number 106
Event Date 09/17/2016
Event Type Injury
Event Description
Follow up information received that the patient has been implanted on right vagus nerve because it was impossible to find a place to attach the electrode on the left side when the previous lead had been removed. This was due to adherences on the vagus nerve. The generator has been implanted on the right side as well. Both right and left vocal cords are paralyzed and physician believes this is definitely related to vns surgery. The left vocal cord was completely paralyzed, the right vocal cord partially paralyzed. The implanted generator has never been programmed on. No diagnostic test results available. The patient has had tracheostomy and still has his tracheostomy with a tracheal cannula in place.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a vns patient is having vocal cord paralysis. The paralysis began after the patient underwent a full vns system replacement surgery. Information was received that the patient was implanted on the right vagus nerve. Review of manufacturing records confirmed all tests passed for the concerned generator prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6066750
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dennis100
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« Reply #99 on: January 06, 2018, 03:27:35 AM »

Model Number 304-20
Device Problem Fracture
Event Date 11/30/2017
Event Type Malfunction
Event Description
It was reported that this patient was going in for a generator replacement due to battery depletion, and high impedance was found during pre-op. The patient was taken in for a full lead revision, and the original lead electrodes were so scarred down that they could not be removed safely. The new lead could not be implanted on the left side due to the fibrosis, and therefore the new generator and lead were implanted on the right side. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7120774
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dennis100
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« Reply #100 on: March 10, 2018, 01:24:22 AM »

Device Problem No Known Device Problem
Event Date 12/10/2017
Event Type Injury
Manufacturer Narrative
Device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.

Event Description
A research article was received that compared seizure outcome from early (<= 5 years of age) and late (> 5 years of age) implantation of vns in children. This report captures a report of one patient, who was part of the late implant group, postoperative infection that resulted in implantation on the right side of the chest in addition, one patient in the study experienced an increase in seizures, captured in mfr. Report # 1644487-2018-00165. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7241147
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« Reply #101 on: April 02, 2018, 12:10:56 AM »

Model Number ASKU
Event Date 11/14/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the nurse practitioner at the neurologist's office reporting the patient did come in for clinic visits and diagnostics were done on her vns which is typical. She was exhibiting behavior that they thought were seizure related. The seizure activity is not believed to be above pre-vns baseline levels but no additional information was provided regarding the seizures. Diagnostics revealed high impedance on (b)(6) 2012, and chest/neck x-ray was performed on this date which found a fractured wire. The device was subsequently turned off on (b)(6) 2012. Lead was replaced in another town so the additional follow-up was performed by another physician's office. Attempts for additional information from the currently treating/local nurse practitioner have been unsuccessful to date.
 
Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the date incorrectly due to new information received.
 
Event Description
It was initially reported that the patient had vns replacement on (b)(6) 2012 placed on the right side. Follow-up with the implanting surgeon was performed which revealed that the lead was replaced on (b)(6) 2012. (the generator was not replaced as it was recently implanted on (b)(6) 2012. ) the lead was implanted on the right vagus nerve rather than the left vagus nerve, which is off-label. Manufacturer labeling indicates the lead to be implanted on the left vagus nerve. The lead was implanted on the right vagus nerve due to 'high risk for nerve injury with a third neck dissection, particularly given the prior injury' of vocal cord paralysis. The vocal cord paralysis is reported in mfg report number: 1644487-2004-00262. The lead was replaced due to high lead impedance first observed in (b)(6) 2012, and x-ray images performed on (b)(6) 2012 reportedly showed a fracture of one of the lead wires. There was no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. A copy of the x-rays will not be provided to the manufacturer without patient signed release. The generator was turned off prior to surgery sometime in (b)(6) 2012. The patient exhibited atonic seizures with the high impedance, but it is unclear if there was an increase in frequency or change in seizure pattern. Attempts for additional information from the treating nurse practitioner at the physician's office who found the high lead impedance have been unsuccessful to date. Additionally, attempts to medical records for lead product information have been unsuccessful to date. Attempts for product return have been unsuccessful thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2933487
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dennis100
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« Reply #102 on: May 02, 2018, 01:32:25 AM »

Model Number 302-20
Event Date 06/07/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was reported that the patient has not been seen yet by the physician.
 
Event Description
It was reported that the patient was seen on (b)(6) 2013 and diagnostics were fine.
 
Event Description
On (b)(6) 2013 it was reported that high impedance was observed after the patient had her duty cycle increased on (b)(6) 2013 from 30sec on and 3min off to 30sec on and 1. 8min off. System diagnostics had been performed which showed a high impedance value of 7200ohms. When a subsequent system diagnostics test was performed the result was approximately 3000ohms and two more system diagnostics tests also showed the same results. No changes were observes or clinical manifestations and there were no falls or other trauma reported. It was stated that the patient is bed/wheelchair bound. The patient¿s current settings were noted to be output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time-1. 1min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec. X-rays were performed and it was stated that there were no problems observed; they did not want to send them to the manufacturer for review. The device was left on. It was stated that the generator is located in the right side of the chest so the lead is positioned across the chest. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3221239
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dennis100
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« Reply #103 on: May 09, 2018, 12:27:42 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/14/2012
Event Type  Malfunction   
Event Description
During review of the in-house programming/diagnostic history database, it was observed that high impedance was observed on (b)(6) 2012. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the high impedance reading. It is unknown if surgery has been performed. The device was not programmed off after observing the high impedance reading. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
An article titled "resultados de la estimulación del nervio vago en pacientes con epilepsia farmacorresistente en un centro de referencia nacional de epilepsia" ( results of vagal nerve stimulation in patients with drug-resistant epilepsy at a national referral center for epilepsy) was received and provided additional information for this patient. The patient was noted to have had a new vns device implanted on the right vagus nerve after the extensive fibrosis was found on the left vagus nerve. The replaced lead has not been sent to the manufacturer to date and the exact date of the surgery has not been noted to date. No further relevant information has been received to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and diagnostic results showed high impedance. X-rays were taken and were reported by the physician to be unremarkable. The patient underwent surgery on (b)(6) 2014. Upon opening the neck incision site, an abundant amount of fibrosis was observed and the surgeon determined that surgery could not continue so the patient was closed. No known surgical interventions to resolve the reported high impedance have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3404837
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« Reply #104 on: August 11, 2018, 12:44:37 AM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 07/06/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
High impedance was observed on a patient's device. A lead revision surgery was performed for the impedance issue, and was placed on the right vagus nerve as the left nerve could not be found due to patient anatomy. The generator was not changed, and post-operation diagnostics indicated ok impedance. This was reported in mfg report #1644487-2018-00771. It was later reported that about two weeks after the surgery, high impedance was noted again and the physicians believed there may be an issue with the generator. It was stated that the patient was not very active, so it was not likely any trauma occurred to the site. It was unknown if the patient manipulated the device. A generator replacement, and possible full revision, surgery was scheduled. The surgery occurs and it was noted that various troubleshooting was performed, including lead pin reinsertion and testing the generator with a test resistor. Both the lead and generator were replaced, and post-operation diagnostics indicated ok impedance. It was reported by the representative at the surgery that fluid was found in the tubes of the lead. Device history records were reviewed for the explanted devices and each device was indicated to have passed all quality inspections prior to distribution. No explanted devices were returned to date. No additional information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7692269
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« Reply #105 on: November 09, 2018, 02:20:38 AM »

Device Problem High impedance
Event Date 09/24/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient was hospitalized due to increased seizures, and increased seizure duration and intensity. A company representative then checked the patient's generator and found high impedance and that the current was not being delivered. A new lead and generator were implanted on the right side of the patient. The generator was explanted, but the old lead was left in the patient in its entirety. Per the surgeon, no fluid or visible defects were seen on the lead. The physician believes the high impedance to have been due to scar tissue on the left vagal nerve. Attempts have been made for lead product information, but no relevant information has been received to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7975863
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« Reply #106 on: December 04, 2018, 01:51:15 AM »

Model Number 105
Event Date 08/05/2013
Event Type  Injury   
Event Description
It was reported that the patient had a complete revision surgery on august 5, 2013 and was returning to the operating room on (b)(6) 2013 for another procedure. Operation notes dated (b)(6) 2013 indicate the patient has developed swelling over his pulse generator site over the last 24 hours the patient's mother denies any trauma to the area. The patient¿s axillary incision was opened and yellowish cloudy fluid was observed in the subcutaneous pocket, which was sent for microbiologic analysis. The pulse generator was removed and the pocket was irrigated with large amounts of antibiotic saline. Per the notes, due to the extreme dependency of this patient on his vagal nerve stimulator pulse generator procedure control and his history of refractory epilepsy, it was the surgeon's decision to attempt at first to try to treat the likely infection with a revision of the patient's pulse generator and intraoperative aggressive washout. After soaking the pulse generator in the antibiotic saline tub for a protracted period of time, the device was reconnected to the electrode lead with the torque wrench. It was then re-implanted into the subcutaneous pocket. The device was interrogated and found to be okay. Antibiotic ointment and sterile dressings were placed over the closed skin. The patient left the operating room in stable condition. Operative notes dated (b)(6) 2013 indicate the patient had a postoperative wound infection. Removal of vagal nerve stimulator pulse generator, as well as partial removal of electrode leads and complete drainage postoperative wound was performed. Per the notes, the patient developed a postoperative wound infection which has been shown to be a staph aureus wound infection. Swelling in the patient's chest pocket recurred despite operative washout and neurosurgical intervention was indicated now for removal of the vagal nerve stimulator. The patient was receiving intravenous antibiotics during surgery. During surgery, there was no evidence of obvious purulence in the neck region; however, the physician swabbed the area for intraoperative culture. When entering the subcutaneous pocket, yellowish cloudy fluid was observed. The specimen was sent for microbiologic analysis. The pulse generator and lead were explanted and the pocket was irrigated with large amounts on antibiotic saline. Antibiotic ointment and sterile dressings were placed over the incisions and the patient was taken to recover in the recovery room. No additional information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found and sterility was confirmed with the generator and lead prior to distribution and sterility.

Event Description
The explanted generator and lead were returned to the manufacturer for analysis. The reason for explant was due to infection and no malfunction suspected/identified. Results of diagnostic testing indicated the generator was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Scanning electron microscopy images of the positive coil of the lead show that pitting or electro-etching conditions have occurred on the coil cut end. The most likely cause for the observed pitting condition is that the generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load (cut leads). However, the exact point in time of when this occurred is unknown. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution.

Manufacturer Narrative
Suspect medical device explant date, corrected data: the initial report inadvertently reported the incorrect date.

Event Description
It was reported that the patient underwent re-implant surgery. The new lead was placed on the patient's right side.

Event Description
It was reported that the patient has been scheduled for reimplant of a new vns system. The reimplant surgery has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3316559
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« Reply #107 on: January 21, 2019, 11:28:07 AM »

Model Number 102
Event Date 05/28/2014
Event Type  Injury   
Manufacturer Narrative
Corrected data: this information was inadvertently reported incorrectly on follow-up mfr. Report #01.
 
Event Description
Product information was obtained.
 
Event Description
It was reported that the patient underwent vns reimplant on (b)(6) 2014.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that the patient underwent explant due to infection. The physician noticed redness following the path of the lead and decided to explant.
 
Event Description
It was reported that following generator replacement surgery, the patient had an infection at the generator site within approximately twenty days of the replacement surgery. An additional surgery was performed to move the generator out of the infected pocket and to a new site on the patient¿s right side.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported that the infection was caused by skin contaminant. The infection has resolved and reimplant will occur in the future.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3937896
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« Reply #108 on: February 07, 2019, 08:16:41 PM »

Event Date 02/27/2014
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The generator was programmed off and the patient was referred for x-rays. The patient may be referred for surgery. No known surgical intervention has been performed to date.
 
Event Description
X-rays dated on (b)(6) 2015 were provided to the manufacturer for further review. The generator appears in the right chest in an abnormal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.
 
Event Description
It was reported that through the programming history database periodic review high impedance occurred on vns patient's generator model 102 serial number (b)(4).
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect gender. The previously submitted mdr inadvertently provided an incorrect event date. The previously submitted mdr inadvertently provided an incorrect event description. The previously submitted mdr inadvertently provided an incorrect data.
 
Manufacturer Narrative
The previously submitted mdr inadvertently provided the wrong evaluation codes.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The available programming history data of the patient¿s device (model 102 sn (b)(4)) was reviewed. The data was observed from (b)(6) 2013 through (b)(6) 2014. The device was last programmed on (b)(6) 2014 to 8% duty cycle. The last parameters recorded were 0 ma/20hz/250¿s/21sec/5min and magnet mode was1. 25 ma/21sec/250¿s. Diagnostic data was also found. Last diagnostic recorded was on (b)(6) 2014. The lead impedance was high (dcdc 7) and eri no. The parameters data also indicated that the stimulation ok. The review of the available programming history revealed high impedance observed on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4427254
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« Reply #109 on: February 11, 2019, 01:17:54 AM »

Model Number 103
Event Date 11/18/2014
Event Type  Injury   
Event Description
The reimplanted vns system was placed on the left vagus nerve.
 
Event Description
It was reported that the patient was scheduled for vns debridement. The patient had recent generator and lead replacement surgery on (b)(6) 2014. The surgeon¿s office reported that the patient had a post-operative infection. As a result, the plan was to debride and drain the spot on skin. The patient had surgery on (b)(6) 2015 to debride, and the patient was subsequently referred to the infectious disease doctor.
 
Event Description
It was reported that the patient was scheduled for re-implant surgery. However, surgery has not occurred to date.
 
Event Description
An implant card was received which reported that the patient was re-implanted with a vns therapy system.
 
Event Description
It was reported that the patient was scheduled for revision surgery. The surgeon planned to remove the vns system due to the infection, let it heal for a couple of weeks, and then go back in and either place the generator on right with electrodes on left vagus nerve or completely re-implant the system on the right side anatomy. It was reported that during surgery on (b)(6) 2015, the surgeon nicked the jugular vein when trying to cut the lead with less than 2 cm remaining. The bleeding was controlled with the use of a clip that was inserted. The pocket site culture that was completed was positive for an infection. The plan was to treat the patient with antibiotics. It was reported that the patient first presented with a staph infection on (b)(6) 2015 with a fluid-filled chest pocket. The nurse was unsure if the neck incision was also infected at that time. Antibiotic bactrim was prescribed but not successful as the patient was unable to tolerate. The patient was seen again on (b)(6) 2015 and was referred to infectious disease. The patient was seen on (b)(6) 2015, and keflex was prescribed at that time. After the patient was seen by the surgeon on (b)(6) 2015 again, the decision was made to explant.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing history records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4476743
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« Reply #110 on: February 25, 2019, 02:24:26 AM »

Model Number 304-20
Event Date 05/04/2015
Event Type  Malfunction   
Event Description
The patient¿s mother reported on (b)(6) 2015 that the patient has had poor seizure control lately, and that she was hospitalized over the prior few days. She was admitted to the hospital. At that time, the vns was checked and x-rays were taken. The mother reported that she was told that there may have been an issue with the patient¿s vns leads. Additional information was later received that diagnostics confirmed high impedance on (b)(6) 2015, and the device was subsequently turned off. The patient's mother said seizures increased once "medicines started being adjusted. " the surgeon reported that the x-ray appears to show a kinking-issue with the lead. It was reported that there appears to be a slight fracture above the superficial strain relief loop near the sternocleidomastoid muscle. The surgeon suspected that the lead may have gotten kinked and subsequently fractured. No known surgical intervention has occurred to date.
 
Event Description
The patient underwent full explant on (b)(6) 2015. Per the surgeon, the scar tissue and remaining length of the nerve were such that re-implantation could not be completed. The patient is currently seizure free with her current medication regimen so at this point the patient is going to continue with clinical management and not pursue right sided vns placement at this time. The explanted devices are not available for return therefore product analysis will not be completed.
 
Event Description
On (b)(6) 2016 it was reported that the patient under went a full right-sided nerve placement and left chest placement of the vagal nerve stimulator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4767189
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« Reply #111 on: February 28, 2019, 03:09:14 AM »

Model Number 302-20
Event Date 02/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently reported incorrect information, as it stated that a replacement pulse generator had been implanted. No replacement device was implanted during the reported intervention.
 
Event Description
No replacement generator was implanted during the surgical intervention.
 
Event Description
It was reported that the patient¿s vns system was tested and system diagnostics returned low impedance results with <600 ohms. The pulse generator had been implanted on (b)(6) 2011. The patient underwent revision surgery and it was found during the intervention that the lead was fractured in its upper portion and that the lead appeared to be twiddled. The pulse generator was replaced during the intervention. It was reported that the lead could not be replaced due to lack of an adequate implant site on the left vagus nerve above or below the pre-existing lead electrodes and that implant on the right vagus nerve would be considered. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Further information was received indicating that low impedance was discovered in (b)(6) 2014. The explanted generator was not available for return. Manipulation of the device was not suspected. No known further surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4878237
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« Reply #112 on: March 02, 2019, 03:43:42 AM »

Event Type  Malfunction 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient underwent a lead replacement due to high impedance on (b)(6) 2015. The existing generator was tested upon connection to the new lead and system diagnostics returned high impedance, reported in the mfr. Report #1644487-2015-05010. A new generator was implanted as a replacement and system diagnostics on the new device returned impedance within normal limits. Further information was received indicating that the previous lead was not explanted, but the new lead was implanted on the right vagus nerve. No x-rays had been taken. No known further surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4867412
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« Reply #113 on: March 09, 2019, 01:39:49 AM »

Model Number 1000
Device Problem High impedance
Event Date 01/21/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's m1000 generator. It was stated that on approximately two weeks after the date of implant, the impedance was within normal limits. At the end of that month, the impedance value was within normal limits but approaching the high impedance threshold. Diagnostics performed at the next office visits fluctuated between high impedance and within normal limits remaining near the high impedance threshold. It was stated that the patient is a physically large person and has a right side implant due to a pacemaker on his left side. The leads have to travel "quite a distance" to get to the vagal nerve. No adverse events associated with this high impedance were reported. It was later reported by the company representative that the physician felt the lead was too short as the lead was pulling and was visible across the patient's neck. The patient was referred to the implanting surgeon for evaluation of the lead and high impedance. A review of device history records revealed that the generator passed quality control inspection prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. 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=8375426
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« Reply #114 on: March 23, 2019, 01:10:51 AM »

Model Number 304-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the physician ran a system diagnostic test and received high impedance. The patient was referred to the surgeon. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2016 the patient underwent a full revision. The surgeon first just replaced the generator but high impedance was still observed. The surgeon decided the left side was too scarred so he proceeded with right sided implant of the lead and generator. The old leads were cut with less than 2 cm of lead with electrodes left on the nerve. The explanted devices were requested for return but they have not been received to date.
 
Event Description
On (b)(6) 2016 it was reported that the explanted device cannot be returned for product analysis as the hospital requires a patient signed release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297166
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« Reply #115 on: March 28, 2019, 07:03:19 AM »

Model Number 106
Event Date 01/27/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed staph infection at the generator site that required system explant. The physician indicated that during explant she found signs of infection at the generator site and along the lead. It was reported that the tissue was "like concrete" and required her to cut the lead into pieces to remove it. The surgeon indicated that all of the infection was removed and indicated that prior to, during and after surgery they used several precautions to avoid infection. The surgeon indicated that initially after implant the patient was healing fine; however, over time the redness started and the infection became much worse. No patient manipulation or trauma is suspected to have caused the infection. The surgeon indicated that the patient was very cautious about the incision. The surgeon plans to reimplant the patient when the infection resolves. A review of device history records showed that both the lead and generator were sterilized prior to distribution. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 03/11/2016. There were no performance or any other type of adverse condition found with the pulse generator. Analysis of the lead was completed on 03/21/2016. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Clinic notes dated (b)(6) 2016 note that the patient's incisions are all healed. It was noted that the patient would like to proceed with re-implant. The generator will be placed on the right chest given the adhesions on the left chest wall. There is no pain over the patient's scars.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5451173
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« Reply #116 on: April 15, 2019, 12:16:54 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported the patient needed to be scheduled for a full vns revision due to high impedance. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient underwent full revision surgery on (b)(6) 2016. It was noted the patient had to be implanted on the right side as there was too much scar tissue and too many electrodes and anchor tethers on the left vagus nerve and there was no more room for an additional implant. It was noted the generator was replaced due to neos = yes (near end of service) and that the lead was replaced due to the high impedance observed. After the new generator and lead were replaced, the diagnostics were confirmed as ok. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received noting the devices were discarded after surgery. Therefore, the devices are not expected for return and no analysis will be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5857766
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« Reply #117 on: April 24, 2019, 01:35:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/06/2016
Event Type  Injury   
Event Description
It was reported that a patient had a significant infection at her vns site shortly after implant. The infection was treated with antibiotics and got better, but the patient presented later with drainage from her vns site and signs of infection. Cultures were performed, and the patient was referred to the surgeon. The device history records of the generator and lead were reviewed, and both devices were sterilized prior to release. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by mfr? no. Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
Additional information was received that the patient underwent generator replacement surgery. The generator was replaced because patient's skin at generator site eroded and the generator was exposed. The surgeon removed it from the pocket on the left side and implanted the new generator on the right side. The explanted generator was discarded. According to the neurologist, the infection was ongoing. It would clear up for sometime and then come back. Based on that he made decision to replace the generator and move pocket to right side of her chest.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6193059
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« Reply #118 on: May 11, 2019, 01:27:40 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2014
Event Type  Injury   
Event Description
The patient was referred for vns generator replacement to move their generator back to their left side. The patient had most recently been implanted on the right side, which caused pain in neck when making settings adjustments, wheezing / shortness of breath, and less efficacy than the left side due to the inability to titrate the generator to therapeutic settings. It was reported that the adverse events experienced by the patient were due to the vns stimulation when settings were increased and that the adverse events did not occur previously when the generator was implanted on the left side. No known 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=8527189
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« Reply #119 on: June 06, 2019, 01:45:08 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 07/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The patient's device was also at a low battery indicator and was referred for a full revision surgery to address both events. Further information was received that the high impedance was first seen around the beginning of july according to the patient's mother. The physician's office had diagnostics recorded from earlier which were ok. There was no reported/observed traumatic event for the patient that could have led to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient had a full revision surgery to replace the lead and generator. It was stated that high impedance was observed during pre-op diagnostics. It was stated the surgeon implanted the new lead on the right vagus nerve due to too much scar tissue on the left side. The explanted products have not been received by the manufacturer to date.
 
Event Description
The products were received and analysis was completed on the generator. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
Product analysis was completed on the lead. The lead was returned in 3 portions with one tie down attached. 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. During continuity checks it was noted that the coil was broken close to the electrode bifurcation. The electrodes were not returned with this portion of the lead body. Sem was performed on the suspected coil break and it was noted that there was extensive pitting in the area making it not possible to identify the cause of the fracture. 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=6874986
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