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dennis100
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« Reply #720 on: March 08, 2019, 02:20:24 AM »

Model Number 302-20
Device Problem High impedance
Event Date 02/05/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had high impedance at their appointment. The patient had reportedly heard a pop and felt vibrations in their neck that had since resolved. The patient later reported that they had felt pain in their neck and chest. Per the patient, no trauma had recently occurred to the neck or chest. Surgery is likely but has not occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8379553
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dennis100
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« Reply #721 on: March 19, 2019, 01:58:22 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/22/2015
Event Type  Malfunction   
Event Description
It was reported by a physician that a patient's vns showed high lead impedance on diagnostics at a clinic visit. Additional relevant information has not been received to-date. No known surgical intervention has occurred to-date.
 
Event Description
Follow-up to the physician revealed a chest x-ray was taken and showed that the device migrated down near the left breast and medial to the original location. The x-rays were not sent to the manufacturer for review. The patient reported the migration had occurred over the past three years. The patient reported pain due to the migration which was explained by the physician as mechanical from the patient's bra rubbing on the unit. The last systems diagnostics in (b)(6) 2015 were reportedly fine. The physician did not know whether the sutures were non-absorbable or the relationship of the sutures to the migration. It was reported the patient has not had any significant changes in weight. The physician believes that the high impedance and the migration are related and that the high impedance is the result of the migration of the generator. The device was not turned off, and the settings were not changed.
 
Event Description
Operative notes for the implant surgery were received and indicated that a stitch was used to secure the generator, but the type of suture was not indicated. For the lead, two loops were formed and were stated to be secured with stitches. The type of suture used to secure the loops of the lead was not indicated.
 
Event Description
Clinic notes from a visit on (b)(6) 2016 were received providing that the patient had her generator disabled on (b)(6) 2016 due to discomfort, however she experienced an increase in frequency and more violent seizures since it was turned off. The patient had the device turned back on (b)(6) 2016. Diagnostics on (b)(6) 2016 showed high lead impedance. Follow-up to the physician revealed that the additional discomfort was experienced in the neck due to stimulation and resolved after the device was turned off. The pain at the chest was specified to be in the left superior chest and did not resolve after the device was turned off. Re-enabling the device did not resolve the increase in seizures.
 
Event Description
An implant card was received 05/24/2016 indicating the generator was replaced prophylactically and the lead was replaced due to lead discontinuity. The explanted devices were reported to have been discarded and are unable to be returned for analysis.

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dennis100
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« Reply #722 on: March 19, 2019, 01:59:19 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient was scheduled for lead replacement surgery. Clinic notes were received indicating that the patient had been doing well since prophylactic generator replacement surgery on (b)(6) 2015 until recently she began experiencing painful stimulation in the left neck and chest. The neurologist checked the patient's device and noted "increased lead impedance" so the device was disabled. The device last showed lead impedance within normal limits during an office visit in (b)(6) 2015. No x-rays were taken. The patient underwent lead replacement surgery on (b)(6) 2015. The explanted lead has not been returned to date.
 
Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

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dennis100
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« Reply #723 on: March 20, 2019, 11:23:48 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2015
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing pain around the generator site. Vns output current was decreased from 1. 25 ma to 1. 00 ma to make it more comfortable. Diagnostics were within normal limits and x-rays were reported as unremarkable. No known trauma to the generator site was suspected. X-rays were received and reviewed. The generator placement appeared normal in the left upper chest area and the feedthru wires appear to be intact. The lead pin does not appear to be inserted completely past the connector block but due to the angle of the pulse generator and the image quality, it cannot be conclusively assessed. Based on the images received, the source of the reported pain could not be determined. Clinic notes from an office visit on (b)(6) 2015 were later received indicating that the patient's vns was interrogated with patient in several different positions. Impedance ranged from 3050 to 3089 ohms. It was reported that the lead impedances have slowly increased over several months. Impedance was 2847 ohms in (b)(6) 2015, 2961 ohms in (b)(6) 2015, and 3089 ohms on (b)(6) 2015. Patient stated she has intermittent pain at the generator site which hurts randomly and with position changes. The pain does not only occur when device is stimulating. Patient was referred to surgeon to evaluate the vns site. Additional relevant information has not been received to date.
 
Event Description
Patient underwent generator and lead replacement on (b)(6) 2015. High impedance was observed prior to surgery during diagnostic testing but no obvious lead fracture was observed. It was reported that the patient had an excessive scar tissue surrounding the electrodes. Product return is expected but has not been received to date.
 
Event Description
Generator and lead were received for analysis on 12/01/2015. The reported fracture of lead and high impedance allegations were not verified within the returned lead portion. A portion of the lead (including the electrode array) was not returned for analysis; therefore an evaluation of the missing portion of lead cannot be made. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The reported allegation of ¿high impedance¿ was not verified during the generator analysis. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Additional information was received that the patient was in clinic for a follow up visit on (b)(6) 2015 after the full revision surgery. The patient is still experiencing pain associated with stimulation. The patient reports that when the device is programmed off, the pain subsides. Diagnostics were performed and the impedance was within normal limits (2624ohms). When the wand was placed over the generator in order to run diagnostics and the patient stated that that it was painful. The patient is on rapid cycling and no programming changes were performed. When diagnostics were performed, the patient had no reaction or discomfort. The patient requested that the device be programmed off.

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dennis100
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« Reply #724 on: March 21, 2019, 01:39:44 AM »

Model Number 102
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient went to the er due to choking, shortness of breath, chest pain and an accelerated heart rate. The er physician placed the magnet over the device and the events resolved. Patient visited his treating physician after that and his device was disabled and patient was referred for removal surgery. Physician stated that the patient had no history of heart problems. Physician stated that the patient was set at 01/30/1000/60/180. Additional information received stated that the patient underwent a vns explant surgery. Explanted products were returned to manufacturer for analysis. Analysis is currently in progress for the explanted products.

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dennis100
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« Reply #725 on: March 22, 2019, 02:42:04 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2016
Event Type  Injury   
Event Description
It was reported that the patient was referred for an explant surgery, which at that time was for an unknown reason. Follow up with the treating physician regarding the reason for explant showed that the patient was experiencing pain on the left chest, jaw, and head. The pain did not start immediately, but had progressively gotten worse and required narcotic medications to control. The chest pain was reported to have occurred prior to the referral for explant. The pain was described as a burning sensation was over the generator site. The office of the treating physician did not find anything wrong with the system at that time and observed no warning messages. Surgical intervention has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
Follow up with the patient¿s treating surgeon showed that the vns explant surgery was completed. The physician assessed that the pain was likely caused by the presence of the device since no other cause was found. The surgery was not to preclude a serious injury. The explanting facility reportedly discards of explanted devices. Therefore, product return is not expected. No additional pertinent information has been received to date.

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dennis100
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« Reply #726 on: March 28, 2019, 08:31:16 AM »

Model Number 103
Event Date 06/01/2015
Event Type  Injury   
Event Description
It was reported the patient was scheduled for a full revision on (b)(6) 2016. The full replacement is planned because the physician thought there may be something wrong with the system; however, impedance was not high. An x-ray was taken which was reportedly fine. When the vns was programmed off, because the physician thought there was a lead issue, the patient had an increase in seizures, so the device was programmed back on. The patient's family indicated the issue may be related to karate, but there were no issues on what was wrong with the device. It was noted the x-rays would not be released to the manufacturer. Clinic notes were received due to the replacement referral. It was noted the patient sustained an injury during karate sometime in (b)(6). Since the injury in (b)(6) 2015, the patient had intermittently experienced tightness and discomfort in his left pectoral region. The tightness is described as squeezing and occurs every five minutes though this was not observed by the physician while the patient was being evaluated on (b)(6) 2015. The physician was able to recreate the pain by palpating the tissue overlying the vns generator. Diagnostic testing showed an impedance value of 2083 ohms and an ifi = no condition. It was also mentioned at the visit on (b)(6) 2015 that the last pain the patient experienced was 4 days ago. On (b)(6) 2015, the physician decided to program the vns off to attempt to isolate the cause of the pain. It was later noted in clinic notes dated (b)(6) 2016 that the patient's seizures worsened after programming the vns off. Due to the worsening of seizures, the vns was programmed back on. The physician further described he believed the pain was mechanical because the pain does not occur with stimulation, but the pain did occur when the physician palpated the device. Based on this information, along with the impedance value that is within normal limits, the physician believes there is no malfunction with the lead, and only a generator replacement will be needed. The physician explained his plan to revise the generator pocket and secure the new generator more robustly than typical to prevent migration laterally, which is believed to be the etiology of the patient's discomfort. No known surgical intervention has occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Age at time of event; this information was inadvertently incorrectly reported on the initial mfr. Report. Outcomes attributed to adverse event; this information was inadvertently incorrectly reported on the initial mfr. Report.
 
Event Description
It was reported, through the receipt of an implant card, the patient had generator replacement on (b)(6) 2016 due to mechanical discomfort.

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dennis100
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« Reply #727 on: March 28, 2019, 08:31:59 AM »

Model Number 304-20
Event Date 01/21/2016
Event Type  Malfunction   
Manufacturer Narrative
Suspect device udi#: (b)(4).
 
Event Description
It was reported by the physician that the patient developed twitching in her neck with the use of the vns magnet. The physician suspects the twitching is due to a lead fracture and has advised the patient not to use the magnet as the patient has no other symptoms and the normal vns output current is not causing the same symptoms as magnet use. Settings were adjusted due to the discomfort with the magnet stimulation, which occurred prior to the observance of the muscle twitching. No settings were changed due to the reported muscle twitching.
 
Event Description
The patient underwent vns explant surgery. During attempts at product return, it was revealed that the facility, historically, does not return explanted products.
 
Manufacturer Narrative
Describe event or problem, corrected data: follow-up report #1 inadvertently left out information. (b)(4).
 
Event Description
Clinic notes were received by the manufacturer and indicated that the patient had difficulties with pain at the neck and chest where the vns was implanted. It was stated that she developed issues with tension at the neck when trying to do sit-ups. When the vns activated, she experienced contractions of the laryngeal musculature. The patient reported twitching in her neck muscles with magnet stimulation. The vns magnet mode was programmed off. It was stated that since the magnet mode was disabled, the patient was getting the warning for complex partial seizures for shorter lengths of time, which she did not get before. The operative notes from the initial implant were included and no complications were reported. It was noted that the lead was secured to the surrounding subcutaneous tissues with 4-0 sutures.

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dennis100
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« Reply #728 on: March 30, 2019, 02:39:02 AM »

Model Number 106
Event Date 07/21/2015
Event Type  Injury   
Event Description
It was reported that the patient has shortness of breath with stimulation that started last year. She says that the battery is also moving around in her chest and has become painful in the last 6 weeks. The patient was referred for explant of the vns. Clinic notes dated 2/12/2016 were received which indicate that the patient's vns is going off every minute and causes breathing problems. The implant also seems to be moving. The patient's physician did not recommend that the vns be removed. She has turned the output down to 0. 25ma and the heartbeat detection off. Diagnostics were last performed on (b)(6) 2015 and showed output=ok/lead impedance=ok/impedance value=3183ohms. No interventions have been planned. No causal or contributory programming or medication changes preceded the onset of the shortness of breath. No patient manipulation or trauma occurred. A non-absorbable suture was used to secure the generator to the fascia during implantation of the device per the surgeon; a 3. 0 prolene suture. On (b)(6) 2016 it was reported that the patient's generator would be removed that day. The explanted generator has not been received for product analysis.
 
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2016 it was reported that the explanted device was discarded by the hospital and therefore cannot be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5513325
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dennis100
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« Reply #729 on: April 01, 2019, 01:07:27 AM »

Model Number 302-20
Event Date 01/19/2016
Event Type  Malfunction   
Manufacturer Narrative

vent Description
It was reported that a patient was experiencing painful stimulation and felt like his vns wires were unconnected. The patient had an appointment on (b)(6) 2016, and high impedance was confirmed to be present. The patient was referred for x-rays. No gross fractures were identified in the visible portion of the lead. The electrode portion of the lead could not be assessed as they were not included in the provided images. The presence of a microfracture could not be ruled out. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to high impedance. The explanting facility does not return product to the manufacturer. Therefore, no analysis could be performed.
 
Event Description
Clinic notes were received with further information regarding the high impedance of the patient's device. The patient experienced pain in the chest and neck and coughing with magnet activation. A chest x-ray was performed, and the physician stated that he could see the lead wire going over the sternum and beyond the left border of the sternum. The physician could not feel the lead wire beyond the left border of the sternum even though the lead wire and generator were very superficial, above the pectoralis muscle on the right side of the chest. The physician believed that the lead wire was disconnected either over the sternum or at the are of connection to the "old wire," which was most likely referencing the electrodes on the vagus nerve. No further relevant information has been received to date.

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« Reply #730 on: April 01, 2019, 01:21:33 AM »

Model Number 300-20
Event Date 05/01/2016
Event Type  Injury   
Event Description
It was reported that a patient went to the emergency department because she was experiencing continuous, painful stimulation in the left neck and chest since (b)(6) 2016. However, the patient's device had been programmed off 5 years prior and was not programmed back on. A magnet was placed over the device for 30 seconds but was removed again because the patient complained that it was painful with the magnet over the device. The patient was transferred to a different hospital, and the physician noted that the patient's normal and magnet mode output currents were programmed to 0ma and that the device had been disabled for quite a while. However, the patient was still in pain. The physician asked the patient if anything unusual had happened prior to the pain, and the patient said that nothing happened. Diagnostics were performed, but the results were not provided. The patient's devices were explanted on (b)(6) 2016 due to the pain. The explanted devices have not been received to date. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Describe event, corrected data: initial report inadvertently reported that the devices had not been received to date. Device available for evaluation, corrected data: initial report inadvertently reported that the devices had not been received to date.
 
Event Description
The explanted generator and lead were received on (b)(6) 2016. Analysis has not been approved to date.
 
Event Description
The explanted generator and lead both underwent product analysis. An end-of-service warning message was verified for the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. 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. An analysis was performed on the returned lead portions, but the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. There was an abraded opening in the inner tubing of the lead, but the cause could not be determined. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Additional information was received from the patient's explanting physician stating that the electrodes had been connected to the ansa cervialis instead of the vagus nerve. He believed this was the reason for the patient's reported neck pain. He also stated that the device never worked well for the patient, most likely because it was implanted on the incorrect structure.

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dennis100
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« Reply #731 on: April 01, 2019, 01:22:30 AM »

Model Number 106
Event Date 05/02/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a vns patient was complaining of sporadic painful stimulation at the generator site and radiating down through his left arm starting. Clinic notes received indicate the symptoms started on (b)(6) 2016 and were more intense with magnet activation. The condition progressed to constant sensation of tightness in chest and shortness of breath of approx. 1 hour duration until he taped the magnet over the device. The symptoms were alleviated for around 24 hours following pulse width adjustment from 500usec to 250usec and frequency adjustment from 30hz to 20hz on (b)(6) 2016 but then recurred. Full diagnostics were performed on (b)(6) 2016 and lead impedance on (b)(6) 2016 was normal 3,093 ohms. It was stated that the lead impedance was checked in varying neck positions. The physician elected to disable the device on (b)(6) 2016 and the patient was referred to a surgeon for anticipated exploratory surgery to explant and replace generator due to presumed malfunction/bleeding of current of vns system. X-rays were taken but nothing conclusive could be diagnosed by the providers. The x-rays were not provided to the manufacturer for review. The generator was successfully explanted and replaced on (b)(6) 2016 with no complications noted. The explanted generator was discarded by the explanting facility.
 
Event Description
An implant card was subsequently received for the procedure on (b)(6) 2016 indicating that a normal lead impedance of 3,373 ohms was observed with the newly implanted generator in place.

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dennis100
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« Reply #732 on: April 04, 2019, 02:11:43 AM »

Model Number 302-30
Event Date 03/13/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported on 05/25/2016 that the patient reports having a shocking feeling in her chest area. The neurologist will consult with the surgeon about a possible lead or full revision. The patient went to the er (b)(6) 2016 and the vns was programmed off which resolved the issue. It was stating the diagnostics showed dcdc-0 at (b)(6) 2016 so at the time of the call it was not clear if there was a short circuit. She said that the pocket stimulation never completely went away after his generator was replaced in 2013. It did get significantly better after surgery but it has gotten progressively more bothersome over time. This seems to support the theory about an abraded opening in the lead. No additional information has been received to date.
 
Event Description
Device diagnostics were ran and there was no lead impedance and everything seemed fine, however patient experienced pain near generator. Full revision is planned but has not been completed to date.
 
Event Description
An implant card was received indicating that the patient had replacement surgery on (b)(6) 2016 due to prophylactic replacement and lead discontinuity. The explanted devices have not been received for analysis to date.
 
Event Description
The generator and lead were received for analysis on 10/26/2016. Product analysis for the generator was completed and approved on 11/03/2016. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis for the lead is currently underway but has not been completed to date.
 
Event Description
Product analysis for the lead was completed and approved on (b)(6) 2016. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the low impedance.

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« Reply #733 on: April 07, 2019, 04:10:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/10/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns generator replacement surgery. Clinical notes were received as part of this process which reported the patient was experiencing painful stimulation in the chest as well as coughing with vns magnet stimulation. These began after the patient's vns was adjusted at the previous office visit. The pulse width was lowered due to these events, and then the frequency, pulse width, and magnet output current were lowered and it is indicated the coughing resolved after this further decrease. The neurologist speculated that a lead issue was contributing to these tolerability issues and requested that the lead be replaced if a lead issue is found during the surgery. Lead impedance was measured at the office visit and noted to be within normal limits. Follow up with the patient's neurologist determined that the replacement surgery was being taken to potentially prevent a serious injury. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

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« Reply #734 on: April 08, 2019, 03:23:42 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/08/2008
Event Type  Injury   
Manufacturer Narrative
This report is a continuation of medwatch mfr. Report #1644487-2008-01557.
 
Event Description
The patient has been referred for vns system explant due to generator migration and discomfort. The patient's surgeon has confirmed that the explant surgery is for patient comfort, and not to preclude serious injury. It was reported that the generator has migrated into the patient's breast since the patient has lost 300lbs. The patient's weight loss has been attributed to lifestyle choices, with the patient reportedly walking 5 miles a day. The patient states that the generator is now causing discomfort, which the patient believes is the result of the generator migration. The patient stated that the generator has been depleted for several years; however, they have remained seizure free. No known surgical intervention has occurred to date. No other relevant information has been received to date. This report is a continuation of medwatch mfr. Report #1644487-2008-01557.

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« Reply #735 on: April 08, 2019, 03:24:28 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/07/2019
Event Type  Injury   
Event Description
It was reported that a patient with a model 106 upon interrogation with the resident, the patient complained of chest pains at her chest site. However, the device was off on all parameters at the time. A session report verifies the device is at 0ma and lead impedance shows 4021 ohms with ok battery 75-100%. The ma acknowledged that the device was sitting high near the collar bone and it was discussed with the patient, either a repositioning or possibly a reposition and change to the smaller sentiva device. The neurologist agreed to refer to neurosurgery. No surgical intervention has occurred to date. No additional or relevant information has been received to date.

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« Reply #736 on: April 09, 2019, 12:57:22 AM »

Model Number 300-20
Event Date 12/01/2012
Event Type  Malfunction   
Event Description
It was reported that the patient's vns lead had experienced a fracture. It was not made apparent how the initial reporter determined there was a fracture problem. The device was reportedly disabled in (b)(6) 2012 in relation to this issue. Surgical intervention has not occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
It was reported that the patient's explanted generator was discarded following surgery. No additional pertinent information has been received to date.
 
Event Description
Follow up attempts with the treating physician showed that although a lead break was suspected, it was never confirmed. X-ray images according to the treating physician showed no visible fracture. The vns was reported to have been "interrogated" few times with no abnormal results. The patient complained of pain at the time of the device disablement. The pain was occurring in the area of the left axilla and radiated into the upper left chest and neck, and did not coincide with stimulation. The patient's generator was explanted on (b)(6) 2016. The device has not been returned to the manufacturer to date. No additional pertinent information has been received to date.

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« Reply #737 on: April 10, 2019, 01:48:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/18/2017
Event Type  Injury   
Event Description
A patient was experiencing horrendous pain in a tooth on the left side of his mouth and in the middle of his chest. The pain occurred only once initially, when the patient accidentally swiped his vns magnet over his generator. At a clinic visit 2 weeks prior, the patient's neurologist believed the device was operating normally, per the patient. The following month, the neurologist suspected that a problem with the patient's lead may have occurred based on the clinical symptoms that patient was experiencing. The neurologist ordered x-rays of the patient's vns system; however, the x-rays were not reviewed by the manufacturer. No device malfunction was reported at that time. Two months after his initial report, the patient stated that he felt like a woodpecker was hitting his chest when he turned onto his left side, and he continued to experience pain in his gums. The sensation occurred every 3 minutes with stimulation and went away when stimulation stopped. The patient was evaluated by his dentist, who stated that nothing was wrong with the patient's teeth or gums. The patient reported that though he initially felt stimulation when he was implanted, he stopped perceiving stimulation until his initial report of pain two months prior. The patient noted that the pain was impacting his sleep. The patient had taken pain medication to treat the painful stimulation, but the medication did not help. The patient was seen in clinic a week after the updated report, and device diagnostics were performed and returned results within the normal limits. The patient reported that magnet swipes made him feel as though he could not breathe in addition to the painful stimulation he was previously experiencing. The patient's settings were reduced as intervention for the painful stimulation and dyspnea. The patient was referred for surgery as the neurologist believed that the vns was clearly causing the patient's pain, despite diagnostics being within the normal limits. The surgery was reportedly both required to preclude a serious injury and for patient comfort. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The explanted generator was not returned to the manufacturer by the explanting facility. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6760034
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dennis100
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« Reply #738 on: April 11, 2019, 10:21:22 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was observed during device diagnostics with an impedance value of 5897 ohms. At the recent implant of the lead and generator the impedance was noted to be 2948 ohms. The physician then left the patient programmed at 0. 25ma since the patient was not experiencing painful stimulation and she had been receiving efficacy from vns. Further follow-up with the physician found that patient manipulation or trauma are not suspected to have contributed to the high impedance. Instead the physician suspects the lead pin may have shifted which has caused the high impedance. The patient was sent for x-rays however they have not been reviewed by the manufacturer to date. The manufacturing records of the lead and generator were reviewed and found that both devices passed qc inspection prior to distribution. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was seen by the physician at a follow-up appointment and the high impedance warning message was still presenting. During the appointment the patient reported experiencing painful stimulation in her chest. The generator was then disabled. X-rays were received and reviewed by the manufacturer. There did not appear to be any obvious lead discontinuities in the portion of the lead that could be visualized and the connector pin appeared to be fully inserted. However the presence of a micro-fracture in the lead cannot be ruled out. The x-rays did show that the lead did not have adequate strain relief as described in labeling. The implanting physician was then retrained on proper lead placement. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery. A system diagnostic test was performed during pre-op which showed high impedance 10,000 ohms. The generator was then detached from the lead and the generator was tested on it's own. This generator diagnostic test resulted within acceptable limits. The lead was then replaced and the new lead was connected to the existing generator. A system diagnostic test with the new lead and existing generator resulted in an acceptable lead impedance. The explanted lead has not been received to date.
 
Event Description
It was reported that during the lead revision surgery on (b)(6) 2016 the surgeon attempted to re-insert the existing lead into the generator. However the high impedance did not resolve therefore the lead was replaced.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on mfg. Report #2.
 
Event Description
A company representative reported that the explanted lead was discarded by the hospital following the replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780375
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dennis100
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« Reply #739 on: April 11, 2019, 10:24:03 AM »

Model Number 103
Event Date 01/16/2013
Event Type  Injury   
Event Description
Reporter indicated that a patient had the vns generator removed due to severe pain at the generator site in the chest. There was no known malfunction, and the pain was felt to be due to the device being present in the patient's body, and not due to vns stimulation. The patient was not thin, and had no trauma. It was not known what could be causing the discomfort other than the presence of the vns device in the chest and the neurologist wanted it removed. The pain resolved after the vns was removed, and the patient has fully recovered from her surgery. The explanted generator will not be returned from the hospital per policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3024388
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dennis100
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« Reply #740 on: April 12, 2019, 01:31:09 AM »

Model Number 250
Event Date 07/14/2016
Event Type  Malfunction   
Event Description
It was reported by the company representative that the patient had come in for a vns replacement surgery. Upon interrogation of the device, the settings were found to be indicative of a faulted diagnostic test. It was explained to the surgeon that the settings found during interrogation were indicative of a faulted diagnostic test. The neurologist's physician's assistant was notified and stated the last time the checked the device was (b)(6) 2016 and he was able to provide the intended settings. The physician's assistant noted that when performing diagnostics on that date, the patient had a weird tightening sensation in her chest, so the diagnostics were interrupted. Due to the patient's tightness, they were unable to perform a final interrogation to verify the settings. It was explained to the physicians at that time that the patient would have been programmed at the unintended settings since (b)(6) 2016 until the day of surgery (2 weeks). After the implant was complete, the surgeon decided to program the patient back to the intended settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5913259
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dennis100
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« Reply #741 on: April 24, 2019, 03:06:14 AM »

Model Number 302-20
Device Problem Fracture
Event Date 08/01/2016
Event Type  Malfunction   
Event Description
Patient was referred for generator replacement initially. Additional information was received on 11/14/2016 that the patient is to have a full revision surgery. On (b)(6) 2016, patient underwent full revision surgery due to high impedance. The explanted devices were reported to have been discarded. Additional relevant information has not been received to date despite multiple attempts.
 
Event Description
High impedance was first observed on (b)(6) 2016 from chest x-rays. The chest x-ray revealed a break in the lead. Per notes dated (b)(6) 2016, the patient has had an increase in seizure events (staring, eye-fluttering) and frequent complaints of chest pain since (b)(6) 2016. Patient points to the region of his stimulator as being the area of discomfort. The device is palpable in its submuscular pocket in the anterior left chest wall. Patient does not have any erythema in the chest but does report some tenderness.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6183181
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dennis100
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« Reply #742 on: April 24, 2019, 03:07:00 AM »

Model Number 303-20
Device Problems Fracture; Low impedance
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient¿s device showed low impedance. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the physician provided the device has had increasing impedances values since (b)(6) 2016, resulting in high impedance. The patient reported that she has not had a seizure in two months but she has had a mild shock near the generator site. The patient has denied any trauma or manipulation. No known surgery has occurred to-date.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The physician later provided the patient had high lead impedance still and was referred for lead revision. The patient states she has been having pain on the left side of the neck by the lead for the vns and has heard a cracking noise. She states that she is having pain on the left side of the chest where the magnet is and states there is swelling on that side, and feels like little knots. The patient states that when she lay on the left side of the neck it hurts and feels like it crackles. The patient states that she start having tingling like feeling 2 weeks ago, states that feels like having electric shocking.
 
Event Description
Follow-up from the physician¿s office provided that the swelling was not related to vns, even though the lead impedance is high.
 
Event Description
Follow-up was received indicating the patient does not want to go through with the revision due to her age and other health issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6191236
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dennis100
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« Reply #743 on: May 01, 2019, 01:26:37 AM »

Model Number 300-20
Event Date 03/19/2010
Event Type  Malfunction   
Event Description
It was reported that a vns pt experienced pain at the generator site due to unk reason as no trauma had been reported. Further info from the treating neurologist revealed the pt's pain was noticeable and was exacerbated when the device stimulated. Additional info was received from a company rep indicating that recent system diagnostics on the pt revealed a dc dc of 0 as prior system diagnostics indicated dc dc of 2. The pt was referred for x-rays and programming history was requested. X-rays were received by the mfr and evaluated. The review of x-rays indicated the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The connector pins appeared to be fully inserted inside the connector block and the lead wires at the connector pin appeared to be intact. Furthermore, no lead discontinuities or acute angles were visualized in the lead body of the received images. Good faith attempts to obtain additional info from the treating neurologist resulted unsuccessful to date as the physician is not very proactive according to state laws. Additional info was received in the form of programming history from the treating neurologist confirming that previous diagnostics were dc dc 2 in 2005 and recently dc dc 0 in 2010.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. 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=1686208
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dennis100
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« Reply #744 on: May 01, 2019, 01:27:17 AM »

Model Number 102
Event Date 10/16/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had recently been hospitalized for seizure disorder. The patient recently underwent generator replacement surgery and subsequently experienced pain the left arm and chest, dizziness, and lightheadedness. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4340994
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dennis100
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« Reply #745 on: May 06, 2019, 05:34:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2016
Event Type  Injury   
Event Description
It was reported that the patient had tachycardia and premature ventricular contraction with stimulation that was detected upon a surgical consultation for pain. Initially, the patient reported that she was having a severe burning in her chest, which she associated with her generator being turned on to 0. 625 ma after having a generator replacement surgery for battery depletion. It was later reported by the surgeon that the patient went to the emergency room on (b)(6) 2016 with severe pain at one point on her axilla incision and around her generator. The surgeon believed that the pain was related to a "loose connection" and the patient was referred for a full revision surgery. Her device was also turned off. However, during the surgery consultation, the patient decided to post-pone the surgery indefinitely. When the patient was turned back on to 0. 125 ma, the patient felt severe pain. Her pain was described as a sharp shooting pain around the generator pocket and the incision site which started within 30 seconds of turning the generator on. At this appointment, the surgeon noted that the patient was also having tachycardia during stimulation which resolved along with the pain after the device was turned back off. The relationship between the painful stimulation and the tachycardia is unknown. At a follow-up appointment with a neurologist, the patient was turned back on again and it was noted that the patient had runs of ventricular tachycardia and premature ventricular contractions along with pain when the vns was on but that it self-resolved. The device was turned back off due to the pain. It was noted that the patient had congestive heart failure which is captured in mfg report # 1644487-2016-02900. No additional relevant information has been received to date. No known related surgical intervention has occurred to date.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: the initial report inadvertently reported (b)(6) 2016 as the date received instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6227316
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dennis100
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« Reply #746 on: May 10, 2019, 02:26:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/05/2019
Event Type  Injury   
Event Description
It was reported that the patient was explanted because she was getting shocked even though all output current was off. Programming history was reviewed for the generator. No anomalies were seen. Information was received from a nurse with the neurologist¿s office that patient was explanted as they experienced zapping in their chest and neck. The patient¿s last settings indicate the generator was off. No diagnostic results were available. No other information was available. The device has not been received by livanova 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=8564618
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dennis100
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« Reply #747 on: May 10, 2019, 02:27:40 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A patient's mother posted a report via social media that her daughter had the vns implanted, and as a result the patient's seizures increased, she had complications from her incisions, and still has chest pain around the battery even though the vns has been turned off. The mother also noted that the increased seizure activity was observed while the vns was turned on, and that the patient will most likely never fully recover from the nerve damage. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555408
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« Reply #748 on: May 10, 2019, 02:29:15 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing an increase in seizures due to lowered vns settings. The increased myoclonic seizures were causing headaches, inability to focus, sore and tight muscles and sleeping issues due to the constant movements. The patient stated that the generator tested ok, but questioned if there could be issues with the generator. The patient stated that in february, the patient was admitted to the hospital as the physicians were concerned that the patient was having a stroke due to the patient's face muscles drooping, voice changes, and chest pains. After vns settings were lowered, the symptoms resided, and then further tests were performed confirming that there was no stroke. The patient reported their neck was twitching and was swelling, and there was severe issues with talking. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8557527
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« Reply #749 on: May 11, 2019, 03:50:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/08/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for explant due to discomfort in their left upper chest and lack of efficacy. The patient¿s most recent settings and diagnostics were not available. Programming history was reviewed for the patient. There were no anomalies seen. The patient was explanted. The devices were discarded during surgery and were not available for return. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8516135
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