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dennis100
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« Reply #180 on: March 04, 2019, 08:25:13 AM »

Model Number 105
Event Date 09/01/2014
Event Type  Injury   
Event Description
The explanted generator was discarded after surgery and is unavailable for analysis. No additional relevant information has been received to date.
 
Event Description
Additional information was received that patient continues to have swelling at the bed of the vns. The surgeon stated that the device is protruding/swelling. The surgeon feels that there is risk that it may break through the skin. When the replacement occurs, the new generator will be repositioned in a new location. No known surgical intervention has occurred to date.
 
Event Description
Additional information was received that the patient had 5 - 12 seizures per month prior to vns replacement and now has an average 8-12 seizures per month. It is unknown if this is related to vns therapy. The patient's swelling occurs in the left upper chest over vns generator site. The swelling occurs every 2-4 days and resolves on it own. Physician attempted ice pack to site of swelling but the patient refused.
 
Manufacturer Narrative

Event Description
The patient underwent generator replacement surgery. The new generator was positioned in a different location. The explanted generator has not been received to date. No additional relevant information has occurred to date.
 
Event Description
It was reported that the patient experiences swelling at the implant site from time to time. It was also mentioned that the patient experienced a change in seizure pattern. Additional information was received from the physician that the patient's swelling has been present at least since last fall as patient was seen in (b)(6) 2014. The physician does think that the swelling might be related to the presence of device and had referred patient to the surgeon. Regarding the seizure pattern change, it was reported that the physician was aware of this event. Patient's medication was increased in (b)(6) and patient¿s intractable epilepsy was mentioned to be the underlying reason. The physician was unable to determine the relationship of this event to vns as he was not aware of it.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4906817
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dennis100
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« Reply #181 on: March 06, 2019, 01:54:03 AM »

Model Number 103
Event Date 07/11/2015
Event Type  Injury   
Manufacturer Narrative
Type of device product code: this device was implanted to treat chronic heart failure, which is currently an unapproved indication that is currently undergoing active clinical trial.
 
Event Description
Adverse event form received on (b)(6) 2015 reported that this patient had an occurrence of post-op infection causing pain and swelling at the site. On (b)(6) 2015 the patient presented with a complaint of pain at the surgery site with two episodes of fever for the past 3 days. Upon examination, mild infection at the surgery site was found. Patient was started with oral antibiotics for the infection. The outcome of the event is that it is recovering and the seriousness was considered based on initial hospitalization and intervention required to prevent a serious outcome (medication). The infection is a post-op infection that occurred less than 1 week after implantation. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5000931
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dennis100
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« Reply #182 on: March 08, 2019, 01:33:28 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for vns explantation surgery. Follow up with the surgeon's office revealed that the main reason for explantation was that the patient's parents did not feel that the vns was helping with the patient's seizures. It was also noted that there was a wound on the incision site that had never healed properly. It was reported that it was treated with antibiotics, but redness and swelling were still present. It was stated that the neurologist was in agreement with the patient's parents that the vns did not improve the patient's seizures. Follow up with the company representative revealed that the surgeon stated that there was a local infection at the implant site. The surgeon informed the patient's parents that the infection could be treated with antibiotics, but they elected to explant due to the lack of efficacy. It was stated that there had been no decrease in seizures since the implantation surgery. Diagnostics were within normal limits and the patient was programmed to manufacturer-defined therapeutic levels. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. The patient underwent full vns explantation surgery. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8378792
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dennis100
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« Reply #183 on: March 09, 2019, 02:39:18 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that a patient had an infection at the neck site that was about the size of a golf ball. It was stated that the patient had picked at the site and has had an infection for about two weeks. The physician prescribed antibiotics. No additional, relevant information was received to date.
 
Manufacturer Narrative
Device evaluated by mfr?, code 81: device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8338214
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dennis100
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« Reply #184 on: March 09, 2019, 02:40:38 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/02/2019
Event Type  Injury   
Event Description
It was reported from a patient that she was feeling pain after settings were increased for her seizures. The patient later saw her neurologist who turned the settings down, however the patient was still feeling the pain. It was clarified that the patient was not feeling pain with stimulation, although she only began feeling the pain after settings were previously increased. An update was received stating that the constant pain was occurring behind the patient's electrode site on the neck. It was noted that the patient had been taken to the er due to increased seizures and intolerable pain in her neck. She stated that her vns was "not working" and that she wanted it removed. The patient was still experiencing pain after decreasing settings. Follow up with the physician's office confirmed that when the patient was last seen, the output current was decreased due to pain and swelling in the neck and throat after previously increasing settings. It was unknown what the cause of the pain, swelling, and increased seizures were at this time. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8320621
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dennis100
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« Reply #185 on: March 11, 2019, 07:57:03 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 04/20/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Describe event or problem, corrected data: analysis of the generator was completed on 12/22/2015. Previous supplemental mdr #2 was submitted prior to the completion of the generator analysis on 12/22/2015.
 
Event Description
Analysis was completed for the generator and lead. In the (b)(4) lab, the generator 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 septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Furthermore, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 002 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. 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. The outer silicone tubing has an abraded opening. Other than the above mentioned observation and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
The generator and lead were received on 12/01/2015. Analysis is underway but has not been completed.
 
Event Description
A pocket revision was planned for the seroma but patient underwent full explant on (b)(6) 2015 due to infection on the generator side. Patient was given antibiotics and neurologist was informed to increase medications. The explanted devices are expected to be returned but have not been received. A review of device history records showed that both the lead and generator were sterilized prior to distribution.
 
Event Description
During patient's first follow up appointment after vns implant surgery on (b)(6) 2015, bruising was observed around the generator incision site. No physical trauma is suspected to have occurred to the site. Patient was sent for labs and was referred to a surgeon for second opinion. The patient's bruising was reported to be abnormal and the cause was unclear. It was also reported that the patient had a (b)(6) infection prior to this implant surgery in the chest area and so the patient was referred for a second consult. On (b)(6) 2015, swelling was observed near the incision site but there was no redness or warmth. No interventions were taken and patient was asked to follow up in a few weeks. Additional information was received that the patient has a seroma around the generator pocket, pain in the chest and some significant bruising. Patient is to undergo a generator pocket revision surgery but no known surgical interventions has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5092193
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dennis100
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« Reply #186 on: March 14, 2019, 06:19:46 AM »

Model Number 103
Device Problem Material Protrusion / Extrusion
Event Date 05/01/2015
Event Type  Injury   
Event Description
It was reported that patient had his vns device removed. It was reported that the vns system was implanted in (b)(6) 2015, but patient suffered a wound infection on the generator site in (b)(6) 2015. It was reported that patient was admitted for this infection and treated with iv anti -biotics, patient subsequently recovered and was discharged home. It was reported that patient was seen in (b)(6) 2015 for follow up and on inspection of the wound it was found to be extremely swollen, red and the device appeared to be protruding through the skin. Patient was admitted for investigation and the device was explanted on (b)(6) 2015.
 
Manufacturer Narrative
Date of implant; corrected data: the previously submitted mdr inadvertently provided the wrong suspect device for the event.
 
Event Description
Review of manufacturing records confirmed that both, the generator and the lead were sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5188050
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dennis100
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« Reply #187 on: March 16, 2019, 01:49:32 AM »

Model Number 303-20
Device Problems Circuit Failure; Loss of Power
Event Date 09/07/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient had pain in the neck and throat, and swollen spot in the neck. It was reported that short circuit was suspected, as the dcdc value dropped from 6 to 5, to 3, to 2 and now 0. The generator was switched off. It was reported that the x-rays will be taken then sent to the manufacturer for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that both lead and generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Event Description
It was later reported that the vns patient had eating disorder, hoarseness, dysphagia and protrusion. Review of the available programming and diagnostic history received from the nurse showed normal diagnostic results through (b)(6) 2012. The x-rays were taken and sent to the manufacturer for review. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin seems to be fully inserted into the generator connector block. The electrodes placement seems to be normal. One tie-down, strain relief bend were used to secure the implanted lead but not as indicated in the labeling. Part of the lead was behind the generator. No lead breaks or sharpe angles were visible on the assessed lead parts.
 
Event Description
Further information received indicating that the patient underwent a full revision. The lead was replaced due to lead function issue (low impedance) and the generator was replaced likely due to battery depletion. No explanted devices return is expected at ths time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5123049
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dennis100
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« Reply #188 on: March 19, 2019, 01:27:16 AM »

Model Number 105
Device Problem Electromagnetic Compatibility Problem
Event Date 10/24/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient got shocked by a 1500amp electric fence and was rendered unconscious. The patient started feeling painful stimulation at the generator and electrode sites after the electrocution. The physician believed that the tissue around the generator and electrodes may have been burned during the shock, because the patient had swelling at the electrode and generator sites. The physician was unable to run device diagnostics due to the patient having a seizure during the appointment. The physician disabled the patient's device on (b)(6) 2015. The painful stimulation resolved after the device was disabled. The patient was referred for generator replacement surgery, but no surgical intervention has occurred to date.
 
Event Description
The patient had generator replacement surgery on (b)(6) 2015. The surgeon did not see any indication that the tissue around the generator or electrodes had been burned or damaged in any way. The surgeon also reported that the patient had multiple psychological issues and that the patient made things up to get attention. The surgeon did not believe that there was anything wrong with the tissue or the patient. There was no indication of a device malfunction. The explanted generator was received on 11/30/2015. Analysis identified no performance or any other type of adverse conditions associated with the generator. The generator was returned without the septum, but there was no body fluid observed inside the header septum cavity. This eliminates the possibility of a potential unintended electrical current path through body fluids.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5233377
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dennis100
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« Reply #189 on: March 20, 2019, 11:03:35 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/02/2013
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient had been experiencing pain at both the generator and lead sites since initial implant and before the device was even programmed on. The device was checked and device settings were increased during the office visit and the patient tolerated the procedure well. Additional information was received stating that the patient passed out due to pain on (b)(6) 2015. Following device disablement on (b)(6) 2015, the patient has not reported any further pain and syncope events and does not have a history of syncope. The patient device was tested and diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Follow-up revealed that the painful stimulation was occurring in the left neck.
 
Event Description
Additional information was received from the patient stating that despite device disablement, the patient was still experiencing pain in his neck when moving his head/neck and that there was swelling at his neck/shoulder area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5208395
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dennis100
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« Reply #190 on: March 21, 2019, 01:15:59 AM »

Model Number 304-20
Event Date 09/24/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2015 it was reported that the patient has a neck incision complaint and that the patient is seeing the surgeon on (b)(6) 2015. The physician¿s office reported that the ¿neck incision complaint¿ was an infection at the neck site; there was some bruising or hematoma and slight swelling and discoloration. The nurse said that it was from the vns surgery. They decided to wait to turn the vns on since the patient was having the infection. They did not do cultures; they just prescribed the patient antibiotics. They are not going to do any other interventions besides the antibiotics. They saw the patient again recently on (b)(6) 2015 and she was much better, the bruising had gone down, and they decided to turn the vns on. The manufacturing records for both the lead and generator were reviewed and it was confirmed that the devices were sterilized prior to shipment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5206821
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dennis100
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« Reply #191 on: March 21, 2019, 01:16:52 AM »

Model Number 103
Event Date 09/25/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was complaining of swelling and tenderness around the generator site. The swelling and pain was believed to be due to some scar tissue that had developed since implant that caused severe pain and irritation when the patient moved her arm. The patient underwent a generator pocket revision surgery on (b)(6) 2015 and a hematoma was identified at the generator site. It was reported that this was caused by the patient doing some lifting too soon after vns implant surgery. No migration had occurred. The hematoma was drained and the generator was re-sutured in place. Diagnostics following the revision were within normal limits. No additional relevant information has been received to date.
 
Event Description
The patient was seen in follow-up with the surgeon and it was noted that there was still swelling in the neck area. The surgeon ordered a laser treatment, but is certain he will need to proceed with another surgery. No additional surgical interventions have been performed to date.
 
Event Description
It was reported that the patient was seen by an ent who performed a laser procedure. It was found that there is a gland that is leaking and a procedure will need to be performed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5197508
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dennis100
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« Reply #192 on: March 25, 2019, 01:31:08 AM »

Model Number 106
Event Date 10/23/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported by the patient's mother that she was concerned about the patient's surgical site. The site was determined to be swollen by the surgeon, and she was reportedly asked by the surgeon to follow up if the patient's swelling persists. In the investigation of this issue, follow-up communication with the surgeon's office on (b)(6) 2015 indicated that the surgeon suspected a post-surgical superficial infection with antibiotics prescribed as treatment. Review of device manufacturing record confirmed sterilization for the generator prior to distribution. In addition to the infection, the surgeon also believed that the patient's tendency to hit himself may have contributed to the swelling experienced. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5369668
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dennis100
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« Reply #193 on: March 25, 2019, 01:31:51 AM »

Model Number 106
Device Problem Insufficient Information
Event Date 12/11/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed a post-surgical infection. The infection presented as red streaking down the patient's left arm, and she was treated with antibiotics. The symptoms of infection had reportedly resolved at that time. Subsequently, the patient visited the emergency room with the red streaking returning and accompanied by pain and swelling in the left arm. The physician ruled out deep-vein thrombosis, and concluded with a diagnosis of post-operative thrombophlebitis. No interventions for the thrombophlebitis have occurred. The patient was not admitted to the hospital. The notes received from the physician appear to indicate that the patient has her generator implanted in the left arm. A review of device history records showed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
Follow up communication indicated that the patient's generator was actually implanted in her left armpit. Additionally, it was indicated that the patient was a regular smoker. This was the same location that her previous generator was located. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397383
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dennis100
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« Reply #194 on: March 25, 2019, 01:32:35 AM »

Model Number 103
Event Date 06/18/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the vns patient may have developed an infection at the generator site and was given antibiotics. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Follow-up revealed that there was no infection that developed but the generator incision site had swelling where a suture was located. It was reported that the surgeon revised the incision site because "it was not up to his standards" and he was not satisfied with how the incision appeared. The majority of the sutures had already disappeared except for one at the swollen area. The patient underwent surgery on (b)(6) 2016 to clean and revise the incision site to prevent the potential of an infection occurring.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5397249
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« Reply #195 on: March 28, 2019, 07:26:38 AM »

Model Number 102
Event Date 08/16/2013
Event Type  Death   
Event Description
It was reported by the physician that the patient had died. Follow up found that the date of death was (b)(6) 2013. It was reported that the aptient was found in the bathroom after an apparent seizure. The patient had incontinence. The family was insistent that the patient had not missed any medication and there was no known cause for a seizure. They do not plan for an autopsy. Good faith attempts have been made; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
Date received by manufacturer; corrected date: previously submitted mdr inadvertently provided a wrong date for this field (08/25/2014). The correct date for this field is 09/02/2014. This report is being submitted to correct this date.
 
Event Description
Additional information was received indicating that the vns patient had passed away from "natural causes¿. The coroner noted bruising on the left eyelid and bruising and swelling of the tongue, which indicates that the patient possibly had a seizure and bit his tongue prior to death. An autopsy was not performed and a blood sample was not ordered. The cause of death was listed as ¿seizure¿. The coroner¿s report noted that the patient had a history of seizures and was implanted with a vns device. It is believed that the patient¿s device was not explanted prior to burial; therefore, no analysis can be performed. With the available information, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3350634
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« Reply #196 on: March 28, 2019, 07:27:29 AM »

Model Number 106
Event Date 02/24/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient has swelling at the chest incision. The patient was implanted on (b)(6) 2016. The swelling was described as raised and warm to touch. The vns device is not on. There is no neck swelling. Of note, the patient does cpt (chest percussion therapy) vest therapy. He did cpt the 1st day postop and there was some bleeding of the chest incision site, so since then the cpt therapy has been discontinued. Follow-up with the surgeon's office showed that the patient was seen on the 10th. It was determined that the patient had a seroma above the chest incision and antibiotics were prescribed as a precaution for any infection that may develop and the seroma was drained at the appointment. No infection was confirmed but the precautionary medicines were provided. The patient's home was instructed to give the antibiotics. No explant of the device is planned. On (b)(6) 2016, it was reported that the patient's lead wire is poking through the incision.
 
Event Description
Clinic notes received (b)(4) 2016 and dated (b)(6) 2016 states that patient has problems with lead. It was stated it was complicated by a small seroma which was evacuated 2 weeks ago. The patient returns today with a small portion of the vns lead extruding through the skin. This is in the area where the seroma had thinned out the wound. There is no sign of infection or drainage. The surgeon recommends revising the pocket in such a way that his leads will be placed back in the tissue deeper. Due to the patient's mental status, this will have to be done in the or. The patient's surgical intervention has not occurred to date due to the patient being hospitalized for pneumonia and dehydration.
 
Event Description
It was reported on (b)(6) 2016 that the patient was taken to the hospital due to a hemotoma. The surgeon performed surgery that day to clean out the generator site due to the lead being exposed. System diagnostics performed at this surgery showed the device was working within specifications. It was reported on (b)(6) 2016 that the patient underwent a surgery that morning. It was stated that the patient had a hemotoma at the chest incision and the lead wire was still poking through the skin. The surgeon cleaned out the hematoma, covered the area in antibiotic powder and put a wound vac in place that he planned to keep in through the weekend. Per the nurse, the patient thrashed around a lot, picked at his incision site and they felt that was contributing to the problems.
 
Event Description
It was reported on (b)(6) 2016 that the patient is referred for explant as it appears that his body is rejecting the lead/generator. The patient now has an open incision. No confirmation of the explant surgery has occurred to date.
 
Event Description
The generator and the lead were explanted on (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5529930
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« Reply #197 on: April 02, 2019, 01:20:11 AM »

Model Number 106
Event Date 04/27/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had the vns generator and lead explanted due to an infection and left neck swelling. The patient's device was initially implanted on (b)(6) 2016. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.
 
Event Description
The product analysis for the lead was completed and found that the lead portions received were 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 with no discontinuities identified. Abrasions were noted on the outer silicone tubing and did not penetrate. Slice marks were observed on the inner silicon tubes and quadfilar coils appeared to be cut in multiple locations. Based on the findings in product analysis, there was no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint. Product analysis for the generator showed that generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5674946
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« Reply #198 on: April 04, 2019, 01:29:48 AM »

Model Number 106
Event Date 05/01/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on 05/23/2016 that the patient is experiencing swelling over the generator and lead. At first, it was stated that there hasn't been any trauma to the area but looks like his body is actually rejecting the device and lead. The patient was recently implanted on (b)(6) 2016. The patient was taken back to surgery on (b)(6) 2016 to drain the blood from under his skin and it was stated to look much better. The patient's device was interrogated on (b)(6) 2016 and the device was fine. More information from the physician showed that the patient actually fell from a play structure and caught himself with his arms which is believed to be the cause of the swelling. No further interventions are being taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5727703
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« Reply #199 on: April 04, 2019, 01:30:33 AM »

Model Number 106
Event Date 05/26/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing redness and swelling near her chest incision after she had initial implant surgery on (b)(6) 2016. A culture was taken and the results concluded that there was an infection near the incision site. The patient was prescribed iv antibiotics. It was later reported that the antibiotics were helping clear the infection. The device history record for the implanted generator and lead were both reviewed and verified that both devices were sterilized per manufacturer specifications prior to release for distribution. No known surgical intervention has occurred to date. Additional relevant information has not been received to-date.
 
Event Description
It was reported that the patient is expected to recover.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5746518
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« Reply #200 on: April 04, 2019, 01:31:12 AM »

Model Number 105
Event Date 05/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported the patient had complaints of redness, swelling, and pain at the vns generator site. The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection. Additionally information was received which stated the patient also believes the generator is heating and not working. The patient stated he has had an increase in seizures as well as a change in seizure type. Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue". It is unknown what the nerve issue is, or what may have caused the nerve issue to occur. A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator. No acute finding". Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator". It was mentioned in the notes that the patient was still having seizures. The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator. After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended. It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures. It was confirmed that these seizures have increased from her baseline. It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device. There was not reason specifically given for the increase in seizures. It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits. It was noted the device would not be returned per hospital regulations. It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely. The patient requested to have a 102 as he did not have any issues with the m102. Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator. According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5726096
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dennis100
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« Reply #201 on: April 06, 2019, 02:10:35 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The physician referred a patient for revision surgery due to a suspected lead break. The patient reported that there was no trauma to check or chest; however, they woke up one morning with left neck pain and swelling. The physician reported that that x-rays were reviewed, and that there appeared to be a lead break where the wire for the coils connect to the main wire. The physician ordered an additional x-ray and a ultrasound of the neck to determine the cause of the issue. After reviewing the x-ray and ultrasound, the physician believed that the lead was 100% broken. The physician believes that the left neck pain and swelling are related to the reported lead break. The physician reportedly suspects either the lead was not on the vagal nerve originally or that a small blood vessel in the area spontaneously burst and caused the sudden swelling and lead break. It was noted that the patient has been doing excellent with the vns since, and that the patient's seizures had been significantly reduced. It was noted that the patient's device was turned off and that the patient has seen an increase in seizures as a result. The ap and lateral neck and chest x-rays were received and reviewed by the manufacturer. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the lead pins were fully inserted. The device was placed in the patient¿s left chest per labeling. The lead was observed in the neck and chest. The lead wires appeared intact at the connector pins. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Additionally, four electrode coils were observed in the x-ray, two coils from a previously implanted lead and two coils from the current lead. The previous lead appears to have been explanted around 2-3 inches from the previous electrode coils. The previous and newly implanted electrode coils do not appear to be both implanted in the same location. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465274
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dennis100
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« Reply #202 on: April 09, 2019, 12:44:11 AM »

Model Number 106
Event Date 06/13/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient's wound did not properly heal after her generator replacement surgery on (b)(6) 2016. The patient had two visits to the emergency room and underwent antibiotic treatment, but the wound opened and the generator was visible. The patient's device was then explanted. The device history records of both the generator and lead were reviewed, and the devices were sterilized according to procedure prior to release. The operative report was received from the explanting facility. The patient's wound swelled over the course of a few days and dehisced. The patient was admitted to the intensive care unit and had the generator and most of the lead explanted on (b)(6) 2016 so antibiotics could treat the infection. A suture granuloma was removed from where the generator was placed, and there was an area above the incision of necrotic tissue that was removed as well. No further relevant information has been received to date.
 
Event Description
It was reported that the patient started having redness and swelling at the left neck. The physician performed an ultrasound, which identified a cyst surrounding the remaining portion of the lead. The physician aspirated fluid from the cyst, which was dirty; and looked infected. The patient then had the remainder of the lead explanted. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5835493
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dennis100
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« Reply #203 on: April 14, 2019, 01:42:05 AM »

Model Number 105
Event Date 06/13/2016
Event Type  Injury   
Event Description
It was reported by the patient that she had vocal cord paralysis and she had been scoped by an ent who confirmed the patient's swollen tonsils and left side vocal cord paralysis are associated with the presence of vns and vns stimulation. The patient reported she was told that her tonsils and vocal cord paralysis would not resolve until the vns was explanted. The patient did mention that she has been receiving great efficacy with vns. It was reported by the physicians office that the patient was seen on (b)(6) 2016 and there was no dysfunction found with the device. The physician titrated the patient's setting up and noted she had tolerated the changes well. When asked if they knew whether or not the patient was actually seen by an ent, they stated that had no report of her visiting an ent. The dhr for the generator was reviewed and found to be complete and the generator passed all testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5872199
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dennis100
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« Reply #204 on: April 15, 2019, 01:23:31 AM »

Model Number 303-20
Event Date 12/07/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had significant swelling at the electrode and generator sites. It was initially thought that the patient had an infection, but that was ruled out. The patient then had a nuclear medicine scan, which showed that the patient had lymphatic fluid in the soft tissue surrounding the electrode site and was leaking down to the chest pocket as well. The patient was feeling painful stimulation in the neck, which the physician attributed to the electrode site being irritated and swollen. It was determined that the fluid collection was due to the implant location of the electrodes. The physician performed lead revision surgery on (b)(6) 2016 to replace the lead and position the new electrodes in a different location on the nerve. The physician did not observe any fluid when he was performing the lead revision surgery. The explanted lead was received on (b)(6) 2016. Analysis was approved on (b)(6) 2016. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Other typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5851977
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« Reply #205 on: April 17, 2019, 07:06:14 AM »

Model Number 106
Event Date 08/17/2016
Event Type  Injury   
Manufacturer Narrative
Suspect device udi#: (b)(4).
 
Event Description
It was reported by the physician that the mother believed the patient was having an issue with his incision site and wanted to get in touch with the surgeon. It was later explained that the patient was seen by the surgeon on (b)(6) 2016. The surgeon believed there was a possible seroma. The patient was put on antibiotics and was requested to come back in 2 weeks. On (b)(6) 2016 the surgeon noted that the antibiotics were resolving a possible lymphocele and he saw no strong indication to perform surgery and prescribed 1 more week of antibiotics. Additionally, it was explained that the patient's mother had apparently stuck a needle in the swelling before being seen by the surgeon. Review of the dhrs for both the lead and the generator confirmed sterilization prior to distribution.
 
Event Description
The physician noted concern regarding the issue with the patient's lymph tissue and referred the patient for neck site flushing. It is unknown if the flushing actually occurred. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient was still having problems with infection. The patient was referred to the or to see if the vns would need to be explanted. It was noted the patient had infection before, close to the time of the implant, and it must have returned and there was some fluid build-up in the chest pocket. It was noted the patient had a full vns explant due to the infection.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5952395
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dennis100
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« Reply #206 on: April 19, 2019, 01:26:19 AM »

Model Number 106
Event Date 06/29/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that four weeks post initial vns lead and generator implant there was swelling at the vns site which suggested the presence of an infection. There was no active discharge however the incision appeared inflamed. It was unclear if this was the lead incision or generator incision. The patient was admitted to the hospital for 10 days and placed on an iv of antibiotics and after a few days the swelling had gone down. The patient was then released and sent home with a picc. However about a week later the infection had not resolved and pus was discharging from the incision. The patient was then readmitted to the hospital and referred for explant surgery due to the infection. It was reported that surgery was postponed due to the infection not getting under control. No surgical interventions are known to have occurred to date. The manufacturing records of the lead and generator were reviewed and indicated that both were sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
It was reported that the infection was occurring at the generator incision site however the swelling appeared to improve overnight. The physician did not suspect that patient manipulation or trauma contributed to the infection. The physician reported that the explant surgery was canceled due to the swelling spontaneously resolving and the lab results greatly improving. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5924653
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dennis100
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« Reply #207 on: April 19, 2019, 01:27:07 AM »

Model Number 302-20
Event Date 08/04/2016
Event Type  Injury   
Event Description
It was reported on 08/04/2016 that the patient is scheduled for generator replacement for an unknown reason. However the patient also has swelling around the lead body in the neck site and the neurologist specifically told the surgeon about this so it's not clear if intervention will be taken for this during the time of the generator replacement surgery. While it appears surgical intervention is planned for this issue, surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5924461
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dennis100
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« Reply #208 on: April 19, 2019, 01:28:13 AM »

Model Number 106
Event Date 10/05/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had a history of trauma to the implant area on (b)(6) 2015. The patient was grabbed around the neck by another teenager and there was swelling to the left side of his neck over the lead side. An ultrasound scan at another hospital showed a haematoma. Following this injury, the patient complained of discomfort when the output current was increased and generally on stimulation. It was reported that the pain persisted after the swelling had reduced.
 
Event Description
Additional information was received from nurse that in (b)(6) diagnostics were performed which were fine and the swelling and haematoma resolved without intervention but pain prevented the output current being increased any further following the incident so there was clearly still a problem even though it wasn't visible.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5927567
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« Reply #209 on: April 22, 2019, 01:42:43 AM »

Model Number 103
Event Date 08/01/2016
Event Type  Injury   
Event Description
It was reported that the patient planned to have her vns explanted. The patient was involved in an atv accident which reportedly caused the generator to migrate and caused associated pain. The patient elected to have the device explanted in relation to satisfactory control without vns therapy. Further information received showed the patient was also to have an mri performed in relation to the atv accident and pain, which contributed to the decision to have the device removed. Device explant has not been reported to have occurred to date. Attempts for additional pertinent information have been unsuccessful to date.
 
Event Description
Follow up communications were completed with the respective offices of the treating neurologist and surgeon. The patient had her vns system fully explanted on (b)(6) 2016. The surgeon reported that the explant was exclusively for the desire for an mri. However, the treating neurologist noted the occurrences of the previously reported migration and pain that contributed to the decision to perform surgery. The patient had a recent atv accident that caused pain, swelling, and occasional burning sensations at the generator site. The generator was previously able to be repositioned at will by the patient, but was fixed in place after the accident. The device migrated from its implant location and caused discomfort related to its position. The treating neurologist assessed that the vns was causing discomfort after the atv accident. The surgery was not to preclude a serious injury per the treating physician. Following explant surgery, the patient was reportedly feeling better regarding the reported pain. The device was reported to previously have impedance within normal limits and a full battery. No additional pertinent information has been received to date.
 
Event Description
The explanted lead and generator were reportedly discarded by the explanting hospital. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6084255
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