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dennis100
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« Reply #240 on: June 19, 2019, 04:12:02 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/19/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported originally that the patient was having throat discomfort after his last replacement which he believed to be due to vns stimulation. Later on (b)(6) 2017 the patient was experiencing vocal cord paralysis and was having difficulty managing his airway after consulting an ent. With the magnet in place, the ent could see some movement in the left vocal cord only and the patient was better able to maintain his airway. With the magnet removed and vns back on, the vocal cord stopped moving and his oxygen saturations declined. The device was programmed off. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Later information from the physician provided on 10/25/2017 that the patient was experiencing urine retention, lethargy, difficulty eating and drinking, and needed oxygen support. He had been taken to the hospital for difficulty breathing and maintaining oxygen levels. On (b)(6) 2017 a lot of swelling was found in the throat and was admitted to the hospital a day later. On (b)(6) 2017 the patient was taken to the icu and was put on a ventilator and the airway was almost completely swollen shut. On (b)(6) 2017 the vocal cord paralysis was identified and showed improvement after using the magnet to disable vns. On (b)(6) 2017 movement was seen in both the left and right vocal cord although still partially paralyzed, the patient's stats were normalizing well. The device was turned off at that time. On (b)(6) 2017 follow-up with an ent showed a lot of movement was seen in vocal cord but still had partial paralysis. It was reported that the seizure frequency has actually decreased since turning off the vns device. Diagnostics performed by the company representative on (b)(6) 2017 were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7099705
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dennis100
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« Reply #241 on: June 21, 2019, 12:43:14 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/29/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient was doing fine right after vns surgery, but about a week later complained of hoarseness, shortness of breath and was unable to speak. The ent stated that the patient had left vocal cord paralysis and leukoplakia. The left vc paralysis was stated to most likely be secondary to swelling and inflammation around the nerve after the vns was placed since the symptoms occurred 1 week after surgery. The patient was prescribed antibiotics and steroids due to the symptoms. The doctor stated it might take months for vcp to improve. The patient¿s vns device has not been turned on since surgery. It was also stated that this patient is a heavy smoker. The patient did also complain of numbness on the left neck at the neck incision. Additional information was received from the surgeon indicating that the patient's shortness of breath is likely due to left laryngeal weakness, and that the heavy smoking at approximately 1. 5 packs per day contributes to this as well. The vocal changes are due to laryngeal weakness, and the leukoplakia of the larynx is due to smoking. The patient's numbness at the incision site is an anticipated result of a neck incision. No other relevant information has been received to date.
 
Manufacturer Narrative
Event description, corrected data: the initial report inadvertently did not state the patient's sore throat and increased mucus production. Patient problem codes, corrected data: the initial report inadvertently did not include pain and discharge as patient problem codes.
 
Event Description
It was reported that this patient presented with a sore throat and increased mucus production when visiting the ent regarding their vocal cord paralysis and leukoplakia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7230517
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dennis100
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« Reply #242 on: June 22, 2019, 03:39:25 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2017
Event Type  Injury   
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.
 
Event Description
It was reported that the patient's mother had noticed some redness and swelling at the implant site. The patient's generator and lead were removed shortly after due to wound infection at the generator and neck sites. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7205665
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dennis100
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« Reply #243 on: June 25, 2019, 01:32:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was reported that the patient had undergone vns implant surgery. Post-operatively it was observed that the patient was thrashing around and the neck incision site had started swelling. The patient was taken back to the or where the incision was open because the surgeon suspected that a hematoma had formed. During the second surgery a hematoma was found and evacuated. Following the hematoma be evacuated it was reported that the issues resolved. The device was checked again and found to be functioning properly. It was decided to leave the device programmed off initially post-implant. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7259670
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dennis100
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« Reply #244 on: June 26, 2019, 07:21:46 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?: 81 - device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient was experiencing swelling at his chest incision less than a month after implant. The physician believed that the stitches may have popped open. The physician planned on watching the incision, and it was reported that the device was functioning properly. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7233353
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dennis100
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« Reply #245 on: June 27, 2019, 12:03:48 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient's lead and generator were explanted due to an infection. The operative notes from the procedure state that there was a pustule just over the vns and swelling. Also, the notes state the patient underwent needle aspiration that showed pus in the pocket and was brought in for removal of the vns as well as debridement of fibrinous debris and drainage of the abscess cavity. A review of the device history records for both the lead and the shows that no unresolved non-conformances were found and confirms the products were properly sterilized. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7321041
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dennis100
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« Reply #246 on: June 28, 2019, 10:49:22 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/19/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event(s) have been determined as not related to vns therapy, but rather to the presence of the device.
 
Event Description
It was initially reported that the patient was scheduled for a vns generator replacement less than two months after initial implant. The reason for the replacement was not report at first. Further follow-up found that the patient's generator had been explanted a few weeks following implant after the patient's parents noticed swelling at the generator site. It was later confirmed that the generator site was infected. When the generator was explanted the vns lead was left implanted. The patient was treated with antibiotics via iv and oral medication. Manufacturing records confirmed that the generator was sterilized prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7311871
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dennis100
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« Reply #247 on: July 01, 2019, 10:22:10 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/30/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from a consult that the patient was experiencing an increase in seizures, as well as itching and swelling at the neck incision site. The surgeon suspected that these events were related to an issue with the electrodes from the patient's recent lead revision surgery. He scheduled a surgery to look at the electrodes and to also provide a vocal cord injection as it was also reported that the patient had vocal cord paralysis. The patient underwent exploratory surgery where the surgeon removed some scar tissue, gave vocal cord injections and closed the patient. Diagnostics indicated that the device was functioning as intended within normal limits, and settings were programmed back to pre-op settings. It was noted that no reposition was performed. Device history records were reviewed for the patient's implanted generator and lead. Both devices were sterilized and passed quality inspections prior to distribution. No further relevant information has been received to date.
 
Event Description
An update indicated that the patient's vocal cord paralysis occurred on the patient's left side and that it was attributed to the vns surgery. The physician did not have assessments for the cause of the increased seizures, swelling or itching. It was further confirmed that there were no issues with the anchors as was originally suspected. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7488918
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dennis100
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« Reply #248 on: July 04, 2019, 01:02:01 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/06/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
Report received that a patient developed a chest wound that appeared dehisced. Additionally, the patient's neck appeared red and swollen. The patient had been implanted with a new lead and generator only about a month before these issues were seen. The surgeon reportedly admitted the patient to perform a partial explant and washout. It was later confirmed that the generator and part of the lead were explanted. Further information was received that the chest wound was caused by the patient picking at the chest incision which caused it to become infected. It reportedly developed into (b)(6). The neck redness and swelling was reportedly indicative of an infection, too. A review of the device history records for the lead and generator indicated that both devices had been sterilized per specification prior to being released for distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7592560
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dennis100
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« Reply #249 on: July 04, 2019, 01:03:09 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/21/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported event has been determined as not related to vns therapy but related to the implanting procedure.
 
Event Description
It was reported that a patient's neck incision site was swelling and that part of the site was yellow with a small amount of serosanguinous, yellow draining. The patient reported mild pain at the site and denied any fever. The patient later reported after visiting the surgeon's office, that she seemed to have an infection. Device history records were reviewed for the implanted devices, and found that they were both sterilized prior to distribution. No additional relevant information has been received to date.
 
Event Description
Follow up with the surgeon's office indicated that the patient was seen for follow-up and the incision sites were checked to be showing no issues. It was confirmed that there was no fever, drainage, or chills, and that the incision sites looked fine. The patient had not been in contact with the surgeon's office since this visit. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7693017
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dennis100
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« Reply #250 on: July 05, 2019, 10:30:16 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported from the patient that she had high blood pressure after surgery. She took blood pressure pill and it got better. She also says the incision came apart at some point, but was put back together. It is unclear which incision she is referring to. She states her incision on her chest is red and swollen. No additional or relevant information has been received to date.
 
Event Description
The physician stated that the patient has a history of anxiety, depression and obsessive compulsive disorder. For the allegation that the incision site had opened up post-surgery, he stated that it did not and the patient did not go back to surgery for this. The physician indicated no infection and healing well when asked about the redness and swelling at the generator site. Patient reported she was doing well post op (b)(6) 2018. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7566864
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dennis100
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« Reply #251 on: July 11, 2019, 01:03:44 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/12/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient has neck swelling and that the patient had a recent placement of the vns on the left. The patient also has sensation of throat tightening. The patient was assessed left vocal cord paralysis was identified and abnormal asymmetric thickening of the left aryepiglottic fold which lies cephalad of the paralyzed left vocal cord. There was also a 13 mm solid nodule at the inferior pole of the left thyroid lobe. The patient¿s device has not been programmed on yet. Information was received from the patient that she can barely talk or breathe. The likely cause of the paralysis was from the surgical procedure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7678836
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dennis100
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« Reply #252 on: July 11, 2019, 01:04:28 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2017
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported in (b)(6) 2018 that the patient was being referred for explant due to pain and swelling. In (b)(6) 2018, it was reported that the patient first reported chest pain about a year prior. It was mentioned that the patient wanted to have their device explanted because they felt that the device was not helping, however the device was disabled earlier that year as the physician stated there had been reduction in the frequency of seizures. In (b)(6) 2018, the surgeon believed that it was highly unlikely that the vns device was causing the pain and swelling, and the neurologist believed that the pain was due to possible fibromyalgia, unrelated to the vns therapy system. The surgeon went on to state that he informed the patient that explanting the generator would not guarantee pain reduction or pain alleviation. However, due to the patient being adamant about explanation, the patient was referred for surgery. Device diagnostics information was not received at this time, however it was mentioned that the patient was at a low setting. The patient later reported, in (b)(6) 2019, that the vns caused jerking, falling, strokes, flushing of the breasts (turned red per patient), and pain throughout the body. The patient also mentioned that the vns caused both their breasts to hurt and turn red, and that both breasts needed to be taken out. Multiple attempts have been made to the physician for an assessment of these allegations, and there relationship to the vns and surgery referral, however no response has been received to date. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8724571
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dennis100
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« Reply #253 on: July 14, 2019, 04:27:22 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/15/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient fell and had bruising and swelling around the lead and generator site that appeared infected. The lead and generator were explanted and it was noted that fluid was found at the generator and neck site. The explanted devices were stated not to be returned. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7805737
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dennis100
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« Reply #254 on: August 10, 2019, 12:15:36 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as the reported event of infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient will be having the generator removed due to infection issues. During follow-up, the nurse of surgeon indicated that the infection was first noted in the beginning of the month by the patient's mother where the location of the generator was slightly swollen. The nurse indicated that the location appeared to be red on the chest and the pocket was squishy and bulging. The patient was provided antibiotics and the device was later explanted. Per the clinic notes, the generator was removed and chest wall was washed out and then proceeded with the removal of the electrodes. There was complete removal of vns with no hardware left behind. Per the nurse, the cause of the infection is unknown. The device history record's of the generator and lead was reviewed. The generator and lead passed final quality and functional specifications prior to release. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8771434
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dennis100
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« Reply #255 on: August 10, 2019, 12:16:16 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported by the patient that there was what appeared to be a pocket of pus at the generator site and the electrode/neck site was getting red and swelling. Follow up revealed that there was no infection at the electrode/neck site. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8823755
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dennis100
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« Reply #256 on: August 10, 2019, 12:16:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's vns generator seemed to have migrated. The neurologist indicated that the generator migration may have caused the vns lead wires to press on the patient's thoracic duct and obstruct flow. The patient experienced swelling of the left arm, neck, leg, and hand. The neurologist indicated that the patient's left hand was more swollen than the right and was concerned the swelling may have been related to lymphedema. The patient's neurologist ordered the patient a compression garment. Clinic notes were received that mentioned x-rays were performed of the patient's neck and chest. The x-rays have not been received by the manufacturer for review to date. The notes indicated that the x-rays showed strain relief loop and that the leads were positioned appropriately. The x-ray notes reported the generator appeared to overlie the left chest, and per the x-ray assessment made by the surgeon the generator had not migrated into the armpit where it could endanger the lymphatic area. The patient was referred for generator replacement. No known relevant surgical intervention has occurred to date. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8775657
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dennis100
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« Reply #257 on: August 10, 2019, 12:17:32 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient reported that they experienced pain and swelling in their neck that started about two months prior to the report. The patient described the pain as a pulling sensation and knotting in the neck. Per the patient, the neurologist mentioned that the stimulation is irritating the patient's muscles, but referred the patient to the surgeon for a consult. Further follow up with the neurologist's office confirmed that the cause of the neck pain and swelling was due to the device migrating to the right side. The patient has been referred to the surgeon for further assessment. Per the physician, the referral for surgery is for both patient comfort reasons and to preclude serious injury. It was mentioned that this is all the information that the physician's office has at this point in time. 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=8756469
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