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dennis100
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« on: October 25, 2018, 02:52:54 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Event Description
It was reported that the vns patient was experiencing a ¿shocking¿ and tightness sensation in the neck, possibly due to the strain-relief being lost as the patient grew up. System diagnostics returned impedance within normal ranges. Review of the available programming and diagnostic history showed device disablement on (b)(6) 2011. The patient¿s mother believed that vns therapy was made the patient¿s epilepsy worse, whether it was on or off, as it was irritating the patient. It was therefore decided to explant the vns system without replacement. The patient's device was explanted on (b)(6) 2013. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4664019
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dennis100
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« Reply #1 on: October 25, 2018, 02:53:41 AM »

Model Number 106
Event Date 05/02/2016
Event Type  Injury   
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.
 
Manufacturer Narrative
(b)(4).
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5685905
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dennis100
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« Reply #2 on: October 25, 2018, 02:54:33 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing pain in her chest and neck stiffness. The patient attributed her pain to vns. According to the patient, her pain had been occurring for a long time. The patient's generator was explanted due to the chest tightness. The explanting surgeon also reported that the lead had been placed on the phrenic nerve instead of the vagus nerve. The explanted generator was discarded and is unavailable for analysis. Follow-up with the explanting physician indicated that the patient's normal mode output current had been programmed off sometime prior to the surgery, indicating that the pain was not stimulation related. The patient had been seen by a cardiologist because she had experienced the chest pain, and the cardiologist said that the patient's heart was ok. The patient had experienced inflammation around the electrode site and laryngeal nerve irritation, but it did not appear that the lead had been explanted. No additional relevant information has been received to date.
 
Event Description
Additional follow-up with the nurse at the explanting facility indicated that the surgeon was unable to locate the patient's vns electrodes during surgery, even after dissecting 8 centimeters into the nerve. This led the physician to believe that the patient's lead had been implanted somewhere behind the sternocleidomastoid muscle, causing the tugging sensation and pain in the neck and chest. The lead was confirmed to have also been explanted. The surgeon's office could not determine whether the pain was chronic or related to the vns. Follow-up with the patient's following neurologist indicated that the patient had previously complained that she did not like the vns, stating that it caused her a lot pain. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6768932
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dennis100
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« Reply #3 on: October 25, 2018, 02:55:29 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Event Description
The patient reported that they were having difficulty swallowing, catching their breath, and felt some tightness in their throat. It was reported to first occur with magnet stimulation, and has been getting worse in the past six months. The patient stated that recently the difficulty swallowing, catching her breath and tightness in her throat is constant, and not only occurring with stimulation. The patient stated that they were hospitalized and an upper gi test was performed that came back negative. The patient has not seen a neurologist in some time and was questioning if her battery needed replacement. The patient does not have a current neurologist she visits. No other relevant information has been received to date.
 
Event Description
Additional information was received from the patient's previous neurologist who stated that the patient has not been seen since (b)(6) 2018, and the doctor no longer sees the patient. The device was not interrogated at this time, and there were not medication changes. The patient never mentioned any difficulty swallowing, shortness of breath or throat tightness to the neurologist. No other relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient¿s primary care provider is concerned that the patient¿s throat cancer is returning as the patient has experienced throat pain and hoarseness. Patient reports symptoms have been worsening recently. Patient reports at first inability to tolerate solids and no difficulty tolerating liquids. Patient reports history of throat cancer 2007 when they were treated with surgery as well as chemotherapy. The notes also report that the patient was a former smoker. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7403911
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dennis100
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« Reply #4 on: October 25, 2018, 02:57:50 AM »

Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was initially reported by the treating nurse practitioner that the pt was recently diagnosed with sleep apnea. The nurse believed that they were going to attempt to disable the device in the evenings during sleep to see if that would help resolve the issue as he was not having seizures at night, so the therapy was not needed at that time. The pt later reported that he believed the device was going to be disabled. He said that he was having difficulties breathing, had sinus issues, couldn't breathe through the nose, tightness in his chest and was not getting any sleep. He was said to have had a sleep study which did not provide any further info on the issues. He reported that when the magnet was taped to his chest, the issues resolved. The pt also reported the physician did not believe there was anything wrong with his heart. The pt claimed that since his lead and generator repositioning in 2008 (at the pt's request), he has lost seizure control since the seizures have returned to pre-vns baseline levels and the magnet activations have no longer become affective. The pt is requesting removal of the device. Programming history reviewed in manufacturer's programming history database indicating that the last known diagnostics performed were within normal limits. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889162
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dennis100
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« Reply #5 on: October 25, 2018, 02:58:37 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Event Description
It was reported that a patient's device would be explanted. Upon follow-up on the reason for explant, it was stated that the patient was having difficulty breathing over the past year. The patient had seen several doctors regarding the breathing issues and no doctor was able to determine the reason for the issues. The physician lowered settings for the difficulty breathing. It was unknown if this improved the patient's symptoms. A company representative attended the patient's appointment and noted that the patient was visibly swallowing hard and that the patient was also reporting tightness that occurred about 4-5 times a day. Settings were adjusted. The physician was unsure if the events were related to stimulation. Lead impedance was indicated to be ok. It was noted that the patient's device was replaced. The hospital was noted to be a no return site so the explanted generator will not be returned for analysis. No additional relevant information has been received to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7701207
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dennis100
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« Reply #6 on: October 25, 2018, 02:59:35 AM »

Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 02/15/2018
Event Type  Malfunction   
Event Description
Patient was referred for surgery due to high impedance. Parents could not report any known trauma. The lead and generator were replaced and impedance was within normal limits after replacement. Additional information was received that high impedance was first observed by the neurologist prior to surgery. It is the neurologist's assessment that the lead was fractured based on the lead tightness and lead pin pull out. A lead fracture was not observed by the surgeon. The surgeon also did not visually see the lead pin out of the generator until the lead were removed to replace the generator. Lead fracture is suspected based on the high impedance observed prior to surgery. The explanted lead was received. Analysis is underway and has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7541148
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dennis100
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« Reply #7 on: October 25, 2018, 03:00:18 AM »

Model Number 302-20
Event Date 03/30/2012
Event Type  Malfunction   
Event Description
Reporter indicated a patient had vns generator replacement surgery for battery depletion, and lead replacement due to a suspected abraded insulation issue. No lead anomalies were visualized in the surgery, but the patient was experiencing painful stimulation and tightness in the chest area which was felt to be attributed to a breach in the lead insulation or possible fracture. The explanted devices will not be returned by the hospital per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2614896
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dennis100
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« Reply #8 on: October 25, 2018, 03:02:03 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.
 
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that 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. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
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dennis100
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« Reply #9 on: October 25, 2018, 03:02:59 AM »

Model Number 102
Event Date 07/25/2011
Event Type  Injury   
Event Description
It was initially reported that the pt began experiencing pain and tightness in his chest following a mri. The pain is continuous and not related to stimulation. The physician recommended alternating disablement (2 hours on/off). The physician then disabled the pt for a week and the pain started to resolve. When the device was turned back on the pain returned immediately, so the physician turned him back off. A prophylactic replacement is planned, but has not occurred to date. (b)(6) attempts for more info have been unsuccessful to date.
 
Event Description
Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received regarding the patient. The patient is going to be explanted and not replaced at this time. They are going to see if the pain subsides and potentially re-implant later. The pain was reported to still be present with the generator disabled. The generator had been explanted and has not been returned to the manufacturer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245806
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dennis100
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« Reply #10 on: October 25, 2018, 03:03:56 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that the patient's vns was explanted on (b)(6) 2015 due to the patient not wanting vns any longer and feeling that vns did not help her. Both the generator and majority of the lead was explanted. On (b)(6) 2015, the patient was doing well after explant. The nurse reported that the patient has a lot of psychiatric issues, so the patient thought vns was causing a lot of the problems. However, the nurse does not think that vns necessarily was and that it was likely more psych-related. The explanted devices have not been received by the manufacturer for analysis to date. Clinic notes dated (b)(6) 2015 reported that the presented to the clinic on (b)(6) 2014 with complaints of left shoulder and chest being "inflamed. " she was advised to go to nearest er for evaluation but the patient declined. At that time, the patient was still wanting the vns settings to be adjusted. The neurologist assessed that since the patient had non-epileptic seizures, there was no plan to revise the vns. However, due to the patient's complaints, the decision was made to explant the vns. The patient reported redness and warmth over the left chest intermittently and typically applied an icepack to the area to relieve the symptoms. The patient stated that she had symptoms related to the vns when it is on, including throat tightness and right shoulder pain. However although the device was off, the patient still complained of difficulty swallowing at times with right arm pain and swelling. Therefore at that time, the surgeon assessed that the events very likely may have not been related to vns.
 
Event Description
It was reported that the patient's the device was previously turned off due to painful stimulation. Explant may occur due to reasons unrelated to vns therapy. However, no known surgical interventions have occurred to date.
 
Manufacturer Narrative

Manufacturer Narrative

Event Description
Analysis was completed on the explanted products. In the pa lab, the device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Analysis in the analysis lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.
 
Event Description
Additional information was received stating that the vns patient¿s swollen generator site was causing the patient to experience painful stimulation. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
On (b)(6) 2014, it was reported that the generator site is "extremely" swollen (described as the size of a pocket with four generators inside), which has been like this for about a year. It was confirmed that the swelling was not normal. The patient also reports periodic swelling at the incision site in the neck. Normal mode diagnostics were performed with showed dcdc = 3. It was noted that the patient recently had an mri and it was not turned off during the procedure. At this time, the patient would like it resolved since she is getting efficacy and would prefer to not have the device explanted. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627213
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« Reply #11 on: October 25, 2018, 03:05:54 AM »

Model Number 302-20
Event Date 05/09/2011
Event Type  Injury   
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926
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« Reply #12 on: October 25, 2018, 03:06:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had a consultation visit due to a "cuff complaint. " follow up with the physician's office resulted in the manufacturer receiving the consult notes for the patient. The notes indicated that the patient experienced discomfort at the left neck vns site. The patient had a prominent mass at the location and had experienced difficulty sleeping at night due to the discomfort and sensation of tightness in the neck. It was reported that there was mild bowstringing of the wire and prominence of an anchor at the neck. The patient underwent a superficial vns lead revision to remove the prominent hardware and relax the wire. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707618

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« Reply #13 on: October 25, 2018, 03:07:33 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/04/2014
Event Type  Injury   
Event Description
The physician did not believe that the patient had vocal cord paralysis, but instead just had hoarseness. The dysphagia was occurring with stimulation, and the patient felt the painful stimulation at the neck and electrode and generator incision sites. Diagnostic results from (b)(6) 2015 were within normal limits and did not indicate a device malfunction.
 
Event Description
It was reported that a patient was experiencing tightness in her chest, vocal cord paralysis, dysphagia, and sleeping difficulties due to the tightness in her chest. These events started after she had thyroid surgery in (b)(6) 2014, but they just started getting worse recently. The physician programmed the device off on (b)(6) 2015 to determine if the issues were related to stimulation, but left the patient's magnet output current at 1. 5ma. The physician attempted to perform system diagnostics, but the patient felt pain during the stimulation and was unable to complete the test. The physician planned to turn the patient's device back on at the next appointment, but the patient did not go to the appointment because she was no longer feeling tightness in her chest, the dysphagia had resolved, her voice had come back, and she was no longer feeling painful stimulation. The patient did not want to have her device turned on for at least a month because she did not want to experience the side effects and she could not afford to go to another appointment. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5171609
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« Reply #14 on: October 25, 2018, 03:08:25 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 05/15/2015
Event Type  Injury   
Event Description
It was reported that the patient was seen by the ent and diagnosed with left vocal cord paralysis and will not need a vns revision. It was reported that the vocal cord paralysis may be temporary. The patient is doing physical therapy for the vocal cord paralysis and the ent reported that the neurologist should be able to start ramping up the patient's vns therapy.
 
Manufacturer Narrative

Event Description
Initially, it was reported that the patient had a constant cough and she was unable to eat. It was also reported that the patient had no voice from the surgery but has improved. The patient's generator had not yet been programmed on. It was later reported that the physician met with the patient and the patient's voice was better and the coughing was also improving. The patient's generator has not yet been programmed on. Later it was reported that the patient is having discomfort where the leads are presumably when she turned her neck towards the right. It was also stated that the turning motion, with the device off, prompts coughing. The patient was seen again and reported that the generator site was tender. The generator was protruding, but has not extruded through the skin. Due to the complaints of pain at the electrode site and the generator site, coughing to the point of vomiting, and voice alteration, exploratory surgery was performed. The surgeon ran diagnostics with the lead in multiple positions and all measurements were within the acceptable range. The surgeon redid the strain relief loop and tie downs. After the surgery, it was reported by the physician that the coughing had been resolved and the patient's voice is almost back to normal. The pain in the area of the generator was attributed to the scar related to the vicryl suture. The patient's generator has not yet been programmed on, but the patient is once again complaining of voice changes and tightness when turning the neck towards the opposite side previously reported. The patient was referred to an ent for evaluation. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4). This information was inadvertently left off of the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4911583
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« Reply #15 on: October 25, 2018, 03:09:23 AM »

Model
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« Reply #16 on: October 25, 2018, 03:10:44 AM »

Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".
 
Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.
 
Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.
 
Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236
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« Reply #17 on: October 25, 2018, 03:15:12 AM »

Model Number 302-20
Event Date 01/09/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when the patient stated that her throat hurt with stimulation the night before but not as much in this morning. The patient said the magnet swipes help with seizures, but sometimes her husband swipes the magnet when she is coming out of a seizure and she can't tell him not to, and then it hurts. The patient was seen by the neurologist on (b)(6) 2012 and the vns device was interrogated and system diagnostics were performed which showed results within normal limits; lead impedance=ok/dcdc=2. The patient's generator was programmed to output=1. 5ma/frequency=30hz/pulse width=250usec/on time=7sec/off time=0. 3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. During the final interrogation, the patient appeared to have an absence seizure then coughed and said she was having pain at the generator site. During the seizure, the magnet had been swiped. The generator was then programmed off, both in normal and magnet mode. The neurologist stated that he is going to leave the generator off until a 3 day video eeg can be done. On (b)(6) 2012, the patient reported that she is 2 days into the ambulatory monitoring and says she has had nocturnal seizures and migraines while monitored, but these are better tolerated without vns; she stated that vns gives her after effects like pain. The patient said she has discomfort above the generator randomly for 20-30 minutes at a time which is the same as before vns was turned off. The patient was seen for a follow-up visit on (b)(6) 2012 and the physician stated that he believes the patient's pain and "tightness" or limited range of movement, are psychiatric in nature and not related to vns. The physician turned the patient's device back on and the patient will not be seen again for another month.
 
Event Description
The patient called and was crying and upset. Frustrated that she cannot tolerate the increases to her device. She is depressed because she has not been able to return to her former level of functioning prior to her re-implant last year. The patient's treating physician is aware of the patient's issues tolerating their stimulation and an appointment was going to be made for the patient to be seen for evaluation.
 
Event Description
On (b)(6) 2012, a vns treating neurologist reported to the manufacturer's consultant that the vns patient was experiencing a 'tightness" in her neck and that over the weekend the patient's range of motion decreased and she could only turn her head about 10% in either direction. There is no pain with stimulation and the range of motion is independent of stimulation. Over the weekend, the patient also experienced a seizure and went to the emergency room. It took the patient a few days to recover. It was reported that the patient does not take her medications on a regular basis and she has a stressful lifestyle. On the friday before the weekend, (b)(6) 2012, the physician increased the patient's settings from an output of 1. 5ma to 1. 75ma. The patient remained in the office for 10-15 minutes following the programming change and reported that she was tolerating the increase. The patient was also observed on friday for her report that she had a clicking noise in her throat, however, no clicking occurred during the clinical visit and it lasted for 45 minutes. The patient reported that she had experienced two episodes of clicking in the front of her throat during stimulation. She stated that the clicking lasted for 30-60 seconds and the episodes were two weeks apart. There was no discomfort associated with this. The patient stated that the previous weekend, she also had a breakthrough seizure on (b)(6) 2012. The patient self-medicated with dilantin which elevated her dilantin level. Previously it had been six weeks since she had a seizure. The patient further stated that her husband is not using the recommended magnet swipe technique for her seizures. The husband was reported to be holding the magnet over the chest during the entire seizure, which disables stimulation, and then moved it away when the seizure stops. This then results in an uncomfortable strong stimulation after the seizure. Additional information has been requested but no further information has been received from the physician to date.
 
Event Description
Further reports regarding this patient's increased seizures with the suspect generator were received and all further relevant information regarding this event will be captured mfr. Report # 1644487-2017-03470.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2461478
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« Reply #18 on: December 19, 2018, 01:09:54 PM »

Model Number 102
Event Date 01/01/2006
Event Type  Injury   
Event Description
The pt reported that she had lost 18 pounds in last month or so and was still losing, had no appetite and had to force food down. She additionally reported that she had been receiving ect treatments because her depression was "so bad. " reported "i felt pretty good for a couple of weeks, but as soon as my period arrived, it all went downhill. I'm, perimenopausal and am on hormone therapy. I'm working with my ob/gyn to adjust them, as now i'm having about 2 periods a month - and like clockwork as soon as they hit, i go downhill into serious depression. So i'm averaging about 1 good week per month. " the pt's treating physician did not know if the pt's weight loss was vns related and possibly related to the pt's depression. The pt reported that they were thinking of getting the vns taken out due to throat tightness with stimulation and lack of efficacy, no malfunction suspected. The treating physician did not think that pt was a good candidate for vns therapy. Good faith attempts will be made for product return for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1199909
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« Reply #19 on: December 19, 2018, 01:10:47 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/26/2018
Event Type  Injury   
Manufacturer Narrative
"device evaluated by mfr?": device evaluation is not necessary because the reported events are related to device functionality.

Event Description
At the previous replacement the patient's new generator was placed closer to her clavicle and "causing" discomfort from the generator hitting the clavicle. Now the patient has been referred for revision due to the patient complaining of the vns being too high near the clavicle, the generator turning, and the lead feeling as if there is no slack. Information from the implanting surgeon reported that 3-0 vicryl sutures were used for the implant, which are absorbable sutures. Per the current surgeon, the surgery is both for patient comfort and to preclude serious injury. The surgeon believes the reason for the generator turning is due to a broken tie down stitch and that the placement of the generator near the clavicle could have led to muscle movement contributing to the generator movement. The current surgeon also believes the lead tightness may be due to the healing of the implant as well as possible higher placement of the electrodes. And perhaps the strain relief loop not being sufficient. The last known diagnostics were noted within normal limits. Surgery has not 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=8033126
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« Reply #20 on: December 19, 2018, 01:11:30 PM »

Model Number 302-20
Event Date 01/01/2008
Event Type  Malfunction   
Event Description
Reporter indicated that upon receiving a safety alert letter regarding potential short circuits in the lead, she was certain that the patient had a short circuit. The reporter had previously indicated that the patient has a shocking sensation in the neck, and had also denied that there was a shocking sensation, but that the patient felt a tightness in left pectoral region when the left arm was raised, and is now again alleging that the patient feels a shocking sensation. All attempts for more information, including programming history, so as to confirm or rule out a shor circuit, have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1505059
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« Reply #21 on: December 19, 2018, 01:12:12 PM »

Model Number 103
Event Date 05/25/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient was complaining of hoarseness and dysphagia. At the time, it was noted by the surgeon that the patient may have had these issues prior to vns and it was unclear if the issues had worsened with vns stimulation. Additional information was received on (b)(6) 2012 indicating that the generator had been disabled due to muscle tightness and swelling in the neck, which may have always been there, but now the physician felt that the vns may be interfering with his vocal cords. Per the physician, the patient had been evaluated by two separate physicians and his vocal cord was found to be partially paralyzed as a result of the tightness in his neck. The generator was re-enabled on (b)(6) 2012 to lower settings. It was noted that when the device was on 2. 0ma, the patient had reduced tension in neck and shoulders and felt better with a reduction in seizures. The patient has been recommend for speech/ vocal cord therapy for the dysphonia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2881243
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« Reply #22 on: December 19, 2018, 01:12:58 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/05/2018
Event Type  Injury  
Event Description
It was reported that the patient was experiencing difficulty breathing, wheezing, and throat tightness for which the vns was disabled. The patient was referred to an ent doctor, and it was determined that the patient was experiencing vocal cord paresis that occurred with vns stimulation. There was no reported medical intervention being taken for the events. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8021844
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« Reply #23 on: December 19, 2018, 01:14:53 PM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
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« Reply #24 on: December 19, 2018, 01:15:47 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was having issues with the vns. It was stated that the patient was experiencing asthma, tightness, and a tight throat while attempting to eat during stimulation on times. The vns was previously disabled due to these events, but then was programmed back on. Follow up with the physician's office revealed that the patient stated that she previously had asthma when she was younger and was diagnosed with mild seasonal asthma, but that it had increased. It was unclear if the increase coincided with the implantation of the vns. It was reported that the patient was on oxygen and had a pre-existing pulmonary dysfunction and that the patient's test results were very abnormal. It was stated that the patient may have chronic obstructive pulmonary disease, or copd. The patient stated that she had difficulty swallowing with vns stimulation due to the tightness, but the patient also experienced difficulty breathing through her nose previously, which was why the patient was on oxygen. The patient stated that she was on oxygen immediately following the vns implantation surgery due the pulse ox readings being so bad. The patient was forced to discontinue oxygen use previously due to insurance issues, but upon recently getting back on oxygen, stated that she felt better. The patient had previously been on steroid inhalers and then an asthma disk. The patient reported that she sometimes anticipated the stimulation, would tense up, and then have difficulty swallowing or drinking. However, it was stated that when she was sitting, the patient was fine and did not even perceive stimulation. The patient felt that she anticipated the previous vns on time and that it was too long. The patient was referred for a swallowing study and would also have a ct scan. The patient's stimulation on and off times were reduced to shorter periods and the output currents were increased. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7299811
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« Reply #25 on: December 19, 2018, 01:17:51 PM »

Model Number 304-20
Event Date 02/18/2013
Event Type  Injury   
Event Description
It was reported that the patient was seen by another physician for a second opinion. It was reported that the patient had experienced a weight loss of 35 pounds due to the nausea, vomiting following vns implant surgery. The patient¿s device was programmed on in approximately (b)(6) 2013. System diagnostics were reportedly within normal limits (lead impedance ok and approximately 3,500 ohms. The patient reported that her symptoms have not changed since the device was programmed on. The physician believes that the symptoms are probably due to trauma to the nerve during the implantation as the surgery lasted approximately 5 hours. The physician felt that time will probably alleviate the symptoms. The physician informed the patient to come back in if the symptoms persist in 3-6 months.

Event Description
Further follow-up revealed that the patient's device was explanted "because she has had several problems since the device was placed. The physician's office also reported that the patient experienced excessive nausea, vomiting, tightness of the lead, choking sensations, coughing, and burning pain at the generator site. It was reported that the neurologist recommended removal of the vns system because the neurologist felt that the amount of problems the patient experienced did not seem to outweigh the benefits of having vns therapy. Attempts to obtain additional information have been unsuccessful to date. Attempts to have the explanted devices returned for analysis have been unsuccessful to date.

Event Description
Additional information was received that the patient's device is off, but she is complaining of pain "radiating throughout her whole body," the patient was scheduled to have either a lead revision or vns removal. Additionally, the patient claims that the lead going up to her neck is "too tight" and her device is flipping over. The patient showed the physician how she can manually manipulate it to "flip over. " additionally, it was also reported that the device could easily be manipulated in the pocket. The patient's device was explanted on (b)(6) 2013. The explanted device was discarded by the hospital after the surgery. Attempts have been made for additional information; however, they have been unsuccessful.

Event Description
The patient reported on social media that her vns caused to her almost die due to "catching fire" inside her, causing her to lose 58 pounds in 2 weeks, threw up blood every day for 2 months, and the wires were cut too short in her neck. It was previously reported that the patient felt a burning sensation at her chest, which is most likely what the patient meant by the device "catching fire" inside her. No further relevant information has been received to date.

Event Description
On (b)(6) 2013, it was reported that this vns patient was hospitalized after implant surgery due to a cough. The patient¿s device was not programmed on at the time. Follow-up showed that the condition was not pre-existing and not occurring with stimulation at the present time; however, it could not be determined if the event was related to vns. Currently, the coughing was not occurring with stimulation. It was stated that on occasion, the patient would cough and have a little bit of blood in her sputum. The patient also reported lead protrusion in the neck when turning her head to the right. The patient was seen and the lead appeared very tight when the patient turned her head. The generator was placed in the upper chest, under the clavicle, but the lead just may have been too short. The patient was referred to a surgeon for evaluation but this was for patient comfort. Surgery is likely but has not taken place.

Manufacturer Narrative

Event Description
Follow up with the physician found that he did not believe the choking was related to the vns. The choking was not associated with or occurring with stimulation. During explant, the patient's generator was found to be sutured to the fascia at implant with a non-absorbable suture. The physician believes the patient was manipulating the device. It did not appear that the device had migrated since implant. It was unknown when the device was turned off. The explant surgery was taken for patient comfort. The patient also felt the device was causing "electrical disturbances" in her house. The symptoms have improved since explant.

Manufacturer Narrative
Date received by manufacturer, corrected data: supplemental report #1 inadvertently listed the incorrect date of 05/22/2013, which should have been 06/18/2013 as it was a correction only. Follow-up type, corrected data: supplemental report #1 inadvertently did not list the report as a correction.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125097
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« Reply #26 on: December 19, 2018, 01:18:43 PM »

Model Number 105
Event Date 01/15/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a recently implanted patient is having a hard time tolerating stimulation at around 0. 25mv - 0. 5ma. The patient experiences tightness in the chest, throat pain, and voice alteration and tachycardia associated with vns stimulation. Additional clinic notes were received for the patient. Clinic notes indicate that the patient was able to stop 3 seizures by swiping the magnet. When vns settings were increased from 0. 5 ma to 0. 75 ma, on (b)(6) 2015 the patient experienced mild palpitations and hoarseness of the voice with the increase but was reported to be able to tolerate it at the current level. Due to patient's concerns regarding discomfort with stimulation routinely (voice hoarseness, palpitations (tachycardia), chest discomfort and throat pain), the physician made a decision to decrease settings back to previous settings on (b)(6) 2015. Additional system diagnostic results was received. It was also reported that the patient continues to experience dysphagia when vns output current is increased to 0. 5 ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4583522
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« Reply #27 on: December 19, 2018, 01:21:06 PM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/15/2015
Event Type  Injury   
Event Description
It was reported that the vns patient was having unspecified cardiac issues and was referred for surgery to explant the device. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.

Event Description
Additional information was received which indicated that the generator and lead were explanted on (b)(6) 2015. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The nurse that initially reported the event provided additional information. The "heart problems" started on (b)(6) 2015. The patient had cough, shortness of breath, and chest tightness. Due to the chest tightness, she went to the er and was diagnoses with hyperkalemia, which she interpreted as a heart attack. This was not related to vns and no interventions were taken. The nurse also indicated that there was no actual arrhythmia. She stated that she does not think vns was causing any cardiac issues. She is not sure why the patient had pain, but the pain continued with the device off. The patient still complains of pain with the device removed.

Event Description
The patient's device was explanted on (b)(6) 2015. The explanted device has not been returned to date.

Manufacturer Narrative

Event Description
Product analysis was completed for the lead. There was no evidence to suggest an anomaly with the returned portion of the device. Since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Product analysis was completed for the generator. There were no performance conditions found with the pulse generator. There was a device issue found which was unrelated to the reported adverse event. This issue will be reported in mfr. Report # 1644487-2015-05884.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4876988
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dennis100
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« Reply #28 on: December 20, 2018, 02:03:58 AM »

Model Number 102
Event Date 07/19/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a vns treating physician reported that the vns patient was feeling sporadic stimulation and a tightening sensation. The patient went to the er on the evening of (b)(6), 2012 to have their vns checked and the neurologist on call disabled the device. The physician ran a system diagnostics test on (b)(6), 2012 and everything was within normal limits. The patient is being referred for prophylactic replacement. The physician later reported that the events were first observed on (b)(6), 2012. No causal or contributory programming or medication changes preceded the onset of the events. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. The physician stated that he believes the sporadic stimulation and tightening sensation are related to vns and occur with stimulation. The physician further indicated that the patient feels the tightening sensation/painful stimulation in the neck. The physician plans to replace the patient's generator as an intervention. The patient was scheduled for a battery replacement on (b)(6), 2012 and during surgery the surgeon accidently cut the lead. The battery was not replaced and the patient was re-scheduled for a complete revision surgery. Although surgery is likely, it has not occurred to date. A battery life calculation was performed which showed 1. 87 years remaining until eri=yes.

Event Description
Additional information was received on (b)(6) 2012, when product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of "painful stimulation"). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead was completed on (b)(6) 2012. A large portion of the lead assembly body, including the electrodes, was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The ends of the outer/inner silicone tubes and quadfilar coils appeared to be cut. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the one and a half sets of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. There was no alleged or observed malfunction with the returned portion of the lead. What appeared to be remnants of dried body fluids were observed inside the outer and inner silicone tubes. No obvious path other than the cut ends made during the explant process. No observed product related anomalies were observed with the single returned lead portion; however a lead coil cut was observed.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the patient underwent a revision surgery that day. On (b)(6) 2012, the patient's generator had been explanted and the surgeon accidently cut the lead in the process. At this point the surgeon decided to not implant a generator and closed the patient up. On (b)(6) 2012, the patient returned for surgery and a new lead and generator were implanted at this time. The generator had been replaced for prophylactic reasons. The explanted lead and generator were returned for product analysis on (b)(6) 2012. The lead impedance after surgery was noted to be within normal limits. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2692931
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dennis100
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« Reply #29 on: January 25, 2019, 09:42:59 AM »

Model Number 302-20
Event Date 07/18/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the device was not programmed off after observing the high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2014 indicated that patient reported feeling the device activate in the past, but now he has developed a sense of "tightness" in his neck when he extends his head and neck backwards. The patient notes discomfort over the left anterior triangle of his neck where the vns lead is located. It was noted that the patient's generator was reprogrammed to a signal on-time of 30 sec, the output current was increased gradually to 0. 5 ma and then 1. 0 ma. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the generator was completed on 09/29/2014. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.
 
Event Description
It was reported that the patient underwent generator and lead replacement. An implant card confirmed that the lead and generator were replaced due to lead discontinuity. Lead impedance with the new vns system was within normal limits. The explanted generator was received for analysis on 09/09/2014. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4010236
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