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Author Topic: Shortness of Breath  (Read 49209 times)
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dennis100
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« Reply #210 on: March 08, 2019, 02:22:11 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/13/2019
Event Type  Injury   
Event Description
It was reported that the day after patient settings were lowered for a dyspnea event, the patient began experiencing drop attacks and was admitted to the hospital. The device was checked and showed to be within normal limits. The patient was discharged from the hospital as he had returned to baseline frequency levels. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8317617
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dennis100
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« Reply #211 on: March 19, 2019, 01:54:42 AM »

Model Number 304-20
Device Problem Insufficient Information
Event Date 07/13/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 the patient reported that her voice alteration, which she stated is not related to vns stimulation, has progressed since surgery to the point where she believes she has, at a minimum, partial vocal cord paralysis. The patient noted she also has severe pain when trying to speak. It was previously reported on (b)(6) 2015 that the patient experienced voice alteration and dyspnea following implant surgery on (b)(6) 2015. The patient went to the emergency room and received anti-inflammatories and albuterol. The issues resolved, and it is planned to turn on the vns on (b)(6) 2015. The patient later reported that she still has not yet gotten her voice back and since receiving vns she has been experiencing nausea while eating and it feels like there is "air in her chest". Good faith attempts for further information were unsuccessful.
 
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the suspect device udi on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5242672
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dennis100
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« Reply #212 on: April 07, 2019, 04:08:46 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had pain in their left ear all the time, but pain felt stronger during vns stimulation. It was reported that there was a lot of earwax removed, no inflammation, and that the pain is relieved when the patient lays down with a pillow against their ear. It was also reported that the patient experienced dyspnea and pain in left cheek and teeth. The physician decreased the patient's vns settings to prevent chronic nerve pain in the left cheek and teeth area. The patient's diagnostics were reportedly within normal limits. It was additionally reported that the pain occurred only during stimulation and became less severe. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424598
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dennis100
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« Reply #213 on: April 15, 2019, 01:44:29 AM »

Model Number 304-20
Event Date 02/29/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was experiencing voice alteration and dyspnea described as "almost asthma-like symptoms. " the patient's treating neurologist referred the patient to an ent physician for evaluation. The ent physician showed that the patient had left vocal cord paralysis. Previously, the patient's vns system had been disabled for 2 months for an evaluation period leading up to the ent appointment. The voice alteration and dyspnea continued in this trail period. Furthermore, it was clarified that the voice alteration began soon after surgery. The patient's treating physicians determined that the vocal cord paralysis and associated voice alteration and dyspnea were related to the patient's vns implant surgery. The patient was stated at that time to be planning to undergo speech therapy to mitigate the effects of the vocal cord paralysis. The patient's device was re-enabled. Device diagnostics were reported to be within normal limits from surgery through the date of this report. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5980975
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dennis100
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« Reply #214 on: May 10, 2019, 02:30:51 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/27/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing constant stimulation, pain, and coughing "all the time". The patient was said to be going to the er. Clinic notes and a referral form were received reporting that the patient was referred for surgery due to constant stimulation causing pain, coughing, and shortness of breath. The device was disabled on (b)(6) 2019 for the adverse events. The patient underwent replacement surgery. It was noted pre-operatively that the device was already disabled upon interrogation at surgery. No pre-operative diagnostics were performed. During the surgery, the surgeon looked at the device being explanted and stated seeing some dot marks. At the patient's follow up appointment, it was clarified that the patient's pain, which was in the neck area, had resolved after the device was disabled. Prior to disablement, the patient felt like the pain was constantly going off. No device was returned to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8510188
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dennis100
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« Reply #215 on: May 11, 2019, 03:52:58 AM »

Model Number 303-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2019
Event Type  Injury   
Event Description
After device implant the patient reported hoarseness and shortness of breath. An ent specialist diagnosed the patient with vocal cord paralysis. The patient's treating physician indicated that the events were related to vns surgery. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8514461
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dennis100
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« Reply #216 on: May 11, 2019, 03:53:35 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2014
Event Type  Injury   
Event Description
The patient was referred for vns generator replacement to move their generator back to their left side. The patient had most recently been implanted on the right side, which caused pain in neck when making settings adjustments, wheezing / shortness of breath, and less efficacy than the left side due to the inability to titrate the generator to therapeutic settings. It was reported that the adverse events experienced by the patient were due to the vns stimulation when settings were increased and that the adverse events did not occur previously when the generator was implanted on the left side. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8527189
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dennis100
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« Reply #217 on: May 11, 2019, 03:54:14 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a neurologist reported that he visibly could see and feel stimulation on a patient¿s neck. The neck was seen to be vibrating. Diagnostics were ok. The neck would vibrate a couple times during the day, and did not occur with every stimulation. The patient had noted it to be annoying and uncomfortable. The physician was not sure if it was muscle spasms. Additional information was received that the patient had an allergic reaction to a medication in december and was intubated for four days. Since that time she has had painful stimulation that is palpable through the skin of her neck. She also reports shortness of breath. She indicated that the settings were re-adjusted 8 weeks ago, but she is continuing to experience uncomfortable stimulations, stimulations that are palpable through the skin, shortness of breath, and palpitations. Clinic notes were received that the is referred for lead replacement. Notes state patient is still having 30 or more painful stimulations a day and they have discussed replacing leads. Notes state that they need to check the lead as it hasn¿t been the same since she was intubated. Regarding shortness of breath notes state doing well currently. Regarding dysphagia notes indicated stable related to vns and post intubation, discussed with her local ent and will refer for lead replacement. Complains of hoarseness due to vns. Cardiology notes state the patient denies chest pain, shortness of breath and palpitations. Notes again mention the palpable muscle spasm over the left anterior neck during stimulation. Surgery referral for the lead revision is to diagnose and or rule out vns as the cause. While surgery is likely it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552815
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dennis100
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« Reply #218 on: May 20, 2019, 10:03:18 PM »

Model Number 106
Device Problem Energy Output To Patient Tissue Incorrect
Event Date 04/11/2017
Event Type  Malfunction   
Event Description
It was originally reported by the physician's office that they had performed a vns adjustment and received the message "programmed current not being delivered". The nurse stated diagnostics were not performed, but she did note that no high impedance message was observed. It was later reported the patient began to experience tachypnea and labored breathing after the office visit. It was first occurring every 5 minutes and then it was occurring every 20 minutes, so they were unable to tell if is was occurring with vns stimulation. The device history record for the lead and the generator were reviewed and it was found both devices had passed all testing prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported by the nurse that the patient did not begin to experience the labored breathing until the settings were changed to an output current of 2ma. It was also explained through the conversation that the patient had been programmed to just 0. 125ma back in february and was programmed from 1ma to 1. 5ma just 2 weeks prior to being bumped up to 2ma. It was explained to the nurse that when programming the patient up by a half step as opposed to just a quarter step, they will received a "warning" message stating so, but that it does not indicate there is anything wrong with the device. It was also explained that since the patient is new to vns, the fast titration may be the cause of the labored breathing and they could try going back down in settings a little and giving the patient a couple extra weeks to acclimate to settings. It was explained by the nurse that a different physician had recommended the same thing. The nurse stated she would provide this feed back to the physician. No additional relevant information has been received to date.
 
Event Description
The physician sent a fax stating that the patient's labored breathing and the shortness of breath were both related to vns. The neurologist opted to lower the patient's output current in an attempt to resolve the symptoms and the patient was able to tolerate the new settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6553128
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dennis100
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« Reply #219 on: May 30, 2019, 06:28:22 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/21/2017
Event Type  Injury   
Event Description
It was reported that the patient was experiencing difficulty breathing which the patient attributed to her vns device. The patient felt that the vns stimulation was suffocating her. Chest x-rays were reviewed by the physician who did not observe any anomalies. The physician decided to refer the patient for a vns generator replacement due to the breathing difficulties and the length of the implant. No additional relevant information has been received to date. No surgical interventions are known to have occurred to date.
 
Event Description
Further information was received from the physician which clarified that the surgery was not occurring due to the shortness of breath. However it was reported that the patient believed her shortness of breath was due to the vns.
 
Event Description
It was reported that the generator was replaced prophylactically and the generator was discarded following surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6607524
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dennis100
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« Reply #220 on: June 08, 2019, 07:16:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that since the patient's battery replacement surgery, she was experiencing neck pain. It was stated that right before her battery change due to battery depletion, she had a large seizure where after she felt a "pull in her neck". Since then, there had been a "lump" in her neck and pain with stimulation. She was going to obtain x-rays. There was no reported impedance issue. The patient stated that the vns helped her for years and that she would prefer to keep the device controlling her seizures rather than having it turned off for the pain. The physician did not know the cause of the lump and believed that an exploratory surgery or revision may be needed to know. It was clarified that this surgery would be for patient comfort, and not to preclude a serious injury per the physician's assessment. Diagnostics were indicated to have been within normal limits with ok battery life. X-rays were received for review. The connector pin was seen coming through the second connector block, indicating complete pin insertion. Based on the images provided, the cause of the painful stimulation could not be determined. Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images. Clinic notes were later received. It was stated in the notes that the patient experienced painful stimulation, mainly in her neck, but associated with dysphagia, hoarseness, chest pain, and shortness of breath. The events are non-radiating and only occur with vns stimulation. The pain became so significant that the "voltage" (likely referring to output current) had to be decreased, with increased dosages of seizures meds and pain meds. It was stated that since decreasing settings and increasing meds, the patient stated that she was still getting 2-3 grand mal seizures per week. Further updates were received and the patient reported that she was "now having 2-3 seizures per day" and has very painful stimulation for which she is on medication for. Output current and duty cycle were lowered for the pain. The vns surgeon and breast surgeon agreed to wait to schedule vns surgery until after the patient's mastectomy. No known vns surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8621049
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dennis100
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« Reply #221 on: June 09, 2019, 02:13:10 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was that the patient was experiencing palpitations, intermittent coughing, dysphagia and perceiving erratic stimulation from her vns generator. The patient was evaluated by the physician who lowered the vns magnet mode output current. Diagnostic testing was performed and resulted within normal limits. X-rays and an ecg were performed however no lead issues were observed by the physician and radiologist. The x-ray images have not been reviewed by the manufacturer to date. Over the following weeks, the patient developed a cough and shortness of breath. Then the following month, the patient presented to the emergency room with sepsis that had developed from community acquired pneumonia. The patient was admitted to the hospital and it was noted that the patient was experiencing tachycardia. The physician was unsure what caused the reported symptoms but noted that it could have been related to the patient developing pneumonia. Additionally, the physician suspected that the tachycardia may have contributed to the patient perceiving erratic vns stimulation. If the patient continued to be symptomatic, the physician was going to consider reducing the programmed output. No additional relevant information has been received to date.
 
Event Description
The physician reported that the vns output current was reduced following the tachycardia event. The tachycardia then resolved on its own.
 
Event Description
The patient underwent vns generator replacement surgery due to battery depletion. Attempts at product return revealed that the facility, historically, does not return explanted products.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6446802
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dennis100
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« Reply #222 on: June 23, 2019, 04:21:30 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that after a recent generator replacement surgery the patient now has a depressed cough reflex and an increased heart rate of about 30 bpm higher. The patient's device was checked according to the nurse and appears to be working properly. The patient's neurologist increased her settings in response to the issues. Also, after the replacement surgery the patient was hospitalized with pneumonia. No additional or relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The neurologist indicated the relationship of the depressed cough reflex to vns is unknown, and that she was unable to assess the patient's arrhythmia and pneumonia. It was noted that the patient's heart rate increased preoperatively and returned to a normal value postoperatively. Also, information was received from the patient's neurologist that the patient was hospitalized with fever, constipation, urinary retention, hypoxia, gastric paresis, and dyspnea. Follow up was performed with the neurologist regarding these events. The neurologist stated the cause of these events was unknown as the patient was hospitalized at a separate facility, and she was unable to assess the patient directly. The neurologist was informed the patient had recovered completely and was discharged from the hospital. No additional or relevant information has been received to date.
 
Manufacturer Narrative
Describe event; corrected data; supplemental mdr #1 inadvertently omitted information that was known prior to submission.
 
Event Description
The pneumonia reported on supplemental report #1 occurred before the replacement surgery and it was also noted in this report that the patient's heart rate increased pre-operatively. Since these events occurred before the replacement surgery, they will be reported on report number 1644487-2018-00290.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7171999
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dennis100
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« Reply #223 on: July 06, 2019, 12:09:41 AM »

Model Number 303-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing a sensation of dyspnea while speaking and hoarseness. When seen by otolaryngology, it was noted that the patient has left vocal paresis and had an injection in the vocal fold. It was stated that the patient has had previous neck trauma and had to be trached after an accident due to a seizure, prior to vns placement. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8732750
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dennis100
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« Reply #224 on: July 06, 2019, 12:10:43 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/15/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had dyspnea and voice alteration since implant; however, it got much worse after the patient was intubated november/december 2018. Reportedly, the er had trouble intubating him. He saw his physician to address this issue of worsened dyspnea/voice alteration with the vns after the intubation. The patient reported that he used to be very active but that he now got short of breath when walking a short distance. When he saw his physician, he walked down the hall and it caused him to wheeze badly. His voice was also much more affected than normal by the vns. This had began to occur after the intubation while he was still being titrated. The patient reported that he had seen an ent in (b)(6) 2019 who had told him one of his vocal cords was paralyzed and was "out of place. " the vns was disabled and when the patient walked down the hall, he had wheezing, but it wasn't nearly as bad as when the vns was on. The vns was turned back on at the request of the patient because the patient would rather deal with the shortness of breath and voice alteration rather than seizures. Diagnostics were within normal limits. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8679939
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dennis100
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« Reply #225 on: July 06, 2019, 12:11:36 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/09/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient was having shortness of breath, ¿wrong roads to liquids at the passage¿, issues swallowing, and difficulty coughing up phlegm in their throat. These events occur with stimulation. The physician lowered the settings and was planning to disable the device. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8668192
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« Reply #226 on: July 14, 2019, 04:50:56 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes were received from a visit dated (b)(6) 2018 providing the patient will have a pocket revision due to pain as an x-ray showed the generator has migrated. The patient explains the pain began in (b)(6). It was also noted the patient feels shortness of breath and numbness into her left shoulder and arm. Impedance on (b)(6) 2018 showed impedance within normal limits. Follow-up from the provider indicated the patient states the vns had moved after being placed. Generator replacement surgery. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7747257
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