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Author Topic: Magnet  (Read 60246 times)
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dennis100
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« Reply #510 on: February 09, 2019, 01:40:04 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
Information was received that the patient's device was spontaneously going into magnet mode whether the device was enabled or disabled the patient was reported have painful stimulation and tightness at the generator site. It was also reported that the device was cycling every seven seconds despite parameter changes. Diagnostics from the physician was reported to be fine. Information was later received that the patient's generator was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8265182
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dennis100
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« Reply #511 on: February 11, 2019, 01:52:52 AM »

Model Number 103
Event Date 07/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient presented an increased number of seizures for the past six months. Aed were added for treatment. Vns parameters were increased. There were no changes to medication or vns settings or other external factors that preceded the onset of the increase in seizures. The generator battery appeared to be nearing end of service which was believed to be the cause of the patient¿s increase in seizures. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. The patient¿s device was tested and system diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4472980
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dennis100
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« Reply #512 on: February 11, 2019, 01:53:33 AM »

Model Number 102
Event Date 01/05/2015
Event Type  Injury   
Event Description
It was reported that the vns patient had six seizures in one week in 25 minutes and that the magnet was not aborting the seizures. The patient was subsequently admitted to the hospital. The patient was reported to have a uti and a high intake in soda which may have triggered the seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2007. A battery life calculation using the available programming history showed approximately 2. 6 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4485095
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dennis100
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« Reply #513 on: February 12, 2019, 03:07:37 AM »

Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2014
Event Type  Injury   
Event Description
It was reported that the vns patient felt her generator moving and flipping in her chest which was causing burning sensations. The patient¿s device was tested and showed normal device function. The patient previously reported that her magnet was not aborting her seizures and that magnet mode stimulation was causing burning sensations in the chest. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was found from the surgeon's office who had originally implanted the generator in 2012 that the generator was secured with a non-absorbable silk suture during implantation.
 
Event Description
The patient's generator was explanted and replaced on (b)(6) 2015. The patient's device was discarded after explant and will therefore not be received for analysis.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent surgery to remove the generator from the chest pocket, and place it in the left shoulder. The patient experienced more discomfort following the repositioning of the generator. Additional surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535345
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dennis100
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« Reply #514 on: February 13, 2019, 01:31:24 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that patient's asthma attack was never a problem previously and the patient had a desat of 80. For intervention, the physician decreased the magnet and normal pulse width.
 
Manufacturer Narrative

Event Description
It was reported that the patient's mother indicated that the patient was taken to the hospital because he could not catch his breath and was coughing and wheezing. The hospital indicated that the patient was experiencing an asthma attack and would need to be placed on medication. The patient's mother reported that magnet mode stimulation was initiated during a seizure and the patient's asthma worsened and the patient could not catch his breath. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4517482
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dennis100
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« Reply #515 on: February 16, 2019, 02:06:25 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
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dennis100
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« Reply #516 on: February 17, 2019, 06:05:21 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
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dennis100
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« Reply #517 on: Today at 01:16:56 AM »

Model Number 102
Event Date 06/27/2010
Event Type  Injury   
Event Description
Information was received that a vns patient was admitted to hospital for bradycardia and syncope. It was reported that the patient has recently had many episodes of syncope. They also noticed the patient had pauses on the cardiac monitoring. These pauses are erratic, lasting about 3 sec and does not coincide with stimulation. They placed the magnet over the generator for 24 hours and during that time, they didn't see anymore cases of heart pauses. No vns setting changes were made prior to the onset of the events. The patient was set at 1. 25/30/250/21/0. 5 so, a 49% duty cycle. The patient was discharged from the hospital on (b) (6), and there were no further incidents of the heart pauses or syncope, and the event was not duplicated again on the cardiac monitoring equipment. The cardiologist recommended having the patient wear a holter monitor for 20 days to monitor cardiac activity, and will re-assess the patient at that time. The device remains programmed on and per the physician he tested the device following the onset of the events, and it is operating within normal limits. The cause of the syncope and the irregular heart pauses is unknown at this time. It was reported that the patient had a myocardial infarction (mi) in (b) (6) 2010, and at that time he was put on a beta blocker medication. It is unknown if stimulation may be a contributory factor to the recent events, but their treating physician should have more information after (b) (6). Good faith attempts to obtain additional details have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1775112
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