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Author Topic: Anemic/Cyanotic  (Read 3282 times)
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dennis100
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« Reply #30 on: April 14, 2018, 01:23:02 AM »

Model Number 103
Event Date 11/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was recently implanted and recently had his device turned on to 0. 25 ma output current and 0. 5 magnet output current. Per the pt, when he swiped his magnet, he turned blue and passed out. At the time of the report, the physician had not seen the pt since the episode and had no further information regarding the event. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558272
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dennis100
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« Reply #31 on: May 01, 2018, 01:11:56 AM »

Model Number 102
Event Date 06/04/2008
Event Type  Injury   
Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469
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dennis100
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« Reply #32 on: May 03, 2018, 01:48:47 AM »

Model Number 103
Event Date 08/01/2011
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 that the patient has an oxygen monitor shows oxygen levels drop several times a day which may lead to the patient turning blue. The patient¿s jerks are not necessarily associated with these episodes. The patient had a reduction in the tonic episodes and the oxygen drops at the last visit, but he has had a significant increase in (b)(6) 2011. The seizures range from 673-1477. There was noted to be no obvious etiology for the increase in seizures since the recent ear infection for which he was given a medication for ear infections. On (b)(6) 2013, the patient¿s seizures (myoclonic and tonic episodes and staring) were noted to range from 362 and 916. ¿he has been very agitated for about two weeks. ¿ the patient¿s medication appeared to be helping the patient except the previous month, per the caregiver. On (b)(6) 2013, he had been on a medication for ear infections for 10 days. On (b)(6) 2013, the physician noted that given the number medications and doses, no medication dosing changes were made. The physician¿s impression in the notes showed that it is unclear whether the seizures are primarily generalized tonic episodes or secondarily generalized seizures. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. He reported that he does not believe the increased seizures were related to vns in 2011 or potentially 2013. He was unable to say if it occurred in 2013, but the patient's seizures have never been under good control. He actually believes the patient has a very bad seizure disorder, and the reason the seizure are "34;out of control"; is due to bad respiratory compromise. "in other words, he has tracheostomy and bad lungs, and he has a lot of times when his oxygenation goes down. A lot of his seizures are related to that rather than other else. " the physician has been trying to get the patient monitored to correlate the relationship of the seizures and desaturation, but the monitoring has not occurred to date. He believes the patient's seizures are mostly caused by the desaturation. The relationship between the desaturation and sleep apnea to vns is unknown because he needs to be monitored via sleep study to see if saturation improves when the vns is turned off. The onset of the sleep apnea/desaturation is unknown. Diagnostics on vns were okay as far as the physician knows. He reported that the caregiver reported they want the vns replaced so the physician agreed. The patient has not exhibited any other symptoms that may be related to vns. He did not know the relationship of the increased seizures to pre-vns seizure frequency. This report captures the patient¿s increased seizures since the relationship of sleep apnea/desaturation to vns is unknown to date. Manufacturer report number 1644487-2013-02099-2013-02100 captures the desaturation and sleep apnea. The patient had generator replacement in 2009. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3224901
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dennis100
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« Reply #33 on: May 29, 2018, 02:52:37 AM »

Model Number 103
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient has been hospitalized recently for various issues including seizures, coma, and pneumonia. Patient also experienced trauma when the paramedics had dropped patient on the floor. It was also reported that the patient had some issues with his vns. Additional information was received that the patient experienced seizure after seizures and later woke up to find himself at the hospital with a ventilation tube. Patient experienced pneumonia from the ventilator. When the ventilator tubes were taken out, it caused his throat to be sore and very sensitive. Patient¿s face was reported to turn purple with stimulation which was reported to have resolved on its own. Patient also experienced increased heart rate with stimulation following this incident. It is unknown if this event started recently after the hospitalization or if it was present before. Patient was recommended to visit the neurologist regarding this. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient was having issues with throat closing and tachycardic episodes with stimulation (hr 130) with some recent change in settings on an unknown date. The patient's generator interrogated and found to be with settings of 1. 75/30/500/30/3. 0. The patient's frequency was lowered to 20 hz, which appeared to resolve the issue and the stimulation was still tolerable. At that time the physician was going to monitor the patient to ensure there were no other issues. The impedance was also confirmed to be 3115 ohms with no other issues with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698228
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dennis100
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« Reply #34 on: June 06, 2018, 01:57:58 AM »

Model Number 102
Event Date 02/13/2008
Event Type  Malfunction   
Event Description
It was reported to manufacturer that after the vns patient's device was interrogated at a routine office visit, the device output current was found to be a 2. 25ma, where the patient had previously been set to 0. 75ma. As a result of the high output current, the patient "grabbed her neck and was turning blue". The patient's device was interrogated using a different programming system and the settings were changed to the intentional settings. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful 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=1017637
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dennis100
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« Reply #35 on: July 06, 2018, 10:31:08 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative
Patient problem :1815.
 
Event Description
It was reported that a patient was just implanted with a m1000 device and the device was turned on to the lowest settings. It was stated that the patient was holding his breath and turning blue and aspirating and having a difficult time swallowing. The patient is non-verbal. The patient is also drooling more and choking on his spit. The np advised to go to the emergency room. They instructed the patient to turn device off by placing the magnet over it. The patient's diagnostics were good. The patient is tolerating current settings. It was stated that the believed cause of the issue was possible side effects due to being high risk patient. The patient's settings are going to be increased and the np will monitor the patient's progress. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569735
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dennis100
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« Reply #36 on: September 19, 2018, 01:40:24 PM »

Model Number 102
Event Date 12/11/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2011 for seizures. Patient's mother states she is having one seizure after another and is sometimes cyanotic during that time. She states she is in the icu and her doctors don't seem to know anything about her vns. It is unknown if the patient is currently seeing a neurologist or who it is, so no further information can be obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2429803
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dennis100
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« Reply #37 on: October 06, 2018, 06:28:31 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was having painful stimulation after surgery. It was also reported that the patient was turning purple and coughing with every stimulation like they were choking. The physician subsequently turned the output and magnet currents down as well as turn the off time down from 0. 8 minutes to 3. 0 minutes. Information was received from the physician's office the doctor thinks the patient's settings were too high. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7899101
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dennis100
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« Reply #38 on: October 11, 2018, 06:58:24 AM »

Model Number 102R
Event Date 05/01/2012
Event Type  Injury   
Event Description
Analysis of the generator has been completed. The generator performed to specifications and no anomalies were found.
 
Event Description
It was reported on (b)(6) 2012, that a vns patient would be referred for generator revision surgery as the patient is at high settings, rapid cycling, and the patient' s family wanted to have it replaced prior to a trip they were taking in (b)(6). On (b)(6) 2012, clinic notes were received dated (b)(6) 2012 where it stated that the patient was diagnosed with complex partial seizures. The last seizure occurred on (b)(6) 2012 and was said to be less than 1 minute in duration. The patient's parents stated that the seizure have increased in frequency and duration over the last few weeks despite the patient being compliant with medications. The patient will intermittently appear blue or cold. The device was found to be set to 2. 5/20/250/21/1. 1/2. 75/250/60. The patient's dosage of sabril was increased from 2 tablets to 3 tablets and the patient was referred for generator revision surgery. Good faith attempts to obtain additional information have been unsuccessful to date however it is known that the patient is scheduled for generator revision surgery later next month ((b)(6) 2012).
 
Manufacturer Narrative
 
Event Description
Additional information was received indicating the patient's generator had been replaced. The explanted generator was returned and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2619580
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dennis100
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« Reply #39 on: October 19, 2018, 11:50:46 AM »

Model Number 102R
Event Date 08/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for review prior to a patient going for a prophylactic generator replacement. Clinic notes dated (b)(6) 2012 were received. Reported was that she has unknown seizure frequency, but overall her parents think that they get the sense that her seizures are unchanged or possibly worsened since she was last seen in the clinic. She had increased output on the vns when she was last seen (b)(6) two weeks ago, she had some event reported to the family from the nursing home staff, which were concerning for apneic spells. Were told by the nursing home staff that she suddenly appeared to be "out of it"; and would slump over as if she were unresponsive or asleep. At the time she appeared to be turning bluish, and this resolved. She seemed to arouse when she was laid down flat. It was felt that these were not likely epileptiform events. She has a history of apneic spells in the past and does have obstructive sleep apnea per her parents reports. These event have not recurred since that time and she otherwise has been stable. The patient's vimpat was increased and her parents feel like her seizures may be worsening on this. Good faith attempts have been made and thus far no further information has been attained.
 
Event Description
Product analysis was completed on the explanted generator. 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. No further information has been received in regards to the patient's reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2745363
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dennis100
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« Reply #40 on: January 04, 2019, 11:37:30 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced stridor and cyanosis while using their vns therapy magnet during a 56 minute long episode of continuous seizure activity. After the use of the magnet the patient continued to turn blue every five minutes for the duration of the seizure activity. A second magnet swipe during the seizure also produced temporary cyanosis. It was reported that while the patient typically had stridor/shortness of breath during seizures prior to vns implantation, that the stridor was more noticeable during the magnet swipes. Prior to and following this event, there were no other instances of cyanosis occurring with seizures. The patient had previously encountered minor stridor and shortness of breath events with magnet use during seizures but without complication. The physician decreased the patient's programmed generator settings. It was additionally reported by the patient's caregiver that when the magnet was placed over the device, to inhibit stimulation, the patient's symptoms seemed to resolve. It was reported that the patient's continuous seizure activity was not related to vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175737
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dennis100
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« Reply #41 on: February 11, 2019, 02:44:07 AM »

Model Number 103
Event Date 01/06/2015
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.
 
Event Description
It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4483657
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dennis100
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« Reply #42 on: April 06, 2019, 02:47:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064
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