Pages: 1 ... 10 11 [12] 13 14   Go Down
Print
Author Topic: Misc. Cardiac  (Read 28992 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #330 on: November 05, 2018, 11:41:26 AM »

Model Number 102
Event Date 01/10/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The identity of the patient's current physician was confirmed. However no additional relevant information has been received to date in regards to the patient's congestive heart failure.
 
Event Description
The patient reported that she developed congestive heart failure while on vns therapy and that her physician believes that the vns is causing her heart issues. The patient had made a similar report in 2013 however her treating physician at the time denied that vns was causing the congestive heart failure. The previous physician has not seen the patient recently. The identity of the patient's current physician is unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6182955
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #331 on: November 09, 2018, 03:21:31 AM »

Model Number 102
Event Date 07/19/2011
Event Type  Injury   
Event Description
Clinic notes were received to the manufacturer from the reporter for a vns patient indicating the patient had heart trouble, but this was not specified other than the cardiac status is unchanged throughout the clinic notes. Manufacturer follow up with the reporter revealed the reporter declined to give any additional information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2428068
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #332 on: November 10, 2018, 04:39:12 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/14/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a physician that a patient was interrogated and found to be set to 0 milliamps for all output currents unexpectedly. The patient underwent an ekg about a week prior to visiting the doctor and it was stated that the ekg electrodes were placed over the device. The patient's parent reported an increase in seizure activity and the physician believes that a generator reset occurred. A review of the downloaded data was performed and it was identified that generator hardware resets had occurred on the device on (b)(6) 2017, (b)(6) 2017, (b)(6) 2018, (b)(6) 2018, and (b)(6) 2018 and the output current had been set to 0 milliamps. The cause for the reset could not be determined from review of the data. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939028
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #333 on: November 10, 2018, 04:39:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient is experiencing asystole when the magnet is activated for 15 seconds after the magnet swipe. The patient is reported to be diagnosed with aortic stenosis and rheumatic heart disease. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7980947
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #334 on: November 15, 2018, 08:59:16 AM »

Event Date 02/27/2013
Event Type  Injury   
Event Description
It was reported that the patient has a defibrillator implanted. It is unknown to date if the defibrillator is related to the vns or if it is a separate event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3026370
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #335 on: November 16, 2018, 08:44:07 AM »

Model Number 102
Event Date 02/11/2013
Event Type  Injury   
Event Description
It was initially reported that the patient felt that his heart rate was very slow. It is unknown if the slowed heart rated was related to vns. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001730
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #336 on: November 16, 2018, 08:44:40 AM »

Event Date 10/01/2009
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt was experiencing palpitations. The pt has been seizure free and had placed a magnet over her vns device for the past 1. 5 years. According to treating neurologist, the pt has long q-t interval but hasn't seen a cardiologist. The physician did not know if pt's cardiac symptoms have subsided since he just inherited the pt from another physician. Good faith attempts to obtain more info regarding pt's adverse event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039448
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #337 on: November 18, 2018, 09:26:51 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Injury   
Event Description
It was initially reported that patient had been having recent arrhythmia events. She had been having some atrial fibrillation, which was being treated with medication. Then the patient began having asystole events that last about 6 seconds and well as some bradycardia. The patient had an emergency pacemaker placed and then underwent surgery to have a pacemaker implanted. The relationship of the cardiac events to vns is unknown. Good faith attempt with both the neurologist and the cardiologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261210
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #338 on: November 27, 2018, 08:28:50 AM »

Model Number 102
Event Date 06/21/2011
Event Type  Injury   
Event Description
It was reported in clinic notes received on (b)(4) 2012 and dated (b)(4) 2011, where it was stated that the patient had cad (coronary artery disease). Additional clinic notes were received on (b)(4) 2012 and dated (b)(4) 2011 where it was stated that the patient had cad, cva (cerebral vascular accident - stroke) and cardiomyopathy. The generator was programmed to 2/30/130/60/3/2/250/60 and the patient was to follow up in six months. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when the physician reported that the patient did not have a history of stroke or cardiomyopathy prior to being implanted with vns however he did not indicate a relationship between these events and the patient's vns device. Diagnostic results were provided which indicated normal device function however the date the diagnostics were performed was not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2515621
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #339 on: November 29, 2018, 03:21:32 AM »

Model Number 302-30
Event Date 05/05/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.

Event Description
Neurology reported that they had a vns pt that could not longer feel stimulation (magnet and normal mode) and had increased seizures, below pre-vns baseline. System diagnostics testing was performed and yielded 7 / limit / high. The pt's vns programming physician wanted to disable the device related to their high lead impedance but pt did not want him to. The pt has been referred to their surgeon for revision surgery. At this time no surgical date has been set as pt is status post cardiac stent placement and on plavix. The pt did not recall having any trauma to the site prior to their high impedance being attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1720407
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #340 on: November 29, 2018, 03:22:14 AM »

Model Number 102
Event Date 11/13/2012
Event Type  Injury   
Event Description
On (b)(4) 2013 clinic notes were received dated (b)(6) 2012 which indicated that the patient has a history of open heart surgery. No further information was provided as to why the patient had open heart surgery and the relationship to vns. During this clinical visit the patient denied any chest pain, chest tightness, or chest pressure. The clinic notes indicate that the vns output was set at 2. 5 ma and the magnet output was set to 2. 75 ma. Good faith attempts for further information from the physician have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167280
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #341 on: November 29, 2018, 03:23:56 AM »

Model Number 102
Event Date 01/20/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 information was received by the reporter at a physician office visit that the patient had his device disabled in (b)(6) 2012 due to pain he was experiencing. Attempts for additional information are still in continuation.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2013 information was received from the reporter that the patient¿s pain had first been observed on (b)(6) 2012 and was categorized as pain and shortness of breath. It was determined that the pain occurred whenever stimulation occurred or whenever the magnet was swiped. It was also noted that the patient had a cardiac stent implanted several days prior to the onset of pain. No further interventions have been taken or are planned since the device was disabled. No causal or contributory programming or medication changes preceded the onset of the pain. A manufacturer's review of the programming history database showed that programming history data is available from (b)(6) 2006 (date of implant) to (b)(6) 2009. Follow-up also provides data from (b)(6) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167203
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #342 on: November 29, 2018, 03:24:37 AM »

Model Number 102
Event Date 09/05/2007
Event Type  Malfunction   
Event Description
Reporter indicated the patient has experienced "life changing side effects" from the vns therapy system. The "patient reports a number of non-specific complaints including not feeling well, blood pressure fluctuation, intermittent chest pain, having been in the hospital on several occasions, including receiving a coronary stent. The patient also states the device has not helped his seizure disorder. " the patient elected to have the vns therapy system explanted. Good faith attempts are being made to obtain additional information, but have been unsuccessful to date.

Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=959423
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #343 on: November 30, 2018, 12:23:17 PM »

Model Number 102
Event Type  Injury   
Event Description
Good faith attempts for additional information were made and have been unsuccessful to date.

Manufacturer Narrative

Event Description
It was noted from clinic notes received in regards to a vns patient that they were positive for: irregular heartbeat, tachycardia. The relationship to their vns is unknown. Good faith attempts are underway for further details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3144910
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #344 on: December 02, 2018, 02:11:22 AM »

Model Number 106
Event Date 04/26/2016
Event Type  Injury   
Event Description
It was reported that a vns patient was implanted on (b)(6) 2016 and there were no issues during the implantation; however, while running a system diagnostics (1ma output current, 500c pulse width and 20hz signal frequency), the patient developed an irregular heart rhythm that went into a bundle branch block. This spontaneously resolved within a few minutes. After a while, a second system diagnostics test was performed (while the patient was still under anesthetic) and the same event occurred. Once this was resolved, they programmed the normal mode to 0. 25ma output current, 30hz signal frequency, 250 sec pulse width, 30sec on time and 5min off time. Then an output current of 0. 5ma went fine as well. An output current of 0. 75ma caused a slight arrhythmia which was resolved. At 1ma output current, the patient had the same reaction of an irregular arrhythmia followed by a bundle branch block, which spontaneously resolved. It was reported that the patient has no cardiac history, and the cardiac exam before surgery (in pre-operative assessment) was normal. Vns has been left switched off. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Further information from the nurse indicated that the patient's device has been switched on and turned up to 1. 25ma output current with no repetition of the previous events, on (b)(6) 2016. The patient is currently under cardiac investigation and vns was switched off again. It was reported that the patient was hemodynamically stable during the arrhythmia. An ecg was performed and reviewed by a cardiologist who noted the transient 2:1 av block. His baseline heart rate was 60 - 70bpm. Following stimulation there was a transient 2:1 block followed by a sinus tachycardia with left bundle branch block (hr 95). At no time did the patient go into atrial fibrillation. This lasted 5-10min with no hemodynamic compromise. He reverted back to a normal qrs complex; when the stimulation was tested again there was a transient bradycardia and then he became more tachycardic (hr 90) then sinus rhythm again with a bundle-branch block. This settled again after 5 minutes. It was reported that at emergence the nurse reversed residual neuromuscular blockade with neostigmine and glycopyrrolate which put his heart rate up to 110 bpm (side-effect of the glycopyrrolate) and he moved from a narrow complex to a bundle branch block. The patient was reviewed in recovery by a consultant cardiologist who feels there are 2 things going on here: firstly, he has rate-related bundle branch block with appears to occur above a heart rate of 80. In recovery it was very apparent to see when his heart rate dropped below 80 his qrs complexes were normal. When it rose above 80 he had a broad-complex. Secondly, on the periods immediately following stimulation, he appears to go into a very short-lived (5 seconds or so) 2:1 av block. It was reported that the anesthetics used and their dosage are: induction (intravenous propofol (200mg), fentanyl (200mcg) and atracurium (45mg)); maintenance (inhalational desflurane (end-tidal desflurane 6. 2), incremental fentanyl for analgesia (50mcgs total), intravenous paracetamol (1g)). No further information was provided to date.

Event Description
Further information was received from the nurse indicating that the patient spent 10 days in the hospital undergoing tests by the cardiologist. According to the nurse, the patient indicated to her that his results were normal but the cardiologist suggested to not switch vns on. It was reported that the nurse has finally performed another diagnostic test (which set off the arrhythmia in theatre) and nothing happened. She decided to switch the device on and increased the output current to 1. 25ma, and still no arrhythmia or av block as the day before.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5659529
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #345 on: December 05, 2018, 01:39:35 AM »

Model Number 103
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 noted that the patient has a past surgical history of cardiac surgery. It is unknown if the cardiac surgery occurred prior to vns therapy or the relationship to vns therapy. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3301479
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #346 on: December 06, 2018, 01:47:05 AM »

Model Number 102
Event Date 03/11/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's current treating physician indicated that there is no concern about the vns system.

Event Description
Clinic notes dated (b)(6) 2103 indicated that this patient¿s device was disabled in 2011 because it was felt that it was making her heart rate drop. It was turned on except for the fact that she was able to swipe the magnet whenever she felt a seizure coming on. The patient was not receiving a continuous daily stimulation. When the vns and medication were discontinued, the patient did well. Review of programming history showed that the device was disabled on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3262884
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #347 on: December 07, 2018, 11:42:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/14/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient has a left bundle branch block, enlarged left ventricle, and the vns device was switched off. The physician was inquiring into if there has been long term cardiac problems from prolonged stimulation. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8061848
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #348 on: December 08, 2018, 02:52:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/10/2018
Event Type  Injury   
Event Description
The physician's assistant (pa) reported that the patient presented with left neck pain so pain injections were attempted, which did not resolve the issue. The patient was then sent for x-rays. Per the x-rays the pa believes the generator migrated due to potential chest compressions at an er visit and the er visit was unrelated to vns. It is not "know" when the patient was in the er. The pa believed the migration caused the neck pain due to the lead tightening. The patient was referred for surgery to suture the generator higher. The pa stated the diagnostics were normal. X-ray images were assessed by the manufacturer as well. Based on the images provided, the generator was placed normally in the left chest. Due to the poor quality of the image, nothing further could be assessed concerning the generator. The lead was observed in the patient¿s neck and appeared to be routed toward the patient¿s left chest. Due to the poor quality of the image, nothing further could be assessed concerning the lead. Based on the images provided, there is no obvious cause for the reported pain and generator migration. Additional information from the pa reported that the surgery will be for patient comfort and to preclude serious injury. The settings were initially turned off after the pain to see if there would be a reduction in pain, which there was not. The settings were later turned back on to lower settings. The physician later decided to replace the generator because it was already 2 years old instead of just performing a revision. No additional relevant information has been received to date.

Manufacturer Narrative
"device evaluated by manufacturer": device evaluation is not necessary as the reported events are not related to device functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8034826
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #349 on: December 16, 2018, 05:08:55 AM »

Model Number 102
Event Date 09/01/2013
Event Type  Injury   
Manufacturer Narrative
Corrected data: supplemental report #1 did not indicate that attempts for return of the explanted generator were unsuccessful. The information has been included in this report.

Event Description
Clinic notes dated (b)(6) 2013 note that the patient's mother has noticed a decrease in heartrate into the low 60s and upper 50s. The notes indicate that the patient's heartrate is usually upper 60s and that it may be due to the vns. Clinic notes indicate that the device is near end of service. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Follow up with the physician found that the patient successfully underwent generator replacement on (b)(6) 2013 due to end of service. Since replacement, the patient is no longer vomiting and that all other issues previously mentioned have been resolved.

Event Description
Good faith attempts to for return of the patient's explanted generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3415683
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #350 on: December 17, 2018, 04:28:39 AM »

Model Number 103
Event Date 07/15/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient did not have a history of dyspnea or heart conditions prior to vns implantation and had no risk factors that made the patient more susceptible to these conditions. It was reported that there were medication changes or other factors that caused or contributed to the patient¿s event, but these changes or factors were not specified. The patient had no prior history of cardiac events and no reported family history of cardiac events. It was noted that the patient did not experience any of the following: bradycardia, tachycardia, and asystole.

Event Description
It was reported the patient stated that one morning when he was sleeping, he was unable to breathe and catch his breath. "it almost felt like a dream, but i know it wasn't a dream, it was very scary. " the patient mentioned that he was unsure if lowering his dose of topamax had anything to do with the event. His doctor lowered his dose of topamax, after he turned up the vns device. The patient also reported feeling a rapid heart beat when the device is activated. He then stated "i don't think i experience that now. " he received the vns therapy in (b)(6) 2013. He started using topamax approx. 1- 1 1/2 year ago. The patient is still receiving topamax and still has the vns device implanted. Attempts are underway for additional information. No other relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3408210
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #351 on: December 19, 2018, 01:26:53 PM »

Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently did not include that the patient wanted the device turned off.

Event Description
It was reported that apatient now has a pacemaker implanted. The patient can reportedly no longer use the vns magnet to stop stimulation or it "stops the pacemaker. " the patient planned on following up with her psychiatrists. It is unclear when the patient's arrhythmia first occurred, and the relationship to vns is unknown with the information provided. Attempts for additional information from the psychiatrist have been unsuccessful to date. A review of the patient's programming/diagnostic history was performed with the history available in the in-house database, however there were no diagnostics available.

Manufacturer Narrative

Event Description
The psychiatrist was wondering on (b)(6) 2012 if the patient's device could be disabled, as the patient desired for the device to be turned off. However, the device has not been turned off. It appears that the patient desires for the device to be disabled due to her programmed settings which have been low throughout the implant history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2552987
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #352 on: December 20, 2018, 02:15:45 AM »

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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #353 on: January 05, 2019, 04:06:28 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient's was having their generator replaced as the patient was having pain at his generator site that happens sporadically, lasts for 5 seconds, and makes the patient "feel funny" for about 15 seconds afterwards. Clinic notes were received and stated that "vns device is zapping patient". It was noted that the patient would feel his heart fluctuate up and down after. It was noted that the last diagnostics indicated that the device was functioning as intended. No known replacement surgery has occurred to date. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8123336
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #354 on: January 05, 2019, 04:07:06 AM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #355 on: January 10, 2019, 02:20:32 AM »

Model Number 106
Event Date 01/07/2016
Event Type  Injury   
Event Description
It was reported that the patient has been sick since device was placed. The physician thought it was the medications and changed her medications. Patient stated that she was in the hospital for septic shock from (b)(6) and was in the hospital on (b)(6) 2016. Patient experiences shocking sensations despite holding the magnet over the device. The tape over the magnet is peeling her skin since she has had the magnet in place for 3 weeks and that when she changes the tape it peels her skin. Per the neurologist and primary care physician, patient has permanent ekg changes and electrical conductive problems w/ her heart that is related to the vns device. The patient had a chemical stress test and was in vtach. Patient was given medication to slow her heart rate. Patient would like tc to visit and turn off vns but tcs need physician's written consent to do so and patient has not yet seen their neurologist. Patient was seen by a different neurologist on (b)(6) 2016. Per the nurse at the office, the vns was not evaluated at that time and the device was believed to be off. Additional relevant information has not been received to date.
 
Event Description
The explanted generator was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Additional information was received that the patient underwent surgery to have vns generator removed on (b)(6) 2016. Per the surgeon, patient did not have a history of any heart issues or risk factors that makes them more susceptible to heart issues prior to vns implantation. The patient reported that the sepsis was not related to vns therapy. The explanted generator has not been received to date. No other relevant information was received.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
(b)(4).
 
Event Description
Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5975296
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #356 on: January 18, 2019, 03:47:54 AM »

Model Number 102
Event Date 08/03/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a pacemaker company's representative reported that the vns patient was going to implanted with a pacemaker because the patient has an arrhythmia. The representative did not know the relationship of the arrhythmia to vns. Clinic notes dated (b)(6) 2011 were received from the vns treating physician. The clinic notes revealed that the vns patient was being referred for prophylactic battery replacement. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet pulse width=250usec/magnet on time=60sec. The physician reported that four months ago, while she was in a pain clinic, the patient was found to have bradycardia. Since then, the patient has had multiple presyncopal and syncopal episodes characterized by diaphoresia, light headed and sometimes brief loss of consciousness. The patient was noted to have a prior medical history of mild sleep apnea. The patient is scheduled to have a pacemaker implanted the next week. On (b)(6) 2011, the manufacturer's consultant reported that the vns patient was having their vns battery replaced as well as having a pacemaker implanted that day. The reason for the pacemaker was the patient had a sic sinus syndrome. The battery was programmed to output =1. 75ma/signal frequency=20hz/pulse width=130usec/on time=30sec/off time=3min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's pacemaker was placed on the right side of the chest and was greater than 8 inches away from the vns generator. Good faith attempts for additional information from the patient's physician regarding the sleep apnea and arrhythmia have been to no avail thus far. Attempts for the return of the explanted generator will be made. When additional information is received, it will be reported.
 
Manufacturer Narrative

Event Description
On (b)(6), 2011 additional information was received when it was discovered that the patient's generator had been replaced on (b)(6), 2011 for prophylactic reasons. The lead impedance was ok after surgery. Good faith attempts were made for the return of the explanted generator but the hospital discarded it. If additional information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2224215
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #357 on: January 21, 2019, 12:47:29 PM »

Model Number 103
Event Date 05/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient suffered asystole. The physician reported that the patient was diagnosed with takotsubo syndrome which caused the patient to suffer asystole in early may. The relationship of the asystole and vns is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942289
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #358 on: January 22, 2019, 06:26:15 AM »

Med Hypotheses. 2009 Nov;73(5):725-7. doi: 10.1016/j.mehy.2009.04.036. Epub 2009 May 29.

Vagus nerve stimulation may be used in the therapy of myocarditis.

Li H1, Yang TD.

Author information

Abstract
Although a large number of different causes have been identified as leading to myocarditis, inflammation plays a pivotal role in its pathological process. No specific methods are available in the therapy of myocarditis except symptomatic treatment. Vagus nerve stimulation has been found to lower the heart rate and recover the normal heart rhythm which may relieve the cardiac symptoms in myocarditis. Furthermore, the acetylcholine that secreted by vagus nerve stimulation was found to inhibit the production of such inflammatory cytokines as tumor necrosis factor-alpha (TNF-alpha), interleukin 1beta (IL-1beta). Based on the above, we hypothesized that vagus nerve stimulation can be used in the therapy of myocarditis and lead to relief of symptoms and inhibition of inflammatory process which may kill two birds with one stone.

PMID: 19481875 DOI: 10.1016/j.mehy.2009.04.036

https://www.ncbi.nlm.nih.gov/pubmed/19481875
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #359 on: January 22, 2019, 06:28:53 AM »

J Interv Card Electrophysiol. 2013 Apr;36(3):199-208. doi: 10.1007/s10840-012-9752-8. Epub 2012 Nov 20.

Inhibition of atrial fibrillation by low-level vagus nerve stimulation: the role of the nitric oxide signaling pathway.

Stavrakis S1, Scherlag BJ, Fan Y, Liu Y, Mao J, Varma V, Lazzara R, Po SS.

Author information

Abstract

PURPOSE:
We examined the role of the phosphatidylinositol-3 kinase (PI3K)/nitric oxide (NO) signaling pathway in low-level vagus nerve stimulation (LLVNS)-mediated inhibition of atrial fibrillation (AF).

METHODS:
In 17 pentobarbital anesthetized dogs, bilateral thoracotomies allowed the attachment of electrode catheters to the superior and inferior pulmonary veins and atrial appendages. Rapid atrial pacing (RAP) was maintained for 6 h. Each hour, programmed stimulation was used to determine the window of vulnerability (WOV), a measure of AF inducibility, at all sites. During the last 3 h, RAP was overlapped with right LLVNS (50 % below that which slows the sinus rate). In group 1 (n = 7), LLVNS was the only intervention, whereas in groups 2 (n = 6) and 3 (n = 4), the NO synthase inhibitor N (G)-nitro-L-arginine methyl ester (L-NAME) and the PI3K inhibitor wortmannin, respectively, were injected in the right-sided ganglionated plexi (GP) during the last 3 h. The duration of acetylcholine-induced AF was determined at baseline and at 6 h. Voltage-sinus rate curves were constructed to assess GP function.

RESULTS:
LLVNS significantly decreased the acetylcholine-induced AF duration by 8.2 ± 0.9 min (p < 0.0001). Both L-NAME and wortmannin abrogated this effect. The cumulative WOV (the sum of the individual WOVs) decreased toward baseline with LLVNS (p < 0.0001). L-NAME and wortmannin blunted this effect during the fifth (L-NAME only, p < 0.05) and the sixth hour (L-NAME and wortmannin, p < 0.05). LLVNS suppressed the ability of GP stimulation to slow the sinus rate, whereas L-NAME and wortmannin abolished this effect.

CONCLUSION:
The anti-arrhythmic effects of LLVNS involve the PI3K/NO signaling pathway.

PMID: 23179922 DOI: 10.1007/s10840-012-9752-8

[Indexed for MEDLINE]

https://www.ncbi.nlm.nih.gov/pubmed/23179922
Logged
Pages: 1 ... 10 11 [12] 13 14   Go Up
Print
Jump to: