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Author Topic: Misc. Cardiac  (Read 12098 times)
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dennis100
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« 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
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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dennis100
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« 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
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« 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
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dennis100
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« 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
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dennis100
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« 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
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« 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
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