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Author Topic: Dizziness/Fainting  (Read 125046 times)
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dennis100
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« Reply #300 on: April 08, 2019, 03:26:40 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2017
Event Type  Injury   
Event Description
It was reported that the patient underwent a full revision surgery and developed hoarseness after the procedure. The patient was evaluated by an ent specialist and was diagnosed with vocal cord paralysis. The patient also experienced vertigo spells for which the normal output current and autostim output currents were disabled. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8381956
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dennis100
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« Reply #301 on: May 09, 2019, 07:48:24 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2016
Event Type  Injury   
Event Description
It was reported by the patient that he had been ¿going out¿ and that he wasn¿t sure if the vns was causing it. He said that he could also just be falling asleep, it could be a seizure or it could be his medication, but he was concerned that the vns and/or the vns and his pacemaker could be causing it. No further relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the following information was inadvertently not reported on the initial mdr "it was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. " event problem cds, corrected data: the patient codes were inadvertently not included in the initial mdr (b)(4).
 
Event Description
It was reported by the patient that he had been having problems with the vns. He said that it seemed to be going off randomly all the time and that when it went off it caused pain and voice alteration. He said that he would also get dizzy and he didn¿t know if that was related to the vns or seizure. The patient reported his device was being explanted because it wasn't working because he could now feel stimulation. The patient also indicated that he had a pacemaker for atrial fibrillation. The patient then called and said that his painful stimulation was definitely occurring more often than what he expected it to and that he wanted the company representative to come disable it. The patient then reported to the company representative that nobody had programmed off the device or interrogated it since the last, but that he had talked to his primary care physician and the painful stimulation had resolved. No further relevant information has been received to date. No related surgical intervention has occurred to date.
 
Event Description
It was reported by the physician's office that the patient did not have a good memory. It was also indicated that sometimes he "sometimes just needed to speak to someone to calm him down" after his call to the manufacturer was described. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503540
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dennis100
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« Reply #302 on: May 10, 2019, 02:33:34 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2018
Event Type  Injury   
Event Description
Clinical notes were received which reported that the patient is able to feel vns stimulation (i. E. ¿kick in from time to time), but the patient may still have small seizures and he may faint or pass out. The notes state the vns was interrogated during the vns visit and was found to show end-of-life of the battery. Information was received from the physician¿s nurse that the physician had no had no way to tell what the cause of the fainting was but that the patient appeared to have been doing better after his replacement although the reason for replacement was not due to the fainting. Regarding the relationship of the fainting to vns, the nurse did not directly answer that vns was to blame but appears herself to suspect that end of life was the cause of the patient's fainting. Although at the time when the fainting first began the device was not at end of service. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519789
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dennis100
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« Reply #303 on: May 11, 2019, 03:56:18 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's fiancé reported that the vns was turned up too high at the generator replacement surgery. It was noted that the patient's quality of life is not good, and at the "higher" output current the patient was feeling dizzy, nauseous, and "felt like having seizures", and she "felt like she is being overmedicated". Further follow up confirmed that the patient's generator output current was reduced as a result of the patient's symptoms, and that the patient's symptoms resolved after the parameter adjustment. The physician noted that the patient was feeling "poorly" due to pain and feeling like they were getting too strong of a stimulation. The physician reported that the patient experienced increased seizures due to being very stressed and very much in pain/discomfort, which stemmed from the vns output current being set too high. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8556724
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dennis100
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« Reply #304 on: May 27, 2019, 11:30:25 PM »

Model Number 102R
Device Problem Communication or Transmission Problem
Event Date 05/31/2017
Event Type  Injury   
Event Description
It was reported from the patient¿s full vns replacement surgery that, preoperatively, the patient had pain from a shocking sensation with device diagnostics and lost consciousness for about 30 seconds. The patient¿s behavior was described ¿as if he was having a seizure. ¿ the full diagnostic reading could not be collected due to the poor tolerability of the diagnostic test. It was later clarified that the patient¿s behavior during diagnostic test was that he was ¿incoherent for about 30 seconds¿ but soon recovered. The vns was not disabled prior to surgery. During dissection of the old leads, the patient experienced an episode of asystole while the nerve was being manipulated. The device was disabled at that time to remove it was a variable. The placement of the new leads and generator occurred without incident. The patient¿s explanted lead and generator were reported to have been discarded. Therefore, device return is not expected. Review of the programming history from the surgery showed that a faulted system diagnostic test occurred preoperatively that led to an unintended change of settings. These settings were not resolved until the generator was disabled. No additional pertinent information has been received to date.
 
Event Description
Follow up with the patient¿s surgeon showed that the preoperative ¿episode¿ experienced during the vns diagnostic test represented syncope with the patient being unresponsive for a few seconds. The surgeon knew of no other contributing factors besides vns stimulation. The patient was stated to have fully recovered without intervention and that the episode was assessed to not represent a serious injury. To date, not further pertinent information has been received regarding the intraoperative asystole.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6652801
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dennis100
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« Reply #305 on: June 08, 2019, 07:17:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2019
Event Type  Injury   
Event Description
It was reported that a patient was in the hospital due to a "syncope recurrence" and needed her device checked. Follow up with the company representative confirmed that the device was checked. It was stated that device diagnostics were fine. The patient's physician also monitors the device regularly and had a follow up appointment. It was stated that the syncope had been occurring for a few days and the patient's husband asked if the vns could cause a change in blood pressure. The nurses also asked if vns could be causing the syncope. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600514
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dennis100
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« Reply #306 on: June 14, 2019, 06:29:51 AM »

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/07/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Initial report was that a patient experienced multiple vagal syncopes, fainting, and bradycardia that the patient¿s cardiologist believed were related to vns. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8656770
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dennis100
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« Reply #307 on: August 10, 2019, 03:23:55 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/04/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the er for bradycardia, syncope, and a possible heart blockage. The physician was questioning whether this was related to the vns. It was stated that the patient had been bradycardic ever since implant. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8764641
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dennis100
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« Reply #308 on: August 10, 2019, 03:24:58 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/13/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's neurologist that the patient had significant improvement in their exercise tolerability, ability to "urinate bladder", syncope episodes and bowel symptoms once their vns generator stimulation was disabled. It was reported that the patient noticed discrete episodes similar to syncope / pre-syncope involved with vns stimulation. Multiple attempts were made to obtain additional information; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8774075
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dennis100
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« Reply #309 on: September 07, 2019, 02:50:11 AM »

Model Number 7103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2019
Event Type  Injury   
Event Description
It was reported from a clinical study that a patient is experiencing an event of syncope that is possibly related to stimulation. The event is possibly related to underlying disease. Subject had this happen before when he was started on entresto. Had a syncopal episode. The physician had discontinued and this had not happened again until now. Considered not related to study procedure. The outcome is recovered/resolved. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8922527
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dennis100
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« Reply #310 on: September 07, 2019, 02:50:54 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient experienced dizziness ever since the vns was programmed on and that the dizziness increased when the output current was increased. The patient reported that dizziness was present when standing and subsides when she lays/sits down. It was stated that the dizziness is constant when she stands. The physician reported that the patient has had dizziness in the past due to previously prescribed aeds prior to implant. However, no medications have been changed since vns implantation. The physician lowered the output current from 1. 25 ma to 0. 75 ma and the adverse event did not resolve. The physician disabled the vns in order to determine if the issue resolved. Follow up with the physician's office revealed that they had disabled the "scheduled doses" and that the patient could only manually stimulate, which was confirmed to mean that only magnet mode was programmed on. The physician stated that it was believed that the main component of the dizziness was due to anxiety. Diagnostics were within normal limits. It was later reported by the patient¿s daughter that the patient was referred for vns explant surgery in (b)(6) 2019. It was stated that the vns was ¿triggering epilepsy for the patient¿ and they wanted to move up the surgery date. The daughter later reported that the patient was experiencing dizziness, ambulation difficulties (disbalance), headaches, and a lack of energy. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8927290
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dennis100
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« Reply #311 on: September 07, 2019, 02:51:34 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/09/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a cardiologist that a vns patient was experiencing syncope and her blood pressure was stated be "bottoming out". The physician stated that when the patient stands up or lies down, they have a spell intermittently which drops their blood pressure from 180/100 to 100/80. The physician desired the vns to be disabled to see if the adverse events were related to stimulation. Further information was received that the patient is having severe side effects, specifically uncomfortable twitching at the generator site, slowing heart rate, and dropping blood pressure. It was stated that when the generator was disabled with the magnet, the adverse events ceased. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes were received for the patient's referral for explant as her cardiologist and neurologist had determined that vns was contributing to her cardiac issues. Clinic notes stated that the patient is having issues with her vns misfiring, and states that she has been experiencing low blood pressure, syncope episodes. The cardiologist advised to have the vns turned off. The patient has experienced several seizures since having the vns disabled by the magnet but the disablement has lessened the patient's syncope episodes. The cardiologist does not believe that her symptoms are coming from her heart but the vns unit. It was stated that the vns has been disabled at this time. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8884891
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dennis100
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« Reply #312 on: October 12, 2019, 03:13:20 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2019
Event Type  Injury   
Event Description
Patient presented for a dosing appointment and passed out. The patient¿s mother felt that the episode was a seizure and it was noted that the episodes of passing out had began after the implant surgery. The patient¿s physician did not think the event was a seizure and suspects that the patient is experiencing vasovagal syncope. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9089653
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