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dennis100
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« Reply #30 on: July 23, 2010, 09:42:26 PM »

Event Date 01/01/2008
Event Type  Injury  
Patient Outcome  Other;  
Event Description  
It was reported by the vns pt that she has been experiencing multiple symptoms, which began over the last two years. The pt explained that she had ulcers, heart palpitations which she believes are occurring with stimulation, fainting episodes, and red blotchy, warm sensation on the left chest in the location of the implanted pulse generator. The pt was implanted with the device in 2006. The pt stated that the physician who is treating these symptoms "did not know if it was related to vns". The pt explained that she had not informed her treating neurologist of these symptoms. Further f/u with the treating neurologist revealed that the pt has in fact not informed her of the symptoms, but also stated that they were not believed to be related to vns. The physician explained that the pt has received good efficacy with vns for seizure control. The physician stated that the pt was last seen in (b) (6) 2010, where diagnostic tests revealed normal device function, however, specific results were not provided. The pt is not scheduled for a f/u appointment until (b) (6) 2010.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1650534
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« Reply #31 on: August 06, 2010, 04:11:38 AM »

Event Date 06/02/2010
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
It was reported to the manufacturer that the vns patient experienced an episode of syncope associated with low blood pressure on (b) (6) 2010. The patient's resting blood pressure was 120. After this episode, the blood pressure was re-checked and it was observed to be at 70/42. It was brought back up to 90 at the hospital. It was indicated that the patient has a medical history of mitral valve pro-lapse. The patient was advised to see a cardiologist. It is unknown at this time if the event has been determined to be related to vns therapy. It is unknown if interventions have been taken for the event. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1749838
« Last Edit: February 15, 2015, 04:44:24 AM by dennis100 » Logged
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« Reply #32 on: August 09, 2010, 03:31:18 AM »

Model Number 102
Event Type  Injury  
Patient Outcome  Life Threatening; Required Intervention  
Event Description  
Reporter indicated that vns patient lost consciousness during inadvertent initiation of magnet mode stimulation cycle. The patient was reportedly looking at their magnet, at which time they held the magnet close to the generator site and inadvertently initiated a magnet mode stimulation cycle. During the episode, the patient lost consciousness but regained consciousness upon completion of the magnet mode stimulation cycle. It was reported that the patient's device was not programmed to on at the time of initial implant, but that device interrogation at office visit 15 days later revealed that magnet mode output current was set to 1. 75ma and 60 seconds on time. Implanting surgeon indicated that he performed device diagnostic testing at the time of implant surgery and then interrogated the patient's device to confirm the output currents were set to 0ma pending future office visit to initiate stimulation. Stimulation was scheduled to be initiated at office visit two weeks post-implant; however, the device remains programmed to off at the patient's request. Review of manufacturing records for the pulse generator confirmed that the device was programmed to 0ma output current (both normal mode and magnet mode) when shipped. Investigation has been unable to determine the cause of the inadvertent change in device settings that lead to the syncopal episode during initiation of magnet mode stimulation cycle. Treating neurologist believes that the magnet mode output current was inadvertently programmed to on after implant surgery; however, manufacturer has been unable to confirm because requested device programming history has not yet been received for review.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=612739
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« Reply #33 on: August 09, 2010, 04:31:45 AM »

Event Date 02/01/2010
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
It was reported to the manufacturer that the vns pt experienced syncope that led to cardiac events. The pt was hospitalized for the reported events. The pt's device was temporarily programmed off with the use of a magnet, but it is unk if this resolved the reported events. The relationship between the reported events and vns therapy is unk at this time. It is unk if the pt has a medical history of these events. Good faith attempts to obtain add'l info regarding the reported event are underway.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1656291
« Last Edit: February 15, 2015, 04:45:53 AM by dennis100 » Logged
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« Reply #34 on: August 20, 2010, 04:03:27 AM »

Event Date 07/01/2005
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns patient passes out every time the device is swiped with the magnet. It was reported that the patient has experienced three auras during the past month and that they swiped the device with the magnet each time, resulting in a brief loss of consciousness for an unknown number of seconds. The patient did not experience any chest pain, focal deficits, or altered mental status during these episodes. Programmed parameters were adjusted. Neurologist plans to assess patient's condition at next follow-up appointment in near future. Report is incomplete because device tracking information was not forwarded to manufacturer at the time of initial implant. Attempts to obtain device tracking information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MCRFOI__ID=629337
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« Reply #35 on: August 20, 2010, 04:04:26 AM »

Event Date 11/01/2009
Event Type  Injury  
Patient Outcome  Life Threatening;  
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.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558272
« Last Edit: February 15, 2015, 04:47:06 AM by dennis100 » Logged
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« Reply #36 on: September 11, 2010, 06:40:00 AM »

Event Date 05/14/2010
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
A former vns pt reported to the manufacturer that she had several events of syncope and falling while implanted with the vns device. Per the attending surgeon's office, the pt's vns was explanted due to lack of efficacy. Attempts to the treating neurologist and surgeon for further information are in progress. The explanted vns generator and lead have been returned and product analysis is pending.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1783929
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« Reply #37 on: September 11, 2010, 06:46:05 AM »

Event Date 07/01/2010
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
Initial reporter indicated that while performing a system diagnostic test, their patient fainted. Good faith attempts have been unsuccessful to date in obtaining further information about the reported event.  

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1783800
« Last Edit: February 15, 2015, 04:48:06 AM by dennis100 » Logged
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« Reply #38 on: September 11, 2010, 06:48:49 AM »

Event Date 01/01/2010
Event Type  Injury  
Patient Outcome  Required Intervention;  
Event Description  
It was initially reported that the pt is having possible cardiac events, described as "triples" and "pcas" on the ekgs by the treating neurologist. The pt was referred to a cardiologist for eval. The neurologist indicated that the patient is currently on high doses of benzo medications and also depakote, so he believes the pt may possibly having reactions to the high doses of medication and causing the problems with her heart. Diagnostics were said to have been within normal limits, but no specifics were available at that time. Further f/u indicated that the pt is still having afib issues with occasional episodes of passing out (not associated with stimulation on-times or seizures). The pt is wearing a holter monitor for 22 days to evaluate her issues. The patient is bipolar/depression and is on several medications. The patient has very low weight and body fat, so the neurologist believes that the issues she is experiencing are due to her medications in relation to her physician condition. Last known diagnostics available in the mfr's programming history database were at the time of implant, which were within normal limits. Good faith attempts to obtain add'l info are still in progress.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774910
« Last Edit: February 15, 2015, 04:48:49 AM by dennis100 » Logged
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« Reply #39 on: March 08, 2011, 09:37:10 PM »

Event Date 01/14/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
It was reported by a company representative that a vns pt was being referred for prophylactic replacement of his generator. Clinic notes were received dated (b)(6) 2010 indicating the pt was having episodes of daily screaming along with intermittent behavioral issues. Furthermore, info on an insurance form indicated the pt had used insurance for syncope and collapse on (b)(6) 2010. At the moment, the relationship of the syncope and collapse to vns therapy is unk. Good faith attempts to obtain additional info from the treating neurologist have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993853
« Last Edit: February 15, 2015, 04:49:37 AM by dennis100 » Logged
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« Reply #40 on: March 08, 2011, 09:37:47 PM »

Event Date 01/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Manufacturer received a complaint from a vns pt that she has been feeling dizziness and passed out. She saw her primary care physician and had blood works done which the results appeared normal. She suspects that her condition is related to vns therapy and she was referred to her neurologist. Good faith attempts to obtain more info regarding pt condition have been unsuccessful to date with the treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1987482
« Last Edit: February 15, 2015, 04:50:14 AM by dennis100 » Logged
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« Reply #41 on: April 08, 2011, 08:07:02 AM »

Event Date 03/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
(b)(6) manager in (b)(6) was contacted by a vns treating physician. It was reported that when a pt's vns was titrated they had syncope. When their settings were raised from 0. 5 to 0. 75 ma they had syncope x2 and when raised from 0. 75 to 1ma they had syncope. The event occurred after programming changes were made. The pt was lowered to 0. 75ma and no further events at this time. The event did not occur during implantation of the vns. No further interventions are planned. The next time the pt is seen they will do further ecg monitoring. It is believed the event is related to stimulation. The pt continues their therapy and had no history of this prior to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032385
« Last Edit: February 15, 2015, 04:51:09 AM by dennis100 » Logged
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« Reply #42 on: April 08, 2011, 08:07:42 AM »

Event Date 01/01/2010
Event Type Injury
Patient Outcome Other;
Event Description
A physician reported that a vns pt was having "a lot of fainting spells" over the past year that happened when the pt was upright, sitting, or standing. The doctor described the spells as being on a vasovagal basis called a neurocardiogenic syncope syndrome. The physician had not heard of the condition's being caused by vns, but stated it could possibly be related. Follow-up with the physician indicated that he believed the relation of the event to vns was "unknown/unlikely". He was planning a tilt table test where magnet stimulation would also be initiated, and the patient's "workup" was in progress. Good faith attempts for more info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2020327
« Last Edit: February 15, 2015, 04:53:11 AM by dennis100 » Logged
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« Reply #43 on: April 08, 2011, 08:45:18 AM »

Event Date 02/02/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Mfr received an inquiry from a neurologist regarding whether vns pts tend to experience episodes of syncope. No pt or event details were provided in the initial report. Good faith attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009542
« Last Edit: February 15, 2015, 04:53:47 AM by dennis100 » Logged
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« Reply #44 on: May 05, 2011, 03:47:28 AM »

Event Date 09/10/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
In review of patient's programming history, it was noted that a vns patient's device was disabled on (b)(6) 2003. Follow-up information was obtained from the patient's physician and it was revealed that the patient had been disabled due to an episode of loss of consciousness with magnet use. However, the patient's stimulation was re-enabled on (b)(6) 2008, and there had been no recurrence of the episodes. The generator was later replaced prophylactically for an unrelated reason and was returned to the manufacturer for analysis. The device performed according to functional specifications, and there was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Good faith attempts to gain more information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032419
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« Reply #45 on: May 05, 2011, 03:48:08 AM »

Event Date 03/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
(b)(6) manager in (b)(6) was contacted by a vns treating physician. It was reported that when a pt's vns was titrated they had syncope. When their settings were raised from 0. 5 to 0. 75 ma they had syncope x2 and when raised from 0. 75 to 1ma they had syncope. The event occurred after programming changes were made. The pt was lowered to 0. 75ma and no further events at this time. The event did not occur during implantation of the vns. No further interventions are planned. The next time the pt is seen they will do further ecg monitoring. It is believed the event is related to stimulation. The pt continues their therapy and had no history of this prior to vns.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032385
« Last Edit: February 15, 2015, 04:56:00 AM by dennis100 » Logged
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« Reply #46 on: May 12, 2011, 06:40:36 AM »

Event Date 01/01/2000
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
In the process of contacting the patient's neurologist to notify him that the patient's device may be nearing end of service, it was discovered that the patient had experienced an increase in seizures over a one year period with the vns therapy. The patient had 160 seizures in the year prior to vns implant and 390 seizures in the year after vns implant. The patient's device was subsequently programmed to off approximately 15 months post-implant and was programmed back to on 20 months later. Various medication changes were made during this time. Treating neurologist is attempting to adjust device settings for favorable seizure control and continues medication changes. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. It was reported that during the time of the increased seizures, the patient's post-ictal state was better and their appetite, sleep pattern and behavior were unchanged. Stimulation was gradually reduced over a period of one month prior to programming the device to off. It was reported that the patient had less frequent but more intense seizure without the vns therapy. It was also reported that during the time that the generator was programmed to off, the patient had several episodes of suddenly becoming unresponsive. There was a question of whether there was no heart rate or respiratory effort during these episodes, but by the time caregivers obtained a stethoscope, the patient was reportedly breathing and their heart rate had recovered. The patient was seen by a cardiologist who indicated that the patient was having syncope, but that since patient was a do not resusciate, no further workup was warranted. Caregivers are seeking second cardiac opinion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=487256
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« Reply #47 on: June 09, 2011, 01:07:31 AM »

Event Date 01/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6), 2011, the vns treating physician reported that the vns pt was having her vns explanted on (b)(6) 2011 because she was experiencing syncope and bradycardia. The physician believes that the syncope and bradycardia may be related to vns. The fainting first started around the beginning of (b)(6) 2011, so the pt was sent to an epilepsy monitoring unit from (b)(6) 2011 where the bradycardia was then diagnosed. The pt's heart rate was down to 30 bpm. The pt was last seen before that, on (b)(6) 2010 and everything was fine with her device. Diagnostics read ok with dcdc of 3 and it was not near eos. The settings were. 1. 5/20/250/30/0. 8 with magnet at 1. 75/60/500 and 899 magnet uses. The physician said that there were no triggers or medication changes and that the pt has not history of these events pre-vns. The pt's vns was programmed off on (b)(6) 2011. They do not have any further info about the pt's syncope and bradycardia as they do not monitor it there. Good faith attempts for further info from the pt's cardiologist have been to no avail thus far. When add'l info is rec'd, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082875
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« Reply #48 on: August 25, 2011, 02:25:37 AM »

Event Date 06/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated a vns pt had experienced syncope and hypotension events, and had experienced an episode of asystole while hospitalized for spinal fusion surgery. Attempts for further info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2166843
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« Reply #49 on: October 06, 2011, 05:53:13 AM »

Model Number 102
Event Date 03/24/2011
Event Type Injury
Event Description
Analysis of the explanted generator has been completed. The generator performed to specifications and no anomalies were found however it was noted that the "elective replacement indicator (eri)" was set to "yes"; this indicates that the device was nearing end of service and has a battery voltage less than 2. 6 volts. The battery voltage found during analysis indicated 2. 573 volts. The depleted battery is not expected to have result in the reported syncope.

Manufacturer Narrative
Corrected data: initial report inadvertently reported the incorrect generator model and serial number.

Event Description
It was reported via clinic notes that the pt had previously seen a cardiologist for syncope and orthostasis however the relationship of the events to vns is unk. The clinic notes also noted that diagnostics were normal at the pt's last visit on (b)(6) 2011. Attempts for additional info have been unsuccessful to date. The pt's generator has been replaced prophylactically and it is undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267795
« Last Edit: October 24, 2015, 11:57:46 AM by dennis100 » Logged
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« Reply #50 on: November 04, 2011, 06:26:46 AM »

Model Number 102
Event Date 06/28/2011
Event Type Injury
Event Description
Additional information was received regarding the patient. The syncope that was reported was unrelated to vns.

Event Description
It was initially reported the patient was experiencing blackout spells that were speculated to be syncope related to hypotension; however, it was not confirmed that the blackouts were unrelated to seizures. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301698
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« Reply #51 on: November 12, 2011, 04:25:16 AM »

Model Number 102
Event Date 03/22/2011
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative

Event Description
On september 30, 2011, clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2011 reveal that the patient had a rare seizure. It was noted that if the mother swipes the magnet over the vns, this stops the seizure. The patient was also reported to have episodes of passing out which the mother feels are related to his hypotension. It is unknown what the physician believes the episodes of passing out are related to. A battery life calculation was performed on (b)(6) 2011 which revealed negative years until eri=yes. Additional information has been requested from the physician but no further information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2306126
« Last Edit: September 26, 2015, 12:06:22 AM by dennis100 » Logged
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« Reply #52 on: December 10, 2011, 08:48:59 AM »

Model Number 102
Event Date 10/19/2011
Event Type Injury
Manufacturer Narrative

Event Description
Product analysis of the returned generator found that the device was at end of service du to normal battery depletion. The depletion was an expected event as determined by the battery life calculation and battery voltage measurement. The module performed according to functional specifications as defined in post burn-in electrical test. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. No other information has been provided.

Event Description
It was reported that the patient was being referred for generator replacement due to end of service condition. Clinic notes were received which mention the patient was hospitalized due to syncope and pseudoseizures. Attempts for further information have been unsuccessful to date.

Event Description
Additional information was received which indicated that the patient's generator was replaced on (b)(6) 2013 due to end of service. Diagnostics were performed after replacement without error. The product was returned on (b)(6) 2013 and is pending product analysis. No additional information was received.

Event Description
Follow-up with the physician reveals that the generator battery is dead and needs replacement, so the syncope is not associated with stimulation. The physician is unsure if the syncope is related to vns. The patient has no medical history of syncope pre-vns. No causal or contributory programming or medication changes preceded the onset of the syncope.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341588
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« Reply #53 on: January 05, 2012, 08:14:48 AM »

Model Number 103
Event Date 11/18/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011 a vns treating neurologist reported that the vns patient has fainted several times since her recent settings increase on (b)(6) 2011. The patient was implanted on (b)(6) 2011 and turned on to nominal settings on (b)(6), 2011. The patient's settings on (b)(6) 2011 were output=0. 5ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 75ma/magnet pulse width=500usec/magnet on time=60sec. The neurologist was questioning whether or not the patient may have bradycardia due to the recent fainting events. The patient was reported to be having x-rays performed to assess whether or not electrodes were placed inverted thereby causing bradycardia. The neurologist also reported that she was planning on disabling the vns and connecting the patient to an ecg monitor to assess whether or not bradycardia is present as it has not yet been determined. Additional information was requested from the neurologist including a copy of the patient's x-rays to review but no further information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2375989
« Last Edit: February 15, 2015, 05:03:35 AM by dennis100 » Logged
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« Reply #54 on: February 09, 2012, 08:27:32 AM »

Model Number 102
Event Date 11/29/2011
Event Type Injury
Event Description
Clinic notes were received for the patient that indicated that she had a history of syncope, unknown if related to vns. Good faith attempts for more information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received that indicated that the no syncope was report and no further information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2404361
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« Reply #55 on: February 09, 2012, 08:28:27 AM »

Model Number 102R
Event Date 12/22/2011
Event Type Injury
Patient Outcome Other;
Event Description
Clinic notes were received on (b)(6) 2011 where it states that the patient has a history of syncope/near-syncope. Good faith attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2420526
« Last Edit: February 15, 2015, 05:05:30 AM by dennis100 » Logged
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« Reply #56 on: March 08, 2012, 05:56:43 AM »

Model Number 102
Event Date 08/19/2011
Event Type Injury
Event Description
Additional information was received that the patient's cardiac issues were not related to vns, and that the patient did not really have any cardiac issues. No comment was made on the syncope. The physician will not be providing any additional information as he is very hipaa sensitive.

Manufacturer Narrative

Event Description
It was initially reported that the patient had syncope and general arrhythmia. The physician feels that both events were related to dehydration but the role vns played in the event was not addressed. When the patient experienced the suspected syncope the patient had not eaten or kept himself hydrated. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2460592
« Last Edit: October 22, 2015, 02:11:49 AM by dennis100 » Logged
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« Reply #57 on: March 26, 2012, 10:42:58 AM »

Model Number 101
Event Date 05/01/2006
Event Type Injury
Event Description
Reporter indicated that pt began to experience episodes of syncope and asystole approximately six years post vns implant. The pt reported feeling the need to cough, after which he reportedly lost consciousness. Approximately two months after, the onset of symptoms, the pt was hospitalized for eval of the syncope episodes, at which time and ekg revealed episodes of asystole that coincided with device stimulation cycles; however, not every stimulation cycle would produce this event. The vns therapy system was then programmed to off, after which a repeat ekg was normal. The pt did not experience any further episodes of syncope or asystole in the absence of the vns therapy. Eval by cardiologist did not reveal any abnormalities with the pt's heart. The device remains programmed to off. Both the cardiologist and the neurologist believe that the reported events were caused by the stimulation of the vagus nerve. There had been no recent changes to programmed device settings; however, inderal had recently been added to the pt's medication regimen for treatment of mild hypertension.

Manufacturer Narrative
Results - (b) (4) system labeling lists heart rate/rhythm changes as a potential adverse event possibly associated with surgery or stimulation. Conclusions - treating physician indicates that the reported events appear to be related to device stimulation; however, the physician does not know why the pt began to experience these events after more than six years of successful vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1629932
« Last Edit: February 15, 2015, 05:07:59 AM by dennis100 » Logged
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« Reply #58 on: March 26, 2012, 01:27:20 PM »

Model Number 102
Event Date 03/23/2010
Event Type Malfunction
Event Description
It was reported that the pt was experiencing black out "spells" which she felt were seizures. The pt recently went to see her physician and she thinks he turned her settings down as she no longer feels stimulation. If these spells are seizures, the relationship to pre-vns baseline levels is currently unk. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1675415
« Last Edit: February 15, 2015, 05:08:35 AM by dennis100 » Logged
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« Reply #59 on: March 26, 2012, 03:03:58 PM »

Model Number 102
Event Date 02/15/2004
Event Type Injury
Patient Outcome Life Threatening; Disability Required Intervention
Manufacturer Narrative
Report is incomplete because no response has been received to mfr's request for additional info from treating neurologist.

Event Description
Reporter indicated that vns patient lost consciousness with a seizure and experienced a seizure that lasted longer than normal. It was reported that the patient's legs and feet became numb with a seizure and then patient passed out. Ten days later, the patient reportedly experienced a seizure that lasted for 30-45 minutes and that use of the magnet did not abort the seizure. It was reported that these types of a seizures are not typical for the patient. Overall, the patient has experienced a decrease in seizures with the vns therapy. The patient reportedly experienced 200-300 seizures in a 2-3 hour time span prior to vns implant and now experiences 2-3 seizures in a 5-minute period. Treating neurologist adjusted device settings and added a new medication to the patient's drug regimen.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=516212
« Last Edit: February 15, 2015, 05:09:19 AM by dennis100 » Logged
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