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dennis100
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« on: July 21, 2010, 10:16:09 PM »

1997 FDA CDRH Neurological Devices Panel

DR. NUWER: Okay. Does this device also stimulate enough of the local structures in the neck that it stimulates the sympathetic nerves which are travelling with the carotid artery?

DR. DUFFELL: I'd like to maybe call on Dean Naritoku, if maybe he could comment on that from his clinical observations.

DR. NARITOKU: Well, I think it's hard to know whether they were stimulated or not. I think the best response to that is that there is extensive Holter testing and cardiac function testing on the E05 trial, and in that, there were no changes in rhythm seen; actually, no changes of heart rate, significant changes in heart rate were seen during the time of stimulation. So, I think that's the best index I can use, and that's probably the best estimate that I can give you, that there is no clinically symptomatic effects of that.

DR. WILKINSON: No mydriasis.

DR. NUWER: There's no change in the skin color or blushing; there's no change in--

DR. NARITOKU: I have to say I haven't looked for it specifically, but I have never seen it.

DR. NUWER: No pupillary changes.

DR. NARITOKU: I haven't seen any, no.

DR. NUWER: Has there been a study of the interrictal activity in these patients? In other words, with a device like an ambulatory monitor to show that the rates of spiking or the rates of subclinical electrographic seizures are affected in any way by the use of this device?

DR. NARITOKU: I know in preclinical trials, it reduced the spikes both in pantalene tetrazol treated rats and monkeys with alumina gel foci. In terms of human clinical, I have to defer that.

DR. DUFFELL: No; I don't believe that we have any data of that particular type.

DR. NUWER: That's all I have.


pg.90

http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3299t1.pdf



DR. DUFFELL: Because it has come up twice. I just want to make sure--I don't know that I was perfectly clear. The output current, I understand your concern, both of you. You have to realize that it is a rate limiting phenomenon by the patient himself. I think any of the doctors here would tell you: since this device is going on and off every 5 minutes, if they can't tolerate it, they won't leave. You know, they only go to the level of perceptibility and comfortable tolerance. You would never have an instance where a patient went home and, all of a sudden, should have a reaction to an output current, because they will have seen it before they left the office.
 
Pg. 185

http://www.fda.gov/ohrms/dockets/ac/97/transcpt/3299t1.pdf
___________________________________________________

Event Date 11/08/2002
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention  
Event Description  
Reporter indcated that patient had to go to the emergency room in 2002 because of increased heart rate (230 beats per minute) that caused pt to pass out. The patient's ncp system was programmed to on approximately 3 weeks post-implant but was programmed to off in 2002 during pt's emergency room visit. The patient was discharged from the hospital that same night and has reported no further cardiac problems since the device was programmed to off. There have not been any recent medication changes and the patient reports that they did not do anything out of the ordinary on the day of their emergency room visit. Further follow-up revealed that the patient's device was programmed back to on. The physician indicated that the patient is fine and has had no recurrence of tachycardia.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=432838
« Last Edit: May 25, 2014, 12:56:04 PM by dennis100 » Logged
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« Reply #1 on: July 31, 2010, 11:20:54 PM »

Event Date 10/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Vns pt has experienced several episodes of tachycardia over the past month. It was reported that during one of the recent incidents, the pt's heart rate was over 200 beats per minute for approx one and one half hours. The tachycardia does not coincide with stimulation and device settings had not been changed for over 2 months. Initial reporter indicated that the incidents of tachycardia may not be related to the vns.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=502732
  
« Last Edit: May 16, 2014, 03:29:45 AM by dennis100 » Logged
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« Reply #2 on: July 31, 2010, 11:23:06 PM »

Event Date 03/01/2002
Event Type  Injury   Patient Outcome  Hospitalization; Disability Required Intervention  
Event Description  
Reporter indicated that the pt has had several episodes of tachycardia (increase of heart rate to 130's) for which pt they have been evaluated in the emergency room. It was also reported that the pt experienced significant swelling in tile arms. No infection was seen, but antibiotics were administered to prevent infection. Reporter also indicated that the pt is not doing well and the er does not know what to attribute this to. It was later reported that the pt was explanted due to infection, left vocal cord paralysis, and a red and swollen arm. Tests were taken for blood clots on the pt's arm with negative results. It was reported that the pt began having symptoms a few days after implant surgery and that the pt was hospitalized due to infection at implant site and reflex sympathetic dystrophy of left arm. The pt was seen by an infectious disease consultant and three individual otolaryngologists who all indicated that the pt has no infection. The pt's neurologist and a separate infectious disease consultant indicated that they believed the pt has an infection. The pt was hospitalized for 1 1/2 weeks. Further follow-up revealed that the tachycardia has improved slightly and the pt is seeing a cardiologist as an outpatient. Reporting neurologist believes that the tachycardia and bilateral arm edema are related to the vns implant. The vns was never turned on.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=388401
 
« Last Edit: May 16, 2014, 03:31:12 AM by dennis100 » Logged
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« Reply #3 on: July 31, 2010, 11:24:22 PM »

Event Date 01/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that vns pt was experiencing irregular heartbeat. The pt was last seen by neurologist two months prior and indicated that their neurologist planned to write a letter to the manufacturer regarding the irregular heartbeat with vns therapy. Manufacturer has no record of receiving any correspondence from neurologist regarding this pt. The pt is not scheduled to see their neurologist again for four months. It was reported that the pt has been unable to tell whether the vns therapy is helping their seizures as of yet due to many other co-morbidities. Further follow-up revealed that the pt is doing well and that treating neurologist plans to continue vns therapy. The event has reportedly resolved with medication (amiodarone-200mg daily). It is know whether the event was related to the vns therapy. The pt's condition was described as atrial fibrillation with a tachy arrhythmia. Neurologist indicated that he was not aware of any other chronic conditions or co-morbidities for the pt.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=472086
« Last Edit: May 16, 2014, 03:32:03 AM by dennis100 » Logged
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« Reply #4 on: July 31, 2010, 11:26:00 PM »

Event Date 11/01/2002
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that post-implant, the pt's pulse is thready and weak. The pt's blood pressure was reported to be 120/110. The pt reportedly has no pre-existing cardiac conditions and the implant surgery was uneventful. It was noted that the anesthesiologist did not use muscle relaxers before the surgeon began dissecting the carotid sheath during the implant procedure. The pt's device had not yet been programmed to on. It was later reported that the pt is now experiencing pain in the neck region, hoarseness, and tachycardia with heart rate around 110. Physician plans to see pt for f/u visit in one week and attributes the hoarseness to the endotracheal tube used for anesthesia during implant surgery. The pt was afebrile.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=432884
 
« Last Edit: May 16, 2014, 03:32:42 AM by dennis100 » Logged
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« Reply #5 on: July 31, 2010, 11:27:24 PM »

Event Date 02/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that pt's heart rate has increased from 88-112 beats/min to 120-124 beats/min. The pt's device was programmed to on the same day of implant surgery to the lowest normal mode output current (0. 25ma). Treating neurologist indicated that there is no clear reason for the event, but that it was doubtful that it was related to the vns.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=449716
 
« Last Edit: May 16, 2014, 03:32:58 AM by dennis100 » Logged
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« Reply #6 on: July 31, 2010, 11:56:49 PM »

Event Date 08/01/2001
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization Required Intervention  
Event Description  
Reporter indicated that patient went into a cluster of seizures (status like) and was admitted to the hospital. During the hospital stay, the ekg showed the heart rate as sinus tachycardia (st). The physicians attributed the tachycardia due to dehydration. The patient was discharged from the hospital without any further tests performed to determine the cause of the st. The patient's neurologist followed up with the sinus tachycardia events and referred the patient to a cardiologist. The patient's baseline heart rate is 131 bpm. The cardiologist, after performing a work-up on the patient, concluded the st may be due to the brain/seizures. However, monitoring showed the heart rate did not change with seizure activity. The vns was programmed to off and the heart rate was found to return within normal limits (hr 68). The device remained programmed to off for three days. When the device was reprogrammed to on, the heart rate increased within 15-20 minutes and the patient was tachycardic. The device remains programmed to off. Programmed parameters have not been adjusted for several months preceding the incident. Although the patient is st, patient is asymptomatic. The cardiologist believes the tachycardia and the vns are related, however, since the patient is asymptomatic the pt is not in any danger/harm at this time. The patient is taking oral/pimoziode 0. 5mg bid. A potential side effect of this drug is st. The cardiologist agreed it would be okay for the vns to be reprogrammed to on to low settings with ekg monitoring for st, but wanted consent from family members and neurologist prior to doing so.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=352258

  
« Last Edit: May 16, 2014, 03:33:50 AM by dennis100 » Logged
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« Reply #7 on: July 31, 2010, 11:58:39 PM »

Event Date 05/01/2003
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Vns patient experienced short periods of tachycardia (>140) while device was programmed to rapid cycling parameters. The tachycardia reportedly stopped when device was programmed back to normal cycling parameters. The patient was referred to cardiologist for evaluation.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=469377
 
« Last Edit: May 16, 2014, 03:34:01 AM by dennis100 » Logged
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« Reply #8 on: August 01, 2010, 12:21:03 AM »

Event Date 09/01/2003
Event Type  Injury   Patient Outcome  Life Threatening; Hospitalization  
Event Description  
Vns patient began to experience atrial fibrillation that went into v-tach and was hospitalized for three weeks and almost died. Cardiologist reportedly performed a ep study and diagnosed the patient with superventricular tachycardia related to electroirritability. The ep study was not able to isolate the area of irritability. Cordiologist reportedly believes that the problem could be related to the vns. Device diagnostic testing was within normal limits, indicating proper device function. Treating physician reportedly wanted to program the vns to off, but the patient refused they have experienced significant seizure control with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=497401

« Last Edit: May 16, 2014, 03:34:59 AM by dennis100 » Logged
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« Reply #9 on: August 02, 2010, 11:16:25 PM »

Event Date 06/30/2005
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
The reporter was recently implanted with a new generator and is experiencing a rapid heart rate of 134 bpm, exhaustion, and slightly elevated blood pressure. It was further reported that the pt is also experiencincing pain in the generator area when the device stimulates. The generator was programmed on to 1. 25ma immediately following the implant. The generator was checked and found to be properly functioning. It was also reported that an attempt to alleviate the pain by adjusting the parameters was done, however, the pt still experienced pain during device stimulation. The pain stops when the gneerator is inactivated using the magnet. Further troubleshooting is currently being done. The cause of the reported event are unknown at this time; this event is currently being investigated.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=623815
 

« Last Edit: May 16, 2014, 03:35:20 AM by dennis100 » Logged
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« Reply #10 on: August 02, 2010, 11:18:21 PM »

Event Date 09/01/2005
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
Reporter indicated that vns patient was experiencing periods of high blood pressure and heart rate rhythm changes. The patient was reportedly hospialized in a psych ward at the time of the event, at which time a cardiologist was contacted for a consult due to severe hypertension and tachycardia. It was reported that the patient went into atrial fibrillation, but that the cardiologist was unsure whether it was related to the vns therapy and therefore did not want to discontinue stimulation. Treating cardiologist indicated that the patient is normally well-controlled, but that their blood pressure was recently 180/120 with heart rate 140, per the cardiologist, the patient is doing fine now and there have not been any ecg changes noted.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=638695
 
« Last Edit: May 16, 2014, 03:36:14 AM by dennis100 » Logged
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« Reply #11 on: August 03, 2010, 02:56:38 AM »

Event Date 01/01/2006
Event Type  Other   Patient Outcome  Other;  
Event Description  
Reporter indicated the ncp system was explanted for tachycardia. Since explant, the pt has not experienced any more tachycardia. No serious injury was reported. No further info is available from the reporter.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=795085
« Last Edit: May 16, 2014, 03:36:31 AM by dennis100 » Logged
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« Reply #12 on: August 03, 2010, 07:20:08 AM »

Event Date 03/01/2007
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that the device was programmed off to alleviate the patient's adverse events. Included in the adverse events were the serious injuries of tachycardia and depression. Other adverse events were reported, but are not considered serious injuries. The adverse events subsided once stimulation was halted. Good faith attempts to more information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=852400


« Last Edit: May 16, 2014, 03:36:52 AM by dennis100 » Logged
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« Reply #13 on: August 04, 2010, 01:18:31 AM »

Event Date 10/01/2007
Event Type  Injury   Patient Outcome  Other;  
Event Description  
Reporter indicated that a vns pt has recently experienced tachycardia to 130-150 bpm with minimal exertion. A 12 lead electrocardiogram diagnosed sinus tachycardia. The pt's treating cardiologist is unsure if the vns is causing or contributing to the event. The pt is to undergo a 24 hr halter monitor and possibly have the vns device programmed off to determine the device's relationship to the event.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=954375
 
« Last Edit: May 16, 2014, 03:37:08 AM by dennis100 » Logged
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« Reply #14 on: August 04, 2010, 01:19:33 AM »

Event Date 12/24/2007
Event Type  Injury   Patient Outcome  Hospitalization;  
Event Description  
Reporter indicated that pt was admitted to the hospital with a heart rate of 180 bpm, which does not appear to be related to stimulation. Pt has a history of a similar incident, but it unk if it was post or pre vns. Good faith attempt to obtain additional info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=989700
« Last Edit: May 16, 2014, 03:37:21 AM by dennis100 » Logged
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« Reply #15 on: August 04, 2010, 06:35:02 AM »

Event Date 02/25/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated a vns pt experienced an increased heart rate with stimulation. Diagnostic testing was within normal limits and the physician had not changed the patient's settings "in a while". A cardiologist confirmed a heart rate of 120-140 only during stimulation. However, this was not with every stimulation, it was just with some of the stimulations. The cardiologist believes the increased heart rate is related to vns therapy. The patient's vns therapy system was disabled and all the symptoms have gone away. The physician stated the vns was helping with the patient's epilepsy and depression and has since started working as a social worker. Good faith attempts to obtain additional info have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1058502
« Last Edit: May 16, 2014, 03:37:40 AM by dennis100 » Logged
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« Reply #16 on: August 04, 2010, 07:47:36 AM »

Event Date 08/25/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was reported to the manufacturer that the vns patient was experiencing tachycardia. The patient's heart rate was consistently around 99-108. The patient has her pacemaker implanted on the left and her vns generator on the right with more than 7-10 inches away. We were informed that every time the patient's vns device delivered stimulation, the patient's heart rate dropped and the pacemaker attempt to correct this by firing to increase heart rate. The physician suggested the patient turn the vns device off by taping the magnet over the generator. The patient was informed to visit with her neurologist and cardiologist to resolve the issue. Good faith attempts to obtain additional information regarding this event are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1175970
  
« Last Edit: May 16, 2014, 03:38:11 AM by dennis100 » Logged
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« Reply #17 on: August 04, 2010, 08:18:10 AM »

Event Date 01/01/2008
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
It was reported that pt's vns has been turned off because she experienced tachycardia when it was on. Attempts for further info are in progress.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1148170
  
« Last Edit: May 16, 2014, 03:38:22 AM by dennis100 » Logged
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« Reply #18 on: August 05, 2010, 11:17:04 AM »

Event Date 01/01/2009
Event Type  Injury   Patient Outcome  Other;  
Event Description  
Reporter indicated that the patient was experiencing occasional rapid heart rate, sometimes in excess of 120 bpm. It was stated that sometimes it seemed to be related to stimulation periods, but a relationship could not be confirmed. The patient has a history of extrasystole. All attempts for further information from the patient's treating physician's have been unsuccessful to date, thus the relationship between the tachycardia and vns therapy cannot be determined.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1471032
 
 
« Last Edit: May 16, 2014, 03:38:41 AM by dennis100 » Logged
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« Reply #19 on: August 05, 2010, 11:18:11 AM »

Event Date 08/01/2009
Event Type  Injury   Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that the patient began to experience tachycardia once the device was programmed on. The patient does not have a history or a family history of cardiac issues. The medical professional indicated that some other symptoms were present that suggested arrhythmia and that some other traumatic events occurred prior to the start of the arrhythmia, but did not provide any specifics. The arrhythmia does not correlate with stimulation on times nor does it occur when device diagnostics are performed. The arrhythmia is not believed to be related to device stimulation; however, device stimulation exacerbates or co-currently contributed to the arrhythmia. The patient is taking several medications such as phenobarbital, rozerem, dilantin, and norco, however, there were no medication changes prior to the onset of the event. The patient's device has been programmed off and the arrhythmia has not occurred since the device was programmed off. Device diagnostics have not been performed, due to the patient's low settings. The patient will be scheduled for explant.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1466251
 
« Last Edit: May 16, 2014, 03:40:02 AM by dennis100 » Logged
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« Reply #20 on: August 05, 2010, 11:19:10 AM »

Event Date 07/01/2009
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
It was reported to the manufacturer that the vns patient has been experiencing tachycardia intermittently after a hard fall. The severity of the reported event is unknown at this time. The physician was unable to perform diagnostic tests on the patient's device, due to low settings and tolerability issues. The patient's device has been programmed off to see if the event resolved. It was indicated that the events were exacerbated by vns stimulation. The patient's cardiac workup in 2006 was negative. The patient had similar issues in the past, but the event got worse after the fall. No setting or medication changes were made prior to the event that may have contributed to the patient's symptoms. X-rays were taken to assess the integrity of the device. Based on the x-rays received, no obvious anomalies were identified, which could be contributing to the reported event. The device will be turned back on upon patient's request for therapy. 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=1464536
« Last Edit: May 16, 2014, 03:45:03 AM by dennis100 » Logged
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« Reply #21 on: August 05, 2010, 11:20:23 AM »

Event Date 10/01/2009
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
It was initially reported by the physician that pt has been experiencing tachycardia. Pt's heart beat went from 70 bpm to 120 bpm, then 140 bpm and back down to 130 bpm. This event immediately started after settings were changed. Output current was changed from 0. 75 ma to 0. 5 ma and the tachycardia event started. Pt has done very well with vns, therefore, pt does not want to remove vns. Device was turned off using the magnet but it did not help the event. Physician indicated that the event does not occur with stimulation but he is not sure it is related to vns or not. Device diagnostics showed everything working within normal limits. Physician indicated that the pt did not pre-history of cardiac events. Pt has no pre-existing medical condition. Physician stated that the event did not occur following any medication change. No intervention has been taken till date. Pt's recent heart rate is 108. Pt continues to have episodes of tachycardia event.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1552336
 
« Last Edit: May 16, 2014, 03:47:37 AM by dennis100 » Logged
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« Reply #22 on: August 05, 2010, 11:21:19 AM »

Event Date 04/14/2009
Event Type  Injury   Patient Outcome  Life Threatening; Required Intervention  
Event Description  
It was reported that the pt has been experiencing episodes of tachycardia and bradycardia since 2009. Four months later, the pt's settings were adjusted to alleviate the pt's symptoms. The physician feels that pt's episodes are related to his vns stimulation. Attempts for further info are in progress.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1569370
 
 
« Last Edit: May 16, 2014, 03:47:57 AM by dennis100 » Logged
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« Reply #23 on: August 05, 2010, 11:22:54 AM »

Event Date 07/16/2009
Event Type  Injury   Patient Outcome  Life Threatening;  
Event Description  
It was reported to the manufacturer that the vns patient has been experiencing ventricular tachycardia. An instance of ventricular tachycardia was confirmed during holter monitoring of the patient's cardiac activity. It is unknown if the event is related to vns therapy or stimulation. The patient has been falling and fainting as a result of the arrhythmia. The patient has broken several bones from the syncopal episodes. No allegations against the functionality of the device were made. 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=1523688
« Last Edit: May 16, 2014, 03:48:26 AM by dennis100 » Logged
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« Reply #24 on: May 05, 2011, 03:56:24 AM »

Event Date 07/01/2010
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
It was reported that the vns patient had experienced a stabbing pain in his left and right chest walls and was admitted to the hospital. The pt had a cardiology consult during which his vns was disabled. When stimulation was re-enabled, the pt's heart rate increased to 120 bpm. The physician stated that these symptoms were intermittent and not consistent with stimulation. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039453
« Last Edit: May 16, 2014, 03:48:58 AM by dennis100 » Logged
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« Reply #25 on: May 05, 2011, 03:56:54 AM »

Event Date 01/01/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, it was reported to the mfr by the vns pt that she has been experiencing vertigo for 1 1/2 yrs and is now having tachycardia that started about a yr ago that she thinks may be related to vns. She stated that her physician does not think it's related to her vns but she said she has been hospitalized for her tachycardia and the physician has not found a cause. A physician's office called requesting info regarding precautions for an electrophysiology procedure, (b)(6) study, to test the electrical activity of the heart in the vns pt. It was explained that electrical current going through the generator should be minimized, that the device could be disabled for the procedure, and that the device could be checked after the procedure. Good faith attempts for further info from the physician have been to no avail thus far. If add'l info is rec'd, it will be reported.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2065323

« Last Edit: May 16, 2014, 03:50:11 AM by dennis100 » Logged
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« Reply #26 on: May 08, 2011, 01:19:48 PM »

Event Date 09/22/2010
Event Type Injury Patient Outcome Hospitalization; Required Intervention
Event Description
It was reported that the patient was experiencing pain in the neck believed to be due to the implant procedure. The patient wanted to have stimulation enabled one week after surgery against manufacturer recommendations. The patient experienced painful stimulation at the vns generator site that radiates up to the left ear. This pain had been improving with the use of several medications including lidocaine injections, fentanyl patches and neurontin until the patient had a seizure and now the pain has worsened. The surgeon is considering using botox to alleviate the pain. The patient was then reported as having been hospitalized after having 4 seizures, but the neurologist attributes these to a change in medication. Patient's seizures were doing well with vns therapy prior to the medication change. It was also noted that the lead in the patient's neck was "vibrating" with stimulation. A nurse at the hospital had informed the physician that the generator could be seen vibrating inside the chest wall as well. The "vibration" is likely referring to muscle spasm, but no other information is known at this time. The neurologist also reported that while hospitalized, the patient experienced ventricular tachycardia. At this time, the physician attributes the arrhythmia to vns. The patient does not have a history of any heart conditions. Additional information received indicates that the patient is no longer hospitalized and is continuing vns therapy. No interventions are planned at this time. Attempts for further information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936628

« Last Edit: May 16, 2014, 03:51:34 AM by dennis100 » Logged
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« Reply #27 on: May 13, 2011, 01:26:47 AM »

Event Date 06/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention .
Event Description
Reported indicated that vns pt was hospitalized due to fever and increased heart rate 9>150 bpm). The pt was diagnosed with endocarditis. Tee (transesophageal echocardiogram) could not be performed due to pt's severe developmental disabilities. The pt was prescribed gentamyacin due to positive blood count. The magnet was placed over the device to temporarily discontinue stimulation. The pt's heart rate did not decrease during the time that vns stimulation was discontinued. Treating physicians reportedly did not believe that the pt's symptoms were in any way related to the vns since the pt had been implanted for so long without ever experiencing this type of incident. The pt was discharged and is reportedly doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=535925
« Last Edit: May 16, 2014, 03:52:28 AM by dennis100 » Logged
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« Reply #28 on: June 05, 2011, 01:28:16 PM »

Event Date 09/01/2001
Event Type Injury Patient Outcome Life Threatening;
Event Description
The reporter indicated that since the vns reporter has experienced shortness of breath associated with minimal exertion (i. E. Walking fast). The patient also experiences tachycardia during these events. The patient's heart rate will raise to 120 bpm from a resting rate of 80 bpm. It was reported that the patient had a very high energy level and a good deal of stamina prior to the implant. The patient's oxygen saturation was checked and resulted in normal and all pulmonary testing that has been done has also been normal. The patient reportedly does not notice any relationship between these symtpoms and the cycling of the vns. Patient also reported that the medications have not been changed. Patient stated that patient was having good seizure control until the last parameter adjustment. Subsequent to this adjustment, patient's seizures have increased, but are still below baseline.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=380159
« Last Edit: May 16, 2014, 03:53:06 AM by dennis100 » Logged
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« Reply #29 on: June 06, 2011, 07:25:19 AM »

Event Date 06/01/2002
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt was having some memory problems and wondered if the vns had anything to do with it. The pt also reports irregular heart rhythms (for which pt takes toprol), pain around the vns site since generator replacement surgery for end of service in 2002, and feeling like the leads are "too tight". Pt does not feel stimulation in their throat anymore, just throat spasms, and wonders if the vns is still working. The pt's medications were reportedly increased in december 2002. Pt reports that when pt bends their neck back too quickly or when pt looks up that pt has cramps in their neck. Pt reportedly has to use only one arm while lifting due to pain in shoulder on left side and chest. Further follow-up with pt revealed that the pt was diagnosed with "super-ventricular" tachycardia approximately one and a half years ago, shortly after being re-implanted in 2002. According to the pt, physician believes that pt's condition is related to the vns.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=443012

« Last Edit: May 16, 2014, 03:54:09 AM by dennis100 » Logged
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