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dennis100
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« on: May 12, 2011, 12:46:27 PM »

1997 FDA CDRH Neurological Devices Panel

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 02/01/2004
Event Type Injury Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Further follow-up revealed that the pt experienced a fall after having a breakthrough seizure and experienced a left shoulder injury. The pt indicated that she was hospitalized after experiencing chest pain with loss of consciousness. During hospitalization tested confirmed cardiac, but no cardiac structural abnormalities were evident. According to the pt, the physician declined to perform a cardiac cath due to the presence of the vns therapy system and attributed the pt's cardiac problems to vns therapy. Hosp physician also reportedly requested the pt to have the device programmed to off by treating neurologist. The pt is managed with holter monitoring. Treating neurologist plans to temporarily discontinue the device stimulation during the holter monitoring. Treating neurologist does not believe that the cardiac events are related to vns therapy because the pt had been implanted for approx 1 1/2 years without complication. The holter monitoring was performed and the pt reported that the monitoring showed that the arrhythmia is related to the device stimulation; however, it only occurred following magnet mode stimulation. The pt indicated that she does not want the device stimulation discontinued because of the efficacy she receives. The root cause of the reported event is unknown. The cause of the arrhythmia is possibly due to the lead becoming displaced during the pt's fall and becoming too close to the cardiac branches.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515302
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« Reply #1 on: May 12, 2011, 12:54:54 PM »

Event Date 02/19/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced feelings of heart fluttering and light-headedness while using a microwave. It was reported that the pt had been microwaving several dishes (approximately 6 plates of food, approximately 3 minutes each) when pt experienced light-headedness, irregular heartbeat and a fluttering feeling in their heart that made pt have to go lie down. The pt has a pre-vns history of heart murmur, chest pain and irregular heartbeat, but what pt felt while using the microwave was different. The pt plans to follow-up with their neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=517933

« Last Edit: December 11, 2014, 08:57:36 AM by dennis100 » Logged
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« Reply #2 on: May 13, 2011, 04:06:50 AM »

Event Date 01/01/2004
Event Type Malfunction
Manufacturer Narrative
Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Review of x-rays did not reveal any obvious discontinuities in the vns therapy system. This event is currently under investigation. Report is incomplete because no response has been received to manufacturer's requests for additional information from treating neurologist (via fax x2 and telephone message x1). H. 6. Vns therapy system labeling lists device (generator and/or lead) migration or extrusion as a potential adverse event possibly associated with surgery or stimulation.

Event Description
Reporter indicated that vns patient has experienced intermittent shocks in the neck area. It was also reported that the device may have migrated or turned because the patient can now feel the device in their armpit when patient swings their arm. Additionally, the patient indicates that the lead is tight in their neck.

Event Description
Further follow-up revealed that the pt is not experiencing any current problems. Treating neurologist believes that the device stimulation is related the reported events. It was reported that the cardiac arrhythmias have resolved with the device programmed to off. The pt requested that the vns therapy system remained programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612125

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« Reply #3 on: May 13, 2011, 07:34:30 AM »

Event Date 08/01/2004
Event Type Injury Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6 vns therapy labeling lists heart rate/rhythm changes as a potential event possibly associated with surgery or stimulation.
Event Description
Reporter indicated that vns pt was diagnosed with arrhythmia. It was reported that the pt had recenly "had some ekg changes. " it was reported that the pt did not exhibit any clinical symptoms of arrhythmia, but that treating neurologist wanted to try a new medication and had ordered an ekg prior to making this medication change. The ekg reportedly showed an arrhythmia. Further follow-up with neurologist revealed that the pt was "fine" and that cardiac evaluation showed no problems. It was reported that the pt's qt interval appeared to be borderline, but was not believed to be problematic. Neurologist indicated that the relaionship between the reported event and the vns was unk. Investigation to date has been unable to determine the cause of the apparent arrhythmia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=547650
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« Reply #4 on: May 13, 2011, 12:30:32 PM »

Event Date 11/24/2004
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Reported indicated that pt developed an infection at the incision site after vns implant surgery. Oral antibiotics wre prescribed. Additionally, the pt noticed problems with heart arrhythmia when stimulation was initiated two weeks post-op. The pt also indicated that the device caused depression during stimulation cycles and that the generator has migrated sideways, resulting in a "heavy feeling" and neck pain requiring vicodin. The device was subsequently programmed to off approximately three weeks after stimulation was initiated; however, the pt thinks pt still feels stimulation. The pt was seen for explant consultation by neurosurgeon who reportedly called pt a "baby" and indicated that he would not explant the vns therapy system and that the pt should simply have the device programmed to a lower setting. Treating neurologist reportedly indicated that the pt "is very sensitive to things" and that the pt still wanted to have the vns therapy system explanted. Review of manufacturing records for both the pulse generator and the bipolar lead confirmed sterilization of devices. Investigation to date has been unable to determine the cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571541
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« Reply #5 on: May 14, 2011, 09:43:43 AM »

Model Number 102
Event Date 10/01/2005
Event Type Death Patient Outcome Death; Life Threatening Hospitalization
Event Description
Reporter indicated that pt was hospitalized approximately 15 weeks post vns implant due to respiratory arrest. While hospitalized, an ecg reportedly revealed a cardiac arrhythmia. Further follow-up revealed that the pt had passed away approximately one month from date of hospitalization. It was reported that the pt experienced prolonged cardiopulmonary arrest with significant cerebral hypoxic ischemic injury. Exact cause of death is not known at this time and it is not known whether the pt expired while hospitalized or whether she was discharged prior to death. There is no evidence at this time that the vns therapy system caused or contributed to the reported events. Report is incomplete because no response has been received to mfr's requests for additional info from staff at group home where pt resided. An incomplete response was received to mfr's request for additional info from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=649205

« Last Edit: December 11, 2014, 08:59:57 AM by dennis100 » Logged
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« Reply #6 on: May 15, 2011, 12:47:24 PM »

Model Number 101
Event Date 11/01/2004
Event Type Malfunction
Event Description
Further follow-up revealed that the patient underwent generator replacement surgery. During the surgery, device diagnostic testing was within normal limits and had no cardiac effects. The pulse generator was then disconnected from the bipolar lead and a new generator was connected to the existing lead. Subsequent lead tests were within normal limits and had no cardiac effects. The patient left the operating room with the device programmed to off. The patient reported that the device was initially programmed to off due to what patient believed to be an arrhythmia. The cause of the reported events is most likely due to device stilumlation because the patient's symptoms resolved when the device was programmed to off.

Event Description
Further follow-up revealed that the patient's arrhythmia began approximately on year following implant. Epileptologist indicated that the arrhythmia was related to vns therapy. Epileptologist reported that the patient's symptom were continous and that the symptoms have resolved with ncp system replacement. The cause of the reported event cannot be ascertained because the explanted generator will not be returned to device manufacturer for analysis per the explanting hospital's policy.

Event Description
Reporter indicated that vns pt was hospitalized due to continuous device stimulation for more than 4 hours. The pt experienced coughing, tightness and pain in their chest during the continuous stimulation episode. It was reported that the pt's magnet was taped over the device to discontinue stimulation. The pt's symptoms reportedly subsided when stimulation was temporarily discontinued with the magnet. Device diagnostic testing was reportedly with normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Further follow-up revealed that just prior to the reported continuous stimulation episode, the pt hit their left shoulder, causing them pain on left side of their neck with stimulation. Treating neurologist reportedly decreased normal mode output current from 2. 25ma to 1. 0ma, but the patient's pain did not subside. The pt's device was subsequently programmed to off later that same day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=612054

« Last Edit: December 11, 2014, 09:00:53 AM by dennis100 » Logged
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« Reply #7 on: May 15, 2011, 12:53:41 PM »

Event Date 04/13/2003
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that the vns pt had passed away. It was reported that while away on vacation, the pt suddenly collapsed. Exact cause of death is unknown at this time, although myocardial infarction is suspected. No autopsy was performed. There is no evidence at this time that the ncp system caused or contributed to the reported event. The physician indicated that there was no change in the pt's seizure control with the vns therapy. The pt was receiving vns therapy at the time of death.


http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=461914
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« Reply #8 on: May 15, 2011, 01:00:38 PM »

Event Date 12/06/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported to a cyberonics country manager in the (b)(4) that during titration of the vns device the patient experienced an arrhythmia. The patient's pulse rate decreased as well as the time between pulses. This occurred three times while the vns output current was set on 0. 50ma. The patient was therefore left at a lower output current of 0. 25ma. The patient did not present with any symptoms, traumatic events, or have any triggers suggesting an arrhythmia post operative. No medication changes were noted. The arrhythmia correlated with the on time of the programmed device settings and occurred following a setting change of 0. 25 ma to 0. 50 ma output current. Electrocardiography was used to diagnose the arrhythmia and the physician believes that the arrhythmia is related to vns therapy stimulation. The vns was set to a lower output current as an intervention to prevent the patient from continued arrhythmia. Attempts have been made for information; however, no more information has been received to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2008487
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« Reply #9 on: May 15, 2011, 01:03:16 PM »

Event Date 01/04/2011
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by a vns patient that while following up with his primary care physician, he was informed that he had an irregular heartbeat. Follow up with the patient's neurologist revealed that he told the patient to follow up with a cardiologist. However, the neurologist later released the patient from his care due to behavioral issues. The neurologist did perform device diagnostics prior to releasing the patient and the results were said to be within normal limits however the exact test results were not provided to the manufacturer. 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=2005775
« Last Edit: December 11, 2014, 09:02:31 AM by dennis100 » Logged
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« Reply #10 on: May 15, 2011, 01:08:30 PM »

Event Date 01/01/2009
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported that the pt was having some "cardiac issues," but it was unk about the type of cardiac event that was occurring. There were no further details provided. The pt was referred to a cardiologist for consult, but no information has been provided regarding the outcome of the visit. Good faith attempts have been made to obtain additional information have been unsuccessful to date. The relationship of the device to the patient's event is unknown at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365869
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« Reply #11 on: May 15, 2011, 01:19:21 PM »

Event Date 11/24/2010
Event Type Injury Patient Outcome Other;
Event Description
It was initially reported that a vns pt was "experiencing an extra heart beat with stimulation", which had been occurring for the past several months. The pt's medical professional was able to verify that an extra beat appeared with stimulation from vns. The stimulation events were also correlated to the pt's transient hoarseness from the vns therapy. Further info indicated that the pt had a prior heart condition, resting sinus tachycardia; however, there had been no cardiologist work-up prior to implantation with the vns. Settings at the time of the initial report were 1 ma/15 hz/130 microsec/7 sec/1. 8 min with no current diagnostic data available. There had been no changes in medications or settings to cause the onset of the event. Furthermore, the device was not disabled to see if the symptoms went away. Further info from the pt revealed that she had a "recent cardiovascular event" where "she felt she had an extra heartbeat". It was recommended to the pt that she see a cardiologist by her treating physician. Good faith attempts to gain further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2005854
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« Reply #12 on: May 15, 2011, 01:37:09 PM »

Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt had an abnormal ekg. The abnormal ekg was observed during pre-operative testing for hernia repair. The reporter also indicated that the pt had not previously had an abnormal ekg.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520435

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« Reply #13 on: May 15, 2011, 01:40:06 PM »

Event Date 11/24/2004
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« Reply #14 on: May 15, 2011, 03:53:13 PM »

Event Date 10/01/2005
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« Reply #15 on: May 16, 2011, 04:32:02 AM »

Event Date 09/17/2002
Event Type Injury Patient Outcome Required Intervention;
Event Description
Patient reported that they were experiencing painful stimulation. The device was programmed to off in 07/2002 and turned back on in 2002. Ever since the device was turned back on, the patient has been experiencing the following symptoms and attributes these symptoms to vns: dizziness, inability to sleep (insomnia), increase cough, weight loss (25 lbs), ringing in the ears (tinnitus), heart rate and rhythm changes, only with stimulation (arrhythmia). The patient was not experiencing the painful stimulation anymore as reported initially. The patient used their magnet to turn off their device and all of the above symptoms were gone except the ringing in ears. The physician programmed the patient's output current and magnet output current to 0ma (off) again. The physician checked the patient's blood levels for any chemical imbalance. If the blood level results are normal, then the physician will recommend explant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426466


« Last Edit: December 11, 2014, 09:04:35 AM by dennis100 » Logged
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« Reply #16 on: May 20, 2011, 03:10:29 AM »

Event Date 07/01/2008
Event Type Injury Patient Outcome Life Threatening;
Event Description
It was reported to mfr that the vns pt was experiencing an irregular heartbeat. The pt reported that when the physician attempts to increase the device settings, the arrhythmia occurs and the physician has to turn the settings back down. The pt reported that follow up was performed with a cardiologist, who attributed the irregular heartbeat to vns therapy. Attempts to obtain additional info from the treating physician are underway.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1098147

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« Reply #17 on: May 24, 2011, 01:22:26 AM »

Event Date 11/10/2008
Event Type Injury Patient Outcome Death;
Event Description
It was reported a vns therapy patient passed away. The patient experienced cardiac adverse events 4 months prior to the patient's death. Follow up with the medical professionals did not reveal an exact cause of death as no details of the patient's passing were provided by the patient's family; however, the treating physician stated it was "probably not related" to vns therapy. Follow up with the county medical examiner's office did not know the cause of death as an autopsy was not performed. Manufacturer reviewed available programming/diagnostic history and the most recent device diagnostic test was performed in early 2007, at which time the results were with in normal limits. A battery life calculation revealed the patient's generator was 6. 01 years until the elective replacement indicator read "yes". Good faith attempts to obtain the cause of death listed on the patient's death certificate, as well as the patient's vns therapy system for analysis, have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1398522
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« Reply #18 on: June 03, 2011, 02:25:05 PM »

Event Date 07/30/2010
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
It was reported that the pt was experiencing a lot of side effects due to the vns stimulation. F/u with physician reveals side effects included sleep apnea, arrhythmia, pain, laryngismus, skin reaction, and possible nerve damage. The physician attempted changing the settings, but the side effects persisted. The vns has been turned off to date. X-ray were taken of the device which revealed no anomalies, per physician. No device malfunction was reported. The pt would like to have the vns removed, but no surgery has occurred to date. Attempts for further info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830809
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« Reply #19 on: June 03, 2011, 02:26:38 PM »

Event Date 07/31/2010
Event Type Injury Patient Outcome Required Intervention;
Event Description
It was reported by a vns patient's mother that the patient who was implanted with vns in (b)(6)2009, was sedated for a procedure about one month ago and while sedated, the anesthesiologist informed the mother that the patient had arrhythmia. The patient went to a cardiologist a week later, and an echo cardiogram was performed which indicated good heart function however, the measurements were off a little. The patient was going to follow up with the cardiologist in about 18 months. Follow up with the neurologist revealed that it was unk whether or not the arrhythmia was related to vns. The arrhythmia did not occur with stimulation. There were no causal or contributory medication or programming changes prior to the onset of the arrhythmia. 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=1852350

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« Reply #20 on: June 04, 2011, 03:22:24 AM »

Event Date 10/01/2010
Event Type Injury Patient Outcome Life Threatening;
Event Description
It was initially reported by the nurse that the pt was having some cardiac issues which she attributes to vns. Good faith attempts to obtain additional information has been unsuccessful till date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1905621
« Last Edit: December 11, 2014, 09:06:39 AM by dennis100 » Logged
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« Reply #21 on: June 04, 2011, 03:41:24 AM »

Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt was experiencing chest tightness. It was also reported that the pt had a seizure recently and pt fell down the stairs and hurt their hand. The pt did not see a physician for the hand. Further follow-up revealed that the physician does not know if the chest tightness is cardiac-related and it was indicated that the pt had not had an ekg done.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=477468

« Last Edit: December 11, 2014, 09:06:57 AM by dennis100 » Logged
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« Reply #22 on: June 06, 2011, 07:22:07 AM »

Event Date 11/01/2002
Event Type Death Patient Outcome Death;
Event Description
Vns patient passed away due to heart problems. There is no evidence at this time that ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=440925
« Last Edit: December 11, 2014, 09:07:16 AM by dennis100 » Logged
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« Reply #23 on: June 06, 2011, 12:37:35 PM »

Event Date 03/25/2004
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that vns patient had passed away. It was reported that the patient was walking into a room and simply dropped dead. Treating neurologist indicted that the death may be cardiac-related, but is not sure as autopsy results are pending. Cause of death is not known at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=522043
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« Reply #24 on: June 07, 2011, 12:12:34 AM »

Event Date 05/15/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Vns pt has experienced an increase in heart rate the day after device output current was increased from 0. 75ma to 1. 0ma. The pt also indicated that they have experienced gum swelling and abscess (15 white spots on gums), pain at the generator site and headache. Further follow-up with treating neurologist revealed that the pt's device output current was lowered to 0. 75ma and that the pt is fine. Neurologist believes that the pt became extremely anxious and that the abscess was secondary to the administration of dilantin medication.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=465478

« Last Edit: December 11, 2014, 09:07:52 AM by dennis100 » Logged
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« Reply #25 on: June 07, 2011, 12:13:48 AM »

Event Date 03/01/2003
Event Type Injury Patient Outcome Life Threatening; Required Intervention
Event Description
Vns device was turned "off" due to problems with the patient's heart rate decrease. The reporter indicated that the patient's seizure duration has decreased but the frequency of the seizures are the same. Reporter also stated that the patient's physician has been trying different medication treatments. The patient will see the physician for re-evaluation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=465437

« Last Edit: December 11, 2014, 09:08:10 AM by dennis100 » Logged
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« Reply #26 on: June 07, 2011, 01:22:47 AM »

Event Date 07/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt has been experiencing varying heart rate and tightness in the chest. It was reported that the heart beats very fast and then slows down at times with stimulation. It was reported that the pt had been seen by a cardiologist and was wearing a heart monitor for eval of heart rate. Investigation to date has been unable to determine whether the vns therapy was causing or contributing to the pt's varying heart rate.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=479869

« Last Edit: December 11, 2014, 09:08:30 AM by dennis100 » Logged
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« Reply #27 on: June 07, 2011, 04:02:07 AM »

Event Date 01/01/2003
Event Type Injury Patient Outcome Life Threatening;
Event Description
Vns patient has experienced a slowed heart rate. The patient had recently been seen by a cardiologist for reasons unrelated to the vns at which time the cardiologist reportedly told the patient that their heart rate was below normal and that is was probably caused by the vns device. The patient reportedly did not notice the abnormal heart rate before their visit with the cardiologist. Treating neurologist indicated that the patient has a history of major psychiatric problems and over using of the magnet which results in chest pain. The patient is reportedly hospitalized for their psychiatric problems at this time. Investigation to date has been unable to determine whether the patient has previous cardiac history.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484515
« Last Edit: December 11, 2014, 09:08:51 AM by dennis100 » Logged
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« Reply #28 on: June 07, 2011, 06:59:05 AM »

Event Date 10/01/2003
Event Type Injury Patient Outcome Life Threatening; Hospitalization
Event Description
Vns patient was experiencing dizziness and ct scan of the head was planned. It was also reported that the patient's blood pressure began to "go up and down with stimulation. " at one point during stimulation, the patient's blood pressure was 180/113 and at another point it was around 140/65. The patient reportedly felt dizzy during this time. It was reported that the patient's pulse rate was also running high (around 87 when it is normally 70). Treating neurologist does not believe that the patient's symptoms are related to the vns and has reffered the patient to primary care physician for treatment of blood pressure and heart rate problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=495340

« Last Edit: December 11, 2014, 09:09:15 AM by dennis100 » Logged
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« Reply #29 on: June 07, 2011, 06:59:43 AM »

Event Date 04/24/2002
Event Type Death Patient Outcome Death;
Event Description
Manufacturer periodically compares device tracking information to the social security death index for the purpose of updating device tracking data. Manufacturer became aware of patient death during this process and evaluated available information against current procedures. The event did not meet mdr criteria per manufacturer's current procedures. In an effort to obtain additional information regarding patient deaths for summary reporting request, certificate of death was requested, received and reveiwed by manufacturer. Immediate cause of death is listed as sudden death with underlying cause of seizure disorder and cardiac abnormalities. Hypothalamic hematoma, resected is listed as a contributing condition. There is no evidence that the ncp system caused or contributed to the reported event; however, based on the reported cause of death, although it is not believed that it is likely that the vns therapy caused or contributed to the pateint's death, it cannot be definitively ruled out as a factor.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=496421

« Last Edit: December 11, 2014, 09:09:36 AM by dennis100 » Logged
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