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dennis100
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« Reply #60 on: December 16, 2010, 06:00:11 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
The reporter indicated that the pt is experiencing pain at the generator site and has had an increase in seizures. The reporter also indicated that the increase in seizures may be due to stress or tapering the pt off of their anti-epileptic medication. Investigation to date has been unable to determine whether the pt's chest pain is cardiac-related or whether the increase in seizures is above the pt's pre-vns baseline frequency.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520781
« Last Edit: February 13, 2015, 12:24:41 AM by dennis100 » Logged
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« Reply #61 on: December 16, 2010, 06:01:08 AM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that the pt has been experiencing pain and a burning sensation in the chest, neck and left arm for the past 3-4 weeks. It was also reported that the pt began experiencing continuous blurred vision approximately 2 weeks ago. Further follow-up revealed that the pt's device was programmed to off. Epileptologist indicated that the pt's symptoms and blurred vision resolved after programming the device to off. Epileptologist referred the pt to neurosurgen for possible device explant. Epileptologist would like the pt to be seen for follow-up by a neurophthalmogloist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520134
« Last Edit: February 13, 2015, 12:25:39 AM by dennis100 » Logged
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« Reply #62 on: December 16, 2010, 06:01:51 AM »

Event Date 03/09/2004
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt has been experiencing pain to the left breast, tenderness, and tingling and numbness to their left arm, with pain felt up to their neck. It was also reported that the pain is not related to device stimulation. Pt believes that the device has migrated down into their breast and that the device is palpable through the skin. The pt had been trying to lose weight and has lost 60 pounds since initially being implanted. The pt reports that it feels as if the device may have migrated due to the weight loss. The pt experienced chest pressure and pain to their left chest along with numbness and tingling to their left arm; therefore, thought that pt was having a heart attack and went to the hosp emergency room where pt was told that pt has not had a heart attack. The pt has been seizure-free until two months ago and has since experienced a seizure. Their last seizure involved more of their body and pt experienced urinary incontinence with the seizure. The pt also believes that the device magnet stimulation is weaker than it has been in the past. Further follow-up revealed that device diagnostic testing was within normal limits, indicating proper device function. Neruologist indicated that pt's chest pain has resolved. Neurologist does not believe that the pt's device has migrated; however, has reffered the pt for follow-up wtih neurosurgeon for second opinion and possible generator replacement due to the likelihood of the device nearing end of service.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520253
« Last Edit: February 13, 2015, 12:26:29 AM by dennis100 » Logged
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« Reply #63 on: December 16, 2010, 06:02:24 AM »

Event Date 10/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention  
Event Description
Reporter indicated that patient's device was programmed to off due to adverse side effects. It was reported that the patient was experiencing neck and chest pain with shortness of breath and an increase in seizures. The patient reported that they have been having large seizures like they had before they were implanted with the vns. The patient reports that they sometimes fall with their seizures. Treating neurologist indicated that the patient currently complains of dizziness most of the time, lack of energy, some night time coughing, shortness of breath at times and continuous pain around the generator and along the left side of the neck. The patient also has trouble sleeping and has a noise in their ears at times. It was reported that the increase in seizures was above the patient's pre-vns baseline frequency and that the patient's device was programmed to off to see if symptoms subside wihtout the vns therapy. The device remains programmed to off at this time. Further follow-up revealed that the patient perviously experienced an increase in seizures shortly after implant. The patient's device was programmed to off approx two months after stimualtion was intiated and was programmed back to on two months later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=519523
« Last Edit: February 13, 2015, 12:27:15 AM by dennis100 » Logged
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« Reply #64 on: December 16, 2010, 09:52:33 AM »

Event Date 06/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that pt is experiencing constant pain in their upper chest. Additionally, it was reported that the pt feels magnet mode stimulation in their stomach and then in the center of their upper chest area. Stimulation had just been initiated four days prior to the report of chest pain. The pt was in a psychiatric hosp at the time of the initial report and indicated that pt could not be seen by their neurologist while pt was in the psychiatric hosp. Investigation to date has been unable to determine the cause of the chest-pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=534877
« Last Edit: February 13, 2015, 12:28:07 AM by dennis100 » Logged
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« Reply #65 on: December 16, 2010, 09:53:46 AM »

Event Date 03/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention  
Event Description
Reporter indicated that vns pt was experiencing feeling like the device was "fluttering" and that pt could see the device move in their chest when pt is laying down. The pt can see their chest going up and down during these episodes and that it caused the pt severe pain for which pt has been seen in the hosp e. R. The pt also reports severe shortness of breath with stimulation. Device diagnostic testing was within normal limits, indicating proper device function. The pt has used the magnet to temporarily discontinue stimulation during the reported episodes. Treating neurologist indicated that the events were not related to the implant surgery or to the vns therapy system and no intervention is planned. The pt has requested a replacment vns therapy system. The pt reports that the use of the magnet does not stop stimulation. Cardiac issues have not been ruled out as the cause of the pt's symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=531735
« Last Edit: February 13, 2015, 12:29:07 AM by dennis100 » Logged
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« Reply #66 on: December 16, 2010, 09:54:50 AM »

Event Date 05/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that the pt's device was explanted due to pain at the generator site. It is unknown if the pain was cardiac related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=529263
« Last Edit: February 13, 2015, 12:29:43 AM by dennis100 » Logged
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« Reply #67 on: December 16, 2010, 11:49:33 PM »

Event Date 01/01/2004
Event Type Injury Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns pt was experiencing heart palpitations. The pt reportedly lives in a home that is under large utility wires. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=552078
« Last Edit: February 13, 2015, 12:30:12 AM by dennis100 » Logged
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« Reply #68 on: December 16, 2010, 11:50:13 PM »

Event Date 09/13/2004
Event Type Malfunction
Event Description
Reporter indicated that vns pt experienced "shooting electrical current" through their body after doing some heavy lifting earlier in the day. It was reported that the pt complained to the point of screaming that their device was shooting electrical current all across their chest and into their neck, causing constant sore throat and leading spouse to beleive that they were going to die. The pt's chest was described as being "red like if someone poured hot water on pt" and the pt was short of breath with difficulty swallowing during the episode. It was also reported that the pt had "red blisters" on their chest and that the pt experienced pain in their stomach and the bottom of their feet. The pt's spouse indicated that the pt has a history of heart problems and that spouse planned to sue the manufacturer if the pt died as a result of the shocking sensation. It was reported that the shocking stopped when the pt placed the magnet over the device. The pt was seen by treating neurologist who programmed the device to off. The device was successfully interrogated, but no diagnostic testing was performed because the pt was excessively belligerent to the point that the physician had to call security. It was reported that the pt had not experienced significant efficacy with the vns therapy prior to the incident. Treating neurologist does not believe that the device is malfunctioning and indicated that the pt has psychological issues. The device was later explanted at the pt's request.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612042
« Last Edit: February 13, 2015, 12:31:20 AM by dennis100 » Logged
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« Reply #69 on: December 16, 2010, 11:50:55 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt was diagnosed with sleep apnea after vns implant and that pt uses a bipap machine. The pt also reported slight "twinges" pain at their generator site with itching, and a quick electrical type shock. Device settings were lowered and the pt did not experience any more electrical shocks. Neurologist indicated that the pt is also experiencing hoarseness.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=546877
« Last Edit: February 13, 2015, 12:31:54 AM by dennis100 » Logged
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« Reply #70 on: December 16, 2010, 11:51:38 PM »

Event Date 08/16/2004
Event Type Malfunction
Patient Outcome Hospitalization;
Event Description
Reporter indicated that they were feeling "electrical surges" and experiencing erratic stimulation. The reporter also indicated that they were experiencing pain in the area of their pulse generator, and shortness of breath. The patient was subsequently admitted to the hospital. The patient indicated that the device was shocking them. At that time, the generator settings were decreased. Vns system diagnostic testing was performed and showed the device was delivering therapy; however, the magnet activations were not displaying. After the patient's settings were decreased, the patient no longer felt electrical surges, but the patient had seizures. X-rays were performed and didn't show any apparent anomalies. The generator was replaced. Vns system diagnostic testing was performed immediately prior to surgery and resulted in proper generator function. During generator replacement surgery no anomalies were noted with the replaced generator and the lead. The generator was programmed on to the same settings prior to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=612049
« Last Edit: February 13, 2015, 12:32:53 AM by dennis100 » Logged
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« Reply #71 on: December 16, 2010, 11:52:18 PM »

Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns patient was scheduled for revision surgery due to device migration. It was reported that the patient has been experiencing sharp pain around the generator site that travels up to the lead electrode site. The patient reports that they cannot tell if the pain coincides with stimulation because they do not feel normal mode device stimulation as they have become accustomed to it, but they do feel this pain when they swipe their device with the magnet. The patient also reports constant pain in their left shoulder which causes them pain when they lift their arm. The patient indicated that the generator was "in a weird location" and was causing their pain. The patient continues to experience significant efficacy with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=544818
« Last Edit: February 13, 2015, 12:33:35 AM by dennis100 » Logged
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« Reply #72 on: December 16, 2010, 11:53:20 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Reporter indicated that vns patient experiences a tightening, smothering feeling to their chest wall during device stimulation cycles. The patient reported that during these episodes, their heart "beats faster and harder". Treating neurologist indicated that the patient's symptoms had subsided ant that the patient was feeling better. The patient had reportedly been depressed and under a lot of stress lately and is scheduled for follow-up with their cardiologist. Neurologist indicated that the reported event was not related to the vns, but was possibly caused by angina, anxiety and/or panic attack. No intervention is planned or was taken. Device diagnostic testing was reportedly within normal limits, indicating proper device function. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to determine the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=554657
« Last Edit: February 13, 2015, 12:34:32 AM by dennis100 » Logged
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« Reply #73 on: December 17, 2010, 12:10:25 AM »

Event Date 01/26/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Patient experienced an increase in seizure activity above pre-vns baseline frequency after undergoing physicial therapy. The pt reported that they had an "ultrasound" and that they believed that it may have disturbed their device. The pt reported that they underwent physical therapy twice in four days, during which they used heat and aggressive massage in their left neck area, upper shoulders, and upper back. The pt did not know the exact name of the physical therapy procedure and was not sure whether it included diathermy. Since the physical therapy, the pt feels pain to their left neck and feels as thought the device "fibrates in their chest". The pt reported that they do not feel normal mode stimulation 97% of the time, but that they do feel magnet mode stimulation. The pt reported that since the first physical therapy treatment, they have been having "microseizures" above their pre-vns baseline frequency. The pt planned to contact their neurologist for follow-up. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Investigation to date has been unable to confirm the cause of the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=576815
« Last Edit: February 13, 2015, 12:35:13 AM by dennis100 » Logged
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« Reply #74 on: December 17, 2010, 12:11:05 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient was experiencing pain in their neck and chest in the area of the device and that their blood pressure and heart rate were low. The pt reported that they felt the neck and chest pain with device stimulation, but not with every stimulation cycle. The pt reported that they were seen in hosp emergency room three days due to the pain, at which time the er physician indicated that their blood pressure and heart rate were low and that the vns could be causing it. The pt planned to follow-up with their neurologist for device diagnostic testing. Investigation to date has been unable to determine whether the vns therapy was contributing factor to the reported hypotension and/or bradycardia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=576859
« Last Edit: February 13, 2015, 12:36:07 AM by dennis100 » Logged
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« Reply #75 on: December 17, 2010, 03:37:32 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention .
Event Description
Reporter indicated that vns pt experiences occasional discomfort with stimulation, which they describe as "almost painful" and seeming as if it makes their heart beat "too fast". Treating neurologist indicates that pt is doing well and that the patient's symptoms are likely due to depression. The pt is scheduled for follow-up with neurologist, at which time medication adjustments may be made. The vns therapy system is reportedly functioning without problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=545548
« Last Edit: February 13, 2015, 12:36:38 AM by dennis100 » Logged
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« Reply #76 on: December 17, 2010, 03:38:35 AM »

Event Date 11/01/2004
Event Type Malfunction  
Event Description
Further follow-up revealed that when the pt's device was programmed to on two week post implant the pt responded by "throwing their arms up and their eyes rolled back in their head". The pt's family member also indicated that the pt is experiencing pain with stimulation. The pt's family member reported that the pain brings tears to the pt's eyes and keep him up at night. The pt's family member also reported that without sleep the pt experiences difficulties keeping food down. The pt's family member also indicated that the pt has experienced an increase in grand mel seizures since implant along with throat tightness and hoarseness. The pt was later seen by physician at which time device diagnostic testing was performed and was within normal limits. Physician decreased normal mode output current from 1. 0ma to 0. 75ma and the pt was much more comfortable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=571431
« Last Edit: February 13, 2015, 12:37:19 AM by dennis100 » Logged
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« Reply #77 on: December 17, 2010, 03:40:34 AM »

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: February 13, 2015, 12:38:31 AM by dennis100 » Logged
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« Reply #78 on: December 17, 2010, 03:41:45 AM »

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
« Last Edit: February 13, 2015, 12:39:37 AM by dennis100 » Logged
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« Reply #79 on: December 17, 2010, 03:42:53 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that vns pt has recently experienced feelings of being very tired and weak with feelings of their heart pounding and soreness of the muscles in their upper body. The pt has reportedly discontinued device stimulation with use of the magnet on several occasions, after which their condition improves after "some hours. " the pt does not take any anti-epileptic medications. 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=569107
« Last Edit: February 13, 2015, 12:40:20 AM by dennis100 » Logged
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« Reply #80 on: December 17, 2010, 03:43:42 AM »

Event Date 03/01/2005
Event Type Malfunction  
Event Description
Reporter indicated that vns pt's device was stimulating erratically, causing the pt to have part in their chest. It was reported that the pt's device was stimulating every 2 seconds for a couple of days. The pt planned to follow-up with their neurologist. Programmed parameters were last adjusted approx one month prior to the erratic stimulation event. Review of the manufacturing records for the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=588160
« Last Edit: February 13, 2015, 12:40:56 AM by dennis100 » Logged
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« Reply #81 on: December 17, 2010, 03:45:52 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Vns therapy system labeling lists dyspnea and dizziness as potential adverse events possibly associated with surgery or stimulation. Additionally, vns therapy system labeling states that dyspnea may result from stimulation, pts with chronic obstructive pulmonary disease may have an increased risk of dyspnea. Treating neurologist indicated that the reported events were "positively" not related to the vns. Neurologist indicated that the source of the pt's shortness of breath and chest pain that have caused the pt to become dizzy and to pass out, are most likely cardiac or respiratory problems because of the pt's excessive smoking.

Event Description
Reporter indicated that vns pt has experienced an increase in shortness of breath with exertion over the past seven months and that pt recently experienced a fainting episode preceded by shortness of breath with activity dizziness and lightheadedness. The pt was walking to a bus stop, which was up an incline. When he reached the top of the incline, pt was winded and felt lighteadged. The next thing pt remembered was bieng in the back of an ambulance and having an ekg. The pt was taken to the hosp e. R. And diagnosed as having had a seizure episode, though the pt adamantly deries that the event was seizure-related. The pt expressed concern about their vns settings and the possibility that their lead may be constricted becaused pt feels tautness in the left pectoral area. The pt reportely planned to follow-up with their internist. During a follow-up telephone call to the pt from device mfr, the pt experienced a similar episode, during which pt stopped talking in mid-sentence, began to gasp for air and dropped the telephone. The pt continued to gasp for air for approximately 30 seconds. Afterward, the pt seemed to be experiencing severe postictal confusion. The event was immediately reported to the pt's neurologist who agreed to follow-up. Mfr rep then hung mfr back. When the sequence of evnets was explained to the pt, pt denied having had a seizure and did not recall any of it. The pt reported that this type of episode had never happened before and that pt would follow-up with their neurologist. While undergoing an eeg the following day, the pt experienced another similar episode. Before the tracing began and while the electrodes were being applied, the pt had a spell lasting approximately 30 seconds of total loss of consciousness without any convulsive movements and with a postictal period of confusion lasting 3 to 5 minutes. Treating neurologist has repeatedly referred the ot for chest x-ray and cardiac work-up, but the pt has yet to schedule those appointments.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578582
« Last Edit: February 13, 2015, 12:42:29 AM by dennis100 » Logged
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« Reply #82 on: December 17, 2010, 03:47:30 AM »

Event Date 01/01/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient has experienced an increase in seizure frequency. The pt has been feeling short of breath, even wtih inactivity and that their left arm occasionally twitches. The pt also reports feeling as if their whole chest is burning and itching. The pt has been seen by treating neurologist on two occasions due to the aforementioned events and that neurologist may have adjusted device settings at these office visits. The pt's neurologist instructed pt to relax and to calm down because pt is anxious.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=608260
« Last Edit: February 13, 2015, 12:43:08 AM by dennis100 » Logged
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« Reply #83 on: December 17, 2010, 03:48:37 AM »

Event Type Malfunction  
Event Description
Vns pt underwent generator replacement surgery due to suspected device malfunction. The pt experienced efficacy with the vns therapy for the first six mos after implant, but that they "has gone downhill from there". The pt reports chest pain in the area of the generator and reportedly cannot lay down without increased pain at the site. The pt also reports periodic shocks in their chest. The pt can no longer feel device stimulation when they swipe the device with the magnet and reports that initiation of magnet mode stimulation no longer stop their seizures as it did previously. The pt reports trouble sleeping and less coughing and hoarseness than previously experienced. It was reported that the pt may manipulate the device through the skin. Device diagnostic testing was reportedly within normal limits, indicating proper device function and review of x-rays by treating physician did not reveal any obvious discontinuities in the vns therapy system. The elective replacement indicator was not indicating that the generator had not reached end of life. During the generator replacement surgery, the original lead was examined and determined to be intact. Device diagnostic testing of the replacement generator connected to the original lead was within normal limits, indicating proper device function. It was reported that because the pt was experiencing difficulty performing effective magnet swipes, the replacement generator was secured in a more medial position. It was noted that prior to explant of the original generator, there were greater than two inches of adipose tissue over the generator, which may have affected inition of magnet mode stimulation. The pt has previously complained of difficulty initiating magnet mode stimulation because the generator was placed deep in the tissue pocket. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to confirm proper device function.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=592170
« Last Edit: February 13, 2015, 12:43:54 AM by dennis100 » Logged
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« Reply #84 on: December 17, 2010, 03:50:05 AM »

Event Date 03/01/2005
Event Type Malfunction
Event Description
Reporter indicated that vns patient can no longer feel device stimulation and no longer experiences voice change during stimulation cycles. The patient reportedly feels magnet mode stimulation, but does not feel normal mode stimulation, even when it is set to the same output current as the magnet mode stimulation, 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 life. The patient's family member indicated that the patient's device settings were recently increased and that stimulation after the increase "knocked them down" and they couldn't breathe, they coughed and they could hardly talk since the parameter adjustment. The patient reportedly felt normal mode stimulation 4 times in a row following the increase in parameters and hasn't felt it since. The patient's family member believes that the device is not functioning properly. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=592845
« Last Edit: February 13, 2015, 12:44:31 AM by dennis100 » Logged
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« Reply #85 on: December 17, 2010, 03:51:04 AM »

Event
« Last Edit: May 25, 2018, 12:21:00 AM by dennis100 » Logged
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« Reply #86 on: December 17, 2010, 03:52:55 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
When vns patient is talking or laughing a lot, they feel their heart racing and their chest and arm hurt on the left side. The patient reports that when they are talking, they get tired very fast. The patient reports they occasionally experiences chest pain in the area of the device when they are talking. When this pain occurs, the patient begins to lose their voice and lose their breath and they feel their heart rate accelerate. The pain reportedly lasts for approximately 3 minutes and the patient drinks water to regain their voice and breath and takes over the counter pain medications for the pain. Additionally, the patient reports that they feel as though there is less tissue over the device now than when it was first implanted. The patient reported that months ago, their neurologist referred them back to the neurosurgeon due to complaints of pain in the area of the device and that the surgeon indicated that everything was fine at that time. Treating neurologist does not believe that the patient's complaints are related to the vns and indicated that they may psychogenic or related to anxiety. Treating neurologist indicated that the device had not migrated and that there were no signs or symptoms of infection or other problems. The patient currently experiences 1-2 seizures per day, but has not had to go to the hospital emergency room for seizures in some time. 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=600068
« Last Edit: February 13, 2015, 12:46:49 AM by dennis100 » Logged
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« Reply #87 on: December 17, 2010, 11:31:21 AM »

Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening;  
Event Description
Vns patient has experienced needle-like chest pain during stimulation that radiates from them sternum to left chest and down their left arm along with becoming diaphoretic. The pain reportedly started when the patient began training for long distance marathon racing. The patient participates in a strenuous exercise class that involves much running and sprinting and reportedly becmes symptomatic during stimulation cycles when exerting this much energy. With these symptome, patient ends up stopping and having to kneel down until the symptoms subside. The patient has a history of asthma but was recently cleared by their pulmonologist. The patient has stopped all activity pending consult with a cardiologist. Investigation to date has been unable to determine whether the patient's chest pain is cardiac-related as results of evaluation by cardiologist were not yet available in physician's records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=621150
« Last Edit: February 13, 2015, 12:47:25 AM by dennis100 » Logged
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« Reply #88 on: December 17, 2010, 12:14:41 PM »

Event Date 06/28/2005
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt experienced voice changes, shortness of breath and chest pain with stimulation following an adjustment in device settings. The pt asked their neurologist when the voice changes and shortness of breath would go away, but did not mention chest pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622607
« Last Edit: February 13, 2015, 12:48:04 AM by dennis100 » Logged
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« Reply #89 on: December 17, 2010, 12:15:41 PM »

Event Date 05/01/2005
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt was explanted due to complaints of neck pain and chest tightness. Initial reporter indicated that the pt was not mentally stable and was not reliable when it comes to expressing how pt really feels. Both the generator and lead (excluding electrodes) were explanted. Investigation has been unable to determine whether the chest tightness was cardiac-rleated as no response has been received to manufacturer's requests for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=615372
« Last Edit: February 13, 2015, 12:48:39 AM by dennis100 » Logged
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