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dennis100
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« Reply #30 on: April 21, 2011, 11:08:06 PM »

Event Date 09/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
During the process of a post-implant follow up call with the pt, the mfr's representative learned that the pt is experiencing the following problems: edema in their throat, enlarged veins in their chest area, discomfort in their arm including numbness and tingling, tightness in their chest, and device migration. Further info revealed that during the pt's follow-up visit with their physician, they complained of breakthrough seizures, bowel incontinence, trouble breathing and rash. The pt reported that they were coughing up "yellowish/blood tinged matter. " during subsequent follow-up visits, the pt complained of headaches, ringing in their ears and chronic pain. On the office visit in 2002, the pt indicated that the vns is working well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=443116
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« Reply #31 on: April 22, 2011, 08:03:38 AM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Life Threatening; Disability Required Intervention
Event Description
Reporter indicated that vns pt has been experiencing daily episodes of vomiting since programmed device output current has been set to 1. 25ma. Treating neurologist reportedly did not attribute the vomiting to the vns and increased the programmed device output current to 1. 50ma. After the parameter increase, the pt reportedly began having spells of head bobbing and pt would become uncoordinated with "rubbery legs" and " a palsy appearance". These spells reportedly last for about an hour and then resolve. Treating neurologist reduced programmed output current to 1. 0ma, but the pt's symptoms have not resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=484506
« Last Edit: October 05, 2015, 03:04:24 AM by dennis100 » Logged
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« Reply #32 on: April 22, 2011, 08:04:07 AM »

Event Date 05/24/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Vns pt was hospitalized for two months due to liver enzymes and metabolism problems. The pt was reportedly evaluated by the implanting surgeon, a gastroenterologist, their physician and their neurologist during their hosp stay. The pt had been on a ketogenic diet prior to hospitalization. Medications were stopped upon admission to hosp due to elevated liver function tests. No root cause for either the liver problems or the digestive problems was established. It was reported that the pt's digestive problems did not resolve when vns therapy was discontinued and that the treating neurologist did not believe that the pt's symptoms were related to the vns. Treating physicians are considering programming the pt's vns therapy system back to on. The pt has reportedly been released from hosp and is on iv fluids only at home.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=481332
« Last Edit: October 05, 2015, 03:04:36 AM by dennis100 » Logged
dennis100
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« Reply #33 on: April 22, 2011, 10:19:37 PM »

Event Date 11/02/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. The death certificate listed the immediate cause of death as multiple organ failure, due to (or as a consequence of) hemorrhagic infarction of distal small bowel. The pt died while in the hospital. The manner of death was listed as natural. An autopsy was performed. 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=497597
« Last Edit: October 05, 2015, 03:04:52 AM by dennis100 » Logged
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« Reply #34 on: April 22, 2011, 11:55:44 PM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that patient experienced an increase in seizures and incontinence after device output current was initially programmed to on (0. 5ma). It was reported that the patient experienced a few seizures per month prior to vns therapy system implant and after implantation prior to having the device programmed to on. After programming the device to on the patient experienced up to 3 seizures per day in combination with incontinence. The device was later programmed to off. The patient's family is willing to have the device programmed back to on; however, would like to wait until the patient is on holiday from school to prevent further embarrassment to the patient. It was also reported that the patient usually experiences seasonal deterioration around this time of year, however, it has never been this dramatic or sudden.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=516686
« Last Edit: October 05, 2015, 03:05:04 AM by dennis100 » Logged
dennis100
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« Reply #35 on: April 23, 2011, 05:48:33 AM »

Event Date 03/24/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization
Event Description
Reporter indicated that vns pt was seen in hosp e. R. The day after implant surgery. The pt experienced a severe seizure and was admitted to icu for 3 days with decreased potassium and sodium levels. The pt was vomiting and could not hold down any medications. Stimulation was initiated approx two weeks later and the pt is now reportedly doing well.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=524042
« Last Edit: October 05, 2015, 03:05:19 AM by dennis100 » Logged
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« Reply #36 on: April 23, 2011, 05:49:02 AM »

Event Date 04/28/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away from a stomach hemorrhage. The pt was reportedly riding in the car and began to vomit blood. The pt's family member performed cpr until emergency medical crew arrived, but the pt died while en route to hospital. No autopsy was performed. The death certificate listed the immediate cause of death as cardiopulmonary arrest, due to (or as a consequence of) "ashysim", due to (or as a consequence) aspiration of emesis, due to (or as a consequence of) cerebral palsy. The manner of death was listed as natural. 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=529731
« Last Edit: October 05, 2015, 03:05:32 AM by dennis100 » Logged
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« Reply #37 on: April 23, 2011, 05:49:39 AM »

Event Date 03/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns pt experienced problems with vomiting following an increase in programmed device output current from 0. 75ma to 1. 0ma. Programmed device settings were decreased, after which the pt was reportedly vomiting less but refusing to eat due to gagging. The pt was also more irritable following the parameter reduction. Treating neurologist indicated that the event was possibly related to the vns. The pt has history of chronic pancreatitis, but has not had any problems with the pancreatitis for approximately one year. The pancreatitis was reportedly ruled out as a factor. It was reported that it is difficult to pinpoint exactly what is wrong with the pt as pt is non-verbal. Neurologist believes that device stimulation may be causing the pt to gag; therefore causing pt to not want to eat. It was also reported that the pt recently had what is believed to be a viral infection not related to the vns. Neurologist plans to see the pt for follow-up in one month to see if the decrease in device settings helps symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=528244
« Last Edit: October 05, 2015, 03:05:44 AM by dennis100 » Logged
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« Reply #38 on: April 23, 2011, 05:50:16 AM »

Event Date 12/16/2001
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. The pt was seen by their neurologist six days prior to their death. The pt was started on depakote during this visit. In order to treat the pt's seizure flurries or periods of poor responsiveness, diastat was also prescribed. The physician indicated that the diastat would help to determine if the pt is dealing with hepatic encephalopathy or seizures. The vns generator settings were not changed during this visit. It was reported that the pt died while hospitalized under the care of their gastrointestinal physician. Treating neurologist indicated that the pt had a metabolic and liver disorder and it is unk whether the vns caused or contributed to the pt's death. Certificate of death lists respiratory failure as immediate cause of death, secondary to pulmonary edema. The pt was receiving vns therapy at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=522787
« Last Edit: October 05, 2015, 03:05:59 AM by dennis100 » Logged
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« Reply #39 on: April 23, 2011, 10:33:56 PM »

Event Date 07/04/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt's device was programmed to off due to vomiting. It was reported that the pt vomited for an entire day on two occasions approx 8 days apart, after which the device was programmed to off. The pt continued to vomit after the device was programmed to off. There had reportedly been no parameter adjustments for approx two months prior to the start of the vomiting. The pt's family member indicated that they could see the lead wire move up and down in the pt's neck just before the vomiting would begin. It was reported that the pt experienced a slight increase in seizure activity since gabitril was discontinued from their drug regimen due to high liver enzyme content. Investigation to date has been unable to determine whether the vns therapy caused or contributed to the episodes of vomiting.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=538789
« Last Edit: October 05, 2015, 03:06:11 AM by dennis100 » Logged
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« Reply #40 on: April 23, 2011, 10:34:24 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The reporter indicated that the pt has lost weight, has gastric reflux, and has been vomiting. The reporter also indicated that the pt has eating problems prior to vns implant, however, they were not as bad. The magnet was used to disable the device while the pt ate, but when it was removed, the pt would vomit. Further follow-up concluded that the device was turned off and the pt is minimally better. To date, an appointment to have the vns re-activated has not been scheduled.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=535389
« Last Edit: October 05, 2015, 03:06:21 AM by dennis100 » Logged
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« Reply #41 on: April 23, 2011, 10:34:53 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns pt has experienced bouts of nausea and vomiting since 2 or 3 weeks after electively undergoing revision surgery to revise the placement of the generator. The bouts of nausea and vomiting reportedly occur approximately every 2 or 3 weeks and last anywhere from 4 days to 1 month. The pt has been hospitalized and treated with iv zofran. The pt has reportedly undergone several diagnostic gi tests that were negative.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=535437
« Last Edit: October 05, 2015, 03:06:33 AM by dennis100 » Logged
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« Reply #42 on: April 23, 2011, 10:35:24 PM »

Event Date 10/13/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt has been unable to hear from their right ear since vns implant surgery. The pt was evaluated by an ent for the hearing problem, but no diagnosis was made as the pt was unable to complete all testing due to their lethargy. The pt had been ill with sore throat, headache and gastric problems and subsequent increase in seizures. Pt has history of seizure increase with illness. Treating neurologist indicated that he does not believe that the vns surgery or device caused the pt's hearing loss and indicated that the pt is currently stable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=534841
« Last Edit: October 05, 2015, 03:06:45 AM by dennis100 » Logged
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« Reply #43 on: April 23, 2011, 10:35:54 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns pt's device has not been working properly since it was programmed to off prior to gall bladder removal surgery and was programmed back to on after the procedure. It was reported that the pt experiences throat pain during magnet mode stimulation and has experienced an increase in seizure frequency above pre-vns baseline. Investigation to date has been unable to determine the cause of the increase in seizure frequency or whether the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=551090
« Last Edit: October 05, 2015, 03:06:56 AM by dennis100 » Logged
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« Reply #44 on: April 23, 2011, 10:36:22 PM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Pt's generator was programmed to off due to adverse side effects. It was reported that the pt's seizure control with the vns therapy is great, but that the pt began experiencing nausea, vomiting and falls (not drop attacks). Treating neurologist reportedly does not believe that the pt's symptoms are related to the vns. Intraoperative device diagnostic testing at time of initial implant was within normal limits, indicating proper device function at that time. Investigation to date has been unable to determine whether or not the reported adverse events are related to the vns therapy system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=547451
« Last Edit: October 05, 2015, 03:07:06 AM by dennis100 » Logged
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« Reply #45 on: April 23, 2011, 10:36:53 PM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Disability; .
Event Description
Reporter indicated that over the past year, vns pt has experienced stomach discomfort with gastrointestinal difficulties. It was reported that it takes several hours for the pt's stomach to empty of contents. The pt was intially implanted in 1997 and underwent generator replacement surgery in 2002.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543133
« Last Edit: October 05, 2015, 03:07:21 AM by dennis100 » Logged
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« Reply #46 on: April 23, 2011, 10:37:23 PM »

Event Date 09/16/1999
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient has experienced gastrointestinal problems since being implanted with the vns therapy system. The patient experiences diarrhea and stomach cramping. It was reported that the patient's current generator was programmed to off and that the patient is no longer experiencing the stomach problems with the device programmed off. The patient's surgeon reportedly indicated that the patient could be having stomach seizures. Irritable bowel syndrome has also been considered as a possible cause of the patient's stomach problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543283
« Last Edit: October 05, 2015, 03:07:36 AM by dennis100 » Logged
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« Reply #47 on: April 24, 2011, 10:32:55 AM »

Event Date 03/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that vns pt's device was programmed to off due to side effects. Stimulation was first initiated approx six weeks post-implant and that the pt seemed to tolerate normal mode output current setting of 0. 50ma well. Approx one month later, the pt's father indicated that the pt's seizures had become worse,causing the pt to vomit and have problems with a sore throat. Normal mode output current was reduced to 0. 25ma at that time. The pt's father also indicated at that time that the pt had a throat infection and had been treated with two course of antibiotics. Treating physician left device output current programmed to 0. 25ma and decided to wait and see if the throat infection was the cause of the pt's problems. Approx two weeks later, the pt's father reported that the pt condition had not improved after the reduction in normal mode output current setting and that they had stopped eating. The device was then programmed to off. A month later, the pt's father indicated that pt was doing much better with the device programmed to off. Approx five months later treating physician attempted to program the device back to on at 0. 25ma normal mode output current, but the pt began to experience the same side effects of vomiting,not eating and mode changes. The device was again programmed to off and the pt's condition again improved afterward. Treating physician will attempt to initiate stimulation at the lowest possible device setting in approx six months time. 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=559915
« Last Edit: October 05, 2015, 03:07:56 AM by dennis100 » Logged
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« Reply #48 on: April 24, 2011, 10:34:13 AM »

Event Date 03/29/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that vns patient was hospitalized approximately one month post-implant with possible pancreatitis, clusters of seizures and elevated temperature. The patient had reportedly also developed oedema over the generator site. The generator was programmed to off during hospitalization and the patient was discharged after their condition settled with plans to program the generator back to on in approximately two months. The patient was hospitalized a second time with swelling over the generator site at which time 10 ml of pus was aspirated on two occasions. The generator was explanted. Investigation to date has been unable to determine whether infection was present.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543298
« Last Edit: October 05, 2015, 03:08:09 AM by dennis100 » Logged
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« Reply #49 on: April 24, 2011, 10:34:52 AM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention.
Event Description
In the process of contacting the pt for notification that their generator may be nearing end of service, it was discovered that the pt is plagued with various health problems that pt believes are related to the vns therapy, including shortness of breath, bouts of pneumonia and gastrointestinal problems. The pt was hospitalized and on life support approx six months ago, presumably due to the aforementioned health problems. The pt thought that their device was programmed to off over a year ago. But had recently swiped the device with the magnet and felt stimulation along with shortness of breath. The pt plans to follow-up with neurologist for device interrogation to determine whether or not the device is programmed to off. It is possible that the normal mode output current was programmed to off, but that the magnet mode output current is still programed to on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=543136
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« Reply #50 on: April 24, 2011, 10:35:26 AM »

Event Date 06/01/2004
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns patient experienced a cough with stimulation approximately six years ago, but that it went away. The cough reportedly returned approximately one year ago and the patient recently began vomiting daily and has subsequently experienced weight loss of 15 pounds. The patient's family member reported that the patient almost died from malnutrition and was seen by 5 or 6 different physician's to rule out other causes beside the vns. The patient was finally explanted and is reportedly doing better. 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=555962
« Last Edit: October 05, 2015, 03:08:31 AM by dennis100 » Logged
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« Reply #51 on: April 24, 2011, 10:36:06 AM »

Event Date 10/12/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. The pt had recently been hospitalized for two days due to nausea and vomiting. The pt also complained of some abdominal crampiness. A new medication (keppra) was added to the pt's drug regimen approximately two weeks before and the pt was already using depakote, topamax and lamictal. The pt had reportedly had problems with recurrent seizures, prompting the addition of keppra. Treating physicians at time of hospitalization believed that the nausea and vomiting may have been due to excessive levels of at least one of these medications. The pt was admitted with treatment plan of iv fluid hydration, avoidance of medications for 24 to 48 hours and allowing pt to go home on depakote, topamax and lamictal with keppra being withheld. In the course of pt hosp stay, iv fluids were provided and the pt improved. The pt was discharged with either some musculoskeletal pain or premenstrual type pain that was believed to be the reason for pt cramps. At the time of discharge, the pt indicated that the cramps were greatly reduced. The pt seemed comfortable at the time of discharge. Two days later, the pt began seizing. The pt's family member swiped the device with the magnet, aborting the seizures, but the pt began seizing again after a short while. The pt's family member swiped the device with the magnet again, aborting the seizures, but again the pt resumed seizing after a short while. Ems was called to the pt's home and it was reported that the pt was blue when they arrived. Ems defibrillated and transported the pt to the hosp, but pt was pronounced dead on arrival. The pt's family has refused an autopsy. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. The pt had reportedly experienced a >50% decrease in seizures with the vns therapy. The pt was receiving vns therapy at the time of death. There is no evidence at this time that the vns therapy system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=554223
« Last Edit: October 05, 2015, 03:08:51 AM by dennis100 » Logged
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« Reply #52 on: April 24, 2011, 10:36:41 AM »

Event Date 01/01/2004
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Vns patient developed emesis with stimulation. Pt's generator was explanted after being programmed to off for approximately four months. Treating neurologist, was probably related to the vns therapy. A detailed evaluation reportedly showed no other causes for the vomiting. 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=553521
« Last Edit: October 05, 2015, 03:09:09 AM by dennis100 » Logged
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« Reply #53 on: April 24, 2011, 10:37:14 AM »

Event Date 10/29/2004
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that vns pt had passed away. It was reported that the pt had an internal infection that led to perforated bowel and then death. The vns therapy system was not explanted prior to burial. No autopsy was performed. There is no evidence at this time that the vns therapy system caused or contributed to the reported event. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=557044
« Last Edit: October 05, 2015, 03:09:27 AM by dennis100 » Logged
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« Reply #54 on: April 25, 2011, 03:03:33 PM »

Model Number 101
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Vns pt's device was programmed to off per their family's request several years ago due to intractable vomiting. It was reported that the symptoms continued after the device was programmed to cff. The pt was seen by a different neurologist years later to program the device back on on, at which time the physician was unable to communicate with their device. 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 vomiting or the communication difficulties.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=574024
« Last Edit: October 05, 2015, 03:09:39 AM by dennis100 » Logged
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« Reply #55 on: April 25, 2011, 03:04:11 PM »

Event Date 10/01/2004
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt has experienced a new gastrointestinal pain that pt did not have prior to vns implant. The pt, has pre-existing gall bladder problems, but began to experience this new pain approx five months post-implant. It was reported that the pt's stomach pains were not related to programmed parameter changes. The pt's device was programmed to off, after which pt experienced no further gastrointestinal problems and had no seizures. The pt reportedly did well in the absence of the vns therapy, but because of their mental handicap, it has not yet been determined whether the apparent stomach pains are behavior-related or related to the vns therapy. Treating neurologist planned to leave the device programmed to off for one month and then reassess the pt's condition at next office visit, but the pt did not keep their appointment and has not yet scheduled another appointment for follow-up.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=568503
« Last Edit: October 05, 2015, 03:09:49 AM by dennis100 » Logged
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« Reply #56 on: April 25, 2011, 03:04:54 PM »

Model Number 102
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that vns patient's seizures are "worse than that normally have been". The patient reported that they were wrestling with family member, at which time he stepped patient's neck. The patient reports that they experienced a "real bad" seizure that evening and has since felt a shocking sensation at their neck every time they touches something. Additionally. The patient reports feeling like they have a sore throat and difficulty swallowing along with shortness of breath, fatigue indigestion, vomitting and nausea. The patient attempted to contact their neurologist, but he were on vacation. Investigation to date has been unable to determine whether the patient has experienced an increased in seizure activity above pre-vns baseline frequency. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=596509
« Last Edit: November 16, 2015, 12:55:51 PM by dennis100 » Logged
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« Reply #57 on: April 25, 2011, 03:05:30 PM »

Event Date 02/01/2005
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that vns pt was hospitalized for intravenous administration of depakote because pt has been vomiting and could not keep down their antiepileptic medications. It was reported that the pt has been vomiting for approx four years, but that their family member does not want the ncp system to be programmed to off. With the vns therapy, the pt's seizures frequency is reportedly reduced from 2-10 seizures per day to 1-2 seizures per month. Treating neurologist does not believe that the vomiting is related to the vns therapy. Device diagnostic testing was within normal limits, indicating proper device function. The elective replacement indicator was no, indicating that the generator had not reached end of service. Normal mode settings were increased from 0. 75ma output current/30hz frequency/250p pulse width/21 seconds on/30 minutes off to 1. 0ma output current/30jz frequency /250p pulse width/30 seconds on/5 minutes off. Magnet mode setting were not changed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=578532
« Last Edit: October 05, 2015, 03:10:23 AM by dennis100 » Logged
dennis100
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« Reply #58 on: April 25, 2011, 03:06:09 PM »

Event Date 01/01/2005
Event Type Injury Patient Outcome Required Intervention;
Event Description
Reported indicated that vns pt vomits blood when their device is programmed to certain settings and that the vomiting subsides when device settings are programmed back to original values. The pt has not experienced: any further episodes of vomiting blood since device settings were changed. Treating neurologist indicated that the event could have been related to possible ulcer. 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=578568
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« Reply #59 on: April 25, 2011, 10:21:57 PM »

Event Date 06/01/2005
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Further follow-up revealed that the pt's device was programmed off. Neurologist indicated that the pt's gastro-intestinal problems have abated since programming the device to off. Neurologist also reported that the pt is currently "relatively" stable. Review of manufacturing records for the pulse generator revealed no anomalies that would adversely affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=622421
« Last Edit: October 05, 2015, 03:10:42 AM by dennis100 » Logged
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