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Author Topic: Misc. Gastrointestinal  (Read 204301 times)
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dennis100
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« on: April 21, 2011, 08:43:51 AM »

Event Date 10/22/1998
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient with lennox-gastaut syndrome was implanted with neurocybernetic prosthesis on march 3, 1998, with device activation occurring one week later. On 9/18/98, the pulse generator's duty cycle was increased. On 10/22/98, patient presented with constipation, protein loss in stool, pancreatitis, and bleeding from g-tube site (g-tube present due to pre-existing swallowing difficulties. ) patient was started on mylanta, and pulse generator settings were adjusted to increase output current and decrease duty cycle. Patient's gi symptoms subsequently abated. On 3/17/99, the pulse generator's duty cycle was again increased. On 4/9/99, patient presented with recurrence of gi symptoms. On 4/9/99, the duty cycle was decreased. By 4/15/99, there was a noticeable improvement in patient's gi symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=223151
« Last Edit: May 16, 2018, 03:20:42 AM by dennis100 » Logged
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« Reply #1 on: April 21, 2011, 08:44:18 AM »

Event Date 04/01/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient was diagnosed with gastritis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=330439
« Last Edit: October 01, 2015, 02:24:44 AM by dennis100 » Logged
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« Reply #2 on: April 21, 2011, 08:44:49 AM »

Event Date 04/04/2001
Event Type Death
Patient Outcome Death; Life Threatening Hospitalization Required Intervention
Event Description
Reporter indicated that pt was seen in emergency room and diagnosed with ischemic bowel and went into cardiac arrest. The pt was defibrillated. Pt reported to be in multi-system failure and receiving dialysis treatments. Neurologist reported that he did not believe that the ncp system contributed to this event. It was later reported that the pt expired.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=330465
« Last Edit: October 01, 2015, 02:25:07 AM by dennis100 » Logged
dennis100
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« Reply #3 on: April 21, 2011, 08:45:19 AM »

Event Date 07/13/1999
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Shortly after implant, pt complained of hiccups, side and abdominal pain, and nausea and vomiting. Pt currently hospitalized for eval by gastrologists.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=321618
« Last Edit: October 01, 2015, 02:25:23 AM by dennis100 » Logged
dennis100
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« Reply #4 on: April 21, 2011, 08:45:52 AM »

Event Date 01/01/1999
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Field report: death due to colon cancer. Follow-up visit: pt died of colon cancer, not related to ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318066
« Last Edit: October 01, 2015, 02:25:45 AM by dennis100 » Logged
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« Reply #5 on: April 21, 2011, 08:46:23 AM »

Event Date 08/01/1998
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Field report: pt death reported. Pt death follow-up form: physician reports believed relationship between the ncp system and cause of death to be unk. Pt had seizure and fell face down, vomited, and could not be turned over. Pt seized for approx 10 minutes. Pt's parent called ems and pt could not be revived.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318082
« Last Edit: October 01, 2015, 02:26:01 AM by dennis100 » Logged
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« Reply #6 on: April 21, 2011, 08:47:12 AM »

Event Date 02/15/1999
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Field report: pt's parent reported the cause of death as dic (disseminated intravascular coagulation). Promised autopsy report. Communication with physician: liver failure due to drug toxicity. Pt death follow-up form: physician reports believed relationship between the ncp system and cause of death to be not related. Autopsy report: dissemenated intravascular coagulation and multiple system failure.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318109
« Last Edit: October 01, 2015, 02:26:18 AM by dennis100 » Logged
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« Reply #7 on: April 21, 2011, 08:47:43 AM »

Event Date 07/10/2000
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the pt started to experience vomiting and coughing with stimulation. The pt's mother reported this to the neurologist and was told by the neurologist that the pt felt a "tickling" from the stimulation and he wash having the behaviors as an attention seeking activity. The pt's mother reports that there multiple parameter adjustments during this time and he had little efficacy and did not tolerate the stimulation very well. The pt later started to experience chest swelling around the generator incision site. The swelling continued to increase and the site appeared stretched. The swelling did not resolve and the chest site remained painful and the generator was removed. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=318151
« Last Edit: October 01, 2015, 02:26:36 AM by dennis100 » Logged
dennis100
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« Reply #8 on: April 21, 2011, 08:48:12 AM »

Event Date 01/17/2001
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Pt diagnosed with esophageal and gastric irritations and pharyngitis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=316756
« Last Edit: October 01, 2015, 02:26:51 AM by dennis100 » Logged
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« Reply #9 on: April 21, 2011, 08:48:38 AM »

Event Date 04/13/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
The reporter indicated that the patient suffered from ileus. Further investigation revealed that the device was activated in december 2000. The parameters were adjusted in march 2001. The patient's device was programmed to rapid cycling in august 2001. The device was turned off when symptoms of ileus arose. The patient recovered well from abdominal surgery and it was noted that the patient has been seizure free for two months with the device off. There are no plans to reactivate the device at this time. Surgeons suspect the ncp system because of ileus.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=368382
« Last Edit: October 01, 2015, 02:27:03 AM by dennis100 » Logged
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« Reply #10 on: April 21, 2011, 08:49:11 AM »

Event Date 09/01/2001
Event Type Injury
Patient Outcome Hospitalization;
Manufacturer Narrative
The device was programmed off in 12/01. 16 days later it was reported that near ear pain, nausea and vomiting, neck weakness, and increase in seizures had not resolved since the vns was turned off. The physician does not believed that the symptms are related to the vns. There are no plans to turn the vns back on anytime soon.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=359959
« Last Edit: October 01, 2015, 02:27:18 AM by dennis100 » Logged
dennis100
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« Reply #11 on: April 21, 2011, 08:49:38 AM »

Event Date 04/01/2001
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the pt developed severe pancreatitis and was hospitalized one month prior to death. The pt was placed on hospice after being discharged from the hosp. It was reported that the pt had many contributing factors and was very ill prior to death. The dr reported that the pt did not experience a change in seizures with vns therapy. The physician indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=359357
« Last Edit: October 01, 2015, 02:27:30 AM by dennis100 » Logged
dennis100
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« Reply #12 on: April 21, 2011, 08:50:09 AM »

Event Date 04/12/2001
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the pt died from gastric cancer and wasting. The physician reported that the pt was seizure free with monotherapy of vns stimulation. Physician also reported that the pt was receiving treatment at the time of death. Conclusions: the physician indicated that there is no believed relationship between the ncp system and cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355986
« Last Edit: October 01, 2015, 02:27:45 AM by dennis100 » Logged
dennis100
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« Reply #13 on: April 21, 2011, 08:50:42 AM »

Event Date 01/01/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
The physician indicated that the vns is not related ot the pt's death. The cause of death was sepsisintestinal obstruction and intestine cancer.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355855
« Last Edit: October 01, 2015, 02:28:00 AM by dennis100 » Logged
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« Reply #14 on: April 21, 2011, 08:51:15 AM »

Event Date 06/01/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that approx 1 1/2 weeks after parameter increase, pt started grabbing neck, gritting teeth, coughing and gagging, for 30 seconds every five minutes. It got to the point where the pt would throw up. Pt was taken to the emergency room in 2001 because the pain was so severe. Pt went to the emergency room again 3 days later and was admitted to the hosp. Pt was seen by the physician the next day and the device was programmed to off. Pt was discharged from hosp the following day. Pt was again seen by physician one week later. Device has not been programmed back to on. Pt reported to be doing well. Physician plans to keep pt on current dilantin and sonogram dosages. Further investigation revealed that the pt is still experiencing pain at the neck incision site eventhough the device is programmed to off, but the pain is minor as compared to when the device was programmed to on. The pt is still coughing; however, the pt is not vomiting anymore. It was reported that the vns has not helped the pt much with seizure control.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355953
« Last Edit: October 01, 2015, 02:28:13 AM by dennis100 » Logged
dennis100
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« Reply #15 on: April 21, 2011, 08:51:45 AM »

Event Date 08/06/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient has recently begun coughing badly and vomiting when stimulated. When magnet is placed over device to temporarily turn device off, the symptoms stop. Programmed settings were reduced but symptoms continued. Device was programmed to off in 2001. Further investigation revealed that family member stated that pt began coughing as far back as 4 months before, but it was first believed that it was related to allergies. Physician plans to leave device programmed to off for atleast a month and then attempt to turn it back on and ramp up slowly instead of every 2 weeks. Patient reported to have received excellent benefit from the device in controlling the pt's seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=352299
« Last Edit: October 01, 2015, 02:28:25 AM by dennis100 » Logged
dennis100
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« Reply #16 on: April 21, 2011, 08:52:13 AM »

Event Date 07/01/2001
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that patient had been hospitalized for 3 weeks because of a stomach ache and being irritable and restless. Medication changes had taken place prior to being admitted to hospital. Patient has now been weaned off of seroquel and is in the process of being weaned off of klonopin. It was reported that approximately 1 week ago the patient stopped eating and is now having urinary retention. Further investigation revealed that output current was decreased 6 weeks ago due to heavy breathing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=348660
« Last Edit: October 01, 2015, 02:28:38 AM by dennis100 » Logged
dennis100
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« Reply #17 on: April 21, 2011, 08:52:43 AM »

Event Date 07/08/2001
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Rptr indicated that patient was hospitalized because of gastrointestinal problems. Pt vomits undigested food, goes 10-7 days without bowel movements and basically doesn't have any motility. The gi doctors could not find anything wrong and referred the patient back to the pt's neurologist who does not plan to change parameters or turn the device off as he does no believe that the symptoms are related to the ncp system.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=348665
« Last Edit: October 01, 2015, 02:28:51 AM by dennis100 » Logged
dennis100
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« Reply #18 on: April 21, 2011, 08:53:16 AM »

Event Date 03/01/2001
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that pt passed away as a result of a ruptured bowel due to complications during bowel obstruction surgery. Further investigation revealed that the pt developed post-surgical infection/sepsis and subsequently passed away. The physician indicated that the ncp system was not related to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=345885
« Last Edit: October 01, 2015, 02:29:07 AM by dennis100 » Logged
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« Reply #19 on: April 21, 2011, 03:44:02 PM »

Event
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« Reply #20 on: April 21, 2011, 03:44:36 PM »

Event Date 01/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Initial report indicated that pt was prescribed zantac following vns implant because pt physician believed that the vns changed pt's stomach acids. The pt was later diagnosed with reflux and was prescribed prilosec in june 2001. It was reported that an ear, nose and throat believed that the reflux affected the pt's vocal cords. The pt has continued to suffer from various gi problems such as chronic constipation which reportedly caused pt's dysmotility. The pt's seizures are under control with the vns, however, the pt has been hospitalized numberous times with gi problems in the last 6 months. Further follow-up with the pt revealed that pt has experienced intermittent problems with chronic constipation pre-vns and that these problems have worsened following vns implant. The pt reported that pt's constipation worsened post vns causing a rectal prolapse which required a colectomy with post-operative bowel dysmotility. The pt was reportedly hospitalized several times for small bowel obstructions and has undergone numerous egd's. The pt's gi physician believed the pt's gi problems may be related to the vns stimulation. The pt reportedly has a prior vagus nerve injury. It was reported that after vns implant, the pt experienced difficulty swallowing, aspiration and some voice alteration that lasted for days post-implant. The pt reported that pt was diagnosed with vocal cord paralysis by an ear, nose and throat. The pt reported that they still experience difficulty with these symptoms and have started voice therapy. No audible horseness not difficulty in speaking was noted during telephone conversation with pt. Attempts to obtain add'l info have been unsuccessful to date. Pt consent pending for physician to release info from medical records.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=398505
« Last Edit: October 01, 2015, 02:29:39 AM by dennis100 » Logged
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« Reply #21 on: April 21, 2011, 03:45:22 PM »

Event Date 06/05/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention .
Event Description
Reporter indicated that pt is experiencing several complications that are believed to be related to the vns. The reported complications include: shortness of breath leading to loss of consciousness, occasional pain with stimulation, burning at the generator site, stomach complications including pain and discomfort, headaches (migraines) have increased in intensity, pt still feels stimulation at times when magnet is taped over device to turn it off. It was reported that the intensity of the pt's seizures has not decreased much since vns implant. On 06/02, the pt had difficulty breathing. The magnet was taped over the device to temporarily stop stimulation until the pt could be seen by physician on 07/02. During this time, the pt reported that the device was still stimulating while the magnet was taped over it and the pt experienced a burning sensation at the generator site. The pt was seen by physician on 07/02 at which time the programmed parameters for the device were adjusted. This adjustment seemed to worsen the difficulty in breathing over time. On 07/02, the pt experienced an episode of difficulty in breathing and gagged, lost consciousness and had a grand mal seizure. The pt described the episode as a suffocating feeling. The magnet was again taped over the device until the pt could be seen by physician on 07/02. At office visit on 07/02, the pt's device output current was programmed to off, but magnet output current was not. After this office visit, the pt reported that when they swipe the device with the magnet, they feel stimulation for a few seconds but it makes the headache worse, eyes blurry and feel the burning sensation at the generator site. The pt's reported symptoms stopped for 2-3 days after programming the device to off, but after those few days the pt began to have neck pain on the left side, ear pain, migraines and a swelling sensation in the throat. The migraines became so bad that the pt was taken to the emergency room several times during the week of august 2002. The pt was admitted to the hosp on 08/02 and released the next day, at which time was instructed to increase the carbatrol dosage from 800mg to 1200mg qd. A few days later, the pt reportedly became delirious and weak to the point where they couldn't walk. The pt was again hospitalized on 08/02 and discharged three days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414499

« Last Edit: October 01, 2015, 02:29:54 AM by dennis100 » Logged
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« Reply #22 on: April 21, 2011, 03:45:53 PM »

Event Date 01/01/2002
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt developed stomach pains and irritable bowel syndrome after vns implant. The pt had been seen by a specialist and all testing was negative, including blood tests. The pt's device was programmed to off in 7/2002. Physician plans to wait and see if the pt's symptoms improve with the device programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411397
« Last Edit: October 01, 2015, 02:30:10 AM by dennis100 » Logged
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« Reply #23 on: April 21, 2011, 03:47:05 PM »

Event Date 06/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that since vns implant, the patient's seizure frequency has increased above its pre-vns baseline. In 2002, the patient reportedly had 12 seizures. The count has gradually increased from month to month. In september 2002 the patient had approximately 52 by their family member's count. The patient is also vomiting quite often, but the vomiting does not coincide with stimulation. The patient vomits on average approximately 5 times per week. The patient's neurologist programmed the normal mode output current to off in 9/2002. The magnet mode output current remains on because this mode seems to be doing good for seizures that they notice and try to abort. Health professional's assessment is that pre-vns, the patient was experiencing multiple seizure types several times a day and vomiting daily. Post-vns, the patient had a "decrease" of multiple seizure types but the vomiting continued. The physician reported the patient is medically complex and response to vns therapy is questionable. The device was turned off in 9/02 and since then, nausea has improved significantly but the number of seizures remains increased.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426138
« Last Edit: October 01, 2015, 02:30:28 AM by dennis100 » Logged
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« Reply #24 on: April 21, 2011, 03:47:51 PM »

Event Date 07/31/2002
Event Type Injury
Patient Outcome Hospitalization;
Event Description
The reporter indicated that in 2002, the pt presented to the emergency room and received a shot of demerol/phenergan for nausea and the constant pressure pt feels in the left side of their head. Pt stated that the device stimulates irregular; therefore, pt taped the magnet over the device to stop the therapy. Three days after deactivating the device, the pressure on their left side of their head subsided. The reporter also stated that the pt wanted the vns device turned off. The pt is willing to talk about reprogramming their device on at a later date. Physician records indicated that the pt visited the epilepsy clinic in 2002 because pt felt that the device was coming on erratically. In association with that, pt started having a sensation of pressure over the left temple. The physician recommended placing the magnet over the simulator to turn it off. The pt did this and the symptoms subsided. The generator was evaluated and it was determined that it was stimulating more frequently then what it was set to.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=416826
« Last Edit: October 01, 2015, 02:30:41 AM by dennis100 » Logged
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« Reply #25 on: April 21, 2011, 03:48:26 PM »

Event Date 04/01/2000
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that pt has been experiencing urinary incontinence and has also lost control of their bowels since approximately one year following vns implant. Physician indicated that he believed that the vns may be affecting the pt's ability to control their sphincter muscles. The pt's device was programmed to off per the pt's request on 8/30/02. It was later reported that the pt was diagnosed with a weak muscle in the pelvic area that "comes and goes", and that this weak muscle was the cause of the incontinence. It is not known at this time whether the vns was the cause of the weak muscle and whether the pt's symptoms have subsided after programming the vns to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=417775
« Last Edit: October 01, 2015, 02:30:53 AM by dennis100 » Logged
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« Reply #26 on: April 21, 2011, 03:48:59 PM »

Event Date 06/24/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that pt had passed away. The pt reportedly had stomach cancer with multiple complications. The exact cause of death is unknown at this time. There is no evidence that the ncp system caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=406927
« Last Edit: October 01, 2015, 02:31:09 AM by dennis100 » Logged
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« Reply #27 on: April 21, 2011, 11:04:51 PM »

Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Pt was experiencing shortness of breath and is having trouble swallowing, though their seizure control with vns therapy has been very good. Further follow-up revealed that the pt was hospitalized for treatment of gerd (gastric esophageal reflux disease). Physician indicated that the pt's condition was not related to the vns. Investigation to date has been unable to determine whether the pt was diagnosed with gerd prior to vns implant and whether or not the vns therapy has exacerbated this condition.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=437035
« Last Edit: October 01, 2015, 02:31:21 AM by dennis100 » Logged
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« Reply #28 on: April 21, 2011, 11:06:23 PM »

Event Date 06/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt was experiencing stomach problems that physician believed may be caused by the vns therapy. The pt's programmed parameters were reduced by 40% and the pt was reportedly somewhat better afterwards. Physician reduced vns settings further and plans to program the vns to off. Physician plans to perform gastric pacing if interaction with the vns will not be a problem. The pt has reportedly lost 60 pounds over the past six months as a result of their gastrointestinal problems.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435642
« Last Edit: October 01, 2015, 02:31:33 AM by dennis100 » Logged
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« Reply #29 on: April 21, 2011, 11:06:59 PM »

Event Date 01/08/2003
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the pt complained of abdomial pain and increasing somnolence was noted several days prior to death. Progressive hypopnea occurred resulting in respiratory arrest. The pt was last seen by the physician in 2003. The physician indicated that the ncp system was not related to the cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448112
« Last Edit: October 01, 2015, 02:31:45 AM by dennis100 » Logged
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