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Author Topic: Cough/Choke/Gag  (Read 247941 times)
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dennis100
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« on: May 11, 2011, 01:20:48 AM »

Event Date 04/01/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Initial report indicated that patient was experiencing problems with coughing and gagging after parameter increase. Further investigation. Revealed that the patient was hospitalized for pneumonia. Physician stated that the pneumonia was the cause for the coughing and gagging, not the parameters for the stimulator.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=334676
« Last Edit: February 13, 2015, 12:32:32 PM by dennis100 » Logged
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« Reply #1 on: May 11, 2011, 01:21:20 AM »

Event Date 04/08/2001
Event Type Injury
Patient Outcome Hospitalization;
Event Description
Reporter indicated that pt was taken to emergency room exhibiting signs of respiratory distress. The pt appeared to be choking. Emergency room physician did not witness any type of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=332622
« Last Edit: March 08, 2016, 10:38:56 PM by dennis100 » Logged
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« Reply #2 on: May 11, 2011, 01:21:52 AM »

Event Date 03/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that the pt has developed partial left vocal cord paralysis and stridor and had an episode of increased saliva where the pt choked. Vocal cord paralysis has improved since device has been turned off for a couple of weeks.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=330396
« Last Edit: March 08, 2016, 10:39:13 PM by dennis100 » Logged
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« Reply #3 on: May 11, 2011, 01:22:21 AM »

Event Date 03/07/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that five days post-implant pt experienced shortness of breath, vomiting, choking, coughing, difficulty swallowing and inability to eat solid foods. The device was not yet programmed on. Pt went to emergency room and phenergan was prescribed. Six days later pt was evaluated by neurosurgeon and prednisone was prescribed. The prednisone was ineffective in relieving the pt's symptoms. Pt later diagnosed with a lung infection after ent consult which was reported to be contributing to the pt's difficulties with breathing. Pt was also diagnosed with vocal cord paralysis as a result of the ent consult.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=327137
« Last Edit: March 08, 2016, 10:39:30 PM by dennis100 » Logged
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« Reply #4 on: May 11, 2011, 01:22:53 AM »

Event Date 07/01/2001
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that since implant, patient's voice is gone and they experienced an awful cough, chokes on fluids, and has shortness of breath. It was reported that patient was seen by the ear, nose and throat who diagnosed left vocal cord paralysis. Further investigation revealed that the device was not turned on at implant. The device was programmed to on in mid-august 2001 and remains at 0. 25ma output current. Patient reported that they did not want to program the device to off to give the vocal cord paralysis a chance to resolve because pt is already having some seizure reduction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=363399
« Last Edit: March 08, 2016, 10:39:49 PM by dennis100 » Logged
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« Reply #5 on: May 11, 2011, 01:23:23 AM »

Event Type Injury
Patient Outcome Life Threatening;
Event Description
Rptr indicated that pt has a problem with choking at times. It was reported that the pt's pulse width was changed but that did not help the situation. The pt reports that as a result of the choking sensation, the pt doesn't swallow when eating until the pt can feel the cycle stop. Investigation was unable to determine the severity of the dysphagia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=361810
« Last Edit: March 08, 2016, 10:40:06 PM by dennis100 » Logged
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« Reply #6 on: May 11, 2011, 01:23:54 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
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« Reply #7 on: May 11, 2011, 01:24:25 AM »

Event Date 07/26/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient's device was programmed to off in 2001 at the families request due to the following symptoms: increased periphal edema, excesive coughing, difficulty swallowing, neck and muscle pain, weight gain, low grade fever, hiccuping, difficulty with breathing and shortness of breath, choking sensation, facial flushing, heartrate and rhythm changes. Physician is unsure whether the symptoms are related to the vns. Patient's family does not believe that the device has helped with seizure control since implant.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=351106
« Last Edit: March 08, 2016, 10:40:42 PM by dennis100 » Logged
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« Reply #8 on: May 11, 2011, 01:24:58 AM »

Event Date 07/10/2001
Event Type Malfunction
Event Description
Reporter indicated that on two occasions within a 24 hour period, device continuously stimulated for five minutes causing patient to cough and gag. It was later reported that patient was not able to deactivate stimulation with magnet. Patient saw physician who indicated that the device was not malfunctioning. Device was programmed to off. Patient was seen by another physician who diagnosed a viral infection. No medications were prescribed, the virus has run its course, and the patient no longer complains of pain.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=347286
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« Reply #9 on: May 11, 2011, 01:25:42 AM »

Event Date 05/18/2001
Event Type Malfunction
Event Description
The patient experienced gagging, coughing and choking. Reporter indicated that microprocessor had reset. The physician said that he originally set the device to 0. 25ma.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=337995
« Last Edit: March 08, 2016, 10:41:19 PM by dennis100 » Logged
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« Reply #10 on: May 11, 2011, 01:26:20 AM »

Event Date 10/27/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that the patient had a complex partial seizure and swiped the device with the magnet as usual. It was reported that a few seconds after swiping the device with the magnet, the patient experienced a coughing fit that lasted for about 10 minutes. During that time, the patient was very distressed, felt extremely unwell, appearing to be in great pain. The patient curled their legs up to their stomach. The coughing was reported to be identical to that which occurs sometimes during the on cycle after the current has just been increased; however, no parameter changes had been made for several months and the coughing during the episode was continuous. Three days later, the patient had another coughing episode which lasted longer. The patient had a complex partial seizure, the device was again swiped with the magnet and approximately 30 minutes later, the patient had a coughing attack that lasted for approximately 90 minutes. During the second coughing episode the patient again seemed to be in pain and complained of neck pain, headache and feeling very sick. Patient also got hot and sweaty. The device was deactivated by taping the magnet over the device and the coughing eased and the patient gradually felt better. The device was programmed to off on 12/2001. At this appointment, device diagnostics resulted in normal lead impedance reading (dc-dc code 3 and ok). The patient has not suffered any further coughing attacks since the device was programmed off. Patient was seen for follow-up visit on 01/2002 at which time it was reported that there had been a slight increase in seizures since the device was programmed to off. Urinary ketones were fluctuating a bit (were now 8 where as previously they were around 16). Patient started ketogenic diet in october 2001. Patient's diet was modified slightly to increase the calories from fats from a ratio of 2. 8:1 to 3:1. Lamotrigine dosage was increased to 200 mg twice daily. Dosage of melatonin did not change (1/4 tablet per day).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=375423
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« Reply #11 on: May 11, 2011, 01:26:50 AM »

Event Date 07/01/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Initial reporter indicated that patient complained of extremely violent coughing with stimulation after lead replacement surgery. The coughing has even made the patient vomit. When the magnet was taped over the device, the coughing stopped. The physician programmed the device to off and the coughing stopped. Patient could not teolerate a lead test. Device was programmed back to on at a later office visit at which time the patient did not experience any further episodes of coughing/vomiting. Further investigation revealed that the patient's family member requested that the device be explanted becuase the patient began to demonstrate unusual behavior (violent and aggressive). The unusual behavior continued after parameter adjustments and programming the device to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=370882
« Last Edit: March 08, 2016, 10:41:55 PM by dennis100 » Logged
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« Reply #12 on: May 11, 2011, 01:27:30 AM »

Event Date 05/17/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt experienced a 5-hour episode of status which required hospitalization and a reduction in device settings. It was reported that the pt initially experienced a dramatic decrease in seizures with the vns, but increases to device settings seemed to worsen the pt's seizure activity. The pt's generator was programmed to on approximately one week post-implant to the following settings: 0. 50ma output current, 30 seconds on, 5 minutes off. Two minutes later, the programmed settings were increased to 1. 0 ma output current, 4 minutes off (on time remained the same). With the next parameter increase to following parameters: 2. 0ma output current; 45 seconds on; 2 minutes off, the pt experienced a day of clusters and their seizures worsened to the point of the status episode. At the last device settings (2. 0ma output current), it was noted that the pt coughed constantly, was short of breath, and experienced horseness. At the time of hospitalization, the device output current was reduced to 1. 25ma. Since this parameter reduction, the pt did not experience any further seizures for at least 2 days. The pt denies any traumatic brain injury and states that there were no medication changes during the time of the reported event. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=401108
« Last Edit: March 08, 2016, 10:42:13 PM by dennis100 » Logged
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« Reply #13 on: May 11, 2011, 01:27:59 AM »

Event Date 05/01/2002
Event Type Injury
Patient Outcome Disability;
Event Description
The reporter indicated that the patient was implanted with the vns in 2002 and the device was activated the following day. The patient was diagnosed with vocal cord paralysis the following month. The physician plans no intervention to treat the vocal cord paralysis. The patient is experiencing chronic hoarseness, coughing, and reflux. The patient was seen by a speech therapist. The device settings have been increased and the patient has experienced a small decrease in their seizures. Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=399127
« Last Edit: March 08, 2016, 10:42:29 PM by dennis100 » Logged
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« Reply #14 on: May 11, 2011, 01:28:37 AM »

Event Date 01/01/1999
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Disability Required Intervention
Event Description
In the process of contacting the patient to inform them that their generator may be nearing end of service, it was discovered that the patient's ncp system was explanted due to increased seizures and left vocal cord paralysis. It was reported that the explant took place not long after the device was implanted. Reporter indicated that the patient had a short neck and that there was a problem placing the leads initially. It was also reported that the patient's neurologist kept "turning up the device" too high causing left side of the patient's face to twitch followed by choking and coughing when swallowing. It was reported that the ear, nose, throat who explanted the device felt that the high setting was the cause of the vocal cord paralysis. It was reported that the patient continues to suffer from the vocal cord problems. Further follow-up revealed that the patient's lead was replaced in 1999 and that the explant of the ncp system took place after that time (date unknown). Attempts to obtain additional information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=395764
« Last Edit: March 08, 2016, 10:42:45 PM by dennis100 » Logged
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« Reply #15 on: May 11, 2011, 01:29:17 AM »

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: March 08, 2016, 10:43:03 PM by dennis100 » Logged
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« Reply #16 on: May 11, 2011, 02:51:45 AM »

Event Date 11/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that the pt had been choking excessively due to stimulation. The pt's device was turned off using the magnet. The pt was seen by physician in 12/02 and the physician told the pt's parent that the lead was detached from the generator. The physician indicated that the lead had migrated to the center of the pt's neck causing the pt to choke. The pt's parent indicated that they could see the lead in the pt's neck when the pt leaned their head back. The physician planned on removing the ncp system in 2002, but the pt developed aspiration pneumonia in 12/02; therefore, the surgery was cancelled. Physician indicated that the aspiration pneumonia was caused by the choking from the ncp system. The pt was given oral antibiotics for the aspirtion pneumonia and the pt's device was programmed to off. Surgery to remove the ncp system is planned for 2003.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435492
« Last Edit: March 08, 2016, 10:43:19 PM by dennis100 » Logged
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« Reply #17 on: May 11, 2011, 02:53:14 AM »

Event Date 11/14/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt was experiencing pronounced hoarseness/choking sensation and pain at implant incision site. The pt went to the emergency room in 2002 due to the aforementioned symptoms. Device diagnostic testing at follow-up office visit was within normal limits, indicating proper device function. Device output current was reduced on 11/18/2002 from 0. 50ma to 0. 25ma. The pt reports that pt no longer experiences the reported symptoms following the reduction in device output current.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432873
« Last Edit: March 08, 2016, 10:43:36 PM by dennis100 » Logged
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« Reply #18 on: May 11, 2011, 02:53:53 AM »

Event Date 11/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that patient was experiencing a choking and shocking sensation down their neck. It was reported that the device was programmed to off. The patient reportedly experienced 8 grand mal seizures and was hospitalized. The device was programmed back to on, but the patient reports that patient is again experiencing the shocking feeling and continues to have difficulty breathing.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432509
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« Reply #19 on: May 11, 2011, 02:54:26 AM »

Event Date 01/01/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
In the process of contacting the patient to notify them that their device may be nearing end of service, it was discovered that the patient's ncp system was explanted due to choking sensation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=430127
« Last Edit: March 08, 2016, 10:44:11 PM by dennis100 » Logged
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« Reply #20 on: May 11, 2011, 02:55:05 AM »

Event Date 01/01/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that the patient underwent generator replacement surgery in 2001. The patient's new generator was activated in 4/2001. During the patient's office visit in 6/2001, the device parameters were increased. The physician's notes from this visit state that the patient has had a 50% decrease in seizures and is currently taking topamax and neurontin. The physician's notes from the patient's next office visit (8/2001) indicate that the patient was better with the vns; their alertness was better and patient was talking more. Physician's notes from the patient's visit in 10/2001 state that the patient is having briefer post-ictal spells. The patient was weaned off their neurontin as of 9/2001 and continues to take depakote. The patient was started on a weaning program to eventually stop the topomax. The patient was started on dilantin and changed the patient's medication from tegretol to tegretol xr. The patient was next seen in 01/2002. The patient reported that they had been seen by another physician who turned off the vns in 11/2001, due to dysphagia and gagging. The patient's tegretol xr was discontinued. Following these changes the patient was able to swallow liquids better and also began to gain weight. The device remains off and the patient is scheduled to see their neurologist for follow-up in 11/2002.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426455
« Last Edit: March 08, 2016, 10:44:27 PM by dennis100 » Logged
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« Reply #21 on: May 11, 2011, 02:55:35 AM »

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

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426466
« Last Edit: March 08, 2016, 10:44:44 PM by dennis100 » Logged
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« Reply #22 on: May 11, 2011, 02:56:16 AM »

Event Date 09/01/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention .
Event Description
Reporter indicated that patient was hospitalized for infection and that the patient had been experiencing joint pain (ankles and hands), neck pain and back pain. Additionally, the patient has also had a choking feeling. It was reported that the patient's white blood cell count is 19,000 and that it should be 3,000. Further follow-up revealed that on 09/25/02, that patient's family member reported to the treating neurologist that the patient was hospitalized with hands swelling and rash over neck area. At this time it was reported that the rash comes and goes on the patient's legs and arms. The neurologist instructed the patient's family member to take the patient to see primary care physician and to have the primary care physician contact him after the visit. Neurologist's nurse later reported that the notes regarding the neurologist's telephone conversation with the patient's primary care physician were not legible. The patient is scheduled to see the neurologist on 11/21/02.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=424455
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« Reply #23 on: May 11, 2011, 02:56:48 AM »

Event Date 07/01/2000
Event Type Injury
Patient Outcome Life Threatening;
Event Description
When the vns was first implanted, the patient had very marked problems with swallowing on the following regular cycle device settings: 30 seconds on, and 5 minutes off. The treating physician quickly ramped the device settings up to rapid cycling which markedly improved the swallowing problems at that time. Over the past year, the patient has complained of occasional intermittent episodes of choking where they have indicated that it is difficult to breathe. This does not coincide with eating or swallowing and there are no obvious triggers. The first episode seemed to follow a severe respiratory infection. The patient has other significant neurological problems with bilateral perisylvian polymicrogyria and a very severe facial palatal paresis. Physician is unclear about the relationship of the vns to the most recent events that the patient is experiencing because they did not have these problems pre-vns, but they did not begin until after vns had been implanted for some time. Device diagnostic testing was within normal limits, indicating that the device is functioning properly.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=424174
« Last Edit: March 08, 2016, 10:45:18 PM by dennis100 » Logged
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« Reply #24 on: May 11, 2011, 08:40:41 AM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that pt was experiencing decreased sleep, chest pain, severe tooth pain that prevents pt from sleeping and choking/dyspnea with stimulation. It was reported that the pt's neurologist had decreased device settings several times but that the pt has had little relief from the above symptoms. Further follow-up revealed that the pt was hospitalized during the first week of march 2003 due to dilantin toxicity and that the pt was having coughing with stimulation. Device settings were decreased while the pt was in the emergency room. The pt reports that pt told neurologist at their last office visit when device settings were increased that pt could not tolerate the device settings, but the neurologist would reportedly not decrease the settings at that time. The pt reports that now that device settings have been decreased pt has no side effects and is starting to have less seizures. Investigation to date has been unable to determine the severity of the reported adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448084
« Last Edit: March 08, 2016, 10:45:38 PM by dennis100 » Logged
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« Reply #25 on: May 11, 2011, 08:41:27 AM »

Event Date 12/12/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Patient began gagging in 2002 and a few days later, the patient experienced six drop attacks (seizures that they had not had for quite a while). The patient reportedly continues to have staring spells about 4-5 times per day. Neck x-ray did not reveal any discontinuities in the ncp system and confirmed proper lead electrode placement. Physician added zonegran (200mg b. I. D. ) to patient's drug regimen and plans to see the patient again in six weeks for follow-up. Physician indicated that he does not know at this point what the cause of the patient's symptoms are. Recent device diagnostic testing was within normal limits, indicating that the ncp system was functioning properly. The patient's last parameter adjustment was in 2002 and there have been no changes in medication that could be contributing to the seizure increase. It was reported that the patient's overall health condition is not worsening at this time and that there were no enviromental stimuli that could have caused the increase in seizures.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=438644
« Last Edit: March 08, 2016, 10:45:55 PM by dennis100 » Logged
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« Reply #26 on: May 11, 2011, 11:16:04 AM »

Event Date 01/01/2003
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
The patient experienced an increase in coughing which wouldn't subside along with a painful feeling in the area around the vagus nerve. The patient was rushed to the hospital in attempt to alleviate the patient's symptoms; however, there was no one available experienced with vns therapy to help the patient. It was reported that the patient put the magnet over the device, which made the symptoms resolved. The patient was later seen by their neurologist who reduced programmed parameters. Neurologist indicated that it was still unclear why the patient's problem occurred so abruptly and that the patient is doing well since the reduction in programmed parameters. It was reported that the patient experienced a 50% reduction in seizures with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=453307
« Last Edit: March 08, 2016, 10:46:12 PM by dennis100 » Logged
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« Reply #27 on: May 11, 2011, 01:18:24 PM »

Event Date 02/04/2003
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that since the day after implant surgery, the pt has been experiencing constant coughing and hoarseness. The implant surgery reportedly took a long time and the neurologist believes that the vagus nerve was manipulated during implantation of the lead coils. The pt's coughing and hoarseness is reportedly not consistent with stimulation and the neurologist does not believe that it is related to the stimulation. It was later reported that evaluation by an ear, nose, throat confirmed partial left vocal cord paralysis that would probably go away in time. Ear, nose, throat has reportedly recommended a medialization thyroplasty to attempt to repair the damage. The pt is reportedly having seizure control since initiation of stimulation in 2003. As of the following month, the coughing seems to have improved at least 50% but the voice alteration persists.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=456889
« Last Edit: March 08, 2016, 10:46:29 PM by dennis100 » Logged
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« Reply #28 on: May 11, 2011, 01:19:27 PM »

Event Date 05/01/2003
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt's device was programmed to off due to shortness of breath. Pt initially reported episodes of shortness of breath approximately one week after a parameter increase. Follow-up with treating neurologist revealed that the pt had problem with allergies and that the shortness of breath was not related to the vns. Device output current was reduced from 2. 0ma to 1. 75ma at that time. Device output current was reduced further three days later (from 1. 75ma to 1. 50ma along with a reduction in pulse width (from 250 to 130) as the pt continued to complain of shortness of breath, mostly in the middle of the night. It was later reported that the pt's device was programmed to off due to approximately 50 spells of shortness of breath in the last month. The pt had reportedly experienced spells of gasping, shortness of breath, feeling of breath being taken away and a choking feeling. These symptoms were occurring mostly at night, but had begun to occur during the day as well. It was reported that the pt had no upper respiratory or allergy symptoms at the time that the device was programmed to off.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=468498
« Last Edit: March 08, 2016, 10:46:49 PM by dennis100 » Logged
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« Reply #29 on: May 11, 2011, 01:20:07 PM »

Event Date 04/01/2003
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Vns patient has expierienced two episodes of coughing that resulted in choking. It was reported that the "strangling feeling" that the patient experiences during these episodes seems to coincide with stimulation. The patient is reportedly experiencing a greatly reduced number of seizures with the vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=467442
« Last Edit: March 08, 2016, 10:47:25 PM by dennis100 » Logged
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