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dennis100
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« on: April 05, 2011, 01:56:43 AM »

Event Date 12/01/2000
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Late report due to administrative error.

Event Description
Reporter indicated that patient was asleep and woke up and couldn't breathe for about 8 seconds.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=334672
« Last Edit: May 02, 2017, 02:02:32 AM by dennis100 » Logged
dennis100
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« Reply #1 on: April 05, 2011, 01:57:22 AM »

Event Date 03/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Patient indicated that has been experiencing shortness of breath while lying down and almost asleep.

Manufacturer Narrative
The physician stated the pt's shortness of breath was not clinically significant. No pulmonary tests were performed. The device settings had not been adjusted and the pt feels that the symptoms have resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=327796
« Last Edit: February 14, 2015, 12:33:54 AM by dennis100 » Logged
dennis100
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« Reply #2 on: April 05, 2011, 01:58:02 AM »

Event Date 02/23/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Rptr indicated that pt complained of being unable to sleep due to the vns sensation. The pt complained that the sensation was positional and that in certain positions the pt would feel pain in throat, temple, and forearm "like being hit with a rock". Pt states that the pt is unable to sleep if lies on right side due to the pain in throat and shortness of breath. Pt reported to be experiencing dysesthesias in left hand and pain around the site of surgery which is constant but increases with stimulation when lies on right side. This pain radiates to ear and at times to left temporal region. Pt has also complained of increase in seizures since activation. Device programmed to off 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=328089
« Last Edit: February 14, 2015, 12:34:29 AM by dennis100 » Logged
dennis100
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« Reply #3 on: April 05, 2011, 01:58:50 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.

Manufacturer Narrative
Programming history was reviewed. Programming history revealed that after the pt was programmed to receive 0. 25 ma of therapy, the pt code was programmed for the first time. When the pt code is programmed, it automatically sets the output current to 0. 0 ma. The pt left the office. Upon return at the next visit, the device was interrogated. The parameters reported 0. 0 ma of output current just as would be expected per physician's manual for the model 250 ncp programming software. Interrogating the device as the last step of any programming session is addressed in device labeling and was not followed in ths case. The event did not contribute to loss of therapy that could have contributed to an adverse event since this was the pt's first visit and there was not enough time for the pt to get accustomed to the possible benefit of vns therapy before going home that day.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=337995
« Last Edit: February 14, 2015, 12:35:21 AM by dennis100 » Logged
dennis100
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« Reply #4 on: April 05, 2011, 02:00:21 AM »

Event Date 02/24/2001
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Reporter indicated that pt experienced respiratory arrest 3 days post-implant.

Manufacturer Narrative
Code: mfg records reviewed. Code: review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Device was programmed to on during implant surgery. Ncp system labeling states that the ncp system should not be programmed to on for at least 14 days after the initial or replacement implantation. Further investigation revealed that the pancreatitis was due to a viral illness and not related to the vns. The cause of the respiratory arrest remains unknown. The physicians do not believe the vns contributed to the respiratory arrest. The device remains programmed to on and the pt is tolerating the stimulation without any complications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=323861
« Last Edit: February 14, 2015, 12:36:31 AM by dennis100 » Logged
dennis100
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« Reply #5 on: April 05, 2011, 02:01:02 AM »

Event Date 05/19/2001
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
Further investigation revealed that the device has been helping control the pt's seizures and that the pt has been a lot more alert. Attempts to obtain add'l info have been unsuccessful.

Event Description
Reporter indicated that pt developed continuous stridor and was hospitalized in 2001. During the hospitalization, a tracheostomy was placed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=342440
« Last Edit: February 14, 2015, 12:37:24 AM by dennis100 » Logged
dennis100
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« Reply #6 on: April 05, 2011, 02:01:45 AM »

Event Date 06/01/2001
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Method: manufacturing records reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

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: February 14, 2015, 12:38:44 AM by dennis100 » Logged
dennis100
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« Reply #7 on: April 05, 2011, 02:02:23 AM »

Event Date 05/01/2001
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that she had heard that there have been several deaths at one of their developmentally delayed centers over the previous months including some patients with vns. Reporter reiterated that the physician involved did not believe that any of the deaths of the vns patients were related to the vns and that many of those patients had experienced problems in the past due to their illness. Further investigation revealed that there were 2 vns patients who had passed away. Patient aspirated their food resulting in respiratory problems and being put on a ventilator. They were unable to wean the pt off the ventilator.

Manufacturer Narrative
Physician indicated believed relationship between vns and cause of death to be not related. Manufacturing records reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Manufacturer Narrative
Programming history was reviewed. No anomalies in the programming history were found that would affect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=353700
« Last Edit: February 14, 2015, 12:39:44 AM by dennis100 » Logged
dennis100
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« Reply #8 on: April 05, 2011, 02:03:09 AM »

Event Date 08/14/2001
Event Type Injury
Patient Outcome Required Intervention;
Event Description
Reporter indicated that patient had a breakthrough seizure and programmed settings were increased in 2001. Later it was discovered that patient had stopped taking the pt's tegretol. Pt complained of anxiety and shortness of breath. The following month, programmed settings were decreased. Patient has since been seen in the emergency room several times complaining of anxiety. A complete cardio workup and x-rays were negative and patient is not pregnant. The device was programmed to off 2 weeks later per the patient's request. The physician ran a lead test and the impedance was fine - eri (elective replacement indicator) flag was "no". Physician plans to keep device programmed to off for 4-5 weeks. Patient plans to see the pt's primary care physician for anxiety medications. Neurologist does not believe that the event is related to the vns.

Manufacturer Narrative
Follow up with both the pt and the physician indicated that the pt's shortness of breath resolved after device was programmed to off. The pt reported that she believed that the vns made her bladder infection worse. The pt reported that the shortness of breath and pain in her back and stomach that she experienced was after a parameter increase. Pt also reported that the device migrates and causes chest pain. Physician reported that the pt is very inconsistent in her descriptions of her health condition and skips many of her appointments. The physcian does not believe that the vns caused the pt's bladder infection. The pt's device was programmed back in 2001 at a lower setting. At the 9/01 office visit, the physician noted that there appeared to be a problem with the stimulator surgical pocket with the pt reporting that she can feel the stimulator moving in and out of the pocket either up toward the clavicle or the sternum which creates discomfort as well as anxiety for her. A surgical revision was performed to create a new pocket and the pt has not complained of any other side effects since the revision.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=352293
« Last Edit: February 14, 2015, 12:40:47 AM by dennis100 » Logged
dennis100
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« Reply #9 on: April 05, 2011, 02:03:57 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: February 14, 2015, 12:41:51 AM by dennis100 » Logged
dennis100
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« Reply #10 on: April 05, 2011, 02:06:03 AM »

Event Date 07/26/2001
Event Type Injury
Patient Outcome Required Intervention;
Manufacturer Narrative
Further investigation revealed that none of the pt's symptoms have resolved since programming the device to off. Physician plans to program the ncp system to on, however, no date is set at this time.

Manufacturer Narrative
Manufacturing records reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

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: February 14, 2015, 12:42:37 AM by dennis100 » Logged
oreo
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« Reply #11 on: April 05, 2011, 10:21:17 AM »

Although I mostly tolerate the several crummy side effects I have from VNS, I realize how blessed I am after reading all the work you do to show the devastating effects so many experience.
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The most successful people are those who are good at plan B.
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dennis100
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« Reply #12 on: April 05, 2011, 01:23:56 PM »

I'm on a mission oreo. This device is killing innocent people who's only mistake was listening to their doctor and trusting the FDA. It's time for those idiots at the CDRH to take action.
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dennis100
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« Reply #13 on: April 05, 2011, 01:25:12 PM »

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.

Manufacturer Narrative
This report is a duplicate of a previously submitted report. This event was previously reported under mfr. Report number 1644487-2001-00522.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=363399
« Last Edit: February 14, 2015, 12:43:47 AM by dennis100 » Logged
dennis100
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« Reply #14 on: April 06, 2011, 06:11:44 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: February 14, 2015, 12:44:28 AM by dennis100 » Logged
dennis100
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« Reply #15 on: April 06, 2011, 10:33:23 PM »

Event
« Last Edit: May 24, 2018, 01:28:46 PM by dennis100 » Logged
dennis100
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« Reply #16 on: April 07, 2011, 09:46:10 AM »

Event Date 01/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
The physician stated that a decrease in the programmed parameters improved the apnea, but not the dyspnea. A sleep study on 11/7/01 concluded that the pt still had mild dyspnea and apnea. The physician stated that the pt's device is programmed to the most effective settings for her. The pt had her tonsils and adenoids removed in 12/01 in an attempt to decrease the chances of obstruction when she sleeps. On 1/13/01 the pt's family member indicated that the pt was not 100% better, but had "marked/significant improvement in breathing and a decrease in snoring" following the surgery to remove their tonsils and adenoids. The pt doesn't have another appointment scheduled with the neurologist.

Manufacturer Narrative
The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Reporter indicated that when she sleeps closely with the patient, she feels like she is picking up some of the electrical current from the vns. These events were described as lasting for approximately 20-30 seconds, occurring once or twice per week, and without any pain or discomfort. Additionally, reporter indicated a concern that the device may be "misfiring". Occasionally she would witness the patient making a strange noise and a "jeering" movement. Following these episodes, the device will stimulate. These episodes commenced in 2000 and are infrequent (once every three months). These episodes last 30-40 seconds. Reporter indicated that she is uncertain if these may be seizures. It was reported that there were no unusual environmental hazards present. Further investigation revealed that the reporter no longer believed that the device was "misfiring"; however, some irregular night breathing was reported. These different breathing patterns began in 2001. It was reported that the patient changes medication dosages and frequencies very often and is currently on four anti-convulsive drugs. It was reported that since the vns implant, the patient has had mild seizure control, but is more aware and alert than before the implant. Physician reported that the patient developed irregular breathing after patient had a prolonged seizure that was probably related to an inadvertent elevated lamictal administration. Physician indicated that he did not believe that the vns was the cause of the irregular breathing. An ent reviewed the patient's sleep tapes and concluded that there were periods of apnea throughout the night when the patient was asleep. The device was temporarily programmed to off and the patient's breathing returned back to normal, but patient had an increase in seizures and developed dyspnea. The device was programmed back to on with parameter adjustments in hopes of maintaining seizure control without further breathing difficulties.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=356058
« Last Edit: February 14, 2015, 12:46:34 AM by dennis100 » Logged
dennis100
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« Reply #17 on: April 11, 2011, 12:27:21 AM »

Event Date 06/13/2000
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Rptr indicated that on event date, pt had a violent 18 minute seizure. The magnet was used at the onset of the seizure. The pt vomited and aspirated into their lungs resulting in adult respiratory distress. Pt was hospitalized for three months. Pt spent the first month in neuro-critical care, the second month in the respiratory unit being weaned off of the ventilator, and the third month in therapy to regain strength and weight pt had lost. Also while in the hosp, the pt developed a bleeding ulcer and needed 6 units of blood. In 2000, just 6 weeks after being home, the exact same seizure pattern occurred. The magnet was again used at seizure onset. The pt again vomited and aspirated, but a vacu-aide suction machine was used and eliminated a great deal from entering the lungs. Pt was again hospitalized for another 6 weeks and placed on a ventilator. The physician decreased the device output current to 0. 75 the following month while pt was still in hosp. The magnet has not been used at seizure onset. There have been no more incidents of this nature. There have been many seizures, but no life-threatening aspiration.

Manufacturer Narrative
Method: mfg records were reviewed. Results not review of the mfg records did not identify any anomalies or abnormalities that would have an adverse effect on device performance. Two written requests and three phone calls were made to gather further info; however, the info was not rec'd.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=355868
« Last Edit: February 14, 2015, 12:47:49 AM by dennis100 » Logged
dennis100
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« Reply #18 on: April 12, 2011, 04:30:36 AM »

Event Date 04/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt did not experience an increase in seizures as initially reported. It was reported that the pt did not experience any changes in seizures with vns therapy. Further follow-up also revealed that the pt did not have dysphagia as initially reported. The pt has had difficulty clearing secretions since birth and this did not change with vns therapy. The ncp system was programmed to off on 5/9/2002. The pt does not have any plans to explant the ncp system at this time. H. 6. Results: device labeling lists dyspnea as a potential adverse event that may result from stimulation. H. 6. Conclusions: pt's mother reported that the dyspna resolved by itself without any changes in the device parameters.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and bipolar lead revealed no anomalies that could have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3, date event.

Event Description
In the process of contacting the pt to inform pt that generator may be nearing end of service, it was discovered that the pt was experiencing symptoms of dyspnea, dysphagia, and an increase in seizures. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=397658
« Last Edit: February 14, 2015, 12:48:17 AM by dennis100 » Logged
dennis100
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« Reply #19 on: April 12, 2011, 04:31:38 AM »

Event Date 01/01/2001
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. Death certificate listed the cause of death as respiratory failure, due to (or a consequence of) status epilepticus, due to (or a consequence of) lennox-gastaut. The death certificate listed the manner of death was listed as natural.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
In the process of contacting the pt to inform them that their generator may be nearing end of svc, it was discovered that the pt had expired. The cause and exact date of death are unk at this time. Attempts to obtain add'l info have been unsuccessful to date. The pt's family member would not give any details regarding the pt death. Follow-up with pt's last known physician revealed that she was no longer the pt's treating neurologist at the time of death. Last known physician reported that she believed that the pt had been hospitalized for status epilepticus and that during the pt's hospitalization, pt's family members decided to withdraw life support and pt died. It is unk whether the pt's ncp system was explanted. There is no allegation of device deficiency. There is no indication that the vns therapy caused or contributed to the event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=390523
« Last Edit: February 14, 2015, 12:48:48 AM by dennis100 » Logged
dennis100
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« Reply #20 on: May 05, 2011, 03:39:00 AM »

Event Date 03/01/2002
Event Type Injury
Patient Outcome Hospitalization; Life Threatening Required Intervention
Event Description
Pt reported that they had an increase in seizure activity. It was reported that there have been some recent changes to their medication regimen and that pt has a low sodium level. The pt reported that pt feels like they have more of an awareness of their seizures. The pt reported that they had eeg monitoring to prove that pt is now having generalized instead of partial seizures. Further follow up revealed that the pt went in for telemetry monitoring because of an increase in seizures. The pt reported that when they would have seizures, use of the magnet would decrease the duration of the seizure. The pt reported they were an in-patient for 8 days during the testing. During the hospital stay, their sodium level decreased. The pt's trileptal prescription was changed to dilantin (600 mg po bid) in 2002. The pt reported that they used their magnet so often during the hospital stay that their voice was hoarse. Device programmed parameters were reduced in hopes of helping their voice recover. The pt was discharged from the hospital the following day. On the next day the pt experienced blurred vision, tachycardia, and trouble breathing. The pt was seen in the emergency room and was prescribed diastat. The er physician attributed the pt's symptoms to the sudden change to dilantin. Their dilantin dosage was reduced to 400mg on that day. It was later reported that the pt was hospitalized again 13 days later because they were experiencing a flurry of seizures. The physician did not make any further changes to the vns programmed parameters. Attempts to obtain additional info have been unsuccessful to date.

Manufacturer Narrative
The pt was released from the hosp in 2002. No parameters were changed during the stay. The physician told the pt their symptoms were psychological. The physician reported to the pt that the tachycardia and trouble breathing were related to stress and the position they sleep in. Chaning sleep positions resolved these symptoms and the pt did not have any further problems. The pt did not follow up with the physician after being discharged from the hosp. The pt followed up with another neurologist one week later and had their parameters adjusted. 2 days later they had an spisode of status and was hospitalized. During this hospitalization, the treating physician changed their medications (stopped dilantin and gabitril). The pt was released 6 days later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=388523
« Last Edit: February 14, 2015, 12:49:30 AM by dennis100 » Logged
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« Reply #21 on: May 05, 2011, 03:39:42 AM »

Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Event Description
Reporter indicated that pt had actual vocal cord swelling by endoscopy and evidenced by stridor clinically. The physician assumed that the device programmed parameters may have been too aggressive and reduced normal mode output current to 0. 75ma and magnet mode output current to 1. 00ma. It was reported that the pt was initially fine after the parameter reduction, but that 2 months later the pt was again showing some stridor again. Attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=387323
« Last Edit: February 14, 2015, 12:49:54 AM by dennis100 » Logged
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« Reply #22 on: July 07, 2011, 02:49:18 AM »

Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening; Hospitalization Required Intervention
Event Description
Reporter indicated that pt started having very mild spells with just "gasping" (no convulsions). Previously the pt's arms and legs would extend out and pt would convulse when having a seizure. The pt had 3 very severe seizures in 2002. No injuries were reported. 3 days later, the pt had 4 very severe seizures and 5 mild seizures about 3-4 mins in between. The physician reduced the device output current from 3. 5 ma to 2. 5 ma 2 days later. 2 days later, the pt had 9 mild seizures. The physician programmed the pt's device to off the following day. That night, the pt started having very severe seizures. Pt was taken to the emergency room. The dr prescribed 5mg of diastat (a valim suppository), but the pt's family member were not able to get the prescription filled. 2 days later, the pt had 1 medium seizure that lasted about 2 minutes and 15 seconds. During six days, the pt didn't have any seizures at all. In 02/02 the pt had 4 severe seizures which continued to the following day. The next day, the pt went in for an appointment and the stimulation output current was turned up to 1. 0ma. The physician prescribed 15mg of diastat. The pt had 16 mild seizures on this day. The following, the pt took 15mg of diastat and didn't have any seizures following this. The next day, the device was set to 30 sec on, 5 mins off. The pt had small seizures every 5 mins. When the horsehsoe magnet was used it slowed the frequency of the seizures to 15 mins - 45 mins apart (most were 25-35 mins in between). The following day, the block magnet was used. The pt had many small seizures throughout the night at 5 min intervals that the block magnet did not stop. No magnet was used at all. The pt was given 15mg of diastat and pt continued having seizures. The block magnet was used again and the pt was still having seizures. Following all of this, the pt's family member took pt to see the physician again (date unknown). The physician ran a lead test which resulted in ok lead impedance, indicating proper device function. The pt's family member is in the process of changing physician's. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
Further follow-up revealed that the patient's device was turned off on 02/12/2002. The patient was last seen by the physician on 03/19/2002 and was much improved. The patient's device has not been returned back on.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=385294
« Last Edit: February 14, 2015, 12:50:31 AM by dennis100 » Logged
dennis100
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« Reply #23 on: July 07, 2011, 02:50:16 AM »

Event Date 02/12/2002
Event Type Malfunction
Patient Outcome Required Intervention;
Manufacturer Narrative
Further follow-up revealed that the pt was explanted after complaining of "electrical shocks".

Manufacturer Narrative
Device manufacturing records were reviewed. Device programming history was reviewed. Review of manufacturing records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. Review of programming history did not reveal any anomalies that would have an adverse effect on device performance. Lead test results were within normal limits, indicating proper device function. Eri (elective replacement indicator) was no, indicating that the generator was not at end of service.

Event Description
Reporter indicated that patient complained of erratic and painful stimulation. When this occurred the patient would become pale and short of breath. The physician ran two lead tests one of which resulted in a "fault" and one that resulted in "okay" readings. The physician did not report what the eri (elective replacement indicator) flag was. The physician programmed the patient's device to off which relieved their discomfort. Further follow-up revealed that the patient also complained to their surgeon of chest pain, tightness in chest and a pinching and pulling sensation. The surgeon did not believe that these symptoms were related to the vns since the device had been programmed to off. The patient was seen in the emergency room and reportedly had a negative cardiac work-up. The patient's neurologist plans device replacement due to suspected malfunction.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=382808
« Last Edit: February 14, 2015, 12:51:16 AM by dennis100 » Logged
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« Reply #24 on: July 07, 2011, 02:51:06 AM »

Event Date 09/01/2001
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Physician indicated that the reported events of shortness of bret and tachycardia are now resoved; however, dr did not state how the event was resolved. Device programming history was reviewed. Review of device manufacturing records did not reveal any anomalies nor abnormalities.

Manufacturer Narrative
Further follow-up revealed that the pt experienced an increase in seizures following a parameter change in 2/2002. The pt's mother reported that she is unsure whether this change is due to the pt's parameter change or due to the pt's seizure disorder as the pt has had periods like these in the past. The pt's mother dose not feel like the increase in seizures is not manageable.

Manufacturer Narrative
Dyspnea and heart rate and rhythm changes are listed as potential adverse events in the labeling for these products. The following dates are estimated. Only the month/year is known: b,3. , date of event.

Event Description
The reporter indicated that since the vns reporter has experienced shortness of breath associated with minimal exertion (i. E. Walking fast). The patient also experiences tachycardia during these events. The patient's heart rate will raise to 120 bpm from a resting rate of 80 bpm. It was reported that the patient had a very high energy level and a good deal of stamina prior to the implant. The patient's oxygen saturation was checked and resulted in normal and all pulmonary testing that has been done has also been normal. The patient reportedly does not notice any relationship between these symtpoms and the cycling of the vns. Patient also reported that the medications have not been changed. Patient stated that patient was having good seizure control until the last parameter adjustment. Subsequent to this adjustment, patient's seizures have increased, but are still below baseline.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=380159
« Last Edit: February 14, 2015, 12:51:52 AM by dennis100 » Logged
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« Reply #25 on: July 16, 2011, 02:25:40 PM »

Event Date 01/22/2001
Event Type Injury
Patient Outcome Life Threatening; Disability Other
Event Description
In 2001 rptr had a vagus nerve implanted for control of epilepsy. When rptr came out of the surgery rptr had a paralyzed left vocal cord, no sense of smell, or taste, deep inner ear nerve pain and head aches constantly. Has had their air intake and has to sit up in bed so not to aspirate. They cannot do a thing, rptr has to deal with this the rest of life. The drs could not turn the device on because of rptr's problem. They took the vagus nerve stimulator out 8 mos later. Rptr does not know if it was caused by the device or not, but others should be told before they make the decision to have the surgery and end up like the rptr. Such a device should be looked into.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=380583
« Last Edit: February 14, 2015, 12:52:22 AM by dennis100 » Logged
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« Reply #26 on: July 16, 2011, 02:26:15 PM »

Event Date 10/24/2001
Event Type Death Patient Outcome Death;
Event Description
Reporter indicated that pt was found "with breathing standstill and stopped heart functions, successful reanimation". Device was turned off in 2001. Further follow-up indicated that the pt suffered from pneumonia that was untreatable. Pt was last seen at the physician's office 6 days ago.

Manufacturer Narrative
Reviewed manufacturing records. Review of manufacturing records did not reveal any anomalies that would have had adverse effect on device performance. Physician indicated that the ncp system was not related to the cause of death.

Manufacturer Narrative
Physician was not willing to provide copy of death certificate. It was reported that the pt had taken all anti-epileptic medications available at one time or another. Pt was implanted on 9/4/01. Pt was found not breathing on the morning of 9/6/01. Pt's device was programmed to off on 9/14/2001. Pt was last seen by phsyician on 10/18/2001. Pt expired on 10/24/2001 due to complications from untreatable pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=377400
« Last Edit: February 14, 2015, 12:53:04 AM by dennis100 » Logged
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« Reply #27 on: July 16, 2011, 02:26:50 PM »

Event Date 01/01/1999
Event Type Injury
Patient Outcome Disability;
Manufacturer Narrative
Reviewed mfg records. Review of mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the year is known: b. 3, date of event.

Event Description
Pt said that pt has had vocal cord paralysis for 2. 5 years. Also, the pt wanted the device implanted under pt's armpit and the surgeon implanted the device in pt's chest area. When pt woke up from surgery, pt had no voice and could not breathe. Pt has been to an ent a few times and the ent said that the right vocal cord is compensating. No intervention was taken by the ent. Pt's device has been turned on and off multiple times in the past 2. 5 years, but pt received best seizure control when it was off. An attmept has been made to obtain add'l info via federal express letter to physician.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=377656
« Last Edit: February 14, 2015, 12:53:36 AM by dennis100 » Logged
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« Reply #28 on: July 16, 2011, 02:27:29 PM »

Event Date 02/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
Late report due to administrative error. Method: device mfg records were reviewed. Results: review of device mfg records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance.

Event Description
Reporter indicated that the pt began to experience heart fluttering and shortness of breath after parameter increase. The pt's device was programmed to on two weeks post-implant (output current 0. 25ma). Within a two-week period after being programmed to on, the programmed output current was increased (0. 75ma). The physician reduced the programmed output current to 0. 50ma after the pt complained of heart fluttering and shortness of breath. Three attempts to obtain additional info have been unsuccessful to date (1 via u. S. Mail to physician, 2 via telephone call to physician's office - unable to leave message, no answering machine or answering service).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=376920
« Last Edit: February 14, 2015, 12:54:01 AM by dennis100 » Logged
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« Reply #29 on: July 16, 2011, 02:28:04 PM »

Event Date 10/01/2001
Event Type Injury
Patient Outcome Required Intervention; Life Threatening
Manufacturer Narrative
Device mfg records were reviewed. Review of device mfg records did not reveal any anomalies or abnormalities that would have an adverse effect on device performance. The following dates are estimated. Only the month/year is known: b. 3, date of event.

Event Description
Rptr indicated that in 2001, the pt was unable to swipe magnet prior to onset of grand mal seizure. As a result, the pt had a drop attack and 911 was called. When the pt stopped breathing, the attending emt began to revive the pt and bruised the pt at the generator site. The pt immediately saw the physician. The physician ran diagnostic tests on the device which indicated that the device was functioning properly. Device programmed parameters were increased a few weeks following the event. It was reported that the pt has fully recovered. Investigation to date has been unable to determine why the pt was not able to activate magnet mode stimulation on the day of the event. Four attempts have been made to obtain add'l info with no reponse to date (2 via telephone conversation with nurse at site, 1 via us mail to physician, 1 via telephone message to site).

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=376577
« Last Edit: February 14, 2015, 12:54:30 AM by dennis100 » Logged
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