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dennis100
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« Reply #30 on: July 16, 2011, 02:28:43 PM »

Event
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« Reply #31 on: July 16, 2011, 02:29:20 PM »

Event Date 04/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
In the process of contacting the pt to notify pt that pt's device may be nearing end of service, it was reported that when the pt is asleep and snoring pt experiences episodes of severe dyspnea that last for 3 to 4 minutes. These episodes began after the pt's device was programmed to off for x-rays and then programmed back to on. Further f/u with pt's last known physician revealed that the pt was experiencing difficulty breathing, but the physician could not clinically diagnose that pt was asthmatic. The pt was tested and asthma was ruled-out. Physician could not provide an answer regarding whether or not he believed that the vns contributed to the pt's condition. Vns re-implant for end of service is not scheduled at this time as the pt will undergo brain surgery in 2002. Attempts to obtain add'l info have been unsuccessful to date.

Event Description
Further follow-up revealed that the pt was explanted due to end of service. It was also reported that the pt underwent brain surgery and was "cured".

Manufacturer Narrative
H. 6. Device mfg records were reviewed. H. 6. 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 month/year is known: b. 3 date of event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=408870
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« Reply #32 on: July 16, 2011, 02:30:21 PM »

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.

Manufacturer Narrative
Further follow-up revealed that the patient's device was programmed to off after experiencing coughing and hoarseness shortly after implant. It was reported that after a period of time the device was programmed back to on wihtout any further problems. It was reported that the patient is having great seizure control.

Manufacturer Narrative
Conclusion: device labeling states that "pt's whose seizures are well controlled at follow-up should not have their settings changed unless they experience uncomfortable side effects. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=401108
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« Reply #33 on: July 16, 2011, 02:31:26 PM »

Event
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« Reply #34 on: July 16, 2011, 02:32:10 PM »

Event Date 03/07/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. H. 6. Results: review of manufacturing records revealed no anomalies that would have adverse; effect device performance.

Manufacturer Narrative
Further follow-up revealed that the pt never reported any problems or dissatisfaction with his ncp system to the physician. H. 6. Physician indicated that the relationship between the ncp system and cause of death were not related.

Event Description
Reporter indicated that patient had passed away. The patient presented to the emergency room for evaluation of new onset dyspnea that occurred with reclining throughout the evening before this presentation. Patient had a long history of seizures, hypertension and a long history of cigarette use (one and one-half packs per day). After referral to the hospital emergency room, patient was noted to be hypoxemic by o2 saturations and received oxygen with improvement. Initial laboratory analysis was done in addition to chest x-ray, echocardiogram and venous doppler of the lower extremities (results unknown). Initial therapy was recommended regarding patient's obstructive airway disease. In follow up, the respiratory therapist was checking on patient. Patient was trying to sit up on the side of the stretcher to urinate when patient complained of severe precordial discomfort and turned blue from the waist up. Patient was subsequently noted to have a barely palpable pulse at 30 and was not breathing. Cpr was begun. Despite prolonged cpr and acls protocol, patient was pronounced dead. Physician indicated that the death seemed natural, but the precise reason for sudden decline is unknown. A provisional diagnosis of acute cardiopulmonary arrest was made. No autopsy was performed and death certificate is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418940
« Last Edit: February 14, 2015, 12:58:30 AM by dennis100 » Logged
dennis100
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« Reply #35 on: July 16, 2011, 02:33:10 PM »

Model Number 100
Event Type Death
Patient Outcome Death;
Event Description
In the process of updating device tracking info, it was discovered that the pt had passed away. The pt's last known physician was contacted in an attempt to obtain the name of the pt's new physician since the last known physician had relocated. The cause and date of death is unknown at this time. The pt was seen by last known physician in 3/2000. Last known physician suspects that the pt died of natural causes and does not know whether an autopsy was performed.

Manufacturer Narrative
The report is incomplete because the pt's last known physician is no longer practicing at the same facility. Attempts to obtain additional info from physicians remaining at the facility have been unsuccessful to date. The pt's treating physician at the time of death is unk at this time. Request for a copy of the death certificate is pending with the state dept of health. H. 6 method: device mfg records were reviewed. Results: review of mfg records for both the pulse generator and the bipolar revealed no anomalies that would adversely affect device performance.

Manufacturer Narrative
Further follow-up revealed that the death certificate listed the cause of death as cardiorespiratory arrest, due to (or a consequence of) suspected hypoxia and acidosis, due to (or a consequence of) possible hypoventilation secondary to tracheostomy. The manner of death was listed as natural.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The physician described the circumstances of death as: the patient developed respiratory progressive distress and appeared in a septic state. H. 6: physician indicated that there was no relationship between the ncp system and cause of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418941
« Last Edit: February 14, 2015, 12:59:23 AM by dennis100 » Logged
dennis100
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« Reply #36 on: July 16, 2011, 02:33:47 PM »

Event Date 06/26/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. Conclusions: there is no evidence at this time that the ncp system caused or contributed to the reported event.

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 had passed away. Autopsy report attributes cause of death to sepsis and respiratory failure with multi-organ damages including hepatic central lobular necrosis, adrenal necrosis, acute tubular necrosis, and diffuse pulmonary intra-alveolar interstitial fibrosis. There is no evidence at this time that the ncp system caused or contributed to the reported event. Further investigation revealed that the patient was hospitalized from 05/02 until the date of their death. The patient was taken to the emergency room by their mother in 05/02 for a sore throat, difficulty breathing, "making sounds" (stridor) for three days intermittently. The patient was intubated in the emergency room, during which a mass completely obstructing the left main stem bronchus was visualized and biopsies of the mass were performed with follow-up laser therapy. The patient aspirated during this initial procedure. Post-operatively, patient's respiratory status declined. Patient was subsequently reintubated and the mass was debulked to ventilate the left lung with rigid bronchoscopy. Once the rigid bronchoscope was withdrawn, attempt to reintubate the patient was unsuccessful and an emergent cricothyroidotomy was performed. Possibly one of the internal jugular veins and the esophagus were partially lacerated in the event. During the procedure, the patient developed bradycardia, asystole and ventricular tachycardia requiring electrical defibrillation to restore sinus rhythm. Patient was subsequently transferred to the intensive care unit. The transbronchial biopsies of the left main stem bronchus mass done during this hospital admission was determined to be from a squamous papilloma with severe dysplasia. The patient's hospital course gradually worsened with adult respiratory distress syndrome, sepsis, and intractable seizures. Although patient's multiple blood cultures continued to be negative for organism, their urine and respiratory sputum samples grew enterobacter cloacae and candida albicans. Patient developed bilateral pneumothoraces and chest tubes were placed. The patient also developed a deep venous thrombosis in the left common femoral vein as determined by doppler ultrasound and was given anticoagulant prophylaxis. Patient's respiratory status continued to deteriorate and their family decided to change code status to no code. The patient suffered cardiopulmonary arrest and was pronounced dead in the hospital 5 weeks later.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=418268
« Last Edit: February 14, 2015, 01:02:57 AM by dennis100 » Logged
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« Reply #37 on: July 16, 2011, 02:34:23 PM »

Event Date 08/15/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6: cause of death reported as respiratory failure as a result of many multi-system organ failures and high co-morbidity. Physician indicated that the ncp system was not related to the cause of death.

Event Description
Reporter indicated that vns pt had passed away due to repiratory failure. The pt reportedly suffered from many multi-system organ failures and had a high co-morbidity. Further investigation revealed that the pt was last seen by the last known treating physician in 07/2002. The pt was receiving vns therapy at the time of death and their condition had not changed. It was revealed that an autopsy was performed but attempts to contact the last known physician have not been successful to date. The device was not explanted and is subsequently not available for an analysis. The pt had a history of being worked up for resective epilepsy surgery but had never undergone such surgery. 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=416474
« Last Edit: February 14, 2015, 01:03:59 AM by dennis100 » Logged
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« Reply #38 on: July 16, 2011, 02:35:09 PM »

Event Date 07/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
The report is incomplete due to the anonymous nature of the reported event.

Event Description
Reporter indicated that when programmed device settings are increased, the pt experiences pain and difficulty in breathing. It was also reported that the pt experiences extreme voice alteration at higher device settings. When the pt squats or bends over, they reportedly begins breathing hard and then cannot breathe at all. Investigation to date has been unable to determine the severity of the reported symptoms.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=416425
« Last Edit: February 14, 2015, 01:04:44 AM by dennis100 » Logged
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« Reply #39 on: July 16, 2011, 02:35:53 PM »

Event Date 06/05/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Review of mfg records revealed no anomalies that would adversely effect device performance.

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: February 14, 2015, 01:06:31 AM by dennis100 » Logged
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« Reply #40 on: July 16, 2011, 02:37:01 PM »

Event Date 11/27/1999
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that the pt developed respiratory and cardiac arrest following a seizure. The physician indicated that the pt did not have efficay with vns therapy. H. 6. Conclusions: physician indicated that the relationship between the ncp system and cause of death was not related.

Manufacturer Narrative
Method: device mfg records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that could have an adverse effect on device performance.

Event Description
In the process of contacting the patient to notify that the device may be nearing end of service, it was discovered that the patient had passed away. Exact date and cause of death are unknown at this time. There is no evidence that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
Further follow-up revealed that the patient developed respiratory and cardiac arrest following a seizure. The physician indicated that the patient did not have efficacy with vns therapy. H. 6 physician indicated that the relationship between the ncp system and cause of death was not related.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414511
« Last Edit: February 14, 2015, 01:07:19 AM by dennis100 » Logged
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« Reply #41 on: July 16, 2011, 02:37:37 PM »

Event Date 07/28/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6-device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that could have and adverse effect on device performance.

Event Description
Reporter indicated that the pt had passed away and that the cause of death was hypoxia. Attempts to obtain add'l info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414552
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« Reply #42 on: July 16, 2011, 02:38:30 PM »

Event Date 07/20/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H6: device manufacturing records were reviewed. Review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Physician indicated that the ncp system was not related to the reported event.

Event Description
Reporter indicated that vns pt had passed away. Certificate of death lists respiratory arrest as the immediate cause of death, due to or as a consequence of mitochondrial disorder of oxidative phosphorylation, due to or as a result of epilepsy. No autopsy was performed. Physician indicated that the pt died of respiratory arrest during the night and there was no seizure associated. Physician indicated that the ncp system was not related to the cause of death. The pt reportedly experienced a >50% reduction in seizures with the vns therapy. Return of explanted product for analysis is pending.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=412627
« Last Edit: February 14, 2015, 01:08:46 AM by dennis100 » Logged
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« Reply #43 on: July 16, 2011, 02:39:31 PM »

Event Date 06/07/2001
Event Type Death
Patient Outcome Death;
Event Description
In the process of notifying the pt that their device may be nearing end of service, it was discovered that the pt had passed away. The cause of death is unk at this time. There is no evidence that the ncp system caused or contributed to the reported event. Attempts to obtain add'l info have been unsuccessful to date.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. Results: review of mfg records did not reveal any anomalies that would have an adverse on device performance.

Manufacturer Narrative
Corrected dat: h. 10. - the paragraph in follow-up 01 referenced the wrong year. See correction below. Further follow-up revealed that the pt was admitted to the hosp on 5/15/2001, in respiratory distress with a temperature of 103 degrees fahrenheit. The pt was intubated and put on a ventilator which they were unable to wean. The pt aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. On 6/5/2001, the pt aspirated again and had a lower gi bleed. The family decided to withdraw care and the pt died on 6/7/2001. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia.

Manufacturer Narrative
Further follow-up revealed that the pt was admitted to the hospital in 2002, in respiratory distress with a temperature of 103 degrees fahrenheit. The pt was intubated and put on a ventilator which they were unable to wean. The pt aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. In 2002, the pt aspirated again and had a lower gi bleed. The family decided to withdraw care and the pt died in 2002. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia. H. 6. Physician indicated that the relationship between the ncp system and cause of death were not related.

Manufacturer Narrative
Further follow-up revealed that the patient was admitted to the hospital in 2001, in respiratory distress with a temperature of 103 degrees fahrenheit. The patient was intubated and put on ventilator which they were unable to wean, the patient aspirated and developed pneumonia mrsa with decreased urine output, ascites, acute renal failure, and pulmonary edema. In 06/2001, the patient aspirated again and had a lower gi bleed. The family decided to withdraw care and the patient died two days later. No autopsy was performed. The death certificate stated that the immediate cause of death was sepsis due to (or as a consequence of) bilateral pneumonia.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411200
« Last Edit: February 14, 2015, 01:10:18 AM by dennis100 » Logged
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« Reply #44 on: July 16, 2011, 02:40:13 PM »

Event Date 05/17/2000
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6 method: device manufacturing records were reviewed. Results: review of manufacturing records did not reveal any anomalies nor abnormalities that would have an adverse effect on device performance. Conclusions: per death certificate, immediate cause of death listed as "cerebral edema", due to or as a consequence of seizures that were due to or a consequence of ventriculo-peritoneal shunt malfunction.

Event Description
In the process of contacting the pt to notify them that their device may be nearing end of service, it was discovered that the pt had passed away. The pt was reportedly seizure-free from january 2000 to may 2000. In 2000, the pt was admitted to the hospital for break-through seizures with fever. The pt had been in their normal stage of health until earlier that morning. The pt was admitted and was observed overnight and was hemodynamically stable, but did not wake up; pt remained very sleepy. The following morning, the pt was noticed to have mental status change and was unresponsive in respiratory failure. Pt began experiencing abnormal breathing and was taken to the operating room for a vp shunt revision. After the vp shunt revision, the pt was started on rocephin and nafcillin, but mental status did not improve. Two days later, the pt remained in a deep coma and was unresponsive to painful stimuli. An apnea test was performed and the pt was apneic for seven minutes. A neurologic exam was done twice, and the pt was pronounced dead by brain death criteria. The pt reportedly developed massive cerebral edema and died. The pt's parent stated that they feel the vns is partially responsible for the pt's death; however, they did not state why they feel that way. The death certificate stated the cause of death as cerebral edema along with seizures and a ventriculo-peritoneal shunt malfunction as consequences of death. The pt was taking phenobarbitol, but it had been discontinued. The pt was currently prescribed 45mg of topirmate. No autopsy was performed and the lead and generator were not explanted.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411250
« Last Edit: February 14, 2015, 01:11:11 AM by dennis100 » Logged
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« Reply #45 on: July 16, 2011, 02:41:15 PM »

Event Date 06/18/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
Further follow-up revealed that the pt has been experiencing shortness of breath and sometimes stops breathing during the night. The pt reported that she has had trouble sleeping since having their device programmed to on. The pt also reported that they have been experiencing pain at the generator site for since 2002. The physician's office indicated that th ept has not been seen by the physician one month ago. During office visit 2 months ago the pt denied having chest pain, shortness of breath, fever and chills and was doing well. The pt has not contacted the physician's office concerning any problems since being seen 2 months later.

Manufacturer Narrative
H. 6. 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
Reporter indicated that pt began to experience episodes of dyspnea, during which they would lose conciousness due to shortness of breath. The pt started a new medication (klonipin) at approx the same time that the episodes of dyspnea began. The shortness of breath has reportedly resolved. Further follow-up with pt's neurologist revealed that the pt had not been in contact with their office since the last visit in 5/2002. The pt has an appointment scheduled for 8/2002 at which time the neurologist will address the reported event.

Manufacturer Narrative
Further follow-up revealed the pt is doing well. Device labeling lists dyspnea as a potential adverse event that may result from stimulation. Physician indicated that the reported events have resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=411401
« Last Edit: February 14, 2015, 01:11:48 AM by dennis100 » Logged
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« Reply #46 on: July 16, 2011, 02:42:16 PM »

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.

Manufacturer Narrative
Further follow-up revealed that the pt has had a good response from vns therapy. The pt has not had any major seizures since being implanted with the ncp system. Device diagnostic testing was within normal limits and eri (electvie replacement indicator) flag was no, indicating that the device was not at end of service. Device settings are currently set to 7 seconds on and 18 seconds off.

Manufacturer Narrative
Report is incomplete because the physician was out of the country for a period of time and was not available. Recent attempts to contact the physician through international distributor have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=424174
« Last Edit: February 14, 2015, 01:12:36 AM by dennis100 » Logged
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« Reply #47 on: July 16, 2011, 02:42:57 PM »

Event Date 09/09/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Method: device manufacturing records were reviewed. Results: review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
Reporter indicated that pt was found dead in their bed by their family three days post-vns implant. It was reported that the pt had some 'breathing problems' after the surgery. The pt's family reported that the evening before their death, the pt appeared fine and they did not suspect any problems. Autopsy report is not complete, but it was reported that the cause of death was pulmonary edema. It was also reported that the vns was programmed to on the day of implant surgery and was on at the time of death.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=421693
« Last Edit: February 14, 2015, 01:13:18 AM by dennis100 » Logged
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« Reply #48 on: July 16, 2011, 02:43:35 PM »

Event Date 08/14/2002
Event Type Death
Patient Outcome Death;
Event Description
Reporter indicated that the pt had passed away. The pt was admitted into the hospital in 2002 with multiple medical problems and was a dnr (do not resuscitate). The cause of pt's death was listed as respiratory failure. The reporting physician did not have full details on the event as pt was out of town and another doctor was covering for them.

Manufacturer Narrative
The report is incomplete because the treating physician has been out of town and unable to respond to requests for add'l info to date. Method: device mfg records were reviewed. Results: review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=420624
« Last Edit: February 14, 2015, 01:13:47 AM by dennis100 » Logged
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« Reply #49 on: July 16, 2011, 02:44:21 PM »

Event Date 11/28/2002
Event Type Injury
Patient Outcome Life Threatening;
Manufacturer Narrative
H. 6. Device manufacturing records were reviewed. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

Event Description
The magnet was used at the onset of a seizure and the patient indicated that their chest and throat hurt and then the patient became cyanotic. This reportedly occurred on two occasions. The patinet's programmed parameters were changed and the magnet had been used daily since then without incident. The magnet was tested before leaving the physician's office at the time that the adjustment in parameters was made, also without incident. Physician advised patient not to use magnet until manufacturer completes a review of the reported information. Physician is considering reducing the magnet pulse width to a more tolerable setting. No device malfunction is suspected.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435937
« Last Edit: February 14, 2015, 01:14:20 AM by dennis100 » Logged
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« Reply #50 on: July 16, 2011, 02:45:10 PM »

Event Date 12/01/2002
Event Type Injury
Patient Outcome Life Threatening; Disability
Manufacturer Narrative
Further follow-up revealed that the physician indicated that the pt's condition is "stable".

Event Description
Reporter indicated that the patient has been "heaving" and feels like there is something wrong with their lungs. The patient is asthmatic, but reports that their family doctor indicated that the heaving is not related to their asthma. Further follow-up revealed that the patient had an episode on 12/10/02 where pt woke up and couldn't breathe. The patient reported that this started about 9 years ago and happens about once a year. The patient has been implanted with the ncp system since 1991. The patient was seen by a laryngologist in 12/02 and was diagnosed with paradoxical vocal cord dysfunction. The laryngologist is considering using botox as a treatment.

Manufacturer Narrative
Report is incomplete because no response to manufacturer's requests for additional information has been received to date from physician. H. 6. Results: the ncp system labeling lists dyspnea (difficulty breathing, shortness of breath) as a potential adverse event possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=435868
« Last Edit: February 14, 2015, 01:14:58 AM by dennis100 » Logged
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« Reply #51 on: July 16, 2011, 02:46:18 PM »

Event Date 11/01/2002
Event Type Injury
Patient Outcome Life Threatening; Required Intervention
Manufacturer Narrative
H. 6: device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance. The ncp system labeling lists aspiration (fluid in the lungs) and dysphagia (difficulty swallowing) as potential adverse events possibly associated with surgery or stimulation. The following dates are estimated. Only the month/year is known: b. 3, date of event.

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: February 14, 2015, 01:15:49 AM by dennis100 » Logged
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« Reply #52 on: July 16, 2011, 02:47:14 PM »

Event Date 01/01/2002
Event Type Injury
Patient Outcome Life Threatening;
Event Description
Reporter indicated that the pt has experienced wheezing following device parameter increase. Reporter also indicated that the pt has experienced a decrease in seizures. The physician indicated that the wheezing was due to the device parameter increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432862
« Last Edit: February 14, 2015, 01:16:12 AM by dennis100 » Logged
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« Reply #53 on: July 16, 2011, 02:47:59 PM »

Event Date 11/14/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
Further follow-up revealed that the pt reported that she is "not doing very well. " the pt also reported that she has intermittent swelling in her neck, a sore throat, shortness of breath, and that she as experienced no change in her seizures.

Manufacturer Narrative
H6 results: ncp system labeling lists hoarseness, choking sensation and pain as potential adverse events possibly associated with surgery or stimulation.

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: February 14, 2015, 01:17:01 AM by dennis100 » Logged
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« Reply #54 on: July 16, 2011, 02:48:43 PM »

Event Date 11/01/2002
Event Type Malfunction
Patient Outcome Life Threatening; Hospitalization Required Intervention
Manufacturer Narrative
It was initially reported that the pt's device was programmed to stimulate every minute. The physician has since reprogrammed the pt's device to stimulate every five minutes (normal device settings). H. 6. Device mfg records were reviewed. Review of mfg records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely effect device performance.

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.

Manufacturer Narrative
Report is incomplete due to the anonymous nature of the reported event. H. 6 results: ncp system labeling lists dyspnea, dysphagia, and painful stimulation as potential adverse events possibly associated with surgery or stimulation.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=432509
« Last Edit: February 14, 2015, 01:17:31 AM by dennis100 » Logged
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« Reply #55 on: July 16, 2011, 02:49:55 PM »

Event Date 01/01/2000
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Manufacturer Narrative
H. 6. : ncp system labeling lists choking sensation as a potential adverse event possibly associated with surgery or stimulation.

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: February 14, 2015, 01:18:08 AM by dennis100 » Logged
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« Reply #56 on: July 16, 2011, 02:50:49 PM »

Event Date 10/04/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Conclusions: physician indicated that the ncp system was not related to the cause of death.

Event Description
In the process of contacting the pt's physician to notify them that their pt's device may be nearing end of service, it was discovered that the pt had passed away. Circumstances of death are described by physician as sepsis and/or respiratory compromise. It was reported that the pt's seizure frequency/intensity was greatly decreased with vns therapy, but that as the pt's health was failing, their seizures increased. The pt was receiving vns therapy at the time of death. No autopsy was performed.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=429237
« Last Edit: February 14, 2015, 01:18:37 AM by dennis100 » Logged
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« Reply #57 on: July 16, 2011, 02:51:36 PM »

Event Date 10/01/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The physician reported that the patient experienced a great than 50% reduction in seizures. H. 6. Conclusions: physician indicated that the hcp system was not related to the cause of death.

Manufacturer Narrative
Further follow-up revealed that the death certificate listed the cause of death as postictal apnea, due to (or a consequence of) life long seizure disorder. The death certificate listed the cause of death as natural.

Manufacturer Narrative
Further follow-up revealed that an autopsy was not performed. The dr reported tha the pt experienced a > 50% reduction in seizures. Dr indicated that the ncp system was not related to the cause of death.

Event Description
Vns pt had passed away. Exact date and cause of death are unknown at this time. There is no evidence at this time that the ncp system caused or contributed to the reported event.

Manufacturer Narrative
H. 6. Method: device mfg records were reviewed. H. 6. Results: review of mfg records revealed no anomalies that would adversely effect device performance.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=428344
« Last Edit: February 14, 2015, 01:19:15 AM by dennis100 » Logged
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« Reply #58 on: July 16, 2011, 02:53:09 PM »

Event Date 10/16/2002
Event Type Death
Patient Outcome Death;
Manufacturer Narrative
H. 6. Results: the labeling for the ncp pulse generator states that the safety and efficacy of vns therapy has not been established for patients with a history of respiratory diseases or disorders, including dyspnea and asthma. Conclusions: it was reported that the physician did not attribute the death of the patient to vns therapy.

Event Description
Reporter indicated that patient was hospitalized following an asthma attack. The patient had been remodeling their home approximately one week prior to the hospitalization and was around a lot of dust. Further investigation revealed that while in the hospital, the patient became brain dead and was put on a ventilator. The following day, the patient died. An autopsy was not performed. It was reported that the cause of death was respiratory arrest. Patient received a greater than 50% reduction in seizure auras with vns therapy.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=427963
« Last Edit: February 14, 2015, 01:19:50 AM by dennis100 » Logged
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« Reply #59 on: July 16, 2011, 02:53:52 PM »

Event Date 08/12/2002
Event Type Injury
Patient Outcome Hospitalization; Required Intervention
Event Description
Patient's device was programmed to off in 2002 following an emergency room visit due to difficulty breathing and chest pain. The patient reported that they felt as if they were having a heart attack. The patient complained of numbness and left arm tingling, but not with stimulation. Device diagnostic testing at that time was within normal limits. In august 2002, the patient reported that they were no longer having any pain or numbness with the device still programmed to off. Physician instructed patient to follow-up with their cardiologist to rule out any heart problems, but it is not known whether or not pt has been seen by cardiologist. The patient's device is still programmed to off at this time. Patient was again seen by neurologist in 10/2002 at which time they reported that pt no longer had any numbness or chest discomfort since the vns was programmed to off and there are no plans to program the vns back to on at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=426771
« Last Edit: February 14, 2015, 01:20:43 AM by dennis100 » Logged
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