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Author Topic: Anemic/Cyanotic  (Read 4467 times)
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dennis100
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« on: April 14, 2018, 01:00:36 AM »

Model Number 103
Event Date 12/01/2011
Event Type  Injury  
Event Description
It was reported that the patient reported cyanosis, tachycardia and shallow breathing after having vns increased from 1. 25 ma to 1. 75 ma. The clinic notes state patient was increased over a short period of time (a couple of weeks). Patient came in to have the settings turned back down to 1. 25 ma. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2400668
« Last Edit: October 11, 2018, 06:56:52 AM by dennis100 » Logged
dennis100
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« Reply #1 on: April 14, 2018, 01:01:14 AM »

Model Number 102R
Event Date 03/03/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. The cause of death was unknown by the physician's assistant. The funeral home director indicated that the patient was buried with the device and that the immediate cause of death was heart failure due to atrial fibrillation >3 years, due to or as a consequence of atrial fibrillation >3 years, due to or as a consequence of sleep apnea >5 years. The death certificate noted other significant conditions contributing to death, but not resulting in the underlying cause was serious anemia. No autopsy was performed. The manner of death was listed as natural, and tobacco did not contribute to the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641033
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dennis100
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« Reply #2 on: April 14, 2018, 01:01:41 AM »

Model Number 103
Event Date 11/30/2011
Event Type  Injury   
Event Description
It was reported that ifi=yes was observed, and the generator was implanted on (b)(6) 2011. However, the pt's settings were at a high duty cycle (51%) since the date of implant. Per the mfr battery life estimations for m 103 generators, ifi=yes was expected. The physician lowered the settings to on time=30 sec and off time=1. 1 min to increase the battery life a bit until replacement surgery. The clinic notes from (b)(6) 2011 were received and revealed that the pt was having frequent seizures for the previous three weeks with five to eight seizures per day. The seizures were generalized twitching with cyanosis lasting one to two minutes. In addition, the pt had a fever for the previous couple of days and was seen by his primary care physician who did not find any source of infection. The pt's medications were altered. Attempts for add'l info have been unsuccessful to date. The pt's generator was received, but product analysis has not been completed to date. Return product form indicated reason for explant as end of service/battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2425922
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dennis100
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« Reply #3 on: April 14, 2018, 01:02:54 AM »

Model Number 103
Event Date 07/16/2009
Event Type  Death   
Event Description
It was reported that the pt was found dead in the morning by his mother. He was cyanotic and lying on his stomach. Per the physician, the relationship of the death to vns is unk, however, the pt was recently implanted, so he had not reached a level of efficacy with the vns in regard to his seizure control. No autopsy was performed. The product was not explanted, so it cannot be returned to the mfr. The exact cause of death is unk at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1440031
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dennis100
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« Reply #4 on: April 14, 2018, 01:03:24 AM »

Event Date 01/01/2006
Event Type  Malfunction   
Event Description
On (b)(4), 2012 it was reported that the vns patient was initially implanted with vns in the (b)(4) 2002 and began to feel ill with significantly more seizures and absence seizures in 2006. The patient's condition also worsened and he began to cough often and long and coughed until he threw up. The patient was reported to have seen the neurologist on several occasions. In (b)(4) 2009, the patient visited the dentist and the patient's teeth were ground and an ultrasound was performed. The patient 'jumped in the chest' and was hurt by the vns. It was noted that this was pain at the generator site. The patient had severe coughing, felt sick, and had trouble breathing when he left the dentist's office. When the patient came home, the patient's mother suspected that something was not right with the vns. When the settings of the vns could be adjusted by the hospital, the patient coughed hard and long, lost her breath, and turned blue in the face. It was reported that the physician had not been through something like this before. It was noted that this event occurred three times. In the (b)(4) 2010 it was reported that the manufacturer concluded that the vns was broken in the patient's body and the patient underwent revision surgery for a new vns to be implanted. It was reported that the explanted product had been previously been returned for product analysis however as the product information was not provided nor was additional patient identifying information, this could not be verified. Additional information has been requested from the physician but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
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dennis100
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« Reply #5 on: April 14, 2018, 01:05:02 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.
 
Manufacturer Narrative

Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
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dennis100
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« Reply #6 on: April 14, 2018, 01:05:48 AM »

Model Number 106
Event Date 10/28/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
The death summary from the patient's hospitalization was provided. The patient presented at the emergency room after he had a seizure, administered ativan, and was taken to the hospital by emergency medical services. The patient had a history of seizure disorders and developmental delay. The patient also had a urinary tract infection. The initial assessment upon the patient's arrival was encephalopathy postanoxic, postictal cardiac arrest, pulseless electrical activity (pea), postanoxic myoclonus, status epilepticus, acute respiratory failure, and elevated hepatic enzymes. The patient was given antiepileptic medications while in the hospital. The patient also had evidence of kidney injury, and the assessment was acute kidney injury, metabolic acidosis, and anemia. The patient was in the icu, and the assessment was that the patient had respiratory to cardiac arrest, secondary to seizure and ativan administration. A chest x-ray revealed a left lower lobe infiltrate and presumptive pneumonia. Subsequent to this, the patient remained in an anoxic state and ventilator dependent. An mri was performed, which was consistent with anoxic brain injury. The patient's family and physicians decided to remove the patient from life support, and the patient passed away due to respiratory failure secondary to anoxic encephalopathy.
 
Event Description
The physician provided the patient's device settings, but diagnostic results were not provided. No further relevant information has been received to date.
 
Event Description
It was reported that the patient was hospitalized due to feeling sick and having a few seizures, which were not alleged to be related to the patient's vns. The patient was intubated and experienced cardiac arrest while in the emergency department. The patient was then transferred to the icu, and a brain mri was scheduled. It was later reported that the patient was placed on life support on (b)(6) 2016 and was deemed brain dead. The patient passed away on (b)(6) 2016, and the device was not explanted. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6122170
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dennis100
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« Reply #7 on: April 14, 2018, 01:06:38 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/18/2012
Event Type  Death   
Event Description
Reporter indicated a patient implanted with the vns passed away on (b)(6) 2012, due to seizures per the patient's parents. Attempts for additional information are in progress.
 
Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient's cause of death was status epilepticus.
 
Event Description
Reporter indicated the cause of death was a seizure and the death was not related to the vns. The vns was not explanted, and there was no autopsy. The patient did have seizure reduction with vns. The vns was programmed on at the time of death. The mother found the patient "half out of bed and cold/blue in am. " the death was not witnessed. The position of the body when found suggests the patient died due to a seizure. The patient had a history of nocturnal seizures but no febrile seizures, and the seizures began at 7 years of age due to an unknown etiology. The patient's seizures were secondary generalized and complex-partial. The patient never had any respective surgery. The patient had no drug/alcohol abuse and no cardiac/respiratory problems.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2830680
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dennis100
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« Reply #8 on: April 14, 2018, 01:07:18 AM »

Model Number 103
Event Date 05/29/2014
Event Type  Injury   
Event Description
Clinic notes were received for the vns patient¿s office visit with his neurologist on (b)(6) 2014. The notes indicate that the patient was recently experiencing an increase in seizures. The patient had four seizures in the past year which consisted of a blank stare, cyanosis around the lips, and a stiff dystonic posture. The notes also indicate that the patient¿s lead was protruding in the neck. The patient¿s device was tested and diagnostic results showed an ifi condition with normal device function. The device on-time was increased and the patient began experiencing significant bouts of coughing. Further follow-up revealed that the patient underwent generator replacement surgery on (b)(6) 2014. It is unclear if the patient¿s lead was revised or replaced during the procedure. The explanted generator has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported that the patient only underwent generator replacement. An implant card was received indicating that only the patient's generator was replaced. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3902433
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dennis100
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« Reply #9 on: April 14, 2018, 01:08:13 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 10/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that a patient passed away in the hospital due to an unknown reason. The patient's device was not explanted. Programming history showed that the device was functioning properly approximately two weeks prior to the death. No further relevant information has been received to date.
 
Event Description
The records from the patient's hospitalization and subsequent death were received. The patient presented in the emergency department with cardiac arrest. The patient had a history of chronic heart failure, tracheostomy, and a g-tube. An x-ray of the chest was performed, and there was total opacification of the right lung and lower left lung, which could have been due to pneumonia, effusion, or post-obstructive atelectasis. Labs were performed, and the results indicated hyperkalemia, acute renal failure, and metabolic acidosis. The official cause of death was primarily hyperkalemia and secondarily acute renal failure, anemia, cardiac arrest, metabolic acidosis, respiratory acidosis, respiratory failure, and septic shock. The death was not attributed to the patient's vns in any way.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6342620
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dennis100
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« Reply #10 on: April 14, 2018, 01:09:00 AM »

Model Number 103
Event Date 03/10/2014
Event Type  Injury   
Event Description
It was reported that the patient's device has been programmed off after the patient was seen in the hospital for cyanosis. It was reported that the patient is hospitalized and undergoing a swallowing test. Further follow-up revealed that the device was programmed on and the patient was unable to tolerate device stimulation the device was programmed off. The physician plans to leave the vns programmed off for a few months before programming the device back on. It was reported that the patient was non-verbal and was not eating or drinking per the patient's mother. The mother reported that the patient seemed agitated. No medication changes occurred that is believed to have caused or contributed to the events. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
New information changes the address previously reported in initial mfr. Report.
 
Event Description
Additional information was received stating that the vns patient had approximately 80 ¿big¿ seizures in a week. The patient was taken to the er and was induced into a coma on (b)(6) 2014. It was reported that the patient¿s device was affecting her vocal cords and her ability to swallow. The patient experienced bad gagging episodes for three months and subsequently had her device disabled on (b)(6) 2014. The device has not been programmed back on to date. Further follow-up revealed that the reported event was not related to vns. The patient had a medical history of cyanosis prior to vns. The patient has since recovered. No other interventions have occurred to date. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the cyanosis and hospitalization. This event was also reported in manufacturer report # 1644487-2014-01178.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the event occurred on (b)(6) 2014.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3752033
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dennis100
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« Reply #11 on: April 14, 2018, 01:09:49 AM »

Model Number 103
Event Date 12/12/2012
Event Type  Death   
Event Description
Reporter indicated that the patient passed away in his home on (b)(6) 2012 while on hospice care. It was reported that the patient was expected to pass away. Further follow-up revealed that the cause of death was listed on the death certificate as metastatic colon cancer. Anemia was listed on the death certificate as other significant conditions contributing to death but not resulting in the underlying cause given. No autopsy was performed. Attempts to obtain additional information have been unsuccessful to date. The explanted generator was returned to device manufacturer on (b)(4) 2012 for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
Analysis of the pulse generator revealed that the generator showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 37. 421% of the battery had been consumed. The battery does not suggest an ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2895299

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dennis100
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« Reply #12 on: April 14, 2018, 01:10:37 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
Product analysis for the explanted generator was completed. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
Clinic notes dated (b)(6) 2012 revealed that the patient has experienced worsening seizures, and the caregiver reports that the vns magnet does not consistently work like it has in the past. The patient has lennox-gastaut syndrome and has intractable generalized tonic-clonic seizure activities. The notes revealed that the patient had these seizure activities about seven times a month. The patient also suffers from atonic, partial, and myoclonic seizures. However, the patient had recently been experiencing more seizures accompanied with behavioral issues. The patient's seizure diary revealed to the physician that she had increased frequency of seizures of both generalized tonic-clonic and "bloom" seizures. For the previous two months, the post-ictal state had been up to two hours. Her generalized tonic-clonic seizures appeared to be more severe, and she was sometimes having cyanotic lips during seizures. It was also mentioned that the "increase in seizure activities could be due to recent illness with upper respiratory infections and possible uti. " follow up with the referring physician revealed that the increase in seizures began in (b)(6) 2012 and was "likely due to low battery of vns. " no additional information was provided regarding the increased seizures and change in seizure pattern. The patient had prophylactic generator replacement surgery on (b)(6) 2012. The patient's device was programmed to the pre-operative settings following generator replacement, and post-operative diagnostics were within normal limits. The generator was received by the manufacturer for analysis on (b)(6) 2012. However, product analysis has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
(b)(4).
 
Event Description
The return product form was received by the manufacturer which reported that the generator was replaced prophylactically on (b)(6) 2012. However, product analysis has not been completed to date.
 
Event Description
Follow up with the physician's office regarding the reported cyanosis with the patient's seizures prior to replacement. It was reported that the cyanosis is not believed to be related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2578417
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dennis100
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« Reply #13 on: April 14, 2018, 01:11:26 AM »

Model Number 102R
Event Date 03/03/2015
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. The cause of death was unknown by the physician's assistant. The funeral home director indicated that the patient was buried with the device and that the immediate cause of death was heart failure due to atrial fibrillation >3 years, due to or as a consequence of atrial fibrillation >3 years, due to or as a consequence of sleep apnea >5 years. The death certificate noted other significant conditions contributing to death, but not resulting in the underlying cause was serious anemia. No autopsy was performed. The manner of death was listed as natural, and tobacco did not contribute to the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4641033

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dennis100
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« Reply #14 on: April 14, 2018, 01:11:58 AM »

Model Number 102
Event Type  Malfunction   
Event Description
It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month. The patient could not talk due to cyanotic lip. The patient has 5 times of seizure where 3 were stopped by magnet. The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline). The patient parameters are currently at: 1. 75ma, 30hz, 250usec, 30sec on and 1. 8min off. Follow up indicated that the patient¿s parameters were changed to 1. 25ma; 250's; 30s on; 5mins off. The patient feels very little numb during stimulation. The patient will come back after 3 months for the next follow up visit. The drugs were not changed. The seizure start area in the brain is still unknown for the physician. It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe). Further follow up indicated that the vns system works fine. Numb feeling disappeared after the parameters decrease. However; the patient has several general seizures after this parameters change. Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns). It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6016651
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« Reply #15 on: April 14, 2018, 01:12:38 AM »

Model Number 103
Event Date 11/14/2013
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the vns patient passed away. No additional information was provided at the time of initial report. An online obituary was found and noted that the patient passed away at the hospital. Further follow-up revealed that the patient was admitted to the hospital with a low hemoglobin and hematocrit and tachycardia; however, a cause of death was not yet known. Attempts to obtain additional information have been unsuccessful to date.
 
Event Description
It was reported that it was believed that the death certificate listed gastrointestinal disease/ulcer as the cause of death, but that the copy was too hard to read. It was reported that no autopsy had been performed and there was no knowledge of device explant. The patient was cremated. The hospital discharge summary indicated that the patient was admitted after being found severely anemic with dark bloody stools and more frequent seizures. It was noted that the patient had significant blood loss and had hemorrhagic shock requiring 6 units of packed red blood cells and vasopressor support. The patient underwent endoscopy with control of bleeding, but developed supraventricular tachycardia. The patient failed to return to his usual state of mental activity and his anti-epileptic therapy was adjusted. An eeg showed subclinical seizure activity. On the day prior to death, the patient developed persistent heart rates in the 170s to 180s that did not respond to cardizem, adenosine or amiodarone and he became more hypotensive. It was noted that the patient's family decided on comfort measures only, and the patient ultimately expired. It was noted that the vns was interrogated and was functioning appropriately. The esophagogastroduodenoscopy showed a large duodenal ulcer. Echocardiogram showed hyperdynamic left ventricular systolic function and eeg showed abnormal eeg consistent with both a generalized seizure disorder and possibly a focal area of dysfunction in the right temporo-parietal region. The final diagnoses was listed as acute upper gastro-intestinal bleed due to large duodenal ulcer, complex seizure disorder with subclinical seizure activity, acute blood loss anemia with hemorrhagic shock, supraventricular tachycardia, hypertension, hypothyroidism.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3530505
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« Reply #16 on: April 14, 2018, 01:13:21 AM »

Model Number 102
Event Date 06/15/2009
Event Type  Injury   
Event Description
It was initially reported that the patient has a history of sleep apnea and cyanosis, unknown if related to vns. The patient has been reported to have not used her cpap machine since last year. Good faith attempt for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the cyanosis and sleep apnea were not related to vns. The patient has been scheduled for treatment of the sleep apnea but does not follow-through with the treatment. The patient does have a history of sleep apnea pre-vns. In 2006 the lowest oxygen level was 79%.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2410533
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« Reply #17 on: April 14, 2018, 01:13:57 AM »

Model Number 102
Event Date 08/14/2012
Event Type  Death   
Event Description
Reporter indicated that the patient was receiving vns therapy at the time of death. The patient was found in a cyanotic state in bed by caregivers, and resuscitation was unsuccessful. The death was not witnessed. The patient had a history of nocturnal seizures but no febrile seizures, no drug abuse history, and no history of cardiac or respiratory problems. The patient was compliant with seizure medications, and the last known blood drug levels were normal. The death was not felt to be related to the vns and was felt to possibly be due to sudep. Analysis was completed on the returned generator and lead. No anomalies were noted with the generator, and the generator performed per specifications. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since a large portion of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Reporter indicated a vns patient had died due to confirmed sudep on (b)(6) 2012. The death was not related to the vns per the reporter. The vns lead and generator were explanted and have been returned for analysis. Attempts for further information are in progress.
 
Manufacturer Narrative

Manufacturer Narrative
Report source, corrected data: the initial mdr report inadvertently omitted the 'foreign' designation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2745827
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« Reply #18 on: April 14, 2018, 01:14:30 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/13/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a full generator and lead revision due to a possible lead fracture. Follow-up with the patient's physician found that high impedance had been detected at the patient's last appointment. A month prior to the appointment, the patient reportedly had an increase in seizures, a change in seizure profile, and was cyanotic during and after her seizures. The physician attributed these events to loss in therapy due to a lead fracture. The surgeon indicated that he had performed generator diagnostics and visualized a lead fracture during surgery. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6502912
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« Reply #19 on: April 14, 2018, 01:15:09 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 04/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
The explanted products were received on (b)(4) 2015 for analysis. In the pa lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead is underway but has not been completed to date.
 
Event Description
Analysis was completed on the returned portion of the lead. A majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. There appeared to be white deposits observed in various locations, which contained silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings , there is no evidence to suggest an anomaly with the returned portion of the device.
 
Manufacturer Narrative
Suspect device udi: (b)(4). Corrected data: this information was inadvertently left off of initial mfr. Report.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. Follow-up with the physician¿s office revealed that the cause of death was believed to be sudep and not related to vns. The death was not witness and the patient was found cyanotic in the bathroom. The patient had a history of illegal substance abuse and compliant with aeds. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872433
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dennis100
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« Reply #20 on: April 14, 2018, 01:15:45 AM »

Model Number 103
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 that the patient has an oxygen monitor shows oxygen levels drop several times a day which may lead to the patient turning blue. The patient had a reduction in the tonic episodes and the oxygen drops at the last visit, but he has had a significant increase in (b)(6) 2011. The patient had a recent, apparent increased seizures, captured in manufacturer report number 1644487-2013-02100. The patient had previously sleep study that showed obstructive sleep apnea, but he was not considered a candidate for tracheostomy due to anesthetic risk. The obstructive sleep apnea was noted to possibly be contributing to his episodes of desaturation. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. The patient's seizures have never been under good control. He actually believes the patient has a very bad seizure disorder, and the reason the seizure are "out of control" is due to bad respiratory compromise. "in other words, he has tracheostomy and bad lungs, and he has a lot of times when his oxygenation goes down. A lot of his seizures are related to that rather than other else. " the physician has been trying to get the patient monitored to correlate the relationship of the seizures and desaturation, but the monitoring has not occurred to date. He believes the patient's seizures are mostly caused by the desaturation. The relationship between the desaturation and sleep apnea to vns is unknown because he needs to be monitored via sleep study to see if saturation improves when the vns is turned off. The onset of the sleep apnea/desaturation is unknown. Diagnostics on vns were okay as far as the physician knows. He reported that the caregiver reported they want the vns replaced so the physician agreed. The patient has not exhibited any other symptoms that may be related to vns. This report captures the patient¿s desaturation and sleep apnea. Manufacturer report number 1644487-2013-02100 captures the increased seizures and referral for generator replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3224902
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dennis100
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« Reply #21 on: April 14, 2018, 01:16:14 AM »

Model Number 103
Event Date 11/06/2009
Event Type  Injury   
Event Description
It was reported that the recently implanted vns pt is experiencing syncope and pallor, which the mother believes to be a new seizure type. The mother reported to the nurse that two hours after an increase in the device's programmed settings, the pt became pale and absent. The mother explained that this has occurred the last two times the device settings have been increased. Review of the available in house programming history shows that the device settings have been increased incrementally about once a week. Device diagnostics have been regularly performed and the last available history reveals normal device function, which is from a f/u appointment in 2009. Good faith attempts to obtain add'l info have been made, but no add'l info has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577946
« Last Edit: June 06, 2018, 01:56:59 AM by dennis100 » Logged
dennis100
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« Reply #22 on: April 14, 2018, 01:16:53 AM »

Model Number 102
Event Date 02/01/2013
Event Type  Injury   
Manufacturer Narrative
The initial report inadvertently reported the age incorrectly due to the date of event being reported inadvertently incorrectly. (b)(4).
 
Manufacturer Narrative

Event Description
It was reported that the patient's device has been turned off for a few years with perceived lack of efficacy (however, review of the manufacturer's programming history shows the device was programmed on in (b)(6) 2011, the last known date of history programmed by the nurse practitioner). The family requested to have it turned back on as vns therapy may help the patient. Upon turning back on, magnet stimulation caused the patient pain and he became cyanotic. Therefore, the magnet output current was decreased, and the device is currently on with no issue. The physician wants to replace the device due to the length of implant. Follow-up with the nurse practitioner revealed that the cyanosis is believed to be related to the battery nearing end of service although the eri flag is no. The magnet stimulation was only 0. 25 ma above the normal output current, and magnet use caused a violent cough and cyanotic episode. This led the nurse to believe the battery may be dying. The patient does not have a medical history of cyanosis, and there were reportedly no causal or contributory programming or medication changes precede the onset of the events. The patient's mother reported the device had been off for about 3-5 years, but this is not substantiated by the history in the manufacturer's database. Stimulus is on every minute and a half. The nurse indicated that there is suspected potential erratic stimulation as the battery is clearly not completely off as the patient is receiving therapy via witnessed voice vibration and cough, which she noted is just the patient's reaction to stimulation. She is not sure if the patient's symptoms are related to the device being turned off for some time. Both normal and system diagnostics were all okay but the specific results and programming settings were not provided. The patient is referred for generator replacement due to clinical end of service. Although surgery is likely, it has not occurred to date.
 
Event Description
The implant card was received which reported that the patient had prophylactic generator replacement surgery on (b)(6) 2013. It was reported that the explanted device has been discarded since the device has not been sent back to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993702
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dennis100
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« Reply #23 on: April 14, 2018, 01:17:38 AM »

Model Number 103
Event Date 05/01/2012
Event Type  Injury   
Event Description
Additional information was received from the nurse practitioner indicating that the increase in seizures was not back to pre-vns seizure frequency but it was increasing. It was believed to be due to the loss of vns therapy. The patient's cyanosis is not related to vns therapy. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase seizures. The clinical symptoms have improved since generator replacement on (b)(6) 2012. The patient's tonic seizures were not previously aborted by magnet stimulation prior to (b)(6) 2012. The generator was received by the manufacturer; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as battery depletion.
 
Manufacturer Narrative

Event Description
Product analysis for the generator was completed. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The reported ifi=yes was duplicated in the lab. Results of bench diagnostic testing indicated the device was operating properly with ifi yes. The data in the diagaccum consumed memory locations revealed that 96. 675% of the battery had been consumed. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage value stored within the generator suggests an ifi battery partially depleted condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative

Event Description
Clinic notes were received for the patient's prophylactic generator replacement surgery since the patient's device was at ifi=yes. During the review of the clinic notes dated (b)(6) 2012, it was observed that the patient an improvement in seizure control until the prior few weeks when her seizures again increased so for no apparent reason. Her seizures decreased to three to four per day after depakote was increased to the current dose at her last office visit. As noted on (b)(6) 2012, she had an average of five to six seizures per day. Most of the seizures were generalized tonic-clonic seizures lasting approximately one minute. Swiping the vns magnet is not helpful for these seizures, and these seizures are associated with cyanosis. The atonic seizures remained decreased and were occurring three to four times per month, as opposed to daily prior to the last increase in depakote on (b)(6) 2012. The patient has increased seizures during her menses, and the patient had not recently been ill. The physician noted that the vns was nearly at end of service, but continued to deliver stimulation. It is possible that she is not receiving the full output current due to gradual depletion of the generator thus the increase in seizures. Although she has never been seizure-free post vns implant, the patient's mother feels the vns has been efficacious and wished to have generator replacement as soon as possible. No changes were made to the vns settings on this visit. The patient had generator replacement on (b)(6) 2012, however, attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2697513
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« Reply #24 on: April 14, 2018, 01:18:16 AM »

Model Number 104
Device Problems No device output; Device operates differently than expected
Event Date 08/18/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that vns patient was admitted in hospital for cluster of convulsive seizures, and came by ambulance to the epilepsy clinic for checking the vns and anti-epileptic drugs. It was reported that patient stated that he could not feel the vns stimulation anymore. The vns system was not interrogated since (b)(6) 2014 due to patient failing to attend clinics. On checking, the magnet was last used on (b)(6) 2015. It was reported that, the near end of service flag was on on (b)(6) 2015. Upon attempt to perform the system diagnostic test, patient began to cough profusely over a period of 2- 3mins, with reddening of the face and hyperventilation. The vns system could not be interrogated due to patient distress with coughing. Patient then had a witness seizure lasting 1. 5 min with cyanosis requiring rescue medication and oxygen. When the seizure had ceased, patient began again to cough every 40 seconds or so. The vns system was re interrogated and the output and magnet mode current whereas programmed during the last follow up in (b)(6) 2014. A copy of patient notes were provided with patient settings indicating an increase in seizures on (b)(6) 2011 and on (b)(6) 2011. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Further information was received from the nurse, indicating that no chest xray was performed in the referring hospital. It was reported that a battery replacement surgery is planned. The nurse indicated that seizure control has deteriorated with vns battery failure. It was reported by the nurse that in the past, she has witnessed clinically seizures for that patient as an inpatient which have resulted in cyanosis. Whether this has been a feature of seizures in recent years is unknown; the patient did not give a good description of seizures. It was reported by the nurse that the vns stimulation did most definitely result in excessive coughing and hyperventilation which seemed to proceed this seizure witnessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5229094
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dennis100
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« Reply #25 on: April 14, 2018, 01:18:46 AM »

Model Number 102
Event Date 02/22/2011
Event Type  Injury   
Event Description
It was reported in the pt's clinic notes on (b)(6) 2011 that the pt had a "harder and longer" seizure, during which the pt stopped breathing for 45-50 seconds and became cyanotic. The physician also commented that it was "clear that the staff was able to swipe [the vns] magnet. " the pt's settings and diagnostic info from this date were given, and the device was shown to be properly functioning. Attempts for further info have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2329459
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dennis100
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« Reply #26 on: April 14, 2018, 01:19:19 AM »

Event Date 02/26/2009
Event Type  Death   
Event Description
It was reported that a vns patient died three days post implant and prior to the vns device being programmed on. Further information provided by the medical professionals revealed that the patient had several health issues including sickle cell anemia. The patient was implanted in 2009, and left the hospital the following day. Two days later, the patient was transported to the emergency room and died the following day. Information received by a company representative revealed that the patient was turning blue on the way to the emergency room. Moreover, the patient's grandmother did not authorize an autopsy and it is not believed that the vns device was explanted before burial. Further follow up from the treating neurologist revealed that he did not believe that the patient's death was related to vns therapy and an official cause of death has not been determined. The treating neurologist believes that the patient's blood may have sickled and possibly caused the patient's death. The patient reportedly had abnormal blood work prior to the vns implant surgery. Although the patient was not receiving vns therapy at the time of death, the relationship of the death and vns implant surgery is unknown. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1355311
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dennis100
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« Reply #27 on: April 14, 2018, 01:19:48 AM »

Model Number 103
Event Date 04/07/2011
Event Type  Injury   
Event Description
It was initially reported by a physician that a pt was having laryngeal spasms, which had required her hospitalization in the past. At this time, the pt had 3 spasms and the pt turned cyanotic. The pt's vns physician turned the output current down from 2. 5 ma to 2. 0 ma, stopping the spasms. The pt was reported to be "doing better" after the change in parameters. Further info was received from the physician, which stated the spasms did correlate with the vns stimulation, but the pt "was having other issues going on, too". Consequently, it was difficult for the physician to say what was causing the effect exactly. Diagnostic results were not available from the site, there were no other factors that could have contributed to the event, and the pt did not have a history of this event prior to vns. However, the site then claimed the relationship to vns for this event was not known. The site claimed that the pt's mother was going to "see what happens" at the lowered setting and re-evaluate at a later time. A search of the mfr's programming history database revealed that last known diagnostics on (b)(6) 2011 were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2098645
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dennis100
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« Reply #28 on: April 14, 2018, 01:20:25 AM »

Model Number 102
Event Date 02/07/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported via clinic notes received for review that a vns patient was having seizures on clinic visit date (b)(6) 2012. Reported patient doing ok. Currently off vimpat. Doing about the same, still having some drops and the seizures which last about a minute. The patient gets a little cyanotic with these spells. On visit date (b)(6) 2012 the patient reported that he's been having more seizures. Over the prior 3-4 weeks he had been having more episodes of not breathing for over a minute and can be cyanotic. The patient was going to be referred to their surgeon for follow up. It is unknown the relationship of their seizures to the vns baseline and if this is a new seizure type for the patient. Thus far no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2775951
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dennis100
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« Reply #29 on: April 14, 2018, 01:21:20 AM »

Model Number 102
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was complaining of shortness of breath and at times she would turn blue. Pt stated the event occurred with stimulation. Physician did not visualize event when pt was seen in the office. Pt's settings had been increased in 2009, from 1ma to 1. 25 ma output. Attempts for add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1512746
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