VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on April 14, 2018, 01:00:36 AM



Title: Anemic/Cyanotic
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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



Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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



Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 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


Title: Re: Anemia/Cyanosis
Post by: dennis100 on April 14, 2018, 01:23:02 AM
Model Number 103
Event Date 11/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was recently implanted and recently had his device turned on to 0. 25 ma output current and 0. 5 magnet output current. Per the pt, when he swiped his magnet, he turned blue and passed out. At the time of the report, the physician had not seen the pt since the episode and had no further information regarding the event. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1558272


Title: Re: Anemia/Cyanosis
Post by: dennis100 on May 01, 2018, 01:11:56 AM
Model Number 102
Event Date 06/04/2008
Event Type  Injury   
Event Description
Initial reporter indicated that the pt was experiencing dyspnea with stimulation. Taping the magnet over the vns resolved the dyspnea. The pt had their vns programming adjusted a month earlier for painful stimulation and resolved but then started having the dyspnea with stimulation. All diagnostics were within normal limits. The pt reported an episode where she "stops breathing". The pt additionally reported neck "spasms". Reported "that it grabs at the neck and then results in her sweating, can't breathe, and heartbeat increasing. She's not sure whether the last three symptoms are due to the vns or due to her getting nervous about the grabbing. She feels like it paralyzes her neck where she can't get air down and her mom said she turned purple yesterday. It happens about once a day and using the magnet won't make it go away". The pt normally doesn't feel stimulation so did not know whether the neck spasm is during stimulation or not but it doesn't seem to occur every few mins. There was no report of any trauma or accident. X-ray review by mfr did not reveal any gross lead discontinuities or anomalies that may have contributed to the reported event. The pt underwent generator replacement surgery. During the surgery a large amount of scar tissue was noted around the pt's lead. Good faith attempts are being made for the prod return for analysis.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by mfr, no gross lead discontinuities or anomalies noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1077469


Title: Re: Anemia/Cyanosis
Post by: dennis100 on May 03, 2018, 01:48:47 AM
Model Number 103
Event Date 08/01/2011
Event Type  Injury   
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¿s jerks are not necessarily associated with these episodes. 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 seizures range from 673-1477. There was noted to be no obvious etiology for the increase in seizures since the recent ear infection for which he was given a medication for ear infections. On (b)(6) 2013, the patient¿s seizures (myoclonic and tonic episodes and staring) were noted to range from 362 and 916. ¿he has been very agitated for about two weeks. ¿ the patient¿s medication appeared to be helping the patient except the previous month, per the caregiver. On (b)(6) 2013, he had been on a medication for ear infections for 10 days. On (b)(6) 2013, the physician noted that given the number medications and doses, no medication dosing changes were made. The physician¿s impression in the notes showed that it is unclear whether the seizures are primarily generalized tonic episodes or secondarily generalized seizures. Follow-up was performed with the treating physician who assumed care for the patient after initial implant. He reported that he does not believe the increased seizures were related to vns in 2011 or potentially 2013. He was unable to say if it occurred in 2013, but 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 "34;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. He did not know the relationship of the increased seizures to pre-vns seizure frequency. This report captures the patient¿s increased seizures since the relationship of sleep apnea/desaturation to vns is unknown to date. Manufacturer report number 1644487-2013-02099-2013-02100 captures the desaturation and sleep apnea. The patient had generator replacement in 2009. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3224901


Title: Re: Anemia/Cyanosis
Post by: dennis100 on May 29, 2018, 02:52:37 AM
Model Number 103
Event Date 03/01/2015
Event Type  Injury   
Event Description
It was reported that the patient has been hospitalized recently for various issues including seizures, coma, and pneumonia. Patient also experienced trauma when the paramedics had dropped patient on the floor. It was also reported that the patient had some issues with his vns. Additional information was received that the patient experienced seizure after seizures and later woke up to find himself at the hospital with a ventilation tube. Patient experienced pneumonia from the ventilator. When the ventilator tubes were taken out, it caused his throat to be sore and very sensitive. Patient¿s face was reported to turn purple with stimulation which was reported to have resolved on its own. Patient also experienced increased heart rate with stimulation following this incident. It is unknown if this event started recently after the hospitalization or if it was present before. Patient was recommended to visit the neurologist regarding this. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient was having issues with throat closing and tachycardic episodes with stimulation (hr 130) with some recent change in settings on an unknown date. The patient's generator interrogated and found to be with settings of 1. 75/30/500/30/3. 0. The patient's frequency was lowered to 20 hz, which appeared to resolve the issue and the stimulation was still tolerable. At that time the physician was going to monitor the patient to ensure there were no other issues. The impedance was also confirmed to be 3115 ohms with no other issues with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698228


Title: Re: Anemia/Cyanosis
Post by: dennis100 on June 06, 2018, 01:57:58 AM
Model Number 102
Event Date 02/13/2008
Event Type  Malfunction   
Event Description
It was reported to manufacturer that after the vns patient's device was interrogated at a routine office visit, the device output current was found to be a 2. 25ma, where the patient had previously been set to 0. 75ma. As a result of the high output current, the patient "grabbed her neck and was turning blue". The patient's device was interrogated using a different programming system and the settings were changed to the intentional settings. Attempts to obtain additional information from the treating physician have been made, but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1017637


Title: Re: Anemia/Cyanosis
Post by: dennis100 on July 06, 2018, 10:31:08 AM
Model Number 1000
Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative
Patient problem :1815.
 
Event Description
It was reported that a patient was just implanted with a m1000 device and the device was turned on to the lowest settings. It was stated that the patient was holding his breath and turning blue and aspirating and having a difficult time swallowing. The patient is non-verbal. The patient is also drooling more and choking on his spit. The np advised to go to the emergency room. They instructed the patient to turn device off by placing the magnet over it. The patient's diagnostics were good. The patient is tolerating current settings. It was stated that the believed cause of the issue was possible side effects due to being high risk patient. The patient's settings are going to be increased and the np will monitor the patient's progress. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569735


Title: Re: Anemia/Cyanosis
Post by: dennis100 on September 19, 2018, 01:40:24 PM
Model Number 102
Event Date 12/11/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2011 for seizures. Patient's mother states she is having one seizure after another and is sometimes cyanotic during that time. She states she is in the icu and her doctors don't seem to know anything about her vns. It is unknown if the patient is currently seeing a neurologist or who it is, so no further information can be obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2429803


Title: Re: Anemia/Cyanosis
Post by: dennis100 on October 06, 2018, 06:28:31 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/27/2018
Event Type  Injury   
Event Description
It was reported that the patient was having painful stimulation after surgery. It was also reported that the patient was turning purple and coughing with every stimulation like they were choking. The physician subsequently turned the output and magnet currents down as well as turn the off time down from 0. 8 minutes to 3. 0 minutes. Information was received from the physician's office the doctor thinks the patient's settings were too high. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7899101


Title: Re: Anemic/Cyanotic
Post by: dennis100 on October 11, 2018, 06:58:24 AM
Model Number 102R
Event Date 05/01/2012
Event Type  Injury   
Event Description
Analysis of the generator has been completed. The generator performed to specifications and no anomalies were found.
 
Event Description
It was reported on (b)(6) 2012, that a vns patient would be referred for generator revision surgery as the patient is at high settings, rapid cycling, and the patient' s family wanted to have it replaced prior to a trip they were taking in (b)(6). On (b)(6) 2012, clinic notes were received dated (b)(6) 2012 where it stated that the patient was diagnosed with complex partial seizures. The last seizure occurred on (b)(6) 2012 and was said to be less than 1 minute in duration. The patient's parents stated that the seizure have increased in frequency and duration over the last few weeks despite the patient being compliant with medications. The patient will intermittently appear blue or cold. The device was found to be set to 2. 5/20/250/21/1. 1/2. 75/250/60. The patient's dosage of sabril was increased from 2 tablets to 3 tablets and the patient was referred for generator revision surgery. Good faith attempts to obtain additional information have been unsuccessful to date however it is known that the patient is scheduled for generator revision surgery later next month ((b)(6) 2012).
 
Manufacturer Narrative
 
Event Description
Additional information was received indicating the patient's generator had been replaced. The explanted generator was returned and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2619580


Title: Re: Anemic/Cyanotic
Post by: dennis100 on October 19, 2018, 11:50:46 AM
Model Number 102R
Event Date 08/02/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for review prior to a patient going for a prophylactic generator replacement. Clinic notes dated (b)(6) 2012 were received. Reported was that she has unknown seizure frequency, but overall her parents think that they get the sense that her seizures are unchanged or possibly worsened since she was last seen in the clinic. She had increased output on the vns when she was last seen (b)(6) two weeks ago, she had some event reported to the family from the nursing home staff, which were concerning for apneic spells. Were told by the nursing home staff that she suddenly appeared to be "out of it"; and would slump over as if she were unresponsive or asleep. At the time she appeared to be turning bluish, and this resolved. She seemed to arouse when she was laid down flat. It was felt that these were not likely epileptiform events. She has a history of apneic spells in the past and does have obstructive sleep apnea per her parents reports. These event have not recurred since that time and she otherwise has been stable. The patient's vimpat was increased and her parents feel like her seizures may be worsening on this. Good faith attempts have been made and thus far no further information has been attained.
 
Event Description
Product analysis was completed on the explanted generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. No further information has been received in regards to the patient's reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2745363


Title: Re: Anemic/Cyanotic
Post by: dennis100 on January 04, 2019, 11:37:30 AM
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/23/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced stridor and cyanosis while using their vns therapy magnet during a 56 minute long episode of continuous seizure activity. After the use of the magnet the patient continued to turn blue every five minutes for the duration of the seizure activity. A second magnet swipe during the seizure also produced temporary cyanosis. It was reported that while the patient typically had stridor/shortness of breath during seizures prior to vns implantation, that the stridor was more noticeable during the magnet swipes. Prior to and following this event, there were no other instances of cyanosis occurring with seizures. The patient had previously encountered minor stridor and shortness of breath events with magnet use during seizures but without complication. The physician decreased the patient's programmed generator settings. It was additionally reported by the patient's caregiver that when the magnet was placed over the device, to inhibit stimulation, the patient's symptoms seemed to resolve. It was reported that the patient's continuous seizure activity was not related to vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175737


Title: Re: Anemic/Cyanotic
Post by: dennis100 on February 11, 2019, 02:44:07 AM
Model Number 103
Event Date 01/06/2015
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative

Event Description
Additional information was received that the patient's reported episode is not a new seizure type, unknown cause for episode (drop attack with lips turning blue). No interventions were taken. Medications taking at the time of the event. Depakote-6. 25 mg bid / fycompa 8 mg qhs / zonisamide-150 mg qhs / banzel 17. 5 ml in am, 3. 5 ml in afternoon , 7 ml evening / onfi-5 mg bid.
 
Event Description
It was reported that the vns patient experienced a drop attack and blacked out following a magnet swipe. It was noted that this seizure type was not typical for the patient. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4483657


Title: Re: Anemic/Cyanotic
Post by: dennis100 on April 06, 2019, 02:47:06 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The patient¿s mother initially reported that the patient¿s oxygen saturation level was 83 (percent) and the patient¿s heart rate was elevated to 130bpm. The patient¿s breathing was a little rapid and her fingers were semi-purple. Additionally, the patient¿s body temperature was 100. 8 f. Information was later received that the patient was treated for these symptoms at the er and these events were referred to as ¿respiratory infection¿ symptoms. The patient was reportedly feeling better after treatment but it was unknown if the patient was discharged. The patient¿s device was left off per the neurologist¿s request. After the implant surgery and lead impedance was normal at 1955 ohms. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The device met all specifications for release and were verified to have been sterilized prior to distribution. Follow up with the patient's neurologist determined that the er physician and neurologist assessed that the patient had pneumonia which was not believed to be related to vns therapy or surgery. Additionally, the increased heart rate, fever, and discoloration of skin were assessed to be symptoms of the pneumonia and were unrelated to vns as well. There was no mention of the rapid breathing or hypoxia. The neurologist reported that the most recent update regarding the patient was that she was doing much better. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465064


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 03, 2019, 03:26:39 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/24/2007
Event Type  Death   
Event Description
It was found through an obituary search that the patient had passed away. A battery life calculation was reviewed and showed the device was working as intended as the dcdc value was within normal limits. No anomalies were observed. Additionally, the battery life calculation estimation showed approximately 9. 4 years were remaining at the time of the patient's death; therefore, the device was likely still functioning. It was later reported by the patient's last known physician that he saw the patient the spring prior to her death. He stated he believed the death was not related to vns; however, since he did not see her at the time of her death, he could not be certain. Additionally he noted the patient also had lung issues (unrelated to vns) and rhett's syndrome.
 
Event Description
A death certificate was later received showing the patient died of leukopenia, anemia, and thrombocytopenia. The death was noted to be natural.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6438083


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 03, 2019, 03:27:16 AM
Model Number 102R
Event Date 02/01/2015
Event Type  Injury   
Event Description
It was reported that a vns patient had vagal episodes from (b)(6) 2015 and persisted for 6 months. The device parameters were not changed. It was reported that during that period, the patient was in a clinic study (trial) from (b)(6) 2015. But due to high discomfort, she stopped it in (b)(6) 2015. It was reported that those discomforts included especially dizziness with nausea, sometimes accompanied by blurred vision and pallor, without loss of consciousness. It was reported that when a cardiologist saw the patient in (b)(6) 2015 for a clinic examination / ecg / abpm, the patient showed a sudden hypotension (70-80 systolic) without symptoms reported above. The patient was again seen by the cardiologist in (b)(6) 2015, who indicated that everything was fine. It was reported that the patient was initially implanted with vns in 2002, and then replaced in 2010. No patient adverse events were reported during that period before (b)(6) 2015. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5245961


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 03, 2019, 03:27:59 AM
Model Number 102
Event Type  Injury   
Event Description
It was reported that the vns patient has new small seizures and balance disorders in addition to his usual seizures. No end of service flag was seen during interrogation. A battery life calculation using the available programming history showed approximately 4. 6 years left until near end of service is yes. Additional information was received from the physician with all data regarding the patient's follow-up records since the vns implantation in (b)(6) 2012: on the visit 1 in (b)(6) 2012, the device was programmed at 0. 25ma output current - 250¿sec pulse width - 20hz frequency - 30sec on time and 5min off time. No special adverse event was and everything was ok. On the visit 2 in (b)(6) 2013, the patient was stable. He has spent 1 week without seizure (after vns activation) which is rare. He had some seizures during the (b)(6) period. The output current was increased at 0. 5ma. On the visit 3 in (b)(6) 2013, it was found that the patient's seizures increased a little in 2 months. The parents reported dysphonia and small cough but the patient's mood had improved well. The output current was increased to 0. 75ma without any adverse event. No cough was noted. On the visit 4, it was reported that the patient spent 9 days without seizures. The vns stimulation was well tolerated but some episode of cough was reported. The output current was increased to 1ma. System diagnostics returned impedance results within normal limits. On the visit 5, some episode of fever was reported (but not more than 38°c). The cause was unknown but, as reported by the physician, this is a known event to encephalopathic patients with lennox gastaut syndrome. No infection occurred. The output current was increased at 1. 25ma. On the visit 6 in (b)(6) 2013, it was reported an increases in seizures but not intense. It was reported that this could be related to patient's emotions. The output current was increased at 1. 5ma. On the visit 7 in (b)(6) 2013, frequent seizures were noted but not intense. It was reported by the caregivers that the vns magnet was more used because it stops immediately 80-90% of seizures. The output current was modified to 1. 75ma and the frequency was increased to 30hz. On the visit 8 in (b)(6) 2013, the patient seizures frequency was stable and not intense. No voice alteration and cough were reported. The output current was increased at 2ma and the pulse width to 500¿sec. On the visit 9 in (b)(6) 2013, it was noted that the patient mood and behavior were improved well. But it was reported that the patient had one big seizure and fall. Small tonic seizures were noted too. The output current was changed to 2. 25ma. On the visit 10 in (b)(6) 2014, the physician reported that a positive evolution of the situation was noted. A small cough was reported. System diagnostics returned impedance results within normal limits. The duty cycle was changed by modifying the off time from 5min to 3min. On the visit 11 in (b)(6) 2015, a progressive increase in seizures was noted during the past 7 months. No change in medications was performed. It was reported by the physician that this could probably due to the modification of duty cycle (from 5 to 3min off time). The physician decided to change back the duty cycle to the initial settings. System diagnostics returned impedance results within normal limits. On the visit 12 in (b)(6) 2015, it was reported that since the duty cycle was modified back to initial settings, an improvement was noted; seizure reduction was noted. It was reported that the patient was still sensible to emotions. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. On the visit 13 in (b)(6) 2016, it was reported that since (b)(6) 2015 the patient had more seizures. It was reported that on (b)(6) 2016, the patient had a big seizure and fall. That day, he had pallor, muscle spasms, brief respiratory arrest and wound on eyebrow which was treated by antibiotics. It was reported that the patient had later 2 other big unusual seizures: they were generalized tonic chronic seizures. System diagnostics returned impedance results within normal limits. Vns device was functioning perfectly. The output current was changed to 2. 75ma. On the visit 14, on (b)(6) 2016, the patient was seen for a follow-up of lennox gastaut syndrome. Eeg was ok with some improvement. It was reported that the patient had ambulation difficulties and fall; he could not stay up for a long time. An increase of hemiparesis was reported. Nevertheless, patient's seizures reduction was noted. The vns stimulation was well tolerated. System diagnostics returned impedance results within normal limits and the near end of service flag was no. It was reported that the last vns parameters were at 2. 5ma output current ¿ 30hz frequency ¿ 500¿sec pulse width ¿ 30sec on time ¿ 5min off time. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5789779


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 03, 2019, 03:29:23 AM
Model Number 103
Event Date 02/09/2010
Event Type  Injury   
Event Description
It was reported by the vns pt's mother, that the vns pt, who was implanted with the device on (b) (6) 2010, had experienced a syncope event, was very pale, not stable on his legs, and appeared lethargic. The device had not been programmed on at the time of the report of the events. Follow up with the treating physician revealed that the relationship of the syncope event to surgery/vns is unk, however, it was noted that the pt does not have a pre-existing history of syncope events. Additionally, it was noted that the pt "has autism and every change in his life is very difficult for him" and that the pallor, a lethargy were "probably not related to vns". No interventions have been taken for the events, the device has been programmed on, and the physician is in the process of titrating the settings up to therapeutic settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1631437


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 07, 2019, 07:34:58 AM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that the patient's generator had migrated and the edge was pushing against the skin causing a breakdown of tissue. Clinic notes were received showing the patient was referred for an urgent evaluation of an extruding generator. It was also noted the patient had been experiencing some discomfort at the generator site and that the generator had seemed to migrate towards the axilla and recently developed a bluish discoloration with thinning of the skin, but without discharge. The patient denied fever, chills, or any change in status and the generator was still functional. Subcutaneous fluid collection and swelling were also noted at the generator site. The patient was referred for explant of the generator and the lead. It was later reported by the physician that the patient did not have an infection as the culture had come back as negative.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. If explanted, give date; corrected data: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient underwent vns explant on (b)(6) 2017. The physician did not know the cause of the migration.
 
Event Description
It was reported that the patient was experiencing an increase in seizures that began prior to the explantation of the vns. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6398375


Title: Re: Anemic/Cyanotic
Post by: dennis100 on May 11, 2019, 03:33:20 AM
Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/29/2019
Event Type  Injury   
Event Description
It was reported by the patient that he had a bad coughing fit after using his magnet and turned blue until he caught his breath. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8546726


Title: Re: Anemic/Cyanotic
Post by: dennis100 on July 05, 2019, 11:44:20 PM
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/24/2003
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient believes they had better seizure control was pre-vns therapy and post-vns therapy. It was also reported that the patient's finger tips and lips turn blue with longer seizures, and that the vns therapy magnet was never effective for the patient. Attempts have been made for information, and no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8664897