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dennis100
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« on: May 17, 2018, 01:49:48 AM »

Model Number 102
Event Date 04/07/2010
Event Type  Death   
Event Description
Company rep became aware that epileptic vns patient passed away on (b)(6), 2010. F/u with funeral home revealed that vns device was buried with the deceased. The cause of death in the death certificate was mentioned as: sepsis/septic shock (48 hours), gangrenes left foot (1 week), atherosclerotic peripheral vascular disease (aspvd) (1 year). Also, no autopsy was performed. Good faith attempts with the pt's treating neurologist have been unsuccessful to date to question the relationship of death to vns device. Sudep eval was conducted by mfr and based on the available info, it has been determined not to be sudep since the death was not sudden or unexpected. The dhr for the lead and generator were reviewed and sterility prior to shipment was confirmed.
 
Manufacturer Narrative
Eval, method: device mfg records were reviewed. Results: review of mfg records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1938703
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dennis100
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« Reply #1 on: May 17, 2018, 01:50:26 AM »

Model Number 103
Event Date 03/02/2011
Event Type  Injury   
Event Description
On (b)(6) 2011 a treating physician reported to the manufacturer's consultant that their vns patient was experiencing a "drooping foot". Which was reported to have been caused by vascular damage from the outside appearance of the patient's leg. This is causing the patient to have walking difficulties on the left side. The physician reported that during the patient's initial implant surgery on (b)(6) 2011, a tourniquet was placed on the patient's left foreleg and remained in place for eight hours. The treating physician does not know at this time why this was put in place and remained on the patient for eight hours. The physician is concerned that the patient is going to develop gangrene. The physician reported that the patient has been scheduled for vascular studies. The patient has a foot brace to assist with some of her bearing and stability functioning. The patient has been scheduled for physical and operation therapy but there is likely a poor prognosis. The tourniquet was placed by the anesthesiologist prior to surgery and then left in place for several hours per their treating physician. The patient has homological deficits and vascular deficits, but the exact reason for applying the tourniquet is not known by their treating physician at this time. If further information is received it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2045121
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dennis100
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« Reply #2 on: May 17, 2018, 01:51:02 AM »

Model Number 103
Device Problems Device Operates Differently Than Expected; Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2010
Event Type  Malfunction   
Event Description
Additional information was received from the neurologist stating that vns patient¿s psychosis was related to the event. The patient was having fixed delusions. The patient¿s device was disabled on (b)(6) 2014. The patient was referred for surgery but no know interventions have occurred to date. The patient believed that the police were accessing her device and harassing her.

Event Description
The patient again reported concerns that the vns device has been ¿hacked¿ to the physician. The physician was asked to interrogate the device to confirm that the device is still off and that the output currents are set to 0ma. It was later found out that the patient¿s vns was re-initiated in 2015 and patient has done well with vns stimulation for several months. Patient quit taking her antipsychotic medications again and now is stating that someone again is trying to "hack" her vns and the fbi is reading her thoughts through the vns device. Per the patient, the vns also causes vaginal pain and stimulations and the fbi is sexually assaulting her through the vns device. Additional information was received from a different nurse practitioner that the patient's device had been turned on and off three times over the course of a few months in 2015 and 2016. The neurologist disabled the patient's device on (b)(6) 2016. Diagnostics were not performed patient was referred to a psychiatrist.

Event Description
Additional information was received that the patient is able to feel the stimulation on demand when the magnet is swiped across the generator in spite of this device being disabled by the neurologist. It is unknown if the magnet mode stimulation was also disabled. Attempts for additional relevant information were unsuccessful.

Event Description
Additional information was received stating that the vns patient believed someone had hacked into her device and was experiencing difficulty with stimulation. The patient did not have any seizures since vns. The patient wanted to have her device removed. The patient¿s device was programmed off on 04/02/2014. The neurologist stated that there were no issues with the patient¿s device and that the patient was suffering from some type of psychotic disorder. The patient continued to have issues after her device was programmed off. The neurologist stated that the patient¿s issues were not related to vns attempts for additional relevant information were made but have been unsuccessful to date.

Event Description
Patient was seen by a new neurologist, who turned the device on as he was not aware of patient's history of complaints with vns therapy and patient's psychiatric history. Patient reported that her device is erratically firing and wants her device evaluated. The neurologist was later informed of patient's previous several complaints about stimulation.

Event Description
Patient reported having episodes of dizziness, increased heart rate, difficulty breathing, etc. These episodes began one night when she was trying to sleep and her heart rate increased and she began having tingling in her body. She then heard a voice telling her ¿allegations¿ that someone was tampering with her body. She reported getting a jolt and repeated her previous concerns of device being hacked to spy on her. She is concerned about getting the device replaced and is not confident in the device security as it was disabled and turned itself back on at one point in time. Based on available information from physicians, the device has been disabled since (b)(4) 2016. Patient was seen by multiple neurologists and psychiatrists and has been found to have schizophrenia and multiple other psychiatric conditions. She has been found to have pseudo seizures and some real seizures controlled when she takes her meds. The neurologists and psychiatrists have been unable to verify the reports that patient had reported and turned vns off as it make the patient more paranoid.

Event Description
On (b)(6) 2013, the patient stated that she feels tingling in her heels, legs, and groin when she is around cell phones or technology. She said that the magnet is not turning off her device. She said she sleeps with the magnet taped on and she said that it is still stimulating. She said the device is stimulating erratically. The patient stated that her physician does not entirely believe that she is feeling these things. Per the patient, diagnostics come back fine, and the doctor says the device is working properly. She stated that the device turns on and off at "suspicious intervals". She said that the vns has worked really well for her, and these events began in (b)(6) 2013. The patient¿s new following physician will not provide information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3483718
« Last Edit: December 19, 2018, 12:29:32 PM by dennis100 » Logged
dennis100
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« Reply #3 on: May 17, 2018, 01:51:58 AM »

Model Number 103
Event Date 10/07/2009
Event Type  Injury   
Manufacturer Narrative
Date of this report, corrected data: the initial report inadvertently reported the aware date incorrectly. Suspected device implant date, corrected data: the initial report inadvertently reported the incorrect implant date.
 
Event Description
An article titled "intractable episodic bradycardia resulting from progressive lead traction in an epileptic child with a vagus nerve stimulator: a delayed complication," which was written by (b)(6), was received by the manufacturer. Upon reviewing the article it was identified that the content was in reference to the previously reported vns patient adverse events in addition to those reported via manufacturer report # 1644487-2006-00432. The contents of the article were previously reported in supplemental manufacturer report # 1644487-2006-00432/4.
 
Event Description
Additional information was received the physician was considering implanting the patient with a pacemaker for the patient's preexisting ictal bradycardia and bradycardia possible contributed to by vns. The patient had blank stare, poorly arousable, cold hands and feet, apnea concurrent with the bradycardia. The patient had low of <30 bpm, when their normal heart rate was of around 80. When monitored during bradycardia at eeg showed no concurrent seizure. The patient was symptomatic during stimulation with their eyes closing and less responsive which was also associated with apnea. There was no good correlation of the bradycardia with vns stimulation and the physician could not be sure it was related to vns but the bradycardia episodes did not seem to occur with seizures. When vns was set to 0 ma, he had a few days of heart rate in the 40's - 50's, then increased to normal for the past week. Bradycardia at while at stanford was not below 50 bpm, persisted for about 5 days after turning vns off, and has not recurred in the following week. He is intubated from status epilepticus, so apnea is impossible to assess. I have left vns in place, but set to 0 ma. A trigeminal nerve stimulator was placed and has been in place for a week with inconclusive change. There is still a possibility of turning the vns back on, but with discussion of concurrent cardiac pacemaker.
 
Event Description
Reporter indicated a vns pt was experiencing bradycardia, central apnea, and obtundation with vns stimulation. The vns is beneficial for the pt's seizure control, but the pt has a significant history of bradycardia with vns since 2001. The previous bradycardia event is reported via mdr #1644487-2006-00432. The apnea and obtundation, and continuing bradycardia, are noted since the pt was reimplanted with new vns products in 2009. If the vns is disabled for several hours, the pt has frequent, uncontrolled seizures. If the vns output current is reduced to 1. 0ma, the seizures increase. The pt has progressive bradycardia and obtundation, mostly responsive to arousal, within days to weeks after the vns output current is increased to 1. 25ma. The pt has central apnea, awake and asleep, when the vns duty cycle is increased. The apnea is intermittent and timed to periodicity of the stimulator. On the one occasion that a higher duty cycle was tried at 1. 0ma, the respiratory depression was progressive and lead to respiratory failure. The respiratory failure was treated in the intensive care unit at the hospital and managed by changing the vns settings. The pt is currently stable with infrequent partial seizures only as of two months later at his last clinic visit. The current vns settings are 1. 2ma/25 hz/250 pulsewidth/21 sec on/5 min off.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1571192
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dennis100
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« Reply #4 on: December 19, 2018, 12:30:27 PM »

Model Number 102
Event Date 04/01/2009
Event Type  Malfunction   
Event Description
A vns pt's wife called and reported that her husband is implanted with the vns for depression. She called mfr for mri precautions. She reported that her husband had a seizure in (b)(6) of this year. He also lost (b)(6) pounds in the last 8 months and recently has had more seizures. Additionally reported that he is also experiencing left foot drop and left leg paralysis and that is why they need to do an mri. Good faith attempts are being made to determine if the reported events are related to their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577003
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dennis100
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« Reply #5 on: February 09, 2019, 01:55:04 AM »

Model Number 302-20
Device Problem Fracture
Event Date 10/14/2013
Event Type  Malfunction   
Event Description
It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8223185
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