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dennis100
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« on: July 20, 2010, 11:31:27 PM »

Event Date 09/25/2001
Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
Rptr indicated that pt has suffered from blindness in their left eye since implant. It was reported that at first, there was complete darkness, but lately pt has been able to see light but everything is extremely blurred. Pt is taking the following anti-epileptic medications: tegretol and gabatril. Pt's device was programmed to on in 10/2001 and parameters were increased in 11/2001.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=365910
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« Reply #1 on: July 20, 2010, 11:33:03 PM »

Event Date 04/26/2004
Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
Reporter indicated that vns pt's family member noted 2 different pupil sizes after implant surgery. Treating neurologist indicated that the symptom could be due to horner's syndrome or to other nerve damage during the implant procedure. The pt is scheduled for exploratory surgery.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=525742
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« Reply #2 on: July 20, 2010, 11:34:38 PM »

Event Date 01/01/2003
Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
Reporter indicated that vns pt has been seeing double since an increase in programmed device frequency. There have reportedly been no recent medication changes. Treating neurologist reportedly does not believe that the pt's vision problem is related to the vns. The pt reduced their nighttime dosage of medication from 600mg to 200mg and reports an improvement in their vision since the reduction in medication.  
  
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508865
« Last Edit: October 01, 2015, 02:04:02 AM by dennis100 » Logged
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« Reply #3 on: July 20, 2010, 11:36:02 PM »

Event Date 08/16/2004
Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
Vns pt had 20/20 vision before initiation of stimulation, but after stimulation was initiated, the pt experienced left facial swelling and lazy left eye which has affected their 20/20 vision. Treating neurologist reportedly referred the pt to an eye specialist. Further follow-up with neurologist revealed that the pt was diagnosed with "left horner's syndrome secondary to surgical intervention" and that their condition was unchanged. Neurologist indicated that he believes that the pt's condition is related to the vns implant surgery. No intervention has been taken and none is planned at this time. Neurologist is reportedly waiting to see if the problem resolves spontaneously. It was later reported that the pt had developed constant hoarseness. The pt was evaluated by neurosurgeon who reportedly believes that the hoarseness is related to swelling and will subside.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543673
« Last Edit: October 01, 2015, 02:04:19 AM by dennis100 » Logged
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« Reply #4 on: July 21, 2010, 10:18:01 PM »

Event Date 04/02/2008
Event Type  Injury  
Patient Outcome  Other;  
Event Description  
Initial reporter indicated that the pt after being implanted with the vns developed, a left eyelid droop, left pupil constriction, excessive tearing of the left eye. All events are reported to be related to the implantation surgery of the vns. No interventions taken.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1045304
« Last Edit: October 01, 2015, 02:04:38 AM by dennis100 » Logged
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« Reply #5 on: July 22, 2010, 01:09:07 AM »

Event Date 08/23/2008
Event Type  Injury  
Patient Outcome  Hospitalization;  
Event Description  
Reporter indicated that approximately 5 minutes after a vns pt swiped the vns magnet across her device to initiate vns stimulation, the pt lost her vision for approximately 60-90 seconds. The event has occurred multiple times. The neurologist sent the pt to the er for a ct scan. Nothing has been found, and the pt has been sent home. The neurologist is unsure if the vision loss event is related to vns therapy. Good faith attempts to obtain additional info have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1176198
« Last Edit: October 01, 2015, 02:04:54 AM by dennis100 » Logged
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« Reply #6 on: July 22, 2010, 06:11:14 AM »

Event Date 11/19/2008
Event Type  Malfunction  
Patient Outcome  Required Intervention;  
Event Description  
Reporter indicated that a vns patient had never felt stimulation since she was implanted, even at high settings. Vns diagnostics were normal. During stimulation, it was noted that the patient's left eye would tear and the pupil would dilate. The patient also had decreased visual acuity. The reporter felt the vns lead was possibly on the wrong anatomical structure or on the vagus nerve in such a way that proper stimulation was not possible. The patient has also not had any efficacy for her depression since the vns was initially implanted, but her depression is not worse than before the vns was implanted. The patient underwent lead revision surgery and now feels stimulation. Attempts for return of the explanted lead are in progress.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1350812
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« Reply #7 on: July 24, 2010, 10:42:27 PM »

Event Date 11/13/2003
Event Type  Injury  
Patient Outcome  Life Threatening;  
Event Description  
Patient's seizures have been shorter, but more aggressive since an increase in magnet mode output current. It was also reported that 30 minutes after using the magnet with a seizure, the patient went blind for approximately 30 minutes. The patient reportedly experienced this blindness following magnet use with a seizure once before.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=502159
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« Reply #8 on: August 02, 2010, 02:35:29 AM »

Event Date 07/20/2004
Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
The pt experienced left vocal cord paralysis and horner's syndrome. The pt's neurologist indicated that the vocal cord paralysis is only observed during device stimulation. It was further reported that the pt's voice is not effected. The pt also has very slight drooping of the left side of the pt's face and their left pupil is smaller than the right one. The device was deactivated as requested by the pt's ent. Further follow-up revealed that there were no problems during the implant surgery that may have contributed to the events.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=543643
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« Reply #9 on: September 17, 2010, 08:19:40 AM »

Event Type  Injury  
Patient Outcome  Disability;  
Event Description  
Reporter indicated that vns pt experienced left-sided facial drooping that affected the left eyelid, causing problems with vision. Report incomplete due to the anonymous nature of the reported event; unable to follow up on web site posting due to lack of availability of contact info.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=640200
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« Reply #10 on: September 17, 2010, 08:21:19 AM »

Model Number 103
Event Date 08/05/2011
Event Type Injury
Event Description
It was reported by the pt that she had experienced an arrhythmia while in the hosp for her vns initial implant. She did not specify what kind of arrhythmia it was but only stated that it "was not there before. " it was not clarified if it occurred during the surgery or post-implant. F/u with the neurologist's office found that the site had not heard of any adverse events and the pt was doing well at the visits following vns implant. Per the site, the pt's vns is functioning normally however specific vns diagnostics were not provided. A staff member at the surgeon's office said she was not aware of any of the events but would confirm with the surgeon. The pt also reported hotness and swelling at the wound site, nausea, visual disturbance, difficulty swallowing, and choking following surgery as well however none of these events were able to be confirmed with the neurologist or surgeon at this time. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249204
« Last Edit: October 25, 2015, 03:24:14 AM by dennis100 » Logged
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« Reply #11 on: April 21, 2011, 02:15:53 PM »

Event Date 07/26/2002
Event Type Injury
Patient Outcome Disability;
Event Description
Reporter indicated that pt is experiencing ptosis in the left eye following implant surgery. The pt is reportedly unable to open their left eye completely. Additionally, the pt reported that initially after the implant surgery, an area under the chin was numb on the left side. Currently the chin area now feels more like a bruise and the numbness is no longer as evident. The feeling under the chin is now described as a stinging or poking sensation that comes and goes. Both symptoms occurred post-operatively and are not related to stimulation. Physician is unsure at this time whether the condition will be permanent. The physician indicated that it is possible that some nerve damage occurred during implant surgery and that it may resolve in time or may be permanent. Physician attributed the pt's symptoms to traumatic horner's syndrome. Stimulation was initiated on 8/2002 and the pt has tolerated parameter adjustments well. The pt has been referred to a neurosurgeon for a second opinion.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=414528
« Last Edit: October 01, 2015, 02:10:41 AM by dennis100 » Logged
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« Reply #12 on: June 09, 2011, 12:27:28 AM »

Event Date 03/01/2011
Event Type Injury
Patient Outcome Required Intervention;
Event Description
We rec'd an email from a country mgr in the netherlands mentioning that he was directly contacted by a vns pt. The pt mentioned that their optic nerve was affected by the placement of the vns. Pt was first implanted 3 years ago ((b)(6) 2008) with generator # 102 s/n (b)(4) and lead # 302-20 s/n (b)(4), which were subsequently replaced (b)(6) 2011 due to high lead impedance/possible lead fracture. This is reported under file # (b)(4) medwatch number 1644487-2011-00195. Currently, the pt is reporting that their "eye is aching and she has a headache when writing emails", in addition to the report that her optic nerve was affected from the recent revision surgery. No treatment has been reported. The pt reported that they went to an ophthalmologist who told her that the nerve could cure in a few months or a year or never. However, further f/u is recommended with the physician to confirm the diagnosis and cause. At this time all events have been reported by the pt. Further investigation is underway to determine what the event is and if any interventions are planned or have been taken. Another report will f/u upon receipt of further info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2082877
« Last Edit: October 01, 2015, 02:11:10 AM by dennis100 » Logged
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« Reply #13 on: June 13, 2011, 02:50:31 AM »

Event Date 06/01/2005
Event Type Injury
Patient Outcome Hospitalization; Disability
Event Description
Reporter indicated that vns patient was seen in hospital emergency room due to complaints of difficulty walking, eyes "shaky, wobbly, and rolling around", as well as nausea. The patient was discharged, but was seen in hosp emergency room the following day with the same complaints. It was reported that at the time of the second emergency rome visit, the patient was unable to walk. The patient reportedly began to notice his "eyes jiggling" approx one month prior. Device normal mode output current is currently programmed to 1. 0 ma and there have not been any recent changes in the patient's medications. Investigation has been unable to determine whether the reported events are related to the vns therapy as no response has been received to manufacturer's request for additional information from treating neurologist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=618083
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« Reply #14 on: June 13, 2011, 11:58:48 AM »

Event Date 07/27/2006
Event Type Malfunction
Event Description
Patient had mri head performed after vagus nerve stimulater turned off, according to device manuals instructions and using scanning parameters indicated. Patient experienced burning sensation in neck and feeling that eyes were going to pop out. Scan stopped and symptoms resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__ID=754828
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« Reply #15 on: June 14, 2011, 08:45:18 AM »

Event Date 10/01/2005
Event Type Death
Patient Outcome Death;
Event Description
Death certificate was obtained and revealed that an autopsy was performed. The immediate cause was listed as epilepsy with the underlying cause listed as natural. Manner of death was marked natural.

Event Description
Reporter indicated that vns patient has passed away. Cause of death is not known at this time. It was reported that the patient was found dead in the morning by family members. The patient was schedules for a follow up appointment with treating neurologist the day before her death for the purpose of discussing changes to device settings due to some vision issue that had been reported to her physician. The vision issue was not suspected to be related to the vns therapy. The appointment was cancelled for unknown reasons and it was later reported that the patient had passed away the next day. The patient was reportedly receiving vns therapy at the time of death. There is no evidence at this time that the vns therapy caused or contributed to the reported event.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=643876
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« Reply #16 on: June 14, 2011, 11:54:53 AM »

Event Date 11/22/2005
Event Type Injury
Patient Outcome Life Threatening; Disability
Event Description
Reporter indicated that patient suffered a `small' stroke post vns implant with subsequent double vision and difficulty walking. Treating physician reported that the stroke was mild but would require rehabilitation for mobility and speech. It was reported that the stroke was verified using serial cat scans. There had not been any recent changes to the patient's medication regimen. Stimulation was initiated 14 days post implant at 0. 25a normal mode output current. Further follow-up revealed that the patient's speech issues had resolved. The patient has reportedly been under a great deal of stress due to pending divorce. The patient still reports weakness in right side, arms, hands, and legs for which she is undergoing rehabilitative therapy. Device normal mode output current setting has since been increased to 0. 50ma without incident.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=655218
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« Reply #17 on: June 15, 2011, 03:00:59 AM »

Event Date 02/01/2004
Event Type Injury
Patient Outcome Disability; Required Intervention
Event Description
Reporter indicated that the pt has been experiencing pain and a burning sensation in the chest, neck and left arm for the past 3-4 weeks. It was also reported that the pt began experiencing continuous blurred vision approximately 2 weeks ago. Further follow-up revealed that the pt's device was programmed to off. Epileptologist indicated that the pt's symptoms and blurred vision resolved after programming the device to off. Epileptologist referred the pt to neurosurgen for possible device explant. Epileptologist would like the pt to be seen for follow-up by a neurophthalmogloist.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=520134
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« Reply #18 on: November 27, 2011, 11:14:43 AM »

Model Number 302-20
Device Problems High impedance; Device operates differently than expected
Event Date 12/01/2014
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Additional clinic notes dated (b)(6) 2014 were received indicating that the patient's seizures were controlled until the past week or so, when she had 2 seizures. Per patient, these 2 seizures were the worst seizures she has ever had. The physician noted that the patient had been driving up to that point. It was associated with headaches, nausea, and photophobia. Patient got a head ct without contrast, which was normal. Patient does not have frequent headaches. It is unusual for patient to have a headache in the setting of a seizure. The symptoms are severe. There are no apparent precipitants. There are no aggravating or alleviating factors. There are no other associated complaints. Patient's output current was increased from 2. 0 to 2. 25 milliamps. The magnet current was increased from 2. 25 to 2. 50 milliamps. Patient is off all medications. Notes were also received from surgery date on (b)(6) 2015. The surgery noted that there was what appears to be a crimp on the battery lead. Excellent exposure of the carotid. There was a lot of scar tissue in the area. The surgeon tried for a very long time to find the vagus nerve but was unable to locate it. Dissection was taken down inferiorly to what was the previous lead insertion and went at least 3 cm beyond the previous insertion but the vagus nerve could not be found for lead revision.

Event Description
Additional information was received that the patient was dissatisfied with the device as she experienced a seizure and a fall recently.

Event Description
Clinic notes received indicate that the patient experienced numerous seizures on (b)(6) 2015. Patient visited the emergency room and patient was provided with medications. The neurologist notes that they have been trying to manage her seizures off any anticonvulsants and simply adjust her vagus nerve stimulator. There are no apparent precipitants and no aggravating factors or other associated complaints. There were no changes to vns settings or medications prior to this event. The physician did start to adjust the medications after the patient had reported increase in seizures. The seizures were reported to be possibly related to vns as patient was stable for a long time until recently. It was also reported that the patient recently had many changes in her life and that patient had restarted smoking and has stress, mood swings, etc. Patient underwent generator replacement surgery on (b)(6) 2015. During the surgery, the generator was initially replaced. High impedance was observed with the new generator when connected with the old lead. As the surgeon went in to replace the lead, a neck incision was made which was confirmed to be in the right location by the tc. However the vagus nerve and the electrode coils were not found in this location. The surgeon was reported to have performed a very deep and wide search for the other end of the lead, the electrodes and the vagus nerve. The lead was not replaced. X-rays were taken and there does not appear to be any gross fractures or discontinuities that might explain the high impedance. The connector pin inside the connector block did not appear to be completely inserted but it was confirmed that the surgeon inserted it completely. The explanted generator was not returned to manufacturer. No known surgical interventions were taken after the observation of high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4737993
« Last Edit: October 01, 2015, 02:13:14 AM by dennis100 » Logged
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« Reply #19 on: November 27, 2011, 11:55:13 PM »

Model Number 102
Event Date 11/01/2003
Event Type Injury
Patient Outcome Life Threatening; Disability
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity since implant. It was also reported that pre-vns implant, the pt would experience episodes of blindness for 4-5 minutes and that since implant the episodes last for up to 1 1/2 hours.

Manufacturer Narrative
H6: the vns therapy system is indicated for use as an adjunctive therapy in reducing the frequency of seizures in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications. In the us the vns therapy system is approved for use in adults and adolescents over 12 years of age with partial onset seizures that are refractory to antiepileptic medications.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=508389
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« Reply #20 on: December 05, 2011, 11:04:08 AM »

Model
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« Reply #21 on: December 05, 2011, 11:04:55 AM »

Model Number 102
Event Date 10/02/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6), 2013 indicate the patient had more seizures since the last visit. It was stated that these seizures are small ones, but occur almost daily. The patient experienced no recent illnesses, had adequate sleep, no depression or anxiety, and no change in medications except a few months ago. The vns device was interrogated and reprogrammed. Notes dated (b)(6), 2013 indicate the patient is doing well, but is still having small seizures per the patient's mother. On (b)(6), 2013, the notes indicate the patient has been back and forth to the emergency room for episodes he is having, where for hours the patient is hardly able to move and is wobbly when able to walk. The patient complains of blurry vision, which is not seizure like, and feels like "jello". Attempts are underway for additional information; however, no additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3428301
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« Reply #22 on: December 10, 2011, 09:02:43 AM »

Model Number 102
Event Type Injury
Event Description
It was reported via clinic notes dated (b)(6) 2011 that the pt had a "history of bilateral retinoblastoma. " attempts for further info have been unsuccessful to date.

Event Description
The eye cancer is not believed to be related to vns device as the eye is not near the vns nor is it affected by vns therapy. Clinic notes do not indicate any relationship to vns and state the patient has a history of eye cancer.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340084
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« Reply #23 on: April 05, 2012, 06:14:19 AM »

Model Number 102
Event Date 09/01/2011
Event Type  Injury  
Patient Outcome  Required Intervention;
Event Description
On (b)(6), 2012 clinic notes were received through case management. Review of the clinic notes dated (b)(6), 2012 revealed that the vns patient has been experiencing daily partial seizures. The vns generator battery was reported to be depleted. The patient was referred for replacement. The patient stated that she has never been able to feel the vns activate but remembered that her previous neurologist told her last year that it was almost time for her to have a generator replacement. The clinic notes also state that the patient has been having some hives on her elbows and knees since (b)(6) 2011 and that in (b)(6) 2012. Her face became swollen and she had to go to the emergency room. She took steroids and it got better but periodically she has eye swelling and hives all over, the patient worried that her medication lamictal may be the cause. The physician later reported that the patient was only seen by him on (b)(6), 2012 but the patient reported increased seizures for the last 6 months. He did not have any diagnostic results as they only saw the patient once. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increased seizures. He said they interrogated her vns at this appointment and saw that the battery was dead. A battery life calculation was performed with the programming history available which showed a remaining time of negative years until the elective replacement indicator showed yes. Although surgery is likely, it has not yet occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2493133
« Last Edit: February 15, 2015, 04:12:13 AM by dennis100 » Logged
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« Reply #24 on: May 02, 2012, 02:46:55 AM »

Model Number 101
Event Date 01/01/2003
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention
Event Description
Reporter indicated that vns patient experienced an increase in seizure activity approximately three months post-implant. The patient had reportedly been under stressful situations and stated that things were getting better. Two and one-half months later, the patient still reported more seizures since vns implant. Twenty months later, the patient reported confusion and memory problems that were believed to be related to the vns therapy. The patient continues to have seizures "quite frequently" and treating neurologist does not know whether it is an increase above pre-vns baseline frequnency because this has been a continuous problem during their therapy. The patient also complained of "shocks" to their head, blurred vision and muscle contractions to their right leg. The patient's device was programmed to off pending an mri to rule out other medical possiblities. Review of manufacturing records for both the pulse generator and the bipolar lead revealed no anomalies that would adversely affect device performance. Investigation to date has been unable to determine that cause of the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=596488
« Last Edit: February 15, 2015, 04:12:39 AM by dennis100 » Logged
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« Reply #25 on: May 12, 2012, 01:44:13 AM »

Model Number 101
Event Date 12/29/2005
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
Vns patient felt as though her battery was going dead and that she could 'feel her seizures coming, more and more'. The pt reported that she began feeling more seizueres coming on and that she felt dizzy and couldn't see very well, but that she could still feel device stimulation, though not as strong. Investigation to date has been unable to determine the severity of the event as no responses have been received to manufacturer's request for additional information from treating neurologists (via fax x2. ).
 
Event Description
Further follow up from the treating neurologist indicated that the pt's cause of increase in seizures was due to stress of family issues. The reported increase in seizures was not an increase above pre-vns seizure baseline. There were no changes to medications or vns parameters. Pt is currently stable.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=669395
« Last Edit: February 15, 2015, 04:13:06 AM by dennis100 » Logged
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« Reply #26 on: June 08, 2012, 07:18:05 AM »

Model Number 102
Event Date 03/22/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Clinical received into (b)(6) on (b)(6) 2012 from cm (b)(6) regarding patient (b)(6)'s upcoming replacement. It was reported through clinic notes received on (b)(4) 2012 that the patient felt his seizures had changed. It was reported that he had three seizures which were 'somewhat different'. He reported that with these seizures, he began shaking and then stiffened, the patient also reported eye jerks. It was indicated by the physician that the patient needed his vns battery checked. There were no diagnostic results or patient settings provided in the clinic notes. The patient has since been referred for revision; however, this has not occurred to date. Attempts for additional information have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2579096
« Last Edit: February 15, 2015, 04:13:34 AM by dennis100 » Logged
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« Reply #27 on: August 10, 2012, 01:43:33 AM »

Model Number 103
Event Date 03/05/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Clinic notes dated (b)(6) 2012 were received on (b)(6) 2012. These stated that the patient's vns generator recently reached end of life. The patient was having increased seizures. Recent lead tests showed that it was ok. The battery life was evaluated in (b)(6) 2011 with the reading indicating 18 months of remaining battery life. It was checked again in (b)(6), and the battery life still appeared sufficient. One month later (b)(6), the patients seizures activity increased, and the red light started flashing on the battery indicator. The patient's reported that the patient typically has between 2 and 40 seizures per day of brief duration. The seizures were described as drop seizures manifested by fluttering of eyelids, upper extremity laxity and gibberish speech. The seizures tend to occur in clusters. The patient had three seizures during the exam. The patient's eyes fluttered up and rhythmically beat, and there was behavioral arrest. The seizures lasted 30-45 seconds. During one seizure, the patient became quite limp during falling forwards. ; however, she immediately returned to baseline. Shortly after (b)(6) of the previous year, the patient began a ketogenic diet and the seizure frequency decreased. Additional clinic notes were received on (b)(6) 2012. Clinic notes dated (b)(6) 2012 described the patient's seizure semiology: the patient has brief drop seizures where her body will collapse down and the head flexes forward. Prior to the ketogenic diet, the patient had 40 to 50 seizures per day; however, at this time, she was having 6 to 15 per day. The patient also had tonic stiffening all over. These occurred 40 times per day pre-diet and 30 per day at this time. The patient also had spacing out seizures with the eye deviating upwards and outwards disconjugately. These may have been from one to 200 times daily, lasting five to 30 seconds. This frequency has stayed the same since the diet; however, they have become a new seizure type: the patient will speak and the speech will become unintelligible. The eyes will flicker, and the head drops. The patient tried to refocus but has difficulty with speech or her head will drop again. These last 90 to 120 seconds. Sometimes she will howl with these seizures. The patient had 15 of these in the last month. The patient's device was interrogated at this appointment. Clinic notes dated (b)(6) 2012 indicated that the reason for appointment was a history of rsv/ congestion. (it was also indicated that the patient had a cough for the past two days. ) clinic notes dated (b)(6) 2012 indicated that the patient's battery life was red. In (b)(6) 2011, the device was reported to have one-third of its life remaining. The patient's seizures had increased back to 30 per day. On (b)(6) 2012, additional programming and diagnostic history was provided from (b)(6) 2012 and (b)(6) 2012. Attempts for additional information have been unsuccessful. Surgery is likely, but has not occurred.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2665729
« Last Edit: February 15, 2015, 04:14:19 AM by dennis100 » Logged
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« Reply #28 on: March 08, 2013, 10:59:28 AM »

Model Number 103
Event Date 10/16/2012
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the patient's seizures "worsened" after the patient's generator replacement on (b)(6) 2012. Additional information was later received which indicated that over the last several months, the seizures have been more frequent, both before the replacement (mfr # xxx) and after the replacement. It was also stated that the patient was recently having almost continuous eye blinking and several facial twitches. It was stated that the patient's vns was tested; however, the diagnostics results were not provided. To clarify what was meant by "worsened seizures", the physician stated that the patient's seizures increased above pre-vns baseline levels. In addition, it was restated that the patient experienced eye blinking which increased from 10 - 20 per day to almost constant eye blinking. The patient's facial twitches increased from one to two per week to one to two per day. There was no causal or contributory programming changes, medication changes, or other external factors which caused or contributed to the worsened seizures. It was stated that the cause was unknown. Interventions were taken to preclude a serious injury. These interventions included increasing the patient's settings and turning on the patient's vns after surgery. The patient continued to have seizures despite these interventions; however, they were improved with medication. It was stated that the patient's vns settings have stayed the same throughout these events with the battery replacement. Clinic notes dated (b)(6) 2012 stated that the patient had a two to three week period during which she was seizure free. Over the past month the patient had four seizures, with two occuring the last week before this visit. Most recently, the patient was found seizing in her bed in the morning. The patient was experiencing full body "quick twitches' which included extensive facial twitching. A noise started the patient and the overt seizure activity resolved. Per the notes, a second early morning seizure occurred as the patient was waking up. There was a quick session of rapid eye blinking that "morphed into full body twitches". This episode lasted eight minutes, which the patient's mother confirmed is about the time it usually lasts. On (b)(6) 2012 the patient had a ten minute episode involving face twitching and difficulty speaking. No diagnostic results were available. No other information has been provided.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2970529
« Last Edit: February 15, 2015, 04:14:51 AM by dennis100 » Logged
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« Reply #29 on: August 10, 2013, 08:06:06 AM »

Model Number 102
Event Date 06/01/2013
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative

Event Description
The generator was received by the manufacturer for analysis. However, analysis has not been completed to date. The implant card and return product form indicated the reason for generator replacement was "recurrent seizures after long period of complete control with vns. ".

Event Description
Additional information was received that the patient was seen on (b)(6) 2013 at which time the patient was doing much better. The patient had been put on trileptol due to the increase in seizures and it was now being discussed that the medication could be reduced/removed.

Event Description
The generator analysis was completed on (b)(4) 2013. In the pa lab, 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 generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

Event Description
The surgeon reported that the patent is controlled by vns alone and was now experiencing more absence spells. The patient uses the magnet a lot whenever he feels something is ¿wrong. ¿ therefore, the surgeon requested a battery life calculation. Diagnostics were provided as being within normal limits with near end of service showing as ¿no. ¿ the surgeon¿s clinic notes from the patient¿s visit on (b)(6) 2013 reported that the mother noted over the prior several weeks that there had been an increased number of what she describes as absence types of spells where he will walk into a room and not remember why he is there. Previously, the patient¿s seizures were controlled by vns. Then the prior saturday, the patient had four episodes that seemed pretty frightening to him where he complained that several seconds he could not hear at all. They were not followed by any big seizures. In past year the patient was having complex partial seizures, they would often proceed to more extensive motor seizure, but had not had a seizure like that in almost two years. The surgeon noted that it seems the vns is still working; however with the patient on rapid cycling since implant that it is quite possible that some of the increased small episodes recently could be ¿because the battery is starting to wear out. ¿ the patient was therefore scheduled for generator replacement. Notes from the patient¿s neurology visit on (b)(6) 2013 revealed that the patient was having no issues with his vns. The mother thought the last seizure was (b)(6) 2011. It was noted the patient¿s recurrent status epilepticus and partial seizures responded very well to vns alone and the patient was off of anticonvulsants. No changes were made at this visit. Later the neurology notes from visit on (b)(6) 2013 indicated the patient had at least three breakthrough seizures over the prior two weeks. The patient reported episodes of sudden visual loss in one case. He had sudden trouble hearing in another. In both cases, the episodes stopped with swiping the vns magnet. He has not had any episodes that did not respond either to the magnet or diastat. However the prior weekend, the patient had an episode with sensory changes again and then had forceful head and eye version to right, unresponsiveness, and generalized tonic posturing. The mother used diastat twice in the prior to weeks. The patient by (b)(6) 2013 was currently back to completely normal baseline with no cognitive impairments or other changes. He continued to feel vns activate without any difficulty or discomfort. He had no recent head trauma. Diagnostics again showed the device was functioning ¿normal¿ with no ¿end-of-battery¿ life warning present. However as the device was nearly seven years old, the neurologist ¿expected that his vns would be close to failure. ¿ the neurologist was worried that the age of the battery may be contributing to his breakthrough seizures, so the patient was scheduled for generator replacement. Attempts for additional information have been unsuccessful to date. The patient had generator replacement on (b)(6) 2013. Attempts for product return are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3235232
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