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dennis100
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« Reply #60 on: January 08, 2018, 02:37:18 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/01/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient that his seizure type changed approximately 1. 5 years ago. He clarified that his seizures were not more frequent, but they were just a different type of seizure. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6300402
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dennis100
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« Reply #61 on: January 09, 2018, 03:07:05 AM »

Model Number 102
Event Date 04/01/2009
Event Type Injury
Event Description
Pt had cluster of 7 seizures over 2 days, resulting in emergency room visit and hospitalization on epilepsy monitoring unit. A few days prior to this, patient had a suspected seizure that was different in appearance than prior events. Medication changes were made. During the hospitalization, patient was placed on eeg telemetry where two seizures were recorded with a period of asystole lasting 18 seconds during the seizure. The patient did not have a prior history of bradycardia or cardiac difficulties. Since patient had an implanted vagus nerve stimulator, this was interrogated and tested to ensure that the device was working properly. Testing the device was not associated with change in heart rate. Epilepsy team believes that the seizure was associated with asystole and not the vagus nerve stimulator, but since asystole had been reported in a few instances of new implants with vns, the vns device was watched carefully in this patient. A cardiac pacemaker was implanted and the vns was tested during this procedure. The vns was not found to interfere or affect the cardiac pacemaker. The vns is gradually being reprogrammed to the patient's usual settings as a treatment for her seizures. Patient's medications were adjusted during the hospitalization, and she was discharged twelve days later in 2009. Pt seen in clinic today for follow-up of vns and no further problems have been noted. Diagnosis or reason for use: intractable epilepsy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1365329
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dennis100
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« Reply #62 on: January 09, 2018, 03:07:45 AM »

Model Number 104
Event Date 04/22/2009
Event Type Injury
Event Description
It was reported by the physician that the patient had a drop attack seizure a few days after the generator replacement due to eos. The patient's settings were programmed to the last known settings upon completion of surgery. The physician indicated that he feels that the patient's seizure was attributed to the vns therapy and being turned on abruptly to the last known settings since she had never experienced a drop attack seizure before. The device has been disabled at this time. Diagnostics performed indicate that it is within normal limits. There is no suspected device failure at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1393199
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dennis100
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« Reply #63 on: January 10, 2018, 02:05:43 AM »

Model Number 103
Event Date 01/01/2009
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history.

Event Description
The pt's treating physician reported that when he tried to interrogate the pt's device, the settings had been reset. During the time, the device was off the pt went to the er following a generalized tonic colonic seizure, which is a new seizure type for the pt. The treating physician did not specify a cause for the new seizure type. Review of programming history confirmed that generator being disabled was due to a burst watchdog timeout. However, the reporter indicated a pt name that did not match the initials in the downloaded programming history. Attempts to clarify the pt- initials discrepancy with the physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1338733
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dennis100
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« Reply #64 on: January 11, 2018, 02:44:55 AM »

Model Number 102R
Event Date 05/01/2009
Event Type Injury
Event Description
It was reported to manufacturer that the vns patient was recently experiencing a new seizure type and an increase in the pre-existing seizures, below the pre-vns baseline. The reporter indicated that the vns device is believed to be nearing end of service. A battery life calculation was performed with the available programming history and confirmed that the generator is likely at end of service. Good faith attempts to obtain additional information from the treating physician regarding the events have been made, but have been unsuccessful to date. The patient subsequently had surgery where the generator was replaced without incident. The explanted generator has been returned to manufacturer and the device analysis is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1403970
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dennis100
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« Reply #65 on: January 11, 2018, 02:45:51 AM »

Model Number 102
Device Problem Device inoperable
Event Date 04/10/2009
Event Type Malfunction
Event Description
It was reported that a pt's seizures had worsened recently and that the physician indicated, the device was not working and would need to be replaced. The pt states that now seizures are occuring two to three times a day and now the seizure type has changed in that the pt will now black out and feel like time is passing by rapidly. A battery life calculation was performed using the limited data available in the in-house programming database and it was found that the pt's device is currently at end of service. Good faith attempts to obtain additional info from the pt's physicians have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1468064
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dennis100
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« Reply #66 on: January 11, 2018, 02:46:45 AM »

Model Number 100 C
Event Date 09/26/2000
Event Type Injury
Manufacturer Narrative
Article citation: koutroumanidis, michael, michael j. Hennessy, colin d. Binnie, and charles e. Polkey. "aggravation of partial epilepsy and emergence of new seizure type during treatment with vns. " neurology 55 (2000): 892-93.

Event Description
It was reported in a scientific article that a vns patient, who had initially responded to vns therapy, began to experience an "abrupt worsening of her epilepsy" after increasing her therapy output current by 0. 25ma (2. 25ma to 2. 50ma). The author indicated that this worsened seizure activity consisted of an increase in seizure frequency, above pre-vns baseline levels, as well as the development of a new seizure type. The article states that the patient had "no history of recent aed changes or dose omission, protracted sleep deprivation, stressful events, trauma, or intervening infection could be elicited and both the generator and the lead were functioning normally". The author states that once the patient's ncp device was programmed off, "2 days later the new seizure type ceased and the patient's habitual seizures settled down to pre-implantation baseline. " in light of these events, the pt's device was reportedly programmed back on a month later due to the initial efficacy she had received from vns therapy. The pt's output current was gradually increased up to 1. 75ma and after six months of follow up, the patient reportedly regained the efficacy that she had initially obtained with no relapse of the new seizure type.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1400101
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dennis100
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« Reply #67 on: January 11, 2018, 02:48:15 AM »

Model Number 102
Device Problem Extrusion
Event Date 06/20/2008
Event Type Malfunction
Event Description
A vns patient reported that she began experiencing numerous issues with vns therapy since implantation including weight loss, continuous abdominal pain and painful stimulation. The patient indicated that she had attempted to inhibit vns stimulation by taping her vns therapy magnet to her chest, but this had only resulted in the initiation of magnet stimulation and added that she would be seeking surgical consult for device explantation. Additional information was received from the patient who reported that in addition to developing a new seizure type, her seizures have increased "a thousand fold" since implantation. The patient also indicated that her carotid artery had been cut during implant surgery and added that she has lost around "2/3rd of her body weight" since implantation without any changes in diet or exercise. The patient stated that due to this weight loss, her generator and lead are now visible under the skin. Follow up with the patient's implanting surgeon revealed that the patient's carotid artery had not been cut during her implant surgery and that she has actually only lost around (b) (6), since being implanted with her vns device. The surgeon indicated that he had agreed to remove the device at the patient's request and added that explant surgery would occur within the week. Device diagnostics were performed at the patient's recent surgical consult and reportedly confirmed proper device function. Good faith attempts to the patient's past and present treating vns therapy physicians for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1473053
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dennis100
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« Reply #68 on: January 12, 2018, 01:55:17 AM »

Model Number 101
Event Date 01/01/2004
Event Type Injury
Event Description
Reporter indicated that the pt began having grand mal seizures approximately 5 years ago, which he did not have before vns was implanted. It was also noted that the pt has had an increase in his seizure activity. Info suggests that a number of medication changes have occurred to try to help control the pt's seizures more effectively. Info received suggests that the pt was receiving vns therapy for approximately 3 years prior to the onset of the grand mal seizures, and no timeline is known for the onset of the increased seizure activity. All attempts for further info have been unsuccessful, thus the relationship between the reported events and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1449915
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dennis100
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« Reply #69 on: January 13, 2018, 01:46:47 AM »

Event Date 01/01/2004
Event Type Injury
Manufacturer Narrative
Article citation: vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al.

Event Description
Reporter indicated via the published journal article "vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al. " that a newly implanted vns pt developed a new seizure type (cluster seizures). All attempts for additional info from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1488715
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dennis100
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« Reply #70 on: January 13, 2018, 01:47:28 AM »

Model Number 102
Event Date 01/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt was experiencing an increase in seizures and was now also having grand mal seizures, which the pt had not previously had. All attempts for further info regarding the issue have been unsuccessful to date, thus the relationship between the issues and vns therapy cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1502871
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dennis100
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« Reply #71 on: January 14, 2018, 01:43:59 AM »

Model Number 302-20
Event Date 04/21/2009
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause a death.

Event Description
Clinic notes were received that reported a pt had high lead impedance, having a change in their seizure type and increased seizures around the time of the event. The pt underwent full revision surgery, and the explanted product is at the mfr pending completion of product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1514166
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dennis100
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« Reply #72 on: January 14, 2018, 01:44:40 AM »

Model Number 102R
Event Date 06/15/2009
Event Type Injury
Event Description
Clinicals were received and reviewed at mfr. Notes reported that the pt had several admissions to the hosp for breakthrough seizures and grandmal seizures, diastat did not abort the pt's seizures. Medications were titrated. The pt had also been having a change in seizure type based on the pt's presentation during her seizures. It is unk if the pt's seizures are above their pre vns seizure rate. The pt will be scheduled to have a prophylactic generator replacement. Good faith attempts are being made for add'l details.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1461374
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dennis100
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« Reply #73 on: January 14, 2018, 01:45:20 AM »

Model Number 103
Event Date 06/27/2009
Event Type Injury
Event Description
The patient's treating physician reported that their patient was having increased seizures and that they were a new seizure type since raising their vns settings. When the patient's vns settings were raised from 0. 5ma output current to 0. 75ma output current the event started. The patent's therapy was lowered back down to 0. 25 ma output current and they have now been seizure free for three weeks, the patient since the change in programmed settings has been doing very well with their vns therapy and the treating physician attributes the event to their settings being raised to fast and over stimulating the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1464534
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dennis100
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« Reply #74 on: January 15, 2018, 02:25:35 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated that the patient was experiencing a new type of seizures, and that she had been having a flurry of seizures. The patient was put on felbarnate to try to control the reported events. All attempts for further information have been unsuccessful to date, thus the relationship between vns therapy, and the reported events cannot be determined.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1509540
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dennis100
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« Reply #75 on: January 20, 2018, 02:50:09 AM »

Model Number 302-20
Event Date 06/12/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death.

Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2014 and system diagnostic results showed high impedance (dc dc ¿ 7). The patient¿s parent stated that she no longer heard the patient¿s voice alteration that normally occurred with stimulation. The patient went to the hospital on (b)(6) 2014 after having three generalized seizures the previous week. It was noted that a football hit the patient in the chest/clavicle the previous week. The physician stated that the reported event was related to vns stimulation. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. Further follow-up revealed that the patient¿s device was disabled on (b)(6) 2014. The patient¿s seizures had changed in type and were longer. Prior to the event, the patient only had simple seizures. The patient underwent lead replacement surgery on (b)(6) 2014. The explanted lead has not been returned to date. The patient was doing well following lead replacement surgery.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records were reviewed. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery due to lead discontinuity. The explanted lead was returned to the manufacturer for analysis. Based on the findings, there is evidence to suggest discontinuities in the returned portions of the lead may have contributed to the reported high impedance. During the visual analysis, quadfilar coil 1 appeared to be broken approximately 24mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break and identified the area on two of the broken strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The area on a third broken coil strand was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. The area on the remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Scanning electron microscopy was performed on the electrode (mating end) of quadfilar coil 2 coil break (found at 24mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity. The abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other 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 portions were performed and no other discontinuities were identified. Note that since the (+) white electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3918410
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dennis100
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« Reply #76 on: January 22, 2018, 02:16:42 AM »

Model Number 101
Event Date 04/27/2010
Event Type Injury
Event Description
Clinic notes for this pt were received which documented a new seizure type of an unspecified cause. There was note that there was suspicion of psychogenic non-epileptic seizures (pnes), however, the physician requested an ambulatory eeg be performed as soon as possible in order to characterize the seizure type. It was noted that the pt was scheduled for generator replacement surgery, which took place on may 27th to prophylactically replace the device. The explanted generator has been returned to mfr where analysis is underway. Good faith attempts to obtain additional info regarding the new seizure type and the believed relationship to vns therapy have been made, but no additional info has been received to date. Diagnostic testing done one month prior to the report of the new seizure type revealed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1739603
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dennis100
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« Reply #77 on: January 22, 2018, 02:17:27 AM »

Model Number 102
Event Date 07/01/2009
Event Type Injury
Event Description
It was reported that a patient experienced a series of seizures that were different from her normal seizure type. The physician wondered if maybe the device was not functioning properly regardless of acceptable diagnostics. The patient could not tell whether or not her device was on. The physician did state that it is difficult to tell if these new seizures are new seizure types of if they are pseudoseizures. The patient has been referred for generator revision however, the surgery is on hold.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1744398
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dennis100
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« Reply #78 on: January 23, 2018, 03:33:04 AM »

Model Number 302-20
Event Date 04/28/2010
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by manufacturer, gross lead discontinuity noted. Conclusions: device failure occurred, but did not cause or contribute to a death.

Event Description
Our country manager for (b)(6) reported that there was a patient with high lead impedance on their system diagnostic testing. Over the last month it was reported that the patient experienced an increase in seizures at their pre vns baseline rate, new seizure type and tonic seizures with falls to the ground. Additionally it was reported that the patient had a violent fall in (b)(6) with trauma on the face. The patient had falls prior to vns implantation with their seizures and now, they have returned. The patient's seizures are being attributed to their high lead impedance/lead break. The patient's mother cannot remember tonic seizures with so violent falls before implantation. Reported it seems that these may be a new type of seizures. X-rays were reviewed at manufacturer and showed a gross lead discontinuity in the anchor tether area of the lead that is in the neck area. Lead replacement is scheduled for (b)(6) 2010. Good faith attempts will be made for the explanted product to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1724222
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« Reply #79 on: January 24, 2018, 03:14:56 AM »

Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the surgeon's office that the patient had generator replacement surgery on (b)(6) 2012. However, attempts for product return have been unsuccessful to date.
 
Event Description
Clinic notes dated (b)(6) 2012 were received by the manufacturer and reported that the patient had been experiencing lue/lee twitching episodes for the prior six months that last for about three to four minutes with no impairment of consciousness. In the notes dated (b)(6) 2012, it was indicated that the patient usually had mix types of seizure including grand mal, petit mal, partial seizure. After vns placement, he has not had any grand mal seizure in the past five years. Currently, he describes the seizure as arm, eye twitch (early sign). These events were now happening about once a week. Follow-up with the treating physician was performed. He reported that the patient's new seizure type is not believed to be related to any vns problem, and his vns seems to be fully functional. However, the manufacturer battery life calculation determined that as of november he had less than half a year left on his battery. That fact, combined with the fact that since then i have increased his settings to 2. 0ma on (b)(6) 2012, which will most likely lead to an even shorter battery life, led the physician to believe that it is best to replace the generator prophylactically. The physician also reported that he has no way to know if the increased seizures are related to vns. The patient feels the vns stimulation, and the interrogation says that it is not near end of service. Therefore, the physician stated that he has no reason to suspect that the vns is not functioning properly, although perhaps the battery is "just low enough to cause an increase in seizures. " although surgery is likely, it has not occurred to date.
 
Event Description
Attempts for product return were unsuccessful as the explanting facility indicated that they could not locate the explanted generator, so it was assumed by the facility that the device was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2874197
« Last Edit: May 14, 2018, 08:49:29 AM by dennis100 » Logged
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« Reply #80 on: January 28, 2018, 02:05:35 AM »

Model Number 103
Event Date 09/07/2010
Event Type Injury
Event Description
It was reported that a vns pt experienced a new type of seizure as the pt began to experience brief tonic-clonic seizures that lasted 10-20 seconds and were increasing in frequency. The pt had recently undergone vns placement and was not programmed on after surgery. The pt was programmed on at a follow-up appointment with the treating neurologist. The neurologist believed the increase in change was possibly due to the anesthesia or trauma/stress but could not confirm. Additional info was received through a fax with clinic notes which stated: "there has been an increase of seizure frequency, especially brief episodes. Given his increased seizure frequency, i am recommending checking drug levels today. Vns was also started at. 25 ma ever 180 min. He appeared to tolerate this procedure well. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872832
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« Reply #81 on: February 09, 2018, 11:59:11 AM »

Device Problem No Known Device Problem
Event Type Injury
Manufacturer Narrative

Event Description
Report received that vns caused a patient's seizure type to change from grand mal to partial complex and atonic. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7192007
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« Reply #82 on: February 09, 2018, 11:59:54 AM »

Model Number 103
Device Problem No Known Device Problem
Event Type Malfunction
Manufacturer Narrative

Event Description
A physician's office reported that a patient was experiencing an increase in seizures and presenting with different seizure types. The patient was referred to another physician in order to be evaluated for another treatment. No additional information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7187914
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« Reply #83 on: February 21, 2018, 02:16:21 AM »

Model Number 103
Event Date 01/01/2014
Event Type Injury
Event Description
It was reported that the patient began experiencing grand mal seizures about six moths prior. It was reported that the patient had never experienced a grand mal seizure prior to this. The patient reported that he previously only experienced petit mal seizures. The patient is scheduled to be seen by the physician, but has not been seen to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3910742
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« Reply #84 on: February 28, 2018, 02:19:26 AM »

Event Date 11/27/2013
Event Type Injury
Manufacturer Narrative

Event Description
A maude event report ((b)(4)) was received indicating that the patient was found unresponsive with a heart rate of 16 bpm. It was reported that the patient was hospitalized and intubated and that the patient was released several days later. It was also noted that the patient has experienced an increase in seizures for the past few months and that the seizures are different than prior seizures. It was reported that the patient no longer experiences her usual aura and no post-ictal state. It was reported that vns induced asystole/bradycardia is suspected. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3651797
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« Reply #85 on: March 05, 2018, 02:34:40 AM »

Model Number 102
Event Date 03/22/2012
Event Type Injury
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.

Manufacturer Narrative

Event Description
The explanted generator will likely not be returned as per the or coordinator at the hospital, they currently do not have the device to return and they assume that it was discarded in surgery. Attempts for additional information have remained unsuccessful. A rough estimate of battery life was performed with programming history that was only available from the date of implant until (b)(6) 2010. This estimation indicated that the generator may have been at or nearing end of service at the time of replacement.

Event Description
Additional information was received on (b)(4) 2012, indicating that the patient underwent revision on (b)(6) 2012. Attempts for product return and additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2579096
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dennis100
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« Reply #86 on: March 08, 2018, 09:55:19 AM »

Model Number 102R
Event Date 11/08/2010
Event Type Injury
Manufacturer Narrative
Review of programming/device diagnostic history performed.

Event Description
On (b)(6), 2012, a fax was received from the physician with information regarding the patient's change in seizure pattern from (b)(6), 2010. The physician stated that there was no relationship of the event to vns. The change in seizure pattern was not significant. The interventions taken included checking the patient's levels, educating the patient, and checking the vns. No causal or contributory programming changes, medication changes or other external factors preceded the onset of the change in seizure pattern.

Event Description
Clinic notes dated (b)(6) 2010 were received on may 6, 2012 regarding this vns patient. The clinic notes allege that the patient's recent seizures have been different than those in the past. The patient reports doing things or having conversations after his seizures and then having no recollection of those events. Sometimes, he will wake up or become aware of his surroundings without knowing how he got there. The patient reports having pre-seizure activity one to two times per week. Occasionally, swiping his magnet will stop the seizure. The patient's last generalized tonic-clonic seizure was about one month ago ((b)(6) 2010). The patient's seizures are characterized as generalize tonic, clonic movements, deviation of eyes and head to one side and focal movements followed by generalized clonic movements. The seizures are preceded by an aura and followed by confusion and lethargy. The patient is having more difficulty remembering how he got to places, losing track of time, and his caretaker reports he just seems "out of it at times. " the patient has been incontinent at times but no tongue biting has been reported. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2595567
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dennis100
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« Reply #87 on: March 09, 2018, 04:18:34 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/01/2018
Event Type Injury
Manufacturer Narrative

Event Description
Patient's vns output currents were increased from about a month ago. Since that time, caregiver has noticed new events that when patient gets excited or laughing, he will suddenly fall to the ground and be limp for a short time. On initial discussion, this was thought to be a new seizure type or cataplexy but the nurse practitioner wanted to know if this could be a type of vasovagal event occurring when the device is stimulating. The nurse practitioner increased the device output current again with the thought the events could be seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7301451
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dennis100
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« Reply #88 on: March 11, 2018, 01:14:23 AM »

Model Number 102R
Event Date 07/21/2009
Event Type Injury
Event Description
It was reported that the vns patient experienced a tonic-clonic seizure following generator replacement surgery and was hospitalized overnight. The patient reportedly never experienced tonic-clonic seizures before the event. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4442826
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dennis100
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« Reply #89 on: March 12, 2018, 01:51:38 AM »

Model Number 103
Event Date 03/05/2012
Event Type Injury
Manufacturer Narrative

Event Description
Product analysis on the explanted generator was approved on (b)(6) 2012. Review of the data indicated that the pulsedisabled was set to a value that does represent a vbat

Manufacturer Narrative

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.

Event Description
On (b)(6) 2012, it was reported that this vns patient underwent surgery. During surgery, high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-02047. The explanted generator was received on (b)(4) 2012 and is currently undergoing product analysis. On (b)(6) 2012, follow-up with the patient's physician was performed. The patient's device was last interrogated in (b)(6) 2011 and low battery was seen (one-quarter to one-third of battery life remaining). When the device was patient was seen for follow-up, it was noted that the battery was dead. The increase in seizures was attributed to the battery being dead. The physician believed the battery depleted very quickly from (b)(6) 2011 to (b)(6) 2012. The patient's device was turned on after surgery. The patient was seen post-operatively on (b)(6) 2012, with ok impedance at 3059 ohms. The patient was doing okay with modest seizure control, and the patient's settings were provided. It was stated that the settings would be gradually increased to their previous values. (the exact values were not provided.).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2665729
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