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dennis100
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« Reply #30 on: October 13, 2017, 11:57:48 PM »

Model Number 102R
Event Date 01/01/2007
Event Type Injury
Event Description
It was reported that the physician does not have any further information on the drop attack seizures that the patient experienced in 2007.

Manufacturer Narrative

Event Description
Clinic notes were received for review that report that the patient was having a new seizure type identified as drop attack seizure on (b)(6). Good faith attempts are underway for further details about the reported event. At the time of this reported event their generator was not at end of battery life. They have had this battery replaced and it was returned for analysis. Generator eos was confirmed based on the measured battery voltage. The ¿as received¿ settings indicated a 58% duty cycle. Based on module performance according to the functional specifications. The unit exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion. No condition was noted during the product analysis evaluation that would suggest any anomaly with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3174676
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dennis100
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« Reply #31 on: October 16, 2017, 12:32:07 AM »

Model Number 102
Event Date 04/01/2012
Event Type Injury
Manufacturer Narrative

Event Description
It was observed in the patient¿s clinic notes dated (b)(6) 2013 that the patient was experiencing a new and unusual seizure type and was referred for a generator replacement. The unusual seizure was followed by left sided weakness that last 1-2 hours with full recovery (most likely todd's paralysis). Work up including head ct, echo and "carotid us" were unremarkable. System diagnostics were performed and the device was not at end of service. However, it is believed that a warning message was observed during interrogation to replace the device as soon as possible. The patient's medication was increased, and no vns programming changes were made. Good faith attempts were made to the physician and it was later reported by the physician that the patient was experiencing an increase in seizures, not new and unusual seizure types. The patient¿s seizures improved since vns implantation initially then her seizures worsened. The physician stated that the patient was experiencing left side weakness in their body with a longer recovery time needed after the seizures took place. This event was first observed (b)(6) 2012. He is unsure at this time if the increase in seizure frequency is due to todd's paralysis or vns therapy. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the change in seizure type. The patient has been referred for a generator replacement, due to the message noted on the handheld during interrogation stating that the device should be replaced as soon as possible. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(6) 2013, the patient underwent generator revision. The explanted generator was destroyed per hospital protocol.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3250578
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dennis100
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« Reply #32 on: October 19, 2017, 01:07:29 AM »

Model Number 104
Event Date 06/03/2013
Event Type Malfunction
Event Description
On (b)(6) 2013, it was reported that this patient was referred for end of service generator revision and prophylactic lead revision. The patient¿s seizures were stronger. Clinic notes dated (b)(6) 2013 indicated that the patent¿s last seizures was on (b)(6) 2013. The patient has complex partial seizures with typical post-ictal duration of 2 minutes. The vns was noted to be not working, and the patient was referred due to worsening seizures. Notes dated (b)(6) 2013 indicated exacerbation of seizures, and phenytoin was added. The notes did not indicate that the generator was interrogated or adjusted at this appointment. Notes dated (b)(6) 2013 indicated no worsening of seizures with a post-ictal duration of 3 minutes. Follow-up showed that the patient was implanted with vns and now had more frequent seizures. On (b)(6) 2013, they checked the vns, and it was completely dead. The same programming system was used successfully with other patient¿s. The patient was using 3 heavy duty medications, and it was not controlling her seizures. After she was implanted with the vns the seizures got better. When the battery died she started having generalized seizures that she didn't have before. The physician attributed the increase seizures to the battery being at end of service. The patient was referred for revision. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3358054
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dennis100
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« Reply #33 on: October 20, 2017, 12:27:48 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 indicate that the patient has been experiencing a new type of seizure that is different than the patient's usual staring episodes. It was noted that the new events are more of confusional episodes, and have been occurring approximately 3 times per week. It was noted that the patient does not have any evident seizures prior to the confusional episodes. It was noted that the patient's mother describes the patient's eyes as glazed over and he is unresponsive for a few minutes. Following the episodes, the patient has a headache and may be agitated. The patient was referred for generator replacement. The patient underwent generator replacement on (b)(6) 2013. The generator was returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not yet been completed to date.

Manufacturer Narrative

Event Description
Further follow-up revealed that overall, the patient has been doing reasonably well after the generator replacement.

Event Description
The generator analysis was completed on (b)(6) 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. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3336683
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dennis100
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« Reply #34 on: October 22, 2017, 01:26:42 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2013 note that the patient has a new type of seizure this year where his legs go out from under him and he will just fall backwards and convulse. The relationship of the new type of seizure to vns is unknown. Attempt to obtain additional information have been unsuccessful to date.

Event Description
The generator was returned for analysis on (b)(4) 2013. The returned product form indicated that the generator was explanted on (b)(6) 2013 due to prophylactic replacement. Attempts to obtain additional information have been unsuccessful to date. Analysis of the generator 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3397235
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dennis100
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« Reply #35 on: October 24, 2017, 01:16:18 AM »

Model Number 103
Event Date 09/23/2013
Event Type Injury
Event Description
On (b)(6), 2013, the patient reported that she saw the physician around (b)(6). The patient stated that the physician doubled her keppra dosage and left the vns settings the same. Following the change in medication, the patient experienced an increase in seizures and began having a new seizure type. The patient had two mini grand mal seizures and one grand mal seizure. The patient attributes the increase in seizures to the medication changes, but did not specifically comment on the relationship of the new seizure type to the medication changes or vns. No other information has been provided.

Manufacturer Narrative
Evaluation codes-conclusions, corrected data: based on the initial report, there is no allegation of a device failure as the adverse event is believed to be related to medication changes. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528909
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« Reply #36 on: October 24, 2017, 01:17:06 AM »

Model Number 250
Event Date 05/03/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history confirmed reported settings.

Event Description
It was reported that a patient was seen in clinic and their vns was interrogated and showed 0. 25ma/10 hz. It was intended for the patient to be programmed to 1. 5ma/30/500/30/3 min off time. The patient event was discovered on (b)(6)2010. It is unk if another programming system was used to program the patient to these settings as not default settings. The patient was programmed back to their intended therapy. Around the time of their programming event, the patient was having an increase in seizures from weekly to daily when they were at unintended therapy. Their seizures had changed and involved left side stiffening and head turning to the left that lasted 30 seconds. Overall, in the past several months, it has been reported that their seizures have been slightly more frequent. Good faith attempts are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1774009
« Last Edit: January 24, 2018, 03:13:53 AM by dennis100 » Logged
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« Reply #37 on: October 31, 2017, 03:05:17 AM »

Model Number 103
Event Date 02/01/2014
Event Type Injury
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Clinic notes were received indicating that the vns patient reported having an increase in seizures during an office visit on (b)(6) 2014. The increase in seizures is believed to be below pre-vns baseline levels. The patient was also experiencing new type of seizures consisting of muscle jerks. No issues with the patient's device were noted. No changes were made to the patient¿s device settings or medications during the office visit. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3894713
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« Reply #38 on: November 01, 2017, 01:27:37 AM »

Model Number 105
Event Date 03/15/2013
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2014 note that since the patient's last visit on (b)(6) 2013, the patient has experienced an increase in seizures. It was noted that the patient's lamictal was increased and the patient's seizures improved. It was noted that the patient suffered a second increase in seizures in september 2013. It was noted that the lamictal was increased a second time; however, little improvement was seen. It was noted that the patient's seizures went from one seizure a month to 4-5 seizures a month. It was noted that the seizures tend to occur two weeks prior to her menses and either the week of or the week after her menses. The seizures often occur in pairs; she has a seizure in the evening around dinner time and one the following morning several hours after awakening. The notes indicate that the patient's seizures have changed in character since (b)(6) 2013. It was noted that the patient now becomes still and "falls like a tree, often on her face". It was noted that in the past her habitual seizures were described as staring and lip smacking. Initially, the increase and change in seizures was reported on mfr. Report # 1644487-2014-01499 as the increase and change in seizures were thought to be related to the high impedance event in this report. Information received on (b)(6) 2014 indicates that the increase and change in seizures occurred prior to the high impedance event. It is unknown if the increase in seizures is above the patient's pre-vns baseline frequency. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3963844
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dennis100
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« Reply #39 on: November 02, 2017, 01:23:28 AM »

Model Number 103
Event Date 06/27/2011
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient went to the er and was admitted to the hospital on (b)(6) 2011. The patient had approximately 15 ¿episodes¿ that were different from the patient¿s normal seizure types. The episodes involved the patient chewing his tongue and losing consciousness. The patient was sleepier and more confused during the post ictal period. Since hospitalization, the patient had 1-2 seizures. Attempts for additional relevant information have been unsuccessful to date.

Event Description
On (b)(6) 2014 it was reported that the patient¿s physician retired and the patient was not seeing the other physician in the practice.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942259
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dennis100
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« Reply #40 on: November 02, 2017, 01:24:11 AM »

Model Number 302-20
Event Date 12/22/2011
Event Type Malfunction
Manufacturer Narrative
Analysis of programming and device diagnostic history performed. Device failure is suspected but cannot be confirmed.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned.

Event Description
It was initially reported that during prophylactic generator revision surgery on (b)(6) 2011, high lead impedance was obtained with the old generator and new generator therefore the lead was replaced. A company representative called back later and stated that originally, they thought the high lead impedance was due to the patient's output current being high (3. 5 ma) however with the new generator attached to the existing leads, high lead impedance was obtained therefore it was decided to replace the lead. The surgeon noticed that some of the helices did not appear to be attached to the nerve and were embedded. This portion of the lead was not removed as the surgeon did not feel it was safe to do so. Once the new lead and generator were implanted, the impedance value was 1350 ohms. Per the patient's mother, the patient started having more seizures (below baseline levels) and about a month ago, the patient had two grand mal seizures which had not occurred previously. The magnet also appeared to be less effective in aborting seizures. The explanted lead and generator were returned on 12/27/2011 and are currently undergoing device evaluation. Good faith attempts to obtain additional information have been unsuccessful to date. The patient¿s programming and device diagnostic history available in the in-house database were reviewed and no records of high lead impedance were found however the data was only available up to 12/07/2010.

Event Description
Additional information was received on (b)(4) 2012, where it was reported that there were no x-rays available to send to the manufacturer for review. There were no reports of trauma or manipulation. The relationship of the seizures to vns is unknown as well as the relationship of the seizures to vns as they did not detect any high lead impedance until the date of surgery. The patient was hospitalized due to the seizures and her medication was adjusted. The patient does have multiple types of seizures and all increased. It was difficult to assess whether any causal or contributory programming/medication changes or other external factors preceded the onset of the seizures. Product analysis of the explanted generator and lead was completed. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2420397
« Last Edit: February 21, 2018, 02:15:16 AM by dennis100 » Logged
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« Reply #41 on: November 03, 2017, 02:59:33 AM »

Model Number 102R
Event Date 05/31/2014
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced different seizures than she's had in the past. It was reported that the patient squinches her eyes closed prior to the spells and her eyes stay closed during. The patient appears to be fighting the spell and then will go into it. Her hands and arms will go forward and if she is laying down they go over her head and she will go limp. It was noted that these last only a few seconds and with in a few minutes she will be back to whatever she was doing. It was noted that the patient is generally incontinent with these spells and they do not occur when she is dancing. It was noted that the patient was seizure free from 01/2013 to 05/30/2014 and that the only change was diazepam was discontinued. Diazepam was resumed and the seizures have continued. The physician reported that the patient has experienced some increase in seizures with a loss of therapy, but that the seizures were not above pre-vns baseline frequency. It was reported that medication changes have helped. The physician does not believe that the discontinuation of diazepam was related to the seizures. The patient has been referred for prophylactic generator replacement. No known surgical intervention has been performed to date.

Manufacturer Narrative

Event Description
It was reported that the patient underwent prophylactic generator replacement. Pre-operative device diagnostics were within normal limits (neos - no). Device diagnostics with the new generator connected to the existing lead were within normal limits. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the generator was completed on 10/02/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027967
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« Reply #42 on: November 07, 2017, 01:58:43 AM »

Model Number 102
Event Date 09/01/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient had been experiencing an increase in seizures and a new seizure type for the past week. On (b)(6) 2014, the patient had a seizure that lasted for approximately 35 minutes and was taken to the er. The patient was given medication and admitted to the icu. The patient¿s seizures were determined to be non-epileptic but a new type for the patient. It was noted that vns had improved the patient¿s epileptic seizures. Follow-up revealed that the patient¿s device was tested and diagnostic results showed normal device function. The patient¿s device pulse width was decreased from 500usec to 250usec. The physician believed that the patient would have an anxiety attack that could trigger seizures if the patient felt stimulation from the device. With the adjustment to the device pulse width, the patient no longer felt stimulation and did not have another event since the adjustment. The patient¿s seizures have improved past pre-vns baseline levels.

Event Description
On 03/18/2015 it was reported that the patient¿s device was turned off on (b)(6) 2015. He was having ¿panic attacks¿ that would lead to seizures. The physician believes that the panic attacks may be brought on from the stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4131946
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« Reply #43 on: November 12, 2017, 03:22:51 AM »

Model Number 304-20
Event Date 06/26/2012
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
An implant card was received on (b)(4) /2012. Diagnostics following the replacement were within normal limits. The explanted products were returned to the manufacturer on (b)(4) 2012. Analysis is not yet complete.

Manufacturer Narrative

Event Description
Analysis on the returned products has been completed. Analysis on the generator was completed on (b)(6) 2012. The results of bench diagnostic testing indicated the device was operating properly. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead was completed on (b)(6) 2012. During the visual analysis the end of the connector pin quadfilar coil appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break and identified the area on one of the coil strands 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 remaining coil strands were identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Secondary break lines and pitting were observed on the coil surface. Scanning electron microscopy was performed on a second connector ring quadfilar coil break and identified the area as having extensive pitting which prevented identification of the coil fracture type. The abraded openings and incision mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. Abraded openings were also identified in the inner tubing. 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 which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Event Description
An article titled "twiddler syndrome with a twist: a cause of vagal nerve stimulator lead fracture" was received by the manufacturer which referenced a case report of a vns patient. ¿approximately 3 months after placement of the vagal nerve stimulator, the family noted subcutaneous protrusion of the device leads deep to the skin below the clavicle. Device function did not appear to be compromised and there was no change in the child¿s seizure frequency. A chest radiograph was obtained at that time and the vagal nerve stimulator leads were noted to be intact. Use of a compressive sling and snug-fitting clothing were advocated at that time. At 7 months after initial placement, the child¿s mother noted the onset of a new type of seizure. Interrogation of the vagal nerve stimulator revealed high impedance and chest radiograph showed twisting of the vagal nerve stimulator wires in the chest wall with fracture of the leads in the low neck. " x-rays were performed, and per the article, they showed there was longitudinal twisting of the vagal nerve stimulator leads in the chest wall and redundant portions of the wires are tightly looped/knotted in the chest wall just above the pulse generator. The device was deactivated and replaced one month later.

Event Description
It was reported that the patient's lead was fractured, confirmed through an x-ray. Additional information was received indicating that high impedance, greater than 10,000 ohms was observed during a follow up visit on (b)(6) 2012. At that time, the patient was referred for x-rays which showed a lead fracture. There was no manipulation or trauma to the device, and the x-rays will not be sent to the manufacturer for review. The lead was replaced on (b)(6) 2012. The explanted product has not been returned to the manufacturer to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2669473
« Last Edit: March 11, 2018, 01:13:22 AM by dennis100 » Logged
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« Reply #44 on: November 13, 2017, 02:45:35 AM »

Model Number 103
Event Date 11/01/2014
Event Type Injury
Event Description
It was reported that the vns patient had been experiencing nocturnal seizures for the past two weeks. The patient stated that the seizures were convulsions and did not cause her to lose awareness. The patient also reported experiencing a change in seizure pattern; she stated she began having other feelings ¿inside¿ along with automatisms. It was noted that the magnet mode stimulation had been helpful in aborting the patient¿s seizures. The patient was instructed to activate magnet mode stimulation a few times before bedtime or during the day. The patient denied any life stressors but believed her ipad may have been triggering her seizures. The patient was instructed to visit with the following physician. Attempts for additional relevant information will be made.

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient had been experiencing an increase in seizures and a new seizure type in november and (b)(6) of 2014. The seizures were attributed to stress during the holiday season. The patient was seen on (b)(6) 2015 and was doing well. The seizures had resolved and the patient¿s device was functioning well. There was no mention of potential issues with her ipad during the office visit and no further information was obtained as the patient was doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377912
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« Reply #45 on: November 15, 2017, 01:59:43 AM »

Model Number 105
Event Date 10/01/2014
Event Type Injury
Manufacturer Narrative
This information was inadvertently left off of previous mfr. Report: suspect device udi: (b)(4).

Manufacturer Narrative

Event Description
It was reported that the patient experienced a new type of seizures in the form of clusters. It was also reported that the patient has experienced pain at the generator site. Clinic notes dated (b)(6) 2015 note that the patient's mother reports a significant number of complex absence / confusional episodes one every five days that last two days. The patient's fycompa was increased. It was noted that the patient complained of pain at the generator site when moving both arms. The patient was referred to surgeon for review and or revision of the vns regarding the pain. No additional relevant information has been received to date. No known surgical interventions have been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632395
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« Reply #46 on: November 20, 2017, 03:16:34 AM »

Model Number 104
Device Problem Device operates differently than expected
Event Date 06/01/2012
Event Type Injury
Event Description
Additional information received indicates that the provider is aware that the patient has grand mal seizures but does not believe the emergence of this seizure type to be related to the patient's vns device. The provider states that in addition to vns therapy the patient is being treated medically for all of her seizures types.

Event Description
The provider reported that the parent's reports of patient movements were considered psychogenic by another provider. Clinic notes were provided indicating that the events reported by the parents were ultimately determined to be abnormal behavioral movements and likely not seizures. Any actual seizures the patient was experiencing were attributed to the patient starting oral contraceptives.

Manufacturer Narrative

Event Description
It was reported that the vns patient began experiencing grand mal seizures approximately three years ago following initial vns implant. The patient had not experienced these types of seizures in the past. The patient¿s parent indicated that vns was effective in controlling her other types of seizures but not effective in controlling grand mal seizures. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874395
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« Reply #47 on: November 21, 2017, 02:52:01 AM »

Model Number 102
Device Problems Failure to deliver energy; Unexpected therapeutic results
Event Date 01/20/2015
Event Type Injury
Event Description
The patient underwent replacement surgery on (b)(6) 2015 due to prophylactic neos=no. The explanted generator was received for analysis on 10/23/2015. Analysis is currently underway but has not been completed to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Product analysis for the m102 generator was completed and approved on 11/17/2015. Based on the electrical test results, the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an eri condition. Therefore, the electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the eri condition is an expected event. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes were received on (b)(6) 2015 for referral for battery replacement due to less efficacy being received from the device. Notes dated (b)(6) 2015 state that the patient has had few seizures and seizures are infrequent. The patient does not recall any seizures in the prior months. Follow-up showed that the patient is having an increase in seizure activity which is why less efficacy is thought to be received. The physician is concerned because her seizures have now included cluster seizures which is a new seizure type for the patient. It was noted that the patient doesn¿t feel stimulation as much and seizures have been aborted with magnet activation. There have been no change in medications leading to the increase in seizure activity. The patient can't tolerate vns settings beyond 1. 75ma. The physician opted for prophylactic replacement and increased her oral medications until surgery. Surgery is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4848231
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« Reply #48 on: November 21, 2017, 02:53:22 AM »

Model Number 102
Device Problem No Information
Event Date 05/05/2015
Event Type Injury
Event Description
Information was received from the neurologist via a company representative on (b)(6) 2015. The date of onset of the new seizure type was (b)(6) 2015. The patient's seizures are less severe since vns. The new seizure type is not related to vns, but is related to external factors. No interventions were planned or taken. Diagnostic results were not reported.

Manufacturer Narrative

Manufacturer Narrative
The previously submitted mdr inadvertently provided an incorrect event date.

Event Description
It was reported that the patient experienced an unusual seizure during device settings adjustments; therefore, the physician left the settings as previously programmed. The patient reported that the seizure was different than what she was used to. Attempts to obtain additional relevant information have been unsuccessful to date. The relationship of the unusual seizure to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4860270
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« Reply #49 on: November 22, 2017, 03:46:09 AM »

Model Number 103
Event Date 12/30/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the patient did not have any change in medications prior to their increased seizures. Titrations of therapy were made as follows. They were set at 1ma, 30hz, 500msec, 30sec, 5min on (b)(6) 2012. The physician assessed the stimulation may be too high, so he decreased the stimulation and the setting was 1ma, 25hz, 500msec, 30sec, 5min. The seizure control was still poor and their absence seizures increased, so the last parameter setting was changed (b)(6) 2012, which is 1. 25ma, 25hz, 500msec, 30sec, 5min. The seizure control has improved little bit since that time. They plan on monitoring the seizure control of this case. The final system diagnostic was at (b)(6) 2012, which result is normal. No further information has been attained.

Event Description
It was reported that the patient's seizures are progressively getting worse. Device diagnostics in september 2014 were within normal limits. Device settings options were discussed. No additional relevant information has been received to date.

Manufacturer Narrative
Adverse event or product problem: corrected data to serious injury. Type of reportable event - corrected data to serious injury.

Event Description
Our local partner in (b)(6) was contacted by a treating physician and it was reported that after a patient received their vns therapy on (b)(6) 2011, seizure control has become poor. The number of their average seizure attacks has increased from 4. 9 to 27. 4 /per day. Also, the seizure type has become more serious (for example: absence seizure attack combines silly laugher or shouting, it hasn¿t happened before vns implanted). Moreover, by family's concern and physician's experience, physician has changed the parameter setting frequently (2wks). The patient's seizure control has become worse. Good faith attempts are underway for further details about the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2867808
« Last Edit: March 31, 2018, 01:18:48 AM by dennis100 » Logged
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« Reply #50 on: November 26, 2017, 03:20:58 AM »

Model Number 304-20
Device Problems Leak; Positioning Issue
Event Date 11/08/2014
Event Type Malfunction
Event Description
Follow-up was performed with the patient's neurologist. He was informed that product analysis found lead fractures and high impedance. He was not aware of any high impedance. System diagnostics were always within normal limits to his knowledge. The patient's mother was adamant that the device was not helping, but he did not agree. He programmed the device off in (b)(6) 2014 and left the magnet on. At that time the impedance was 3980 ohms. The patient had a lower seizure frequency about a year after implant. He disabled the device in (b)(6) 2014 to prepare for explant in 2015 as requested by the patient's mother. His protocol is to leave the device off for 6 months to determine whether vns is actually helping the patient. Within 6 months of disabling the device, the patient started to experience drop seizures, which he has never had before. The neurologist maintained that vns was clearly helping the patient as the patient did not have a new seizure type in 14 years until vns was programmed off. He did not think the patient hitting himself was in any way related to the high impedance which was found, as the patient was hitting himself as soon as the device was implanted.

Manufacturer Narrative

Event Description
It was reported that the vns patient underwent explant surgery on (b)(6) 2015 due to lack of efficacy. It was noted that the patient was developmental delayed and was hitting himself in the chest. The explanted generator and lead were returned to the manufacturer for analysis. Analysis of the lead identified that the connector pin had evidence of pitting and electro-etching on the surface. It was also found that the lead had not been fully inserted into the cavity of the generator. Lead discontinuity was found in both positive and negative quadfilar coils in the body region of the returned lead portions. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The as-received internal device data showed that the last 25% change in the impedance value was estimated to have occurred on (b)(6) 2014, where the impedance value changed from high lead impedance to a normal limits range. Complete analysis of the generator was reported in manufacturer report # 1644487-2015-05615.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5029418
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« Reply #51 on: November 28, 2017, 02:39:37 AM »

Model Number 103
Device Problem No Information
Event Date 07/21/2015
Event Type Injury
Event Description
A provider reported that a patient had experienced a new seizure type of greater than 10 minutes duration and that the patient was taken to the emergency room and hospitalized. It was reported that the patient had not experienced any seizures since the date of implant, (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Follow up with the treating facility indicates that the patient was discharged home from the emergency room and did not receive any medical intervention while in the emergency room. The patient was instructed to follow up with his neurologist. Available programming history and diagnostic data was reviewed and no anomalies were noted. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4961275
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« Reply #52 on: November 29, 2017, 01:41:18 AM »

Model Number 302-20
Event Date 03/29/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected.
 
Event Description
It was initially reported that diagnostics performed indicated that high lead impedance was present, but specifics were not available. It was also mentioned by the parent that the magnet activations were no longer being perceived for approx two months prior. The pt's seizures were also said to be "different", but no further details have been made on the issue. X-rays were taken and sent to the mfr for analysis. No gross lead fractures or discontinuities were visualized on the portions of the lead body that could be assessed. However, the image quality in the neck area was poor, and there was a portion of the lead body located behind the generator that could not be assessed. Based on the x-rays received, there were no gross lead discontinuities or anomalies observed that could be contributing to the high lead impedance event. However, a led discontinuity cannot be ruled out on the portions of the lead that could not be fully assessed. Good faith attempts to obtain additional info have been unsuccessful to date. A review of the mfr's programming history database indicated that the last known diagnostics were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686255
« Last Edit: June 11, 2018, 12:35:47 AM by dennis100 » Logged
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« Reply #53 on: December 06, 2017, 02:45:38 AM »

Model Number 105
Device Problem Device inoperable
Event Date 10/20/2015
Event Type Malfunction
Event Description
Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.

Event Description
It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.

Event Description
Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. No additional relevant information has been received to date.

Event Description
It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5216170
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« Reply #54 on: December 08, 2017, 03:29:28 AM »

Model Number 103
Event Date 01/12/2015
Event Type Injury
Event Description
It was reported that the patient's vns battery is "shutting down". Additional information was received that the patient's battery was seen to be low (about 10%). Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free. These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards. Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation. No additional relevant information has been obtained to date.

Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. It was reported that the explanted generator was discarded by the explanting facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5339671
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« Reply #55 on: December 20, 2017, 08:30:56 AM »

Model Number 105
Event Date 05/12/2016
Event Type Malfunction
Event Description
It was reported the patient had complaints of redness, swelling, and pain at the vns generator site. The physician programmed the vns off and referred the patient back to the ent for evaluation of the site for infection. Additionally information was received which stated the patient also believes the generator is heating and not working. The patient stated he has had an increase in seizures as well as a change in seizure type. Later it was reported the physician does not feel the patient's symptoms were related to vns, but believed it was a "nerve issue". It is unknown what the nerve issue is, or what may have caused the nerve issue to occur. A x-ray assessment was provided by the physician which stated "gross satisfactory vagal nerve stimulator. No acute finding". Attempts for additional relevant information have been unsuccessful to date.

Event Description
Clinic notes were received due to re-implant surgery referral due to a "problem with the vagus nerve stimulator". It was mentioned in the notes that the patient was still having seizures. The patient's replacement occurred on (b)(6) 2016 and it was noted he was switched from a model 105 generator back to a model 102 generator. After the generator was replaced with the new generator, the system diagnostic results confirmed the device was working as intended. It was reported by the physician's office that the patient was last seen on (b)(6) 2016 and had mild pain, redness, and 4 seizures. It was confirmed that these seizures have increased from her baseline. It was noted that an additional event had occurred which lasted for hours and the patient felt heating around the vns device. There was not reason specifically given for the increase in seizures. It was noted that the vns settings on (b)(6) 2016 were at therapeutic levels and the diagnostics were within normal limits. It was noted the device would not be returned per hospital regulations. It was further reported by the company representative who was at the surgery that the m105 was "faulty" and needed to be replaced, or per patient request, would be removed completely. The patient requested to have a 102 as he did not have any issues with the m102. Per the patient and the surgeon, the believed cause of the burning sensation and irritability was due to the 105 generator. According to the patient, the burning sensation occurred immediately after the 105 settings were adjusted, but continued even after the device was programmed off. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5726096
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« Reply #56 on: December 21, 2017, 03:06:52 AM »

Model Number 102
Event Date 11/01/2011
Event Type Injury
Event Description
The patient had their generator replaced on (b)(6) 2012. The explanted generator is being returned for analysis. Additional information was received. It is unknown when the patient's seizure event first started. She has poor memory. Their dcdc was a 5 so referred for a battery change. Unknown if their seizure frequency was above their prevns level as not documented. The patient's last medication change was on (b)(6) 2011 an increase in keppra. It is unclear the relationship of their psychosis to their vns.

Event Description
The patient had a prophylactic generator replacement. The generator is at the manufacture pending completion of product analysis.

Event Description
Clinic notes were received for review from a patient office visit dated (b)(6) 2012. The vns patient does not remember all of her seizures and believes that they have not increased in frequency. Her husband believes her seizures have been increasing in frequency over the last few months. He also reports she is now having seizures that start as staring spells and did not have these prevns. The patient's vns was interrogated and set at 1. 75/500/30/30/5 magnet 2/500/60. Normal mode diagnostic testing showed at dcdc 5 and system diagnostic results of dcdc 2 eri no. However, according to her husband, the patient has been having an increase in seizure activity over the last few months. He also notes she is having seizures that start as staring episodes, and then she will fall. He states, she has not had these types of event since prior to her vns implantation. Therefore, it appears that the vns is likely nearing eos and today she will be referred for battery change. No surgery is scheduled at this time. On (b)(6) 2011, the patient was admitted to hospital for 2 weeks due to psychosis. Device function was confirmed. The patient has a history of major depression/catatonia. Good faith attempts have been made for further details about the reported event and thus far no further information has been attained.

Event Description
Analysis was completed on the patient's generator. In the 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The patient's implant card reported their generator was replaced for prophylactic reasons.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434874
« Last Edit: February 28, 2018, 02:18:23 AM by dennis100 » Logged
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« Reply #57 on: December 31, 2017, 02:40:31 AM »

Model Number 103
Event Date 10/19/2013
Event Type Injury
Manufacturer Narrative

Event Description
Initially, it was reported that the patient developed a new seizure since generator replacement that was head bobbing. Clinic notes dated (b)(6) 2014 were received indicating that the patient's father would like the vns removed because he feels that the patient's head bobbing was related to vns. It was noted that the vns remains off and no head bobbing episodes have been seen. The patient was referred for surgery. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4226801
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« Reply #58 on: January 03, 2018, 02:07:54 AM »

Model Number 102
Event Date 01/12/2015
Event Type  Malfunction   
Event Description
It was reported that the recently implanted vns patient experienced successive seizures nonstop for 30 minutes. The patient was taken to the or and the seizures stopped at that time. The patient¿s device output current was increased from 0. 25ma to 0. 5ma earlier that day. No intervention was taken. It was noted that the patient had not previously experienced seizures of this type. No medication changes preceded the onset of the event. Prior to vns, the patient averaged three seizures per day. Diagnostic results showed normal device function at the time of implant. The physician indicated that all of the patient¿s seizure types had increased. The patient was reported to be stable now.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4491065
« Last Edit: February 11, 2019, 02:23:28 AM by dennis100 » Logged
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« Reply #59 on: January 06, 2018, 04:36:42 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/13/2017
Event Type Injury
Manufacturer Narrative

Event Description
The patient reported that for the past two to three weeks she believes to have experienced a new type of seizure. The patient reported approximately twice a week to have woken up in a sweat feeling as if she had fallen. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140101
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