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Author Topic: Increase/Worsening of Seizures  (Read 217473 times)
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dennis100
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« Reply #2370 on: February 15, 2017, 03:05:36 AM »

Model Number 102R
Event Date 05/01/2010
Event Type Malfunction
Event Description
Good faith attempts were made an no further information was made.

Event Description
Clinic notes were received that a vns patient was having an increase in seizures in (b)(6) 2010. Reported as the patient was having daily seizures. The patent is taking keppra, trileptal, tranxene, lamictal, lorazepam. It is unknown the relationship to their vns and the relationship to their baseline seizure rate. Investigation is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2483554
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dennis100
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« Reply #2371 on: February 15, 2017, 03:06:31 AM »

Model Number 300-20
Event Date 09/01/2006
Event Type Malfunction
Event Description
It was reported that the patient was experiencing an increase in seizures following a chiropractor's visit for a neck adjustment. Diagnostic testing resulted in high impedance following this visit. The last known good diagnostic results were obtained in (b)(6) 2006 (exact results not given). A review of x-rays by the physician revealed that a lead discontinuity was present at the levels of the c6-c7 vertebrae. The device was turned off. The physician reported that the believed cause for the break was related to the neck adjustment at the chiropractor's office and the increased seizures were due to the loss of therapy from the lead break. It was decided not to replace the patient's device at that time as they wanted to think about it. The patient later underwent full revision surgery on (b)(6) 2011 and explanted products were returned to manufacturer for analysis. An analysis was performed on the returned lead portions and the reported lead fracture was confirmed. During the visual analysis of the returned 88mm portion the end of the marked quadfilar coil appeared to be broken approximately 139mm from the end of the connector boot in the lead body area. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 254mm portion the unmarked connector quadfilar coil appeared to be broken in various locations of the lead body area. Scanning electron microscopy was performed and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The areas on the remaining quadfilar coil strands was identified as either being mechanically damaged or having extensive pitting which prevented identification of the coil fracture type. 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, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. No other 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. 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. No anomalies were noted with the returned generator.

Manufacturer Narrative
Device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480529
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dennis100
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« Reply #2372 on: February 15, 2017, 03:07:28 AM »

Event Date 04/01/1999
Event Type Malfunction
Event Description
Manufacturer review of the published article entitled "vagus nerve stimulation for medication-resistant generalized epilepsy. E04 vns study group. Neurology 1999:52:1510-1512; labar d, murphy j, tecoma e. " identified one patient who developed increased seizures after the vns was implanted. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative
Article citation: vagus nerve stimulation for medication-resistant generalized epilepsy. E04 vns study group. Neurology 1999:52:1510-1512; labar d, murphy j, tecoma e.

Event Description
Additional manufacturer review of the article noted the increased seizures event was previously captured and reported, and was reported again in error.

Manufacturer Narrative
Adverse event or product problem, corrected data: the increased seizures event was previously reported, and was reported again in error.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2481676
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dennis100
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« Reply #2373 on: February 15, 2017, 03:08:26 AM »

Model Number 102
Event Date 12/31/2011
Event Type Malfunction
Event Description
Additional information was received that the increase in seizures were below baseline and are believed to be related to the generator depleting. The patient's seizures are doing much better since their generator replacement. There was no malfunction suspected and last diagnostics were within normal limits.

Event Description
Additional information was received that the generator was discarded and will not be returned to the manufacturer for evaluation. The hospital does not hold product more than two weeks and a company representative would have needed to be present at the surgery to take the generator for return.

Event Description
Additional information was received that the patient had a prophylactic generator replacement. Product return attempts are in process.

Manufacturer Narrative
Analysis of programming history.

Event Description
On (b)(6) 2012, it was reported that a patient was experiencing an increase in seizures since being involved in a car accident on (b)(6) 2011. The patient's seizures were reported to be worse than the pre-vns baseline. The patient was referred to her physician. Diagnostics were reported to be within normal limits. Attempts to obtain further information regarding the patient's condition have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2491052
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dennis100
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« Reply #2374 on: February 15, 2017, 03:08:58 AM »

Model Number 101
Event Date 02/17/2012
Event Type Malfunction
Event Description
A vns patient's wife called and reported that her husband was having an increase in seizures. It is unknown the relationship to their vns and if above or below baseline. The patient's generator has been implanted over 10 years. The patient followed up with their neurologist and it was reported that when her husband saw the doctor a few weeks ago, he did change the settings on their vns. He still has seizures periodically and she did not know why. His wife reported that they know he needs to take his medicine very timely every 12 hours or we will see a seizure. He is also going thru a stem cell treatment and they aren't sure if that's stimulating anything. Their seizures are not that often and they are the focal seizures that he recovers very good from. It was reported that she believed the vns helps with the recovery as we have seen all along since he has had it. (b)(4) attempts have not provided any more information thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2491003
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dennis100
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« Reply #2375 on: February 15, 2017, 03:09:43 AM »

Model Number 102
Event Date 01/31/2012
Event Type Injury
Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the explanted generator. In the product analysis 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. 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 and there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2012, a vns treating neurologist's medical assistant reported that the vns patient was experiencing more seizures. The patient's magnets were also reported to not be aborting seizures as they did in the past. The patient was seen that day for a clinical visit and they had difficulties interrogating the patient's device. The physician later reported that the vns patient was seen by him on (b)(6) 2012 after an episode of status epilepticus on (b)(6) 2012 that required hospitalization. He checked the patient's vns device on (b)(6) 2012 in the clinic and had difficulties establishing communication with the device but was indeed able to interrogate the device. The physician used the same programming system on other patients that same day with no problems. The patient's family had noticed that the patient was not responding to magnet swipes as she had previously. The physician stated that the patient's device may be nearing end of service. The patient's settings on (b)(6) 2012 were reported to be output=2. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=500usec. A system diagnostics test performed that day showed the device to be functioning properly and was not at end of service. The physician further stated that he thinks there are several factors that may be playing a role in her increased seizure frequency but he did not specify what these factors were. Attempts were made for the patient's implanted lead information but that information has not been received to date. A battery life calculation was performed with the programming history available which revealed 1. 89 years until the elective replacement indicator (eri) shows as yes. On (b)(6) 2012, the patient had prophylactic battery replacement surgery. Attempts will be made for the return of the explanted generator. System diagnostics performed prior to surgery showed results within normal limits of output=ok/lead impedance=ok/dcdc=1/eri=no. The patient's settings were output=2. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec. After battery replacement system diagnostics again showed results within normal limits of output=ok/lead impedance=ok/impedance value=1629ohms. The patient was then programmed to output=2ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=2. 25ma/magnet pulse width=500usec/magnet on time=60sec.

Event Description
Additional information was received on (b)(4), 2012 when the explanted generator was returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2492499
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dennis100
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« Reply #2376 on: February 15, 2017, 03:10:30 AM »

Model Number 103
Event Date 02/10/2012
Event Type Injury
Event Description
Additional information was received that the patient has not been seen since their surgery therefore it is unknown how their seizure activity is currently.

Event Description
Additional information was received from the patient's nurse practitioner on (b)(6) 2012. She stated that the patient started experiencing an increase in seizures in (b)(6) 2011. The patient's seizures were reported to be generalized tonic-clonic and went from one every two weeks to one per night, and from only nocturnal to day-atonic. Both seizure types atonic and atonic-clonic had increased. The only changes reported before the onset of the increase in seizures was that the generator was at end of service. Additionally it was reported that the patient's dose of vimpat has been increased to decrease seizures. The patient is being scheduled for generator replacement surgery.

Event Description
Clinic notes were received through case management on (b)(4) 2012 and dated (b)(6) 2012 indicates that the vns patient had experienced an increase in seizures. Patient initially responded well to the start of vimpat with decreased nocturnal generalized tonic-clonic events. She was even able to go a few days without any events. However, over the past few weeks, she has returned to one generalized tonic-clonic event per night. These are shorter in duration and less intense in general. Patient also experienced a drop seizure, which has not been experienced for some time. System diagnostics indicated that the generator is at near end of service. Patient referred to ent for battery replacement, but the surgery has not been scheduled. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
The device was returned due to demipulse eos, eos=yes and low battery. The patient was having an increase in seizures. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the analysis lab. The battery is partially depleted, 2. 768 volts as measured during completion of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 88. 540% of the battery had been consumed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The confirmed ifi flag is set to yes; following an interrogation/diagnostic test; appears to be appropriate based on downloaded device data; generator performed according to functional specifications.

Event Description
The patient had her generator replaced and it is at the manufacture pending completion of product analysis.

Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report. Date received by manufacturer (mo/day/yr) in supplemental 02 report should have been (b)(4) 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488289
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dennis100
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« Reply #2377 on: February 15, 2017, 03:11:03 AM »

Model Number 101
Event Date 12/09/2010
Event Type Malfunction
Event Description
The patient had generator replacement surgery due to an unrelated reason of battery end of service on (b)(6) 2012. Follow up with the physician revealed that when she last saw the patient in (b)(6) 2011, her vns was still working. Attempts for additional information were unsuccessful to date.

Event Description
It was reported that a vns patient was experiencing an increase in seizures, and the physician believed the patient's device was at end of service. Vns had reportedly helped the patient greatly in the past with combination of medications. Additional information was attained which revealed that diagnostics were performed on (b)(6) 2011 which showed that the vns system was functioning properly at the time of the event, and the generator was not at end of service. Therefore, the increase in seizures as noted in (b)(6) 2010 were not actually due to end of service. Clinic notes dated (b)(6) 2012 were later received which reported that the patient's last seizure was in (b)(6) 2010. The physician is referring the patient for generator replacement as a result of the generator nearing end of service. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2488638
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dennis100
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« Reply #2378 on: February 15, 2017, 03:11:56 AM »

Model Number 102R
Event Date 07/13/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received that the patients seizures have returned back to baseline since their generator was replaced.

Event Description
Analysis was completed on the patient's returned generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the (b)(4) 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.

Manufacturer Narrative

Manufacturer Narrative

Event Description
The patient's generator was returned for analysis. Product analysis completion is pending.

Event Description
The patient had their generator replaced and it has not been returned for analysis at this time. Good faith attempts are underway for product return. Prior to explant diagnostics were performed. System diagnostic testing: output status ok, lead impedance ok, dcdc 2 eri no. The patient had been having seizures regularly and was the reason for their battery replacement.

Event Description
Clinic notes were received for review on a patient implanted with the vns. It was reported that the patient on (b)(6) 2012 had been having episode of headaches and also experiencing sleep apnea. The relationship of the patient's sleep apnea to their vns is unknown at this time and under investigation. The patient does use a cpap machine for their sleep apnea. The patient's output current was noted to be at zero at this time and unknown if programmed to zero output current. This is under investigation. Additionally on (b)(6) 2011, the patient was reporting pain after going through a scanner at the court house. The pain was reported to be in their left neck when their vns goes off. Otherwise, no trauma or injury verbalized. The patient's vns was interrogated all system diagnostic testing was ok. Their output current was decreased and no pain verbalized. The patient was going through transition and personal stress and having seizures. It was reported at their office visit dated (b)(6) 2011 that they were having more frequent seizures and that past month their seizures have been worse. The patient has had a seizure every day for the past two weeks. The patient had a grand mal seizure in the past month. The patient had not had any changes in medication in years. It is unknown the relationship of their seizures to their vns device, nor if it was a change in seizure type for the patient. The patient will be referred for battery replacement, surgery has not been scheduled at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2483548
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dennis100
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« Reply #2379 on: February 15, 2017, 03:12:38 AM »

Model Number 103
Event Date 01/01/2012
Event Type Injury
Event Description
Additional information was received on (b)(6) 2012 where it was reported that the patient's increase in seizures activity is believed to be due to an upper respiratory infection. The infection is not related to the patient's vns device. The patient was re-evaluated and the physician adjusted the output current to 1. 25 ma and the magnet output current to 1. 50 ma. The patient is said to be doing much better with the seizures responding to the magnet swipes. The patient's seizures are said to be very sensitive to any changes in the patient's body (i. E. Illness) with the seizure frequency increasing once a month around the patient's menstrual cycle (due to the menstrual cycle). Diagnostics were said to have been performed and the results were within normal limits however the specific test results were not provided. The patient will be seen again for additional titration of her vns settings.

Event Description
It was reported on (b)(6) 2012 that a vns patient was experiencing an increase in seizures above pre-vns baseline levels. The seizures affected were the patient's drop attacks. The patient has experienced a decrease in her generalized tonic clonic seizures. The patient does have lennox-gausteux and drop attacks are common; however, there has been a significant increase in the occurrence of the drop attacks after the patient was implanted with vns in (b)(6) 2011. The patient's settings were 1/30/500/30/5/1. 25/500/60. Diagnostics have not been performed since device implant as they were okay at implant. The physician does not know the cause of the seizures and has not ruled out whether or not there were any factors that contributed to the increase in drop attacks. The patient will follow up with the physician again in march and be re-evaluated. The patient's programming history available in the manufacturer's in-house programming database was reviewed and the data was available up to (b)(4) 2012 where the settings were increased by the physician as reported.

Manufacturer Narrative
Analysis of programming history performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2483551
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dennis100
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« Reply #2380 on: February 15, 2017, 03:13:15 AM »

Event Date 02/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
Attempts for the patient's vns model and serial number information were unsuccessful as the site indicated that signed patient consent is required for release of medical records.

Event Description
It was reported by the patient's father that the vns patient had initially experienced a decrease in simple seizures with vns therapy however her complex seizures had increased. The patient then tried deep brain stimulation so the vns was turned off. After some time on deep brain stimulation, the patient had some large seizure episodes which prompted the physician to stop deep brain stimulation and resume vns in (b)(6) 2011. The patient was also noted as having difficulty breathing during magnet stimulation and therefore is reluctant to perform magnet activations to abort seizures. The patient's deep brain stimulator has recently been reactivated as per the patient's father. The patient's settings have been turned down to help with the difficulty breathing. The patient's neurologist office has declined to provide any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2487671
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dennis100
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« Reply #2381 on: February 16, 2017, 01:51:57 AM »

Model Number 302-30
Event Date 01/01/2011
Event Type Injury
Event Description
On (b)(6) 2011, it was reported by the vns treating physician to the mfr's consultant that the pt was experiencing pain in their chest consistently throughout the day, near the device. The pt does not recall how long the pain has gone on. A system diagnostics test was run and it showed a dcdc of 0. The pt has had a dcdc of 0 ever since visiting that practice, beginning on (b)(6) 2010. Review of prior programming and diagnostic history revealed that the pt had a dcdc code of 2 in 2003-2004 and then a dcdc code of 1 in 2005 and 2006 which led to the reported low impedance dcdc code of 0. The pt has also been experiencing an increase in seizures, with relationship to pre-vns baseline unk. The physician was referring the pt for a complete revision. The generator remained programmed on at that time. The physician did not request x-rays to be performed. The physician felt that the pt's clinical symptoms had gotten worse so he referred him for prophylactic replacement. On (b)(6) 2011 the pt went for prophylactic replacement; however, only the generator was replaced. Since the dcdc code was at 1 they did not replace the lead. The generator was returned to the mfr for product analysis on (b)(6) 2011. The generator is currently undergoing product analysis so no info is available at this point. Once add'l info is received regarding the product analysis, it will be reported. The physician reported that the increased seizures started around (b)(6) 2011. The physician did not provide a date for when the pain started nor the pain's relationship to vns. He says the pain is not associated with stimulation. No causal or contributory programming or medication changes preceded the onset of the pain or increased seizures. No pt manipulation or trauma is believed to have caused or contributed to the low impedance. The physician reported that it is unk whether the increased seizures are below, above, or back to pre-vns baseline levels. The physician also reported that the pt's clinical symptoms that are believed to be related to the low impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032411
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dennis100
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« Reply #2382 on: February 16, 2017, 01:52:34 AM »

Model Number 300-20
Event Date 03/01/2011
Event Type Malfunction
Event Description
Reporter indicated a patient had high lead impedance readings at an office visit. The vns was disabled. Additional information was received that the patient had also been having an increase in seizures, but it is unknown if the seizure level is greater than pre-vns baseline or not. It was not known if any trauma or device manipulation had occurred. The last acceptable vns diagnostics results were in (b)(6) 2010. X-rays were received and reviewed by the manufacturer. No obvious lead anomalies were identified. The lead pins were fully inserted into the generator header, ruling out a lead pin issue and making a lead fracture the more likely scenario. Vns revision surgery appears likely.

Manufacturer Narrative
Method: manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions: device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2066197
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« Reply #2383 on: February 16, 2017, 01:53:07 AM »

Model Number 300-20
Event Date 01/01/2011
Event Type Malfunction
Event Description
It was reported that the patient had a suspected lead fracture. Diagnostics are not available to confirm high impedance and it is unknown why a lead fracture is suspected, but per physician, the patient has been experiencing pain and has had an increase in seizures recently. It was reported that the patient fell recently and fractured her wrist from slipping on ice. The generator is also currently depleted which may be contributing to the seizures. However, the patient does claim to still feel stimulation. X-rays of the device were taken and reviewed by the manufacturer. Based on the x-ray images provided, no lead fracture was confirmed, however, the presence of a micro-fracture or lead discontinuity in the portion of the lead behind the generator cannot be ruled out. The patient has been referred to a surgeon for possible revision surgery. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2043102
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« Reply #2384 on: February 16, 2017, 01:53:42 AM »

Model Number 102
Event Date 05/01/2010
Event Type Malfunction
Event Description
In review of a patient's clinic notes, it was noted that on 11/09/2010 the doctor stated that in the "last 6 months" the patient's seizures were harder to control, and they were "worsening. " the vns was not interrogated at this time. Also on (b)(6) 2011, the device was found to be at end-or-service. Consequently, the patient will likely be sent for a replacement surgery due to the end-of-service (eos) condition, but it is unknown if the increase is related to eos. A review of the manufacturer's programming history showed last known diagnostics on (b)(6) 2008. A normal mode diagnostics was performed on this date and results were within normal limits with a dcdc code of 3. Eos was "no" at this time. Good faith attempts to gain more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2043153
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« Reply #2385 on: February 16, 2017, 01:54:36 AM »

Model Number 103
Event Date 02/15/2012
Event Type Injury
Event Description
The patient had their generator replaced on (b)(6) but it will not be released from the replacing hospital for analysis.

Event Description
Clinical notes were received and reviewed on a vns patient who has been referred for generator replacement surgery. Surgery at this time is on hold till the patient can have his teeth checked. Clinic notes dated (b)(6) 2012 reported that the patient's seizures are unchanged, but perhaps more intense at times, 3-4 daily, plus more clustered once per month. Good faith attempts were made for further details surrounding the patient's seizures. Thus far no further information has been received.

Manufacturer Narrative

Event Description
Additional information was received that the patient was going to be scheduled for generator replacement surgery sometime in may if insurance approval goes through.

Event Description
Additional information was received that the patient's more intense seizures are attributed to the battery life decreasing. There is no relationship between the sleep apnea and vns. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient's sleep apnea was first observed prior to vns. Sleep apnea is unconfirmed because a test cannot be done. The apnea is not associated with stimulation. The patient has a medical history of sleep apnea pre-vns. No additional information was provided.

Manufacturer Narrative
Suspect medical device : user corrected to patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2474015
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« Reply #2386 on: February 16, 2017, 01:55:13 AM »

Model Number 103
Event Date 02/20/2012
Event Type Malfunction
Event Description
It was reported that the physician may be considering a prophylactic generator replacement within the next four to six months based on the pt's implant time. The pt had generator replacement surgery on (b)(6) 2009. The company rep then spoke with the pt's father, who reported that he is not sure if vns therapy has worked for the pt. The father also explained that vns may have made the pt's seizures "worse. " the father indicated that the pt is having more seizures than before vns. The pt's parents are not sure if the increase in seizures was related to vns because, the pt has had four surgeries and has tried different medications. F/u with the physician revealed that the pt was seen in the clinic on (b)(6) 2012, and in addition to vns therapy, the pt is taking trileptal, topomax, and clonazepam. The pt has reportedly had no generalized tonic-clonic seizures since (b)(6) 2008 and has had decreased complex partial seizures. The physician believes that generator replacement is indicative since the generator is getting old. Although surgery is likely, it has not occurred to date. No add'l info was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2481352
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« Reply #2387 on: February 17, 2017, 01:36:40 AM »

Model Number 102
Event Date 02/14/2011
Event Type Injury
Event Description
A doctor's office reported that a pt started having an increase in seizures on approx (b)(6) 2011. It was unk if the pt was having more or less seizures still than prior to vns. A system diagnostic test was performed and results were within normal limits with dcdc=2 and eos=no. The pt was reportedly last seen on (b)(6) 2011 and her settings at that time were 2. 50 ma/20 hz/130 microsec/21 sec/0. 8 min and 2. 75 ma/60 sec/130 microsec. Furthermore, the pt had no issues with medication compliance and she had been seizure free since 2003. F/u revealed that normal mode diagnostic results were within normal limits with 2. 5 ma delivered, ok impedance, ok output status, dcdc=3, and eos=no. When asked for the relationship of the increase in seizures to vns, the physician responded that the pt had her first recurrence of depression since 2003 when the vns was implanted. The pt was started on an antidepressant. There was no causal or contributory programming, medication changes, or external factors that preceded the event. However, the physician indicated that the device may be more effective if the generator were replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032439
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dennis100
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« Reply #2388 on: February 17, 2017, 01:37:23 AM »

Model Number 102
Event Date 02/17/2011
Event Type Malfunction
Event Description
It was reported by an epileptologist that a vns pt was having increased seizures above pre-vns baseline. The pt usually has 1-2 clusters but the increase has been about 6 seizures in a cluster. Diagnostic settings were performed and the results were within normal limit. There has been no medication or programming changes since the increase in seizures occurred. The possible cause of increase seizure is not known by the treating neurologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2041425
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dennis100
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« Reply #2389 on: February 17, 2017, 01:38:06 AM »

Model Number 102
Event Date 02/17/2011
Event Type Injury
Event Description
It was reported via clinic notes received that the patient had been experiencing an increase in seizures. The notes indicated that the patient had developed tonic/clonic seizures at the physician's office, had experienced status epilepticus, and was experiencing complex partial seizures daily. The patient's generator is not believed to be at end of service. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2032516
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dennis100
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« Reply #2390 on: February 18, 2017, 03:51:38 AM »

Model Number 102R
Event Date 02/02/2011
Event Type Injury
Event Description
It was reported by a nurse practitioner that vns pt was referred for vns generator replacement due to a "slight" increase in seizure activity. F/u with patient's nurse practitioner revealed that the frequency of seizure increase compare to pre-vns baseline was unk. The vns device was not at the end of service but the battery, however, the mfr battery life calculation indicated that device may be nearing end of service. There have not been any medication or programming changes prior to increase in seizures. Mfr rec'd the explanted generator where it is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026138
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dennis100
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« Reply #2391 on: February 18, 2017, 03:52:12 AM »

Model Number 102
Event Date 08/10/2010
Event Type Injury
Event Description
It was reported through clinic notes dated (b)(6) 2011 that a vns patient's seizures had been getting worse. The patient at the moment wants to have his vns battery replaced, however, good faith attempts to obtain additional information from the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026124
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dennis100
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« Reply #2392 on: February 18, 2017, 03:53:22 AM »

Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
A vns pt was initially reported to be referred for replacement surgery due to increased seizure activity. Also, in clinic notes received from the physician, it was noted that the pt had a history of depression and attempted suicide in 2009, and seizure triggers have included missed medications. On (b)(6) 2011, the physician noted that the pt stated the vns was helping him. On this date, the settings were interrogated at 1. 5 ma/25 hz/250 microsec/30 sec/5 min and 1. 75 ma/60 sec/250 microsec/ eri = no. The settings were then increased to 1. 5 ma/25 hz/250 microsec/30 sec/1. 1 min and 2 ma/60 sec/250 microsec/ eri = no. The pt underwent a prophylactic battery replacement surgery. However, the product was stated to have been discarded. Attempts to gain more info surrounding the pt's events have been unsuccessful to date.

\https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026176
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dennis100
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« Reply #2393 on: February 18, 2017, 03:54:09 AM »

Model Number 103
Event Date 02/13/2011
Event Type Injury
Event Description
It was reported by the patient that she was experiencing an increase in seizures. The patient indicated that she believed she was having an increase in seizures due to increased stress and medication issues; however, this has not been confirmed with the physician. The patient had noted an improvement in her seizures following vns replacement on (b)(6) 2010. Attempts to the physician for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026039
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dennis100
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« Reply #2394 on: February 18, 2017, 03:55:00 AM »

Model Number 102
Event Date 12/01/2010
Event Type Injury
Event Description
It was reported on (b)(6) 2011 through clinic notes received by manufacturer's consultant from vns patient's physician that the patient was experiencing an increase in seizures and sleep apnea. It is unknown whether the increase in seizures is below, at the same level as, or above pre-vns baseline. It appears in the clinic notes dated (b)(6) 2011 that the increase in seizures started in (b)(6) of 2010 and the patient was hospitalized during this time for the increase in seizures and other un-related health issues. The physician states that he checked the patient's generator at that time and it was operational. The notes also state on (b)(6) 2011 that the patient has a history of obstructive sleep apnea. The relationship of the patient's sleep apnea to vns is unknown. Good faith attempts for more information have been to no avail thus far. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026170
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dennis100
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« Reply #2395 on: Today at 02:41:10 AM »

Model Number 102
Event Date 10/18/2011
Event Type Injury
Manufacturer Narrative

Event Description
Further information received from the physician indicates that at the visit on (b)(6) 2011, the patient had "normal settings" and was at 0. 5 ma. Per physician, the increased seizures were back to pre-vns baseline levels and could be due to a "combination of factors". Patient has intractable epilepsy. The patient had an increase before vns placement and the vns was at low settings. Patient also reports stress and sleep changes which may have contributed to the seizures. Per physician, the patient did not report suicidal thoughts at the last visit, but did report anger and mood changes. The relationship of the level of suicidal thoughts to pre-vns baseline levels is unknown. No known patient manipulation or trauma occurred that is believed to have caused or contributed to the pain. The cognitive changes have multifactorial causes, per physician. The patient is frustrated that the seizures are not controlled and the primary care physician has made medication changes. No known causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. The patient has been treated for depression in the past by a different physician. The patient's settings were adjusted on (b)(6) 2011 visit and is scheduled for follow-up with physician. The patient was not diagnosed with arrhythmia and no cardiac testing was performed, but the patient reported that his "heart hurt" and felt palpitations. The patient has no history of cardiac issues. Physician does not believe the possible arrhythmia is related to vns, but is unable to rule it out. The event occurred following an increase in depression and seizures.

Event Description
It was reported by the patient's mother that things have gone "downhill" since the patient saw the physician on (b)(6) 2011 to have titration performed. She stated that her son was implanted a couple of months ago and has been set to a very low output current since implant. On (b)(6) 2011, the physician changed the output current to 1 ma (which was a large jump according to the patient's mother). She stated that her son expressed to the physician how much pain he was in and said he didn't want to go that high yet, but the physician told him that she could not turn it down. The patient's mother thinks that the physician might have turned his output current back down to 0. 75 ma or 0. 5 ma but isn't sure. No history is currently available to confirm the patient's settings. Since the visit, the patient has been in intense pain during stimulation. In addition, the mother reported that the patient also has a flutter in his heart and his heart rate changes with the stimulation. Patient has experienced an increase in seizures that is above pre-vns baseline levels and the patient has become very angry since the setting change. The patient's mother went on to say that the patient has become so angry that he has had suicidal thoughts. She clarified that this was only once and that they were monitoring him closely and he seems to not have considered that anymore. The patient had an appointment on (b)(6) 2011 and has reportedly been doing very well since that appointment when the settings were changed. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2341562
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dennis100
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« Reply #2396 on: Today at 02:42:05 AM »

Model Number 101
Event Date 03/03/2008
Event Type Injury
Event Description
Initial reporter called to ask if manufacturer had any info on vns pt's experiencing asystole caused by swiping their magnet or stimulation. It was additionally reported "a pt had a seizure and the nurse swiped with a magnet. Afterwards the pt went into asystole, which lasted several seconds. The pt was in the hospital due to seizures and connected to a monitor so they were able to see it. " the pt's seizure rate was above their pre vns seizure rate and was a change for the pt. No further info has been attained from the site after good faith attempts have been made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1022608
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