Pages: 1 ... 108 109 [110] 111 112 ... 133   Go Down
Print
Author Topic: Increase/Worsening of Seizures  (Read 577646 times)
0 Members and 3 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3270 on: August 19, 2017, 03:19:02 AM »

Model Number 103
Event Date 09/21/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6), 2011 a vsn patient reported that he has been experiencing an increase in seizures and he cannot feel normal mode or magnet mode stimulation. The patient reported that he had 15 seizures the other night which is very abnormal for him. The patient reported that he could not make it to see his physician until the end of october. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2297931
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3271 on: August 19, 2017, 03:19:41 AM »

Model Number 103
Event Date 10/06/2011
Event Type  Injury   
Event Description
It was reported that the pt had been experiencing an increase in seizures a couple months after having his generator replaced prophylactically. It was later found that the pt has been experiencing gran mal seizures which the pt has not had before. The pt's mother indicated that the pt has switched neurologists shortly following generator replacement. The pt's previous physician started the pt on depakote some time after generator replacement. Attempts for further information are in progress.
 
Event Description
Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the patient was referred to a surgeon for evaluation; however, the vns has not been evaluated to determine proper device function. The patient's "seizure status is better" after being placed on clonopin. It is unknown if the patient's vns settings are at the therapeutic settings programmed prior to replacement. No interventions appear to be scheduled at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2301696
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3272 on: August 19, 2017, 03:20:14 AM »

Model Number 103
Event Date 09/01/2016
Event Type Injury
Manufacturer Narrative
Date of this report, corrected data: the date of the report for follow-up report #1 was inadvertently provided as 11/01/2016, but should have been 12/20/2016. (b)(4).

Event Description
Follow-up to the provider clarified that there was no increase in seizures. She indicated the battery was replaced prophylactically.

Event Description
Generator replacement surgery occurred and the explanted generator was received by the manufacturer. Analysis is underway, but has not been completed to-date.

Manufacturer Narrative

Event Description
Analysis was completed for the returned generator. The device output signal was monitored while 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. An automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, measured 2. 802 volts. The downloaded data revealed that 66. 553% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Clinic notes were received for a generator replacement referral due to the patient experiencing an increase in seizures, which is suspected to be related to battery nearing end of life, however there is no indication the device is at end-of-service. The device was reported to be interrogated and no changes were made. The staff at the patients group home indicated an increase in seizures in (b)(6). Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6071074
« Last Edit: January 02, 2018, 03:03:58 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3273 on: August 19, 2017, 09:27:36 AM »

Model Number 102
Event Date 09/07/2011
Event Type  Injury   
Event Description
Attempts for the return of the patient's explanted generator have been unsuccessful to date.
 
Event Description
It was reported that the pt was being referred for prophylactic vns battery replacement because the pt had been experiencing an increase in seizures recently. System diagnostics were performed that did not indicate any errors. A battery life calculation was performed that indicated that the generator was likely not at end of service. Surgery to replace the pt's vns has occurred. Attempts for info on the pt's seizures have been unsuccessful to date. Attempts for the return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2296001
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3274 on: August 20, 2017, 08:13:33 AM »

Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Event Description
Further information indicates that the patient has recently turned her device off a few times with her magnet due to painful stimulation. Clinic notes from (b)(6) 2011 were received indicating that the patient's pain in neck and seizures were worse, though the patient has been doing well overall with vns. Per notes, the physician increased the output and pulse width and was to reassess in 3 months. It also noted that the patient wakes up with bifrontal headaches which have been worse for the past 6-7 months.
 
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in seizures and also reported an increase in migraines. The patient had a surgical consult for possible generator replacement. The patient has had great efficacy with vns (is off seizure medications and no longer uses a wheelchair) and does not want the battery to deplete. The patient is also feeling pain at the generator site with stimulation and feels like the generator is vibrating. The patient was seen by a surgeon and the generator was determined to be operating fine. Exact diagnostic results not given. X-rays were taken of the device, but have not been sent to manufacturer for review. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2275285
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3275 on: August 20, 2017, 08:14:25 AM »

Model Number 102R
Event Date 09/13/2011
Event Type  Malfunction   
Event Description
Reporter indicated a patient's vns generator had migrated in the chest and was perpendicular to the chest wall as a result of body growth. It was also reported the vns had "not been working" for the past (b)(6) months, and that the patient had also had an increase in seizures that was above pre-vns baseline seizure levels. The increased seizures were felt to be due to malposition of the vns generator. Surgery to reposition or possibly replace the vns generator was considered, but surgery is no longer planned and the patient is reported to be doing well. A battery life estimate was performed for the vns generator revealed 2. 89 years remaining, indicating the generator is likely not at end of service. Attempts for further information are in progress.
 
Manufacturer Narrative

Event Description
Reporter indicated that the patient was doing well and no surgery is planned at this time. All attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2286224
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3276 on: August 20, 2017, 08:15:07 AM »

Model Number 103
Event Date 09/21/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a vns patient's mother reported that the patient had one seizure that night and went to the emergency room. The patient was then given diastat. The patient was just recently implanted on (b)(6) 2011 and was programmed in the operating room on to an output of 0. 25ma. The manufacturer's consultant reported that the physician was informed that the patient was in the hospital for the seizure and the physician reported that he would contact the patient's mother. Additional information will be requested from the physician by the manufacturer's consultant but no further information has been received to date. The manufacturer's consultant did report that the patient is not above an output of 0. 5ma so no diagnostics have been performed yet.
 
Event Description
On (b)(6), 2011 the manufacturer's consultant went over the questions concerning the patient's increase in seizures with the physician's nurse. On (b)(6), 2011 the physician reported that the patient taped the magnet over the vns implant until the office visit but the increase in seizures were found to not be related to vns. The increase in seizures were the same as pre-vns baseline levels. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the event. The patient's current settings are output=0. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2292001
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3277 on: August 20, 2017, 08:15:49 AM »

Event Date 09/12/2011
Event Type  Injury   
Event Description
It was reported that the pt had recently been experiencing an increase in seizures and has had more "acting out" behavior. The neurologist referred the pt for prophylactic generator replacement as a result. Surgery to replace the pt's generator has occurred. Attempts for further info have been unsuccessful to date. Attempts for return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2298021
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3278 on: August 21, 2017, 05:07:49 AM »

Model Number 103
Event Date 11/02/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Further information was received from the area representative indicating that a new physician saw the patient. The physician indicated he calibrated the generator and now is able to see improvement in the patient's clinical status. The physician indicated the patient's increase in seizures was due to normal disease progression. No arrhythmia was found on the patient in accordance to the physician. The reported lack of efficacy was due to sub-optimal programming of the vns hence not achieving optimal therapy. No interventions have been planned at the moment as the patient is doing well clinically. No further information was received regarding the other events as it was unknown if they were related to vns.
 
Event Description
It was reported by vns patient's parent that the patient experienced increased seizures, arrhythmia, voice alteration, coughing, vomiting, lack of efficacy, and pupillary miosis. The patient's parent also reported that the use of the magnet did not help abort the patient's seizures. The patient's voice was reported to be suppressed and sometimes presented vomit after coughing. The patient's mother indicated that a physician in (b)(6) tried to increase the frequency but it led to overstimulation for the boy, and the doctor switched the frequency back to 0,75 ma. The patient was reported to have been implanted in the us and now resides in (b)(6) where the patient is not being treated.
 
Event Description
Additional information was received from the area representative indicating the physician confirmed the reported increasing seizures were due to lack of ramping the patient up. The dosing is being determined now and the patient is being followed up. Moreover, the physician confirmed the arrhythmia event had not occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353606
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3279 on: August 21, 2017, 05:08:35 AM »

Model Number 103
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was experiencing sleep apnea and makes strange noises during stimulation which was documented in a sleep lab. The sleep apnea is possibly a pre-existing condition, but the physician believes the vns is exacerbating it. The device was turned off, but the magnet is still on so a pt can swipe it a few times a day as needed. The pt was also started on more anti-seizure medication. After intervention, the pt has not had further issues during the night. It was also noted that the pt is having more general tonic-clonic seizures than pre-vns baseline levels. It is unk if this occurred before or after the device was programmed off. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1858416
« Last Edit: January 28, 2018, 02:19:43 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3280 on: August 21, 2017, 05:09:14 AM »

Model Number 102R
Event Date 10/31/2011
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that she felt her vns device was not functioning properly and had been experiencing an increase in seizures. The patient was unable to comment on the relationship of the increase in her seizures to her pre-vns baseline and did not know exactly when the increase began. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2350006
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3281 on: August 22, 2017, 05:51:52 AM »

Model Number 103
Event Date 10/28/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient reported that his seizures had increased as of late. He was not sure how his current seizure frequency compared to his pre-vns levels. Furthermore, he did not currently have a vns physician. Consequently, attempts for further information are not possible at this time. However, the last known programming information for the patient's device showed it to be properly functioning.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2343884
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3282 on: August 22, 2017, 05:52:30 AM »

Model Number 102
Event Date 07/01/2013
Event Type Malfunction
Event Description
Additional information was received indicating that the patient experienced an increase in seizures since (b)(6) 2014. It appears that the patient's seizures have resolved and then worsened again in (b)(6) 2014. Attempts to obtain additional relevant information have been unsuccessful to date. The increase in seizures that were reported to have started in (b)(6) 2014 are reported in mfr. Report #1644487-2014-01320.

Event Description
It was reported that the patient has been experiencing an increase in seizures since (b)(6) 2013. It is unknown whether or not the increase in above the patient's pre-vns baseline frequency. Attempts to obtain additional information have been unsuccessful to date.

Event Description
Additional information was received indicating that the vns patient experienced an increase in seizures in january 2014, which suggests that his seizures improved sometime between (b)(6) 2013 and (b)(6) 2014. The increase in seizures from (b)(6) 2014 was reported in manufacturer report # 1644487-2014-01320.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3467745
« Last Edit: October 22, 2017, 02:13:38 PM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3283 on: August 23, 2017, 04:12:57 AM »

Model Number 102
Event Date 10/01/2011
Event Type Injury
Event Description
Clinical notes dated (b)(6) 2011 were received by the mfr which revealed that the pt had two seizures in (b)(6) and had five since the pt's last visit on (b)(6) 2011. It was reported that the pt's seizures are not well controlled. The pt is being referred for prophylactic generator replacement. Although surgery is likely, it has not occurred to date. Attempts for add'l info have been unsuccessful to date. A battery life calculation was performed with the history available in the mfr's in-house programming database, and the results were approx 3. 22 years until eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2378444
« Last Edit: February 19, 2018, 01:27:01 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3284 on: August 23, 2017, 04:13:53 AM »

Model Number 102R
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported that a vns pt was experiencing an increase in seizures. However, the pt's vns system has not been evaluated since (b)(4) 2011. A battery life calculation was performed with the pt's available programming history from the date of implant, (b)(6) 2009, through (b)(6) 2011, and the results were 14 years until eri=yes. This is likely attributed to the pt's low settings with the off time being 180 minutes. The pt has been referred to a neurologist but has not been evaluated to date. No add'l info has been provided thus far.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2354816
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3285 on: August 23, 2017, 04:15:08 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
Analysis of the explanted generator has been completed. The vns generator performed to specifications and no anomalies were found. The generator was not at end of service.
 
Event Description
The explanted vns generator has been received and is currently undergoing analysis. An implant card was also received that indicates that the generator replacement was due to the generator end of service indicator now showing "yes"; however this has not been confirmed in analysis.
 
Event Description
It was reported via clinic notes received dated (b)(6) 2011 that the pt's seizures had increased from 5 seizures per month to 10 seizures per month over the past yr. The pt's vns settings have been increased and the pt was referred for prophylactic replacement of this vns. Diagnostics taken indicate normal device function; however, the physician indicates that he believes the seizures may be due to the generator approaching end of life. A battery life calculation was performed that the estimated that the generator was likely not at end of service. Attempts for further info have been unsuccessful to date. Surgery to replace the pt's generator has occurred. Attempts for the return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2343431
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3286 on: August 23, 2017, 04:15:57 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the vns pt was being referred for prophylactic generator revision due to the duration of the implant. Clinic notes received from the treating neurologist's office indicates that the device was performing within normal limits (specifics not provided), so she would be referred for revision. It was later indicated that the pt was having an increase in seizures, but the increase in relation to the pre-vns baseline levels is unclear and if this was the reason for revision. The patient's pulse generator was replaced as expected. The explanted pulse generator has not been returned to the manufacturer for analysis. Good faith attempts to obtain the device has been unsuccessful to date. Good faith attempts to obtain additional info have been unsuccessful to date. A search performed in the manufacturer's programming history database indicated that the last known diagnostics performed on (b)(6) 2008 were within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1910701
« Last Edit: January 29, 2018, 02:02:28 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3287 on: August 23, 2017, 06:13:06 AM »

Model Number 101
Event Date 10/19/2011
Event Type  Injury   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received on (b)(4) 2012, when analysis of the explanted generator was completed. The generator was found to deliver the programmed amount of therapy and the device performed according to functional specifications. There was no abnormal performance or any other type of adverse condition found with the generator. Additional information was received from the patient's physician on (b)(6) 2012, when he reported that the patient was last seen on (b)(6) 2012 and the patient's seizure control has improved. The patient can also now feel stimulation from the device. The physician stated he did not receive any end of service warning messages prior to replacing the generator however the patient had reported that he could no longer feel the device stimulation and was having an increase in seizures.
 
Event Description
It was reported by the brother of a vns patient that the generator needed to be replaced as he believed it was at end of service and the patient was having an increase in seizures. It was also reported that the patient could no longer feel device stimulation. The patient will be referred for generator revision surgery; however, surgery has not occurred. Good faith attempts to obtain additional information have been unsuccessful to date.
 
Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient had the generator replaced on (b)(6) 2012 prophylactically. Originally it was thought the battery was depleted however at surgery, it was determined that the replacement would be occurring for prophylactic reasons and not because the generator battery had been depleted. The explanted generator was returned to the manufacturer on (b)(6) 2012 and product analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2333588
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3288 on: August 23, 2017, 06:13:58 AM »

Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported by the pt's physician that the pt had been having an increase in seizures for the past 2 months. The pt was having 3-5 seizures a day, but it was not known if this was above or below the pt's pre-vns frequency. Device diagnostic tests showed the device to be properly functioning. The pt had no changes in medication prior to the increase. Further info indicated the pt was being referred for a replacement surgery. Attempts for further info have been unsuccessful to date.
 
Event Description
Additional information was received through clinic notes indicating that the patient experienced suicidal thoughts and voice alteration during the same time period in which an increase in seizures was reported. At the moment good faith attempts to obtain further information regarding the event have been unsuccessful to date.
 
Event Description
Further information was received from the treating nurse indicating the patient is not being treated for depression and there is a likelihood the event of suicidal ideations are related to medication.
 
Event Description
Analysis on the returned generator was completed by the manufacturer. Analysis of the returned generator indicated the device performed according to functional specifications. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Event Description
Additional information was received from the surgeon indicating the patient underwent generator replacement surgery. Information from the area representative clarified the patient was explanted due to prophylactic replacement and the device was interrogated successfully prior to explant. The explanted generator was returned to the manufacturer and remains under analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2340063
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3289 on: August 23, 2017, 06:14:54 AM »

Model Number 102
Event Date 08/11/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, a vns patient's brother reported that the patient is having an increase in seizures and falling from them. A battery life calculation was performed which revealed 10. 58 years until eri=yes. The patient's last settings on (b)(6) 2010 were output=1. 25ma/frequency=20hz/pulse width=130usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250/magnet on time=60sec. The last system diagnostics performed on (b)(6) 2010 showed output=ok/lead impedance=ok/dcdc=3/eri=no. Good faith attempts for additional information from the physician have been made but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2333565
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3290 on: August 24, 2017, 12:24:09 AM »

Model Number 102
Event Date 10/04/2011
Event Type  Injury   
Event Description
Additional information was received that indicated that the patient had a generator replacement. It was confirmed that the generator was not at end of service. (b)(4) attempts for product return have been unsuccessful to date. Follow-up with the physician indicated that she felt the change in seizure pattern may be related to the generator nearing end of service, but is unclear if that is the cause of the change in seizure pattern. The patient has been doing much better since the generator replacement and his seizure frequency and length had decreased. No further information was provided.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient's mother reported the patient was having seizures that were longer in duration. The physician commented that the patient was stable with no comment as to the allegation of the longer seizure duration. Surgery is planned but has not occurred to date. Good faith attempt for more information are in process.
 
Event Description
Additional information was received that indicated that the generator was discarded and will not be returned to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2325494
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3291 on: August 24, 2017, 12:24:55 AM »

Model Number 102
Event Date 09/01/2011
Event Type  Injury   
Event Description
On (b)(6), 2011 additional information was received when the neurologist's office reported that the patient was explanted on (b)(6), 2011. The hospital reported that they have the explanted devices but they are snowed under and will mail them to the manufacturer for product analysis as soon as they are able. The product still has not been received by the manufacturer.
 
Event Description
Additional information was received that product analysis was completed on the generator. In the pa lab, the generator 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.
 
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis is completed on the lead but has not been completed on the generator. Note that the majority of the lead assembly (body) including the electrode section was not returned for analysis and, therefore, a complete evaluation could not be performed on the entire lead product. 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 pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since the majority 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.
 
Event Description
It was reported that the pt is now wanting her device explanted due to her recent events. Reporter indicated that after the pt's recent settings adjustment on (b)(6) 2011, she started having some nausea. It appears that the issue wasn't immediately taken care of by the physician, so the pt then began to report tightness in her throat, chest pain, shortness of breath and then increase in seizures, so the pt went to the er where no cardiac issues found by the hosp or physician. It was indicated that the physician was frustrated with the pt since her issues appeared to be due to anxiety from the settings adjustment, so he disabled her device. When the device was disabled, all issues resolved, but the pt still wants device immediately explanted due the events. The physician does not want to explant, and would like to go back to the previous settings, but the pt is adamant about the removal, so the pt is being referred to a surgeon for explant. Reporter also notes that since implant, the pt was responding to stimulation and magnet activations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2328831
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3292 on: August 24, 2017, 12:25:32 AM »

Model Number 103
Event Date 10/01/2011
Event Type  Injury   
Event Description
It was initially reported that the patient began having an increase in seizures 5-7 days after having their vns generator initially turned on. The patient was also experiencing behavior changes. The patient exhibited aggression and weeping. The patient has experiencing weeping with seizure activity but never experienced aggression. The patient was recently confused and forgot to take their medication on schedule. This resulted in the patient aspirating during and seizures have having to be hospitalized. The generator was disabled while in the hospital.
 
Event Description
Additional information was received that indicated that the increase in seizures were not related to vns but were due to the patient missing a dose of medication. No further information was provided.
 
Event Description
Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2331542
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3293 on: August 24, 2017, 12:26:18 AM »

Model Number 102
Event Date 10/01/2011
Event Type  Injury   
Event Description
It was reported through clinic notes dated and received on (b)(4) 2011, that the patient had been experiencing an increase in seizures over the previous three weeks. At that time, it was noted that the elective replacement indicator on the patient's generator had been set to "yes. " additional information was received from the patient's treating physicians indicating that the believed cause of the increase in seizures was the depleting battery. The increase in seizures was above the patient's pre-vns baseline, were first noticed in early (b)(6) and it was indicated that all of the patient's seizure types had increased. The patient was referred for and underwent a generator replacement. The explanted generator has since been returned; however, product analysis has not yet been complete.
 
Manufacturer Narrative

Event Description
Product analysis on the explanted generator was completed on (b)(4) 2011. 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. The elective replacement indicator (eri) was set. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. During product analysis an out of specification component was identified in the generator. This will be reported under manufacturer's report number: 1644487-2012-00132.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2332338
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3294 on: August 24, 2017, 12:27:00 AM »

Model Number 102
Event Date 07/16/2011
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. The explanted vns generator has been returned and is currently pending product analysis.
 
Event Description
Product analysis of the vns generator was completed. No anomalies were identified during the analysis and the generator performed per specifications. The generator was not at end of service.
 
Event Description
Reporter indicated a patient had vns generator migration, neck, shoulder, and chest pain, swelling over the generator site, erratic vns stimulation, and increased seizures. The vns generator was also reported to be nearing end of service and not working at full power. The patient had vns generator replacement surgery performed on (b)(6) 2011. A battery life estimation for the generator performed by the manufacturer yielded approximately 2. 69 years remaining, but 1. 5 years of programming history was missing. Attempts for further information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2330300
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3295 on: August 24, 2017, 12:27:39 AM »

Model Number 102
Event Date 02/20/2015
Event Type Injury
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently provided the wrong method code for the event.

Manufacturer Narrative

Event Description
Additional information was received indicating that the increase in seizures started on (b)(6) 2015 and ended on (b)(6) 2015. The severity of the event was moderate. It was reported that the event was not related to implant nor to vns stimulation. The treatment was not changed but they changed the dose / schedule of medication. It was reported that the event was considered as a serious adverse event because it resulted in an initial or prolonged hospitalization.

Event Description
It was reported that a patient who is subject to a vns study was hospitalized on (b)(6) 2015 and stayed in unit for reanimation due to increase of seizures. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2015 (adjusted date). No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5681542
« Last Edit: December 17, 2017, 02:25:54 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3296 on: August 24, 2017, 12:28:44 AM »

Model Number 102R
Event Date 03/23/2010
Event Type Injury
Event Description
Reporter indicated a vns pt was having increased seizures and increased seizure intensity. The generator is not at end of service, but the reporter feels the generator is at end of service due to the pt's clinical presentation of increased seizures and past experiences with previous vns patients. A battery life estimate performed for the generator with incomplete data yielded -1. 29 years remaining. Generator replacement surgery is planned, but a surgery date has not been set. Attempt for further info from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1667282
« Last Edit: January 20, 2018, 03:21:15 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3297 on: August 25, 2017, 03:39:40 AM »

Model Number 102R
Event Date 12/02/2011
Event Type  Injury   
Event Description
It was reported that the patient was being referred for prophylactic vns generator replacement because he had been experiencing an increase in seizures. Diagnostics were normal with all checks ok as per the physician. The physician indicated that she felt the patient's battery was almost out of life and the patient would benefit from replacement. Clinic notes were received dated (b)(4) 2011 that indicated that the number of seizures the patient has experienced since the previous visit is "lots. " the patient is noted as normally experiencing complex partial seizures with secondary generalization as well as tonic clonics. The vns was noted as reducing the patient's seizure frequency by 0-25%. The physician stated in this note that she increased the frequency that the vns fires to combat the increase in seizures. Surgery to replace the patient's vns generator has occurred. The explanted vns generator has been returned and is currently undergoing analysis. Attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the seizures are believed to be related to the battery depletion and no medication changes or external factors are believed to have contributed to the seizures. The relationship of the increased seizure frequency to the pre-vns baseline frequency is unknown. Diagnostics taken on (b)(6) 2011 were normal as per the physician. Analysis of the patient's generator has been completed. The generator performed to specifications and no anomalies were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2400653

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3298 on: August 28, 2017, 03:00:31 AM »

Model Number 103
Event Date 10/06/2011
Event Type Injury
Event Description
Further information was received from the area representative indicating the patient was explanted of vns therapy due to a lack of efficacy and patient will pursue surgical route. No product will be returned to the manufacturer for analysis as the patient kept the devices; however, the company representative indicated both generator and lead were working well prior to explant. Good faith attempts to obtain further information have been unsuccessful to date.

Event Description
It was reported by a physician that a vns pt had deteriorated clinically the last few months and was in a chronic non-convulsive status epilepticus with a major set back in functioning. At the moment, attempts to gather further info regarding the clinical deterioration remain underway as the relationship to vns therapy is unk.

Event Description
Further information was received from the neurosurgeon indicating the patient was not being explanted for lack of efficacy but rather for worsening condition and in order to prepare the patient for other surgical evaluations.

Event Description
Additional information was received from the treating physician indicating there was no relationship between the reported increase in seizures and vns therapy. Attempts for further information were unsuccessful to date as the physician was very co-operative and communication has taken some time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2310233
« Last Edit: February 13, 2018, 01:20:50 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 50859


« Reply #3299 on: August 28, 2017, 03:01:08 AM »

Event Date 12/06/2010
Event Type  Malfunction   
Event Description
All attempts to the author for further information have been unsuccessful to date.
 
Event Description
During manufacturer review of the published abstract entitled (b)(4) ((b)(6)), it was identified that a patient had increased seizures following vns implant. Attempts to the author for further information are in progress.
 
Manufacturer Narrative
Article citation: (b)(4). (b)(6).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2390249
Logged
Pages: 1 ... 108 109 [110] 111 112 ... 133   Go Up
Print
Jump to: