Pages: 1 ... 117 118 [119] 120 121 ... 139   Go Down
Print
Author Topic: Increase/Worsening of Seizures  (Read 795511 times)
0 Members and 6 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3540 on: October 28, 2017, 03:10:15 AM »

Model Number 105
Event Date 02/07/2014
Event Type Malfunction
Event Description
It was reported by the vns patient that she was not feeling right and was experiencing an increase in seizures and multiple physical problems secondary to seizures. The patient was programmed to an output current of 3. 5ma prior to her replacement surgery on (b)(6) 2013; however, the patient states that her neurologist refuses to program her output current back to this setting. The neurologist increased output current only one increment at the patient¿s office visit on (b)(6) 2014. The patient attributes her increase in seizures to the lack of appropriate programming by her physician. Attempts for additional information have been made, but no further details have been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3667644
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3541 on: October 29, 2017, 03:16:19 AM »

Model Number 102R
Event Date 06/01/2012
Event Type Malfunction
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Clinic notes were received indicating that the vns patient was experiencing an increase in seizures during the summer of 2012. The patient¿s seizures did not change in type and were not continuous. The patient reported that summer heat was a potential trigger and did not have any health changes. The clinics notes indicate that the neurologist increased the device¿s normal mode and magnet mode output currents during an office visit on (b)(6) 2012; however, review of the available programming history showed that the patient¿s device was already programmed to those settings. Review of the available diagnostic history showed normal diagnostic results through (b)(6) 2011. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3754325
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3542 on: October 29, 2017, 03:17:07 AM »

Model Number 103
Event Date 03/13/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the generator was replaced prophylactically and that the migration of the device was believed to be due to the trauma from the patient falling off of the porch. The increase in seizures was reported to be not related to vns. The patient was reported to be doing "fine" since generator replacement and no longer experiencing the reported events.

Event Description
It was reported that the patient suffered a fall off of the front porch which resulted in injury to her left neck. The patient indicated that she began experiencing an increase in seizures. It was reported that the patient began experiencing painful stimulation the night of the fall after she felt something "snap" while laying in bed. It was reported that the patient also began experiencing pain in her chest around the generator and felt as if the generator had slipped down lower toward her breast. The patient was awaiting scheduled prophylactic battery replacement at the time of the fall; however, the physician wanted to get the patient to surgery sooner as a result of the events. The patient underwent generator replacement. It was reported that pre-operative device diagnostics were within normal limits (2323 ohms). The generator was replaced and diagnostics were again within normal limits (2048 ohms). It was reported that the explanting facility does not return explanted devices; therefore, no analysis can be performed. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3757141
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3543 on: October 29, 2017, 03:17:47 AM »

Model Number 101
Event Date 09/25/2012
Event Type Malfunction
Event Description
Clinic notes dated (b)(6) 2012 note that the patient noticed more seizures in the last six months. The patient reports one seizures in (b)(6) 2012, three in (b)(6) 2012, six in (b)(6) 2012, three in (b)(6) 2012, two in (b)(6) 2012, two in (b)(6) 2012, four in (b)(6) 2012, and two in (b)(6) 2012. It is unknown if the increase 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=3762357
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3544 on: October 29, 2017, 03:18:38 AM »

Model Number 103
Event Date 09/01/2013
Event Type Malfunction
Event Description
It was reported that the vns patient¿s seizures began increasing in frequency, severity, and duration approximately six months ago. The patient was also experiencing an increase in anxiety and a decline in her mood. The neurologist decreased the device¿s off-time around that time. Attempts for additional relevant information were made but have been unsuccessful to date.

Manufacturer Narrative

Event Description
Product information was received. Additional information was received stating that the reported events did not appear to be related to vns. The patient was given medication for her anxiety. Clinic notes from the (b)(6) 2014 office visit did not indicate that there were any issues with the patient¿s device.

Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data. Manufacture date, corrected data: previously submitted mdr indicated this information was unknown. It is now known. This report is being submitted to correct this data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3764818
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3545 on: October 29, 2017, 03:19:18 AM »

Model Number 102
Event Date 10/11/2010
Event Type  Injury   
Event Description
It was reported via clinic noted that the pt's mother had called 8 months ago indicating that the pt was experiencing an increase in facial seizures. She reports that the pt wakes up with facial twitching and the vns magnet does not abort the seizures. It was also noted in clinic that the vns device was at end of a service. Per pt's mother, the seizures are under such good control now and they are afraid of anesthesia, so they do not know of they will undergo replacement surgery. Further info reveals that the pt underwent generator replacement surgery on (b)(6) 2011. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129985
« Last Edit: August 26, 2018, 02:02:45 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3546 on: October 29, 2017, 03:20:05 AM »

Model Number 102
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported to the manufacturer that the vns patient has been experiencing one seizure per week. The patient's device was off for a period of time due to an unknown reason and the patient did not experience any seizures during this time. It is unknown if the patient's current seizure activity is above pre-vns baseline level. Diagnostic tests performed on the patient's device revealed proper device function in (b) (6)2003. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1613207
« Last Edit: January 16, 2018, 07:43:32 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3547 on: October 30, 2017, 03:02:41 AM »

Model Number 103
Event Date 02/28/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient¿s duty cycle was adjusted to a 30 sec on time and 5 min off time but did not resolve the patient¿s issues. The patient¿s device was disabled with the magnet for two days and then normal mode stimulation resumed for two days for three cycles, and it was reported that the patient¿s issues were occurring with stimulation. The patient¿s device output current was to be reduced to 0. 25ma and at a 10% duty cycle.

Event Description
It was reported that since vns implant the patient has experienced an increase in tonic clonic seizures since implant. It was reported that the patient experiences forty brief atonic seizures per day, several absences, several head drops per day and some generalized tonic clonic seizures. It was reported that the patient's generator settings were set to rapid cycling right away rather than slowly increasing the settings which is believed may have caused the increased seizures. The physician was informed to try and readjust the duty cycle and see if this helps the seizures. It was reported that there were no medication changes that could have caused or contributed to the increase in seizures. It was reported that the physician believes the vns is related to the patient's increase in seizures. It was reported that it is hard to determine whether or not the seizures are increased above the patient's pre-vns baseline because the patient's seizures are so high pre-vns. It was reported that the generalized tonic clonic seizures are certainly above baseline. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3728359
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3548 on: October 30, 2017, 03:03:25 AM »

Model Number 102
Event Date 02/01/2013
Event Type Malfunction
Event Description
It was reported that the physician requested generator explant because the patient underwent brain surgery. No additional relevant information has been received to date.

Event Description
It was reported that the patient experienced an increase in seizures from (b)(6) 2013. The patient suffers from simple partial seizures, complex partial seizures and secondary generalized tonic clonic seizures. The patient's monthly seizure frequency was noted to be twenty-eight in (b)(6) 2013, forty-one in (b)(6) 2014, thirty-one in (b)(6) 2013, thirty-six in (b)(6) 2013 and twenty-eight in (b)(6) 2013. It is unknown whether or not the increase was 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=3827050
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3549 on: October 30, 2017, 03:04:05 AM »

Model Number 103
Event Date 02/01/2014
Event Type Malfunction
Event Description
It was reported that the patient has experienced an increase in seizures over the last two weeks. It was reported that device diagnostics were all "ok". It is unknown whether or not 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=3728627
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3550 on: October 30, 2017, 03:04:47 AM »

Model Number 103
Event Date 10/21/2010
Event Type Malfunction
Event Description
Clinic notes were received indicating that during an office visit her neurologist on (b)(6) 2010, the vns patient reported experiencing a recent increase in seizures. The patient had previously responded well to vns. Review of the available programming and diagnostic history showed normal diagnostic results around the time of the event. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.

Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3750682
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3551 on: October 30, 2017, 03:05:34 AM »

Model Number 102
Event Date 07/07/2008
Event Type  Injury   
Event Description
The patient had their generator replaced and it will not be returned from the explanting hospital for analysis.

Event Description
The physician requested a battery life calculation which resulted in a negative amount of years until end of service, however, the physician indicates that the eri is still showing no, so some data is likely missing. The patient has been referred for prophylactic generator replacement surgery, but it has not occurred to date.

Event Description
It was reported that the patient has experienced an increase in seizures above pre-vns baseline levels since being implanted with her current generator. Before the last generator replacement surgery, the patient was seizure-free for quite some time. The physician did not know why the seizures had increased. Physician stated that patient was programmed to 2. 5 ma/30 hz/500 msec/21 sec on/3 min off. Per physician, no medications have been changed. A rough battery life calculation was performed which resulted in a negative amount of years remaining until end of service, though the device was not showing end of service and should still be delivering the proper therapy. The physician stated that he was going to monitor the patient closely and was also going to decrease her output current to 2. 0 ma as he read in a study that 2. 0 ma combined with an off time of 1 minute can be efficacious.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2348309
« Last Edit: September 13, 2018, 02:28:57 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3552 on: October 31, 2017, 03:23:00 AM »

Model Number 102
Event Date 02/01/2014
Event Type Malfunction
Event Description
It was reported that the vns patient began experiencing an increase in seizures in february 2014 and was no longer able to feel magnet mode stimulation. The patient was having difficulty staying awake due to the number of seizures he was experiencing. It is unclear whether the increase in seizures was above or back to pre-vns baseline levels. The patient¿s device was not at end of service and diagnostic results showed normal device function at the time. The patient also reported experiencing some discomfort but it is unknown whether the discomfort is related to vns. A battery life calculation using the available programming history revealed approximately 1. 41 years until eri = yes.

Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
Attempts for additional information were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3803260
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3553 on: October 31, 2017, 03:23:45 AM »

Model Number 103
Event Date 05/30/2012
Event Type  Malfunction   

Event Description
Analysis of the generator has been completed. The generator performed to specifications and no anomalies were found. Follow-up with the physician's office found that the high impedance was first found on (b)(6) 2012 and indicated the lead impedance was greater than 10,000 ohms. Last good diagnostics were reportedly taken on (b)(6) 2012, however no specifics were provided. No trauma or manipulation was reported. X-rays were taken on (b)(6) 2012, that reportedly showed no issues. The x-rays will not be sent to the manufacturer for review. The patient was reported as experiencing an increase in seizures due to the high impedance. The relationship of the increased seizure frequency to the pre-vns baseline is unknown.

Event Description
It was reported by the surgeon that the vns patient had undergone a generator revision because the generator had previously indicated high impedance. Troubleshooting had been performed during surgery for lead pin reinsertion and tightening of the setscrew. A manufacturer representative was previously informed that the surgery was only for battery replacement, however the surgeon's office indicated that the surgery was due to correct the high impedance. Last known diagnostics were taken on (b)(6) 2011. An implant card was later received indicating only the vns generator had been replaced with the reason for replacement noted as "vns malfunction (unclear)" and "lead discontinuity. " the explanted generator has been returned and is currently undergoing analysis. Attempts for additional information have been unsuccessful to date. No adverse events have been reported.

Manufacturer Narrative
Date of event, corrected data: additional information received indicates the event date is earlier than previously reported.

Event Description
Additional information was received regarding the patient. The high impedance was first observed (b)(6) 2012. There was no report manipulation or trauma that could have contributed to the high impedance. The increase in seizure began (b)(6) 2011 and (b)(6) 2012. There is no clear relationship of the increase in seizure to vns. The increase in seizures was occurring while the impedance was still within normal limits. The increase in seizures was below baseline. Seizure improved with increase of onfi (medication management). There were no causal or contributory programming or medication changed that preceded the onset of the seizures. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.

Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2635965
« Last Edit: October 10, 2018, 03:23:26 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3554 on: October 31, 2017, 03:24:22 AM »

Model Number 103
Event Date 04/29/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s seizures initially decreased following vns implant surgery but recently had an increase in seizures. It is unknown if the increase in seizure was at or above pre-vns baseline levels. The patient was also experiencing coughing, dysphagia, and voice alteration. The patient was referred to an ent physician to determine if his symptoms were due to vocal cord paralysis. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3828122
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3555 on: October 31, 2017, 03:25:00 AM »

Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient has more seizures with vns therapy. It was reported that the patient has experienced more problems than help with vns therapy. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813641
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3556 on: November 01, 2017, 01:36:30 AM »

Model Number 104
Event Date 03/26/2014
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the vns patient complained of having pain at her right eye and teeth during an office visit on (b)(6) 2014. The patient's device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently reported having an increase in seizures above pre-vns baseline levels during an office visit on (b)(6) 2014. The patient¿s device output current and on-time were increased during this office visit. X-rays were taken during the office visit and reported to be normal. The physician stated that the increase in seizures was related to vns stimulation. Further follow-up revealed that all of the patient¿s seizure types had increased. There was no change to the duration of the patient¿s seizures or post-ictal period. The patient¿s device was reported to be functioning properly and her device off-time had been adjusted since her last office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800629
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3557 on: November 02, 2017, 01:46:40 AM »

Model Number 102R
Event Date 06/10/2014
Event Type Injury
Event Description
Clinic notes were received indicating that the vns patient was hospitalized on (b)(6) 2014 after having four generalized tonic clonic seizures. No triggers were identified. The patient had been doing well for the past two months with new medication. The patient¿s last two seizures were on (b)(6) 2014. The patient was referred for surgery. It is unclear whether the patient¿s device was at end of service. While the notes indicate that the patient¿s device was not at end of service on (b)(6) 2014, the patient¿s family stated that the increase in seizures was due to end of service. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3923668
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3558 on: November 11, 2017, 04:33:03 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/25/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported from a post on social media on (b)(6) 2017, that the patient states that vns did not work for her and that she was having more seizures so the device was turned off. It was reported by the physician that the patient used to have 1 to 2 generalized tonic-clonic (gtcs) seizures per year and the seizures were preceded by auras/focal seizures. After vns, she does not have gtcs but started to have 1 to 2 auras and focal seizures per month. Patient preferred to have 1-2 gtcs over 1-2 aura/focal seizures a month. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6956002
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3559 on: November 11, 2017, 04:33:49 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 08/16/2017
Event Type Malfunction
Event Description
It was reported by a vns patient¿s mother that she was last seen by the nurse in neurologist office for vns dosing on (b)(6) 2017 and since that appointment her seizures have increased and magnet does not appear to be working. The mother says it¿s like the vns is not on. The patient was scheduled to visit the neurologist. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6912398
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3560 on: November 11, 2017, 04:34:42 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 09/01/2017
Event Type Malfunction
Event Description
The medical professional reported that she was talking with the patient who said he was having issues such as sleep disturbances, gagging with stimulation, pain with swallowing, constant pain in throat, and increased seizures. No further relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6926689
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3561 on: November 11, 2017, 04:35:45 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 09/13/2017
Event Type Injury
Event Description
It was reported to that the patient was hospitalized due to increase in seizures. Patient's battery is only at (b)(6) but a prophylactic replacement is being considered. No additional relevant information has been received to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6933333
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3562 on: November 11, 2017, 04:36:34 AM »

Model Number 102R
Device Problem No Known Device Problem
Event Date 08/25/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient is starting to have an abundance of seizures recently. It was stated that system diagnostics were performed and were normal but no value was provided and battery was not near end of service. Her father stated that since the last vns check she is having seizures every 3 days. The patient is recommended to have battery replacement despite the battery not being low. It was noted that it has been 10 years since the last device was implanted and even though the settings have not changed since the last clinic visit she continues to have increased seizure frequency which may be due to weakened battery. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6959457
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3563 on: November 11, 2017, 04:37:22 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 09/14/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient was having an increase in seizures. The patient is referred for generator replacement. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6931528
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3564 on: November 11, 2017, 04:38:14 AM »

Model Number 104
Device Problem No Known Device Problem
Event Date 04/30/2012
Event Type Injury
Event Description
A vns patient reported that her seizures increased over time. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6963091
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3565 on: November 11, 2017, 04:39:05 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 10/01/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that the patient had experienced a sudden increase in seizures. The physician believed it may have been related to the vns generator battery being low. It was reported that the battery was still green, but at the lowest level, which indicates that the device is at an intensified follow-up indicator, or ifi, = no condition. It was noted that the patient was in partial status at the time of the report. It was unclear if this was a reference to status epilepticus. The patient was referred for vns generator replacement. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6983413
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3566 on: November 11, 2017, 04:40:02 AM »

Model Number 104
Event Date 08/01/2014
Event Type Injury
Event Description
Product analysis was completed on the generator on 02/04/2015. 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. 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. The battery, 2. 821 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
On (b)(6) 2014 it was reported that the patient underwent generator replacement on (b)(6) 204 due to battery depletion. The explanted generator was returned for product analysis on 12/30/2014. Product analysis is still underway and has not yet been completed.

Manufacturer Narrative

Event Description
Clinic notes were received which indicated that the patient usually averages about 3 seizures a month but since the patient¿s last visit in (b)(6) 2014, he may have had a few more month seizures. The patient was noted to have had 5 or 6 seizures in (b)(6) and 3 so far in (b)(6). The physician stated that he suspects that the increase in monthly seizures to 4 or 5 is caused by his vns battery running low. The patient was referred for generator replacement. Although surgery is likely, it has not occurred to date. Additional information has been requested from the physician¿s office but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4318721
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3567 on: November 11, 2017, 04:40:58 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 03/21/2017
Event Type Injury
Manufacturer Narrative

Event Description
Report received that a patient's physician believed vns stimulation was causing her to have more seizures. As a result, the physician decided to turn off the device. The patient also reported that since the device was turned off, "everything was better". A review of the programming history showed the date on which the device was disabled. The only system diagnostics provided were from the day of implant. Attempts to contact the physician have been unsuccessful to date. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6981430
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3568 on: November 11, 2017, 04:41:48 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 04/03/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
Report received that a patient felt the vns caused her to have an increase in seizures. The available programming history showed the only system diagnostic taken was on the day of implant. The results indicated the system was functioning normally. Further information was received from one of the patient's more recent neurologists that the vns was checked since the allegation was made and showed normal functionality. He was reportedly not aware of the patient having an increase in seizures. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6963638
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59221


« Reply #3569 on: November 11, 2017, 04:42:39 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 12/17/2009
Event Type Malfunction
Event Description
It was reported y a patient¿s mother that the vns had increased seizures when the doctor tried to change settings. The vns was removed in (b)(6) 2017. Additional relevant information has not been received to-date. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6933650
Logged
Pages: 1 ... 117 118 [119] 120 121 ... 139   Go Up
Print
Jump to: