Pages: 1 ... 106 107 [108] 109 110 ... 120   Go Down
Print
Author Topic: Increase/Worsening of Seizures  (Read 333012 times)
0 Members and 4 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3210 on: August 08, 2017, 02:36:29 AM »

Model Number 302-20
Event Date 07/09/2011
Event Type  Malfunction   
Event Description
It was reported that the pt was rushed to emergency room this past weekend for increase in seizures. Emergency room says his lead wires are "tangled". Further info reveals that the pt underwent lead revision surgery due to a lead break and high impedance. The lead break was confirmed via chest x-ray per physician. Attempts for further info and product return have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2227746
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3211 on: August 08, 2017, 02:37:05 AM »

Model Number 101
Event Date 01/01/2004
Event Type  Injury   
Event Description
Pt's predominant seizures were noted as having an increase in the ictal severity of seizures at the 2-year follow-up. The pt was also noted as having tonic-clonic seizures at the most recent visit (3-years post implant) not previously noted for the pt, which appears to be an increase from baseline. A search performed in the mfr's programming history database did not reveal any details on the diagnostics for the device. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2230508
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3212 on: August 09, 2017, 06:16:08 AM »

Model Number 102R
Event Date 03/23/2011
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient's seizures have "gotten worse and more frequent" in a note dated (b)(6) 2011 and "having more generalized seizures" in a note dated (b)(6) 2011. It was noted that the vns battery was low; however, it is unknown if this is the cause of the patient's seizures. The patient has been needing more rectal valium as a result and the patient's dilantin has been increased. Additional information was requested from the site; however, additional information relevant to the investigation was not provided. A rough battery life calculation was performed that estimated the generator was likely at, near, or past, end of service. Surgery to replace the patient's generator has occurred and the explanted product has been returned. The generator is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2275352
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3213 on: August 09, 2017, 06:16:53 AM »

Model Number 101
Event Date 06/03/2011
Event Type  Injury   
Event Description
Additional information was received that the office could not address the questions and request for additional information.
 
Event Description
Additional information was received as clinic notes dated (b)(6) 2012, that indicate the patient has had no more drops and 3 gtcs in the past month. It is not indicated if this is an increase or decrease from the patient's normal seizure behavior and it is unknown if the seizures have resolved following replacement. The notes also indicated the patient had not been at intended settings since (b)(6) 2012, due to a faulted diagnostics test which has been reported in manufacturer report # 1644487-2012-01639. It was also noted that the patient's sleep apnea is not being treated which was previously reported in manufacturer report # 1644487-2011-01491. Diagnostics taken were normal per the clinic notes.
 
Manufacturer Narrative
Corrected data: the initial report inadvertently had the incorrect explant date.
 
Event Description
It was initially reported that the patient was experiencing an increase in seizures, unknown if above or below baseline. The increase in seizures was believed to be related to the generator being at end of service. The patient had their generator replaced and it was returned to the manufacturer for evaluation. The generator was found to not be at end of service so the cause of the increase in seizures is unclear. The end of service allegation was not confirmed in the product analysis lab. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that there was no adverse performance condition found with the generator. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2270410
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3214 on: August 09, 2017, 06:17:36 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient had a generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that indicated that product analysis was completed on the 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. 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
It was initially reported that the patient was experiencing an increase in seizures, unknown if above or below baseline. The seizures are reported to be mild in severity but occurring frequently. The patient is schedule for generator replacement which has not occurred to date. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2270842
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3215 on: August 09, 2017, 06:18:17 AM »

Model Number 103
Event Date 06/28/2011
Event Type  Malfunction   
Event Description
It was reported by the pt's mother that the pt's seizures had worsened to 2 or 3 seizures per week following a change of the vns stimulation off time from 15 mins to 10 mins on (b)(6) 2011. The pt was noted as "doing much better" prior to the change in settings. Attempts for further info from the neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2278268
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3216 on: August 09, 2017, 06:18:51 AM »

Model Number 101
Event Date 06/30/2011
Event Type  Injury   
Event Description
It was reported in a patient's clinic notes that he "recently had more frequent seizures. He says his vns is probably not functioning right, when uses the magnet, it doesn't work". Diagnostic testing was performed on this date; though the results are not known for the tests, there were no issues listed in the notes. The patient's programming history was searched. The patient's last known settings are from (b)(6) 2011. The patient's last known diagnostics on (b)(6) 2010 show proper device function. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196459
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3217 on: August 09, 2017, 06:19:24 AM »

Model Number 101
Event Date 06/23/2011
Event Type  Injury   
Event Description
It was reported by the patient's mother that the patient had an increase in seizures. The patient had not been seen by a physician since 2008, and the mother felt the device was no longer working. The patient was in attempts to obtain a replacement surgery. A review of the manufacturer's programming history showed the patient's last known settings and diagnostics were on (b)(6) 2007. The device was properly functioning at this time. A revision surgery in the future is likely. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196483
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3218 on: August 09, 2017, 06:20:10 AM »

Model Number 101
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient had a right frontal subcortical ischemic stroke that lead to bilateral hematomas, unknown relationship to vns. The patient was also experiencing an increase in seizures, unknown cause or relationship to vns. It is unknown if the increase in seizures is above or below baseline. The patient had a cluster of three seizures on (b)(6) 2011 and it was taken to the emergency room. Blood work showed mild hyponatremia. The patient had a prophylactic generator replacement. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196462
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3219 on: August 09, 2017, 06:20:50 AM »

Model Number 102R
Event Date 01/01/2011
Event Type  Injury   
Event Description
Product analysis was completed on the explanted vns generator. 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
Reporter indicated vns generator replacement surgery was tentatively scheduled for (b)(6) 2012. The patient later had vns generator replacement surgery performed on (b)(6) 2012. An implant card was received to the manufacturer indicating the replacement was prophylactic. The explanted generator has been returned and is pending product analysis.
 
Event Description
Reporter indicated a vns pt had a dramatic increase in seizures over the last six months. Vns settings were adjusted as an intervention. It is felt the generator battery may be nearing end of service per the reporter. The etiology of the seizure increase is unk, and it is unk if the seizure increase is greater than the pt's pre-vns baseline seizure levels. The pt has multiple seizure types, including generalized seizures, and in general all types were increased per the pt's mother per the reporter. The vns is not at actual end of service, but the pt will be monitored for nearing end of service. Vns generator replacement is not planned at this time. It is not known if the setting change has improved the seizures as the pt will not be seen for two months. A battery estimate performed yielded approx 0. 59 years remaining on the vns battery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196563
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3220 on: August 09, 2017, 06:21:33 AM »

Model Number 102R
Event Date 07/05/2011
Event Type  Injury   
Event Description
It was reported that the pt is currently experiencing an increase in seizures which is believed to be related to device end of svc as eri was showing yes. However, it was also noted in clinic notes that the pt was experiencing an increase in seizures prior to the device showing eri = yes. In (b)(6) 2011, the pt was "having a few more daytime seizures" which had been happening for the past 3 months. The increase was noted as being "slight". Her medications were increased slightly to address the increase. At a visit on (b)(6) 2011, it was noted that the eri = no, so it is likely that the increased seizures began prior to eri = yes. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2196990
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3221 on: August 09, 2017, 06:22:07 AM »

Model Number 101
Event Date 09/01/2010
Event Type  Injury   
Event Description
It was initially reported in clinic notes that the patient had an increase in seizures (b)(6) 2010, unknown if above or below pre-vns baseline. Emergency medical technician were called for one seizure when the patient did not respond to sternal rub. The patient blood sugar was low (60) and the physician suspected that low blood sugar was the cause of the seizures but was not completely sure that was the cause. There were no medication changes preceding the increase in seizures. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193840
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3222 on: August 09, 2017, 06:22:47 AM »

Model Number 103
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was initially reported that the pt was experiencing an increase in seizures above baseline and was admitted into the hospital. It is unk when the increase began or if there were any changes in medication or external factors that could have contributed to the increase. Good faith attempts for more info have been unsuccessful to date.
 
Event Description
Additional information was received that the physician did not have any information to provide regarding the patient's increase in seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2193845
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3223 on: August 10, 2017, 07:53:39 AM »

Model Number 102R
Event Date 06/22/2011
Event Type  Injury   
Event Description
Additional information was received regarding the patient. The patient was having an increase in seizures and was hospitalized. Diagnostics were run and were within normal limits but clinically the patient was doing poorly. Since the generator replacement the patient is doing much better. The patient is at the same settings as prior to generator replacement except the off time was shorted to 1. 8 minutes. The patient has both complex and generalized tonic clinic seizures. It is unknown if the increase in seizures are above or below pre-vns baseline since the patient has been implanted with vns since 1999.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient had generator replacement due to end of service (eri=yes). The generator was returned to the manufacturer for evaluation. The generator performed according to functional specifications. No eri flags were observed during testing. The device was continuously monitored for 24. 5 hours. 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. A form that was return to the manufacturer reported that the replacement was prophylactic and patient was having seizures, no mention of if it was actually an increase in seizures. The seizures were initially believed to be related to the generator being at end of service but product analysis confirmed that it was not at end of service. Good faith attempt for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261079
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3224 on: August 10, 2017, 07:54:21 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that the pt was having more convulsions--at least 6 in the past 6 weeks. The pt was also having some dizziness with the increase and did not feel the vns stimulation very strong anymore. Per physician, even though eri=no, he feels the generator needs to be prophylactically replaced based on the length of time implanted. Pt underwent prophylactic generator replacement on (b)(6) 2011. Attempts for further info have been unsuccessful to date. Product has been returned to the mfr, but analysis is pending.
 
Event Description
Additional information was received from the physician. Per physician, the increased seizures is related to loss of generator efficacy; and is back to pre-vns baseline levels. Only one type of seizures have increased. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. The dizziness the patient was experiencing is not related to vns stimulation and is related to the patient's medications. No patient manipulation or trauma occurred that is believed to have caused or contributed to the events. Per physician, the seizures have somewhat improved since the generator replacement.
 
Event Description
Analysis was completed on the returned generator. Upon analysis, no anomalies were noted and the device performed according to specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267804
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3225 on: August 10, 2017, 07:55:01 AM »

Model Number 102R
Event Date 07/01/2011
Event Type  Injury   
Event Description
It was reported via clinic notes dated (b)(6) 2011 that the pt had some increased seizures last month, but they were able to manage with oral keppra. Pt still has a few seizures a day which is normal for pt based on clinic notes. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267802
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3226 on: August 10, 2017, 07:55:43 AM »

Model Number 102
Event Date 08/31/2011
Event Type  Injury   
Event Description
Manufacturer follow-up with the treating neurologist revealed the patient was having increased complex partial seizures, and it was not known if the increase was greater than pre-vns baseline seizure levels. The etiology of the seizure increase was unknown. No medication changes had occurred, and the vns was not at end of service. No vns programming events or other events precipitated the seizure increase. The vns settings were increased as an intervention. Since the vns settings were adjusted, there have been less telephone calls to the office from the patient's mother.
 
Event Description
Reporter indicated a vns patient was having increased seizures and drop attacks. The reporter was concerned the vns may be approaching end of life. The patient was recently seen by the treating neurologist and the generator was not at end of life per the neurologist. The reporter was encouraged to follow up with the treating neurologist for her concerns. A vns battery estimate performed yielded approximately 1. 5 years of battery life remaining. All attempts to the treating neurologist for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2265683
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3227 on: August 10, 2017, 07:56:36 AM »

Model Number 102
Event Date 08/21/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a vns patient began having increased seizures on (b)(6) 2011. Prophylactic replacement of the vns generator is planned, but no surgery date has been set. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had prophylactic vns generator replacement surgery performed. The reporter attributes the increased seizures to the battery nearing end of service, even though the end of service indicator on the generator was "no". The seizures were increased to pre-vns baseline levels. The patient has multiple seizure types and all were increased but the exact seizure type was not specified. No other interventions were done for the seizure increase other than replacing the vns generator. The generator replacement was not done to preclude a serious injury. The explanted generator has been returned and is pending product analysis.
 
Event Description
Analysis of the vns generator has been completed. No anomalies were noted and the generator performed per specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2267515
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3228 on: August 11, 2017, 08:45:36 AM »

Model Number 102
Event Date 06/01/2011
Event Type  Injury   
Event Description
Reporter indicated a vns patient had prophylactic generator replacement surgery due to increased seizure frequency. Attempts for further information are in progress. The explanted generator has been returned and is currently in product analysis.
 
Event Description
Product analysis was completed on the returned vns generator. There were no performance or any other type of adverse conditions found with the pulse generator, and the generator performed per specifications. All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2253955
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3229 on: August 11, 2017, 08:47:21 AM »

Model Number 102
Event Date 07/01/2011
Event Type  Injury   
Event Description
It was reported that approximately a month ago, the physician attempted to wean the patient off her depakote and she began having increased seizures. They increased her vimpat, and according to the patient, her settings "are the highest they can go". The physician ordered a brain mri and reportedly, the technician told her that it showed "right temporal lobe swelling". The patient has been referred to another physician for further evaluation. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2263378
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3230 on: August 11, 2017, 08:48:06 AM »

Model Number 102
Event Date 09/22/2010
Event Type  Injury   
Event Description
Reporter indicated a vns patient was having breakthrough seizures in (b)(6) 2010 and (b)(6) 2011, and that the patient had sleep apnea. Adjusting the vns settings seems to worsen the sleep apnea per the reporter. Vns diagnostics results from (b)(6) 2011 indicate the vns was performing as intended and was not at end of service. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had vns generator replacement surgery due to end of service. The patient's seizures are attributed to disease process and not the vns, and the level of the seizure increase was about the same as pre-vns baseline levels. No events precipitated the increased seizures. The patient's sleep apnea is worsened by the vns stimulation. A polysomnogram showed that the patient has apnea when the vns stimulates, even when using c-pap treatment. The sleep apnea is pre-existing to the vns implant. The explanted generator was returned for analysis and found to be at normal end of service, and no anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2258122
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3231 on: August 12, 2017, 07:15:37 AM »

Model Number 102
Event Date 03/07/2011
Event Type  Injury   
Event Description
Additional information was received that indicated that the generator was returned to the manufacturer for evaluation. 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. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was initially reported that the patient was being explanted due to lack of efficacy. Further information was received that indicated that the patient was experiencing painful erratic stimulation and pain. The pain was believed to be due to the patient's significant weight loss due to a gallbladder infection, not related to vns, and the potential that the generator may have migrated. The patient went to see a surgeon and he disabled the device for a time but then turned it back to the previous settings with no additional reported issue. The plan is to continue with the generator replacement which as not occurred to date. The patient has also had an increase in nocturnal seizures, unknown if above or below baseline, which was treated with an increase in medication dose. At a later appointment it was reported that her seizures were doing well. Good faith attempts for more information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Additional information was received that indicated that the generator replacement was done prophylactically and for patient comfort as it was believed the painful stimulation was related to the generator nearing end of service. The patient is not having an increase in seizures. The patient reports that she is having an increase in seizures but the family and physician confirm that she is not. The patient is having more nocturnal seizures but they are within normal ranges of frequency and she does not consider it an increase. The patient had their generator replaced. Good faith attempts for product return are in process.
 
Manufacturer Narrative
Follow-up report #1 inadvertently did not provide the explant date for the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250798
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3232 on: August 12, 2017, 07:16:20 AM »

Model Number 103
Event Date 07/15/2011
Event Type  Injury   
Event Description
Additional information was received on december 8, 2011 when the physician reported that the relationship of the increase in seizures to vns is unclear. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. The patient's settings prior to battery replacement were listed as output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec/eri=yes on (b)(6) 2011. The physician also provided clinic notes dated (b)(6) 2011 that state the patient was doing well in terms of seizures and that his last seizures as about a year ago. After battery replacement, the patient was programmed back up to output=3. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 8min/magnet output=3. 5ma/magnet on time=60sec/magnet pulse width=500usec during her follow up visit on (b)(6) 2011.
 
Event Description
Attempts for the return of the patient's explanted generator for product analysis have been made, but the explanted product has not been received by the manufacturer. The patient's programming history was reviewed and on (b)(6) 2010 the patient's generator showed 5 months left till end of service.
 
Event Description
It was initially reported that the patient's generator was showing that it was near end of life. Later, the patient's mother stated the patient had experienced an increase in seizures, and now how voice changes with stimulation were not as intense, indicating the battery may be failing. The patient was sent for replacement surgery, where the near end of service indicator was seen; the battery was still supplying output current at this time. The patient's last known diagnostics showed the device to be properly functioning. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257002
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3233 on: August 12, 2017, 07:17:07 AM »

Model Number 103
Event Date 07/14/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Product analysis of the vns generator was completed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. All attempts to the reporter for further information have been unsuccessful to date.
 
Event Description
Reporter indicated a patient was having increased seizures that were felt to be due to a depleting vns generator, even though the generator was not at end of service. The generator was replaced prophylactically due to anticipation of a near end of service condition. The patient later had generator replacement surgery performed. The explanted generator has been returned and is pending analysis. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2251858
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3234 on: August 12, 2017, 07:17:52 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient's "seizures were under good control until (b)(6) 2011 when she started noticing spells involving confustion and staring. " the patient's amplitude setting was increased and the patient will be referred for prophylactic generator replacement. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received indicating that the patient's generator was replaced. Product has been requested, but has not been returned to the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2257025
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3235 on: August 12, 2017, 07:18:40 AM »

Model Number 101
Event Date 08/01/2004
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received regarding the patient. The cause of the increase in seizures is unclear at this time. Based on the family report the patient only had grand mal seizures pre-vns. The family feels that the frequency and intensity has gotten worse, but the history of the patient's seizures has not been well documented.
 
Event Description
Additional information was received that indicated that the patient felt that the seizures may be related to stress and anxiety. The off time was adjusted from 5 minutes off to 3 minutes off.
 
Event Description
It was initially reported that the patient was having an increase in seizure frequency and more intense seizures which were above pre-vns baseline. The patient's seizures improved and were well controlled for about two years post implant but since that time they have become worse. The patient's device was reported to be "ok" by the physician but he is concerned about her condition so prescribed her more medications. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2250673
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3236 on: August 12, 2017, 07:19:23 AM »

Model Number 102R
Event Date 08/11/2011
Event Type  Malfunction   
Event Description
It was reported in a pt's clinic notes that the pt had been seen on (b)(6) 2011, his diagnostics were within normal limits. However, on (b)(6) 2011, the pt's mother stated that the pt's seizures had become more intense and were occurring with a greater tendency towards clusters in the middle of the month. It was not known if this was caused by the pt's menopausal rhythm. When the generator was attempted to be interrogated, communication was not possible. Multiple, known good wands were used without success. The physician concluded that he suspected the device was still functioning, but was not delivering the full stimulation based on these facts. An arrangement to replace the device was ordered. Attempts for further info have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2271415
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3237 on: August 14, 2017, 03:08:42 AM »

Model Number 102
Event Date 08/07/2011
Event Type  Injury   
Event Description
It was reported by a company rep that a vns pt experienced an increase in seizures after initially responding well to vns therapy. The pt's programmed settings were 1. 75 ma and system diagnostics were within normal limits (ok/ok/2/no). Add'l info was received from the area rep indicating that the pt began having a worsening in seizures in the beginning of (b)(6). The treating physician indicated that the pt's increase is of unk cause and possible causes could be battery depletion and/or pt's worsening condition. Interventions taken were to reprogram the pt to other device settings in hopes to re-establish seizure control. A pre-vns baseline for seizures was unk and future plans are to replace the pt's generator since end of service might be near.
 
Event Description
Attempts to obtain the explanted device have been unsuccessful to date as the physician does not recall the replacement surgery.
 
Event Description
Further information was received through an implant card indicating the patient underwent prophylactic generator replacement surgery. Good faith attempts to obtain the explanted device returned for analysis remains underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2251406
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3238 on: August 14, 2017, 03:09:19 AM »

Model Number 102
Event Date 08/11/2011
Event Type  Injury   
Event Description
It was reported that the pt's vns generator was scheduled to be replaced because it had migrated to the axilla. Diagnostics were within normal limits as per the physician. X-rays were taken to assess the condition of the vns lead however they will likely not be sent to the manufacturer for review. The pt was also noted as experiencing an increase in seizures that coincided with the generator moving beneath the armpit. The relationship of this increased seizure frequency to the pre-vns baseline frequency is unknown. Surgery to replace the pt's generator has occurred. It is believed that the migration is related to the previous surgeon not using a suture to secure the pt's generator properly. No trauma or manipulation was reported. Attempts for further info and return of the pt's explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2256562
Logged
dennis100
Moderators
Hero Member
*****

Karma: +23/-0
Offline Offline

Posts: 47084


« Reply #3239 on: August 14, 2017, 03:10:00 AM »

Model Number 102
Event Date 08/17/2011
Event Type  Injury   
Event Description
Reporter indicated a patient was experiencing severe pain at the vns generator site in the chest that was not related to stimulation. The patient did not want to stop vns stimulation. A referral to a surgeon was made, but no surgery date has been set as the surgeon ordered ct scans of the neck and neck. Surgery appears possible. A battery life analysis performed by the manufacturer yielded 4. 79 years remaining; generator end of service is not suspected. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient had vns generator repositioning surgery performed on (b)(6) 2012. Since the vns generator was repositioned, the patient's pain has decreased significantly. The patient has been released from surgery back to the care of his neurologist.
 
Event Description
Reporter indicated the patient's vns was disabled on (b)(6) 2011 to evaluate for seizures. Replacement of the vns generator is not currently planned. The reporter does not know what to attribute the pain to. The pain was also occurring in the left upper extremity and jaw as well as the generator site. The patient's pain did improve somewhat with lowering the vns settings, but the response varies by appointment date.
 
Event Description
On (b)(6), 2011, a vns implanting surgeon's nurse reported that the vns pt was having their generator replaced due to increased seizures. The pt's programming history was reviewed and based on the pt's last setting of output=2. 75ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=3ma/magnet pulse width=250usec/magnet on time=60sec, the battery longevity tables revealed that the battery should last approximately around 2. 8 yrs from date of implant until eos. Although surgery is likely, it has not yet occurred. Good faith attempts for additional info from the physician regarding the pt's increased seizures have been unsuccessful thus far. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2246510
Logged
Pages: 1 ... 106 107 [108] 109 110 ... 120   Go Up
Print
Jump to: