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Author Topic: Increase/Worsening of Seizures  (Read 879052 times)
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dennis100
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« Reply #4200 on: May 11, 2019, 12:06:17 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2018
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing an increase in seizures clusters since having her vns replaced. The patient used to have an average of 6 seizures/month but reportedly had 13 cluster seizures in the previous night alone. Magnet mode stimulation was attempted to help but did not do anything. It was also stated that autostimulation was programmed but did not work for the patient due to the patient's low heart rate. The patient had not been seen by the neurologist and would not be seeing the neurologist until (b)(6). The nurse stated she had labs run on the patient to determine a cause but nothing was found. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8519876
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« Reply #4201 on: May 11, 2019, 03:45:11 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
It was reported that a patient was in the hospital due to an increase in seizures. No programming history was available to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8509048
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dennis100
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« Reply #4202 on: May 11, 2019, 03:45:47 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
It was reported from clinic notes received that the patient was referred for generator replacement due to increase in seizures and upgrade to sentiva for autostimulation. No additional information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8565988
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dennis100
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« Reply #4203 on: May 11, 2019, 03:46:23 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
Patient presented with an increase in seizures. The patient's mother expressed concern that the increase was related to vns therapy. The patient's treating medical professional adjusted the patient's settings and noted that the patient may tape the magnet over the device to see if the event was related to vns therapy. Autostim output current was disabled. Further information was received that the patient's seizures had settled down. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8555981
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dennis100
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« Reply #4204 on: May 11, 2019, 03:47:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
It was reported that the patient had experienced an increase in seizure frequency, from "a few seizures here and there" to 10-12, following vns generator replacement. The patient's settings were increased due to patient not feeling stimulation, and possibly due to the patient's increase seizure frequency. The physician indicated the cause of the increased seizure frequency, despite the vns, was unknown and that the patient believed the frequency of seizures increased since the vns was turned on. No known external factors were identified that could have contributed to the increase in seizure frequency. The patient's generator did not appear to have been titrated up to therapeutic levels and the device was reportedly disabled. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8553129
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dennis100
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« Reply #4205 on: May 11, 2019, 03:47:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/03/2019
Event Type  Malfunction   
Event Description
It was reported that a patient stated vns therapy made his seizures worse. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8552554
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dennis100
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« Reply #4206 on: May 11, 2019, 03:48:31 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/28/2019
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures and they wanted somebody to check the patient's vns. The physician reported that diagnostics were determined to be within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8542294
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dennis100
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« Reply #4207 on: May 18, 2019, 01:22:13 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported by the surgeon's office to the company representative that the patient has experienced an increase in seizures due to battery depletion and she may have a vns generator replacement. It was unknown when the increase in seizures first began or if the seizures were below or above pre-vns baseline levels. A battery life calculation was performed using the information available within the programming history database. The battery life calculation showed the generator would have approximately 10 years remaining until reaching the neos = yes (near end of service) condition. It was later reported the company representative was able to check the patient's device while at the physician's office. The system diagnostics were ok with an impedance value of 2300 ohms, indicating the generator was working as intended. The physician's office reported they were unable to answer any additional questions due to lack of information from the patient. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported there was no vns generator replacement surgery planned or completed due to the increase in seizures. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6579846
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dennis100
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« Reply #4208 on: May 18, 2019, 01:25:37 AM »

Model Number 102
Event Date 12/12/2011
Event Type  Injury   
Event Description
The patient had their generator replaced and it is at the manufacturer pending completion of product analysis.
 
Event Description
Further information from physician indicates that the patient was having increased of cluster seizures which the patient has a history of. There is no clear provocateur for seizure clusters. The increase was similar to pre-vns levels and the physician feels they may be related to vns battery life decreasing even though eri = no. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the seizures. Depakote was increased to help seizures for now. Patient's mother reports compliance with medications. The patient was been referred for generator replacement, but it has not occurred to date.
 
Event Description
It was reported that the pt's seizures were up. Per physician, even though eri = no and system diagnostics were ok, the pt was being referred for generator replacement surgery. Surgery has not occurred to date.
 
Event Description
The pulse generator was returned due to a prophylactic replacement. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2419283
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dennis100
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« Reply #4209 on: May 23, 2019, 11:39:18 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported to a company representative that a patient experienced an increase in seizures and had gone to the emergency department. At the emergency department the vns was interrogated and the physician notes indicated no issues with system diagnostics. Additional relevant information has not been received to-date.
 
Event Description
Full revision occurred. Normal impedance was reported at surgery. The battery was not at end-of-service. It was provided the generator will not be returned. It was noted in surgery the lead was twisted however, high impedance was not found. The explanted lead was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Date of event, corrected data: it was inadvertently not provided in follow-up report #1 that the date of the event was clarified to be (b)(6) 2017.
 
Event Description
Follow-up from the physician¿s office provided the vns was causing shocks and the shocking was then causing seizures to occur. The mother then wanted the whole device replaced. She stated that after the replacement, all has been well. It was stated that the vns had reduced seizures since being implanted and although more seizures were occurring they were not worse than before. Analysis was completed for the returned lead. The coil appeared to be stretched, kinked, wavy and spiraled, in some areas. The returned connector pin coil appeared to be broken and during the incision process several broken coil strands were observed. Scanning electron microscopy was performed and identified the area as having evidence of a rotational stress induced fracture with secondary break lines and no pitting. Residual material was observed on the coil surface. The analysis supports that the breaks occurred as a result of the explant process due to the rotational type of fracture on the broken coil wire surfaces and secondary break lines. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546464
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dennis100
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« Reply #4210 on: June 01, 2019, 04:00:25 AM »

Model Number 102
Event Date 08/01/2011
Event Type  Malfunction   
Event Description
It was reported that the pt had a recent increase in seizures above pre-vns baseline. There was no change in settings, medication, or lifestyle prior to event. A battery life calculation gave negative results. The pt is not scheduled to be seen again until october. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2264140
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dennis100
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« Reply #4211 on: June 03, 2019, 05:27:03 AM »

Model Number 103
Event Date 12/14/2015
Event Type  Injury   
Event Description
It was reported that a patient went to see her physician with an increase in seizures. An estimate of battery life was performed and indicated the generator had greater than 10 years before near end of-service. The patient's settings were adjusted with the output current set to 1. 0 ma, magnet current set to 1. 25 ma, and off time to 1. 8 min. The battery was reported to be at ifi=no. It was reported that the patient tolerated new settings well. No additional relevant information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5357789
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dennis100
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« Reply #4212 on: June 07, 2019, 05:48:41 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Event Description
It was reported that the patient is referred for replacement surgery. Clinic notes for referral were received. She states that she is not interested in having the device replaced but when asked if she thinks her seizures have been worsening over the last year or 2 during a time the battery is probably becoming depleted, she thinks that her seizures have been worsening. The physician recommended having her device replaced since having an additional way of improving seizures may be worthwhile. Based on the mention from the md that the device was no longer stimulating it is possible that the device was pulse disabled and potentially at some point rebounded to neos status. Diagnostics are still needed to assess that the device is functioning as intended. No additional or relevant information has been received to date. No known surgical intervention has occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8597185
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dennis100
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« Reply #4213 on: June 07, 2019, 05:49:22 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Event Description
It was reported from the physician that believes that the patient¿s m106 may be depleted. It was noted that the patient is having an increase in seizures which started a couple of weeks ago and the patient almost went into status epilepticus. The physician believes it could be due to the vns battery needing replacement. The physician stated that she believes the increase in seizures are due to the battery life of the generator however she would need further data on this. The physician was asked if she had run diagnostics to ensure that the patient's device is operating within normal limits, and the physician stated that she had done this and there were no issues noted. Additional information was received that the increase in seizures was above baseline and it was the worst seizures she has ever had. The physician stated that she wanted to know how to confirm there was no issue with the lead. She stated last time the patient went in for a battery change when she was referred in (b)(6) 2016 they found the lead was broken (mfr report # 1644487-2017-03071) however there was no indication in the programmer there was something wrong with the lead. She was informed she could refer for x-rays to further assess and stated that she would refer the patient to have this done but regardless the patient was being referred to have the battery replaced and if needed the lead as well due to the increase in seizures. She state that the battery was currently at ifi - no. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8595743
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« Reply #4214 on: June 07, 2019, 05:49:54 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/05/2019
Event Type  Malfunction   
Event Description
Patient reported on social media that her seizures were getting worse and that she was getting seizures that were a different kind as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8575521
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dennis100
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« Reply #4215 on: June 07, 2019, 05:50:30 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/07/2019
Event Type  Malfunction   
Event Description
It was reported on the vns therapy (b)(6) by a patient¿s parent that his son has had more seizures since getting vns. The patient was identified by similarity in last name. Programming history was attempted to be reviewed, however none was available. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8571401
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dennis100
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« Reply #4216 on: June 08, 2019, 07:03:29 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2015
Event Type  Malfunction   
Event Description
Clinic notes mentioned that the patient experienced an increase in seizures on (b)(6) 2015. Along with this comment, it was noted that the physician thought the vns should be checked. Multiple attempts have been made to the patient's neurologist for additional details on the report of increased seizures, however no response has been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8624019
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« Reply #4217 on: June 08, 2019, 07:04:03 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2019
Event Type  Injury   
Event Description
It was reported that the patient recently developed more frequent, possibly different type seizures. The patient's generator was replaced. The suspect product has not been received to date. Multiple attempts for additional information regarding the patient's seizures were made; however, no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8632499
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« Reply #4218 on: June 08, 2019, 07:04:36 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2019
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for vns replacement due to increase in seizures and battery replacement. Clinic notes indicated that the battery was approaching end of life. No known surgery has occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8619809
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« Reply #4219 on: June 08, 2019, 07:05:09 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2019
Event Type  Injury   
Event Description
Clinic notes were received indicating that a patient's generator was unable to be interrogated. The clinic notes also stated that the patient had a cluster of 12 seizures within 8 hours. The physician attributed both the increase in seizures and failure to program to the generator battery being dead, and the physician referred the patient for a battery replacement due to low battery. At the patient's replacement case it was confirmed that the patient's device was able to be successfully interrogated. Additionally, it was noted that the reason for generator battery replacement was prophylactic. The explanted generator was received by the manufacturer. Product analysis is underway but has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8618288
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« Reply #4220 on: June 08, 2019, 07:05:51 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2018
Event Type  Injury   
Event Description
The patient reported that they have experienced an increase in seizures, as well as difficulty swallowing due to the vns. The patient mentioned that they fell in (b)(6) 2018, and that after this fall it felt like the device was "chocking and hurting their throat. " the patient stated that the settings were lowered after this fall, but that this had resulted in an increase in seizures. The patient mentioned that they went back to their physician for further vns adjustment, which the details were not provided. The patient reports that they are still having seizures and difficulty swallowing at this point in time. The patient's following physician reported that this patient has not kept follow up appointments; and therefore, the physician does not currently have an assessment on the patient's events. The physician noted that the patient was referred for neurological evaluation due to seizures, and that the patient was supposed to have vns tested, eeg & x-ray of the chest & neck to check leads; however, no results have been obtained to date. Regarding the patient's mention of vns setting adjustments, the physician clarified that in (b)(6) 2018 the patient requested that the off time be increased; however, the physician then adjusted off time to it's original settings 2 weeks later. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8615383
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« Reply #4221 on: June 08, 2019, 07:06:23 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that a patient was presenting with worsening seizures and was being referred for surgery. Clinic notes were received and noted that the device diagnostics were within normal limits. It was further stated in the notes that swiping the magnet completely resolves the patient's partial seizures. No known surgery has occurred to date. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8606528
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« Reply #4222 on: June 08, 2019, 07:06:57 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/17/2012
Event Type  Injury   
Event Description
It was reported that the patient had an increase in seizures when she was first implanted with vns. It was noted that the patient has a history of drop seizures and they did not improve and she states the device was turned way down. At the low levels the patient was doing a little better seizure wise. The patient's following physician indicated that he does not have an assessment on the reported events. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600235
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« Reply #4223 on: June 08, 2019, 07:07:28 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/23/2019
Event Type  Injury   
Event Description
Patient reported to have been hospitalized due to an increase in seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8616250
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« Reply #4224 on: June 08, 2019, 07:08:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/11/2019
Event Type  Injury   
Event Description
It was reported in clinic notes that the patient has had more seizures lately, and that their seizures were worsening in intensity and frequency. Programming history was attempted to be reviewed, however none was available. Surgery is likely but has not 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=8636127
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« Reply #4225 on: June 08, 2019, 07:08:41 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/16/2019
Event Type  Injury   
Event Description
It was reported that the patient wanted his vns explanted due to multiple visits to the er and increased seizure activity. He planned to be evaluated for brain surgery. It was confirmed that the device was explanted. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600837
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« Reply #4226 on: June 08, 2019, 07:09:13 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/08/2019
Event Type  Malfunction   
Event Description
It was reported that the patient reported an increase in seizure frequency and intensity after their settings were increased to 0. 75 ma in (b)(6) 2019 over a year after implant. The event was noted to be related to surgery. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600376
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« Reply #4227 on: June 09, 2019, 02:00:35 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/29/2019
Event Type  Malfunction   
Event Description
The physician reported that a patient experienced an increase in seizures. It was noted that the patient's device would need to be interrogated to ensure that it was operating properly as the patient recently had surgery, and there was concern that the surgery may have caused some issues with the device. No information has been received to date indicating if the device interrogation and/or device diagnostics were performed. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8638822
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« Reply #4228 on: June 10, 2019, 01:23:00 AM »

Model Number 102
Device Problems Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem
Event Date 09/21/2017
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient's battery had become depleted. The patient was referred for replacement surgery. It was later reported that the patient had experienced psychotic breaks and an increase in seizures that may have been related to the battery depletion. A battery life calculation using data from the month of implant through the next two years indicated that the patient's device was estimated to have more than 10 years life remaining until it had become depleted. The physician believed the psychotic breaks and increased seizures were related to battery depletion. The last known settings and system diagnostic test results were unavailable because the patient's device could not be interrogated at her first clinic visit with the physician nor subsequent visits. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The company representative present at the surgery was able to communicate with the generator and observed that the device had not yet reached an end-of-service condition. Intraoperative diagnostics for the explanted device were within the normal limits. The explanted generator was not available for return to the manufacturer for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6986144
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« Reply #4229 on: June 10, 2019, 01:28:04 AM »

Model Number 102R
Event Date 10/23/2011
Event Type  Injury   
Event Description
It was reported by a vns patient's mother that she believed the device was making the patient's seizures worse. She stated that the patient is also having a sore throat following a recent seizure and she wanted to know if the magnet could be left over the generator for a prolonged period of time to disable the device due to these issues. The caller was instructed to follow up with the treating physician. The caller stated they have experienced this issue in the past; however, the physician believed previous reports were due to seasonal allergies. Good faith attempts to obtain additional information surrounding these recent events were unsuccessful to date.
 
Manufacturer Narrative
Analysis of programming history performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2343426
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