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Author Topic: Increase/Worsening of Seizures  (Read 265369 times)
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dennis100
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« Reply #3030 on: July 12, 2017, 03:39:01 AM »

Model Number 102
Event Date 09/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was initially reported by a nurse responsible for the care of the pt through the state that the pt was experiencing an increase in seizures, unk if above or below baseline. The pt also was exhibiting seizures that have not been occurring for sometime. In the past, pt had slight voice alterations during stimulation but those have not been observed for about a month. At the pt's most recent visit to the neurologist office, the pt had their output current increased. It is unk if this decreased the seizures or if this intervention was taken in response to the seizures. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1921975
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dennis100
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« Reply #3031 on: July 12, 2017, 03:40:56 AM »

Model Number 102
Event Date 09/10/2009
Event Type  Injury   
Event Description
It was reported that the vns pt would be having their generator replaced for an unk reason. F/u with the surgeon found that the pt's mother stated that the pt's seizures had been increasing and swiping the magnet over the generator was not aborting the pt's seizures. The surgeon later confirmed that the generator has been replaced due to approaching end of service. A battery life calculation has been performed using the info available to the mfr that estimated approx 1. 24 yrs until end of service at the time of explant. The explant vns generator has been returned and is currently undergoing analysis. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936118
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dennis100
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« Reply #3032 on: July 12, 2017, 03:41:31 AM »

Model Number 102
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt was scheduled for a battery replacement surgery due to generator was thought to be at end of life. Pt was hospitalized due to status and vns could not be interrogated. Pt was taken into surgery; however, the surgeon was able to interrogate the device and the generator was not confirmed to be at end of service. Reason for increase in seizures is unk. Good faith attempts to obtain additional info have been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936142
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dennis100
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« Reply #3033 on: July 13, 2017, 04:01:03 AM »

Model Number 102
Event Date 11/08/2010
Event Type  Injury   
Event Description
It was reported by surgeon that the vns patient underwent generator replacement surgery due to unknown reason. Further follow up with neurologist revealed that patient was having an increase in seizure and a change in his seizure pattern. The neurologist referred the patient for battery replacement prophylactically based on clinical end of service symptoms. Good faith attempts with the neurologist to obtain additional information, such as relationship of the increase in seizures to pre-vns baseline and recent programming history, have been unsuccessful. Based on the history available in house, the battery life calculation resulted in -0. 9 years remaining. Good faith attempts to obtain product for analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924675
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dennis100
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« Reply #3034 on: July 13, 2017, 04:01:36 AM »

Model Number 102
Event Date 08/01/2010
Event Type  Injury   
Event Description
It was initially reported by the surgeon that the pt underwent a battery replacement surgery due to end of svc and pt was showing an increase in seizures. Explanted generator was returned to mfr for analysis. Analysis was completed on the generator and the reported allegation was not verified. The generator was not found to be at end of life. There were no performance or any other type of adverse conditions found with the pulse generator. F/u with the physician's nurse revealed that they believed the battery was approaching end of life and it was probably at low battery due to which pt showed an increase in seizures. Pre-vns levels were unk. Medication levels were checked and found to be normal. Pt showed seizure activity all of a sudden and replacement improved the pt's condition. Diagnostics showed everything functioning within normal limits with eri status no.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919360
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dennis100
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« Reply #3035 on: July 13, 2017, 04:02:10 AM »

Event Date 08/22/2010
Event Type  Injury   
Event Description
An article was received "cardiovascular modulation during vagus nerve stimulation therapy in patients with refractory epilepsy". The article aimed to see how vns has an effect on cardiovascular events. The study, which was conducted in (b)(6), involved 10 patients affected by drug-resistant partial epilepsy, and testing was performed both pre-and post-implantation of vns (post- was mean of 7. 7months after activation). Upon review of the article one patient experienced an increase in seizures (above pre-vns baseline). A (b)(6), male, had a pre-vns seizure frequency of 19 and then a post-vns seizure frequency of 21, which is a 10% increase. No interventions were taken for the event.
 
Manufacturer Narrative
Article: cadeddu c, et all, cardiovascular modulation during vagus nerve stimulation therapy in patients with refractory epilepsy, epilepsy research. (2010), doi:10. 1016/j. Eplepsyres. 2010. 08/012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919364

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dennis100
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« Reply #3036 on: July 13, 2017, 04:02:48 AM »

Model Number 102
Event Date 01/01/2010
Event Type  Injury   
Event Description
Initially, it was reported that the pt had surgery to replace the pulse generator due to end of svc (battery depletion). The explanted generator was returned to mfr for analysis and the device performed according to specifications, and the device was not at end of svc, and elective replacement indicator (eri) flag was set to no. F/u with the treating physician was performed and the reason for the referral of the pt to have the generator replaced was due to an increase in seizure frequency for which the relationship to the pre-vns baseline is unk. It was also reported that the pt's seizure activity improved after the generator was replaced. F/u with the physician regarding the seizure increase revealed that there had been a decrease in phenobarbital medication , however, the physician did not believe there was a relationship between the medication change and the increase in seizure frequency. Diagnostic testing of the device revealed normal function prior to generator replacement, however, the physician does indicate that the increase in seizures was related to the battery nearing its end of life.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919374
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dennis100
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« Reply #3037 on: July 13, 2017, 04:03:24 AM »

Model Number 103
Event Date 08/18/2010
Event Type  Injury   
Event Description
It was reported that the vns pt has been experiencing an increase in myoclonic seizures since being initially implanted. The neurologist has stated that he does not attribute the increase in seizures to the vns at this time but is still evaluating the root cause. The neurologist indicated that there have been no changes in medication. The pt's vns settings have been increased; however, the increase in settings persisted. The neurologist indicated that the pt has several co-morbidities that could be causing or contributing to the increase in seizures. Further attempts for information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1920055
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dennis100
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« Reply #3038 on: July 13, 2017, 04:04:01 AM »

Model Number 250-7.1
Event Date 06/01/2010
Event Type  Malfunction   
Event Description
It was initially reported through clinic notes that the pt had an increase in seizures over the past 2 months and the site suspected the reason behind this, due to end of service generator. Pt underwent a battery replacement surgery and the explanted generator was returned to mfr for analysis. Analysis did not duplicate the end of life generator; however, the parameters of the returned generator were those of an unintended device settings that might have occurred due to a faulted system test. It is likely that the increase in seizures might have been related to these unintended device settings which might have been caused due to faulted system test and no final interrogation was performed to confirm the change in the settings and pt left the office with unintended settings.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1948961
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dennis100
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« Reply #3039 on: July 13, 2017, 04:04:39 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the pt's mother that the pt has an increase in seizures above baseline that began (b)(6) 2010. Pt is also experiencing painful stimulation since the device settings were increased. Physician has adjusted the pt medication doses. Mother stated that the magnet does help with seizures as she no longer passes out with seizures when it is used. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937783
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dennis100
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« Reply #3040 on: July 13, 2017, 04:05:22 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported that the vns pt, who was initially implanted with the device in (b)(6) 2010, was experiencing an increase in seizure frequency, above the pre-vns baseline. The pt's caregiver indicated that the seizures have increased since the vns device was programmed on and the seizures were occurring "one after another". The treating physician had programmed the device to 0ma and the seizure frequency began to decrease. The pt was also experiencing severe hoarseness. At the pts request, the vns device was explanted. Good faith attempts to obtain additional information have been made, but no additional information has been rec'd to date. In addition, good faith attempts to obtain the explanted device for analysis are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1920074
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dennis100
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« Reply #3041 on: July 13, 2017, 04:05:58 AM »

Model Number 102
Event Date 07/01/2010
Event Type  Malfunction   
Event Description
It was initially reported through clinic notes that the pt was experiencing an increase in seizures and diagnostics showed everything working within normal limits. No additional information was provided. Good faith attempts to obtain additional information has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943894
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dennis100
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« Reply #3042 on: July 15, 2017, 01:56:50 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A physician reached out stating that one of his patients had begun experiencing an increase in seizures. He was concerned that the patient's device was not working due to the increased seizures. The physician ran a diagnostic test which provided values 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=6566311

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dennis100
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« Reply #3043 on: July 15, 2017, 01:57:29 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 04/18/2017
Event Type  Injury   
Event Description
It was reported that a patient was having increased seizures after their vns was turned. The device was disabled due to the increase in seizures. System diagnostics results were within normal limits. A review of device history records for the generator shows that no unresolved non-conformances were found. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6568171
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dennis100
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« Reply #3044 on: July 15, 2017, 09:59:19 AM »

Model Number 102
Event Date 07/22/2010
Event Type  Injury   
Event Description
Clinic notes were received for review that reported a vns patient was having an increase in seizures and it is unknown if over their prevns rate. Unknown relationship to their vns. System diagnostic testing on their vns showed that it was not at end of battery life and eri no. The patient is scheduled for battery replacement on (b)(6)2010 based on their clinical presentation. Good faith attempts will be made for the product to be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1784937
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dennis100
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« Reply #3045 on: July 16, 2017, 07:11:56 AM »

Model Number 102
Event Date 01/26/2011
Event Type  Injury   
Event Description
It was initially reported on (b)(6) 2011 that a vns pt was in the hospital due to an episode of status and also had an increase in seizures. An interrogation of the pt's generator on (b)(6) 2011 showed the device not to be at end-of-service, and diagnostics were performed resulting in a dcdc=1. The site decided they would prophylactically replace the pt's device. Further info revealed that the pt underwent a battery replacement on (b)(6) 2011. Despite attempts to date for product return, the explanted material has not been returned to the manufacturer. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2003672
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dennis100
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« Reply #3046 on: July 16, 2017, 07:12:31 AM »

Model Number 102
Event Date 09/07/2010
Event Type  Injury   
Event Description
It was initially reported that a vns pt underwent a battery replacement due to an increase in seizures that the pt had been having. The replacement was prophylactic in nature. The product was returned to the manufacturer and underwent product analysis. The generator was found to have performed according to functional specifications and no end-of-service (eos) condition was observed during testing. There were no programming anomalies noted in the manufacturer's analysis. Good faith attempts to date for more info regarding the pt's increase in seizures have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2003659

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dennis100
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« Reply #3047 on: July 16, 2017, 08:18:15 AM »

Model Number 102
Event Date 12/20/2010
Event Type  Injury   
Event Description
It was reported through a clinic note dated (b)(6) 2010 that a vns pt was seen for a follow-up on seizures. The note indicated that the pt's last seizure was (b)(6) 2010 and it was prolonged that the pt had to go to the er. The magnet was reported to be ineffective at the time. Vns was interrogated but no programming changes made. Magnet diagnostics showed no abnormalities but swipe did not appear in the log. Pt felt magnet stimulation when swiped. Further info was received from a company representative indicating the pt underwent generator replacement surgery. An implant card was received indicating the pt underwent generator replacement surgery due to prophylactic replacement. Good faith attempts to obtain additional info from the treating neurologist regarding the pt's increase in seizures and relationship to vns have been unsuccessful to date. Attempts to obtain the explanted generator have also been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000314
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dennis100
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« Reply #3048 on: July 16, 2017, 08:18:59 AM »

Model Number 102
Event Date 10/07/2010
Event Type  Injury   
Event Description
It was reported that the pt was experiencing an increase in seizures believed to be due to vns generator end of service. The generator was replaced and the explanted product was returned for analysis. Analysis of the generator was found that although the elective replacement indicator was set, the generator was able to deliver the intended stimulation. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000337
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« Reply #3049 on: July 16, 2017, 08:19:33 AM »

Model Number 102R
Event Date 01/19/2011
Event Type  Injury   
Event Description
It was reported to our country manager in (b)(6) that a vns treating office had a pt who had been having more severe seizures this week. It is unk if this is a change in seizure type or if above their pre-vns seizure rate. The pt had one cluster of major seizures and no further seizures that week. Their vns device is not at end of battery life. Diagnostic testing was reported to be fine and impedance ok. No further specifics provided. Good faith attempts were made an no further information has been attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000315
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« Reply #3050 on: July 16, 2017, 09:21:46 AM »

Model Number 102
Event Date 11/21/2010
Event Type  Malfunction   
Event Description
Reporter indicated a vns pt was having an increase in seizures over the last several months. A battery life estimation performed for the vns yielded approx 3 years remaining. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2006854
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« Reply #3051 on: July 16, 2017, 09:39:04 AM »

Model Number 102
Event Date 11/20/2008
Event Type  Injury   
Event Description
Study paperwork from a retrospective study was received from the (b)(6). It was reported that their was a study patient with a dramatic increase in seizures and deterioration in their behavior from their seizures. The patient was implanted (b)(6) 2008 and the event started around (b)(6) 2008. Their vns therapy was raised to try to gain further seizure control but their seizures persisted. As a result, their vns therapy was permanently stopped. The event started (b)(6) 2008 and continued through (b)(6) 2009. Their seizures were reported to be severe, and probably related to their vns stimulation. Once their vns was programmed off and a medication added, their seizure rate returned to their baseline seizure frequency. The seizure increase with the vns was above their baseline rate. No device complication was reported to have caused the event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000202
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« Reply #3052 on: July 17, 2017, 01:57:49 AM »

Model Number 102
Event Date 08/08/2008
Event Type  Injury   
Event Description
It was initially reported that the pt had two grand mal seizures and was admitted into the hospital. The pt had only two other grand mal seizures in her life. The pt reported no change in lifestyle or medications. The physician believes that the pt seizures that lead to the hospitalization were related to a depleted generator. The pt reported that she feels her seizures are worse than before vns. The pt had generator replacement and the explanted generator has been returned to the mfr for eval. Product analysis is planned, but has not been completed. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993857
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dennis100
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« Reply #3053 on: July 17, 2017, 01:58:35 AM »

Model Number 102
Event Date 10/11/2010
Event Type  Injury   
Event Description
It was reported via clinic notes that the vns patient had been experiencing an increase in seizures since the last office visit. It was indicated that vns diagnostics were performed and the vns battery was nearing end of service; however, specific diagnostics results were not provided. Diagnostics from the previous office visit noted normal lead impedance and a dcdc code of 1. Follow-up with the neurologist's office found that the patient's seizures had increased in severity. Both the increased frequency and severity have been attributed to the vns battery approaching end of service. The battery is believed to still be able to deliver stimulation. The patient has a history of seizures occurring with increased stress. Surgery to replace the vns generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999577
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« Reply #3054 on: July 17, 2017, 01:59:17 AM »

Model Number 102
Event Date 01/12/2011
Event Type  Injury   
Event Description
It was reported through clinic notes dated (b)(6) 2009 that a vns pt was having more frequent seizures and went to the hospital. The patient's keppra was lowered as an intervention and as a result of the hospital visit a bladder infection was diagnosed. Further review of the notes indicated the pt had blackouts and were considered to be related to the patient's seizure nature. At the moment, the relationship of the frequent seizures to the infection is unk as good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993868
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« Reply #3055 on: July 17, 2017, 01:59:59 AM »

Model Number 102
Event Date 07/01/2006
Event Type  Malfunction   
Event Description
It was reported by the vns patient that she experienced an increase in seizures after the vns device was programmed on initially. The patient had been implanted with the vns device back in (b)(6) 2006. Review of programming history available in house reveals that the device was programmed on back in july 2006 and the settings were incrementally increased up thru (b)(6) 2007. The device was interrogated as recent as (b)(6) 2010 where the device was still programmed to deliver stimulation. Good faith attempts to obtain additional information from the treating physician have been made, however no further information has been received to date. It was also reported that the treating neurologist was planning to refer the patient for generator replacement, however, the patient has expressed that she does not want to have surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1997812
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« Reply #3056 on: July 17, 2017, 02:01:05 AM »

Model Number 302-20
Event Date 01/07/2010
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt experienced a loss in weight and had to decrease the pt's vns settings due to the pt losing weight. The event of loss in weight started last yr. Further info from the nurse indicated the pt was also complaining of severe neck and left lateral chest pain which was positional. Additional info was received from the treating nurse indicating the cause of the pt's loss of weight was related to vns pain in the throat as the pt could not eat due to pain. The nurse did not know a cause for the pt's positional pain as the pt stated that the event has been ongoing since vns placed. Interventions planned are to have a second opinion and replace vns as it significantly improves the pt's seizures. Additional info was received through clinic dated (b)(6) 2011 notes indicating the pt's seizures are worse due to lack of rest, pt is experiencing painful stim, cannot swallow, increase in acid reflux allegedly due to vns, device disabled (b)(6) 2011 - pain stopped as a result of device being disabled. Interventions taken were to increase meds as vns is disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999589
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« Reply #3057 on: July 17, 2017, 02:01:53 AM »

Model Number 102
Event Date 01/20/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt had an increase in seizure and swiping the magnet does not work for him anymore. The pt is non verbal and severely impaired. The neurologist referred the pt for prophylactic generator replacement. The patient's diagnostic settings prior to surgery were within normal limit. It is unk if patient's increase seizures were above or below pre-vns baseline. Good faith attempts to obtain more info regarding vns pt has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000221
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« Reply #3058 on: July 17, 2017, 02:02:40 AM »

Model Number 103
Event Date 01/19/2011
Event Type  Injury   
Event Description
It was reported by a neurologist that a vns pt was having seizures above pre-vns baseline since his prophylactic generator replacement. Vns generator's diagnostics were ok and no malfunction is suspected. There has been no medication or programming changes and neurologist is not sure if increase seizure is related to vns therapy. No interventions have been planned so far per neurologist. Mfr reviewed pt's x-ray images. The alignment of the positive and negative electrode appeared to be normal. There were strain relief bend and loop present. The lead was routed towards the generator. The generator was placed on the left chest and a small amount of lead was placed behind the generator. The connector pin appeared to be fully inserted. The filter feed-thru wires appeared to be intact. The lead also appeared to be intact at the connector pin. No obvious anomalies could be identified in visualized portion of the pt's vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000224
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« Reply #3059 on: July 17, 2017, 02:03:19 AM »

Model Number 102
Event Date 01/19/2011
Event Type  Injury   
Event Description
Reporter indicated that a vns pt was hospitalized for increased seizures. Attempts for additional info from the reporter have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999560
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