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Author Topic: Arthritis  (Read 1105 times)
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dennis100
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« on: October 18, 2018, 02:10:12 AM »

Event Date 01/01/2009
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Voluntary report # (b)(4) was received indicating that the patient began experiencing increased neck and shoulder pain as well as increased seizures. The report date of the voluntary report was indicated as (b)(6) 2012. The physician reportedly indicated that they believed this was arthritis and referred the patient to a pain specialist. The device could reportedly be seen migrating and had "disconnected". The report indicated that the physician "decreased the voltage". The vns was reportedly removed 6 months following the initial complaint however it was not indicated if this refers to the vns lead, generator, or both. It was noted keppra and vimpat were added to the patient's treatment plan and she was already taking dilantin and gabapentin. The patient reportedly developed anorexia and is losing weight. There is a comment indicating "she is now (b)(6)" however it is not indicated what this is referring to. It was also noted that the patient is having trouble walking and has developed tremors however the patient reportedly feels these are related to the medication but it is indicated that drug levels have not been taken in some time despite requests from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2721027
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dennis100
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« Reply #1 on: October 18, 2018, 02:13:45 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that the vns study patient¿s generator was explanted due to pain on (b)(6) 2014. The patient¿s device was programmed to deliver stimulation four times a day. The patient experienced mild pain when moving, sleeping, and touching the generator site for the past year; however the pain intensified in (b)(6) 2014. The device was programmed off per the patient¿s request but the pain persisted. After the generator was removed, the patient¿s pain was resolved.
 
Manufacturer Narrative
Common device name: type of device product code: this device was implanted to treat rheumatoid arthritis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3705846
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dennis100
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« Reply #2 on: October 18, 2018, 02:16:11 AM »

Model Number 10X
Event Date 12/29/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that this vns patient had shown symptoms of autoimmune process which is appeared with subfebrile temperature, pains in joints etc, but the locus with generator is absolutely intact. The event began on (b)(6) 2012. The symptoms included high temperature, pain in the right knee and left elbow joints while moving, and swollen, hot joints. The patient was hospitalized with anti-inflammatory therapy. The antibiotics were applied successfully, and the patient left the clinic. The high temperature and pain began again on (b)(6) 2013. The locus of generator was intact. Anti-inflammatory therapy was continued. The number of seizures was increased almost to the pre-vns baseline (after vns implant, the patient experienced a 50% seizure elimination). Doctors did not determine the clear causes of the situation, but pediatricians tended to relate it to vns. The patient's heredity is free of distinctive features. The mix of antiepileptic drugs and vns parameters were not modified. The previous week, the patient left the clinic with satisfied status. The diagnosis was juvenile rheumatoid polyarthritis. The rheumatoid tests are negative. Cytostatics are not prescribed because the diagnosis is disputable. The generator was never disabled. No diagnostics are available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2976156
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dennis100
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« Reply #3 on: October 18, 2018, 02:17:04 AM »

Event Type  Injury   
Manufacturer Narrative

Event Description
An article titled "vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis" was reviewed which included adverse event involving vns patient. It was reported that the patient presented bradycardia during the study. This adverse event was related to the implantation procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5917241
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dennis100
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« Reply #4 on: October 18, 2018, 02:17:55 AM »

Model Number 102
Event Date 08/27/2003
Event Type  Injury   
Event Description
It was reported that the patient wants to have the device explanted due to gastric issues. It was reported that the patient has lost 70 pounds and it is still being considered that the vns could be the cause of the gastric issues which resulted in the weight loss. It was reported that the surgery would be for patient comfort and not to preclude a serious injury. No surgical intervention has been performed to date.
 
Event Description
It was reported by the vns patient that she has not had a seizure in a "very long time" but has been having chronic gastritis for years. She indicated that her gastroenterologist suggested she have her vns disabled and explanted. The gastritis was reportedly not attributed to vns however the physician indicated that it might impede improvement with digestion. The patient indicated that her heart rate has increased with stimulation since her vns was first turned on. The patient stated this takes her breath away and the increased heart rate was observed on an ekg. The patient indicated that she has not had her vns checked in a long time. The patient indicated that the vns has been beneficial so she would like to avoid turning the vns off but may pursue vns disablement if it is necessary to help resolve the digestion issues. The patient also indicated that her generator may have migrated due to weight loss and her chest is now more uncomfortable as a result. She indicated that she also sleeps on the same side as her generator is implanted on and that may be contributing to the discomfort. The patient is considering having her vns disabled and/or removed however she had not discussed with a physician. Attempts for follow-up have been unsuccessful to date. Although the patient indicated she may be pursuing intervention, no interventions appear to be planned at this time.
 
Event Description
Additional information was received that the patient had their generator turned off and that the patient was having the vns system explanted due to needed mri for osteo-arthritis. The imaging center will not do the mri with the system implanted. Another call was received the same day that stated that due to the other issue the patient has had with vns the patient would not be re-implanted.
 
Event Description
Additional information was received that the patient was explanted. The hospital required as sign authorization to have the explants sent to the manufacturer for evaluation, so the lead and generator will not be returned to the manufacturer for evaluation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2682077
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