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Author Topic: Appetite  (Read 3896 times)
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dennis100
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« Reply #30 on: April 03, 2019, 01:19:34 AM »

Model Number 102
Event Date 01/01/2016
Event Type  Injury   
Event Description
Clinic notes were received on (b)(6) 2016 and mention that the patient's vns output current was decreased at the last visit which did not help with her appetite. Notes mention that system and normal mode diagnostics were not able to be checked because the patient was agitated. Follow-up with the physician showed that they are unsure if the loss of appetite is related to vns therapy or not.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5624637
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dennis100
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« Reply #31 on: April 06, 2019, 02:05:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Event Description
It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly. The patient was at 0. 75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week. When the patient practiced with the magnet she experienced massive abdominal pain. The patient was ramped up to normal output current 1ma. Two weeks later, the patient had reduced continuous abdominal pain. The duty cycle was changed. Two weeks after that, the patient stated that the pain was reduced further but still not gone. The frequency was lowered from 30 hz to 20 hz. After a month, the patient still had pain and developed symptoms of diarrhea and no appetite. The patient¿s general practitioner had no assessment of the symptoms. The patient¿s device was disabled at the request of the patient and the pain resolved. X-rays were received and reviewed for the patient. Per the x-rays, the generator placement appeared to be normal in the left axillary chest area. Complete pin insertion was confirmed as the pin can be seen coming through the second connector block. The feed through wires, and the lead wire continuity appeared normal. The lead was observed in the neck and chest. Part of the lead appears to be behind the generator and could not be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation. Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8445038
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dennis100
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« Reply #32 on: April 24, 2019, 02:06:01 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/15/2017
Event Type  Injury   
Event Description
It was reported to a company representative by a surgeon¿s office that a vns patient wants to have her vns removed. Follow-up to the treating neurologist¿s office provided the patient was last seen on (b)(6) 2016 and requested that device be turned off due to perceived weight loss. The neurologist turned off the device at that time and told the patient to contact the surgeon if she wanted it removed. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Clinic notes were received for surgical referral providing the patient reports it won¿t allow her to gain weight.
 
Event Description
The patient was referred for replacement due to decreased appetite and weight loss. The neurologist did not know if the decreased appetite and weight loss was related to stimulation or presence of the device. Programming history was reviewed and no programming anomalies were seen. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6405006
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dennis100
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« Reply #33 on: July 27, 2019, 12:35:15 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2018
Event Type  Injury   
Event Description
It was reported that the patient was not eating, drinking and was losing weight. Device diagnostics for the vns device were within normal limits. Information was received in a fax from the physician that the loss of appetite and weight loss were present prior to the vns implant. The physician stated that the patient feels the vns device may have worsened the symptoms. The physician also felt that vns may have exacerbated the issues however did not believe it was a primary cause of the weight loss and reduced appetite. The physician stated that the loss of appetite and weight loss were attributed to a general medical condition and dysphagia. The physician stated that the vns device was turned off to see if the symptoms improve. The patient has also been referred to a gastroenterologist for further evaluation. A feeding tube was considered to be used for the patient as well. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8218860
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