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Author Topic: Warmth/Burning/Melted  (Read 41022 times)
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dennis100
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« Reply #180 on: June 06, 2019, 02:07:02 AM »

Model Number 106
Event Date 08/11/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient stated she has been having a burning sensation under her skin where the vns generator was placed and had a burn mark. It was reported that the issue has been going on for a while (exact date not reported). The patient's mother also mentioned that she can sometimes smell a burning smoke smell coming from the patient's mouth when she talks. It was also reported that the patient feels the generator gets warm whenever it is interrogated. Additional information was received that the patient's device was disabled on (b)(6) 2016 due to persistent chest pain, and the patient was also referred to a surgeon for evaluation. The chest pain did reportedly resolve once the patient's device was disabled. No additional relevant information has been received to date.
 
Event Description
The patient consulted another physician, who believes that the patient's events are due to the placement of the device as opposed to the device itself. The patient complains of constant pain around the superior portion of the chest incision and at the neck incision where the electrode appears to course above the platysma muscle. The discomfort appears to be related to the fact that the implant was placed too superficially, such that it is in direct contact with the dermis and is irritating the skin. The patient states that these symptoms have been present since the device was placed. During stimulation, the patient was extremely uncomfortable and noted the following symptoms: sensation of tasting something burning, pulling sensation in her neck, burning sensation in the neck and near the generator, coughing and nausea. There was no discoloration or heating of the skin around the generator that the physician observed. Per the physician, the above symptoms would be most consistent with inadvertent placement of the device on the hypoglossal or glossopharyngeal nerve instead of the vagus nerve, or potentially placement too superiorly on the vagus, or current spread to those nerves,. Per the physician's opinion, these are not necessarily indicative of a malfunction in the device itself. In addition, the recorded impedance of the device was 2183 ohms confirms no lead related issues. Per the implant operative report, the lead was implanted on the vagus nerve near the jugular vein and carotid artery. No other relevant information was obtained from the operative report as to the cause of pain. Patient underwent full revision surgery on (b)(46 2016. The explanted products were not received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5405291
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dennis100
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« Reply #181 on: June 28, 2019, 10:47:46 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/13/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient felt warmth at the generator site and had "complications" from a fever after her vns implant surgery. Clarification was later received that the fever after implant was related to an infection at the generator site. The surgeon provided antibiotics, and no other interventions were taken. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7544730
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dennis100
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« Reply #182 on: July 05, 2019, 10:28:30 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/28/2019
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the patient was being referred for explant due to unknown reason. During follow-up for the reason, it was stated that the patient was not able to tolerate titration and was the reason for explant. Information was received indicating that the patient has a low pain tolerance. Vns diagnostics were stated to be normal and autostim is off. The patient has not been able to up titrate due to pain/tolerance. The patient is the one who requested that vns be removed and the physician's office is not able to do anything about this. Clinic notes were received indicating the patient is scheduled for explant due to vns pain and a burning sensation. The physician attempted to titrate the patient's settings up but was unable to tolerate and is no longer willing to have the settings increased. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8716055
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dennis100
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« Reply #183 on: July 16, 2019, 11:31:38 PM »

Model Number 304-30
Device Problem Fracture
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had an emergency surgery to explant a lead that was stated per the stepdad to be internally burning him. It was unknown if there was trauma to the site, if devices were explanted, diagnostics, or who the surgeon was. A call was received confirming that both the generator and lead were explanted due to painful stimulation, exposed lead wires and "drainage" from the exposed wires. The devices were to be shipped back for analysis. Surgical operation notes were received indicating pus, an infection at the electrode site and "exposed, infected" devices, however it was stated per the patient's physician that nothing had happened to the lead or generator and that the patient had also been sent to "infectious disease" who had clarified that there was no infection seen. Impedance measurements from march 2018 showed ok impedance, within normal limits. The physician stated the patient had been doing well with vns and was looking to have the patient re-implanted with vns. The devices were returned for analysis, however analysis has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7883963
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