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Author Topic: Warmth/Burning/Melted  (Read 43899 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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dennis100
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« Reply #184 on: August 10, 2019, 02:09:14 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/07/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr? device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator and lead were explanted due to infection on (b)(6) 2019. The patient's generator was recently implanted on (b)(6) 2019. The surgeon reported that the chest incision site was red, hot inflamed and had a pus discharge due to infection. The manufacturer's device history records for relevant lead and generator were reviewed. Sterilization of the products prior to release for distribution was verified. Product return/device evaluation is not necessary as infection is not related to the functionality or delivery of therapy of the device no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8807906
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dennis100
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« Reply #185 on: August 10, 2019, 02:09:53 AM »

Model Number 7304
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/14/2019
Event Type  Injury   
Event Description
It was reported that a study patient experienced a neck burn considered to be "probably related" to the vitaria implant procedure. Attempts for further information could not be made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8754589
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dennis100
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« Reply #186 on: August 10, 2019, 02:10:36 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/17/2019
Event Type  Injury   
Event Description
It was reported that a patient felt like their generator was going off for prolonged periods of time and is having a burning sensation. Information was received from the patient's treating nurse practitioner that the patient's device was disabled to mitigate the burning sensation, and that surgical intervention is planned for the patient's reported burning. It was stated that the surgical intervention is inspection of the device and lead wire since the patient is uncomfortable. It was stated that the patient's autostimulation is not turned on. Per the physician, he does not believe that the device is staying on for prolonged periods of time, however the patient does have a burning sensation when the device fires. 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=8828038
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dennis100
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« Reply #187 on: September 07, 2019, 01:20:15 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/21/2019
Event Type  Injury   
Event Description
The patient visited their primary care physician due to recent swelling, heat, and tenderness over their vns generator site. The patient informed that they have experienced no painful stimulation or pain in the lead area. The patient's primary care physician confirmed that the swelling and heat over the generator was due to an infection. The primary care physician administered an antibiotic prescription for the patient's infection. A review of device history records showed that the implanted generator and lead were sterilized prior to distribution. All other quality tests also passed prior to distribution. In addition to the infection, the patient expressed concern that the vns generator battery had depleted due to a lost perception of magnet stimulation and increased seizures, which the patient was hospitalized for. Further follow up confirmed that the system diagnostic test results for the patient's vns generator are within normal limits. The patient has not established care with a neurologist, and their vns has not been programmed since 2017. As a result, their seizure medications have not been adjusted and the vns has not been titrated to higher therapy settings. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8900897
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dennis100
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« Reply #188 on: September 07, 2019, 01:21:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2019
Event Type  Injury   
Event Description
It was reported from the physician¿s office that the patient reported that she popped a stitch from her incision that day. The patient¿s initial implant surgery for vns was the day prior. The stitch popping did cause the incision to open and a bit of oozing occurred. It happened over night for the patient. The surgeon did prescribe antibiotics and clipped the actual exposed stitches back. For the cause, the surgeon believes some kind of manipulation overnight, but otherwise unclear. Reported by patient, tenderness around generator and noticeably hotter to the touch. When patient moves neck, feels a pulling sensation in the neck. Device itself is in good working order and diagnostics check out fine. Both generator and lead were confirmed hp sterilized prior to distribution into the field. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8889289
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dennis100
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« Reply #189 on: September 07, 2019, 01:22:10 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/23/2019
Event Type  Malfunction   
Event Description
The patient reported to their case manager that the vns stimulation is sometimes causing a burning sensation, and that the site over the generator hurts. The patient also mentioned that they have been to the emergency department of the hospital due to their seizures but could not elaborate further on this event, besides that they went home afterwards and were not admitted to the hospital. The patient indicated they have been in the emergency department a few times recently due to their seizures, which is abnormal for them. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8896637
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dennis100
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« Reply #190 on: October 12, 2019, 01:41:14 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/19/2019
Event Type  Injury   
Event Description
It was reported from the physician¿s office that the patient reported that she popped a stitch from her incision that day. The patient¿s initial implant surgery for vns was the day prior. The stitch popping did cause the incision to open and a bit of oozing occurred. It happened over night for the patient. The surgeon did prescribe antibiotics and clipped the actual exposed stitches back. For the cause, the surgeon believes some kind of manipulation overnight, but otherwise unclear. Reported by patient, tenderness around generator and noticeably hotter to the touch. When patient moves neck, feels a pulling sensation in the neck. Device itself is in good working order and diagnostics check out fine. Both generator and lead were confirmed hp sterilized prior to distribution into the field. Believed cause of pulling sensation is lack of strain relief loop (not a big enough loop). Mfr report # 1644487-2019-01568 houses the report of the redness and tenderness at the chest site. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9078333
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