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Author Topic: Deep brain stimulator - Warmth/Burning  (Read 3749 times)
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dennis100
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« on: May 09, 2015, 01:47:03 AM »

Model Number 37601
Event Type Injury
Manufacturer Narrative
Concomitant products: product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, explanted: (b)(6) 2015, product type extension; product id 3389s-40, lot # v476627, implanted: (b)(6) 2010, product type lead; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 37085-60, serial # (b)(4), implanted: (b)(6) 2010, product type extension; product id 3708660, serial # (b)(4), product type extension; product id 37601, serial # (b)(4), product type implantable neurostimulator; product id 3389s-40, lot # v475868, implanted: (b)(6) 2010, product type lead. (b)(4).

Event Description
It was reported that there were high impedance values of 2139-2190 monopolar and 4161 bipolar on c/8, c/9, c/10 and 8/10. There was a loss of therapeutic effect/stimulation and a shocking/jolting sensation. Impedance testing and reprogramming were done. There was a kink on the intracranial lead wire. The location of the kink in was the lead/extension connection. Patient experienced burning sensation, pain and less than 50% therapy relief at the device pocket and left side implant. The patient had left breast pain at the ins site when the system was on and loss of therapy effect. The pain was resolved when channel 2 was turned off. The extension and implantable neurostimulator (ins) were explanted and replaced and impedances had remained high. The impedance issues had occurred pre-operatively, intra-operatively and post-operatively. The cause of the impedance was not determined. The issue was not resolved. The patient was doing the same as they were pre-operatively in that the patient was not receiving therapy on one side, it had been turned off. The patient may return at a later date to have the lead replaced. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4710927
« Last Edit: September 07, 2015, 07:18:07 AM by dennis100 » Logged
dennis100
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« Reply #1 on: May 09, 2015, 01:47:40 AM »

Model Number 37601
Event Type Injury
Event Description
It was reported that the patient experienced a shocking/jolting sensation and a burning sensation postoperatively. Dyskinesia was also reported. Impedances had been measured intraoperatively and were within normal ranges. X-rays showed no problems with the system and the leads were in the correct position. The patient had not fallen. The implantable neurostimulator (ins) was replaced.

Manufacturer Narrative
(b)(4). Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4728440
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dennis100
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« Reply #2 on: September 07, 2015, 07:18:48 AM »

Model Number NEU_INS_STIMULATOR
Event Date 07/30/2015
Event Type Injury
Event Description
The health care provider (hcp) reported via the company representative (rep) that at first the patient complained that there was an issue with their recharger but it was established this was not the issue following replacement of the recharger. The patient was recharging twice to four times a day and cannot get the charge up past 50%. There was also heating at the electrodes after one hour of charging. Impedance checks were done, which were stable as they have been over the past year, and the recharger replaced all settings. It was suspected that there was a fluid short due to the impedance values and heat sensation. It was suggested that they would assess to see how the patient gets on but had a slot the following day if they decide they wanted to remove the implantable neurostimulator (ins). The rep confirmed that the ins was explanted and replaced. The patient was doing fine with no recharging issues and no feeling of heat. The battery change seemed to have resolved the issue. It was noted the surgeon was yet to confirm if the battery was kept as he suspects the hospital did not keep it for return and analysis. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 3389, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5025145
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dennis100
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« Reply #3 on: September 07, 2015, 07:19:36 AM »

Model Number 37601
Event Date 02/12/2015
Event Type Malfunction
Manufacturer Narrative
Product id 3389s-40, lot# va0pdv4, implanted: 2015 (b)(6); product type lead product id 3389s-40, lot# va0pdv4, implanted: 2015 (b)(6); product type lead product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2015 (b)(6); product type extension product id 37642, serial# (b)(4); product type programmer, patient. (b)(4).

Event Description
The consumer reported that the area around the implantable neurostimulator (ins) felt warm. The patient's deep brain stimulator provided no beneficial effect and had actually participated in the regression of the patient's symptoms. Following implant the patient's diagnosis was changed from parkinson's disease to progressive supranuclear palsy. Palpation of the device by the patient and his wife had led to the warmth and observation had led to the lack of efficacy. Impedances were checked and all were within normal range. The manufacturing representative and patient's wife were unable to feel a difference in the ins site from the surrounding areas in terms of warmth when the patient was seen on (b)(6) 2015. No interventions were taken and the ins was off. It was unknown if the issue had resolved. The patient had an appointment scheduled for (b)(6) 2015. Further follow-up is being conducted for the cause of the event. If additional information is received a supplemental report will be submitted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5025178
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dennis100
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« Reply #4 on: September 07, 2015, 07:20:22 AM »

Model Number 37601
Event Date 07/14/2015
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3389s-40, lot# va0fghq, implanted: (b)(6) 2014, product type: lead. Product id 3389s-40, lot# va0fghq, implanted: (b)(6) 2014, product type: lead. Product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id 3708640, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. Product id 3389s-40, lot# va0fghq, implanted: (b)(6) 2014, product type: lead. Product id 3389s-40, lot# va0fghq, implanted: (b)(6) 2014, product type: lead. (b)(4).

Event Description
The patient reported via the manufacturer representative that their device was "running warm" and that the skin above the device was red/purple in color and very warm to the touch. This indicated that the warm was running to the brain. The patient first started experiencing the sensation of the implantable neuro stimulator running warm on (b)(6) 2015. The patient saw their health care provider (hcp) on (b)(6) 2015. There were no circumstances that the patient could recall that would have led to the device running warm, they had just noticed that it felt warm, the extension line was sensitive to touch and the skin over the device had fluid over it. The skin was warm, became pink and then red. The hcp felt that it was blood flow and instructed her to wash the area and contact him if she noticed any pain. The patient was admitted to the hospital and the implantable neuro stimulator (ins) and lead were removed. The patient was on intravenous antibiotics (iv) on (b)(6) 2015. The indication for use (ifu) was movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5032569
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dennis100
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« Reply #5 on: September 19, 2015, 03:15:46 AM »

Model Number NEU_INS_STIMULATOR
Event Date 08/06/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4). (b)(6).

Event Description
It was reported the patient "frequently felt that the implantable neurostimulator (ins) got warm while charging. " the issue reportedly was "starting already after about 15 minutes. " no further information was reported regarding the event. Additional information has been requested regarding potential actions and interventions and to determine the patient's outcome. A supplemental report will be filed if additional information is received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5042821
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