Pages: 1 ... 9 10 [11]   Go Down
Print
Author Topic: Deep brain stimulator - Misc. Adverse Events  (Read 101111 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #300 on: August 08, 2015, 09:32:47 AM »

Model Number 37601
Event Date 12/15/2012
Event Type Injury
Event Description
It was reported the patient had a urinary tract infection and retention. Penicillin was administered and the patient was hospitalized. The retention required an invasive therapeutic procedure. The urinary tract infection was related to the study and the retention was related to the study and implant procedure. Both the retention and infection were resolved.

Manufacturer Narrative
Concomitant products: product id 3387s-40, lot # v986836, product type lead; product id 3387s-40, lot # v 986836, product type lead; product id 37085-60, serial # (b)(4), product type extension; product id 37085-60, serial # (b)(4), product type extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4891557
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #301 on: August 08, 2015, 09:33:34 AM »

Model Number 37601
Event Date 01/01/2014
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# va0b8zw, product type: lead; product id 3387s-40, lot# v a0b8zw, product type: lead; product id 3708660, serial# (b)(4), product type: extension; product id 3708660, serial# (b)(4), product type: extension. (b)(4).

Event Description
It was reported the patient had urinary retention that was related to the implant procedure and study. Corrective action was noted as other but was not specified. The event was considered resolved. If additional information is received a follow-up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4891885
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #302 on: August 08, 2015, 09:34:11 AM »

Model Number 37601
Event Date 01/30/2013
Event Type Injury
Event Description
It was reported the patient had urinary retention that was related to the implant procedure and study. No intervention was noted and the event was considered resolved.

Manufacturer Narrative
Concomitant medical products: product id 3387s-40, lot# v986836, product type: lead; product id 3387s-40, lot# v 989565, product type: lead; product id 3708660, serial# (b)(4), product type: extension; product id 3708660, serial# (b)(4), product type: extension. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4892094
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #303 on: August 08, 2015, 09:35:10 AM »

Model Number 7428
Event Date 06/17/2015
Event Type Injury
Event Description
It was reported that 48 hours ago the patient was going through airport security and he passed through a medical detector. After passing through the patient sat near a security archway for about 15 minutes and then was required to pass through again. The patient was hospitalized, and had gone from a fully functional brain to now not able to hold a thought; he was unable to make a sentence and does not know where he is. The patient¿s wife described the patient¿s dementia as off the chart. The patient was incoherent and has been strapped down for safety. The patient¿s device was confirmed to be on, but the settings were unknown. Loss of therapy was reported. The patient¿s wife was trying to get a hold of the patient¿s implant doctor, but the doctor was currently away; she was going to try to get the patient transferred to his city. Follow up was performed but no additional information was available. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4900086
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #304 on: August 08, 2015, 09:35:53 AM »

Model Number 37603
Event Date 01/02/2013
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 3708660. Serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3389-40, lot# v005943, implanted: (b)(6) 2006, product type: lead. (b)(4).

Event Description
It was reported that the patient had a pain/tugging sensation which was on her left side when the patient would move her head to right side following plant on (b)(6) 2013. The pain/tugging sensation was located on the patient¿s head. The left deep brain stimulator device was removed in (b)(6) 2013 due to a confirmed infection. The device had been contaminated when it was inserted; the patient had had immediate symptoms of infection. The infectious disease team had confirmed the implantable neurostimulator (ins) was contaminated when it was implanted in the patient. The area of the infection was the ins. Symptoms included redness around body and ins site on the left and pain in the head and body. The infection had gone down with oral medication but medication had only suppressed infection and then it had come back worse. The entire device including leads was removed; it was unclear what was removed because additional information indicated half the device was taken out from the left side. Since the left side was removed the patient had had a hard time not leaning head to the left. The patient¿s whole body leaned left from her waist up. The patient had not had torticollis before the left side was taken out. There was torticollis of the head and torso. The patient still had the device on the right side and was interested in getting another device on the left side.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4935490
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #305 on: August 08, 2015, 09:36:31 AM »

Model Number NEU_INS_STIMULATOR
Event Type Injury
Event Description
It was reported that the patient began convulsing during a mri because the implantable neurostimulator (ins) had not been turned down to 0 volts. The ins was toggling on and off during the mri. The reporter pulled the patient from the mri and then the convulsing movements stopped. The ins was turned down to 0 volts and the mri was conducted without incident. The reporter estimated that this event occurred three to five years ago, but was not sure. The patient had a ¿legacy dbs system,¿ but the reporter was unsure of what device was involved. The reporter had no further information, such as the patient or healthcare provider (hcp) name.

Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_ext, product type: extension. Product id: neu_unknown_lead, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4950570
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #306 on: September 07, 2015, 07:27:50 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #307 on: September 07, 2015, 07:28:50 AM »

Model Number 37602
Event Type Injury
Event Description
The consumer reported that the patient¿s symptoms had returned and they could not ¿stand sit down or eat and sleep¿ beginning in (b)(6) 2015. A loss of stimulation and therapy was reported. The patient was on medication, but this was not helping. The patient was also drowsy and was said to have hallucinations at night. The consumer wanted to have the device checked because they thought the battery was low or depleted, however the patient programmer had not been used to check the device because they were afraid to use it. No diagnostics/troubleshooting, actions/interventions, or patient outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indication for use: movement disorders.

Manufacturer Narrative
Concomitant products: product id: 37602, serial# (b)(4), implanted: (b)(6) 2013, product type: implantable neurostimulator. Product id: 3389-40, lot# l84348, implanted: (b)(6) 2000, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. Product id: 3389-40, lot# l84348, implanted: (b)(6) 2000, product type: lead. Product id: 7495-51, serial# (b)(4), implanted: (b)(6) 2000, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4977096
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #308 on: September 07, 2015, 07:29:42 AM »

Model Number 7426
Event Type Malfunction
Event Description
(b)(4): the consumer reported that they've had three deep brain stimulator (dbs) devices and they "are not working. " no interventions, troubleshooting, potential causes or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indications for use: essential tremor movement disorders.

Manufacturer Narrative
Concomitant: product id 7426, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2013-(b)(6), product type implantable neurostimulator. Product id 7482a51, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type extension. Product id 3389s-40, lot# v210850, implanted: 2010-(b)(6), explanted: 2014-(b)(6), product type lead. Product id 7482a51, serial# (b)(4), implanted: 2010-(b)(6), product type extension, product id 7438, serial# (b)(4), product type programmer, patient. Product id 3389s-40, lot# v561214, implanted: 2011-(b)(6), product type lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001804
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #309 on: September 07, 2015, 07:30:40 AM »

Model Number 37602
Event Type Malfunction
Event Description
A consumer reported they had a loss of therapy and therapy was intermittent and erratic. The patient wanted to know why their deep brain stimulation (dbs) was not working. The patient's indication for use is essential tremor and movement disorders. The patient had worked with a manufacturing representative multiple times and they kept trying to "regulate" and reprogram the implantable neurostimulator (ins). The patient would think the ins was fine, but two days after reprogramming the therapy would quit doing what it was supposed to and the patient would start shaking again. The problem started prior to the patient having their current ins implanted. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant product(s): product id: 3387s-40, lot# v176477, implanted: (b)(6) 2009, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5010677
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #310 on: September 07, 2015, 07:31:21 AM »

Model Number 37603
Event Type Malfunction
Manufacturer Narrative
Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6)2014, product type: extension. Product id: 3389s-40, lot# va0mm43, implanted: (b)(6)2014, product type: lead. Product id: 37602, serial# (b)(4), implanted: (b)(6)2013, product type: implantable neurostimulator. Product id: 3389s-40, lot# v561214, implanted: (b)(6)2011, product type: lead. Product id: 7482a51, serial# (b)(4), implanted: (b)(6)2010, product type: extension. (b)(4).

Event Description
The health care provider (hcp) reported via the consumer and the consumer themselves reported that they've had three deep brain stim ulator (dbs) devices and they "are not working. " the patient's tremors were getting worse and they had not been to the doctor until three days prior. The patient's hcp had reportedly stated that they had "done all [they] could do. " the hcp had reportedly given up on programming. No interventions, potential causes, or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow-up report will be sent. Indications for use: essential tremor movement disorders.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5001003
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #311 on: September 07, 2015, 07:32:13 AM »

Model Number 37612
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3387s-40, lot# va0v7nm, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0tkv5, implanted: (b)(6) 2015, product type: lead. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 37642, serial# (b)(4)product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

Event Description
The manufacturer representative (rep) reported that the patient was having difficulty charging and got two coupling boxes. An antenna locate had not been attempted yet, so the rep would try this with the patient. The rep also noted that the patient was thin and she could feel the implantable neurostimulator (ins) and suspected she could feel the wires on top of the ins. The pocket did not appear deep or the ins tilted. However, no x-ray had been performed to check. There were no associated symptoms. On (b)(6) 2015 the rep further reported that the patient got a maximum of two bars in coupling. They reportedly used the metal detector and it was still no better. The doctor ordered and x-ray of the ins and it showed the ins had flipped. The patient would be scheduled for surgery to flip the ins back. The patient's indications for use were parkinson's dual and movement disorders. No patient outcome was reported, so additional information was requested. If additional information is received a supplemental report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5024688
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #312 on: September 07, 2015, 07:33:07 AM »

Model Number 7428
Event Date 05/04/2009
Event Type Injury
Manufacturer Narrative
Concomitant medical products: product id: 3389-40, lot# v004936, implanted: (b)(6) 2006, product type: lead. Product id: 3389-40, lot# v004137, implanted: (b)(6) 2006, product type: lead. Product id: 7436, serial# (b)(4), implanted: (b)(6) 2006, product type: programmer, patient. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2006, explanted: (b)(6) 2009, product type: extension. Product id: 3389-40, lot# v004936, implanted: (b)(6) 2006, product type: lead. Product id: 3389-40, lot# v004137, implanted: (b)(6) 2006, product type: lead. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. Product id: 748266, serial# (b)(4), implanted: (b)(6) 2009, product type: extension. (b)(4).

Event Description
A consume reported the patient's deep brain stimulation (dbs) system was now inactive. The surgery never worked for the patient and the surgeon placed the wires in the wrong place. The patient went through four more surgeries that were all unsuccessful. The reporter believed the surgery would have been successful had they gone to another health care provider (hcp). The reporter was not sure if it was something with the hcp or the device. The patient's indication for use is parkinson's dual. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021582
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #313 on: September 07, 2015, 07:33:57 AM »

Model Number 7424
Event Date 07/17/2015
Event Type Injury
Manufacturer Narrative
Concomitant products: product id: 7495-25, serial# (b)(4), implanted: (b)(6) 1991, product type: extension. Product id: 3487a, lot# l20847, implanted: (b)(6) 1991, product type: lead. (b)(4).

Event Description
The consumer reported that they had a deep brain stimulation device that was used for pain stimulation therapy and it was removed years ago. The patient believed that it was 15 years ago. The patient went in to see his health care provider (hcp) for a check-up and the hcp ¿fiddled with it and he got it cranked up and he couldn¿t shut it down, he was jumping and hopping around from the pain of the shocks. ¿ the hcp put the ¿telephone up to his side to program the device. ¿ after this was done, an assistant was able to turn the device off. The patient was followed up with a wanted to be left alone as he already reported that the device was taken out. The indication for use (ifu) that is known is pain stimulation therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4976965
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #314 on: September 07, 2015, 07:34:42 AM »

Model Number 37601
Event Date 08/11/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
A manufacturing representative reported that a health care provider discovered a hair in the packaging of an implantable neurostimulator (ins). The ins was not implanted and a new one was used.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5035643
« Last Edit: September 19, 2015, 12:31:27 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59179


« Reply #315 on: September 19, 2015, 12:34:17 AM »

Model Number 37601
Event Date 07/25/2015
Event Type Malfunction
Event Description
A consumer reported the felt a little off. Stimulation was verified to be on and the patient had not made any adjustments. When the patient turned their head to the far right, the wires felt loose. The wire was implanted on the left side of the patient's neck. The patient had fallen backwards off of a bicycle the day prior to this report, but the feeling of being a little bit off started before that. While the patient was at the hospital for speech therapy, they stopped by their neurologist's office and they were not able to see them. The patient's indication for use is parkinson's disease. There had been no changes in the patient's medication. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

Manufacturer Narrative
Concomitant medical products: product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 37085-60, serial# (b)(4), implanted: (b)(6) 2011, product type: extension. Product id: 3389s-40, lot# v535392, implanted: (b)(6) 2011, product type: lead. Product id: 3389s-40, lot# v632892, implanted: (b)(6) 2011, product type: lead. (b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5021997
Logged
Pages: 1 ... 9 10 [11]   Go Up
Print
Jump to: