Pages: [1]   Go Down
Print
Author Topic: Fibromyalgia  (Read 737 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« on: September 18, 2018, 08:36:56 AM »

Model Number 102
Event Date 12/01/2010
Event Type  Injury   
Event Description
On (b)(6) 2013, the patient reported that she has been having very bad digestion issues and difficulties swallowing since (b)(6) 2010. She stated that both issues started around the same time and said she has been to many specialists and physicians for the issue. The patient described the difficulty swallowing as "her food won't go down"; and confirmed that she was not vomiting her food back up, but was having a difficult time getting it to her stomach. Per the patient, solid foods will not digest at all and only liquids go down, but they go down very slowly. The patient stated that she has had many tests performed and has tried several different diets (e. G. The gluten-free diet, sugar free-diet, and dairy-free diet); however, nothing has worked and there has been no improvement. The patient explained that she has been diagnosed with gastroparesis and stated that several physicians believe her vagus nerve has been damaged. Per the patient, her physicians have stated that the vns device has caused nerve damage to her vagus nerve which has caused her to stop digesting food to her stomach. The patient's device stimulates for 30 seconds every 3 minutes, but the difficulty swallowing and digestion problems occur constantly and not just with stimulation. Per the physician's suggestion, the patient's device was turned off on (b)(6) 2013. Additionally, the patient stated that she has gained weight since (b)(6) 2012 as a result of the various diets she has been placed on. The patient stated that since this time she experiences shortness of breath with exertion that occurs all the time and not just with stimulation. Secondly, the patient began experiencing pain under her right rib which started when she gained weight in (b)(6) 2012. The pain was described as a constant pain that has gotten worse over time. This pain gets worse when the patient tries to eat or drink anything. At the time of this report, the patient stated that she had only had her vns device programmed off for a couple hours, but the pain has already lessened, though it was still present. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.
 
Event Description
On (b)(6) 2013 the physician reported that the patient had gastroparesis and laryngeal difficulty. Per the physician, the patient¿s entire vns system was removed in (b)(6) 2013 with nothing in the operative note indicating nerve damage.
 
Manufacturer Narrative
This device was implanted to treat fibromyalgia which is an unapproved indication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3096041
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #1 on: September 18, 2018, 08:38:22 AM »

Event Date 11/01/2006
Event Type  Injury   
Event Description
An article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that 2 study participants experienced worsening depression, reportedly due to the device and stimulation. This mdr was submitted to report the worsening depression of the first participant. Attempts for add'l pt and event info have been unsuccessful to date.
 
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.
 
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324439
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #2 on: September 18, 2018, 08:40:47 AM »

Event Date 11/01/2006
Event Type  Injury   
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.
 
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.
 
Event Description
An article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on (b)(6) 2011. During the review of the article it was reported that a study participant developed an infection and fever following implant. Attempts for add'l pt and event info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324437
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #3 on: September 18, 2018, 08:41:46 AM »

Event Date 11/01/2006
Event Type  Injury   
Event Description
An article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that 4 study participants experienced sleep disturbances including worsening of their pre-existing obstructive sleep apnea and/or insomnia. This was reportedly related to the device or stimulation. The specific event that each participant was experiencing is unk. This mdr was submitted to report the event experienced by the first participant. Attempts for add'l pt and event info have been unsuccessful to date.
 
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.
 
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324464
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #4 on: September 18, 2018, 08:42:58 AM »

Model Number 102
Event Date 11/21/2006
Event Type  Malfunction   
Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.
 
Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.
 
Manufacturer Narrative

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.
 
Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.
 
Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2405008
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #5 on: September 18, 2018, 08:48:56 AM »

Event Date 11/01/2006
Event Type  Injury   
Event Description
Follow up was performed with the authors of the article. It was indicated that no other information, besides what was available previously in the paper, would be available for disclosure. Per the reporter, information was previously provided to the manufacturer on issues which the authors deemed to be significant; however this cannot be confirmed as patient information was not provided.
 
Event Description
An article titled "safety and efficacy of vagus nerve an article titled "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial" was received and reviewed on 10/03/2011. During the review of the article, it was reported that a participant developed an upper respiratory infection following implant. Attempts for add'l pt and event info have been unsuccessful to date.
 
Manufacturer Narrative
Citation: lange, gudrun, malvin n. Janal, allen maniker, jennifer fitzgibbons, malusha fobler, dane cook, and benjamin h. Natelson, "safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase i/ii proof of concept trial". Pain medicine 2011; 12: 1406-1413.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2324465
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #6 on: September 18, 2018, 08:51:36 AM »

Model Number 102
Event Date 08/11/2011
Event Type  Injury   
Event Description
Additional information was received that they have tried to increase the patient's settings but she developed ringing in her ears. The patient reported that her vns has been moving. About a year ago she was run over by a horse and has had issues with vns since. She was in the hospital for concussion. It was reported her lead was ok. She was seen by a surgeon and the generator for the device has become dislodged from the subclavicular area into her left breast. This is causing tension on the implant wires and the device is quite painful within her breast. She feels the device is still functional and she can feel when it activates with temporary hoarseness. Fiberoptic laryngoscopy shows normal true vocal fold movement. She does have some baseline hoarseness and she does smoke. Her seizures have been under much better control with the device. If the patient has surgery they will attempt to create a new pocket higher on the chest and secure the implant to the pectoralis fascia. At this time surgery is not scheduled.
 
Event Description
The patient's generator was confirmed to have migrated during revision surgery. The suture attaching the generator in the pocket had become dislodged likely when the patient fell off their horse. The product analysis was completed on the patient's explanted lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the explanted generator. Although the reported allegation of "painful stimulation", "increased seizures", and "pain" cannot be evaluated in the laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, addressing the allegations of "painful stimulation" and "pain". In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
It was reported that the patient was feeling a "shocking feeling" in chest near generator when sleeping on side. Per patient, a horse fell on her, and she had an x-ray in (b)(6) 2010. Further information reveals that the patient also has pain in her neck and chest below the neck and has experienced an increase in seizures recently. Per reporter, the lead was checked awhile ago and everything was okay. The patient later went to the er due to the pain and she feels her generator is moving around. Attempts for further information have been unsuccessful to date.
 
Event Description
Additional information was received from the patient. She reported that diagnostics had been run on her vns since her horse accident. She reported that one time they were inconclusive and then the next time they were fine. She also mentioned that sometimes she has a pain with stimulation and then at times the magnet doesn't always work and she has to swipe it twice. The patient had a prophylactic replacement of their lead and generator. Their explanted products were returned for analysis and they are pending completion. The patient's voice alteration was a preexisting condition, but she still had it with vns stimulation as well.
 
Event Description
Further information reveals that the patient has fibromyalgia and other problems, so her personality changes quite a bit and she blames things. The patient also had an ear infection that has been treated. Recent diagnostic tests were normal and ok (system and normal mode). Her vns settings have been the same since she's had it, once it reached a therapeutic dose. Nothing has changed with her other than her other non-vns related issues. There has not actually been an increase in seizures, she just had one. She said she has not had any seizures in 6 months, and this seizure was believed to be due to the ear infection and sickness. It is unknown whether chest pain is due to stimulation. The patient taped the magnet over her chest for days and had no stimulation, but said she still had the pain occasionally. The physicians do not know what the pain is from, possibly anxiety. It is unknown what kind of suture was used to secure the generator. The patient had previously indicated that a horse fell on her, but diagnostics were normal after that event. No patient manipulation of device has occurred. No interventions have been taken.
 
Manufacturer Narrative
Cyberonics, inc. Submits this report to comply with 21 c. F. R. Part 803, the medical device reporting regulation, based on information that cyberonics has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2353195
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #7 on: January 07, 2019, 03:11:03 AM »

Model Number 302-20
Event Type  Injury   
Event Description
On (b)(6) 2014, the nurse reported that the patient has vocal cord paralysis, but the patient has not been seen yet. Follow up with the physician found that the patient was supposed to bring in their old clinic notes to their appointment, but the patient was a no-show. No other information was provided.
 
Event Description
The patient reported permanent vocal cord paralysis. The patient has not been evaluated for vocal cord paralysis, but did report to her currently treating physician that her vocal cord does work on the left side. The patient does have a medical history of unrelated health issues, such as fibromyalgia and laryngeal cancer.
 
Manufacturer Narrative

Manufacturer Narrative
Brand name, corrected data: the initial report inadvertently reported the incorrect data. Model #, serial #, lot #, expiration date, corrected data: the initial report inadvertently reported the incorrect data. Device manufacture date, corrected data: the initial report inadvertently reported the incorrect data.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3627219
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #8 on: January 23, 2019, 02:35:11 AM »

Pain Med. 2011 Sep;12(9):1406-13. doi: 10.1111/j.1526-4637.2011.01203.x. Epub 2011 Aug 3.

Safety and efficacy of vagus nerve stimulation in fibromyalgia: a phase I/II proof of concept trial.

Lange G1, Janal MN, Maniker A, Fitzgibbons J, Fobler M, Cook D, Natelson BH.

Author information

Abstract

OBJECTIVE:
We performed an open-label Phase I/II trial to evaluate the safety and tolerability of vagus nerve stimulation (VNS) in patients with treatment-resistant fibromyalgia (FM) as well as to determine preliminary measures of efficacy in these patients.

METHODS:
Of 14 patients implanted with the VNS stimulator, 12 patients completed the initial 3-month study of VNS; 11 patients returned for follow-up visits 5, 8, and 11 months after start of stimulation. Therapeutic efficacy was assessed with a composite measure requiring improvement in pain, overall wellness, and physical function. Loss of both pain and tenderness criteria for the diagnosis of FM was added as a secondary outcome measure because of results found at the end of 3 months of stimulation.

RESULTS:
Side effects were similar to those reported in patients treated with VNS for epilepsy or depression and, in addition, dry mouth and fatigue were reported. Two patients did not tolerate stimulation. At 3 months, five patients had attained efficacy criteria; of these, two patients no longer met widespread pain or tenderness criteria for the diagnosis of FM. The therapeutic effect seemed to increase over time in that additional participants attained both criteria at 11 months.

CONCLUSIONS:
Side effects and tolerability were similar to those found in disorders currently treated with VNS. Preliminary outcome measures suggested that VNS may be a useful adjunct treatment for FM patients resistant to conventional therapeutic management, but further research is required to better understand its actual role in the treatment of FM.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00294281.

Wiley Periodicals, Inc.

PMID: 21812908 PMCID: PMC3173600 DOI: 10.1111/j.1526-4637.2011.01203.x

[Indexed for MEDLINE] Free PMC Article

https://www.ncbi.nlm.nih.gov/pubmed/21812908
Logged
Pages: [1]   Go Up
Print
Jump to: