Pages: [1]   Go Down
Print
Author Topic: Drooling  (Read 4748 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« on: January 01, 2016, 12:08:18 PM »

Model Number 103
Event Date 06/28/2013
Event Type Injury
Event Description
It was reported that the patient's vns device was checked on (b)(6) 2015 and it was requested by the patient's mother not to increase settings due to continued drooling. Diagnostics were checked and were within normal limits.

Event Description
Clinic notes dated (b)(6) 2013 indicated that the patient was seen for activation of the recently implanted vns. It was noted that the vns was interrogated to confirm the output current and magnet currents were zero. The vns was then activated to 0. 25ma and the patient experienced hoarseness and drooling. It was noted that the patient was given water to drink which resulted in gagging. The vns was then programmed off and it was noted that the hoarseness and drooling returned baseline. The patinet was referred to ent for an evaluation. It was reported that the ent confirmed left vocal cord paresis with some movement. It was noted that the patient will return to ent in two weeks for reassessment of vocal cord and that when the symptoms resolve the vns will be activated. Attempts to obtain additional information have been unsuccessful to date.

Event Description
The nurse practitioner believes the vocal cord paralysis is related to vns as it appeared immediately post-operatively and feels it is related to the surgical presence of the vns. It was reported that the patient still has vocal cord paralysis, but her symptoms are slightly improved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3309457
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #1 on: January 07, 2016, 06:50:01 AM »

Model Number 102
Event Date 01/01/2012
Event Type Injury
Event Description
On (b)(6) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the patient has had increased seizure activity in the past three months. The patient was noted to be having refractory complex partial seizures and now needs a battery replacement. The patient was referred for generator replacement and it was stated that the patient's battery is dead. Clinic notes dated (b)(6) 2013 mention that the patient is not currently complaining of any pinching or pain from vns that he had in the past. The patient had reported on clinic notes dated (b)(6) 2012 that "it hurts when he rolls over" and he wants his vns removed. The clinic notes dated (b)(6) 2012 stated that the paint has been having multiple seizures all day; the patient had 7 seizures between 3:45pm and 4:05pm. The nurse stated that there have been no missed doses and no new medications. The clinic notes dated (b)(6) 2012 state that the patient was seen for a follow-up because of an increased number of spells. The patient did have at least 6 of those seizures that morning, but the physician found that the patient was spending most of his nights awake watching tv or playing video games. The physician stated that the patient has worn his vns out. The clinic notes dated (b)(6) 2012 indicated that the patient has pain when lying on the left side at his vns stimulator site and again the patient expressed desire for its removal. On (b)(6) 2012 the patient underwent a 4 day video eeg as the patient recently started having different type of spells. The new spells were described as humming, drooling, aphasia, and trembling. They were noted to last about 10 seconds, but can happen multiple times a day. The spells were suspected to be behavioral especially that changing his seizure medications was not helpful. The patient underwent generator replacement surgery on (b)(6) 2013 and it was noted that there was no end of service warning upon interrogation in pre-op. The explanted generator was returned for product analysis on (b)(6) 2013. It was later reported that the reason for generator replacement was for prophylactic reasons. The physician later reported that the increased seizures were first observed around (b)(6) 2012. The physician stated that the pain the patient feels is a "pinching" sensation in the vns neck site that occurs with stimulation. No patient manipulation or trauma occurred that is believed to have caused/contributed to the pain. No further information was provided from the physician. Product analysis on the generator is still underway and has not yet been completed. A blc was performed with the programming history available which showed 9. 05 years remaining until eri=yes.

Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis 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. During the product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3001934
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #2 on: January 11, 2016, 06:57:03 AM »

Model Number 102
Event Date 01/01/2013
Event Type Injury
Event Description
It was initially reported that the patient had an infection. It is unknown at this time where the infection is located, the type of infection or the relationship to vns. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Good faith attempts for more information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Event Description
Additional information was received that the physician does not feel the infection or the drooling were related to vns. The vns is functioning fine with no issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986190
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #3 on: January 19, 2016, 01:38:57 AM »

Model Number 300-20
Event Date 10/09/2012
Event Type Malfunction
Event Description
Reporter indicated high lead impedance with vns systems diagnostics testing was noted on (b)(4) 2012 at an office visit, and a lead break is suspected. The vns was disabled. No patient trauma occurred, and the patient was sent for x-rays. The patient has also had increased seizures that are felt to be due to the high impedance. The patient has also been having excessive drooling and altered mental status with the increased seizures. Surgery to replace the vns lead and generator is likely. Attempts for further information are in progress.

Event Description
Review of the vns lead device history record confirmed the lead met all final testing specifications prior to distribution.

Manufacturer Narrative
Device failure is suspected.

Event Description
Reporter indicated the patient now wishes to proceed with vns replacement surgery. Onfi medication has been added to help with the increased seizures. A surgery date has not been set yet, but is likely in the near future.

Event Description
Surgery to replace the vns is no longer planned as the patient's family does not want to proceed with surgery. The vns remains disabled. Attempts for further information have been unsuccessful to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the lead passed all final testing specifications prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2830804
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #4 on: January 22, 2016, 08:47:50 AM »

Model Number 103
Event Date 09/26/2012
Event Type Injury
Event Description
Reporter indicated a patient had debridement surgery at the vns generator site on (b)(6)2012 due to infection. The generator was not explanted. The patient is currently doing very well and was recently seen. The infection is resolving and the patient is healing. The patient has completed her course of antibiotics and has been released back to the care of neurology, and will follow up with the surgeon only if needed. The patient had no trauma, but she does drool a lot, and this may have been a factor in the infection. It is also possible the patient may have picked at the incision. Cultures of the wound were performed, but there was no growth.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2801936
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #5 on: March 01, 2016, 04:49:41 AM »

Event Date 09/09/2011
Event Type Injury
Event Description
The pt's husband reported that he wanted the device removed. Per the reporter, the pt had "nothing but problems and they had to have it shut off and now they have to have it removed". Specifics were requested, but the report only stated the pt "drooled a lot and had difficulties". Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276546
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #6 on: April 21, 2016, 02:25:28 AM »

Model Number 103
Event Date 08/01/2010
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Results: review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that a vns patient developed an infection at the generator site area due to patient continually drooling on the incision and eventually picking at the incision. The patient recently had undergone a generator replacement surgery 2 months prior to the reported event of infection. The generator was explanted and will be re-implanted when the infection dissipates. At the moment, it is unknown if cultures were taken as good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1830960
« Last Edit: July 20, 2018, 12:44:35 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #7 on: July 19, 2016, 10:52:27 AM »

Event Date 04/13/2014
Event Type Injury
Event Description
Additional information was received that confirmed that the patient did have a history of swallowing issues with aspiration and the issues with the drooling and aspiration pneumonia are unrelated to vns.

Event Description
It was reported that the patient has experienced drooling since changes in device settings from 30 seconds on and 5 minutes off to rapid cycling (7 seconds on; 0. 3 minutes off). The patient's father reported that the patient has fluid in her lung with fever of 105 degrees. The patient's father reported that the patient has probable aspiration pneumonia and he is driving the patient to the hospital. It was reported that the patient would be seen by the physician to change device settings back to previous settings. The patient has a pre-vns history of swallowing issues with aspiration. Attempts to obtain additional relevant information have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892553
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #8 on: July 20, 2016, 02:14:37 AM »

Model Number 102
Event Date 02/02/2015
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on (b)(6) /2015 that the patient is having violent coughing and drooling each time he swipes the magnet. It was noted that they tried that day to increase the output current to 1. 5 ma and keep everything else the same, but he had another coughing and drooling ¿attack. ¿ after decreasing settings, back to 1. 25ma the symptoms resolved and he hasn't had issues since (b)(6) 2015.

Event Description
Physician decreased pulse width on (b)(6) for more tolerability and patient is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4570298
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #9 on: July 21, 2016, 01:39:35 AM »

Event Date 09/09/2011
Event Type Injury
Event Description
The pt's husband reported that he wanted the device removed. Per the reporter, the pt had "nothing but problems and they had to have it shut off and now they have to have it removed". Specifics were requested, but the report only stated the pt "drooled a lot and had difficulties". Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276546
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #10 on: March 10, 2017, 05:12:41 AM »

Model Number 101
Device Problem No Known Device Problem
Event Date 10/12/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient¿s generator was at end-of-service. Upon follow-up for whether they wanted to replace the device, it was decided that the family did not want to pursue the replacement as stating that the patient is "drooling and now has a trach". Follow-up to the treating physician provided that the vns had been at end-of-service for a while and it was provided to be unclear that the drooling and presence of the trach tube was related to vns. The physician provided that the device exacerbated sever sialorrhea. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6296329
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #11 on: May 14, 2017, 12:04:19 AM »

Model Number 102
Event Date 06/12/2008
Event Type Injury
Event Description
Reporter indicated a vns patient presented with excessive drooling. The patient's mother stated the patient had a stroke as a result of brain surgery. After the stroke, the patient began to have drooling issues. The drooling got better, but did not resolve with setting adjustments. A fluoroscopy determined the patient would aspirate liquids and is now having to "thicken" the patient's fluid intake. Device diagnostics are within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1150407
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #12 on: August 16, 2017, 04:11:54 AM »

Model Number 102
Event Date 01/01/2005
Event Type  Malfunction   
Event Description
During a retrospective study of a multi-center pt record review for pt's previously implanted in europe, it was indicated that the pt's drop attacks were noted as increasing at the 1-year follow-up visit. It was also noted that the pt was experiencing "severe difficulties in swallowing and dribbling having a knock on effect on eating - leading to severe weight loss. " the manufacturer's programming history database was reviewed, which indicated that the pt's last known diagnostics were within normal limits. Good faith attempts have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2260299
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #13 on: July 06, 2018, 08:27:44 AM »

Model Number 1000
Device Problem No Known Device Problem
Event Date 05/14/2018
Event Type  Injury   
Manufacturer Narrative
Patient problem :1815.
 
Event Description
It was reported that a patient was just implanted with a m1000 device and the device was turned on to the lowest settings. It was stated that the patient was holding his breath and turning blue and aspirating and having a difficult time swallowing. The patient is non-verbal. The patient is also drooling more and choking on his spit. The np advised to go to the emergency room. They instructed the patient to turn device off by placing the magnet over it. The patient's diagnostics were good. The patient is tolerating current settings. It was stated that the believed cause of the issue was possible side effects due to being high risk patient. The patient's settings are going to be increased and the np will monitor the patient's progress. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7569735
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #14 on: July 20, 2018, 12:45:23 AM »

Event Date 06/13/2006
Event Type  Injury   
Event Description
It was reported in an article following pediatric patients that were implanted with vns, that a patient with right hemisphere epilepsy experienced excessive drooling and aspiration pneumonia on higher current settings, which were resolved with lowering the current intensity. The patient's device was turned off 42 months after implantation due to lack of clinical benefit. There is no allegation of device malfunction. Good faith attempts to obtain additional information from the author of the article have been unsuccessful to date.
 
Manufacturer Narrative
Article: long-term results with vagus nerve stimulation in children with pharmacoresistant epilepsy. Alexopoulos, a. Et al. Seizure 2006 pp. 1-13. See scanned pages.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1303637
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63980


« Reply #15 on: November 26, 2018, 04:34:22 AM »

Model Number 102
Event Date 04/03/2013
Event Type  Injury   
Manufacturer Narrative
Initial report inadvertently listed wrong event date.

Event Description
It was reported that the patient's seizures have worsened and that the patient's symptoms such as control of head/neck movement, and drooling have been worsening. The patient underwent surgery on (b)(6) 2013 where the vns generator was replaced. Attempts to return the product to the manufacturer for product analysis are underway. Attempts to contact the physician regarding the events have been unsuccessful to date. A battery life calculation was performed using the available programming history and resulted in 3. 41 years until end of service.

Event Description
New information was received from the physician¿s office stating that the increased seizures were noted on (b)(6) 2013, and the reason of the increased seizures was that the vns generator needed to be replaced. On (b)(6) 2013 the patient¿s seizures became better and the seizures were back to normal. The patient¿s muscle weakness and the drooling were not reported to the patient¿s physician. The explanted vns generator will not be returned to the manufacturer due to the site¿s policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3097519
Logged
Pages: [1]   Go Up
Print
Jump to: