Pages: 1 ... 16 17 [18] 19   Go Down
Print
Author Topic: Magnet  (Read 67486 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #510 on: February 09, 2019, 01:40:04 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
Information was received that the patient's device was spontaneously going into magnet mode whether the device was enabled or disabled the patient was reported have painful stimulation and tightness at the generator site. It was also reported that the device was cycling every seven seconds despite parameter changes. Diagnostics from the physician was reported to be fine. Information was later received that the patient's generator was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8265182
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #511 on: February 11, 2019, 01:52:52 AM »

Model Number 103
Event Date 07/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient presented an increased number of seizures for the past six months. Aed were added for treatment. Vns parameters were increased. There were no changes to medication or vns settings or other external factors that preceded the onset of the increase in seizures. The generator battery appeared to be nearing end of service which was believed to be the cause of the patient¿s increase in seizures. It was noted that the patient¿s magnet was not aborting the patient¿s seizures. The patient¿s device was tested and system diagnostic results showed normal device function. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4472980
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #512 on: February 11, 2019, 01:53:33 AM »

Model Number 102
Event Date 01/05/2015
Event Type  Injury   
Event Description
It was reported that the vns patient had six seizures in one week in 25 minutes and that the magnet was not aborting the seizures. The patient was subsequently admitted to the hospital. The patient was reported to have a uti and a high intake in soda which may have triggered the seizures. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2007. A battery life calculation using the available programming history showed approximately 2. 6 years remaining. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4485095
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #513 on: February 12, 2019, 03:07:37 AM »

Model Number 102
Device Problem Device Operates Differently Than Expected
Event Date 06/20/2014
Event Type  Injury   
Event Description
It was reported that the vns patient felt her generator moving and flipping in her chest which was causing burning sensations. The patient¿s device was tested and showed normal device function. The patient previously reported that her magnet was not aborting her seizures and that magnet mode stimulation was causing burning sensations in the chest. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
It was found from the surgeon's office who had originally implanted the generator in 2012 that the generator was secured with a non-absorbable silk suture during implantation.
 
Event Description
The patient's generator was explanted and replaced on (b)(6) 2015. The patient's device was discarded after explant and will therefore not be received for analysis.
 
Manufacturer Narrative

Event Description
It was reported that the patient underwent surgery to remove the generator from the chest pocket, and place it in the left shoulder. The patient experienced more discomfort following the repositioning of the generator. Additional surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4535345
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #514 on: February 13, 2019, 01:31:24 AM »

Model Number 103
Event Date 01/01/2015
Event Type  Injury   
Event Description
It was reported that patient's asthma attack was never a problem previously and the patient had a desat of 80. For intervention, the physician decreased the magnet and normal pulse width.
 
Manufacturer Narrative

Event Description
It was reported that the patient's mother indicated that the patient was taken to the hospital because he could not catch his breath and was coughing and wheezing. The hospital indicated that the patient was experiencing an asthma attack and would need to be placed on medication. The patient's mother reported that magnet mode stimulation was initiated during a seizure and the patient's asthma worsened and the patient could not catch his breath. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4517482
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #515 on: February 16, 2019, 02:06:25 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #516 on: February 17, 2019, 06:05:21 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/14/2017
Event Type  Injury   
Event Description
It was reported by the patient that she felt like she was having a heart attack and questioned if the vns would make you feel like that. It was explained to the patient that vns does not make you feel like that. The patient took some of her husband's nitroglycerin, which made her feel better. She explained that she still felt that she had a knife stabbing her in the shoulder and her jaw hurt when using the vns magnet. The patient was urged multiple times during the call to speak with emergency care if she suspects a heart attack. The patient insisted on seeing a neurologist. It was later reported the vns was programmed off. The device history records for both the lead and the generator were reviewed and they had passed qc review prior to distribution. Attempts for further relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician's office. It was explained the patient had come in the month prior complaining of headache, left arm numbness, nausea, and chest pain. The device was programmed off and x-rays were performed. Nothing remarkable on the x-rays; the x-rays were normal. It was noted the patient came back a few days later and the physician stated since the patient was doing fine with the vns programmed off, they decided to leave it programmed off. No diagnostics were performed and it was not noted if the battery was low or not. A battery life calculation was performed showing the vns should have approximately 2 years remaining until neos = yes (near end of service), so it is not suspected the issues are due to a depleted battery. Additionally, the information available in the in-house programming history database was reviewed, and there were no anomalies observed with the patient's vns. However, the last diagnostic tests available were performed back in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489520
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #517 on: February 18, 2019, 01:16:56 AM »

Model Number 102
Event Date 06/27/2010
Event Type  Injury   
Event Description
Information was received that a vns patient was admitted to hospital for bradycardia and syncope. It was reported that the patient has recently had many episodes of syncope. They also noticed the patient had pauses on the cardiac monitoring. These pauses are erratic, lasting about 3 sec and does not coincide with stimulation. They placed the magnet over the generator for 24 hours and during that time, they didn't see anymore cases of heart pauses. No vns setting changes were made prior to the onset of the events. The patient was set at 1. 25/30/250/21/0. 5 so, a 49% duty cycle. The patient was discharged from the hospital on (b) (6), and there were no further incidents of the heart pauses or syncope, and the event was not duplicated again on the cardiac monitoring equipment. The cardiologist recommended having the patient wear a holter monitor for 20 days to monitor cardiac activity, and will re-assess the patient at that time. The device remains programmed on and per the physician he tested the device following the onset of the events, and it is operating within normal limits. The cause of the syncope and the irregular heart pauses is unknown at this time. It was reported that the patient had a myocardial infarction (mi) in (b) (6) 2010, and at that time he was put on a beta blocker medication. It is unknown if stimulation may be a contributory factor to the recent events, but their treating physician should have more information after (b) (6). Good faith attempts to obtain additional details have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1775112
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #518 on: February 21, 2019, 01:40:29 PM »

Model Number 300-20
Event Date 03/25/2015
Event Type  Injury   
Manufacturer Narrative
Evaluation codes: device failure occurred, but did not result in a death.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to jaw pain which occurred during magnet mode stimulation on-times. Clinic notes were received indicating that the patient¿s magnet mode output current was increased from 1ma to 1. 5ma during an office visit on (b)(6) 2015. The physician also attempted to increase the normal mode output current of the device from 1ma to 1. 25ma but was unable to keep this setting due to patient tolerability issues. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analyses of the returned generator and lead have been completed. Analysis concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. The positive coil was found to be protruding out (still within the outer tubing) from the inner silicone tubing at what appear to be abraded/tear openings. Also, an abraded opening was noted on the inner tubing of the negative coil. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4704217
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #519 on: February 21, 2019, 01:41:10 PM »

Model Number 303-20
Event Date 08/01/2014
Event Type  Injury   
Event Description
The lead was returned for analysis on 04/24/2015. Operative notes state that the electrode appeared to be in good shape throughout its course. It seemed to have good adhesion and attachment to the vagus nerve. There were no obvious flaws or problems that were identified. Analysis of the device is underway but has not been completed to date.
 
Event Description
Clinic notes were received dated (b)(6) 2015. Notes mention that the patient was seen for follow-up regarding her neck pain associated with vns. The patient states that swiping the magnet causes uncontrollable pain. Today he reduced her magnet settings to match the normal mode of 1. 75ma, 30sec, 250 pulse width. Normal mode diagnostics were ok. The patient noted severe pain in the areas where her vns wire seemed to protrude from her neck. The physician repeated the x-ray of her neck and compared to her prior x-ray and showed no change. The patient feels the vns has shifted. The patient had a referral in place to have the surgeon evaluate vns due to the migration focal pain and to evaluate to see if there needs to be repositioning of the device. The physician stated that way the wire is looped is very uncomfortable and has been ongoing since insertion but recently the issue is worse. The lead was replaced on (b)(6) 2015. The explanted device has not been received to date.
 
Event Description
Product analysis for the explanted lead was completed and approved on 05/20/2015. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4707673
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #520 on: February 21, 2019, 01:42:04 PM »

Model Number 103
Event Date 01/12/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient experienced pain and chest discomfort with vns stimulation when magnet was swiped. Interrogation of the generator showed that the patient¿s magnet mode output current was set higher (3. 0 ma) than what was previously programmed (2. 75 ma). The pulse width and the normal mode on time were also changed. The physician questioned about the possibility of vns settings automatically changed without the physician programming the device. The patient also mentioned that no other physician changed the vns settings. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received that the patient's vns device was programmed by a different physician on (b)(6) 2015 to the settings observed on (b)(6) 2015. It was noted that the pulse width had been decreased from 250 to 130.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702201
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #521 on: February 24, 2019, 09:07:34 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Information was received that the patient's seizure increased from (b)(6) to (b)(6) 2017. Vns was returned to original settings by april after being turned off for surgery few months back. Yet the seizures are still worse currently. Per the physician, the relation of the seizures to vns is unclear. Patient's magnet swiping technique was observed to confirm that it is effective in initiating magnet stimulation. Normal mode diagnostic test results were provided with a dcdc - 5. Patient's device was disabled for patient's hysterectomy. Following that, the settings were titrated up to 2. 75 ma. The patient experienced pain in the throat which went away when the settings were decreased to 2. 5 ma. Since then the patient noticed that vns has not helped with her seizures and wanted it removed. Patient saw a neurosurgeon, who recommended that the vns be programmed off to see changes in seizures before removing. The patient did receive benefit from vns initially but has had a lot of stress. The nurse practitioner mentioned that she can't say the increase in seizures is directly related to vns. The seizure rate in comparison to pre-vns baseline is unknown.
 
Manufacturer Narrative

Event Description
Per the neurologist's note, patient is receiving benefit from device. No known surgical interventions to remove the vns has occurred to date.
 
Event Description
Clinic notes were received for patient, who would like to have her device removed, because she feels she no longer is receiving efficacy from the therapy. Notes dated (b)(6) 2017 indicate that patient's seizure frequency is worse than before over the last several months. Patient reported that the use of the magnet has had no effect in reducing seizure frequency or aborting seizures. Since patient's visit in (b)(6), patient has ben seen several times for vns adjustment. In (b)(6) visit, patient noted that she had increased frequency of seizures and that she has had multiple different types including drop events, convulsions, and starring/spacing. Patient cannot identify any changes in her life or medication use to correspond with this worsening. Patient also tried cbd oil and found it to be somewhat helpful. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822371
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #522 on: February 27, 2019, 08:19:03 AM »

Model Number 104
Device Problem Battery Problem
Event Date 04/27/2015
Event Type  Injury 
Event Description
Information was received from the neurologist. She was unaware of the relationship between the increase in seizures and vns, if any. The patient is not having more seizures than prior to vns implant. She indicated that replacing vns is an intervention for the increased seizures. Information was received that the patient¿s generator was explanted and replaced on (b)(6) 2015. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently did not include the information which was provided by the neurologist.

Manufacturer Narrative
 
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2015 indicating that the patient had been experiencing an increase in seizures since her previous office visit on (b)(6) 2015. The seizures included gtc seizures which were noted to be previously rare, but the patient had been having several of these seizures per week which commonly lasted an hour in duration. The patient also had a gtc seizure a few days prior to the office visit which lasted four hours. At the (b)(6) 2015, the patient also began having an increase in falling episodes from clusters of small seizures. The patient¿s legs subsequently weakened and the patient was unable to walk for up to 45 minutes following the cluster seizures. The notes indicate that the majority of the seizures were small and would last up to a minute in duration, but clusters of these seizures sometimes lasted up to an hour up to 2-3 times per day. It was noted that the patient did not use the magnet in the past three years due to painful stimulation; however, the physician stated that magnet mode stimulation was frequently activated. The patient¿s medication levels were checked and the dph level was found to be 2. 8 so the physician increased the dosage which provided initial improvement. The patient¿s device was tested and showed normal device function and an ifi condition. The physician indicated that the patient¿s events may be due to the depleting battery of the device or due to medication levels. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Product analysis was completed for the generator on 07/22/2015. The data downloaded from the generator supports the infrequent use of the magnet function, which shows three magnet swipes since the final electrical test. In addition, magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. No evidence of body fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an if=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently did not include all product analysis details.

Event Description
Further review of the product analysis results indicated a battery voltage of 2. 804 volts when the generator was initially received. The generator was received with the output current disabled. Time with the output current disabled allows the battery voltage to recover slightly. This supports a previously observed ifi or neos flag as stated in the clinic notes.

Event Description
Additional clinic notes were received and reviewed by the manufacturer. Within the clinic notes it was stated the patient also experienced an increase in seizure severity prior to the vns replacement which occurred in 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4866237
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #523 on: February 28, 2019, 03:17:32 AM »

Model Number 102
Device Problem Insufficient Information
Event Type  Injury   
Event Description
It was reported that the vns patient's device was disabled years ago due to arrhythmia. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Review of the available programming and diagnostic history showed that the device output current was programmed off on (b)(6) 2009; however the magnet output current remained programmed on.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4956556

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #524 on: March 04, 2019, 08:12:51 AM »

Model Number 103
Event Date 06/11/2015
Event Type  Malfunction   
Event Description
Additional information received from the provider indicated that the patient experienced a temporary breakthrough in seizures, attributed the patient's start of menses and birth control medication, on or around (b)(6) 2015. The overall seizure frequency of the breakthrough seizures was back to, but not above, pre-vns level. It was reported that the patient had experienced weight gain (not vns-related) that may have also contributed to the breakthrough seizures in the opinion of the provider. The breakthrough seizures were not related to vns. During the temporary breakthrough seizures the patient experienced one extended duration seizure of 30 min for which the magnet was attempted 14 times but did not abort the seizure. This extended seizure was also attributed to the patient's menses start, birth control medication start with recent weight gain being another possible contributing factor. The extended seizure was not related to vns. On (b)(6) 2015 the patient's vns parameters were changed in an attempt to achieve increased efficacy; normal and magnet output current were each increased one step to 2. 25ma and 2. 75ma, respectively. Off time was increased from 1. 8 min to 3 min. Normal vns function was observed at this visit with diagnostics within normal limits. The provider stated that the patient has not reported any seizures since the (b)(6) visit. It was noted that the patient is on several anti-seizure medications and 2-3 adhd medications and the provider stated belief that birth control medication can negatively impact anti-seizure medication efficacy.
 
Event Description
Information was received indicating that a vns patient had experienced an increase in seizures and reported that the magnet is not working. A battery life calculation was requested which revealed an expected time of 2. 9 years until neos would be reached for the patient's device. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4916181
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #525 on: March 04, 2019, 08:13:28 AM »

Model Number MODEL 250
Event Date 05/12/2015
Event Type  Malfunction   
Event Description
Clinic notes dated 5/12/2015 were received with indication of an interrupted system diagnostics test which caused an unintended change in device settings. The physician corrected the settings, however, the magnet on time was not corrected.
 
Manufacturer Narrative
Review of the available programming and diagnostic history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4889466
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #526 on: March 05, 2019, 06:40:27 AM »

Model Number 102
Event Date 05/02/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
A provider reported that a patient was experiencing dizziness due to vns stimulation. The provider ordered magnets to provide to the patient to allow the patient to disable vns stimulation as needed. The physician stated the intervention of providing magnets to the patient was to preclude a serious injury to the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5027580
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #527 on: March 08, 2019, 01:21:11 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported that a patient had experienced vns magnet-induced asystole. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371729
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #528 on: March 09, 2019, 02:01:21 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced painful stimulation/shocking in the neck when the magnet was swiped over the generator and their pain management physician requested information about explanting the patient's generator. It was reported that the patient had been strangled and that the nurse believed the patient's lead may be broken due to the reported assault. It was additionally reported that the patient's lead was bent and was "poking out. " clarification from the medical professional indicated that the device was not coming out of the skin. The patient no longer felt the vns cycle like she had in the past. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8302654
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #529 on: March 11, 2019, 07:45:22 AM »

Model Number 103
Event Date 08/14/2015
Event Type  Malfunction   
Event Description
Review of patient's clinic notes indicated that the patient experienced an increase in seizures. The patient feels that the vns is not working and that the magnet stimulation feels different. Diagnostics were performed and the impedance was noted to be 2706 ohms. Attempts for additional relevant information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5085807
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #530 on: March 13, 2019, 01:29:46 AM »

Model Number MODEL 250
Device Problem Device Operates Differently Than Expected
Event Date 08/13/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Clinic notes received on (b)(6) 2015 and dated (b)(6) 2015 mention that the patient's magnet count is not accurate. It is unclear exactly what issue is happening. Attempts for additional information have been made but no additional relevant information has been received to date.
 
Event Description
It was reported that the patient is using proper magnet swipe technique and has had success with the magnet in the past. It was indicated that the issue was that there were incorrect dates on the tablet which then displayed inaccurate dates for the magnet counts. Once this was adjusted the issue was resolved.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5070622
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #531 on: March 20, 2019, 10:44:10 AM »

Model Number 102
Device Problems Generator; Vibration
Event Date 10/05/2015
Event Type  Injury   
Event Description
It was reported the patient is experiencing constant vibration at her generator site and alleges the vns has stopped controlling her seizures. It was noted the patient had a new implant on (b)(6) 2014 and was relatively well controlled prior to reporting the vibration and lack of efficacy. It was later reported the patient self-referred herself to the surgeon but the patient did not see her neurologist. The patient was reporting vibration with her generator but the surgeon didn't find anything wrong. It was reported the patient is having an increased in seizures and the magnet doesn't work anymore like it used to. It is unknown if the increase in seizures is below, at, or above pre-vns levels. It was reported that diagnostics were run and everything was fine. The surgeon wanted to change out the patient's generator. Surgery is expected; however, no surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was reported the patient had her generator replaced on (b)(6) 2015 as the device was unable to be interrogated due to battery depletion. Product analysis for the returned generator was completed on (b)(6) 2015. The battery life calculation estimate was made using the "as received" parameters which resulted in approximately 7 years remaining until near end of service (neos) = yes. During product analysis, the generator's output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. Magnet activations were performed during the output monitoring and the generator demonstrated the appropriate magnet output for the programmed settings. Diagnostics were performed and the results were as expected for the programmed parameters. Additionally, an electrical evaluation showed the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additional information was received which showed the surgeon's serial cable was the cause of the reported failure to program, not a depleted generator battery. The failure of the surgeon's serial cable has been captured in mfr. Report # 16444487-2015-06478. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225237
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #532 on: March 21, 2019, 12:29:40 AM »

Model Number 103
Device Problem Device Operates Differently Than Expected
Event Date 10/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
In clinic notes dated (b)(6) 2015, it was reported that the patient was experiencing breakthrough seizures over the last year, and had a grand mal after "behavioral arrest" which has been identified from the patient history as her normal seizure type. The patient's friend who was at the visit noted that swiping the magnet appeared to make the seizure almost "worse". The notes reported that prior to these events she was seizure/spell free for 3 months. The vns was interrogated and the battery was indicated at <10%. No medication changes were made. The patient was referred for generator replacement surgery. No known surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
Follow-up from the physician's office was received. It was reported that the increase in seizures were above the pre-vns baseline. No device diagnostics were performed at the last check-up. The increase in seizures was stated to be due to battery end-of-life. Magnet mode diagnostics were not performed. The issue regarding the report of magnet mode making seizures worse was stated to be due to battery end-of life as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5206766
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #533 on: March 22, 2019, 02:08:53 AM »

Model Number 304-20
Device Problems Fracture; High impedance; Lead
Event Date 12/07/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device showed high lead impedance on (b)(6) 2015. X-rays were taken and the radiologist identified a lead fracture, although the neurologist did not visualize a fracture. It was stated that the patient was still receiving efficacy from vns magnet swipes. Device manufacturing records were reviewed and found all specifications met prior to distribution. The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and lead fracture. The explanted generator and lead have been received by the manufacturer for analysis. However, analysis has not been completed to date,.
 
Event Description
Analysis of the returned generator and lead was completed. Analysis of the generator revealed no observed anomalies. The generator performed according to functional specifications in the analysis lab. Review of the associated generator data showed that the impedance value changed from a value of 14,048 ohms to 21,979 ohms on the day after surgery. Analysis of the returned lead showed abraded openings on the outer tubing. A coil break was identified in both positive and the negative lead coils. Scanning electron microscopy images of the positive and the negative coil show that pitting or electro-etching conditions have occurred at the break location. Appearance of the negative coil suggests a stress-induced fracture occurred in at least one strand. However, due to metal dissolution, surface contamination and/or mechanical distortion (smoothed surfaces) the fracture mechanism of other strands cannot be ascertained. 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 the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5332681
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #534 on: March 24, 2019, 02:40:51 AM »

Model Number MODEL 250
Event Date 12/08/2009
Event Type  Malfunction   
Event Description
Review of device programming history identified that the generator has been disabled due to a burst watchdog timeout associated with the version 7. 1 software. Investigation determined that a flaw within the programming software results in a longer than expected ramp up/ramp down periods associated with magnet stimulation at certain programmed parameters. The programming system software was upgraded as a result.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5271585
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #535 on: March 25, 2019, 12:46:08 AM »

Model Number 102
Event Date 09/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for patient's generator replacement. The notes mention that the patient experienced increased seizures in the recent months and is no longer experiencing coughing and voice changes with magnet activation as it normally does. The physician suspects that the generator is nearing eos based on the clinical symptoms despite device diagnostics indicating end of service - no. Additional information was received that the patient began having increased seizures three months prior to the visit in (b)(6) 2015. The patient's seizures in relation to the vns baseline is not known. There were no causal factors and the only medication changes were increase in dosage. Patient's vns device was replaced on (b)(6) 2016. The explanted generator will not be returned to manufacturer per the explant facility. No other relevant information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5396418
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #536 on: March 25, 2019, 12:47:17 AM »

Model Number 104
Event Date 12/30/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2016 that the patient was having an increase in seizures as well as claimed that the magnet was not aborting seizures as well. This began on (b)(6) 2015. The patient was last seen in (b)(6) and at that time his output current was 1. 25 ma and diagnostics were fine. The neurologist was not aware of the increase in seizures so scheduled the patient to titrate the vns device. The patient was scheduled to see his neurologist in (b)(6) but then rescheduled for (b)(6) so no relevant information is available to assess the patient's seizures.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5393287
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #537 on: March 26, 2019, 02:16:48 AM »

Model Number 302-20
Device Problems Fracture; Lead
Event Date 08/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2015 it was reported that every time the patient uses the magnet, she feels as though her vein is popping out of her neck. The patient says she had a fall in (b)(6) 2015 on her face and neck and since then when she uses the magnet, it feels like the vein in her neck is popping out. The patient thinks she damaged the lead. It was also noted that the discomfort in (b)(6) was not too bad but that it has returned the last few days. The patient was scheduled for lead replacement. The patient's vns was disabled on (b)(6) 2015. The patient's surgery was later rescheduled due to issues at the hospital. The patient now has a fever and has had two rounds of antibiotics. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2016, the patient was seen by the physician and system diagnostic test results were in normal range. The patient is still having a lead replacement; although surgery is likely, it has not occurred to date. The patient's discomfort was noted to be in the neck area and associated with magnet stimulation at 0. 5ma. The device was disabled. The pain started after her fall in august.
 
Event Description
On (b)(6) 2016 it was reported that the patient underwent lead revision surgery. The explanted lead was discarded by the hospital and therefore cannot be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5353880
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #538 on: March 27, 2019, 01:32:41 AM »

Model Number 103
Event Date 01/12/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient's vns battery is "shutting down". Additional information was received that the patient's battery was seen to be low (about 10%). Also, the patient has started having seizures a few weeks prior to visit on (b)(6) 2015 after previously being seizure free. These new seizures are also of a different type than previously, a "black-out seizure" where the patient does not recall events surrounding the black out and 3-4 hours afterwards. Furthermore, it was reported that when swiping the magnet the patient does not feel the magnet stimulation. No additional relevant information has been obtained to date.
 
Event Description
An implant card was received indicating that the patient underwent prophylactic generator replacement. It was reported that the explanted generator was discarded by the explanting facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5339671
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #539 on: March 30, 2019, 01:51:40 AM »

Model Number 300-20
Event Date 06/21/2001
Event Type  Malfunction   
Event Description
It was reported that a patient's device was disabled about 8 years ago due to shortness of breath. The patient was seen by a new physician on (b)(6) 2016, and high impedance was identified during normal mode and system diagnostics. The patient was referred for full revision surgery. Programming history was available from the date of implant, (b)(6) 2001, and a system diagnostic test performed during implant showed high impedance. No further diagnostic results were available, so it is unknown if the high impedance resolved during surgery or not. Clinic notes were received on 02/29/2016. The patient felt that the vns took his breath away, especially when he used the magnet. The patient then had his vns turned off. The physician discussed turning the vns back on, and the patient agreed. The notes also mention that the patient was positive for chest pains, shortness of breath, and wheezing on (b)(6) 2016. This indicates that the patient still had shortness of breath after the vns was disabled. However, the shortness of breath may have been worsened by the magnet stimulation. Also, it is unknown if the shortness of breath was related to the high impedance or not. No further relevant information has been received to date.
 
Event Description
Clinic notes were received on 04/01/2016 from the surgeon's office. The physician stated that the patient has a broken lead, which needs to be replaced during surgery. The patient had vns initially implanted in the 1990's, and vns stopped his seizures. However, he had it deactivated because it took his breath away and made him feel like he could not breathe. The patient is wanting to use vns again. The notes also mention that the device was recently tested, and it was not working. The patient uses an inhaler for breathing issues, which supports that the patient has breathing issues without vns stimulation as well and were not related to the high impedance. Attempts for further information were unsuccessful to date. No surgical intervention has occurred to date.
 
Event Description
It was reported that patient underwent lead and generator replacement surgery. The explanted lead and generator were discarded following the surgery. Therefore, product analysis cannot be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5512641
Logged
Pages: 1 ... 16 17 [18] 19   Go Up
Print
Jump to: