Pages: 1 ... 9 10 [11] 12 13 ... 16   Go Down
Print
Author Topic: Misc. Pain  (Read 16979 times)
0 Members and 4 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #300 on: December 15, 2018, 02:50:23 AM »

Model Number 302-30
Event Date 09/01/2013
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #2 inadvertently did not include this information.

Event Description
Additional information was received from the physician's office. The patient has a device that is misfiring, low battery, or completely out. This was detected in (b)(6) 2013. The device was disabled due to the feelings it was giving the patient. No other information was provided.

Event Description
It was reported that the patient went to the surgeon after being referred from her psychiatrist. The surgeon reported that he was unsure what the problem was and has no plans to follow-up with the patient. The patient reported that about a month ago she though her device stopped working because she felt like it wasn't working for her depression. The patient reported that her depression was not worse than it was pre-vns baseline. The patient reported that she saw her physician and the device was programmed off because she felt achy all over and her physician thought there may be an issue (short) with the lead. The patient was unsure if diagnostics had been performed at that time. The patient stated that the device will remain off for now and that she will only proceed with surgery if her insurance will pay for it because it is expensive.

Manufacturer Narrative
Manufacturer reviewed device history records. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution.

Event Description
It was reported the patient's device was programmed off in (b)(6) 2013.
Manufacturer Narrative

Event Description
Review of the manufacturer¿s in-house programming history revealed that on (b)(6) 2013 high impedance had been found on systems diagnostics. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3441194
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #301 on: December 16, 2018, 04:59:54 AM »

Model Number 102
Event Date 05/14/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicate that the device settings were increased from 5 mins off to 0. 2 mins off, but that it was too bothersome to the patient so the settings was changed back. The notes indicate that the battery is ok, but in the past few months a few times a week the patient feels a sharp pain over the device intermittently. It was noted that despite the reading the battery is likely running low and the patient will be scheduled for surgery in the summer. The physician indicated that no patient manipulation or trauma occurred that is believed to have caused or contributed to the sharp pain. The physician indicated that the patient will undergo generator replacement due to the pain. It is unknown if the generator replacement will be done for patient comfort or to preclude a serious injury. Surgery is likely, but has not occurred to date.

Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(4) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3425035
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #302 on: December 17, 2018, 04:17:07 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
Initially, it was reported that the patient was scheduled for vns system explant due to having had brain surgery and no longer experiencing seizures. It was reported that the patient wanted the device removed. It was later reported that the patient underwent the explant secondary to pain. The physician reported that the patient underwent epilepsy surgery and was seizure free so the vns system was removed. No other information was provided. The generator was returned and analyzed. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3408211
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #303 on: December 18, 2018, 01:05:07 PM »

Event Date 10/01/2013
Event Type  Injury   
Event Description
It was reported that the patient was scheduled for surgery because she has a lump in the area of the neck where the cut lead portion remains. It was reported that the patient was seen the week prior and stated that she had pain where the lump was. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3491525
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #304 on: December 18, 2018, 01:05:37 PM »

Model Number 102
Event Type  Injury   
Manufacturer Narrative
Event Description
It was reported that the patient's vns device slips under the patient's left underarm/ breast area and can be painful. The patient's mother requested surgery to reposition the device. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3404966
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #305 on: December 19, 2018, 01:04:23 PM »

Model Number 300-20
Event Date 11/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure occurred, but did not cause or contribute to a death.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full revision on (b)(6) 2013 due to pain at the site. Attempts for additional information have been unsuccessful. The explanted devices have not been returned to date.

Event Description
Analysis of the generator was completed on (b)(4) 2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(4) 2014. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the end. The exact reason for this condition is unknown. Due to metal dissolution a distinction whether a break or cut occurred at the end cannot be made. Scanning electron microscopy images of the negative coil at the abraded opening location show that pitting or electro-etching have occurred on the coil surface. The coil has what appears to be wear (smoothed surfaces) at the exposed portion. No obvious pitting was noted at the discolored surface. No obvious adverse effect was identified on the device performance as a result of this condition. Also, a suspected stress-fissure was noted in one strand. An abraded opening in the outer silicone tubing and in the inner tubing of the negative coil was identified. Although not conclusive, it is believed that this condition may confirm this to be a contributing factor to the reported patient ¿pain¿ allegation. However, the exact impact of this condition and when it occurred is unknown. 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 portions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484645
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #306 on: December 19, 2018, 01:05:25 PM »

Model Number 102
Event Date 04/12/2012
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when analysis of the explanted lead was completed. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Pa of the explanted generator was completed on (b)(6) 2012. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of pain). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2012 that a vns patient would have the device removed as it was causing her pain. On (b)(6) 2012 it was reported that the device would be removed due to a lack of efficacy and it was bothersome to the patient. The generator and lead were explanted on (b)(6) 2012 and returned to the manufacturer on (b)(4) 2012. Analysis is underway. 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=2566224
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #307 on: December 20, 2018, 01:48:37 AM »

Model Number 102
Event Date 01/01/2005
Event Type  Injury   
Manufacturer Narrative

Event Description
The nurse reported that the patient was initially implanted with vns in 2004. About a year or less later, the patient began having "some sore of neck swelling or possible infection", so the vns device was disabled. The device was disabled for years until about a year ago (around 2012). No other information was provided.

Event Description
Additional information was received stating that the vns patient began having issues with her device since implant. The patient¿s device was disabled because the patient would experience neck pain and swelling during stimulation on-times. The patient was unable to tolerate a device output current above 0. 5ma. The patient underwent surgery on (b)(6) 2014. Pre-operative system diagnostic results showed normal device function at the time. During the procedure, the surgeon noted that the lead electrodes were tightly wrapped around the vagus nerve and another unknown branch which was surrounded by a large amount of scar tissue. The surgeon attributed the patient¿s issues to the incorrect placement of the electrodes around both the vagus nerve and the unknown branch. The patient¿s lead and generator were replaced during the procedure. The patient¿s generator and lead were replaced during the procedure. The generator and lead replacement was reported in manufacturer report #1644487-2013-03847.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3528935
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #308 on: December 21, 2018, 09:49:46 AM »

Model Number 103
Event Date 10/17/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator replacement. The generator has not been received to date.

Event Description
It was reported that the explanted generator had been discarded by the hospital and therefore could not be returned for product analysis.

Manufacturer Narrative

Event Description
The patient's vns device was disabled on (b)(6) 2014 by the physician due to the apparent random activation of the generator. However, it was also reported that the device was disabled due to the shocking sensations the patient experienced which is reported in manufacturer report #: 1644487-2014-00314.

Event Description
On (b)(6) 2014 it was reported that the patient is rather histrionic. The patient was in an abusive relationship at the time and he hit her in the area of the device. She was never in an area with any strong magnets.

Event Description
On (b)(6) 2013 the patient reported that she experienced a magnet activation without a magnet swipe. On (b)(6) 2013, it was reported that this vns patient tripped and fell on (b)(6) 2013 and thought she pulled on the lead. The site was not red, just bruising and healing well. There was no drainage. On (b)(6) 2013, the patient reported that the device was on and that she didn¿t like it because it was uncomfortable. On (b)(6) 2013, the patient reported that her heart hurts to the point that it was making her sick. The patient left another voicemail indicating that she spoke to her physician who told her that her heart was hurting because the stitches were drying up. The physician told the patient to take an ibuprofen, so she did, and the pain went away. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3468449
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #309 on: December 21, 2018, 09:50:42 AM »

Model Number 102
Event Date 09/12/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Product analysis of the generator was performed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. A cut was identified in the positive coil. Although, not conclusive, it appears this observed condition is the result of the explant procedure. 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. Dried remnants of what appeared to be dried fluid was seen inside the inner tubing. There was no obvious point on entry other than the cut ends and the mentioned cuts. Other than the above mentioned observations typical wear, and explant related observations, no anomalies were identified in the returned lead portions.

Event Description
On (b)(6) 2013, it was reported that this vns patient underwent full explant on (b)(6) 2013 due to pain the chest and arm although the device had not been disabled for some time. The lead and generator were returned on (b)(4) 2013 and are pending analysis.

Event Description
On (b)(6) 2013, it was reported by the patient that the pain she was experiencing was causing her depression to increase. She stated that she wanted the device explanted. Attempts were made for additional information on the pain; however, they were unsuccessful. No additional information has been provided. Surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3473303
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #310 on: December 21, 2018, 09:51:27 AM »

Model Number 101
Event Date 06/08/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013 clinic notes were received dated (b)(6) 2010 that indicated the patient feels her stimulator go on quite strongly at night a couple of times and has voice changes from the vns. It was stated that the vns was checked and it works fine. The patient¿s settings were noted to be output=1. 75ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 5min/eri=no. Clinic notes dated (b)(6) 2010 indicate that although her voice changed while the vns was turned on, it was not as significant as before. The patient stated that she only had one time when she had decreased hearing in her ear and ear pain. The physician adjusted her vns settings by increasing the output current from 1. 5ma to 1. 75ma and the magnet from 1. 75ma to 2ma. The rest of the settings were left at frequency=20hz/pulse width=250usec/on time=14sec/off time=0. 5min. Good faith attempts for further information from the physician have been made but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3468339
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #311 on: December 22, 2018, 11:14:27 AM »

Model Number 302-20
Event Date 11/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, a physician reported that he was unable to interrogate a patient¿s device over the last few weeks. The patient stated that he could not feeling stimulation and his voice was not changing, so he doesn't know if his device was working. The physician did not believe the device was at end of service. The patient was seen again on (b)(6) 2013, at which time system diagnostics showed high impedance. The patient¿s device was disabled on (b)(6) 2013 as the patient was experiencing pain in the lower head. The patient was also the programming system was verified to be functioning properly and did verify the high impedance. On (b)(6) 2013, the patient underwent surgery. The generator was replaced, and a system diagnostic showed normal impedance (2000 ohms). Diagnostics after the patient was closed were also within normal limits. System diagnostics later in the day showed high impedance. Surgery is likely but has not taken place.

Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Event Description
The settings of the new generator were lowered, and the patient may be referred for lead revision at a later date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3534338
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #312 on: December 22, 2018, 11:15:27 AM »

Type of Device:     STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device Brand         VNS Therapy Pulse
Name:
Device                   CYBERONICS, INC.
Manufacturer's
Name:
Date of this            12/19/2014
Report:
(mm/dd/yyyy)
Describe the           The patient is a white male with intractable epilepsy. One month ago the patient
Event                     underwent removal of his vagal nerve simulator due to "pain," "burning," and
or Problem:            discomfort. The device did not prevent/reduce seizure activity as intended. This
                             particular generator and lead were implanted approximately three and a half years
                             ago. Of note, the patient underwent vagal nerve stimulator implantation originally
                             eight years ago. Of note, the patient initially underwent implantation of vagal nerve
                             simulator which was removed and replaced three times due over the course of five
                             years due to various reasons including pain, discomfort, infection and migration of
                             device due to weight loss.
the device(s) may
have                      Minor injury to the patient or health care provider
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=42681
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #313 on: December 22, 2018, 11:16:53 AM »

Event Date 10/16/2013
Event Type  Injury   
Event Description
Attempts for product information were made but were unsuccessful.

Manufacturer Narrative

Event Description
It was reported that per the physician's notes every is in working order. It was reported that the x-rays showed no issues and the patient has not reported any more issues.

Event Description
On (b)(6) 2013, it was reported that the patient has been instructed to use the magnet to disable the vns device. The patient reported that she is having problems with the vns and it is not working properly. She also reports pain where the leads are located. Follow up with the physician found that the patient was seen on october 18, 2013 for worsening seizures, neck pain, and concern over vns malfunction. X-rays of the neck for the vns lead were assessed. The diagnosis indicated neck pain along the vns wire. The patient is to continue the same seizure medication for now. Interrogation and diagnostic testing of the device indicates it is in proper working order. The seizures five days ago are of no clear reason at this point. The site is pending blood work to further assess and may make adjustments to the medications. The patient was last seen on (b)(6). The patient reports extreme pain in the left neck around the vns wires, with a severity of 10 out of 10. The patient does not believe the vns device is working properly as she cannot feel stimulation. The patient had two seizures five days ago. Before that, seizures were in (b)(6) 2012. The seizures five days ago were grand tonic clonic. The first one was ten minutes and the second one was two minutes, consisting of generalized convulsion with no unilateral onset. No other triggers. Denies side effects of medication. The patient's settings were increased, after which the patient coughed, indicating the vns stimulation is being provided. The patient is able to tolerate the settings. X-rays will not be sent to the manufacturer for review. Per the physician, the results were fine. The site stated that something has definitely changed to cause the patient to experience these seizures. The patient will be seen by a rheumatologist for another event as sometimes unrelated events could cause seizures per the site. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3442712
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #314 on: December 23, 2018, 10:39:54 AM »

Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.

Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/01/2014. The puncture mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints.

Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3527747
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #315 on: December 29, 2018, 04:30:49 AM »

Model Number 103
Event Date 10/03/2013
Event Type  Injury   
Event Description
Additional info received on 2/26/2014: our son was riding in the car watching a movie and his head jerked downward and back up three times. This happened very quickly and lasted just a few seconds. He is tired and holds his head after. He had these start happening immediately following the replacement of the vns generator on (b)(6) 2013. There were several other episodes but i did not log them all down. The vns settings were adjusted by his neurologist and we didn't see any events for several days. Then on (b)(6) 2014 we saw it happen again while riding in the car. These events were reported to his neurologist dr. (b)(6) and she called cyberonics on three occasions. They have not responded to our issue with this generator. I happened to see two of cyberonics sales rep at an informal epilepsy meeting in (b)(6), and i did tell them about it, and they stated they knew dr. (b)(6) had called and that they were supposed to call us but had not at that time. It had been a week and we received no call. About a week or two later we were in dr. (b)(6)'s office and she asked if anyone had called us and we told her no. She made one or two other phone calls to cyberonics and explained what was happening and they have failed to follow up with us on this problem. We have just seen this one episode since the last vns adjustment, but we feel they may just be happening less often and nor always visualized.
 
Event Description
Vagus nerve stimulator generator was replaced and re-implanted on (b)(6) 2013. That evening he experienced his first uncontrolled head movement. It appears to jerk forward and down then back very quickly. We saw this happen on (b)(6). There were probably other dates it happened, but these are the ones that were witnessed. On (b)(6) he had a 24 hr eeg during which he had several of these movements. On each date these movements happened multiple times and was causing great discomfort to our son. Each time this happened he was left tired and would say his head hurt. Our son is mentally disabled and is not able to fully explain his experience. On 3 occasions he was holding an ipad, or iphone and we thought it was related to that, but following episodes he was not holding anything. The vns settings were set in surgery. Since the surgery, he has had to endure a 24 hour eeg to rule these out as seizures. It was determined that they are not seizures therefore we believe they are indeed the device causing this. The neurologist has adjusted the vns twice and after the second time we haven't seen any yet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3599446
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #316 on: December 29, 2018, 04:31:55 AM »

Model Number 304-20
Event Date 01/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2014, the patient reported tha ther surgeon told her the neurologist observed high lead impedance the day before while communicating with the vns device. The surgeon said that he reviewed x-rays and there did not seem to be anything wrong with the device. The patient stated that the vns device was turned on (b)(6) 2013, and she was seen yesterday ((b)(6) 2014) when the high lead impedance was detected. No surgery was discussed as the physician did not believe there was an issue. The surgeon reported to the manufacturer on (b)(6) 2014, that he saw the patient earlier and did not believe there was any issue with the device because it was tested in the operating room multiple times and was within normal limits. On (b)(6) 2014, the patient reported that she had implant surgery 3 weeks ago and was in a lot of pain. The patient stated that she believed that the surgeon "cut a nerve". On (b)(6) 2014, the patient stated that she was still in pain and that she believed the device was not working. Ap and lateral chest and neck x-rays were sent to the manufacturer and reviewed. The connector pin appears to be fully inserted inside the connector block and the feedthru wires appear to be intact. The placement of the generator appears to be normal. A strain relief bend appears to be present; however a strain relief loop does not appear to be present. Two tie-downs appear to be present. A portion of the lead is behind the generator, and cannot be assessed. There appears to be no gross fractures, discontinuities or sharp angles in the portion of the lead that is visible. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3600778
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #317 on: December 30, 2018, 06:18:07 AM »

Model Number 102R
Event Date 06/01/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2014, it was reported that this vns patient experienced a cluster of seizures in (b)(6) 2013. The seizures did resolve to baseline again; however, the physician was unable to determine a reason for the patient's increase in seizures. He had no other information regarding interventions or device functionality at the time. The relation to the pre-vns baseline was unknown. The physician reported that the patient reported neck pain on (b)(6) 2013 by a phone call. No interventions were taken about the pain, and the physician could not determine if this was occurring with stimulation. This event resolved spontaneously in (b)(6) 2013. Diagnostics on (b)(6) 2013 showed high impedance. High impedance is captured in mfr report #1644487-2014-00205.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3575811
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #318 on: December 30, 2018, 06:18:56 AM »

Model Number 102R
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient was experiencing an increase in seizures. Diagnostics showed the device was not at end of service and was within normal limits. The pre-vns baseline levels were unknown; however, it was said that the patient usually has one to two seizures per year, and they were occuring more frequently now. No plans for surgical or medical interventions were made. X-rays were taken and sent to the manufacturer for review. Included were ap and lateral views for the neck and chest. Placement of the generator appears normal in the left chest, and the feedthru wires appear intact. The ability to see the lead is mildly compromised due to inconsistent brightness and contrast in the images. There does appear to be a strain relief bend and a strain relief loop, which are both placed as per labeling. Three tie-downs are present and appear to be placed as per labeling. There does appear to be lead behind the generator. There does not appear to be any gross fractures or discontinuities in the lead. There does not appear to be any sharp angles in the lead. The lead wires appear intact at the connector pin. Additional follow up with the physician found that the patient is experiencing periodic pain and discomfort near the lead site. The physician stated that it would be best to follow up with the patient and try to reduce the vns settings to see if this resolves the pain and discomfort issues. She said that she has considered scar tissue as a possibility for the cause, and thinks it is likely. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3574360
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #319 on: January 03, 2019, 08:53:24 AM »

Model Number MODEL 250
Event Date 02/20/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's generator was found to be programmed to 1. 5ma output current at 180 minutes off postoperatively which caused pain in the neck for the patient. It was reported that the generator was not deliberately programmed to these settings. It was reported that the device was programmed off and the pain subsided. The generator is now programmed on and the patient is doing well. It was reported that two patients were implanted this same day and it is believed that a cross-programming event occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Additional information was received stating that the vns patient did not experience any lasting symptoms from this event. Additional programming and diagnostic history was provided; however, it did not show the cross programming event and could not be fully assessed due to incorrect timestamps of the programming events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4118480
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #320 on: January 03, 2019, 08:54:02 AM »

Event Date 01/01/2011
Event Type  Injury   
Event Description
This vns patient reported that she has been having pain off and on that started three years earlier that has progressively gotten worse. Her current neurologist had made adjustments, lowered her dosing, and started her on medication to try and manage the pain. Approximately one month earlier, the device was disable, but the patient still reported pain as if there was swelling on the inside. When the patient lies down, it cuts off her air way. Follow-up with the neurologist showed that the pain was present at the left neck and left chest. The dyspnea was not occurring with stimulation. As intervention, the patient was referred to a surgeon to remove the lead. Explant surgery is likely but has not taken place.
 
Event Description
Additional information was received stating that the vns patient underwent surgery on (b)(6) 2014. It is unknown what type of surgery was performed. Attempts for additional relevant information were made but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3639783
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #321 on: January 04, 2019, 09:46:09 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/03/2018
Event Type  Injury   
Event Description
It was initially reported that the patient complained of pain throughout her arm and numbness from her should to finger tips. It was stated that this occurred all of the time. The physician's office stated the diagnostics were within normal limits. The patient was informed to follow up with a surgeon, but the surgeon's office did not take the patient's insurance. The patient later reported that she had been experiencing problems with her arm and could not move it. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8189859
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #322 on: January 04, 2019, 09:46:58 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the physician that their patient's wires are painful under their neck and requested to have their generator removed as the therapy was no longer required. No relevant 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=8138352
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #323 on: January 04, 2019, 09:47:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing pain at the generator site, which was at the left armpit due to a chest tattoo. The device was causing discomfort due to being much larger (m106) than the patient¿s previous m103. The patient has a follow-up appointment with the surgeon to discuss moving the vns generator. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8181673
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #324 on: January 04, 2019, 09:48:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Event Description
It was reported by an emergency room physician that the patient's generator was continuously stimulating for several hours. It was reported that the physician attempted to disable the device using the vns magnet as well as a pacemaker magnet, but that the device continued to stimulate and the patient was admitted to the hospital. A company representative reported that the patient experienced neck pain and hoarseness that persisted despite the device being programmed off. The patient's device diagnostics were within normal limits. It was reported that the patient had recently had a seizure and had fallen and either hit her head or neck. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8178588
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #325 on: January 04, 2019, 09:49:33 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/27/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Patient is being referred for explant due irritation/pain. The patient's device is currently disabled and high impedance was observed before disablement. The disablement and high impedance is captured in mfr. Report 1644487-2014-00658. It is unclear at this time what the location of the pain is and whether or not the pain is related to the high impedance. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8171119
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #326 on: January 04, 2019, 11:08:40 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/24/2014
Event Type  Injury   
Event Description
It was reported that the patient's incision did not appear to have healed properly after their implant. The patient was also experiencing pain at the generator site. The patient was referred for replacement in part to try to relieve the pain. It was clarified that the scar is thick and appears that it was stretched more than expected. Programming history was reviewed for the generator. Surgery is likely but has not occurred to date. No additional or relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8173689
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #327 on: January 05, 2019, 03:04:48 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/06/2018
Event Type  Injury   
Event Description
The patient reported that they experienced an increase in seizure frequency due to the low battery of the generator. The physician attributed the patient's increase in seizure frequency to battery depletion. Per the physician, the patient also indicated that she experienced pain, with and without stimulation, all over her body that worsened with stimulation. The patient stated that the pain was due to the low battery of the generator as well. The physician indicated that the patient was referred for generator replacement due to patient comfort. The manufacturer's battery life estimation tool was unable to verify battery depletion based on the available patient programming data. No relevant 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=8122322
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #328 on: January 05, 2019, 03:05:24 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a patient's was having their generator replaced as the patient was having pain at his generator site that happens sporadically, lasts for 5 seconds, and makes the patient "feel funny" for about 15 seconds afterwards. Clinic notes were received and stated that "vns device is zapping patient". It was noted that the patient would feel his heart fluctuate up and down after. It was noted that the last diagnostics indicated that the device was functioning as intended. No known replacement surgery has occurred to date. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8123336
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 59353


« Reply #329 on: January 05, 2019, 03:06:02 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2009
Event Type  Injury   
Event Description
It was reported that the patient underwent a vns repositioning surgery in 2009 due to pain. This patient also underwent a prophylactic generator replacement in 2009. This generator was received by the manufacturer and an analysis was performed. The generator was found to be operating within designed limits and there were no performance or any other type of adverse conditions found. Multiple attempts for follow up were performed with the patient's neurologist, but no additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8164931
Logged
Pages: 1 ... 9 10 [11] 12 13 ... 16   Go Up
Print
Jump to: