Pages: 1 [2] 3 4  All   Go Down
Print
Author Topic: Head  (Read 12615 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #30 on: January 30, 2018, 02:28:44 AM »

Model Number 103
Event Date 11/12/2010
Event Type Injury
Event Description
It was reported by a pt through a company representative that since vns surgery, she has been having head and neck pain. The pt was admitted to the hospital and was treated for pneumonia. The pt was then released with oxygen saturation in the 80s according to the patient's sister. At the moment, the patient's device remains off and good faith attempts to obtain additional info from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1936140
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #31 on: January 30, 2018, 02:29:36 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type Injury
Event Description
It was reported by a psychiatrist that a vns patient experienced pain going up the left side of the neck and down into the left shoulder with stimulation. Patient's current settings were 1. 75/20/500/30/5 and treating psychiatrist stated that diagnostics were all ok (no specifics) and have been in the past. The patient denies any trauma to the area. Additional information was received from the patient indicating that she is still experiencing painful stimulation only when her head is turned to the left. Patient stated that when her head is straight there is no pain. The patient stated she would like to see a surgeon to see if he can offer any solutions to the reported pain. However, at the time no interventions have been scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919376
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #32 on: January 31, 2018, 01:47:47 AM »

Model Number 302-20
Event Date 01/17/2011
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported by a vns pt that she experienced sharp pain in her neck when turning her head along with headaches with pain over her right eye. Add'l info was received from a company rep indicating the pt's treating neurologist had in his notes from (b)(6) 2010 that high impedance was noted. Follow-up was made with the pt treating neurologist and nurse. The nurse indicated that the pt was taken to an mri and results were normal for the pain and headaches, hence she did not know what caused the pain and headaches. No x-rays were taken for the reported high lead impedance and it was unk if pt manipulation or trauma contributed to the reported high lead impedance. Current plans were to increase the pt's vimpat and follow-up in 3 months as the pt's battery is dead. Review of the manufacturer's programming history database was not indicative of high lead impedance although history was limited to (b)(4) 2005.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2036841
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #33 on: February 03, 2018, 03:04:50 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 11/01/2016
Event Type Injury
Event Description
Report was received that a patient had experienced painful stimulation during magnet activation. The magnet output current was reduced and the painful stimulation subsided temporarily. About 7 months later, the patient began feeling painful stimulation on the side of the head and ear with normal and magnet mode stimulation. No adjustments in therapy or trauma occurred prior to the reoccurrence of the painful stimulation. System diagnostics were performed and returned within normal limits. A review of the programing history did not show a presence of high impedance. A review of chest x-rays did not indicate there was any malfunction present. The patient was referred for a generator replacement because adjusting settings did not resolve the painful stimulation and the physician indicated he believed the generator was malfunctioning. No surgical intervention has occurred and no further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6801108
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #34 on: February 04, 2018, 02:12:37 AM »

Model Number 302-20
Event Date 03/01/2011
Event Type Injury
Event Description
It was reported by a vns pt that she felt dizzy with stimulation. Also, she indicated she had a pain in the back of her head and her vns lead had been implanted over a goiter that she had, so the lead was now protruding. Follow-up was obtained from the pt's physician's office and they stated the pt did not indeed get dizzy with stimulation; however, the pain's relationship to vns was not known. The device had been "checked" and the doctor's notes indicated "proper device function", although no specifics were available. The site stated that the lead was "not protruding per se", but that the doctor could palpate the wires in the pt's neck, and "everything seemed to be located where it should be". The pt was to undergo a ct scan angiogram to investigate the dizziness and pain further, but the doctor did not indicate that this was to preclude a serious injury. No changes were made to the pt's settings preceding the onset of the events, and no changes had been made when the device was checked. However, later info was given to a company rep stating the pt was referred to a surgeon as she had a lead that was protruding due to the goiter. The surgeon's nurse indicated that the pt may be explanted with no replacement. The pt subsequently underwent a replacement surgery where her generator was explanted. It was not decided if the lead would be replaced yet. Furthermore, it was stated that the issue was the pt's tie-down. During the surgery, the surgeon removed one tie-down and replaced the generator as there was "no issue with the lead at this time". Good faith attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2063732
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #35 on: February 06, 2018, 02:28:23 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type Injury
Event Description
On (b)(6) 2011, it was reported by a vns treating physician that the vns pt was experiencing some scarring around the lead and was being referred for a full revision surgery. The pt was not presenting with high impedance. The physician reported that the scarring started in (b)(6) 2011. The pt feels some pulling and it hurts him when he turns his head to the right; it feels like a pinch. The scarring is around the lead body and electrodes he is scheduled for surgery for scar revision (b)(6) 2011. Interventions are being taken for comfort and to hopefully prevent any injury that could occur because of the excessive scar tissue. The physician reported that there wasn't anything that happened that would have contributed to this condition. The physician provided clinic notes dated (b)(6) 2011 that state that the pt complains about pain and is tugging at the vns lead site on his left neck. He mentions the pain at least once per day. The pt has some scar tissue on his left neck. The pt's programmed settings are 1. 25/30/500/30/3/1. 5/60/500 with a systems test and a normal mode test reading ok/lead impedance = ok/dcdc = 2/ eri=no. When additional info is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2088584
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #36 on: February 07, 2018, 03:15:34 AM »

Model Number 302-20
Event Date 05/09/2011
Event Type Injury
Event Description
It was initially reported by the epileptologist that the patient was to undergo a prophylactic generator replacement, and at the same time have his lead released from scar tissue. Additional information was received through an implant card indicating that the patient's lead was replaced and the patient had been experiencing coughing, tightness in the lead, and difficulty breathing. A review of the patient's history showed that the patient was implanted in 2006. The patient had started experiencing pain and tightness in his neck, following implant. This resulted in a procedure to release his lead wire from scar tissue in (b)(6) 2009. At that time, the procedure was performed for patient comfort. Follow up with the surgeon revealed that the patient's pain and tightness had reoccurred approximately a year after the previous surgery. The symptoms had gradually worsened, until it caused the patient pain and coughing when he turned his head to the right. During the procedure to loosen the lead wire from the scar tissue, the surgeon noticed damage to the "lead sheath" so he replace the lead wire. He indicated that the patient had developed severe fibrosis which entrapped the cable causing the pain, coughing, and discomfort. The fibrosis was also restricting the patient's neck motion. The surgeon stated that the procedure was performed primarily for patient comfort, but also potentially to preclude a serious injury. Follow up for additional information regarding the damage to the lead has been unsuccessful to date. The explanted products have not been returned to the manufacturer for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2129926
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #37 on: February 07, 2018, 03:16:31 AM »

Model Number 102
Event Date 03/01/2011
Event Type Injury
Event Description
The pt reported that his lead had slipped and is now in a knot. The pt reported that he is able to see the knot in his neck. Also, the pt reported being shocked with stimulation in the neck and ear. The pt saw his physician regarding the issue, and the was told the device "works. " the pt's settings were reportedly decreased on (b)(6) 2011 due to the shocking sensation, which has helped the issue. He had also been sent for x-rays and a surgery consult. Furthermore, the pt stated that prior to the setting decrease, the left side of his head had been numb; he had also been having an increase in seizure activity. The mfr's programming history was searched and the pt's last known settings were on (b)(6) 2010. Diagnostic testing on this date showed normal device function. Later info was rec'd indicating no trauma or manipulation had occurred. Recent diagnostics were stated as being "ok", and the pt was still having less seizures than before vns. No medication changes had been made prior to the increase in seizures. The site also said that there were no medication changes prior to the painful stimulation, but the pt's pulse width and frequency were decreased, and the pt then could tolerate stimulation. The physician indicated that the numbness that the pt had experienced was not related to vns. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2133423
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #38 on: February 08, 2018, 01:56:50 AM »

Model Number 102
Event Date 06/24/2011
Event Type Injury
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case mgmt. Review of the clinic notes revealed that on (b)(6) 2010, the pt was experiencing pain in their neck and shoulders on and off. The physician decreased the vns pulse width to see if it would help the pt. The physician also reported that on (b)(6) 2011 the pt had seizures at night, but did not try and swipe their magnet. In clinic notes dated (b)(6) 2011, the physician reports that the pt has a history of neck pain. The physician also reported that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. Due to the pt's flare of symptoms, the physician referred the pt for prophylactic battery replacement. In clinic notes dated (b)(6) 2011, the physician provides further info about the pt's history of neck pain, stating that it spreads into the occipital area in keeping with neuralgia. The physician again reports that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. The mfr's consultant later reported that the physician believes the pt's pain was not related to vns. Surgery has not yet been scheduled. Attempts for additional info regarding the pt's seizures have been made to the physician, but no further info has been received to date. When further info is received, it will be reported. A blc performed with the programming history in the mfr's programming history database which revealed negative yrs until eri = yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180923
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #39 on: February 09, 2018, 03:11:36 AM »

Model Number 103
Event Date 07/04/2011
Event Type Malfunction
Event Description
Further information reveals the patient has a consult for the painful stimulation issue and a decision will be made on how to proceed. Attempts for further information have been unsuccessful to date.

Event Description
Decoder spreadsheet analysis was performed for the patient's vns programming history. A review of patient programming data revealed that on (b)(6) 2011 the initial interrogation of the device resulted in a measured battery voltage of 2. 849v, indicating that a 25% battery status indicator was displayed to the user during this interrogation (e. G. 25% remaining is displayed at measured voltages of 2. 85v with demipulse generators). All subsequent communication operations resulted in a measured voltage of 2. 68v at the same programmed settings, based on charge accumulation this would have resulted in the expected 100% status indicator. Based on this data, it is possible that battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life. The manufacturer addressed this issue with demipulse generators by adding a 0. 5v offset to measured battery voltage during the first 7. 5% of battery consumption to mitigate the potential for artificially low voltage measurements during this period. The fact that the voltage measurement of 2. 894v was received at 9. 560% of consumption may indicate that battery impedance for this particular generator was longer than most (e. G. An outlier). Based on all subsequent programming data the device appears to be functioning as intended.

Manufacturer Narrative
Analysis of programming history. The battery associated with this generator may have been an outlier in terms of the battery impedance that is experienced at the beginning of battery life.

Event Description
Further manufacturer investigation revealed that the root cause of the observed battery voltage behavior has been determined to be the result of either an extended duration of the reduced conductivity (i. E. High battery impedance) experienced by cfx batteries during the beginning of life (bol) or a minute internal short that managed to "burn" itself out resulting in the observed voltage rebound following 10% of discharge (e. G. Consumption). No change to risk has occurred as a result of this investigation, which continues to be "low. " change request numbers (b)(4) were created as a result of this investigation. (b)(4) proposes that the duration of the 0. 5v offset, implemented by the firmware for model 103/104/105/106 generators be extended from 7. 5% to 15% of consumption within 11. X programming software in order to mitigate such events in the future. (b)(4) proposes that this issue be mitigated either through the firmware (as the device is still under development) or through the programming software as well.

Event Description
It was reported that the pt started feeling painful stimulation at generator site a few weeks prior. Pt's current setting are 2. 5/30/500/30/5 magnet 30/60/500. Diagnostics were performed and results were within normal limits, 2595 ohms, ifi: no. The green light showing battery consumption was showing half full and the physician does not think this is correct. Based on pt's current settings, the pt's device should last about 4 years and half green light means the battery has 25% to 50% remaining battery life which is not expected. X-rays of the pt's device were taken and reviewed by the mfr. No anomalies were seen on the x-rays. The physician ran diagnostics with pt's head turned different ways. When the head was turned to the right, the pt did not feel painful stimulation, but when the head was turned to the left, the pt felt the painful stimulation. Diagnostics in all positions were ok. The physician lowered the settings and the pain resolved. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2245770
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #40 on: February 09, 2018, 03:12:41 AM »

Model
« Last Edit: June 18, 2018, 01:41:40 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #41 on: February 13, 2018, 01:41:32 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 07/10/2017
Event Type Injury
Manufacturer Narrative
(b)(4).

Event Description
It was reported that this patient is experiencing vocal cord paralysis. The surgeon believes it might be due to the vns strangulating the nerve. Therefore a vns lead revision occurred to determine if nerve strangulation is the cause. It was later reported that the patient began having sharp pains up her left ear to her left suboccipital area when her output current was increased. The patient had numbness of her left neck, left throat and left tongue. This made swallowing difficult. This did not get better with time, and when the output current was turned back down, she did not feel any stimulation unless her head was tilted to the left. It was mentioned that the doctor reported that the patient's nerve was pretty sizeable. The sharp pain that led to the patient's ear and suboccipital area was occurring with stimulation. It was also reported that it was too early to know the cause of painful stimulation, numbness, and vocal cord paralysis. The doctor spent 8 hours in the operating room probing the patient to determine what to do, and decided to cut the anchor tether, and snipped off the end of the positive electrode, and per the doctor, he did not cut any wire. He also believed the negative electrode was kinked and he fixed that. Overall the doctor kept the implanted lead intact with some modifications. The patient's generator was programmed off to allow the nerve to rest after surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6878406
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #42 on: February 14, 2018, 01:44:39 AM »

Model Number 103
Event Date 02/23/2011
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received indicating that the patient's painful stimulation started following her generator being programmed back on in (b)(6) 2011. During stimulation, the patient experienced pain in left side of neck that proceeded to back of her head. She also noted more pain during magnet activation. She does; however, have seizure control. The patient's settings were provided and diagnostics were also run with ok results, however, no specifics were provided. The physician then lowered the patient's signal frequency to 20hz and pulse width to 250usec. The patient's magnet mode pulse width was also adjusted to 250usec. Diagnostics were repeated and tested ok. The patient was able to tolerate both normal stimulation and magnet stimulation following these adjustments and stated it was much better. The patient also complained of chest discomfort at generator site which the physician felt it was due to scar tissue and not stimulation related. The change in patient settings was performed for patient comfort, and no other interventions are planned at this time.

Event Description
It was reported that the patient was experiencing constant burning at her generator site as well as a shooting pain into the back of her head, hot flashes, and trouble breathing when her device would go off. This started following her recent replacement in (b)(6) 2011. The patient was told that this may be due to a lack of fatty tissue and possible scarring. The patient has been referred for a generator, and possible lead replacement. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2351767
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #43 on: February 21, 2018, 02:19:44 AM »

Lot Number 686260
Event Date 01/06/2012
Event Type Injury
Event Description
On the morning of (b)(6), i woke up with a shocking feeling in my head, accompanied by a migraine. When it didn't subside by monday the (b)(6), i decided to email the company that makes my vns, cyberonics. On tuesday the manager called me back and after telling him everything that was happening, he said to turn the device off and see if i still have the shocking feeling by taping my magnet to my vns for a few hours. After taping the magnet to the device, although the shocking went away, my skin started feeling like it was on fire. After removing the magnet a few hours later, the shocking feeling and migraine came back immediately, and there as a burn mark on my chest where the device is. Then on wednesday the (b)(6) i had to be taken to the hosp by ems for severe chest pains. The feeling still hasn't gone away. Frequency: on 30 sec off 1. 5 min.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2423729
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #44 on: February 25, 2018, 01:41:21 AM »

Model Number 102
Event Date 11/21/2006
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient was seeking to have her device explanted. The patient reported experiencing memory loss and losing her sense of direction. No known interventions have occurred to date.

Event Description
On (b)(6) 2013, it was reported that this patient wanted her device removed due to choking, occasional stuttering, and memory problems that the patient attributes to vns. The patient also felt the device did not help with depression. No additional information was available. Surgery is likely but has not taken place.

Event Description
On (b)(4) 2012, it was reported that this vns patient wanted her device explanted. No additional information was provided. Surgery is likely, but has not occurred.

Manufacturer Narrative

Event Description
Additional information received from the physician revealed that the neurological issues the patient reported were mainly pain however the patient's chart was not available for him to confirm. The pain was not isolated to device stimulation. The physician did not have any additional information to provide.

Event Description
The patient was seen on (b)(6) 2013, and clinic notes dated (b)(6) 2013 were received. The notes indicated that the patient had a previous medical history of depression/anxiety, irritable bowel syndrome, fibromyalgia, and scoliosis. The patient's depression was initiated by a familial death. The patient attributes multiple problems to her vns, including a sensation of spark in her left occipital region, occasional choking sensation, stuttering speech, and memory problems. The patient also reports an occasional left-sided headache, occasional parethesias on the left side of her neck, weakness in her right hand, and balance problems. The patient was seen on (b)(6) 2013. Diagnostics were run and were within normal limits. Settings were provided.

Event Description
Additional information was received on (b)(4) 2012, when the patient reported that she was experiencing choking, burning at the top of the generator, memory loss, "zapping" on the left side of neck and back of her head and that she is not able to eat food properly. When she tried to disable the device using her magnet, the symptoms did not resolve. She stated that her settings were lowered however she is still having problems. The patient stated that she now has scoliosis and is on disability due to her issues with vns. Good faith attempts to obtain additional information from the patient's physician have been unsuccessful to date.

Event Description
It was reported that a vns patient stated she developed a variety of neurological symptoms as a result of a device that she felt was broken resulting in pain and other issues. Per the patient, the neurologist she saw attributes all her symptoms to the device and advised her to have it explanted. On (b)(6) 2011, it was reported that the patient was complaining of pain even after the physician instructed her to place the magnet over the generator to temporarily inhibit stimulation. (b)(4) attempts to obtain additional information have been unsuccessful to date.

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

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #45 on: March 08, 2018, 02:35:14 AM »

Model Number 304-20
Event Date 05/19/2012
Event Type Injury
Event Description
On (b)(6) 2012, the vns patient reported that she has been experiencing some post-operation surgery effects. The patient was implanted on (b)(6) 2012. The patient stated that the vns is protruding, the patient's voice is altered and is high, and the patient's head is turned away from incision mark 4 and there is redness around the site. The patient's mother stated that the patient had to go back to the hospital overnight on (b)(6) 2012 due to pain as the patient had a hematoma and could not turn his head to the left. The patient's voice was still impaired. The patient's mother stated that the patient is doing better now. The physician later stated that they have no explanation for why the patient couldn't turn his head to the left however; the physician did not believe it was due to vns. The pain is located on the right side. No interventions were planned or taken and on (b)(6) 2012 the device was turned on. The physician does not believe the pain is related to vns. The physician clarified that there is no protrusion; the patient's mother was worried because the events occurred right after surgery, but the physician stated that the patient is healing quite nicely. The patient's implanted product information has been requested from the implanting hospital but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2620968
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #46 on: March 09, 2018, 03:34:32 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 01/17/2018
Event Type Injury
Manufacturer Narrative

Event Description
It was reported by a patient¿s mother that the patient was sick and ever since then she has started turning her head to the left and is keeping her eye closed. She is worried there might be a nerve issue or something wrong with the vns and maybe the vns is not working properly. It was later reported by the patient¿s mother that she was in the icu. She had severe seizures and in a sedated coma to stop the seizures, and the relationship to vns was unknown. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7297582
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #47 on: March 10, 2018, 02:26:58 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/04/2018
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing a tingling sensation at the electrodes that traveled from her ear to her head. Diagnostics were performed after the tingling started, and high impedance was present. The patient used the magnet to disable the device, and she planned on asking her physician to program it off. No 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=7262565
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #48 on: March 10, 2018, 02:28:13 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 08/25/2008
Event Type Injury
Event Description
It was reported that a vns patient would experience shortness of breath with exercise. The device was programmed off however the patient continued to experience shortness of breath and the patient was scheduled to have the device removed. The shortness of breath occurred sporadically and was not related to stimulation on times. Additional information received indicated that the patient suffers from anxiety and that was why the device was explanted. The anxiety is not related to vns and is pre-existing however the physician believed that due to the patient¿s anxiety, she could not handle being implanted with the device. The physician indicated that the shortness of breath could be related to the anxiety but was not sure. Additional information was provided that the device was explanted due to syncope and other complications. The explanting surgeon stated that at the time he noted that it was causing intermittent traction of the vagus nerve. It was noted that the patient also had increased heart rate. Clinic notes dated (b)(6) 2008 (a few months after implantation (b)(6) 2008), it was noted that since vns was implanted, before it was turned on, the patient has complained of shortness of breath and exercise intolerance (this may have been why the patient had increase in heart rate). There was a note that the patient did have exercise induced asthma prior to vns implantation. However, the patient states that it specifically causes problems with her breathing and believes it is all because of the vns. The notes then go on to state that vns was interrogated and settings were 0. 5ma (changed from 30sec on to 60sec). Notes indicated that the physician tested the patient¿s pulse oximetry and pulse before turning the vns on. There were no notable changes and the physician stated that based on the results the physician did not think there was any obvious change both with exertion and at rest whether or not the vns was on. The patient was still quite upset so they elected to turn it off. Notes dated (b)(6) 2009 indicate the device has still been off since (b)(6) 2008 and the patient still has had problems of a sense of pulling in her throat, difficulty breathing, exercise intolerance, syncopal episodes, left facial numbness, all of which she reports are intermittent. She can reproduce some of these problems when she turns her head to the right for prolonged periods of time or when she pushes upon the sternomastoid muscle a few cm from the incision. This would be at the location of the lead itself. The surgeon assessed the patient and attributed that there is excessive traction on the nerve with turning of her head and most of not all of her other symptoms are likely related to intermittent traction on the vagus nerve. Surgeon offered surgical intervention to possibly increase the size of the strain relief loop in an attempt to ameliorate the traction that she suspects caused these issues. He also offered a more extensive option to remove the vns if she preferred. The patient decided to remove the device entirely on (b)(6) 2009. The entire system was removed including all 3 helical coils. Notes dated (b)(6) 2009 did state that the patient has had none of the symptoms she had previously. No additional or relevant information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237189
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #49 on: March 15, 2018, 02:16:30 AM »

Model Number 302-20
Event Date 08/23/2012
Event Type Malfunction
Manufacturer Narrative
Device available for evaluation, corrected data:the supplemental report #2 inadvertently did not include the date in which the lead suspect device was received by the manufacturer.

Event Description
Patient reported on (b)(6) 2012 that she is doing well.

Manufacturer Narrative
Conclusion, corrected data: the supplemental report #4 inadvertently reported the incorrect conclusion code. No device failure is suspected. No device malfunction is suspected, and the (b)(6) 2012 x-rays did not show a lead fracture, so the event is coded as confirmed invalid. In addition, normal mode and system diagnostics were reportedly within normal limits.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.

Manufacturer Narrative

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Event Description
An implant card was received by the manufacturer on (b)(4) 2012 which revealed that the patient had lead replacement surgery on (b)(6) 2012 due to "lead discontinuity. " the explanted lead was received by the manufacturer on (b)(4) 2012. However, product analysis has not been completed to date.

Event Description
Additional information was received indicating that the physician performed both normal mode and system diagnostics which resulted in okay results. They were perplexed because the diagnostics are okay but the x-rays show a partial lead break (which the physician and company representative also observed). A/p and lateral x-ray images of the chest and neck dated (b)(6) 2012 were also received by the manufacturer. The generator placement appears lower than normal in the left chest. Without images from immediately following implant surgery in (b)(6) 2010, it is difficult to assess whether the generator has migrated. The connector pin appears to be fully inserted inside the connector block, and the lead wires appear to be intact at the connector pin. The filter feed-through wires also appear intact. No portion of the lead appears to be located behind the generator. The electrodes were visualized in the neck and appear to be in the proper orientation. Unlike the previous images dated (b)(6) 2012, there do not appear to be any lead fractures in the chest area above the generator. No gross discontinuities or sharp angles are visualized in the images provided. However, a micro-fracture or unpronounced lead discontinuity cannot be ruled. It appears that there was likely an artifact in the images dated (b)(6) 2012 that made it appear as though there were two partial lead fractures in the chest area. Based on the x-ray images provided, no anomalies can be observed to account for the reported pain and potential generator migration. It can be noted that these are adverse events and not device malfunctions, and therefore, they are not expected to be observed on an x-ray. No gross lead discontinuities or sharp angles could be visualized, however an unpronounced lead discontinuity cannot be ruled out. No anomalies were identified that could account for the adverse event. The physician believes inadequate strain relief in the neck may be contributing to the patient's pain in the neck. She only gets the painful stimulation when she turns her head to the right. They believe the generator has migrated which may be pulling on the leads from the two tie-downs due to poor strain relief. The patient has received good efficacy from vns therapy. The physician believes the way to resolve this is to fix the strain relief, however, no interventions have been planned to date. Although surgery is likely, it has not occurred to date.

Event Description
Product analysis on the returned lead assembly was completed. The lead was returned in three portions. The connector pin, connector ring, and lead's electrodes were not returned for evaluation. The reported high impedance and lead discontinuity allegations were not verified within the returned lead portions. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portions.

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

Event Description
X-rays were received on (b)(6) 2012, by the manufacturer, and the radiology report indicated that the patient was experiencing neck pain. Review of the ap and lateral chest and neck x-rays, dated (b)(6) 2012 revealed that the generator can be visualized in the left chest and it appears to be in a normal orientation. The lead pin appears fully inserted into the connector block. The filter feedthru wires appear intact and the lead wires appear intact at the connector pin. The lead wire does not appear to be located behind the generator. The electrodes were visualized in the neck and appear in the proper orientation. There appears to be two partial lead fractures in the chest area above the generator. No additional gross discontinuities or sharp angles in the images provided are visualized. Based on the x-rays received, there are two partial lead fractures present in the chest area which may be contributing to the pain. Follow up with the company representative revealed that the patient's pain was thought to be the same pain the patient experienced before in the neck and shoulder area in 2011 due to generator migration and patient trauma from a car accident (before the physician was aware that there appears to be two partial lead breaks). The physician believed the pain may be related to the generator migration or potentially scar tissue at the electrode site which may be making the strain relief less prominent during neck movement. However now, the pain occurs during stimulation and when she turns her head ot the right or left. The plan is to discuss this with her on the next visit and evaluate if surgery may be needed. The physician suspects that the strain relief may or may not be present anymore due to scar tissue or it may be pulling the lead wire back into the neck area. The physician reported that all diagnostics are within normal limits, and he does not think there is a lead break but only associated with the strain relief. It could have had more of a strain relief and then when the generator migrated, caused a less prominent strain relief. If the pain is still present and it is decided to pursue surgery, the physician and company representative indicated that he would suggest to open up the pocket and neck, move the generator higher in the pocket, capture the lead wire and make a proper loop/strain relief. The physician did not know when the patient will be seen next and does not know how much dysfunction the pain is causing her. The pain does not occur every time during stimulation and is not constant, but only when she turns her neck. The device had not been turned off to date as of (b)(4) 2012. Attempts for additional information have been unsuccessful to date thus far.

Event Description
The return product form indicates that the reason for lead replacement on (b)(6) 2012 was due to lead discontiuity. Product analysis on the explant lead has not been completed to date. The generator was not replaced.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2754445
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #50 on: March 19, 2018, 02:00:58 AM »

Model Number 302-20
Event Date 09/11/2012
Event Type Malfunction
Event Description
The patient had surgery on (b)(6) 2012. The surgeon removed the pin and tried with a new generator several times and continued to get high impedance. He elected to do a complete revision of the generator and lead. Lead impedance was okay at that time. Attempts for product return have been unsuccessful as the explanting facility will not release without a patients signed release.

Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a serious injury or death. Suspect medical device brand name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device type of device name, corrected data: with the additional information, the suspect device is now the lead. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information, the suspect device is now the lead. Device manufacture date, corrected data: with the additional information, the suspect device is now the lead.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of the generator.

Event Description
It was reported that the patient presented to an office visit on (b)(6) 2012 complaining of hoarseness during vns stimulation but the day that it began was unknown by the patient. The physician lowered the pulse width from 500 usec to 250 usec. The patient later reported in the morning of (b)(6) 2012 that she was experiencing a sharp pain at the generator site continually. The physician sent the patient to the emergency room. The patient was reevaluated by the physician on (b)(6) 2012, and high lead impedance was observed on both system and normal mode diagnostics. The patient clarified that the hoarseness was always present with stimulation, but the pain around her generator site started on (b)(6) 2012. She was experiencing the pain with stimulation and if she turned her head side to side or lifts her left arm. She denied any falls or trauma recently. Clinic notes dated (b)(6) 2012 indicate that the patient was complaining of sharp pain in the left upper chest and site of the generator. X-rays were taken when she went to the emergency room. The notes indicated that the x-rays were unremarkable. While the patient was in the emergency room, she went into violent tremors and was extremely tearful. It took about 15 minutes to calm her down and then she was back to baseline. There was no new neurological findings, and the violent tremors are reportedly not new and/or unusual for the patient, per the physician. The violent tremors have no relationship to vns. Follow up with the physician on (b)(6) 2012 revealed that the painful stimulation still isolated to the chest area near the generator site. The device was turned off on (b)(6) 2012. There were causal or contributory programming or medication changes precede the onset of the events. Although revision surgery is likely, it has not occurred to date. Ap and lateral views of the chest dated (b)(6) 2012 were received and reviewed by the manufacturer. The filter feedthru wires were intact at the generator, but the lead pin did not appear to be fully inserted into the generator (noted by how the lead pin does not extend past the second generator block. )there were two separate leads found within the patient. Lead a extends into the neck area and out of the view of the x-ray. No x-rays were taken of the neck area, so it is not possible to assess the lead in the neck area. The second lead, lead b, appears to no longer be on the nerve and is in the upper left chest area. It is difficult to determine which lead is connected to the generator because both leads extend down and behind the generator. No lead breaks were seen in the x-ray, and the lead is intact at the connector pin. Based on the x-rays provided, the cause of the high lead impedance is likely due to the lead pin being not fully inserted into the generator. However, if lead b is the lead the generator is connected to, then it may be that the lead is no longer on the nerve. The presence of additional micro-fractures in the lead can also not be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2784912
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #51 on: April 03, 2018, 01:11:56 AM »

Model Number 304-20
Event Date 11/06/2012
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high lead impedance (>7000 ohms, neos - no). The high impedance was seen when the physician interrogated the patient's device and a high impedance warning message was received. The patient had been doing some heavy lifting while moving apartments. Following this he began experiencing some pain on the left side of his neck, head and shoulder. The pain was described as constant throbbing which was not relieved with tylenol. The patient can into the physician office for an appointment related to his and the high impedance was seen. The patient had their setting turned down and them off and the high impedance remained. The physician chose to turn the patient back on as vns has helps with seizures. The patient was referred for x-rays. X-rays will not be provided to the manufacturer for review. The physician reviewed the x-rays and there were no lead breaks visualized. The patient also had a more intense seizure about the same time of the move. The physician increased his dose of keppra and asked him to get his level checked. It was determined that his keppra level was low. He did not have any more seizure at the time of the report to the manufacturer. It is unknown by the physician if the more intense seizure was related to vns or the high impedance. The patient had a generator and lead replacement. Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. 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 as defined in (b)(4). The battery, 3. 012 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 119% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. 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. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2911574
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #52 on: April 04, 2018, 01:17:59 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
Event Description
Additional information was received which indicated that the voice alteration was occurring with stimulation, there were no change in medication, and the increased impedance was seen on the vns device diagnostics, but there were no visible lead fractures in x-rays. There was no patient manipulation or trauma that might have caused the lead impedance. After the full revision the patient's seizures are now gone. The patient's settings on (b)(6) 2013 are output current= 0. 25 ma/ frequency= 15 hz/ pulse width= 130 usec/on time= 30 sec/off time= 3 min / magnet output current= 0. 5 ma/ on time= 60 sec/ pulse width= 250 usec. The device history report for the 302-20 sn (b)(4) was reviewed. No unresolved non conformances were found.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported through clinic notes received on (b)(6) 2012 that the patient had high impedance upon interrogation of her vns device on (b)(6) 2012. It was noted that the patient was last seen on (b)(6) 2012. The patient had been experiencing pain and soreness over the chest during stimulation which started on (b)(6) 2012 when the patient went to the er because she was experiencing burning in the neck. On (b)(6) 2012 it was stated that the patient had a fall approximately 1 week prior and the physician was uncertain if it was related to the patient's pain. At that time the patient described "mouth vibrations", chest pain near the generator radiating to her teeth head and arm with electrical qualities. Per the physician, an x-ray at that time did not show any gross lead fractures. On (b)(6) 2012 the pain was said to radiate to ear when the device stimulates and it was stated that the patient had discomfort when lifting her left arm. When the device was disabled the discomfort was gone. It was also indicated that the magnet had become more painful recently. Additionally it was noted that the patient had been experiencing an increase in seizure frequency. It was indicated that the patient usually experiencing 4-5 seizures per month when sleepy, however she had started experiencing 2-3 per month during the day as well as an increase in staring spells. The patient was referred for and underwent a full revision on (b)(6) 2012. A review of available programming history for the patient's generator was performed and diagnostic results in (b)(6) 2012 were within normal limits. Attempts for additional information and product return are in progress.
 
Event Description
An implant card was received on (b)(6) 2013 indicating that the reason for the replacement was due to an adverse event. The impedance from the date of surgery was not provided. Per the hospital's policy the hospital will not return explanted devices without a signed consent form and the patient, however the physician's will not ask for the signed release; therefore the product will not be returned. Attempts for additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #53 on: April 07, 2018, 01:14:55 AM »

Model Number 304-20
Event Date 04/03/2014
Event Type  Injury   
Event Description
Clinic notes were received indicating that the vns patient was in a car accident on (b)(6) 2014 and sustained a neck injury. The patient had neck pain and immediately had a seizure following the car accident. The patient had been seizure free for nearly a year prior to the car accident. The patient¿s device settings were increased during an office visit on (b)(6) 2014. The patient¿s neck pain worsened with stimulation. The patient began having head and ear pain. The patient also began experiencing voice hoarseness, occasional drooling, and head tilting with stimulation. (the patient pulled her neck toward her chest during device on-times. ) x-rays were taken and were reported by the physician to be unremarkable. The patient¿s device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently had four generalized convulsions within 24 hours. The patient¿s device settings were increased during an office visit on (b)(6) 2014 and the patient was able to tolerate her adjusted device settings. 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.
 
Manufacturer Narrative
New information changes the suspect device.
 
Manufacturer Narrative

Event Description
Additional information was received stating that, despite normal diagnostic results, the vns patient¿s lead was replaced due to the patient¿s increase in seizures following the motor vehicle accident. Furthermore, it was reported that the patient did not have a history of acid reflux. The reported acid reflux is believed to be related not to stimulation but to the patient¿s psychosomatic issues. Lead replacement surgery occurred prior to the onset of the acid reflux.
 
Event Description
It was reported that the patient's symptoms resolved after lead replacement surgery.
 
Event Description
Additional information was received stating that the vns patient underwent lead replacement surgery on (b)(6) 2014. The patient¿s generator was not replaced. The explanted lead has not been returned to date. Further follow-up revealed that the patient¿s device was tested during an office visit on (b)(6) 014 and diagnostic results showed normal device function. The patient was concerned that there was a potential relationship between vns and the patient¿s acid reflux. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Corrected data: this date on follow-up mfr. Report #03 inadvertently reported the incorrect year. The date should have been reported as 07/28/2014. The report was not a late submission.
 
Manufacturer Narrative
The previously submitted mdr inadvertently did not include information regarding the reason for lead replacement surgery and the patient¿s acid reflux. The previously submitted mdr inadvertently did not include that no device failure is believed to have occurred as diagnostic results showed normal device function.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854244
« Last Edit: January 20, 2019, 12:50:57 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #54 on: April 08, 2018, 01:09:18 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 02/20/2018
Event Type  Injury   
Event Description
It was reported that the patient went to the emergency room due to pain shooting up her neck and back of her head that had been occurring for a few hours. The patient also had spasms and twitching on the left side of her body. The physician wanted to disable the device, so instructions on how to use the magnet to disable it were given. The patient was then admitted to the icu and intubated due to unknown reasons, and it was reported that most of the patient's seizures were pseudo-seizures. The physician stated that the patient was reporting that her vns was misfiring, but he did not seem to believe the patient based on her report of false seizures. Because the patient had no insurance or following neurologist, the physician requested that the device be programmed off until it could be properly managed. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7343586
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #55 on: April 12, 2018, 12:54:13 AM »

Model Number 106
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been experiencing an increase in seizure frequency and duration. The patient had two 4-minute seizures in one month and it was noted that the length of the seizure was unusual for the patient. The patient had also been experiencing hyperventilation and reported that his head was not feeling well. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient¿s issues were not related to vns but to an endocrine problem that resulted in a loss of appetite.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4309662
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #56 on: April 15, 2018, 12:40:09 AM »

Model Number 304-20
Event Date 02/04/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a patient was seen urgently on (b)(6) 2013 after having 3 strong seizures in which the patient's head was turned to the right. The word "pledget" was used to describe strain in the vns lead wire with the neck muscle. The patient's device is currently disabled for 10-14 days and then the patient was to have the device re-tested. X-rays did not visualize the top of the lead wire but the area observed did not show any overt breaks per the reporter. All attempts for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated the patient's lead-pulling sensation was possibly due to the patient's strong seizures which may have caused inflammation along the lead wire. There was no specific patient trauma experienced other than the previously reported strong seizures which may have been the cause. The vns was disabled for two weeks, and then turned back on (b)(6) 2013. There have been no issues reported since that time. Current diagnostics are within normal limits. The "pledget" noted is felt to be the tie-down securing the lead in the neck.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2987998
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #57 on: April 26, 2018, 01:26:49 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported that the vns caused the patient's gastroparesis, and their seizures were still not controlled. It was stated that the device didn't work for the patient and was therefore it was turned off. Scar tissue formed in the patient's neck, which was very painful, even to turn their head just a little bit was reported to be torture. Patient reported undergoing surgery to remove device and scar tissue. Patient also reported that there was damage to the vagus nerve. The patient's neurologist who managed the patient's vns did not know about any of the symptoms or issues. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7008994
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #58 on: April 27, 2018, 02:06:29 AM »

Model Number 102
Event Date 05/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
The explanted device was returned on (b)(4) 2013. In (b)(6) 2013 notes, a system diagnostics test was also performed which showed results within normal limits and eos=no. Therefore, the event coding was not updated to indicated neos. Although the reported allegation of ¿change in seizure pattern¿ and ¿increased seizures¿ listed in (b)(4) cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. 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. The generator performed according to functional specifications as defined in final electrical test (b)(4). During the product analysis there were no anomalies found with the pulse generator. Attempts for additional information were unsuccessful.
 
Event Description
On (b)(4) 2013 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2013 indicated that the vns patient has experienced clusters of myoclonic seizures and head drops since (b)(6) 2012. It was stated that the myoclonic seizures were occurring 2-4 times a day but now he has them once a day. It was also stated that patient has been experiencing myoclonus seizures twice per week which the mother thinks is new, but previous clinic notes indicate longstanding myoclonus. The patient¿s vns settings were noted to be output=1ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec. A system diagnostics test was also performed which showed results within normal limits and eos=no. The clinic notes also mention that the patient is experiencing an increase in the frequency of his tonic seizures, especially at night. The patient was referred for generator replacement for an unknown reason. Additional information has been requested from the patient¿s physician but no further information has been received to date. A battery life calculation was performed which showed 5. 74 years remaining until eri=yes.
 
Event Description
Additional information was received that the patient had a generator replacement. Attempts for product return have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3192307
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #59 on: April 28, 2018, 12:55:07 AM »

Model Number 304-20
Event Date 05/23/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Additional information was received indicating that cultures returned positive for (b)(6).
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization and confirmed all quality tests were passed for both the generator and lead prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent revision surgery on (b)(6) 2013. It was reported that the device "worked 100%". It was later reported that the patient was seen for checkup and that it was found that the patient has a "broken lead". It was reported that during the office visit diagnostics were performed with the patient's head a different orientations. It was reported that when the patient turned his head to one direction high impedance was always observed. Then the patient turned his head the opposite direction the impedance was "ok". The patient was referred for surgery and the device was programmed off. Surgery is likely, but has not occurred to date.
 
Event Description
It was reported that this vns patient underwent surgical debridement (without disconnecting the generator) due to chronic inflammation in the surgical wounds in the neck and chest. The patient was seen for a vns check, and system diagnostics indicated high impedance (10000 ohms). The device was disabled. During the operation, unipolar electric fields were used. It was believed that the patient had a damaged generator, lead, or both. The patient was referred for surgery. Follow-up showed that the chronic inflammation was believed to neck granulation that was first seen a few weeks prior to surgical intervention. The physician stated that diagnostics prior to the surgery were within normal limits; however, afterwards, they indicated high impedance. No x-rays were taken. Cultures were taken at the wound sites; however, the results have not been provided. Surgery is likely but has not taken place. No additional information has been returned.
 
Manufacturer Narrative
Previously submitted mdr inadvertently omitted the outcome of culture results. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3173892
Logged
Pages: 1 [2] 3 4  All   Go Up
Print
Jump to: