Pages: [1] 2 3 4  All   Go Down
Print
Author Topic: Head  (Read 12618 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« on: September 06, 2017, 08:41:38 AM »

Model Number 102
Event Date 08/06/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing spasms of the sternocleidomastoid muscle with device stimulation which was causing the patient to experience head deviations which resulted in airway obstruction. It was reported that the patient used the magnet to disable the device and that the spasms resolved for about 10 minutes, but then started back up. It was reported that it is unclear if the magnet moved off the device because the physician was not present at this time. The patient was seen by the physician at the hospital and the device was programmed off. The physician indicated that it was unclear whether or not the patient's accessory nerve was being stimulated to cause this or whether there is current leakage to the muscle. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3329805
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #1 on: September 06, 2017, 08:42:31 AM »

Model Number 103
Event Date 10/19/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Initially, it was reported that the patient developed a new seizure since generator replacement that was head bobbing. Clinic notes dated (b)(6) 2014 were received indicating that the patient's father would like the vns removed because he feels that the patient's head bobbing was related to vns. It was noted that the vns remains off and no head bobbing episodes have been seen. The patient was referred for surgery. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4226801
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #2 on: September 06, 2017, 08:43:18 AM »

Model Number 102
Event Date 01/23/2013
Event Type  Injury   
Event Description
Additional information was received which indicated that the patient is taking six different medications which is making him sleep a lot and made him lose a lot of weight. It also indicated that the patient's seizures have decreased after the vns battery depleted and the parent prefers not to revise the vns. Additional information revealed that the patient was cleared for surgery and the surgery date was scheduled on (b)(6) 2013. On (b)(6) 2013, the patient's vns generator was replaced. The explanted generator will not be return as the site does not return explanted products.
 
Manufacturer Narrative

Event Description
It was reported by the patient's mother that the patient would jerk his head and that his seizure patterns have changed while the vns battery was reportedly depleted. The programming history database was reviewed and it was noted that the physician had the patient set on a 57% duty cycle from date (b)(6) 2011 which is considered as excessive. The physician was contacted, but did not respond to date. Surgery to replace the vns generator is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2974018
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #3 on: September 06, 2017, 08:44:01 AM »

Model Number 102
Device Problem No Known Device Problem
Event Date 10/13/2013
Event Type  Injury   
Event Description
Clinic notes were received for reimbursement purposes on (b)(6) 2015. Notes dated (b)(6) 2015 indicate that the patient's generator is 10 years old and that it is nearing end of life. Patient was also reported to be having seizures and was referred for generator replacement. Notes dated (b)(6) 2015 from the generator replacement surgery indicates that the patient had increased seizures.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2014 noted that the patient has had increasing episodes where she feels like she is going limp, her head goes ack and her eyes roll back. It was noted that the patient is sleepy the remainder of the day and that this has been occurring for approximately 4-5 months. The device was interrogated and ifi was no. The device output current was increased from 1. 75ma to 2ma. The patient was referred for surgery. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent prophylactic generator replacement on (b)(6) 2015. The explanted generator was reported to be discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4329443
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #4 on: September 06, 2017, 08:44:39 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: 61153


« Reply #5 on: September 06, 2017, 08:45:21 AM »

Model Number 103
Event Date 12/13/2011
Event Type  Injury   
Event Description
Additional information was received on (b)(6) 2012, when analysis of the returned generator was completed. The generator was found to be functioning as intended and the ifi (intensified follow-up indicator) was sent to yes. The data stored in the generator revealed that 84. 075% of the battery had been consumed and the voltage was 2. 791 suggesting a partially depleted battery however the generator could deliver the programmed settings.
 
Event Description
It was reported that the patient was admitted to the hospital on (b)(6) 2011 due to a prolonged partial seizure that consisted of quick jerking of her head to the left. When the patient was in the er, these movements were not identified as seizures and they continued for over an hour after being given 20 mg of valium. The device was interrogated and found to be programmed to 1. 75/30/250/30/1. 8/2/250/60 and 1/3 of the battery was left. The output current was increased to 2 ma and the magnet output current to 2. 25 ma. The physician was also going to increase the dosage of rufinamide and see about different dosing strategies for the vns. Clinic notes dated (b)(6) 2011 stated the seizure frequency increased. In clinic notes dated (b)(6) 2011 stated that the patient had 6 seizures in 1 week which was unusual, however, it was being attributed to the dosage of lamictal. The patient began to experience another increase in seizure activity at the end of (b)(6) 2012 and the patient would be referred for generator replacement surgery. Good faith attempts to obtain additional information were unsuccessful.
 
Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient had the generator explanted and replaced prophylactically. The explanted generator has been returned to the manufacturer and is currently in product analysis. Device evaluation has not been completed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2498678
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #6 on: September 06, 2017, 08:46:07 AM »

Model Number 103
Event Date 01/06/2012
Event Type  Injury   
Event Description
On (b)(6), 2012 additional information was received when the patient further stated that while she was still implanted, she visited the emergency room twice because of burn marks received when using her magnet. The patient stated that both emergency room physicians advised her that she needed the device explanted before she died from it. However clinic notes from the patient's visit from the neurologist on (b)(6), 2012 were obtained which stated the vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The patient said she can't wear her hair down because when it touches her neck she has severe pain. The patient additionally stated that she had traumatic brain injury (tbi) before being implanted and therefore should not have been implanted in the first place.
 
Event Description
On (b)(6) 2012 the vns patient reported that since (b)(6) 2011 she has been experiencing pain in her head that is different from a headache, as well as pain in her right arm and an increase in seizures. The patient stated that the pain usually occurs after she has had a seizure. The patient did not know the relation of her increase in seizures to pre-vns baseline levels. The patient reported to the case manager that she is not currently seeing a neurologist as she has a different insurance now. The patient sated that she is feeling a constant low voltage electrical shock in her brain. The patient taped her magnet over the device and said she experienced a burning feeling from the magnet. She said there was a burn mark on her skin when she removed the magnet. She stated that when the magnet was taped over the device, she did not feel the painful stimulation. The manufacturer's consultant reported that the patient had previously lied about her insurance so finding a neurologist was difficult. They found one the patient could see but the patient's husband refused to drive her there. The patient then showed up at the emergency room where the patient's real insurance information was discovered. The patient was seen by a neurologist and he disabled her device because of her reported pain. He went ahead and referred her to a surgeon because of the pain but she screamed at the neurologist and the staff so he asked her to leave and he will not see her again. The patient stated that she still felt painful stimulation even when the device was off and that the magnet stimulation burned her when she swiped the magnet. The clinic notes from the patient's visit from the neurologist on (b)(6) 2012 were obtained which stated that the patient was tearful and hysterical over the pain due to vns. The patient was angry that vns has not helped her. The pain and burning was reported to have started on (b)(6) 2012. The patient stated that she is currently taking hydrocodone for the pain but asked for more pain medication. The neurologist tried to run diagnostics but the patient would not tolerate it and remained hysterical and belligerent. The vns generator site was evaluated and the neurologist saw no bruising or burn marks that the patient claimed to have. The manufacturer's consultant reported that the patient had her generator and lead explanted on (b)(6) 2012 due to a device malfunction. The patient's husband did not want the explanted product sent to the manufacturer for product analysis; however the surgeon did want the devices sent to the manufacturer. The husband became verbally abusive and was provided the options of having the manufacturer perform product analysis on the device or have the device sent to him without product analysis if he signed a release form.
 
Event Description
Additional information was received on january 26, 2012 when the explanted lead and generator were returned to the manufacturer for product analysis. The electrode array portion of the lead was not returned for analysis, and therefore, an evaluation and resulting commentary cannot be made on that portion of the lead. Visual examination of the lead identified what appears to be a cut opening and a puncture in the outer silicone tubing. No obvious damage to the inner silicone tubing of the lead coils was noted at these locations. The conditions are consistent with those observed due to the explant process. The lead assembly has remnants of what appear to be body fluids inside the inner silicone tubing of the lead coils. The assessment of the believed leakage path was the cuts or punctures made in the lead during the explant procedure. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis on the generator was completed on february 9, 2012. Electrical test results demonstrate that the pulse generator performs according to functional specifications and there are no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2434478
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #7 on: September 06, 2017, 08:46:47 AM »

Model Number 102R
Event Date 04/20/2015
Event Type  Injury   
Event Description
It was reported that the patient has begun experiencing head drops. The patient reported that the feeling is similar to when she had a seizure, but that she had never experienced that symptom before. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4778950
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #8 on: September 08, 2017, 10:21:19 AM »

Model Number 300-30
Event Date 12/01/2010
Event Type Malfunction
Manufacturer Narrative
Corrected data: new information received indicates that the lead was not explanted.

Event Description
It was reported by a nurse that a vns patient reported buzzing and pain in the top of his head that had occurred 3 times within the last 3 weeks of initial report. The patient reported that placing the magnet on the generator ameliorated the pain. Moreover, the patient indicated the pain was not occurring with normal stimulation and no patient manipulation or trauma was reported. The nurse further stated that a generator diagnostic tests was performed and received a low impedance warning. The patient was interrogated and the device was found to be at 0 ma. The patient was re-programmed to 1. 5/25/500/30/1. 1 then performed system diagnostics which resulted within normal limits (ok/ok/1/no). Further information from the treating nurse indicated that the patient was scheduled for complete replacement. Moreover information from a company representative indicated the patient underwent surgery as scheduled. Good faith attempts to obtain the explanted devices have been unsuccessful to date. Additional information was received from the treating neurologist indicating the cause of the buzzing was related to generator with/ or wire malfunction. Moreover, the replacement surgery was done for patient comfort according to the neurologist.

Event Description
Further follow-up revealed that during the surgery a dual pin generator was not available. It was reported that the patient was closed and a dual pin generator was located and the patient was taken back to the operating room the same day for only generator replacement. The lead was not replaced as previously reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1989992&pc=LYJ
« Last Edit: February 03, 2018, 03:03:39 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #9 on: September 16, 2017, 12:56:10 AM »

Model Number 103
Event Date 01/27/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2012, a copy of the physician's flashcard was received. The patient's programming history was reviewed. The programming history provided spanned (b)(6), 2012.
 
Manufacturer Narrative
Analysis of programming history. Relevant tests/laboratory data, including dates, corrected data: previously submitted mdr reported incorrect settings for (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, (b)(6) 2012, and (b)(6) 2012. Additional information was received providing correct settings for these dates. This report is being submitted to correct this information.
 
Event Description
Clinic notes were received on (b)(6) 2012 from, a physician's office. The notes covered the patient's physician visit from (b)(6) 2011 to (b)(6) 2012. The patient was implanted on (b)(6) 2011, at which time the device was not programmed on. On (b)(6) 2011, notes reported pain at the surgical site, hoarse voice, and "multiple grand mal seizures after vns. " the vns incision lines looked good, were both healing well, without tenderness. The neck incision had surrounding swelling. On (b)(6) 2012, notes state that the patient's hoarse voice was gone, there was no more pain at the vns site, and no change in frequency. The notes indicate that the patient's device was turned on, and the patient did not feel anything. No settings are provided for this date, and initial interrogation at the next appointment indicates normal mode and magnet output currents were 0 ma. On (b)(6) 2012, the patient reported an increase in seizures and duration, along with aggression. The notes report that the magnet did seem to stop the seizures and make them shorter; however, settings from this date indicate that the device was programmed off until this appointment. The patient experienced painful magnet mode stimulation for the first magnet activation. On (b)(6) 2012, it was stated that the patient felt he had an upper respiratory infection the previous week. The patient turned during sleep and "felt spinal cord electricity," a lack of consciousness for 30 minutes, and then numbness throughout his head, which continued. There was now a change in seizures: the patient had a warning and then an out of body experience. He was unable to use the magnet during this time. The patient's aggression was reported to be less, he did not have any more headaches, but he did have neck pain. On (b)(6) 2012, notes reported that the seizures did decreased but have recently reoccurred. The patient occasionally coughed with vns but had no serious ill effects. The patient did experience coughing and choking during magnet stimulation; however, the magnet did abort seizures well. The patient's vns was adjusted, and the physician ensured that the patient tolerated both normal mode and magnet stimulation. On (b)(6) 2012, the patient was seen for increased blood pressure and a check of the patient's vns after the patient held a shocking dog collar while the collar was charging. The patient's vns settings were altered. This event is captured in mfr. Report # 1644487-2012-01066. On (b)(6) 2012, notes report that the patient was having the same amount of seizures (4/day) and no issues since turning the stimulator back on from the collar incident. On this date, the patient's settings were adjusted. On (b)(6) 2012, the patient was seen again for marked aggression, agitation, and an increase in grand mal seizures since the adjusted settings the previous day. The magnet did not seem to stop the seizures. The patient's mother taped the magnet over the patient's vns to disable the device, and all symptoms stopped. The patient's settings were reduced to (b)(6) 2012 settings. On (b)(6) 2012, the patient was reported to have a bad mood, irritable, snapping, and having more seizures. He was saying things he wouldn't have in the past and demonstrating almost manic-depressive type behavior. The patient became violent, hit his parents, screamed, held his head, demonstrated symptoms like a grand mal seizure, and later bit his finger. The patient was not able to perceive normal mode or magnet stimulation. The patient's mother felt that things were going well with vns at first, but felt as though the seizures were never really controlled. The patient's normal mode output current was programmed off, and the magnet was programmed to a higher output current that resulted in a cough lasting less than 5 seconds. Follow up with the nurse practitioner revealed the following information: the patient's increase in seizures was below his pre-vns baseline. The patient was treated by his primary care physician for the upper respiratory infection; however, the nurse practitioner did not think that the infection was related to vns. When asked about the change in seizure reported on (b)(6) 2012, no additional information regarding the change in seizures was available; however, the change was attributed to anxiety. The patient's anxiety was caused by vns: the presence of the device and the surgery. The nurse practitioner believes that the vns causes the patient anxiety. The anxiety, in turn, propagates more seizures. The patient was placed on medication to assist with the anxiety and sleep. There are discrepancies between the settings from appointment-to-appointment that may be due to recording errors. Attempts to obtain the physician's flashcard to review the patient's complete programming history are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2584000
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #10 on: September 21, 2017, 12:47:39 AM »

Model Number 103
Event Date 05/15/2012
Event Type  Injury   
Event Description
Attempts for additional information have been unsuccessful. Surgery is still likely, but has not occurred.
 
Event Description
On (b)(6) 2012, a surgeon's office reported that they had received a phone call from a patient's mother. The mother reported that the vns patient had been experiencing continual hoarseness, choking, blue lips, face redness, vomiting, and inflammation at the surgical site. The patient's mother stated that the device was turned on at the date of surgery. At first, the patient's coughing was mild; however, as the day progressed, the coughing and choking became worse. She reported that the patient was feeling anxiety and, as a result, pacing due to the side effects. She also stated that the patient feels "like her head is going to explode. " the mother also reported that the patient has not had a grand mal seizure in two years; however, she has had two grand mal seizures since implant and went to the emergency room. (the date of the hospital visit is unknown. ) the patient went in to see her neurologist and the settings were decreased; however, the symptoms continued. The patient returned to the neurologist on (b)(6) 2012 and the device was disabled; however, the magnet output current was intentionally not programmed to 0 ma, and the patient and mother were told to swipe the magnet if they felt a seizure coming on. On (b)(6) 2012, a physician's office reported that they had spoken to the patient's mother on this date. The mother reported that the neck incision was swollen (there was a somewhat hard bump there that hurt when touched). She also stated that each time the device stimulated, the patient felt like she was being choked, turned red, the lips turned blue, and she would vomit. When the patient spoke, the mother noticed that the nerves were "pulling at her upper lip. " on (b)(6) 2012, a voicemail was received from the neurologist. He stated that he saw the patient and disabled the output current, expect for magnet stimulation. The physician stated that the patient was problematic and could not tell if the patient had a lot of anxiety or if the events were actually occurring. He stated that the patient reported choking; however, he did not see this and thought her swallowing was normal. He also stated that the patient reported tightness in her throat and coughing. In addition, he stated that there is a little swelling at the neck incision that was typical for surgery and not alarming. On (b)(6) 2012, the neurologist reported the patient's wounds were fine; however the patient was very anxious about the device and wanted it removed. The neurologist suggested using vitamin e cream for the wounds and giving the healing process a chance. The neurologist believed that the device was still programmed to only deliver magnet stimulation. The neurologist also believed that it would be best to leave the device in for a few months, especially after wound healing. On (b)(6) 2012, a surgeon's office reported that the patient's anxiety made the mother become anxious and any little pin prick sensation caused them to call everywhere. Surgery is likely but has not taken place to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2638613
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #11 on: September 22, 2017, 01:12:52 AM »

Model Number 102
Event Date 04/01/2012
Event Type  Injury   
Event Description
The patient's explanted generator and lead were retuned on (b)(6) 2012. A 'return product form' indicated that the device were explanted due to prophylactic replacement and because the patient did not feel magnet mode stimulation consistently, along with increasing symptoms. Evaluation of the explanted pulse generator's reed switch was performed on the test bench, which confirmed normal, expected reed switch function and magnet current with magnet activation. 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 device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Follow-up on (b)(6) 2012, showed that the lead was explanted due to a lead discontinuity. Diagnostics from (b)(6) 2012, were also provided. This lead event, along with product analysis results for the explanted lead, is captured in mfr. Report #1644487-2012-02507. Additional follow-up with the initial reporter showed that the patient's events had not resolved since revision. The patient still had the feeling that she was going to have a seizure daily; however, the patient would also feel anxious during these events, so it was difficult to say what the patient was actually experiencing. The patient could also not feel magnet mode stimulation. This was attributed to the patient's current settings being lower than pre-revision settings. The patient was slowly being ramped up. The patient's pre-operative settings and settings from her most recent appointment ((b)(6) 2012) were provided.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient could not feel magnet mode stimulation. The patient did report an inability to perceive normal mode stimulation. The nurse also reported that the patient complained of feeling "seizurey. " this was clarified to mean an increase in seizures. The patient's diagnostics were provided (date unknown). The patient's settings from (b)(6) 2011, (b)(6) 2012, and earlier were provided. A battery life calculation was performed on (b)(6) 2012, with 1. 6 years remaining until eri = yes. On (b)(6) 2012, the patient's nurse provided the following information. The increase in seizures was first observed in (b)(6) 2012. The patient was brought into the hospital for a possible seizure, associated with volume depletion/dehydration. The patient's constant feeling of being "seizurey" started within the past month. The nurse stated that it is unclear if these are prodromal symptoms and/or partial seizures. The symptoms consist of room spinning, numbness left side of head, confusion, and being scared. The patient has a history of mesial temporal sclerosis by mri and generalized activity on eeg. The nurse was unable to get an accurate count of the events. The nurse stated that while diagnostic testing is within normal limits, she presumed that the change in stimulation sensation and increased events are likely related to battery reaching end of service. As intervention, the patient's pulsewidth was decreased on (b)(6) 2012, and the patient's keppra dose was increased on (b)(6) 2012. Prophylactic replacement of generator was also being planned. No information was provided regarding the comparison to pre-vns seizure levels. In response to causal/contributory programming changes or events occurring prior to the increase in seizures, the nurse stated that the patient was admitted to the hospital in (b)(6) 2012, for dizziness followed by loss of consciousness. There was no clear cause, but the patient was hyponatremic, had a subsequent confusion episode and a possible seizure associated with dehydration. Within past month, there have been other possible lifestyle triggers but these were not new. The failure to perceive magnet mode stimulation was first observed within the past month. The patient reportedly uses the magnet frequently and reports being unable to feel magnet stimulation in past month. Previously, she had been able to feel it. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient's magnet mode diagnostics were not run. On (b)(6) 2012, the patient underwent surgery. Attempts for product return have been unsuccessful. An additional battery life calculation was performed on (b)(6) 2012, with updated data. The results indicated 1. 69 years to eri=yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2702307
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #12 on: September 23, 2017, 03:32:27 AM »

Model Number 103
Event Date 06/03/2012
Event Type  Malfunction   
Event Description
A vns consultant was at a patient's clinic visit and it was noted that the patient had high lead impedance. : lead impedance high, output current = low, and impedance value = over 10000ohms. There was no trauma reported. The patient could not feel the stimulation, even after they tried to increase the settings. The patient usually had a noticable change in voice with stimulation, but that was no longer noticable. It was reported that a week ago the patient had turned her head to the right, and had felt like the stimulation was stronger. This was the only occurrence of "stronger stimulation". The patient went to surgery. Their impedance was high when a system diagnostic test was done before surgery. The connector pin was not inserted all the way. The connector pin was taken out and put back in and their high impedance resolved. After the pin was re inserted three system diagnostics tests where run with all ok.
 
Event Description
Programming history was received for review and a change in impedance was noted on (b)(6) 2012 to over 10,000 ohms. Their generator was disabled on 7/19 prior to surgery. No patient fall was reported prior to their high impedance being attained. X-rays were not sent to the manufacturer for review.
 
Manufacturer Narrative
The connector pin was not fully inserted into the header of the generator confirmed in surgery.
 
Manufacturer Narrative
Date of event corrected data: updated to reflect actual date of event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2685054
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #13 on: October 04, 2017, 12:51:17 AM »

Model Number 102
Event Date 09/11/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013, this vns patient¿s caregiver poste a comment on social media. The caregiver reported that the patient has a vns. The system developed a fault: a fractured wire. Through ignorance of the patient¿s caregiver, the event gave the patient a very bad time for four months. Replacement took place, but the event stepped back the patient¿s progress.
 
Event Description
A vns treating physician reported to our country representative from (b)(6) they had a vns patient who was experiencing discomfort with stimulation, coughing with interrogation/programming, possible hoarseness and had his generator disabled. Since (b)(6) 2012, the date the patient had dental procedures and ct brain/facial bones, the patient has experienced the discomfort, making noises and coughing. Information received reported that the patient has experienced recent onset of +++ discomfort , making noises at regular intervals and holding his left side of his face/ head again at regular intervals. The patient in the last 3 - 4 weeks was making noticeable abnormal noises (possibly hoarseness) every 3 mins and also holding his hand to the left side of his head again at definite intervals. The patient is moderately to severely intellectually challenged and this intolerance is not uncommon behaviour. His father also reported that this was noticeable all night long when he picked him up and travelled with him to his neurology appointment. On (b)(6) 2012, vns was interrogated and settings were: 2. 0 ma, 30 hz, 500 pw, ot 30 secs, off t 3. 0, mag 2. 25ma, ot 30 secs, diagnostics system diagnostic test dcdc 2, normal mode diagnostic test 3, telemetry ok, lead ok. On interrogation the patient coughed profusely lasting > 60 secs. At previous visits this behaviour has not been seen. At the clinic session - their output current was lowered down to. 5ma steps to 0. 25ma. With the same outcome - +++ coughing, facial flushing and hand holding left side of head for >60 secs. They also attempted to reduce hz to 20 hz at. 25ma and same results. On turning their device off all symptoms subsided. Since their vns was programmed off the patient experienced an increase in the severity of their seizures with the loss of therapy. Since the patient does not live with the person who reported their seizures their md is not sure the information is reliable. X-rays were received for review. The electrodes are visualized but it is not possible to ascertain the placement in relationship to the cervical vertebrae due to limited views. A strain relief bend and loop are present but are difficult to assess due to the film angle. The loop appears to be in a "head-on" view. Two tie downs are noted securing the lead. It is noted the strain relief bend is not secured lateral to the anchor tether. A strain relief bend was present but there was no tie down present securing the bend, there was what appeared to be a loop with one tie down. A full loop cannot be confirmed based on the angle of the pictures. Another tie down was noted near the header of the generator therefore not placed per labeling. The strain relief should be adequate to allow for full neck movement to its maximum stretched positions. Most of the lead was visible and no obvious lead discontinuities were identified. Some lead is behind the generator and this portion cannot be assessed. The lead was intact at the connector pin but based on the angle of the generator header it could not be determined if the lead pin was fully inserted or not. The filter feedthroughs appeared intact. The patient had full revision surgery and it was noted on (b)(6) 2013 that they had a lead break in the potion that was apparently covered in the x-rays by the generator. Their explanted lead has been returned for analysis and is pending completion.
 
Manufacturer Narrative
X-rays were reviewed and were not able to access the header of the generator. Pin not being fully inserted was confirmed in product analysis. Findings.
 
Event Description
Product analysis was completed on the patient's explanted generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Lead analysis was completed. The lead was returned in five pieces. Two large and several small pieces. A lead break was not observed during this analysis. One set of setscrew marks was found near the end of the connector pin. What appeared to be canted spring indentations were observed on the rear end of the small o-ring. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. The incision, puncture and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found 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. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the pulse generator at one time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a lead discontinuity. When the patient's device was programmed off they had an increase in frequency and in severity of their seizures but still the same type of seizure. The patient was injuring himself during his seizures.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device malfunction suspected, 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=2976596
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #14 on: October 06, 2017, 02:08:13 AM »

Model Number 103
Event Date 09/27/2011
Event Type Injury
Event Description
A vns patient reported to the manufacturer on (b)(6) 2011 that she was experiencing pain "all over" and sometimes in her head and neck. The patient was attributing the pain to vns. The patient did go to the emergency room and was treated with anti-inflammatory medication. The patient is under a great deal of personal stress. The patient was advised to follow up with her physicians, but the physicians would not see the patient. The patient later reported to the manufacturer on (b)(6) 2011 that she was attributing her pain to a fall or her medications or possibly an ulcer. The patient is to follow up with a nurse practitioner in (b)(6) 2011. Attempts to the nurse practitioner for further information are pending.

Event Description
The patient reported that she is ok, but that she no longer has transportation to her physician and is searching for a new physician. No additional relevant information has been obtained to date.

Event Description
Vns generator product information was obtained from the implanting hospital.

Event Description
The patient reported that her settings were lowered by half and the next day she was experiencing pain. She went to the emergency room the day prior and was sent home. The patient noted that her whole body is sore and that she walked a lot yesterday.

Manufacturer Narrative

Event Description
Reporter indicated there "is nothing wrong with my vns" and that the issue of pain was felt to be related to medication and not vns. The vns is felt to be "working well" per the reporter, but she has no physician to check the vns. All attempts to obtain vns generator product information from the implanting hospital have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2309512
« Last Edit: February 13, 2018, 01:40:11 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #15 on: November 01, 2017, 01:25:36 AM »

Model Number 105
Event Date 05/12/2014
Event Type Malfunction
Event Description
It was reported by the patient that her device settings had changed on their own from 5 to 10. It is unclear which device settings she was referring to. The patient was experiencing erratic stimulation, pain with stimulation, coughing and voice alteration. The pain was reported to be unbearable at times. The pain occurred at her electrode site and travelled up the left side of her head and down to her shoulder. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854286
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #16 on: November 15, 2017, 02:40:02 AM »

Model Number 103
Event Date 10/25/2010
Event Type Injury
Event Description
It was later reported that the patient had generator explant on (b)(6) 2015 due to pain and not having epileptic seizures. Vns was originally implanted for seizures and then she later learned she had pseudo seizures. The explanted generator was received by the manufacturer for analysis. However, analysis has not been completed to date.

Event Description
Although explant surgery is likely, it has not occurred to date.
Manufacturer Narrative

Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the incorrect data. Date of event, corrected data: the initial report inadvertently reported the incorrect data.

Event Description
It was identified that the pin portion of lead was discovered in the generator header. Analysis has not been completed to date.

Event Description
It was reported that the patient was scheduled for a vns removal surgery. It was originally implanted for seizures and then she later learned she had pseudo seizures. The device was off for some time and she still had chest wall pain and when on stated her head was twitching. It was noted that the patient could not even tolerate mild stimulation. The physician reported that no causal or contributory programming or medication changes precede the onset of the head twitching and pain. He stated that he did not know if interventions were taken. He also stated that he didn¿t know the relationship of the head twitching and pain to vns. No manipulation or trauma occurred that is believed to have caused/contributed to the chest pain. He was also unable to provide the date of disablement. The patient¿s programming history was reviewed and the patient was disabled on (b)(6) 2010. Diagnostics were normal on that date as well.

Manufacturer Narrative
Device available for evaluation, corrected data: the supplemental report #2 inadvertently did not report this data in this field.

Manufacturer Narrative
Analysis of programming history.

Event Description
Lead product analysis was approved on 05/27/2015. The lead assembly (body) including the section of the connector boot containing the model and serial number tag and the electrode section was not returned; therefore, it was not possible to verify the model and serial number during this analysis, and 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, and no discontinuities were 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. Generator product analysis was approved on 06/03/2015. In the (b)(4) lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the 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. The battery (2. 963 volts as measured during completion of electrical testing) shows an ifi=no condition. 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=4609356
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #17 on: December 09, 2017, 02:09:21 AM »

Model Number 102
Event Date 05/10/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 were received which provide the patient's seizure history. It was stated that the patient is still having seizures daily. The patient's last seizure was a grand mal seizure that lasted 2 minutes that day, and prior to this was the same type and length of seizure on (b)(6) 2013. The patient has continued with nocturnal events semiology of complex partial seizures per his baseline. He began having daily episode of quick head drops about one week prior to this date. His mother noted drainage from his left ear and had scheduled a follow up appointment to the ear nose throat doctor. It was noted that prior ear infections have been a trigger for the patient's epilepsy and mcad related hypoglycemia. Following a neuro metabolic consult, genetic testing confirmed the patient had mcad. Following the introduction of banzel, the patient became seizure free with associated improved cognition and psychomotor activation. Drop seizures returned in clusters with recurrent ear infections. They continued to increase in their daily frequency to greater than one hundred per day despite increasing doses of banzel and increased use of benzos. In addition, they were less responsive to use of the vns magnet. However, the notes also mention that the patient's mother was observed to be using the magnet incorrectly and was instructed on the correct use of the magnet during this office visit. The patient is experiencing nightime seizures which resolved with the addition of banzel; however, it was stated that it was unclear when they began to reoccur nightly. During the patient's last visit, the patient's lack of consciousness and multiple drop attacks of unclear etiology were noted resulting in patient hospitalization. During hospitalization, increased ammonia was noted. In addition, the patient was markedly responsive to iv, concluding that his presenting state was metabolic related. The patient's medication was increased and the eeg was conclusive for non-epileptic as well as epileptic events. At follow up, the patient's cognition was markedly improved over prior visits. In regards to the daily episodes of quick head drops that started a week prior, which had the semiology of non-epileptic events associated with hypoglycemia and increased metabolic needs. Attempts for additional information were made; however, they were unsuccessful. No additional information was provided.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2013. The generator was returned for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. 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 device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3192841
« Last Edit: April 26, 2018, 01:25:53 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #18 on: December 17, 2017, 01:58:09 AM »

Model Number 102
Event Date 04/25/2016
Event Type Injury
Event Description
Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled. It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed. It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth. She states that moving her left arm sets it off. The patient was then referred for generator replacement evaluation. Review of available data in the programming and history database revealed no anomalies. A battery life calculation performed with available data indicated the device has 8. 5 years remaining until neos = yes although the last 4 years of programming data is missing. Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing. " the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on. The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure. Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos. The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons. The provider submitted additional clinic notes containing device settings. An updated blc performed based on the newly submitted settings indicated that the device has approximately 8. 1 years remaining longevity. No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown. The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis. The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

Manufacturer Narrative

Event Description
The generator was received for product analysis. During analysis there were no performance or any other type of adverse conditions found with the pulse generator and the generator performed according to functional specifications. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. 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 device had not reached an neos or eos condition. No new events have been reported following device replacement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5689538
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #19 on: December 18, 2017, 01:50:31 AM »

Model Number 103
Event Date 04/12/2016
Event Type Injury
Manufacturer Narrative
Corrected data, supplemental mdr #1 inadvertently reported that the patient had a replacement while the surgery was only an explant surgery.

Event Description
It was reported on (b)(6) 2016 that the physician saw the patient that day and she was complaining of painful erratic stimulation in her left neck when she turns her head to the left. This started about 1 week prior and there was no trauma or event that seemed to have started it. The physician checked diagnostics with her facing forward and also turning her head to the left. Notes state to follow-up to replace vns / lead if malfunction continues but this likely refers to the painful stimulation as diagnostics showed the vns was functioning well and physician lowered settings to help tolerability. No malfunction of the device was observed. The patient is now scheduled for an explant of the device. Surgery has not occurred to date.

Event Description
The patient generator was explanted (b)(6) 2016. Clinic notes were received on 10/21/2016 for the patient to be re-implant with a m106. The notes state that the previous vns stimulator was removed (model 103) because painful stimulation was triggered by turning head towards it and she has to turn her entire body not just head to avoid trigger of vns stimulation. The electrodes are still in place but the surgeon suspects the electrodes may be fractured but he will check the old lead with the new vns during surgery to see if it¿s still working, otherwise he will implant new electrode. No additional information has been received to date.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 that the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was discarded after explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5653184
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #20 on: December 29, 2017, 02:08:08 AM »

Event Date 08/01/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported on 08/17/2016 from the patient's mother that she was concerned that her daughter's generator battery may be depleted due to recent reports that she has had more seizure events. It was reported that this has only been occurring this month. The patient has been having a feeling of "pins and needles all over her head, arms, and legs" which also leads her mother to fear that her seizures may be returning. No additional information has been received to date.

Manufacturer Narrative
Supplemental mdr #2 inadvertently omitted information that changed the file from a malfunction to serious injury. Information was known prior to submission that intervention was taken for the adverse event.

Event Description
The patient underwent battery replacement on (b)(6) 2016 for battery depletion. The product was discarded after surgery is not available for return.

Event Description
On (b)(6) 2016 it was reported that the patient had not been seen since (b)(6) 2014. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5935884
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #21 on: December 30, 2017, 02:10:07 AM »

Model Number 102
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that vns patient has a numbing feeling on her left neck, face, head, and leg when the stimulation is on since more than one month. The patient could not talk due to cyanotic lip. The patient has 5 times of seizure where 3 were stopped by magnet. The physician reported that those adverse events are related to the stimulation and there is an increase in seizures (above pre-vns baseline). The patient parameters are currently at: 1. 75ma, 30hz, 250usec, 30sec on and 1. 8min off. Follow up indicated that the patient¿s parameters were changed to 1. 25ma; 250's; 30s on; 5mins off. The patient feels very little numb during stimulation. The patient will come back after 3 months for the next follow up visit. The drugs were not changed. The seizure start area in the brain is still unknown for the physician. It was observed that patient has abnormal signals from eeg results (from the frontal-temple lobe). Further follow up indicated that the vns system works fine. Numb feeling disappeared after the parameters decrease. However; the patient has several general seizures after this parameters change. Cyanotic lips happen only during general seizures without direct relationship with the stimulation, and are contributed by the seizures (physician thinks not related to the vns). It was reported also that the increase of seizures maybe related to vns or drug change (medicaments changed/not taken by patient without physician's permission).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6016651
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #22 on: January 05, 2018, 04:24:12 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 11/11/2017
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a vns patient was observed overnight at the er complaining of painful stimulation. And continuous stimulation. The mom said she was feeling burning in her head. The physician requested the device to be turned off. Follow-up to the physician at the hospital provided that use of the magnet to disable the device was tried and did not resolve the issue. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7092861
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #23 on: January 11, 2018, 02:24:23 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #24 on: January 14, 2018, 01:49:09 AM »

Model Number 102
Event Date 03/01/2009
Event Type Injury
Event Description
It was reported that the patient was experiencing pain when she turned her head to either side. Patient had her device turned off in 2009 to see if it would resolve the pain. Patient also saw a surgeon who said he will consider surgery if the pain does not resolve with the device turned off. Physician believes the patient's reported events are a result of a fall she had a few months ago, but it is unknown if it is related to vns. No casual or contributory programming or medication changes preceded the onset of the reported events. Attempts for further information have been unsuccessful to date and surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1520016
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #25 on: January 18, 2018, 02:50:39 AM »

Model Number 303-20
Event Date 04/01/2012
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012. The patient is continuing to complain of pain in her chest (center) and pain up the side of her left neck. Patient is also not feeling magnet stimulation. Diagnostics were run twice 4065ohms and 4350ohm. The magnet current was increased to 2. 0ma and regular current to 1. 75ma and diagnostics were re-run with impedance 4306ohms and low output current. At these settings the patient began feeling nauseous however this was thought to be related to her headache. It was indicated that the patient had not had a big increase in her seizures. The physician was uncertain if the increase in seizures or depression were associated with vns, however he did indicate that he believed that the pain she was experiencing was related to the irregular impedance values. The myocardial infarction was also not believed to be related to vns. Per the physician, the patient's pain varies so he was uncertain if it was occurring with stimulation, however it was indicated that the device was left programmed on as the patient did not want the device disabled. She has again been referred for revision. It was also noted that there were no causal or contributory programming changes, medication changes, or other external factors precede the onset of the events. Additionally the patient was not experiencing voice alterations, per the physician. Revision is likely but has yet to occur.

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

Event Description
It was reported on (b)(6) 2012, that a system diagnostic test performed that day at a patient's follow up appointment revealed high impedance, with an impedance value of 8591 ohms. The patient also reported an increase in seizures the past 8 weeks, and also feels uncomfortable in her neck and chest (generator and electrode sites) when she turns her head to the right. It was unclear if the pain was occurring with stimulation. They were not aware of any manipulation or trauma. X-rays were performed and sent to the manufacturer for review. A/p and lateral views of the neck and chest of the vns patient were received and reviewed on (b)(4) 2012. The generator was seen in the left chest. The placement was normal, and the filter feedthrough wires appeared to be intact. The connector pin could be visualized past the second connector block indicating that the pin was fully inserted. A portion of the lead appears to be behind the generator, so continuity in that portion of the lead could not be fully assessed. The lead was routed upwards to the left side of the neck. There appeared to be a suspect area near the generator; however, this could not be fully assessed due to the contrast in the images provided. The lead wire also appeared twisted and kinked in the chest near the neck. No lead discontinuities or sharp angles were seen in the visible portions of the lead; however, it is possible a lead break has occurred in the suspect area near the generator. Additionally a micro-fracture that cannot be seen in the images provided, or a break in the portion of the lead which could not be assessed cannot be ruled out. Clinic notes were also received indicating that the patient had a myocardial infarction that occurred on (b)(6) 2012, and spent two weeks in the hospital for the myocardial infarction and pneumonia. The patient has also had an increase in depression. The relationship between the patient's depression and myocardial infarction and vns therapy is currently unknown. Additionally, the surgeon reported performing diagnostics on (b)(6) 2012, and was questioning the reason for the replacement, as he checked the device on (b)(6) 2012, and the diagnostics showed everything to be ok, with an impedance value in the lower 6000 range. The diagnostics were run 3 times, with the same results. The neurologist also reported performing diagnostics with results in the 5800-6300 ohm range. At this time, the surgeon is hesitant about performing a full revision he indicated that the patient is very large and he is concerned about performing surgery. It is likely that a positional lead break has occurred, which is causing the intermittent impedance issues. No additional information is known at this time.

Event Description
Information was received on 07/27/212 indicating that the surgeon also reviewed the x-rays and did not feel that there as an issue despite identifying the kink in the lead. Additionally he reported that the neurologist would be increasing the patient's output current to determine if that helped. The patient had also previously reported experiencing voice alterations with stimulation as well as that she was unable to perceive magnet mode stimulation. The surgeon had re-instructed that patient on how to perform magnet swipes as he felt that it may have been related to improper swiping technique. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received on (b)(6) 2012, that the patient had a full revision. Attempts for product return are underway.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
The patient had previously reported voice alterations and failure to perceive magnet stimulation, however this was not included on the initial mdr.

Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2012. Analysis has since been completed. During analysis of the lead, a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends show that pitting or electro-etching conditions have occurred at the break location and in the vicinity of one of the broken ends. Inspection of the positive lead coil indicates a stress-induced fracture has occurred in at least one of the broken strands of the coil. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination, a conclusive determination of the initial fracture mechanism of the broken strands cannot be determined. The silicone tubing is abraded open near the identified break. Additionally, the lead assembly has remnants of what appears to be dry body fluids inside the silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Analysis on the generator revealed no anomalies. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additionally, it was reported by the surgeon, that following the revision, the patient developed vocal cord paralysis. This will be reported under manufacturer's report # 1644487-2012-02752.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2667369
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #26 on: January 21, 2018, 03:27:48 AM »

Model Number 102
Event Date 01/01/2010
Event Type Injury
Event Description
It was reported that the pt was to have her vns device removed for an unk reason. Follow-up with the treating physician reveals that the pt was experiencing a "shocking" sensation when she turned her head to the left. X-rays were taken and reviewed by the manufacturer. Upon review, no anomalies were noted with the device. Pt underwent surgery to replace the generator on (b) (6) 2010. Per treating physician, the surgery was prophylactic and there were no functional problems with the generator either before or after surgery. However, the surgeon felt the surgery was performed to preclude a serious injury as the pt was feeling "shocking" which could have caused injury. The surgeon felt the shocking was due to the generator nearing end of service. No trauma or manipulation occurred and no causal or contributory programming or medication changes preceded the onset of the shocking sensation. Per treating physician, the shocking sensation has resolved since surgery. Product has been returned to manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1692487
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #27 on: January 22, 2018, 02:12:09 AM »

Model Number 302-20
Event Date 05/17/2010
Event Type Malfunction
Manufacturer Narrative
Device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
A vns pt's treating physician reported that system diagnostic testing on one of his vns pt's yielded output: limit, dcdc 7 and lead impedance high, eri no. Normal mode diagnostics resulted in the same. Additionally, it was reported the pt has been having a little shocking sensation sometimes occurring when she turns her head also occurring spontaneously. The pt denies any trauma, which may have caused the high impedance. The physician was provided recommendations to program the vns off. At this time, good faith attempts have been unsuccessful for further details about the reported event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1773831
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #28 on: January 25, 2018, 02:36:57 AM »

Model Number 102
Event Date 01/01/2008
Event Type Injury
Event Description
Reporter indicated a vns pt was having head movements thought to be seizures in 2008. After the vns settings were decreased, the head movements improved. Attempts for further info are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1822573
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61153


« Reply #29 on: January 30, 2018, 02:27:17 AM »

Model Number 103
Event Date 07/28/2010
Event Type Malfunction
Event Description
It was initially reported in a patient's clinic notes that on (b)(6) 2010, the patient's settings were 1 ma/25 hz/250 microsec/14 sec/3 min. The doctor noted that the patient's vns current was "increased back to 1. 25 ma. However, when the system was reprogrammed the default settings were restored and the pulse width jumped to 500. [the patient] received one stimulation at this current strength and width and had significant symptoms. He had pain in his neck and pain in his head. He coughed and had difficulty catching his breath during the coughing. The device was immediately interrogated again and the settings were returned to the previous settings and he tolerated that well. The device was again interrogated to assure that it had returned to its typical settings. [he] recovered from the strong stimulus and was again himself within moments. " good faith attempts to gain more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061986
Logged
Pages: [1] 2 3 4  All   Go Up
Print
Jump to: