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dennis100
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« Reply #30 on: May 03, 2012, 10:32:14 AM »

Model Number 102
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
Reporter indicated that vns pt has experienced a recent increase in seizure activity. The pt has not experienced any recent injury or trauma that may have damaged the vns therapy system; however, it was reported that the pt's device "did not appear to be sitting correctly" and that it has been that way since implant. It was reported that the pt's generator is perpendicular in her chest. The pt reports feeling painful stimulation at the generator site along with feelings of muscle twitching during stimulation cycles for approximately three months. Investigation to date has been unable to determine whether the increase in seizure activity is above pre-vns baseline frequency as treating neurologist cited hipaa regulations as reason for not providing additional info.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=648036
« Last Edit: October 15, 2015, 09:12:56 AM by dennis100 » Logged
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« Reply #31 on: May 03, 2012, 10:33:24 AM »

Model Number 101
Event Date 01/01/2005
Event Type  Injury  
Patient Outcome  Life Threatening
Event Description
Reporter indicated that vns pt has experienced an increase in seizure activity above pre-vns baseline frequency. It was also reported that the pt's seizure type had changed in that she has begun to experience grand mal seizures recently. There have reportedly been no medication changes that may have contributed to the reported events, but that she had recently been crushed by elevator doors. The pt reported that she has never experienced efficacy with the vns therapy. The pt also reports that she has experienced chest pain and pain shooting down her neck and back, shooting through her stomach and down her legs as well as muscle spasms in her leg. The pt was reportedly seen at a local hospital recently, at which time "the doctors there dismissed her as having the flu", although the pt maintains that she did not have the flu. Investigation to date has been unable to determine whether the pt's chest pain is cardiac related or whether it is related to the vns therapy as attempts to identify the pt's current treating physician have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=647201
« Last Edit: October 15, 2015, 09:13:19 AM by dennis100 » Logged
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« Reply #32 on: May 03, 2012, 10:34:05 AM »

Model Number 300-20
Event Type  Malfunction  
Event Description
Vns pt underwent lead replacement surgery at the time of generator replacement surgery due to lead discontinuity. Treating neurologist indicated that in the months prior to ncp system replacement surgery, the pt complained of muscle twitching which was consistent with 'insulation' (likely meaning lead tubing) fracture. X-rays were taken prior to surgery and showed that the lead wire was intact.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=662971
« Last Edit: October 15, 2015, 09:13:34 AM by dennis100 » Logged
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« Reply #33 on: May 12, 2012, 04:16:55 AM »

Event Date 07/01/2006
Event Type  No Answer Provided  
Event Description
Reporter is pt who noticed a discharge from his shoulder every 5 mins. Was seen in his neurologist's office for the continuous spasming in his left shoulder. The neurologist subsequently turned off the device at his visit to the office yesterday and the spasming has stopped. Initially it was thought that the shoulder spasms were from his "open heart surgery" earlier this year (2006). He's reporting spasming brought on by vns usage. He's to see the neurologist again tomorrow to determine what's to be done next.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=770754
« Last Edit: October 15, 2015, 09:13:50 AM by dennis100 » Logged
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« Reply #34 on: May 15, 2012, 12:47:08 PM »

Model Number 300-20
Event Date 01/01/2006
Event Type  Malfunction  
Manufacturer Narrative
Device failure is suspected although no serious injury was reported.
 
Event Description
Mfr rec'd device tracking info indicating that a lead had been replaced due to discontinuity. Further f/u revealed that the pt had experienced shoulder pain and spasms. Diagnostics at the time showed high impedance indicating a potential lead break. The cause of the suspected lead break is unk at this time. Pt underwent lead replacement surgery. Pt outcome is unk at this time. The site refuses to return the explanted product.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=804690
« Last Edit: October 15, 2015, 09:14:06 AM by dennis100 » Logged
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« Reply #35 on: May 15, 2012, 12:47:41 PM »

Model Number 302-20
Event Date 01/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Results - vns therapy system labeling lists vocal cord paralysis as a potential adverse event possibly associated with surgery or stimulation.
 
Event Description
Reporter indicated that the pt had vocal cord paralysis that developed 6 mos post implant of the vns therapy system. Reporter also indicated that he believed paralysis was related to vns, but did not directly correspond with stimulation, and was not related to vns surgery. He stated he believed this because the pt described a "twitching in his left shoulder" prior to the paralysis. The pt's device was turned off and to date, no add'l info is known in regards to improvement of the vocal cord paralysis.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=826242
« Last Edit: October 15, 2015, 09:14:27 AM by dennis100 » Logged
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« Reply #36 on: May 15, 2012, 12:48:08 PM »

Model Number 30X-UNK
Event Date 01/01/2006
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
No device failure, adverse event related to vns therapy or surgery.
 
Event Description
Reporter indicated that pt underwent revision surgery approximately two months after initial implant surgery. The physician reported that the revision was performed "because the leads were too short", due to the size of the pt. Since the revision surgery, the pt is complaining of twitching and dysphagia. Adjustment of programmed setting have not resolved the pt symptoms. The pt is scheduled to see a surgeon for revision surgery. Diagnostic confirm proper device functioning. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=835676
« Last Edit: October 15, 2015, 09:14:47 AM by dennis100 » Logged
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« Reply #37 on: May 15, 2012, 12:48:35 PM »

Model Number 102
Event Date 01/01/2007
Event Type  Malfunction  
Patient Outcome  Other
Event Description
Reporter indicated that the pt was feeling muscle spasms in his neck. It was reported that the spasms continued when the vns device was turned off using the magnet. It was also reported that the pt wanted to have the vns removed because the pt did not think it was helping his depression. Attempts to gather add'l info have been unsuccessful.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962429
« Last Edit: October 15, 2015, 09:15:28 AM by dennis100 » Logged
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« Reply #38 on: May 15, 2012, 12:49:03 PM »

Model Number 302-20
Event Date 01/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
Reporter indicated a pt was having vns stimulation-related muscle spasms in the left neck, arm, and hand. Parameter changes were attempted to relieve the spasms but were unsuccessful. The patient underwent a right-sided vns system placement. The original vns system was left in the pt and disabled. The patient's symptoms have resolved and the patient is currently receiving right-sided vns stimulation. The original vns system will be utilized if needed in the future.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=875017
« Last Edit: October 15, 2015, 09:15:45 AM by dennis100 » Logged
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« Reply #39 on: May 15, 2012, 12:49:34 PM »

Model Number 102
Event Date 03/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
Initial reporter indicated that a patient implanted for depression had a "worsening depression. " due to the depression, the patient had a change in their device parameters and their medication dose and schedule. The depression was reported as "worse than she ever had been". The depression was reported as a single episode that was severe and definitely replated to the patient's stimulation. Additional information received indicated that the patient's device settings were decreased due to an "arm twitch", resulting in the worsening of depression. Programming changes were made to return the patient to their previous settings and the depressive event resolved.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=892210
« Last Edit: October 15, 2015, 09:16:07 AM by dennis100 » Logged
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« Reply #40 on: May 15, 2012, 12:50:00 PM »

Model Number 302-20
Event Date 11/01/2006
Event Type  Injury  
Patient Outcome  Hospitalization
Manufacturer Narrative
X-rays reviewed by mfr. Mfr review of x-rays showed electrode placement at c2 to c3.
 
Event Description
Reporter indicated that a pt was undergoing revision surgery to correct the original placement of his vns therapy lead, as it was too high and was causing his neck muscles to twitch with stimulation. Mfr review of x-rays showed electrode placement at c2 to c3. Explanted lead was returned to mfr for product analysis, however, that analysis is not yet complete. Good faith attempts for further info are currently being made.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=905654
« Last Edit: October 15, 2015, 09:16:34 AM by dennis100 » Logged
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« Reply #41 on: May 17, 2012, 04:09:28 AM »

Model Number 102
Event Date 01/01/2006
Event Type  Malfunction  
Patient Outcome  Required Intervention
Event Description
Reporter initially indicated that a vns patient experienced painful stimulation at the throat and chest. The vns settings were changed in response to the event. It was later reported that the patient was continuing to experience painful stimulation at the chest and muscle spasms at the chest and neck sites. It was reported that decreasing the signal frequency alleviated the symptoms. Mfr's review of x-rays did not reveal any anomalies or potential cause of the reported events, although it was noted that the strain relief was not placed according to labeling. It was also noted that two small objects, which appeared to be staples or similar objects, were visible in the area of the electrodes. Reporter indicated that the patient underwent exploratory surgery in response to the events. The surgeon only opened the generator site and the generator was repositioned. The surgeon identified a "kink" in the lead, although the lead appeared intact and diagnostics were within normal limits. The surgeon elected to leave the lead implanted with no further actions taken during surgery.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no probable cause of events identified.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=932480
« Last Edit: October 15, 2015, 09:16:54 AM by dennis100 » Logged
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« Reply #42 on: May 17, 2012, 04:09:56 AM »

Event Date 08/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
The reporter indicated the patient has a newly reported type of seizures, "myoclonic twitches". The reporter indicated the patient did not have myoclonic seizures prior to implantation of the device, and the treating physician believed they are related to vns therapy. The reporter indicated that he started the patient on lorazepam medication for seizures and the vns therapy system was programmed "off". Good faith attempts are being made for more information.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=927589
« Last Edit: October 15, 2015, 09:17:11 AM by dennis100 » Logged
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« Reply #43 on: May 17, 2012, 04:10:22 AM »

Model Number 302-20
Event Date 06/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that a vns patient was experiencing painful stimulation and muscle spasms near the electrode site. X-rays were reviewed by the manufacturer and no cause for the reported complaint was identified; however, it was observed that strain relief was inadequate. A full revision of the lead and generator was planned due to the painful stimulation and muscle spasms. The treating psychiatrist reported that he believed there may have been "faulty implantation". During the surgery, the surgeon identified that one of the electrodes was detached from the vagus nerve. The lead and generator were replaced.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=922749
« Last Edit: October 15, 2015, 09:17:26 AM by dennis100 » Logged
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« Reply #44 on: May 17, 2012, 04:10:46 AM »

Model Number 102
Event Date 10/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that a vns patient was involved in a motor vehicle accident and since the accident has experienced erratic stimulation, muscle spasms, generator migration, painful stimulation, and a seizure increase, below pre-vns baseline. Diagnostic test results from after the onset of the events are within normal limits. The treating medical professional is unsure of what the cause of the events is. The patient is being referred for revision surgery.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=940413
« Last Edit: October 15, 2015, 09:17:41 AM by dennis100 » Logged
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« Reply #45 on: May 17, 2012, 04:11:11 AM »

Model Number 102
Event Date 10/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
Initial reporter indicated that "she had a muscle twitch in left arm with stimulation. " she said "it keeps her awake at night. " the pt wanted her vns turned off as she could not sleep with it on and was 100 miles from her physician's office. The pt's treating physician believes the pt's insomnia and muscle spasm are related to the vns stimulation and will be programming the pt's vns off per the pt request. Reported "patient lives 100 miles from the nearest location for programming changes and he will just be programming the vns off. ".

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=939865
« Last Edit: October 15, 2015, 09:17:58 AM by dennis100 » Logged
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« Reply #46 on: May 17, 2012, 04:12:47 AM »

Model Number 102
Event Date 11/01/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
Reporter indicated that a vns patient was experiencing painful stimulation. It was reported that the patient felt a "shocking" sensation from his diaphragm to his chest and back. It was reported that the patient was "almost panting" and "trembling. " it was then reported that the device was "stimulating erratically" and that after the patient swiped the magnet to initiate magnet modes stimulation, he would feel erratic stimulation. The patient then underwent generator replacement surgery in response to the events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=969856
« Last Edit: October 15, 2015, 09:18:17 AM by dennis100 » Logged
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« Reply #47 on: May 17, 2012, 04:13:13 AM »

Model Number 102R
Event Date 11/22/2007
Event Type  Injury  
Patient Outcome  Other
Manufacturer Narrative
Chest and neck x-rays were reviewed by mfr. Xrays revealed that the positive connector pin does not appear to be fully inserted in the positive connector block. Conclusions - the lead pin not fully inserted may be contributing to the reported events, but did not cause or contribute to death.
 
Event Description
It was reported to mfr that the vns patient was experiencing a recent onset of painful stimulation in the left arm and left arm muscle twitching associated with stimulation. Further follow up with the physician revealed that ht patient reports that the painful stimulation may be positional and that the muscle spasms occur more when his head is turned to the left. A system diagnostic test was performed by the physician following the onset of the events, and revealed normal device function. The magnet has been used to temporarily disable stimulation of the device. X-rays were taken and were sent to mfr for review. Review of x-rays revealed that the positive lead connector pin did not appear to be fully inserted inside the generator connector block, which may be contributing to the reported events. No other anomalies were observed upon review of the x-rays. The physician has referred the patient to a surgeon and surgery is likely. Attempts to obtain add'l info from the physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=968012
« Last Edit: October 15, 2015, 09:18:40 AM by dennis100 » Logged
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« Reply #48 on: May 17, 2012, 04:13:45 AM »

Model Number 302-20
Event Date 01/01/2007
Event Type  Injury  
Patient Outcome  Other
Event Description
Reporter stated the pt will undergo a lead replacement due to neck muscle spasm and pain. Further attempts for info are in progress.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=964263
« Last Edit: October 15, 2015, 09:19:00 AM by dennis100 » Logged
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« Reply #49 on: May 17, 2012, 04:14:23 AM »

Model Number 102
Event Date 09/19/2007
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported that the vns patient began experiencing multiple adverse events which followed an increase in the device settings. The settings were changed from 1. 75m a/30hz/500usec/30sec/1. 8min to 2. 25ma/30hz/500usec/60sec/3min in 7. The patient left the physicians office tolerating the settings. On the way home, the patient began experiencing pain at the generator site during stimulation when the left arm was in a lifted position. Later in the evening, the patient began experiencing muscle twitching under the axilla on the left side with stimulation of the device. The magnet was used to temporarily disable stimulation and the events resolved. The patient was seen by the treating physician the following day and the device was disabled and no diagnostics were performed to assess the functionality of the device. The physician stated that the patients left arm was numb following the events, and the numbness continued while the device was disabled. The physician referred the patient for an mri of the brain to assess for sensory damage. Chest x-rays were taken and sent to manufacturer for review. The connector pin appeared to be fully inserted beyond the connector block and there were no obvious anomalies observed that could have been contributing to the reported events. After further follow up with the physician, it was revealed that the physician believed that "sensory damage" was confirmed after the mri scan but the mri assessment did not indicate any abnormalities. Additionally, the physician attributed all of the events, including the sensory damage, to vns therapy. The patient was scheduled for revision surgery. Prior to surgery, the patient reported to the surgeon that a second opinion was received by a different neurologist, and the patient stated that the physician indicated that "there was spinal damage" and attributed the damage to vns therapy. Attempts to obtain additional information from the second neurologist are underway. During surgery, a system diagnostic test was performed on the device in question and revealed normal function. The chest pocket was opened and the lead pin was verified to be securely connected inside the generator. A second diagnostic test was performed and again revealed normal device function. Per the patients' request prior to surgery, the existing device was removed and a new device was re-implanted. Attempts to obtain the explanted devices are underway, however, the patient has maintained that the "he owns the device". There were no obvious anomalies observed during surgery. The new device was implanted with no complications.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no anomalies were observed that could be contributing to the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=962544
« Last Edit: October 15, 2015, 09:19:30 AM by dennis100 » Logged
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« Reply #50 on: May 18, 2012, 05:27:48 AM »

Model Number 104
Event Date 07/01/2010
Event Type  Injury  
Patient Outcome  Other
Event Description
In notes dated (b)(6) 201,1 it states that the seizure frequency has decreased from what was occurring in (b)(6) 2011. In notes dated (b)(6) 2011 and received on (b)(6) 2012, it states that the seizures have increased and are occurring with 2-3 tonic-clonic events occurring monthly and usually at night. The seizures start with staring followed by blinking, shoulder twitching, then generalization into tonic clonic episodes. The magnet will work to suppress the seizure but only if used early enough. There is a concern that the patient's babysitter does not keep up with the patient's ketogenic diet. The vns settings were 2/30/500/30/0. 8/2. 25/500/60. The patient weight was (b)(6). The plan was to wean the patient off depakote and start vimpat. Notes dated (b)(6) 2010 and received on (b)(6) 2012 it states that the seizures have increased from the baseline of 1-2 per month to 3 per month. The last seizure occurred the week prior to the visit on (b)(6) 2010. The patient's dosage of zonegran had been decreased but then increased due to the increase in seizure activity. The settings were adjusted from 1. 5/30/500/30/0. 8/1. 75/500/60 to 2/30/500/30/0. 8/2. 25/500/60. The plan included adjustment of the vns parameters and to adjust the aed regime. The weight was (b)(6). Good faith attempts for additional information were unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2552942
« Last Edit: October 15, 2015, 09:19:48 AM by dennis100 » Logged
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« Reply #51 on: May 18, 2012, 05:28:12 AM »

Model Number 103
Event Date 02/01/2012
Event Type  Injury  
Patient Outcome  Hospitalization
Event Description
A caregiver for a vns patient called and reported they had a patient who has been in the hospital, (b)(6), since her device activation about a month ago. He said that she was in the hospital for various reasons. He said that she is having a lot of the side effects noted in the patient's manual. He said that she is experiencing twitching of the body, muscle pain, nausea, vomiting, insomnia (pre-vns, but worse), combative (pre-vns, but worse), agitation (pre-vns, but worse), depression (pre-vns, but worse). Specifics of each event were not known. The patient's vns treating physician was contacted but no further information was known about the reported events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2523091
« Last Edit: October 15, 2015, 09:20:04 AM by dennis100 » Logged
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« Reply #52 on: June 08, 2012, 07:24:05 AM »

Model Number 300-20
Event Date 03/01/2012
Event Type  Injury  
Patient Outcome  Other
Event Description
It was reported on (b)(6) 2012, that a vns patient thought his device was malfunctioning as it was sending electrical impulses to other parts of his body. The patient elaborated by saying he has been experiencing abdominal cramping, chest pain and should pain that was occurring every 5 minutes so he believed it as occurring with stimulation. The patient was also experiencing a shocking pain down his left arm and abdomen. When the patient met with his physician, he described the issues as a sharp pain in the left neck area, and sometimes it affects the left upper extremity, causing it to twitch, almost like a shock. At other times the pain is a funny sensation also in the right upper abdomen going to the right side of the abdomen. This lasts for about 30 seconds and occur every 3-5 days. Overall the pain is not and symptoms are not as severe, but they are still recurring, and strangely they do not occur every rhythmic beat with different time periods in between. The patient has not had any new weakness or numbness. No bowel or bladder changes. No trauma that could explain the symptoms. The patient does not have much of neck pain follow up with the physician revealed that the pain as subsided and the vns settings were lowered. The physician stated that the chest pain, should pain, and abdominal cramping were all related to vns however he did not indicate the relationship. There was no trauma or manipulation prior to the onset of any of the events nor was there any causal or contributory programming or medication changes. The physician will be programming the device off as a result of the reported events. The patient does not have a medical history of chest pain, shoulder pain, or abdominal cramping. When asked if there were any suspected device issues the physician responded "lead break?" however there were no diagnostic results available that indicated a device issue. X-rays were taken and sent to the manufacturer for review however no cause for the patient's adverse events was found. Additionally, no lead break or sharp angles were observed. The patient is going to be referred for revision surgery.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012 when it was reported that the patient denies having any pain with the device programmed off and there has not been any seizure activity either. The patient feels that the medications he is taking are controlling the seizures and he did not want to have his vns replaced at this time.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2565708
« Last Edit: October 15, 2015, 09:20:58 AM by dennis100 » Logged
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« Reply #53 on: June 08, 2012, 07:25:26 AM »

Model Number 102
Event Date 04/09/2011
Event Type Injury
Event Description
The vns patient reported to the manufacturer that her vns had been previously removed due to pain, swelling, and "device shifting" on (b)(6) 2012. Manufacturer follow up with the surgeon's office revealed the generator was not migrating at the time of explant on (b)(6) 2012, as the generator was anchored with a tether suture to the surrounding tissue and had to be "untagged" to remove it. The patient desires reimplant of a new vns system, but this has not occurred to date.

Event Description
Reporter indicated a patient had the vns generator and lead explanted due to "pain, spasms, and discomfort". The explanted generator and lead have been returned and are pending analysis. Review of the patient's vns programming history noted the off time was never changed from the factory setting of 180 minutes from the time of implant ((b)(6) 2011) through (b)(6) 2012, which is the last known date of available programming history. The 180 minutes off time is not efficacious, and means the vns stimulated only once every 3 hours. Attempts for further information are in progress.

Event Description
Analysis of the vns generator and lead was completed. No anomalies were identified with the generator and the generator performed per specifications. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other 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 portions were performed, during the visual analysis, with no other 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. All attempts to the reporter for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2564243
« Last Edit: February 02, 2016, 01:01:23 PM by dennis100 » Logged
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« Reply #54 on: July 04, 2012, 10:50:30 PM »

Model Number 102
Event Date 03/01/2012
Event Type  Injury  
Event Description
It was reported through notes dated (b)(6) 2012 that a vns patient experienced a recurrence of myoclonic jerks for the past 3 months. The jerks are reported to occur when the patient feels under pressure or anxious. Lead impedance at the office visit was noted to be ok. At the moment replacement surgery is likely as the patient is on rapid setting cycle and the physician wants to improve the patient's myoclonic jerks. Good faith attempts to obtain further information and relationship of the jerks to vns therapy have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2633468
« Last Edit: October 15, 2015, 09:21:42 AM by dennis100 » Logged
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« Reply #55 on: July 04, 2012, 10:53:06 PM »

Model Number 102R
Event Date 06/17/2011
Event Type  Injury  
Event Description
The patient had sinus surgery on (b)(6) 2011, and one week afterwards, her symptoms were first noticed.
 
Event Description
Additional information was received from the neurologist's office. It was reported that the neurologist saw the patient and "took care of it. " however, no additional information or clarification was provided.
 
Manufacturer Narrative

Event Description
It was reported that the patient had sinus surgery on (b)(6) 2010 and one week after the surgery, she had a post-surgical check-up and the ent physician used a scope to look at her throat after tilting her head back which reportedly strained it. Since that time, she has been having an altered perception of the stimulation as if it were stimulating stronger, "terrible" tremors, increased seizures, dyspnea, and gasping for breath during stimulation times. The patient reported that she has seen her neurologist about this after she fell and hit her head. The neurologist disabled her device for a couple of days which resolved the tremors. The neurologist then programmed her device to low settings. Additional information was later received on (b)(6) 2012 from the patient reporting that she believes the vns leads were cut or something from the sinus surgery in (b)(6) 2010 because since then, she has been experiencing tremors. The patient explained that she is so frustrated about this that she was thinking about committing suicide. Case management later spoke with the patient and the patient was reportedly calm and grateful for any help offered to her. She showed no signs of harming herself. The patient reported that she had discussed with the neurologist that she thinks her device is "emitting too much electricity," but the physician told her that these adverse events are psychological. The patient wants a permanent solution to her adverse events, even if it means explant of the device. Follow up with the neurologist on 05/22/2012 revealed that additional information will not be provided. The patient has a psycho-muscular disorder, so there is not anything to resolve the issue. He checked the patient's device, and it was "fine. " the neurologist does not want the company representative to run diagnostic tests on the patient's device. It is unknown when the last normal diagnostics were obtained. The company representative did see that the patient had tremor episodes with stimulation on this day. Attempts for additional information form the neurologist's office have been unsuccessful to date.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2602916
« Last Edit: October 15, 2015, 09:22:21 AM by dennis100 » Logged
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« Reply #56 on: July 25, 2012, 05:38:54 PM »

Model Number 302-20
Event Date 01/01/2005
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that after a pt's first vns implantation surgery, she experienced numbness, tingling, and burning sensation, probably representing an infection at her neck site. Followup with the treating surgeon revealed that a mild post op infection had been present. No cultures were taken at the time to confirm the infection. The pt was treated with antibiotics, and the infection disappeared. A review of the device history records showed the device to be sterile prior to distribution.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1040263
« Last Edit: October 15, 2015, 09:22:46 AM by dennis100 » Logged
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« Reply #57 on: July 25, 2012, 05:40:39 PM »

Model Number 102
Event Date 04/10/2008
Event Type  Injury  
Patient Outcome  Required Intervention
Event Description
It was reported to manufacturer that the vns patient recently began experiencing random muscle spasms in the chest at the generator site. Additionally, it was reported that the patient was experiencing shortness of breath during the random muscle spasms, constant hoarseness, an increase in seizure activity, below pre-vns baseline, and migraine headaches 4 or 5 times a week. The physician performed normal mode, system, and magnet mode diagnostic tests following the onset of the events, and the results revealed normal device function. The physician subsequently disabled the device and the events have reported resolved. As a result, the physician has referred the patient to a surgeon to have the lead and generator replaced. Revision surgery is likely.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1047205
« Last Edit: October 15, 2015, 09:23:14 AM by dennis100 » Logged
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« Reply #58 on: July 25, 2012, 05:42:44 PM »

Model Number 302-20
Event Date 04/21/2008
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 to manufacturer that the high lead impedance resulted from a system diagnostic test when the vns patient's device was tested. The physician reviewed x-rays and it was communicated that the lead pin did not appear to be fully inserted passing through the connector block. The patient also reports nausea post implantation as well as muscle spasm sensation around the left ear, and is not sensing stimulation of the device. Attempts to obtain additional information from the physician have been made, but have been unsuccessful to date.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1052421
« Last Edit: October 15, 2015, 09:23:34 AM by dennis100 » Logged
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« Reply #59 on: July 25, 2012, 05:44:48 PM »

Model Number 302-20
Event Date 08/05/2005
Event Type  Malfunction  
Event Description
Initial rptr indicated that after their last surgery the lead wire had "again come out of the plastic casing and the wire is hitting a nerve in her neck,". She complained of muscle spasms and pain when her device stimulates. The pt also stated she has a large scar from her arm pit to breast, which is painful to touch. The pt reported that she went to a neurosurgeon, who did not want to do surgery because "it is too dangerous because of the carotid artery". It is unk if another surgery is planned for the pt.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1057351
« Last Edit: October 15, 2015, 09:23:50 AM by dennis100 » Logged
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