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dennis100
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« Reply #120 on: August 03, 2018, 01:12:25 AM »

Model Number 302-20
Event Date 07/05/2009
Event Type  Injury   
Event Description
It was reported in (b)(6) 2009 that the vns pt began experiencing coughing and pain in the jaw during stimulation on times. At the time of the onset of the events, there had been no preceding setting changes that took place prior to the onset of the coughing and painful stimulation, and no reports of pt trauma. Diagnostic testing following the onset of the events revealed normal device function. The device settings had been unchanged since (b)(6) 2009. The pt was seen by the treating physician for follow up following the onset of the events, where the output current was decreased from 1. 75ma to 0. 5ma and the events had significantly improved; however, the pt did begin experiencing an increase in seizure vigor, and per the physician this was a result of having lowered the vns device setting intentionally. The pt was seen by a surgeon in (b)(6) 2009, where diagnostic testing revealed normal device function, and the setting was kept at a low output current. The surgeon advised that they could wait on any surgical interventions at that time, and see how the pt responds with respect to seizure control at the lower settings. The physician had noted that the interventions taken up to this point were for pt comfort, and not to preclude a serious injury. Additional info was received in 12/2010, via receipt of a document from the hospital containing vns implant info, which revealed that the pt had surgery in (b)(6) 2010 where only the lead was replaced. On the documentation received, it was noted that the reason for replacement of the lead was due to "neuropathic pain from stimulation of left nerve. " the documentation provided was hand written and due to poor handwriting, the additional writing on the form was not clear. Good faith attempts with both the surgeon and the treating physician to obtain additional info on the current status of the pt, as well as what was observed during surgery have been made, however, no further info has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947542
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dennis100
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« Reply #121 on: August 03, 2018, 03:19:55 AM »

Model Number 102
Event Date 10/27/2010
Event Type  Injury   
Event Description
It was reported that the pt felt she had not had efficacy with vns and had possibly even had a slight worsening in seizures since vns was implanted. The pt has always been set to very low settings due to painful stimulation and intolerable hoarseness. The pt's device has been turned off and she may have it removed. No surgery has occurred to date. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1933757
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dennis100
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« Reply #122 on: August 05, 2018, 02:13:56 AM »

Model Number 302-20
Event Date 09/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
It was initially reported by the surgeon that he saw the pt in his office for painful stimulation at the electrode site. He performed diagnostics and noticed high lead impedance. He took the pt into surgery as a result and observed a lead fracture in the operating room, so he decided to go ahead and replace the lead. He stated that the last good diagnostics results were obtained about 6 months ago. The pt was referred to him by the treating physician who stated that the impedance said high and they wanted the pt to be checked by him. X-rays were taken but it did not show anything. Copies of x-rays are not available for manufacturer review. No pt manipulation or trauma occurred that might have contributed to the onset of events. Explanted lead was discarded by the hospital; therefore, not available for manufacturer review.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1921929
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dennis100
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« Reply #123 on: August 05, 2018, 02:14:33 AM »

Model Number 302-20
Event Date 07/05/2009
Event Type  Injury   
Event Description
It was reported in (b)(6) 2009 that the vns pt began experiencing coughing and pain in the jaw during stimulation on times. At the time of the onset of the events, there had been no preceding setting changes that took place prior to the onset of the coughing and painful stimulation, and no reports of pt trauma. Diagnostic testing following the onset of the events revealed normal device function. The device settings had been unchanged since (b)(6) 2009. The pt was seen by the treating physician for follow up following the onset of the events, where the output current was decreased from 1. 75ma to 0. 5ma and the events had significantly improved; however, the pt did begin experiencing an increase in seizure vigor, and per the physician this was a result of having lowered the vns device setting intentionally. The pt was seen by a surgeon in (b)(6) 2009, where diagnostic testing revealed normal device function, and the setting was kept at a low output current. The surgeon advised that they could wait on any surgical interventions at that time, and see how the pt responds with respect to seizure control at the lower settings. The physician had noted that the interventions taken up to this point were for pt comfort, and not to preclude a serious injury. Additional info was received in 12/2010, via receipt of a document from the hospital containing vns implant info, which revealed that the pt had surgery in (b)(6) 2010 where only the lead was replaced. On the documentation received, it was noted that the reason for replacement of the lead was due to "neuropathic pain from stimulation of left nerve. " the documentation provided was hand written and due to poor handwriting, the additional writing on the form was not clear. Good faith attempts with both the surgeon and the treating physician to obtain additional info on the current status of the pt, as well as what was observed during surgery have been made, however, no further info has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1947542
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dennis100
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« Reply #124 on: August 05, 2018, 02:15:09 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919376
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dennis100
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« Reply #125 on: August 06, 2018, 02:23:44 AM »

Model Number 102
Event Date 09/23/2008
Event Type  Injury   
Event Description
It was reported that a vns patient's device was programmed off due to painful stimulation at the generator site. The patient experienced an increase in depression while the vns device remained off. Further interventions were to program the patient's vns on, but the depression stage continued after vns was programmed on. At the moment it is unknown what triggered the patient's increase in depression and pre-vns depression levels are unknown. Additional information was received from the office of the treating psychiatrist asking for a company representative to be present at the patient's next office visit and ensure vns was working correctly. Further information was received from a company representative indicating she was present at the patient's most current office visit. Patient's current settings were 0. 75/30/500/14/10 magnet 0. Normal mode diagnostics results ok/ok dcdc:2 eos:no and system diagnostics were within normal limits dcdc:2 eos:no. The patient was seen at another follow-up appointment and patient settings were changed (decreased pw to 250 from 500) which helped the patient with the reported pain. The patient still continued to cough at these settings, but it would not cause the bronchial spasms that she had been experiencing before from the vns (patient pre-vns diagnosed with asthma). Good faith attempts to obtain additional information from the treating physician have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1924673
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dennis100
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« Reply #126 on: August 06, 2018, 02:24:17 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the pt's mother that the pt has an increase in seizures above baseline that began (b)(6) 2010. Pt is also experiencing painful stimulation since the device settings were increased. Physician has adjusted the pt medication doses. Mother stated that the magnet does help with seizures as she no longer passes out with seizures when it is used. Good faith attempts to gain more info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1937783
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dennis100
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« Reply #127 on: August 06, 2018, 02:24:52 AM »

Model Number 102
Event Date 11/01/2010
Event Type  Injury   
Event Description
It was initially reported by the surgeon's nurse that the patient has been scheduled for a full revision surgery due to unknown reason. Follow up with the surgeon revealed that the patient was experiencing neck pain with vns stimulation approximately for 5 minutes. Patient was unable to swallow or talk during this time. Patient also had one episode of pain around her generator. Diagnostics showed everything working within normal; however, the treating physician felt it was necessary to replace the device. They suspected an intermittent dysfunction of vns system. The surgery was to prevent a serious injury as the pain was intense. No medication changes or trauma contributed to the onset of the event. Additional information received stated that the patient underwent a full revision surgery. Good faith attempts to obtain explanted products for analysis has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917817

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dennis100
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« Reply #128 on: August 07, 2018, 01:15:14 AM »

Model Number 103
Event Date 11/30/2010
Event Type  Malfunction   
Event Description
It was initially reported by the physician that an error message was received with diagnostics were run on the pt. A company representative came to the site to troubleshoot the issue. The warning message and result were duplicated by the company representative on her programming system. A generator reset was perform and appeared to correct the issue. The patient's previously programmed parameter cause painful stimulation, hoarseness and tingling which it has not done before. Pt was programmed to lower output current to allow them to adjust to stimulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1956837
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dennis100
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« Reply #129 on: August 07, 2018, 01:16:01 AM »

Event Date 12/07/2010
Event Type  Injury   
Manufacturer Narrative

Event Description
Reporter indicated a vns patient was hospitalized due to having painful stimulation in the neck. No known trauma occurred. The patient was hospitalized to preclude a serious injury per the reporter. The vns was disabled, but the patient continued to report, she felt painful stimulation and was observed to have voice alteration with the reported stimulation. The patient had the vns settings increased slightly three days prior to the painful stimulation occurring. The patient later had generator replacement surgery only due to the painful stimulation; the original lead was not replaced. Since the surgery, the patient's new vns generator has been turned on and the patient is no longer experiencing any painful stimulation. Attempts for return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1953644
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dennis100
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« Reply #130 on: August 07, 2018, 01:21:31 PM »

Device Problem No Known Device Problem
Event Date 05/25/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from an er physician that a vns patient was in the emergency room (er) presenting with seizures and was coughing rhythmically. The physician stated that the parents put the magnet over the stimulator and that stopped the seizures. She thought that it might be the generator that might be causing the coughing and wanted to have it checked. The company representative went to the er at request of the physician. The patient stated it feels like the device is going off continuously and giving painful stim in the throat. The physician thought the coughing was related to the stimulation. He indicated that the physician thinks it may attention seeking as when the magnet is removed from the generator, the patient coughs and reports difficulty breathing from the coughing. The patient was worried that if the magnet was used to inhibit stimulation her seizures may increase. The next day, the patient had been moved to a new room and didn't seem to be having the issues reported earlier. The magnet was not being used at that time. It was reported that when the magnet is in place she seems to be ok. Then she seizes, the magnet moves off, and cough reflex starts again. She stated that they think the settings may be too high. The company representative was requested to turn off the device. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7617895
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dennis100
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« Reply #131 on: August 08, 2018, 12:49:11 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 09/01/2016
Event Type  Injury   
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.
 
Event Description
It was reported that a vns patient was experiencing painful and erratic stimulation for about three months prior to an appointment on (b)(6) 2016. She stated that her autostimulations were going off "constantly and painful" at times, particularly at night. The provider changed device settings comfort measures. The device was then disabled. It was later provided that explant surgery was scheduled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.
 
Event Description
Follow-up from the provider indicated the reason for explant was that the patient did not think the vns helped.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6953908
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dennis100
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« Reply #132 on: August 08, 2018, 12:49:50 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/09/2018
Event Type  Injury   
Event Description
The patient had generator explant surgery. The device was received, but analysis has not been approved to date.
 
Event Description
It was reported that the patient experienced painful stimulation when she was near an mri machine and afterwards as well, even though her device was programmed off (normal and magnet modes). The patient's device was communicated with after the mri, and it was confirmed that the output currents were set to 0ma. A generator reset was performed to make sure it was disabled, but the patient still felt stimulations and had voice alterations. Programming data from the generator was reviewed, which showed that there were multiple magnet activations on the date of the mri, most with 0 to 1 second between activations. However, since the magnet mode output current was programmed off, no stimulation was delivered. The therapy time recorded by the generator did not show any unexpected stimulation time. The only increase in stimulation time was from a system diagnostic test being performed, which is expected as the device delivers a short stimulation during the test. Therefore, the data showed that the device was not delivering stimulation to the patient. The physician and patient decided to have the device explanted to prevent the patient from feeling any more stimulation. No further relevant information has been received and no surgery has occurred to date.
 
Event Description
Analysis on the generator was approved. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully 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 pulse 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7400487
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dennis100
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« Reply #133 on: August 08, 2018, 11:43:48 AM »

Model Number 103
Event Date 01/07/2011
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt had an increase in seizures above pre-vns baseline. The treating nurse believes that the increase in seizures is due to loss of therapy. There has been many medication and programming changes for pt's seizure control. Additionally, pt complained about painful stimulation which did not resolve with settings adjustment. Placing a magnet over the generator to disable the device; however, alleviated the pain in neck. There has been no trauma or manipulation to the vns generator and lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1993856
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dennis100
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« Reply #134 on: August 08, 2018, 11:44:19 AM »

Model Number 302-20
Event Date 07/19/2010
Event Type  Injury   
Event Description
It was reported by an epileptologist that a vns pt experienced intermittent pain in the chest generator area and electrode site due to unk reason. The epileptologist indicated the pain was not always associated with stimulation and current diagnostics were within normal limits (no specifics). The epileptologist reduced the pt's settings from 1. 75 ma to 1ma, in turn this reduced the pt's pain. Moreover, f/u from a company rep with the epileptologist revealed the pt is doing well and was not complaining of pain or any migration. The epileptologist does not believe the pt's device migrated as there might have been a complaint from the pt regarding the event. Additional information was rec'd from a company rep indicating the pt continued to have painful stimulation at the neck site and now felt like there was a knot there. The pt's epileptologist was now referring the pt to the surgeon for possible full revision. At the moment, it is unk if medical intervention is being taken for the reported painful stimulation as good faith attempts to the treating epileptologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2000313
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dennis100
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« Reply #135 on: August 09, 2018, 05:35:23 AM »

Model Number 102
Event Date 01/31/2011
Event Type  Injury   
Event Description
It was reported by an emergency room (er) physician that a vns pt was having painful stimulation in her neck and felt that the device was stimulating too often. Later info from the pt's physician, however, indicated that the pt had a manic episode - during the episode the pt had visited the er multiple times, and all of the reported events were due to her psychiatric problems with the manic episode. The physician stated that none of the events were caused or even related to vns whatsoever, but solely a part of her mental disease. The pt's device was "off for right now" and the physician indicated that "he did check it", and no problems with the device were reported (no specifics available). The physician indicated that the vns was not shut off to preclude a serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2039473
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dennis100
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« Reply #136 on: August 09, 2018, 05:35:54 AM »

Model Number 300-20
Event Date 09/21/2010
Event Type  Injury   
Manufacturer Narrative
Mfr reviews x-rays of implanted device. X-rays reviewed by the mfr, no anomalies visualized.
 
Event Description
Reporter indicated that a vns pt was unable to have the vns settings increased to therapeutic levels due to coughing, painful stimulation, and muscle twitching. The patient's seizures have increased slightly but are still below pre-vns baseline levels due to the vns settings not being therapeutic. Different vns settings were tried but the events have continued. No changes to the vns settings were made prior to when the events began. Prior to the pt being unable to tolerate the stimulation, she had a neck adjustment by a chiropractor, which may be contributing to the issues. X-rays were reviewed which did not note any anomalies. Surgery to replace the vns appears likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026137
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dennis100
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« Reply #137 on: August 09, 2018, 05:36:26 AM »

Model Number 102
Event Date 02/07/2011
Event Type  Injury   
Event Description
It was reported by a neurosurgeon that a vns patient's device was explanted due to erratic and painful stimulation, however, the patient would like to be re-implanted. Good faith attempts to obtain more information and retrieve the devices for product analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2026023
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« Reply #138 on: August 09, 2018, 05:36:58 AM »

Model Number 101
Event Date 02/01/2011
Event Type  Injury   
Event Description
It was reported by a neurologist via clinic notes that a vns pt was having painful stimulation in neck and jaw since 2009 with vns stimulation for 30 seconds every 5 minutes. The pain in her neck and jaw were resolved with the vns device being turned off. The pt suffered from a possible trauma while she was playing "body block" with her grandson. She took number of x-rays before where no abnormalities were observed. The x-ray report states that the generator was placed in left chest and the lead, which extends into the left lower neck, as visualized, appears stable in alignment and is intact. Single lateral view of the neck demonstrates the lead out of the chest into the left lower neck. The visualized leads appear intact, this report was found in clinic notes as the x-rays images were not returned to the manufacturer. The physician referred the pt for a full revision suspecting a lead problem where the surgery took place. Good faith attempts to get the generator and lead back for product analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2017496
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« Reply #139 on: August 10, 2018, 04:12:11 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/19/2018
Event Type  Injury   
Event Description
It was reported by the physician that the patient was experiencing painful stimulation in the neck where the electrodes were located. The patient's settings were subsequently turned down and the patient was referred for a full revision surgery. Diagnostics were not performed at the patient's appointment. The patient's device was subsequently disabled later in the day. It was later reported that the patient was also having erratic stimulation. No additional relevant information has been received to date. No surgical intervention has been known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7721758
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« Reply #140 on: August 11, 2018, 01:20:33 AM »

Model Number 304-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 06/25/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a lead revision due to a lead fracture. It was later reported that the lead revision was also due to painful stimulation in the neck area. The lead was replaced. The explanted device has not been received for analysis to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7707636
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« Reply #141 on: August 11, 2018, 01:21:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/25/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was in a motor vehicle accident and the vns generator migrated. The patient reported feeling the generator slipping under her arm. The patient reported having headaches that were constant and had worsened overall. The patient continued to utilize her vns for all symptoms, but it was stated that this had not helped with her headaches. The patient reported at an appointment a year following the accident that she felt a shocking pain in her neck. The patient reported that she could feel a wire and continue to complain regarding the generator slipping under her arm and causing constant pain. The patient stated that she feels shocks, which are causing more headaches. The diagnostics were reported as within normal limits. The patient was referred for full vns replacement surgery to address the migration and the painful stimulation. The physician stated that the intervention was to preclude serious injury. The patient underwent replacement surgery. The patient reported following the vns replacement surgery, the patient still feels painful stimulation despite the vns not being programmed on. The physician believed that this may be due to a pinched nerve. The patient was in a motor vehicle accident previously and had neck and back surgery in the past. The physician planned to allow the patient to heal prior to programming the vns back on. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
During attempts at product return, it was revealed that the facility does not return explanted products without a patient signed release and will not return explanted devices to the manufacturer.
 
Manufacturer Narrative
Patient problem :(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7686856
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« Reply #142 on: August 13, 2018, 01:11:58 AM »

Event Date 01/01/2010
Event Type  Injury   
Event Description
It was reported in a scientific article that a vns pt experienced severe neck pain synchronous with the duty cycle resistant to alteration of parameters and requiring lead revision. Good faith attempts to obtain add'l info have been unsuccessful to date.
 
Manufacturer Narrative
Article citation: elliot, robert, a. Morsi, a. Silverberg, c. Carlson, e. Geller, o. Devinsky and w. Doyle. "vagus nerve stimulation in 436 consecutive patients with treatment-resistant epilepsy: long-term outcomes and predictors of response. ".

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« Reply #143 on: August 13, 2018, 01:12:28 AM »

Model Number 250
Event Date 08/19/2009
Event Type  Malfunction   
Event Description
It was reported that a pt was having painful stimulation at the neck and generator site whenever she tried to use her magnet to disable the device. The physician reviewed the pt's settings and found that the magnet output current was set to 1. 0 ma when it should have been set to 0 ma. Review of the pt's programming history by the physician who reported the event revealed that a faulted diagnostic test occurred on (b)(6) 2009 and all the settings were corrected however the magnet output current was left at 1. 0 ma when it should have been 0 ma. The physician stated that she believed the test was interrupted because it is run at higher settings than what the pt is programmed to and the pt experienced pain when the test was being performed. The physician was reminded of the importance of performing final interrogations to ensure all of the settings are correct including magnet settings. Good faith attempts to obtain current programming and device diagnostic info have been unsuccessful to date therefore the programming anomaly cannot be confirmed at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092178
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« Reply #144 on: August 13, 2018, 01:13:08 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type  Injury   
Event Description
It was reported that the pt was very sensitive to stimulation and was feeling pain during stimulation. The pt was not able to tolerate stimulation at 0. 50ma, so the device was disabled for several months. The pt was then set to 0. 25ma in (b)(6) 2010 and was able to tolerate the stimulation as she could not feel it. Diagnostics were not able to be performed at this time. The pt was later programmed to 0. 75ma and able to feel the stimulation. X-rays were received by the mfr for review, which revealed no anomalies. Later, it was indicated that it was very difficult from the very beginning to increase the output current, due to pt's sensitivity. The physician tried for a year and a half to raise the output and managed to do so up to 0. 5ma with the pulsewidth at 250 and 130. The stimulator was stopped (b)(6) 2010 and started again in (b)(6) 2010. The pt was said to be feeling the painful stimulation since being turned on and the physician confirmed that is believed to be related to the vns therapy. There is no known pt manipulation or trauma that occurred that is believed to have caused/contributed to the painful stimulation. No programming changes were taken as the pt was already at low settings. The pt later had vns lead revision surgery due to the painful stimulation. At the time of surgery, the surgeon noted that the electrodes were placed a little too low on the nerve in his opinion. The pt is doing much better since surgery and is currently having a new vns titrated up. The explanted lead was returned to the mfr, but no anomalies were noted with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2075905
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