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dennis100
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« on: January 09, 2015, 07:45:25 AM »

Model Number 103
Event Date 10/20/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient developed an infection. The patient had an allergic reaction to the surgical glue used during the procedure at the neck incision site. Following the implant procedure, the patient also experienced numbness on the side of her face and left arm. When the patient¿s device was tested, the patient subsequently experienced pain in her neck and head and was unable to breathe or speak during stimulation on-times during the test. The patient¿s device was disabled. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received that the patient's device was turned on during (b)(6) 2014 and that the patient is doing well. Patient also experiences pinching sensation in her chest during stimulation and when she lies down. Patient's pain when turning her head was reported to be better and was attributed to be due to patient having a bulging disc.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300491
« Last Edit: December 12, 2015, 11:13:40 AM by dennis100 » Logged
dennis100
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« Reply #1 on: June 05, 2015, 02:02:03 AM »

Model Number 103
Event Date 02/18/2013
Event Type Injury
Event Description
It was reported that following generator and lead replacement surgery on (b)(6) 2013 due to high impedance, the vns patient experienced throat tightness and pain that did not occur with stimulation on-times. The patient was unable to tolerate the device settings that were programmed on the previous device. The patient reported that, since replacement, his face would sometimes swell. Diagnostic results showed normal device function. Follow-up revealed that physician attributed these issues to vns. The patient was given anti-inflammatory medications and his device settings were decreased. The physician also indicated that stress may have contributed to the events and that no medication changes preceded the onset of the events additional information was received stating that the patient also began experiencing numbness in the jaw and neck. The patient¿s seizures were noted to be more frequent and longer in duration. The physician attempted to increase the device settings but was unable to due to the patient¿s pain. The physician attributed the increase in seizure frequency and duration to the inability to increase device settings to therapeutic levels. Attempts for additional relevant information have been unsuccessful to date. The high impedance event was reported in manufacturer report #1644487-2013-00524.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4789910
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dennis100
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« Reply #2 on: September 23, 2015, 02:53:10 AM »

Model Number 304-20
Device Problem Device operates differently than expected
Event Date 08/25/2014
Event Type Injury
Manufacturer Narrative
Describe event or problem, corrected data: it was inadvertently reported on the initial report that the physician attributed the tachycardia to vns. Brand name, corrected data: the suspect device was inadvertently reported as the generator and was the brand name was reported incorrectly on the initial report. Type of device, corrected data:the suspect device was inadvertently reported as the generator and the type of device was inadvertently reported incorrectly on the initial report. Model, serial number, lot number, expiration date, corrected data: the suspect device was inadvertently reported as the generator and the model, serial number, lot number and expiration dates were inadvertently reported incorrectly on the initial report. Explanted date, corrected data: the suspect device was inadvertently reported as the generator and an explant date was incorrectly reported on the initial report. No known surgery to explant the suspect lead device has occurred to-date. Evaluated by mfr, corrected data: it was inadvertently reported on follow-up #1 that the device was not returned to the manufacturer when it had already been correctly reported on the initial mdr, resulting in a duplicate statement. Device manufacture date, corrected data: the suspect device was inadvertently reported as the generator and the device manufacture date was incorrectly reported on the initial report. Evaluation codes, corrected data: the conclusion code was inadvertently reported incorrectly on the initial report.

Event Description
It was reported by the patient that she has experienced nerve damage in her face, and paralysis on the left side of her face as a result of vns surgery. The patient reported swelling on her neck with the nerve damage to her face. The patient's physician and cardiologist have reported they believe the tachycardia to be pre-existent and not related to vns. Attempts for additional information have been unsuccessful to-date.

Event Description
It was reported by the patient that the vocal cord paralysis was permanent. The explanted generator was requested for evaluation; however, it was discarded and cannot be returned.

Manufacturer Narrative

Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2015 to explant the generator due to vocal cord paralysis and tachycardia which the physician attributed to vns. The lead was not explanted during the procedure. The patient began experiencing these issues following initial implant surgery on (b)(6) 2014. No further information relevant to the event has been received to date.

Event Description
The patient has stated that the generator was removed because her left vocal cord was clipped during the surgery and has caused voice issues. The patient reported pain in her neck and stated she had no feeling on the left side of the face as a result of the surgery, which has not fully resolved to-date. Attempts for additional information have been unsuccessful to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4762712
« Last Edit: December 01, 2015, 12:14:34 PM by dennis100 » Logged
dennis100
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« Reply #3 on: September 30, 2015, 03:28:28 AM »

Model Number 103
Event Date 10/17/2013
Event Type Injury
Event Description
On (b)(6) 2013, this vns patient reported that he began having severe swallowing issues two weeks prior and was taken to the hospital. The patient was told that he may have had a stroke as he had numbness on the left side of his face. The patient¿s primary care physician stated that he may need his vns settings adjusted to help with the swallowing issues. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3484481
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dennis100
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« Reply #4 on: October 05, 2015, 12:46:31 PM »

Model Number 105
Event Date 04/18/2013
Event Type Injury
Event Description
On (b)(6) 2013, this patient¿s mother reported that the patient has been diagnosed with horner¿s syndrome by the neurosurgeon who implanted the device and that the left side of her face has been droopy since the day of implant and still is. This has been going on for about six weeks now. It was also stated that, since implant, the patient has not been able to swallow normally and was admitted to the hospital as a result. The patient was also diagnosed with left vocal cord paralysis, but no interventions were being taken. The patient could not burp since implant. The patient¿s mother stated that the neck incision scar looked like a brutal scar; however, the surgeon stated that this occurred because the patient has an unusually thick neck. The device had not yet been programmed on. Attempts for additional information have been unsuccessful.

Manufacturer Narrative

Event Description
Additional information was received that the horner¿s syndrome, vocal cord weakness, and difficulty swallowing were all noted 1-2 days post-operatively. These three events were believed to be related to vns. The patient did not have a pre-vns medical history of vocal cord paralysis, difficult swallowing, or being unable to burp. No causal or contributory programming or medication changes preceded any of the events. The patient¿s vocal cord weakness was evaluated by an ent. The device was programmed on and being managed by the epileptologist.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3195992
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dennis100
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« Reply #5 on: October 15, 2015, 02:21:14 AM »

Model Number 102
Event Date 01/01/2009
Event Type Injury
Event Description
On (b)(6) 2012, it was reported that this vns patient's device was disabled in 2009 due to an adverse event. At the time of implant, the patient had almost continuous discrete facial and right hand myoclonus. After passing the magnet on two occasions, the patient went into status epilepticus, and the device was disabled. Follow-up showed that the device was never programmed back on. The device was programmed off due to an increase in seizures. The patient's device was explanted (not replaced) on (b)(6) 2012. After the patient was implanted in 2009, it was suspected that the patient had rasmussen syndrome. This was later confirmed and the patient's physician decided to remove the device and move forward with other therapies. The explanted devices were not available for product return as the explanting hospital was responsible for discarding them. Attempts for additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2835841
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dennis100
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« Reply #6 on: November 04, 2015, 12:41:27 PM »

Model Number 302-20
Event Date 03/25/2009
Event Type Malfunction
Event Description
It was reported that a vns pt was explanted of both generator and lead due to constant pain in left side of the face and left side of the chest at the generator site. Trauma was reported by the pt prior to experiencing pain and as the generator was programmed off the pain was relieved. Moreover, both the generator and lead were returned and analyzed by the mfr. Product analysis on the generator indicated there were no performance or any other type of adverse conditions found with the pulse generator as the pulse generator performed according to specs. However, product analysis on the lead revealed that the outer and inner silicone tubing appeared to be punctured. It is believed that this condition could have potentially contributed to the pt's pain event, but currently, the exact impact of this condition and when it occurred is unk.

Manufacturer Narrative
Device failure occurred, 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=1485553
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dennis100
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« Reply #7 on: November 12, 2015, 03:14:57 AM »

Event Date 05/01/2006
Event Type Injury
Event Description
It was reported to manufacturer that the vns pt was experiencing "shooting pain in the face all the time" and that it began the first week following implantation of the device. The pt reported that the condition has been diagnosed as trigeminal neuralgia. Additionally, the pt reported that the device has been turned off since 2008, however the pain had persisted. The pt is seeking to have the device removed. Attempts to obtain additional info from the treating physician have been made, but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1022607
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dennis100
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« Reply #8 on: November 13, 2015, 12:03:40 PM »

Model Number 102
Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated that her daughter was not getting efficacy from vns therapy and wanted the device explanted. She stated that her daughter's physician; however, believed that the patient was doing well on vns therapy and should stay implanted. Reporter also stated that her daughter was experiencing the adverse events of sore throat, left facial drooping, and swelling of her lower lip. Good faith attempts to obtain information from the patient's physician are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=937315
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dennis100
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« Reply #9 on: November 13, 2015, 01:18:29 PM »

Event Date 01/01/2007
Event Type Injury
Event Description
Reporter indicated that a patient underwent vns surgery, and the patient then experienced nerve damage, trouble with their voice, and partial paralysis of the face. Attempts to gather additional information from a medical professional have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=932366
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dennis100
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« Reply #10 on: November 15, 2015, 02:34:10 PM »

Model Number 302-20
Event Date 01/01/2007
Event Type Malfunction
Event Description
Reporter indicated that the 'pt's electrodes were coming off the vagus nerve. " physician notes received by manufacturer indicated that the pt started to "have problems with seizure management" and was experiencing "pain over the left side of face, about the left eye, problems swallowing, problems speaking, and pain with tingling and burning referred into the arms, hands, and now sometimes legs. " "it appears that the lead attached to the left vagal nerve is not well attached and may actually be totally displaced. " the pt was admitted to the hospital, her settings were planned on being changed, and revision surgery planned in an attempt to resolve the pt's issues. Follow-up with the physician indicated that he looked at the pt's x-rays and did not see anything. He also explained that the normal mode diagnostics obtained were ok. Additionally, it was reported that the pt was experiencing headaches and jaw pain. The physician thinks tha it may have something to do with the pt's anatomy that causes the lead to come off. He explained that the pt was extremely psychotic prior to the vns and is now a "completely different person. " revision surgery was performed in 2007. Diagnostics were performed prior to surgery and obtained all normal results with a dcdc code of 3 and eri=no. It was reported that the surgeon found that there was inadequate strain relief "due to improper positioning of the tie downs, the lead was in the shape of a figure 8, and there was a great deal of scar tissue which was never removed from previous surgery that contributed to the pt's events. " the surgeon removed the lead implanted in 2006 and almost all of the scar tissue that was present on the vagus nerve of the pt. There was part of the scar tissue that he did not remove to avoid damage to the vagus nerve. The replacement lead's electrodes were positioned right below the original site of the scar tissue. Diagnostics performed after the surgery obtained normal results.

Manufacturer Narrative
Device malfunction is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=861962
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dennis100
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« Reply #11 on: November 28, 2015, 03:05:24 PM »

Model Number 302-20
Event Date 08/01/2014
Event Type Malfunction
Event Description
On (b)(6) 2015, patient's vns device was disabled due to painful stimulation and lack of efficacy. Patient experienced headache, pain in the chest, neck and radiating pain in the left ear with stimulation. Systems diagnostics were performed and high impedance was observed. On (b)(6) 2015, the patient came back and wanted the device turned on. The patient had reported initially that she did not receive much benefit from vns. Once the device was disabled, the patient returned and said that she did receive benefit from it and therefore the vns was turned back on. Patient was referred for x-rays but it is unknown of the device was turned on again. Patient had previously reported headaches, painful stimulation in the neck and face and pulsating at the generator site since (b)(6) 2014. No known surgical interventions have occurred to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is 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=4957000
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dennis100
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« Reply #12 on: November 28, 2015, 04:58:30 PM »

Model Number 304-20
Device Problem Dislodged or dislocated
Event Date 03/09/2015
Event Type Malfunction
Event Description
It was later reported through clinic notes the patient experienced widespread muscle spasms in the neck and face prior replacing the lead.

Manufacturer Narrative

Event Description
It was reported that the patient is feeling a bulging sensation with stimulation. The vns device was tested and no high impedance was found so the neurologist chose to keep the vns device programmed on. X-rays were taken and it was reported that the electrodes appear dislodged from the nerve. The neurologist believes the electrodes were dislodged because the patient began golfing too soon after surgery. It was also reported that the bulge was not visible from the outside; no protrusion. The patient had lead revision surgery on (b)(6) 2015, the generator was not replaced. After the new lead was implanted and connected to the vns generator, diagnostics were performed and were within acceptable levels. Attempts to obtain additional relevant information have been unsuccessful to date. The explanted generator has not been received to date. It was reported that it was likely discarded by the explanting facility.

Event Description
It was verified that the lead was detached from the nerve. It was also reported that the lead revision surgery resolved the bulging sensation that the patient was feeling previous to the revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4953543
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dennis100
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« Reply #13 on: November 30, 2015, 07:00:35 AM »

Model Number 102
Event Date 12/01/2014
Event Type Injury
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the generator and the lead passed all functional tests prior to distribution.

Event Description
It was reported that the patient had undergone lead replacement and a prophylactic generator replacement. Further information was received indicating that the patient had benefited from very good efficacy on seizure control with vns. The antiepileptic drugs were discontinued and the patient presented one or two seizures per year. The treatment for depression could be discontinued too. The patient¿s quality of life was highly improved. Frequent seizures occurred again in (b)(6) 2014, together with the onset of painful muscle spasms in the left face which coincided with stimulation pulses, the patient indicated that the spasms could be stopped by applying pressure on the neck, close to the lead implant area. The spasms had been previously noticed ten months after implantation and they resolved reducing the intensity of the stimulation. The medical professionals suspected a leakage of current due to the presence of increased seizures and muscle spasms. The generator had been implanted for ten years already and it was estimated that the battery would be approaching the end of life. Therefore it was decided to replace the whole vns system. The explanted lead was not kept as it was damaged during the explant. The pulse generator was disposed of by mistake. Programming and diagnostic history was reviewed and it confirmed that system diagnostics returned normal impedance results through (b)(6) 2012. Attempts to obtain further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877263
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dennis100
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« Reply #14 on: December 02, 2015, 11:37:09 AM »

Model Number 103
Event Date 03/01/2015
Event Type Injury
Event Description
It was reported that the patient has been hospitalized recently for various issues including seizures, coma, and pneumonia. Patient also experienced trauma when the paramedics had dropped patient on the floor. It was also reported that the patient had some issues with his vns. Additional information was received that the patient experienced seizure after seizures and later woke up to find himself at the hospital with a ventilation tube. Patient experienced pneumonia from the ventilator. When the ventilator tubes were taken out, it caused his throat to be sore and very sensitive. Patient¿s face was reported to turn purple with stimulation which was reported to have resolved on its own. Patient also experienced increased heart rate with stimulation following this incident. It is unknown if this event started recently after the hospitalization or if it was present before. Patient was recommended to visit the neurologist regarding this. Attempts to obtain additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Additional information was received that the patient was having issues with throat closing and tachycardic episodes with stimulation (hr 130) with some recent change in settings on an unknown date. The patient's generator interrogated and found to be with settings of 1. 75/30/500/30/3. 0. The patient's frequency was lowered to 20 hz, which appeared to resolve the issue and the stimulation was still tolerable. At that time the physician was going to monitor the patient to ensure there were no other issues. The impedance was also confirmed to be 3115 ohms with no other issues with the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4698228
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dennis100
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« Reply #15 on: December 07, 2015, 12:18:56 PM »

Event Date 01/26/2015
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). The patient¿s device showed lead impedance within normal limits (dcdc ¿ 2) at the previous office visit on (b)(6) 2014 the patient was referred for surgery but no known surgical interventions have occurred to date.

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

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed. Clinic notes were received indicating that the vns patient presented with new symptoms during an office (b)(6) 2015. The right side of the patient¿s lower face and upper neck was twitching which would occur for a few minutes and then stop. The patient also was having sharp pains on the left side of her head that occurred daily. High impedance was observed during the office visit and the patient¿s device was not disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532847
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dennis100
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« Reply #16 on: December 14, 2015, 03:44:23 AM »

Model Number 102
Event Date 08/13/2014
Event Type Injury
Manufacturer Narrative
Type of reportable event; corrected data: the initial mdr inadvertently selected malfunction instead of serious injury for this field. This mdr is being submitted to correct this data.

Manufacturer Narrative

Event Description
It was reported that the vns patient had been experiencing painful stimulation, dyspnea and coughing with stimulation for the last two weeks. The patient described the pain as beginning at the generator site and then traveling up to the left side of her face to her jaw during stimulation on-times. The patient indicated that the painful stimulation was to the point of wanting the device disabled, so the device was programmed off. A system diagnostic showed normal device function. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted device has 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=4266673
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dennis100
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« Reply #17 on: December 15, 2015, 06:12:22 AM »

Event Date 09/08/2014
Event Type Injury
Manufacturer Narrative
Adverse event and/or product problem; additional information indicates that the event was not a product problem but an adverse event. Type of reportable event; additional information indicates that the event type was not a malfunction but a serious injury.

Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient was experiencing painful stimulation and went to the er on (b)(6) 2014. The er physician stated that the patient¿s device was ¿misfiring¿. Follow-up revealed that during the er visit, the er physician had concerns of a potential lead break and subsequently disabled the device. The patient was sent for x-rays. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011. No known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility will not return explanted devices to the manufacturer for analysis and discard explants after 30 days; therefore, no analysis can be performed. Clinic notes were received indicating that the patient's device was tested during an office visit on (b)(6) 2014 and diagnostics showed lead impedance within normal limits (impedance value - 3000 ohms). After disabling the patient's device, the er physician prescribed medication for the patient. The notes indicate that the patient's painful stimulation occurred abruptly at her until the device was disabled and subsequently began having breakthrough seizures. A lead issue was suspected because of the patient's painful stimulation and not based on diagnostic results or x-rays. Operative notes for the patient's replacement surgery indicate that there was a significant amount of scarring around the nerve which required an external neurolysis as well as neurorrhaphy to prepare the nerve for placement of the new lead. The notes indicate that following placement of the new devices, the device was programmed on and showed low impedance. It is unclear whether the notes were referring to a low impedance reading or a low numerical impedance value that was within normal limits.

Event Description
Additional information was received from the physician¿s office that the patient experienced painful stimulation on the left side of the face, neck and chest abruptly on (b)(6) 2014. The patient was seen post- surgery by the physician on (b)(6) 2014 and that the incision sites were reported to be healing well. Attempts were made for product information but were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4171248
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« Reply #18 on: December 16, 2015, 10:30:39 AM »

Model Number 102R
Event Date 05/14/2014
Event Type Injury
Event Description
It was reported that the patient was still very weak. The device was not checked. It was later reported that the patient was doing better and walking and gaining strength. It was reported that the plan is for the patient to be seen in a few weeks to discuss proceeding forward with the revision. No surgical intervention was performed to date.

Event Description
Additional information was received stating that the vns patient¿s seizures had improved but the patient¿s magnet appeared to making the seizures worse. The patient was also experiencing pain in her neck whenever the magnet was used. The patient was referred for surgery but no known surgical interventions have occurred to date.

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

Event Description
Additional information reported that the patient was scheduled for generator replacement. Generator replacement occurred on (b)(6) 2015 but the lead was not replaced.

Event Description
Additional information was received that the patient is now going to have generator replacement and prophylactically replace the lead to prevent a potential revision in the future for patient comfort. No known surgical intervention has occurred to date.

Event Description
It was reported that the lead revision had been cancelled. Additional information was later received that the patient was referred for generator replacement for an unrelated reason.

Event Description
The explanted generator was received on 6/3/2015. In the (b)(4) 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. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
It was reported that the vns patient was hospitalized due to a seizure she experienced when a system diagnostic test was performed on (b)(6) 2014. The patient had also been experiencing painful stimulation in her chest and neck as well as coughing and facial twitching with stimulation. The patient again experienced a seizure when the next system diagnostic test was performed on (b)(6) 2014 so the patient¿s neurologist stated that the system diagnostic tests were causing the seizures. The patient was given medication and taken to the er. It was noted that the patient¿s device settings were higher than those for system diagnostics and that system diagnostic results showed lead impedance within normal limits (dc dc ¿ 2). Follow-up revealed that the patient¿s seizures were above pre-vns baseline levels. Clinic notes were received for the patient¿s office visit on (b)(6) 2014. The notes indicate that the patient had been experiencing an increase in seizures since she began using a hearing aid and that she had three seizures since her last office visit. The patient experienced a seizure the before the office visited which resulted in bruising in the arms. The patient stated that she was unable to tolerate magnet mode stimulation. The patient¿s device was tested during the office visit and the patient again experienced a seizure. Diagnostic results showed lead impedance within normal limits. The patient was sent to the er where the patient¿s device settings were lowered. X-rays were taken and were reported by the physician to be unremarkable. The physician recommended replacement surgery due to concerns with the patient¿s lead. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4052095
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« Reply #19 on: December 18, 2015, 09:42:09 AM »

Model Number 304-20
Event Date 06/06/2014
Event Type Injury
Event Description
It was reported that the recently implanted patient¿s neurologist noticed drainage at the patient¿s neck incision and noted that there may be an infection. The patient was advised to call the surgeon. The patient was referred to the emergency room for treatment by the surgeon, and given antibiotics. The neurologist later reported that the infection was mild and he believed it had resolved. No additional relevant information has been received to date.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and the lead prior to distribution.

Event Description
Additional information was received indicating that the patient had facial numbness and swelling that was unrelated to vns stimulation. The patient was referred to the emergency room (er) and treated. Additional information received from the physician indicated that the infection was mild and he believed it was resolved. The physician believed that the reported facial numbness and swelling was a result of the infection as well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3917276
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« Reply #20 on: December 22, 2015, 01:37:39 AM »

Model Number 105
Event Date 01/25/2014
Event Type Injury
Manufacturer Narrative
Review of the available programming and diagnostic history.

Event Description
It was reported that the vns patient began experiencing pain at the electrode site on the left side of her face and neck on (b)(6) 2014. Additionally, the patient had difficulty chewing during stimulation. According to the neurologist, the relationship between the reported pain and vns is increased sensitivity to vns stimulation due to unknown etiology. The pain appeared to occur with stimulation. To preclude a serious injury, the neurologist lowered the patient¿s programmed settings. Product information is not available due to hospital policy. The available programming history did include any diagnostic results.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3677841
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« Reply #21 on: December 22, 2015, 09:16:39 AM »

Model Number 102
Event Date 01/01/2014
Event Type Injury
Event Description
Analysis of the returned generator showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no anomalies found with the pulse generator. Additional information was received stating that the vns patient was not experiencing an increase in seizures.

Event Description
Clinic notes dated (b)(6) 2014 note that the patient has experienced good control of seizures. It was noted that the battery life is low and generator replacement is recommended to continue control of seizures. The notes indicate that the patient is not having seizures, but that the patient is complaining of episodes of abnormal sensations on the left side of the face. The patient describes the sensations as his face and head being twisted. The notes indicate that the patient experienced these sensations prior to vns and that vns fully controlled these together with the seizures. The notes indicate that the patient is concerned the vns is not working. The device was interrogated and found to be working within normal limits and was not at end of service. It was noted that the patient would be referred for generator replacement. An implant card was received indicating that the generator was replaced on (b)(6) 2014 due to prophylactic reasons. The generator was returned for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3668141
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« Reply #22 on: January 03, 2016, 12:46:55 AM »

Model Number 103
Event Date 01/01/2013
Event Type Malfunction
Event Description
It was initially reported that the patient had generator replacement on (b)(6) 2013 prophylactically. Clinic notes dated (b)(6) 2012, a month prior to surgery, indicated that the patient's seizures have decreased. A referral for generator replacement was performed on this date. The generator was returned to the manufacturer for analysis, and the return product form from the hospital reported the reason for replacement as end of service (battery depletion). However a nurse at the neurologist's office reported on (b)(6) 2013 that the reason for generator replacement was that the device was "not working properly". No further details were provided at that time. Attempts for additional information for clarification for the reason for replacement have been unsuccessful to date. Product analysis of the explanted generator revealed that there were no adverse functional, mechanical, or visual issues identified with the returned generator. Results of diagnostic testing and monitoring indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. The results of diagnostic testing indicated that the battery status indicated ifi=yes which appears to be appropriate based on downloaded device data; generator performed according to functional specifications.

Event Description
Additional information was received from the physician in response to a faxed request from the manufacturer for information. Per the physician, the (b)(6) increase in seizure reported over the phone was the patient experiencing seizure four times per month. After medication changes, the patient experienced two seizures per month. At the (b)(6) visit, the patient's mother reported general tonic clonic seizures at school on (b)(6), which was unusual. Also, the patient experienced voice effect of vns. This was the only change after replacement as of february 5 visit. No causal or contributory programming or medication changes preceded the onset of the decreased perception to stimulation. No patient manipulation or trauma is believed to have caused or contributed to the decreased perception to stimulation. The patient's settings as of (b)(6) 2010 were provided and it was noted that the patient had 2 seizures a month at that time.

Event Description
Additional information was received from the treating neurologist¿s office indicating that a device malfunction was not suspected ¿other than battery strength. ¿ it was initially indicated that the device was ¿not working properly¿ because the patient¿s caregiver had noted less impact on vocalization during stimulation on-times and a slight increase in seizures. The patient¿s average seizure frequency per month in (b)(6) 2012 was about two to four seizures, per mother. The battery indicator was reported to be about greater than 4/5 depleted. Previously in (b)(6) 2012, it was indicated that the patient¿s seizures had decreased from four to two per month, but the relationship of the seizure frequency during that time to pre-vns baseline level was unknown. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Describe event or problem: previously submitted emdr inadvertently omitted additional information regarding the patient¿s seizures from the incoming communication. This report is being submitted to correct this information.

Event Description
Per the physician¿s response that was previously reported, the patient was seen after revision surgery on (b)(6) 2013. The patient experienced brief behavior arrest, facial twitch for a few seconds, no gtc, and was back to early summer 2012 baseline.

Manufacturer Narrative
Review of manufacturing history records performed. Review of the generator manufacturing history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3118336
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« Reply #23 on: January 07, 2016, 09:58:10 PM »

Model Number 105
Event Date 09/29/2015
Event Type Injury
Event Description
Clinic notes dated (b)(6) 2015 report that the patient had a motor vehicle accident on (b)(6) 2015. Since that time, he was experiencing regular shocking sensations in his left face with timing consistent with the vns cycling. The shocking sensation was stronger with magnet stimulation. The patient went to the hospital where x-rays were taken which reportedly did not show any abnormalities with the vns system. The patient had an appointment scheduled with the surgeon on (b)(6) 2015. The neurologist performed diagnostics and all diagnostic testing was normal with normal lead impedance. He assessed that there were no apparent problems on electrical testing. The device was turned off, and the patient had no further shocking sensations. So at that time, the device was left programmed off. The plan was to turn it back on to tolerated settings if the surgeon found no problems with no plans for a procedure. Upon follow-up, the surgeon's office upon follow-up that the patient went to the er for the shocking sensation from the motor vehicle accident and then had surgery on (b)(6) 2015 due to the shocking sensation. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5331293
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« Reply #24 on: January 13, 2016, 03:19:30 AM »

Model Number 303-20
Event Date 11/18/2009
Event Type Malfunction
Event Description
An implant card was received which confirmed that the generator replacement was prophylactic. The implant card also indicated that the lead impedance was ok and the lead was not replaced. Attempts for additional information have been unsuccessful. No additional information has been provided. The explanted generator has not been returned.

Manufacturer Narrative
Device failure suspected, but did not lead to a death.

Event Description
Clinic notes dated november 13, 2012 note that the patient has high lead impedance. This was found through diagnostic results that showed a dcdc code of 4. In addition, it was noted that the patient experienced voice hoarseness with stimulation, pain on the left side of the face and jaw, pain in the throat and teeth, and coughing with stimulation. The patient was scheduled for surgery on (b)(6) 2012. Good faith attempts are underway for further details about the reported events.

Event Description
A programming history review was performed which found no anomalies.

Manufacturer Narrative
If explanted, give date (mo/day/yr), corrected data: the initial mdr inadvertantly listed an explant date for the lead; however the lead has not been explanted.

Event Description
On (b)(6) 2012 it was confirmed that the generator replacement surgery took place that day. It was stated that the surgery was a prophylactic replacement. The product is pending return for product analysis.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880622
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« Reply #25 on: January 14, 2016, 03:00:06 PM »

Model Number 102
Event Date 11/08/2012
Event Type Malfunction
Event Description
On (b)(6) 2012 the patient reported that she was trying to use her magnet to inhibit stimulation while eating a meal; however, she continued to feel stimulation. It was confirmed that she was placing the magnet in the right position as she stated she could palpate her generator and was placing the magnet directly over the skin on that spot. It was also confirmed that she was keeping the magnet there for the correct amount of time - greater than 65 seconds. The patient explained that although she did not experience any pain, she could tell the device was stimulating because her face twitched with every stimulation. She further stated that it felt like normal stimulation rather than magnet stimulation. Follow up with the patient found that the issue resolved itself within an hour and the patient was not concerned. It was suggested that the patient see her physician right away to get the device checked; however, the patient stated her next appointment is in six months and it is not known if a closer appointment was made. Attempts have been made to get additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2862380
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dennis100
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« Reply #26 on: January 19, 2016, 02:03:40 AM »

Model Number 102
Event Date 05/09/2012
Event Type Malfunction
Event Description
On (b)(6) 2012, product analysis was completed on a generator that had been explanted due end of service. The reported end of service allegation was duplicated in the pa laboratory. The supply current tests did not meet functional specifications; these measurements demonstrate an increased current consumption for the device. The increased current consumption was isolated to a leaky capacitor (c6). With the capacitor substitution for c6, the pulse generator module performed according to functional specifications. The cause for the c6 capacitors increase in leakage could not be determined. Clinic notes from the vns patient's clinical visit on (b)(6) 2012 were received which indicated that since the last visit on (b)(6) 2011, the patient has had ongoing seizures. In (b)(6) 2011, the patient had onset of leg tremors that were initially thought to represent clonus, but these progressed to involve his arms and legs and sometimes his face. The patient has had no change in consciousness, but does get agitated during these spell; duration 20-60min. Otherwise, the patient has an average of one seizure every 2 weeks lasting 5-10minutes, described as facial grimacing/twitching and myoclonic jerks. Swiping the vns magnet is no longer effective in stopping/reducing the duration of the patient's seizures. The patient takes tranxene 3. 75mg tablet as needed with increased seizures. The patient receives vns stimulation that is programmed to deliver output=1. 5ma/on time=30sec/off time=1. 8min/pulse width=500usec/frequency=30hz/magnet on time=1. 75ma/magnet pulse width=500usec/magnet on time=60sec. The patient tolerates these without any adverse effects. The patient was noted to be more agitated and has a baclofen pump. There have been no changes in his medications or environmental changes. The physician noted that he attempted to interrogate the patient's vns on this visit but was unable to do so with two different systems. The patient was noted to continue to have breakthrough seizures several times a month, but overall his seizure control has been fairly stable. The vns was stated to be at end of service and was not delivering any stimulation. The patient's mother feels the vns has been efficacious for the patient's seizure control and wanted the vns replaced. The patient was again noted to be more agitated over the past few months for unclear reasons but the physician stated that it is possible that his mood was improved with vns and since he is no longer receiving any stimulation, it has deteriorated.

Manufacturer Narrative
Device failure occurred, 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=2828542
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« Reply #27 on: January 19, 2016, 12:35:03 PM »

Model Number 302-20
Event Date 09/19/2012
Event Type Injury
Event Description
Reporter indicated a patient was having twitching and painful stimulation in the face with vns stimulation. The settings were lowered which resolved the issues, but as a result of the decreased therapy, the patient's seizures increased. The patient's lead is also protruding up under the skin in the neck and causing discomfort. The patient has been referred for vns generator replacement and lead repositioning surgery. It is felt the generator may be nearing end of service or the position of the lead may be contributing to not being able to increase the vns settings without discomfort. Surgery is planned, but has not occurred to date.

Manufacturer Narrative
(b)(4).

Event Description
Reporter indicated the patient had prophylactic vns generator replacement surgery performed on (b)(6) 2012. Diagnostics were within normal limits with the new generator and resident lead per the manufacturer's implant card received on (b)(6) 2012. The lead was repositioned as it was noted as being "prominent" due to subcutaneous placement. The patient had no known trauma and does not manipulate the vns. The explanted generator was returned for analysis and no anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2827277
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« Reply #28 on: January 22, 2016, 08:58:39 AM »

Model Number 302-20
Event Date 09/13/2012
Event Type Malfunction
Manufacturer Narrative
Adverse event or product problem, corrected data: the supplemental report #2 inadvertently did not report this data. Outcomes attributed to adverse event, corrected data: the supplemental report #2 inadvertently did not report this data.

Event Description
It was reported that the patient was referred for explant. The patient's caregivers reports noticing warmth and slight inflammation in the left neck and cheek, especially with onset of seizure activity. Clinic notes dated (b)(6) 2014 reported that there were no recent medication changes and unclear reason for seizures but may have been related to stresses. No medication changes were made. The caregiver expressed concern that vns may be triggering the patient's seizures although the device is still programmed off so the patient is not receiving vns therapy. Surgical intervention has not taken place to date.

Event Description
A vns treating neurologist's office reported on (b)(6) 2012 that the patient presented with high impedance. Clinic notes dated (b)(6) 2012, were later received which reported that the patient was having several generalized tonic-clonic seizures but had not had one in the last month. The notes revealed that the patient's symptoms were unchanged. Diagnostics on this date revealed high impedance. The patient's settings were not changed on this visit. The patient was instructed to continue current medication dosage. Follow up with the physician revealed that no trauma or manipulation that was believed to cause or contributed to the high impedance. The physician turned off the device on (b)(6) 2012, due to the high impedance issue. The device was previously set at 0. 5ma output current. No x-rays are being taken at this time, but plans are being made for the patient to get a full revision. However, the surgery has not occurred to date.

Event Description
The physician's office reported that the warmness and inflammation were not related to stimulation since the device was off but may have been related to presence of the device. The cause was unclear, but the parents requested explant as they believed that the vns may have been triggering seizures although the device was off.

Event Description
Additional information was received indicating the patient's mother decided not to pursue vns revision surgery at this time due to the patient having good control on medications.

Event Description
It was reported that the patient had generator and lead explant surgery. The electrodes were not removed off of the nerve. The explanted products were discarded. Therefore, analysis is unable to be performed.

Manufacturer Narrative
Device failure is 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=2803688
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« Reply #29 on: January 23, 2016, 09:21:47 AM »

Model Number 102R
Event Date 08/01/2008
Event Type Malfunction
Manufacturer Narrative

Event Description
Clinic notes were received for review reporting that a vns patient in (b)(6) 2008 had an episode of status. The seizures were partial with secondary generalization, with the face twitching. It is unknown if this is usual for this patient. The patient's treating neurologist will not release any further information in regards to this event. Unknown what interventions were taken.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2796363
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