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Author Topic: Painful Stimulation  (Read 31002 times)
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dennis100
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« Reply #30 on: July 02, 2018, 03:03:39 AM »

Model Number 103
Event Date 03/29/2016
Event Type  Injury   
Event Description
It was reported that a patient had laparoscopic nissun fundoplication surgery on (b)(6) 2016. Postoperatively, the patient was complicated by a seizure and then had cardioversion at 125j for arrhythmia. A ct scan was obtained, which showed a pericardial effusion. The patient was then emergency transported to another hospital for exploration surgery. During the surgery, it was determined that there was a hole in the pericardium and a tear in an arterial branch of the circumflex coronary artery. The vns magnet was placed over the device during this surgery. After the reparative surgery, the patient experienced recurrent episodes of painful stimulation, bradycardia, drop in blood pressure, and asystole during vns stimulation. The patient's magnet was placed over the generator, but, due to the patient being morbidly obese, the skin where the magnet was taped would move and allow stimulation to occur. The patient then had a temporary pacemaker implanted, and the vns was programmed to 0ma on (b)(6) 2016. Diagnostics were performed, and the results were all within normal limits. The arrhythmias and painful stimulation no longer occurred after the device was programmed off. The physician planned to leave the device programmed off for a while and slowly reintroduce therapy after the patient stabilized. It was also reported that the patient had a history of mild bradycardia prior to this event. No further relevant information has been received to date.
 
Event Description
Data was received from 03/29/2016 and 03/30/2016. No anomalies were noted - the data indicated that the device was functioning within normal limits. It was observed that the impedance had dropped from 2674 ohms to 1419 ohms (-47. 0% change) on (b)(6) 2016, 5:57:24 (estimated). The sudden temporary drop in impedance could be attributed to the nerve¿s response to injury (i. E. Expel of ionic endoneurial fluids from damaged nerve cells; an observed increase in this fluid via mri is often used as an indicator of nerve injury). It was found that electrical current from the external defibrillator (cardioversion equipment) can transfer through the generator and leads to the vagus nerve, where the resulting charge density and energy delivered to the nerve from the defibrillation is at levels considerably higher than what the nerve experiences with vns therapy, even at maximal settings.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5598322

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dennis100
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« Reply #31 on: July 02, 2018, 03:04:33 AM »

Model Number 302-20
Device Problem No Known Device Problem
Event Date 01/01/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. Further follow-up revealed that the patient underwent surgery for patient comfort and not to preclude a serious injury. Patient manipulation or trauma is not believed to have caused or contributed to the lead discontinuity. The patient¿s pain was occurring with stimulation and due to lead discontinuity. The explanted products have not been returned to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: this information (spasms, fatigue, nausea) was inadvertently not included in the initial mfr. Report. Describe event or problem, corrected data: this information (pain, coughing) was inadvertently not included in the mfr. Supplement report #3. Additional manufacturer narrative, corrected data: mfr. Supplemental report #2 should have included the description of the corrected data as "describe event or problem, corrected: this information was inadvertently not included in the initial mfr. Report. ".
 
Event Description
It was reported that the patient experienced abdomen and chest spasms, fatigue and nausea. The patient experienced pain and coughing at the time of device interrogation.
 
Event Description
Surgical notes dated (b)(6) 2014 indicated that the vns was malfunctioning and that the patient underwent generator and lead replacement.
 
Event Description
The patient¿s pain was occurring with stimulation and due to lead discontinuity. The lead discontinuity is likely due to a short circuit situation (dcdc code = 0).
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death. Adverse event and/or product problem; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Brand name; corrected data: additional information indicates that the suspect device is the lead. Type of device, name; corrected data: additional information indicates that the suspect device is the lead. Model #, serial #, lot#, expiration date; corrected data: additional information indicates that the suspect device is the lead. Type of reportable event; corrected data: additional information indicates that lead discontinuity was causing the patient¿s pain. Device manufacture date; corrected data: additional information indicates that the suspect device is the lead.
 
Event Description
It was reported that the vns patient was experiencing very painful side-effects from vns. Further follow-up with the patient revealed that the patient was experiencing pain on the left side of her neck that radiated up to her temple. This mostly occurred through the patient¿s jaw and roof of her mouth causing headaches. The patient was most uncomfortable at night and when she was lying down. The patient later reported that the pain was getting worse and that she was feeling sick and panicking. The patient¿s device was eventually programmed off on (b)(6) 2014 despite it being effective in treating the patient¿s depression. The patient was referred for generator and lead replacement surgery due to severe headaches and neck spasms. The patient¿s normal mode output current was programmed off and system diagnostic results showed normal device function. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3808957

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dennis100
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« Reply #32 on: July 02, 2018, 03:05:09 AM »

Model Number 304-20
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was initially reported that the patient was recently turned on a few prior and was now experiencing some swelling in her neck and throat, and has been unable to turn her head. It was said that the patient was diagnosed by her treating neurologist that she has a neuroma. The patient was said to have been given a steroid injection, which provided some improvement. It was also indicated that the patient is experiencing some painful stimulation in the neck. No further details have made available on the events. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1698103

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dennis100
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« Reply #33 on: July 02, 2018, 03:08:48 AM »

Model Number 103
Device Problem Failure to shock or properly shock
Event Date 12/01/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the available programming and diagnostic history. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution.
 
Event Description
Further information was received indicating that the patient had undergone bi-phasic cardioversion in the morning with adhesive patches in anterior-lateral left position. The energy value used for the cardioversion was 100j. The generator's decoder spreadsheet was reviewed. On (b)(6) 2013 the patient underwent the first cardioversion treatment. On (b)(6) 2013 the battery voltage was 3. 440v and the lead impedance 3782 ohms. On (b)(6) 2013 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the patient underwent the second cardioversion. On (b)(6) 2014 the battery voltage was 2938v and the lead impedance 2401 to 2430 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms. On (b)(6) 2014 the battery voltage was 3. 455v and the lead impedance 1965 ohms.
 
Event Description
It was reported that the vns patient was to be hospitalized in (b)(6) 2015 for disabling the vns stimulation and enabling it again in a controlled environment. It was reported that the patient had undergone cardioversion in (b)(6) 2013 as a treatment for heartbeat disorders that had followed myocardial infarction. The vns stimulation was turned off during cardioversion by fixing the magnet on the generator. After cardioversion and removal of the magnet the patient experienced an extreme burning sensation in the throat and neck, suffocation, flushing and eyes watering. The reported effects stopped when stimulation was stopped by fixing the magnet on the generator. The pulse generator was programmed at the mildest stimulation settings and the side effects improved. The pulse generator was programmed at output current 1. 50 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. Further information was received indicating that the patient¿s system was tested on (b)(6) 2013 and system diagnostics returned impedance within normal limits with 3119 ohms. On (b)(6) 2013 the pulse generator was programmed at output current 0. 75 ma, frequency 30 hz, pulse width 500usec, 30sec on and 5min off. On (b)(6) 2013 the pulse generator was programmed at output current 0. 5 ma, frequency 20 hz, pulse width 250usec, 30sec on and 5min off. It was later reported that the patient underwent cardioversion again on (b)(6) 2014 and that the pulse generator was disabled by fixing the magnet on the generator. After cardioversion was completing and the magnet was removed the patient experienced painful stimulation. The patient could not tolerate the output current set at 1. 75ma. The output current was programmed to 0. 5ma. The patients vns system was tested and system diagnostics returned impedance results within normal limits. Further information was received stating that before the first cardioversion session on (b)(6) 2013 system diagnostics returned impedance results within normal limits with impedance = 3781 ohms, and ifi=no. After the first cardioversion session, system diagnostics on (b)(6) 2013 returned impedance results within normal limits with impedance = 3119 ohms, and ifi=no. Before the second cardioversion session on (b)(6) 2014 system diagnostics returned impedance results within normal limits with impedance = 2922 ohms, and ifi=no. After the second cardioversion session, system diagnostics on (b)(6) 2014 returned impedance results within normal limits with impedance = 2429 ohms, and ifi=no. Review of manufacturing records confirmed that generator and the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4877621
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dennis100
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« Reply #34 on: July 02, 2018, 11:01:48 AM »

Model Number 102
Event Date 02/21/2013
Event Type  Injury   
Event Description
Reporter indicated that a patient's mania worsens at higher stimulation settings. The patient has had mood disorders and depression prior to ever having vns implanted. The patient's vns is currently disabled as it was causing painful stimulation in the neck. The vns was disabled on (b)(6) 2013. Attempts for additional information are in progress.
 
Manufacturer Narrative

Event Description
All attempts to the reporter for additional information about the mania event have been unsuccessful to date.
 
Event Description
Reporter indicated the mania did happen with vns stimulation and was strength-dependent. The patient has mental retardation and significant prior psychological trauma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3030699
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dennis100
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« Reply #35 on: July 02, 2018, 11:02:27 AM »

Model Number 302-20
Event Date 02/01/2010
Event Type  Injury   
Event Description
It was initially reported by the physician that the patient was experiencing painful stimulation in the lead area after having a fall while playing football. System diagnostics showed everything working within normal limits. X-rays were done and sent to manufacturer for further review. No obvious anomalies were observed that could be contributing to the report of painful stimulation. Patient is not experiencing pain with every stimulation, but it occurs at certain positions. The physician believes that the lead tubing was compromised during the tackle which is possibly causing a passage for the leakage current to the body. Patient underwent a lead replacement surgery. Patient continued to have painful stimulation at the neck region after surgery but in a few days, the event disappeared. Explanted lead was returned to manufacturer for analysis. Analysis is currently pending on the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1689569
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dennis100
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« Reply #36 on: July 02, 2018, 11:02:56 AM »

Model Number 300-20
Event Date 03/12/2007
Event Type  Malfunction   
Event Description
Reporter indicated a vns patient was experiencing painful stimulation in the neck and generator site and felt that the generator was pulling on the leads. Diagnostics were within normal limits. The device was programmed off at the request of the patient. X-rays were reviewed and no anomies were noted. The patient underwent generator replacement surgery. The lead was not replaced because the surgeon did not believe a problem existed with the generator. The patient's painful stimulation persists. The patient is planning on vns lead replacement surgery. The lead will be implanted on the right vagus nerve. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1297765
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dennis100
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« Reply #37 on: July 02, 2018, 11:03:32 AM »

Model Number 302-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient would have a vns replacement due to high impedance. Follow up found that replacement surgery was for patient comfort and they were not concerned with it resulting in a serious injury. Previously, the patient reported experiencing pain with stimulation which was felt at the neck and travelled up to the left ear. It was confirmed at the time that no trauma, manipulation, programming changes, or medication changes had occurred recently. The patient's settings were originally at 2. 5ma and 2. 75ma for normal and magnet output current respectively. The output currents were reducted to 0. 25ma and 0. 5 ma respectively. Diagnostics taken on this day, (b)(6) 2013, were all ok. X-rays were sent to the manufacturer for review. The generator was seen in the left chest area in normal orientation. The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be present behind the generator. The lead could not be assessed at the connector pin due to the x-ray image quality. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend was present; however, no strain relief loop appeared to be present. There was one tie-down present. Lead is seen routing down toward the generator. No other information has been provided. Surgery is likely, but has not occurred to date. Received a phone call on (b)(6) 2013 from tc (b)(6) who stated that patient (b)(6) is experiencing painful stimulation which is felt at the neck and travels up to the left ear. He stated that he met with the patient yesterday, and the patient confirmed this has been occurring since monday ((b)(6) 2013). It had been confirmed that no trauma/manipulation/programming changes/medication changes had occurred recently. The patient¿s settings were originally 2. 5ma for output current and 2. 75ma for magnet output current, and the settings were decreased all the way down and the event was still occurring at 0. 25ma/0. 5ma. The physician decided to turn the device off and order x-rays. Diagnostics were all ok per tc. I stated that since diagnostics are ok x-rays are typically not recommended since the system appears to be fully intact. Tc insisted that the x-rays may show something and stated that he will be sending these x-rays to cts for review. He stated that he specifically wants these x-rays to be reviewed for a hairline fracture or fluid in the lead. I stated that this is very detailed and that it all depends on the images that are received. Tc inquired about other recommendations for this situation. I stated that it may be helpful to evaluate the patient after it has been disabled and for the physician to observe the patient after turning it back on. I inquired what the physician¿s assessment of this is and he stated the physician does not know. Tc stated they might undergo a full revision if nothing is found to help. I stated that this would be a medical decision which is up to the physician. No further information was discussed.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications 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=3562083
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dennis100
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« Reply #38 on: July 02, 2018, 11:04:09 AM »

Model Number 304-20
Device Problems Detachment of device component; No Known Device Problem
Event Date 10/30/2015
Event Type  Injury   
Event Description
The patient had full revision surgery. The generator was not sutured to the fascia, but was merely buried in subcutaneous tissue, which allowed for generator migration. The generator not being secured and the possible relationship to the pain experienced at the chest will be reported together in mfr. Report #1644487-2018-00847 as these issues now appear to be separate from the events in this report. The tie-downs were not sutured in place, and the surgeon noted that the electrodes were not properly coiled around the nerve. The explanting facility discards of product, so no evaluation could be performed on the devices. No further relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing multiple adverse events. The patient felt throbbing pain in her left neck and significant pain/tenderness at the neck incision and up her neck to her ear for four days. She also reported that she could feel the "clamp" prominently under the incision when she touched her neck. The patient also felt painful stimulation for the past four days, and she had not felt stimulation up to that point. She had been having left ear pain/trouble hearing/feeling like her ear was "stopped up" for about four months, but the physicians did not identify any ear infections. The patient also felt pain in her chest, neck, and left shoulder for two to three days after her vns magnet was swiped. The patient had been feeling pain since she was implanted, but the pain had just recently gotten unbearable. The patient was taking pain medication four times a day, but that did not make the pain go away. The patient's ear hurt so badly that she could not let the wind hit it. The patient's treating physician believed that the surgeon had poor implant technique and the pain was related to the placement of the device. The physician did not know the cause of the pain during magnet swipes, and he didn't know if the hearing loss was related to vns or not. The patient was referred for surgery, and it was being done to preclude a serious injury as the patient was in excruciating pain that was getting worse. X-rays were ordered, but they have not been reviewed to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7373200
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dennis100
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« Reply #39 on: July 02, 2018, 11:04:54 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was experiencing painful stimulation in the neck area. It was reported that the painful stimulation had been occurring for approximately 3-4 months. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. Clinic notes dated 06/03/2013 note that the patient has complained that the area that the device is implanted is sore and hurts, particularly at night. The notes indicate that device settings were decreased to see if the settings had any effect on the discomfort. It was later reported that the patient was scheduled to undergo device replacement at the patient's mother's request so that the patient could continue vns therapy. Both the lead and generator were replaced. The lead and generator were returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Lead analysis was approved on 08/22/2013. An analysis was performed on the returned lead portion. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Generator analysis was also performed. The septa do not appear to be cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Review of the programming history database revealed data from the date of implant through (b)(6) 2013. The last programmed settings were available. The device was returned at these settings.
 
Manufacturer Narrative
Analysis of programming history. Device failure occurred but did not cause or contribute to a death adverse event or product problem, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information. Type of reportable event, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3271718
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« Reply #40 on: July 02, 2018, 11:05:37 AM »

Model Number 303-20
Event Date 02/01/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Reporter indicated the patient had vns lead pin reinsertion surgery performed on (b)(6) 2013. After the lead pin was reinserted into the generator header, diagnostics were within normal limits (3218 ohms). No new devices were implanted.
 
Event Description
Additional x-rays were reviewed by the manufacturer. The lead pin did not appear to be fully inserted. No additional anomalies were noted. The surgeon indicated he felt the lead pin had been fully inserted as two audible clicks were heard when tightening the setscrew. However, the possibility of a lead fracture may also exist. Reporter indicated the patient was also having increased seizures and that the plan of care is to have vns revision surgery; however, this has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a serious injury.
 
Event Description
Reporter indicated intermittent high lead impedance was noted for a patient who recently had vns generator replacement on (b)(6) 2013. The patient had no known trauma. The patient is also experiencing painful stimulation at the electrode site in the neck. X-rays were reviewed by the manufacturer. The electrodes are visualized at approximately t1 and are in alignment; the electrodes are implanted lower than what is usually seen. The generator is implanted in the left axilla. This is much more lateral than what is normally seen. The view does not allow full assessment of the lead pin insertion. The lead wire is intact at the lead pin. The filter feedthroughs are intact. There is a small amount of lead behind the generator that cannot be assessed. The cause of the high lead impedance is unknown at this time, but may be due to inadequate pin insertion or a lead fracture. Attempts for additional information are in progress.
 
Event Description
Manufacturer review of the device history records for the vns lead and generator confirmed both devices passed all final testing prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2993250
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dennis100
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« Reply #41 on: July 02, 2018, 11:06:10 AM »

Model Number 302-20
Event Date 03/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was initially reported to the mfr that the pt was admitted to the er because, the pt was experiencing neck swelling, painful stimulation and dyspnea. The pt was referred to a surgeon and was scheduled for a lead revision surgery due to a suspected lead break. The pt's treating neurologist believes the swelling and dyspnea are related to vns, dyspnea occurs with stimulation and the pt does not have any history of dyspnea pre-vns. The pt's lead body was replaced due to a lead break. It was indicated that there were no casual or contributing factors, or any pt manipulation or trauma that occurred to have contributed to the lead break. Good faith attempts to obtain more info regarding the suspected lead discontinuity have been unsuccessful to date. The explanted lead body has been returned to the mfr and analysis is in process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1675414
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« Reply #42 on: July 02, 2018, 11:06:46 AM »

Model Number 302-20
Event Date 08/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis for the explanted generator was approved on (b)(6) 2012. The device performed according to functional specifications. Analysis of the generator in the (b)(4) lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the explanted lead was approved on (b)(6) 2012. The electrodes of the lead were not returned for product analysis. Setscrew marks on the connector pin provided evidence that proper contact between the setscrew and lead pin existed at least once. Abrasions were identified on the outer silicone tubing at multiple locations and on the connector boot. The outer silicone tubing had cuts at several locations. Some cuts did reach the inner silicone tubing. Abrasions were identified on the silicone tubing of the lead coils. The silicone tubing of the positive coil appears to be abraded and open in the vicinity of the coil end. It is believed that this condition could potentially contribute to the patient "pain" allegation. However, the exact impact of this condition and when it occurred is unknown. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred in the vicinity of the coil cut end. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified within the returned lead portion.
 
Event Description
On (b)(6) 2012, it was reported that the patient was experiencing painful stimulation in the neck area for the last day or so. X-rays were taken, and no lead issue was seen. The x-rays would not be sent to the manufacturer for review. High lead impedance was seen the day before and the patient's device was disabled late on (b)(6) 2012, or early on (b)(6) 2012. The patient underwent surgical consult. The patient was reported to have been seizure-free for three years, and there was no reported increase in seizures. There was no known trauma. On (b)(6) 2012, the patient reported that, during interrogation earlier in the day, an error message popped up which said that her leads are detached or there is tissue build up. The patient stated that x-rays were taken but did not show any detachment. The patient stated that the device was programmed off and that she was referred for lead replacement due to the detachment issue. The patient stated that there had been no trauma or manipulation that she was aware of; however, she occasionally lifted heavy things. The generator and lead were replaced on (b)(6) 2012. X-rays were observed prior to surgery and a definitive lead break was observed in the lead just above the bifurcation. During surgery, it was noticed that the electrode coils appeared to be pulling off of the nerve but that they were scarred in tightly. The patient's generator was replaced prophylactically. The lead and generator were returned on (b)(4) 2012 and are currently undergoing product analysis. A battery life calculation on (b)(4) 2012, resulted in 7. 67 years to neos.
 
Manufacturer Narrative
Analysis of programming history. 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=2758863
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« Reply #43 on: July 02, 2018, 11:07:24 AM »

Model Number 300-20
Device Problem High impedance
Event Date 10/01/2015
Event Type  Malfunction   
Event Description
The explanted devices were discarded after surgery and will not be received for analysis.
 
Event Description
It was reported on (b)(6) 2015 that this patient is experiencing painful and erratic stimulation at an unspecified location. The pain only occurs at night for the patient. At a recent clinic visit high impedance was found on system diagnostics. The patient denies any incident that may have caused the high impedance. The physician was instructed to turn off the device or lower the device settings. The patient will likely receive a m106 to replace her existing system. Clinic notes state over the past month or more she has been having intermittent sensations of her device going off where as she had not really felt it come on at all in the past year. When she swipes her magnet she has no stimulation. Surgery is likely but has not occurred to date.
 
Manufacturer Narrative

Event Description
The patient reported muscle spasms (a fluttering feeling) in her neck and down into her left shoulder which the patient states began around the time of the high impedance.
 
Event Description
The patient had a full replacement on (b)(6) 2015. The explanted devices have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5232625
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« Reply #44 on: July 02, 2018, 11:08:06 AM »

Model Number 102
Event Date 09/02/2012
Event Type  Injury   
Event Description
Additional information was received from the patient's explanting surgeon which revealed that the device explanted due to patient comfort. Only the generator was explanted. The pain was believed to be related to "misfiring - headaches, hoarseness, trouble breathing. " the relationship of these events to vns are unclear with the information provided. No causal or contributory programming or medication changes precede the onset of the continuous/erratic stimulation and pain. In addition, no patient manipulation or trauma occur that is believed to have caused/contributed to continuous/erratic stimulation and pain. As of (b)(6) 2012, it was unknown if the patient's symptoms have resolved since explant because the patient had not returned to the surgeon's office. Attempts for return of the explanted device are unsuccessful, as the explanting facility does not return products per hospital policy. A letter was received from the patient on (b)(6)2012. She indicated that on (b)(6) 2012, she had a "breathing problem and it was as if "she was suffocating". She reported that she did not relate these events vns. Then on (b)(6) 2012, she went to the emergency room and "wore a magnet for over a week. " she reported that her device was tuned off two years ago, and "the surgeon said it was malfunctioning" the neurologist at the emergency room "said this was not normal and also said it was malfunctioning". The patient continued to state that she was told (by an unknown source) that she "could have problems in the future from this problem". She was writing with regards for reimbursement for "pain and suffering". Attempts for additional information from the treating physicians have been unsuccessful to date. Previous follow up with the neurologist regarding the device disablement in 2010 was performed which revealed that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of energy during physical activity. These events were reportedly related to stimulation, except it is unknown if the decreased energy level was. The patient claimed her energy level decreased during physical activity, but this could not be confirmed by the physician's office. There were no noted causal or contributory factors, and no programming/diagnostics were provided. No additional interventions were taken in 2010, and no additional information was provided.
 
Manufacturer Narrative

Event Description
A nurse in the emergency room reported on (b)(6) 2012, that the vns patient had presented with constant pain in the chest that had started that day. The nurse indicated that the only intervention that they would take it using the vns magnet to disable the device temporarily because they did not think that anything is wrong with the device. She said that another nurse had submitted the report indicating that the patient believed the device was malfunctioning, but that is because she misunderstood what the nurse had said. The patient later reported on (b)(6) 2012, that she wanted to have her vns device removed to due to erratic stimulation which is now painful and constantly stimulating. She mentioned that her device was disabled in 2010 and she did not understand why it is now going off. The patient said that she did not like the way the therapy felt at the time which is why the device was disabled. Additional information was received on (b)(6) 2012, indicating that the patent was scheduled for explant. The patient had vns explant on (b)(6) 2012. Attempts for product return are unsuccessful as the explanting facility requires a patient signed release, and they reported that they will not return to the manufacturer. Follow up with the neurologist's office indicated that the patient was only seen at their clinic one time on (b)(6) 2010, at which time her device was turned off due to difficulty swallowing, coughing, unable to catch her breath, and decreased level of activity. There were no noted causal or contributory factors, and no programming/diagnostics were provided. The patient was being treated by a new ent surgeon. (b)(6) also indicated that the patient called their office on (b)(6) 2012, due to the pain and erratic stimulation in the chest for which she wanted the device removed. Follow up with the patient's treating ent surgeon have been unsuccessful to date.
 
Event Description
Additional information was received from the explant surgeon. The generator was explanted at request of patient. No additional information was provided.

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« Reply #45 on: July 02, 2018, 11:08:42 AM »

Model Number 102
Event Date 10/27/2011
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2011, that the pt was admitted to the emergency room due to status epilepticus. The neurologist went to the hospital to interrogate the generator, but the battery was dead. The pt had generator replacement surgery due to battery depletion. The neurologist reported that the generator was at eri=yes and was unable to be interrogated. However, no troubleshooting was performed. No programming settings were provided by the neurologist, as the generator was reported dead prior to the generator replacement, so no programming changes were completely recently. The company rep reported that the neurologist attributed the pt's hospitalization to the generator being at end of service. As a result, they immediately scheduled replacement to get the generator changed. The generator was returned to the mfr for analysis. The generator product analysis was completed, and the 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 reported allegation of "end of service" was not duplicated in the pa lab. No eri flags were observed during eval. The pulse generator module performed according to functional specs. However, it was noted that the generator did not interrogate at two orientations at approx 135 and 315 degrees. Clinic notes were later received which revealed that the pt's increased seizures occurred in a different town and was not being treated by her usual physician. The pt's seizure frequency with vns was one to two seizures per week as generalized-tonic seizures lasting one to two minutes. However on (b)(6) 2011, the pt had at least three seizures back to back for at least two hours and had pain in the chest/neck area. She also reported headache during stimulation. She told the staff at the home that vns was continually firing. The magnet reportedly did not stop the vns. The pt was taken to the er in an ambulance which did not have a vns programming system. The pt was given diazepam which stopped the pain and twitching. The pt was transferred via ambulance to another hospital and during that time, she had pain and twitching again, so they stopped at another hospital because her pain was so bad. In the er, she still had pain and also had convulsions that involved both lower extremities. Another vns physician attempted to interrogate her device in the hospital multiple times and was unsuccessful. Dr. (b)(6) stated that indicated that the battery was depleted, as it is unusual for pt to be in so much pain if battery is depleted. The notes stated that a lead fracture is possible, so x-rays would be obtained and will get a ct to rule our brain abnormalities. Although the possibility of a lead fracture was mentioned in the notes, the pt's lead were not replaced. F/u revealed that there were no programming or medication changes that preceded this onset and there was also no trauma prior to the painful and erratic stimulation.

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« Reply #46 on: July 02, 2018, 11:09:12 AM »

Model Number 302-30
Device Problems Fracture; No Known Device Problem
Event Date 04/10/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was experiencing painful stimulation when the settings are increased. The physician suspected a lead fracture and planned to refer the patient for a full revision surgery as the generator was at near end of service. It was noted from a previous office visit in 2017 that in 2007, the patient had a fall that resulted in pain in the left chest area, which led to the physician turning off the patient's device. The device was turned back on in 2017 to settings that the patient could tolerate. Systems and normal diagnostics were performed, indicating no device malfunction or anomalies. The physician still suspected a lead fracture, though it was unclear why. No surgery has occurred to date. No further relevant information has been received to date.

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« Reply #47 on: July 02, 2018, 11:09:46 AM »

Model Number ASKU
Event Date 01/01/2009
Event Type  Death   
Manufacturer Narrative

Event Description
A manuscript titled "efficacy of vagus nerve stimulation in intractable epilepsy patients in cyprus" was received by the manufacturer for review. The article discusses efficacy of vns over time, which was analyzed in 27 patients. Two patients died of sudden unexpected death in epilepsy (sudep). Date of death unknown and relationship to vns is unknown. The report of the other patient who died of sudden unexpected death in epilepsy (sudep) is captured in mfg report number: 1644487-2013-00104. Attempts for additional information have been unsuccessful to date. The report of one patient who developed an infection is captured in mfg report number: 1644487-2013-00102. The report of one patient who had vns explanted due to dysphagia associated with vns stimulation is captured in mfg report number: 1644487-2013-00103. The report of one focal patient who had worsening of seizures is reported in mfg report number: 1644487-2013-00101. The vns explant due to painful stimulation in the neck is captured in mfg report number: 1644487-2013-00100.
 
Manufacturer Narrative
Corrected data: the previously submitted mdr inadvertently provided an incorrect event date.
 
Event Description
The article titled " sudden unexpected death in epilepsy: experience from a tertiary epilepsy center in cyprus with review of the literature" was received by the manufacturer and reviewed. The patient died on the beach during the day.

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« Reply #48 on: July 02, 2018, 11:10:28 AM »

Model Number 105
Device Problem Device inoperable
Event Date 10/20/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient is able to inhibit stimulation by holding the magnet over the generator. Proper magnet swiping technique was verified and the magnet was not deep in the tissue or tilted. Troubleshooting revealed that the patient swiped her magnet and did feel stimulation, and the magnet swipe was registered upon interrogation. Information was received that the magnet is not often useful in aborting the patient's seizures because the patient normally cannot swipe the magnet in time, not suspected to be caused by a generator issue. It was reported that there are no longer any suspected issues with the patient's generator. No additional relevant information has been received to date.
 
Event Description
It was reported that vns was never efficacious per the mother. Per the mother, the seizures have never changed post-implant. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. It was reported by the patient's mother that they want the vns explanted due to painful stimulation in the neck, breathing difficulties with device stimulation during exertion. The mother reported that since the patient has had difficulty tolerating stimulation and they had not noticed any efficacy the device was disabled for three months. The device was then programmed back on to a very low setting. The stimulation is now tolerable. The mother reported that recently the patient has experienced a change in seizure type and has also had a transient ischemic attack which has contributed to her current state. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Manufacturer Narrative
Corrected data: this information was inadvertently left off of supplemental mfr. Report #01. Corrected data: "it was reported that the patient was experiencing shortness of breath with device stimulation. Device diagnostics were within normal limits and device settings were reduced. The physician believes the patient is overly sensitive to device stimulation. The patient was reported to be fine after device settings were reduced. " this information was inadvertently left off of supplemental mfr. Report #01.
 
Event Description
Follow-up with the surgeon's office revealed that the mother called their office in (b)(6) 2016 and wanted the patient to get a head mri due to increased headaches (with no allegation against vns). However, they had not seen the patient since 2014. The mother had mentioned wanting a mri and vns explant to the last treating physician's office. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's vns magnet mode is not thought to be functioning. It was reported that the patient cannot feel magnet activations and the magnet swipes are (b)(6) 2015 and one on (b)(6) 2015. The patient also experienced a cluster of seizures on (b)(6) 2015 that the magnet was not able to abort. No additional relevant information has been received to date.

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« Reply #49 on: July 02, 2018, 11:11:11 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was experiencing painful stimulation in the neck area. It was reported that the painful stimulation had been occurring for approximately 3-4 months. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. No patient manipulation or trauma occurred that is believed to have caused or contributed to the painful stimulation. Clinic notes dated 06/03/2013 note that the patient has complained that the area that the device is implanted is sore and hurts, particularly at night. The notes indicate that device settings were decreased to see if the settings had any effect on the discomfort. It was later reported that the patient was scheduled to undergo device replacement at the patient's mother's request so that the patient could continue vns therapy. Both the lead and generator were replaced. The lead and generator were returned to device manufacturer for analysis on (b)(4) 2013. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Event Description
Lead analysis was approved on 08/22/2013. An analysis was performed on the returned lead portion. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Generator analysis was also performed. The septa do not appear to be cored and there was no evidence of dried body fluid or corrosion observed in the connector block areas, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Review of the programming history database revealed data from the date of implant through (b)(6) 2013. The last programmed settings were available. The device was returned at these settings.
 
Manufacturer Narrative
Analysis of programming history. Device failure occurred but did not cause or contribute to a death adverse event or product problem, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information. Type of reportable event, corrected data: previously submitted indicated an adverse event; however, additional information is available that a product problem also occurred. This report is being submitted to correct this information.

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« Reply #50 on: July 02, 2018, 11:11:46 AM »

Event Date 01/01/1999
Event Type  Malfunction   
Manufacturer Narrative
Article citation: (b)(4).
 
Event Description
During manufacturer review of the published article (b)(4), it was identified that a patient had a vns generator that was still stimulating with magnet activation after the magnet mode had been disabled. The patient also had painful stimulation with the vns, along with severe painful dysesthesia in the left mandibular and cervical region. Replacement of the vns generator resolved the events. The time of the event is unknown, as the article was a retrospective review from 1999 through 2008. Attempts to the author for further information have been unsuccessful to date.

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« Reply #51 on: July 02, 2018, 11:12:24 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/13/2015
Event Type  Injury   
Event Description
High lead impedance was observed during a system diagnostic test during an outpatient visit. The patient underwent lead and generator replacement surgery several months later to resolve the high impedance. The explanted lead and generator were returned to the manufacturer for analysis. Information received indicated that the physician contacted the distributor for an emergency revision surgery because the patient was complaining of painful stimulation in the neck. The physician then performed diagnostics and saw the high impedance warning. The physician suspected a lead fracture based on x-ray images. The cause of the fracture was believed to be due to generator twiddling by the patient. Further information received indicates that the patient could recognize the auras associated with his seizures and would try to stop the seizures using the magnet on his own; he sometimes groped the location of the generator, strongly grabbing it and moving it. The treating physician believes the patient's manipulation of the device is the cause of the suspected lead fracture. A photo of the explanted lead and generator showed clear evidence of patient manipulation of the implanted device. Analysis of the returned generator revealed no anomalies with the performance of the generator. The generator performed according to functional specifications. Analysis of the returned lead revealed no anomalies. A portion of the lead assembly, including the electrodes, was not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. The bilumen tubing appeared to be wavy in some areas and was returned in a coiled or twisted manner. An abstract from a research article comprised of post-market surveillance data from a hospital¿s vns patients implanted between december 2010 and march 2016 was received several years after the event occurred. The abstract indicated that four patients experienced recurrent vocal cord paralysis. The abstract also indicated that one patient experienced subsequent aspiration pneumonia. Three patients underwent explant due to surgical site infections, and one patient underwent explant due to a patient-influenced revolving of the generator which eventually resulted in lead fracture. The recurrent vocal cord paralysis is reported within mfr. Report # 1644487-2018-00123. A company representative received identifying patient information from the authoring physicians of the article for the patients who experienced surgical-site infections and generator migration and subsequent lead fracture, originally captured in mfr. Report #1644487-2018-00122. It was determined that the infections were previously reported to the manufacturer and are captured in mfr. Report #s 1644487-2013-02562, 1644487-2013-03225, and 1644487-2015-06368. The reported patient-influenced migration and subsequent lead fracture is captured within this report, mfr. Report # 1644487-2018-00289. Per the abstract, the patient revolved the generator underneath the skin, causing the lead fracture and necessitated vns explant. No additional relevant information has been received to date.
 
Manufacturer Narrative
Uchida, d & yamamoto, t. (2017). Experience and solution of complications of vagus nerve stimulation therapy in 139 implant patients. No shinkei geka, 45(12):1051-1057. Doi: 10. 11477/mf. 1436203646.

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« Reply #52 on: July 02, 2018, 11:13:09 AM »

Model Number 302-20
Event Date 03/28/2013
Event Type  Malfunction   
Event Description
On (b)(4) 2013 it was reported that the vns patient was seen on (b)(6) 2013 and low impedance was observed. It was unknown specifically what diagnostic test was run, or what the full results were of the diagnostics tests. The reporter did say that the patient recently started complaining of discomfort with stimulation, and twitching of the muscles in her neck with stimulation. The reporter stated that according to her notes, the patient was seen on (b)(6) 2012 and the parameter settings were increased at that time, and then about a month or two after, the patient reported this discomfort and neck spasms. The patient was then seen on (b)(6) 2013, but they did not change any settings because the patient was tolerating these issues, even though it was still bugging her. No diagnostic testing was performed at that time. The reporter stated that at the most recent appointment on (b)(6) 2013, the patient asked for the settings to be lowered because of the discomfort and neck spasms, so the physician lowered the output current from 2. 25ma to 1. 75ma. The physician then ran diagnostics which is when low impedance was observed. The manufacturing records for the lead were reviewed and the device met all specifications prior to distribution. A battery life calculation was performed which showed 3. 02 years remaining until eri=yes. The physician later reported that x-rays were performed but they have not been sent to the manufacturer to date. The patient reported that the muscle twitching began after the patient's mammogram in (b)(6) 2013. The physician noted that the output was disabled due to the low impedance. No further information was provided by the physician.
 
Event Description
On (b)(4) 2014 product analysis was completed on the explanted generator. The generator performed according to functional specifications; there were no anomalies found with the pulse generator. Product analysis on the lead was completed on (b)(4) 2014. Abraded openings were noted on the outer and the inner silicone tubing. A single broken strand was noted on the positive coil. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
On (b)(6) 2013, the patient reported that when she had a mammogram , they broke the vns wire and afterwards the device read low impedance. Surgery, although likely, still has not yet occurred.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
On (b)(6) 2013 it was reported that about a month ago, low impedance was observed. The device was turned off on (b)(6) 2013 due to the low impedance. X-rays had been performed and the radiologist was not able to see anything of significance. The patient explained that she had a mammogram performed within a week or two of the time that the device stopped working and was very specific with the technician about her implant. The patient believes that the mammogram may have been related to this low impedance condition. She explained that after the mammogram, she began to experience painful stimulation and felt that the muscles in her neck were ¿retracting. ¿ she also mentioned that she was feeling pain at her breast site like the area was being ¿pinched. ¿ a copy of the patient¿s x-rays were received for review. Whether the lead pin was fully inserted into the header of the generator could not be assessed based on the angle of the generator in the images. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities in the portion of the lead that could be visualized. There appeared to be a proper strain relief bend but there did not appear to be a strain relief loop. Based on the x-ray images provided, an exact cause for the reported events could not be determined. However, the lead pin could not be confirmed to be fully inserted and a portion of the lead could not be visualized in the chest due to it being behind the generator. Also, the presence of a micro-fracture in the lead cannot be ruled out. The patient stated that she had a mammogram on (b)(6) 2013 and that on (b)(6) 2013 the vns read low impedance. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted generator and lead have not been returned to the manufacturer to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #53 on: July 02, 2018, 11:13:56 AM »

Model Number 304-20
Event Date 06/01/2012
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did show a breech in outer tubing and fluid in inner and outer tubing. The fluid in the inner tubing is likely explant related. Unknown cause of breech in outer tubing.
 
Event Description
A site reported to our consultant that their was a vns patient who was seen about two months ago regarding pain in the neck during stimulation. The event started at the beginning of (b)(6). Their vns was programmed off (b)(6) 2012. The patient was seen (b)(6) 2012 and they tried to turn the patient on again to 0. 25ma however her eyes were watering and the muscles on the left side of the neck and face were twitching. Diagnostics were then performed with all okay results an impedance value of 3500 ohms, and no indication of approaching eos. The was no report of any trauma reported by the patient that could be associated to the onset of the painful stimulation. There were also no other programming changes noted around that time. Their device was turned off the alleviate these events. Turning the device off resolved events. No medical history of this pre-vns. Although the impedance value was within the accepted limits, the md suspects a lead issue and has ordered xrays. It is unknown if the xrays will be sent to the manufacture for review. The md has decided to refer the patient for a complete revision. The patient seizures are back to baseline. The patient was having 2-3 seizures a week pre-vns but after vns was only having 2-3 a month. Since the pain began, the patient has returned to baseline at 2-3 a week. Their md believes their increase in seizures to baseline is due to the device not working properly and now because vns is programmed off. Surgery is scheduled for (b)(6) 2012.
 
Event Description
Additional information was received that the patient had full revision surgery. Our consultant was at the surgery. A breech in the outer insulation was noted near the generator in the chest pocket. Fluid was seen inside the tubing. The tubing was reported cracked and the internal wire was visable. System diagnostic testing in the or showed 3785 ohms. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Two tie-downs were returned with the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. Also, the outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. Abrasions most likely caused by the presence of tie-downs were identified at approximately 32. 5cm and 33. 1cm from boot. An incision was identified on the outer silicone tubing at approximately 31. 9cm from boot resulting in an opening in the outer silicone tubing. No obvious damage to the inner tubing or the lead coils was identified at this location. The outer silicone tubing has a superficial cut at approximately 31. 6cm and 32. 2cm from boot. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. This is possibly explant related but not confirmed. No discontinuities were identified within the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other that typical wear and explant related observations, no anomalies were identified in the returned lead portion.

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« Reply #54 on: July 02, 2018, 11:14:32 AM »

Model Number 302-20
Event Date 11/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the patient would have a vns replacement due to high impedance. Follow up found that replacement surgery was for patient comfort and they were not concerned with it resulting in a serious injury. Previously, the patient reported experiencing pain with stimulation which was felt at the neck and travelled up to the left ear. It was confirmed at the time that no trauma, manipulation, programming changes, or medication changes had occurred recently. The patient's settings were originally at 2. 5ma and 2. 75ma for normal and magnet output current respectively. The output currents were reducted to 0. 25ma and 0. 5 ma respectively. Diagnostics taken on this day, (b)(6) 2013, were all ok. X-rays were sent to the manufacturer for review. The generator was seen in the left chest area in normal orientation. The filter feedthru wires were intact and the lead pin could be seen past the second connector block indicating that it is fully inserted into the generator. A portion of the lead appears to be present behind the generator. The lead could not be assessed at the connector pin due to the x-ray image quality. The electrodes were observed in the neck and appear to be in proper alignment. A strain relief bend was present; however, no strain relief loop appeared to be present. There was one tie-down present. Lead is seen routing down toward the generator. No other information has been provided. Surgery is likely, but has not occurred to date. Received a phone call on (b)(6) 2013 from tc (b)(6) who stated that patient (b)(6) is experiencing painful stimulation which is felt at the neck and travels up to the left ear. He stated that he met with the patient yesterday, and the patient confirmed this has been occurring since monday ((b)(6) 2013). It had been confirmed that no trauma/manipulation/programming changes/medication changes had occurred recently. The patient¿s settings were originally 2. 5ma for output current and 2. 75ma for magnet output current, and the settings were decreased all the way down and the event was still occurring at 0. 25ma/0. 5ma. The physician decided to turn the device off and order x-rays. Diagnostics were all ok per tc. I stated that since diagnostics are ok x-rays are typically not recommended since the system appears to be fully intact. Tc insisted that the x-rays may show something and stated that he will be sending these x-rays to cts for review. He stated that he specifically wants these x-rays to be reviewed for a hairline fracture or fluid in the lead. I stated that this is very detailed and that it all depends on the images that are received. Tc inquired about other recommendations for this situation. I stated that it may be helpful to evaluate the patient after it has been disabled and for the physician to observe the patient after turning it back on. I inquired what the physician¿s assessment of this is and he stated the physician does not know. Tc stated they might undergo a full revision if nothing is found to help. I stated that this would be a medical decision which is up to the physician. No further information was discussed.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications 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=3562083
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dennis100
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« Reply #55 on: July 02, 2018, 11:15:14 AM »

Model Number 103
Event Date 06/01/2014
Event Type  Injury   
Manufacturer Narrative
Age at time of event, corrected data: the initial report inadvertently reported the age incorrectly.
 
Event Description
Generator replacement surgery occurred on (b)(6) 2015. The reason for replacement was reported to be due to migration of the generator and painful stimulation, per the implant card. It was reported that the system impedance on the date of surgery was okay, suggesting no device failure. The product was discarded by the surgical facility and cannot be retrieved.
 
Manufacturer Narrative

Event Description
Clinic notes were received dated 11/05/2014 that indicate the patient has ¿¿noted the vns wires to be coiled¿ and that the vns is kind of loose since she has lost so much weight. It was reported that it hurts when she touches it. Good faith attempts for further information from the physician have been unsuccessful. The patient was referred for surgery. Although surgery is likely, it has not occurred to date. The patient stated she had a 3 hour mri in (b)(6) of 2014 due to pancreatitis and that her vns generator came loose from the chest wall during this procedure. The generator was noted to move around, causing her pain. When she lifts her arm, the generator migrates into her arm pit.
 
Manufacturer Narrative
Brand name, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time. Model#, serial#, lot#, expiration date, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time. Device manufacture date, corrected data: this information was not identified initially, but was later identified from internal records. The information is correction material as it was available at the time of the initial report, but was not identified at that time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4559707
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dennis100
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« Reply #56 on: July 02, 2018, 11:15:51 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2897410
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dennis100
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« Reply #57 on: July 02, 2018, 11:16:28 AM »

Model Number 102
Event Date 09/15/2014
Event Type  Injury   
Event Description
Additional information was received that product analysis was completed on the lead. A coil break was identified in both the positive and negative lead coils. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) occurred at the coil ends. Secondary fractures were observed in at least two strands of the quadfilar coils. The negative coil shows what appears to be wear (flat surfaces) resulting in reduction of the strand diameter. Although not conclusive the appearance of the lead break location is consistent with patient manipulation of the implanted device, a ¿twiddler¿. The patient had reported painful stimulation for months and the identified coil breaks may confirm this to be a contributing factor. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead. The report issue found with the lead was reported on medwatch 1644487-2014-02836.
 
Event Description
Additional clinic notes dated (b)(6) 2014 were received stating that the patient experienced wound dehiscence following the explant surgery on (b)(6) 2014. Patient's stitches were taken out and replaced with steri-strips. The patient's chest incision was reported to be open with yellow drainage from it. Patient was provided with antibiotics and was noted to be seeing the surgeon in a few days.
 
Event Description
It was initially reported that the patient had their vns explanted. After the explant, the patient picked at the incision and opened the pocket. There was nothing implanted in the patient at that time of the incision being picked open.
 
Manufacturer Narrative
Evaluation not related to event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4147147
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dennis100
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« Reply #58 on: July 02, 2018, 11:17:05 AM »

Model Number 302-20
Event Date 04/18/2011
Event Type  Malfunction   
Event Description
It was reported that a physician received high impedance on a patient's device after performing an unknown diagnostic test on (b)(6) 2011. The patient had been having break through seizures for 2 weeks whose pre-vns baseline comparison was unknown. Furthermore, the patient was having erratic stimulation in the neck area. The device was not disabled, and there had been no trauma or manipulation reported. Last known diagnostics were performed on (b)(6) 2009 and results were within normal limits. The patient's clinical information was received. On (b)(6) 2011, the doctor noted, "since last visit, she was doing extremely well until about three weeks ago. She also notes that her vns has been irregularly going off and at times can be painful. 1. 25 ma, 20 hz, 250 microsec, 30 secs, 60 secs, and 1. 25 ma, 30 secs, and 500 microsecs" and also "she had a recent, what sounds as of a recent breakthrough seizures that i suspect may have been secondary to either tramadol use, change in diet, or perhaps vagal nerve stimulator malfunction. Her vns showed a limited output status and a lead impedance was very high with a dcdc converter code of seven. " follow-up from the physician indicated that x-rays had not been taken of the patient and the patient "was seizure free, now had a seizure. " the patient subsequently underwent a full revision surgery. Attempts for further information have been unsuccessful to date.
 
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=2118888
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dennis100
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« Reply #59 on: July 02, 2018, 11:17:49 AM »

Model Number 105
Device Problems Energy output to patient tissue incorrect; Inappropriate shock; Device displays error message
Event Date 06/12/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was having a lot of trouble with the battery. The patient reported that she was seen by the physician two weeks prior at which time the generator battery showed as "dead". The patient also reported that the physician lowered the device settings. The patient reported that she feels that she is being electrocuted constantly which began approximately a week and a half prior. The patient placed the magnet over the generator to disable stimulation; however, reported that she was still able to feel stimulation. The patient's neurologist wants to replace the generator due to the patient complaining of erratic stimulation. The patient was seen by the surgeon and it was reported that device diagnostics were within normal limits and the device was not at end of service. It was reported that the pain is limited to the patient's chest. The patient's generator was programmed off which did not resolve the patient's pain. The patient indicated that when she presses on the lead at the generator site the patient resolves. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the cause of the electrocution sensation is unknown since the event occurs without device stimulation. It was reported that the patient was scheduled for vns replacement. It was reported that the patient feels the shocking when she presses on the lead and this resolves the pain. Clinic notes dated (b)(6) 2015 note that the patient is having problems with the vns shocking her non-stop. Clinic notes dated (b)(6) 2105 note that the vns is still shocking the patient on the lowest setting. It was noted that the plan is to move the generator to the left scapular area. Surgery is planned, but has not occurred to date.
 
Event Description
The surgeon reported that the patient picked through the skin to access the lead and cut the lead. It was reported that the surgeon will not likely see the patient again.
 
Event Description
It was reported that the patient was scheduled for surgery, but later reported that the surgery had been cancelled and postponed until further notice due to the drug abuse by the patient. Clinic notes dated (b)(6) 2015 note that the patient was see in the emergency department and when no neurologists were available the patient cut the protruding lead wire out herself. The patient noted since first noticing the wire she was being shocked 24/7. It was reported that due to the patient's non-compliance the surgeon will no longer see the patient. The patient will need to be seen by another surgeon. The patient continues to complain of painful stimulation. Clinic notes dated (b)(6) 2016 note that the physician called the patient to explain why he was uncomfortable redoing the vns. The patient had positive drug screens within a week and failed to have a third done a month later. The patient dug into the electrodes under her chest wall skin, pulled the electrode out and cut it off. The patient continued to complain of shocking in the neck and the left side of her chest, even when the generator was programmed off. The surgeon indicated that he does not feel she will be happy after replacing the unit and electrodes, even if the generator is relocated to her suprascapular area where she can no longer dig at the electrodes.
 
Event Description
The patient was scheduled for surgery; however, was unable to undergo surgery due to testing positive for meth and marijuana during pre-operative testing and anesthesia cannot be done. It was reported that is it unknown whether or not the surgeon will reschedule the surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4949640
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