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dennis100
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« Reply #120 on: May 04, 2018, 01:20:59 AM »

Model Number 103
Device Problem Energy output to patient tissue incorrect
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported by a patient that he experienced ear pain and increased headaches (b)(6) 2017-(b)(6) 2017, at which point the physician decreased settings and provided medication, but this did not help. On (b)(6) 2018, the patient went to the emergency room (er) due to headaches. The patient used the magnet and believed this turned off the device and when he saw his physician it was stated the magnet was off. The patient then stated he experiences erratic stimulation since he had seen the physician last. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7469911

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dennis100
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« Reply #121 on: May 18, 2018, 06:41:40 AM »

Model Number 102R
Event Date 10/25/2013
Event Type  Death   
Event Description
It was reported that the patient passed away on (b)(6) 2013. The cause of death was unknown. Attempts have been made for additional information; however, they were unsuccessful. No other information has been provided.
 
Event Description
Additional information was received stating that the vns patient was in the icu at the time of her death. The patient¿s discharge summary and expiration note were received. The patient was admitted to the hospital for persistent right hip pain following a fall six days prior. It was noted that the patient was a ¿medically complex patient¿. The patient had obvious bruises to her right hip and was unable to bear significant weight on her right leg. She had complained of a dry cough for the past week and was placed on antibiotics, and she was recently diagnosed with acute urinary tract infection (uti). A ct of the head revealed left middle ear cavity and mastoid disease suggesting otomatoiditis, status post right mastoidectomy, but no acute intracranial abnormality. Her chest x-ray revealed increased pulmonary lung markings and her inr in the emergency department was 11. 5 (very high). The patient was subsequently admitted for further treatment. The death summary lists additional final diagnoses as follows: mechanical fall with pelvic rami fractures; severe community-acquired multilobar pneumonia; septic shock; and acute hypoxemic respiratory failure. Following her admission, the patient became increasingly dyspneic and tachypneic with a very pernicious cough and she required increasing levels of supplemental oxygen in the icu. The patient developed hypotension and acute hypoxemic ventilatory failure requiring mechanical ventilation, but failed to respond to positive end expiratory pressure and was placed on bi-level ventilation. On the fifth day of her hospitalization, the patient developed profound refractory hypotension and pulseless electrical activity, followed by ventricular tachycardia and subsequent asystole. The physician who drafted the death summary suspected that the cause of the patient¿s death was ¿myocardial ischemia¿. There was no mention of the patient¿s implanted vns system in any of these hospital records. Based on the available information about the patient¿s death, an internal classification has determined that the death may be unlikely sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3551654
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dennis100
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« Reply #122 on: July 06, 2018, 10:25:30 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 05/27/2018
Event Type  Injury   
Event Description
A patient began experiencing painful stimulation, prompting her to go to the er. The patient's device was programmed off due to the painful stimulation, and the pain resolved. The patient's device was then programmed on to low settings, but the patient began experiencing severe pain again in the neck and ear. Diagnostics were performed and returned results within the normal limits. The patient's device was programmed off again and referred the patient for surgery. A company representative reported that x-rays were taken of the patient's neck, and the physician did not identify any issues with the visible part of the vns. X-rays have not been evaluated by the manufacturer to date. The patient attended a surgical consult. During the appointment, the surgeon programmed the vns back on, and the patient did not exhibit symptoms of painful stimulation during the appointment. Per the patient, she did not experience any trauma to the device preceding the painful stimulation, but the patient reported that her large dogs jumped on her chest frequently near her vns implant. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7627365
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dennis100
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« Reply #123 on: July 06, 2018, 10:26:02 AM »

Model Number 105
Device Problem No Known Device Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported via clinic notes received that the patient was experiencing pain in the left neck up to the ear with vns stimulation that was described as a burning sensation. The patient has concurrent ear problems that are being treated by the pcp, but the patient noted this burning as independent of the ear problems. It was also noted that the patient's generator had migrated, which created tension on the vns lead, resulting in protrusion, a lead pulling sensation, and discomfort. The patient was referred for vns replacement surgery. Follow up with the physician's office revealed that the intervention was for both the patient's comfort and to preclude serious injury. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7572226
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dennis100
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« Reply #124 on: August 11, 2018, 01:10:58 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/25/2018
Event Type  Injury   
Event Description
It was reported that the patient has complained of constant stimulation and her device had to be disabled as a result. The physician did not run diagnostics on the device, but stated that the patient had a fall and hit her neck before her visit. As a result the patient will be referred for a full revision. The patient also reported a sore neck, ear, and throat due to the vns. The physician programmed the device off on (b)(6) 2018. Notes state she feels like she has a crick in neck and ct reported as normal. The patient had a full replacement on (b)(6) 2018 and the devices were discarded per the explanting facility's protocols. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7699860
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dennis100
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« Reply #125 on: August 11, 2018, 01:11:27 AM »

Model Number 304-UNK
Device Problems High impedance; Therapy Delivered to Incorrect Body Area
Event Date 06/20/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the er because she was having neck pain near her vns electrodes. Diagnostics were performed, and high impedance was detected. As a result, the generator was programmed off. The patient underwent replacement surgery the next day. The impedance resolved after the generator was replaced, so the lead was not replaced. Generator diagnostics and pin reinsertion weren't performed. After surgery the patient's new generator was programmed on and the patient was fine. A few days later, the patient was admitted due to pain in the neck and ear. Therefore, her device was programmed off. Diagnostics were within normal limits, and no impedance warning messages were observed. The patient was discharged but still experiencing pain in the neck and ear. The neurologist and neurosurgeon didn't think it was related because the device was off. No further relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7688213
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dennis100
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« Reply #126 on: August 22, 2018, 06:56:11 AM »

Model Number 304-20
Event Date 03/01/2016
Event Type  Malfunction   
Event Description
Product analysis for the lead was completed and approved on 05/18/2016. A break was identified in both positive and negative lead coils. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the coil end. Scanning electron microscopy images of both positive and the negative coils suggest a stress¿induced fractured (due to rotational forces) occurred. Scanning electron microscopy images of the negative coil at the break located past the anchor tether show that a stress-induced fracture (due to rotational forces) occurred on the coil. The overall appearance of the lead coils past the electrode bifurcation is consistent with patient manipulation of the implanted device, a ¿twiddler. ¿ the inner silicone tubing of the negative coil has dried remnants of what appear to have once been body fluids inside the inner silicone tubing at the break location.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient is reporting increased seizures, nausea, vomiting with magnet use, increased irritability, extreme voice hoarseness, left throat pain, and incisional pain over the generator. The patient was recently implanted on (b)(6) 2016. The device was turned on to 0. 25ma last week. She returned on (b)(6) 2016 with the above complaints and when system diagnostics was performed it resulted in high impedance over 10,000 ohms. X-rays also show that the generator lead coiled and disconnected from radiopaque structure in left supraclavicular area indicating disrupted vns. It was instructed to turn the device to 0. 0 ma and refer the patient to surgery for replacement. Clinic notes received on (b)(6) 2016 and dated (b)(6) 2016 state that patient believes seizures are worse since the operation. It was mentioned that the patient had a convulsion on (b)(6) and fell, hitting her nose and may have caused trauma to the device as she did mention she could feel it moving in her chest. Post-op symptoms (with device off) included weight loss, nausea, vomiting, increased headaches, and notable negative change in mood. The week prior she was initially activated at the output current of 0. 25 ma with minimal side effects. Over the past week, she has had significant reaction to the device with increasing hoarseness, left throat pain, incisional pain, worsened mood and nausea and vomiting with magnet use. Notes state that from her post-op convulsion, it is suspected that the disconnection of the lead and generator seen on x-rays is likely from her fall and will require surgery to correct the connections. Notes from initial implantation on (b)(6) 2016 also confirm that a non-absorbable suture was used to secure the generator to the pocket. Follow-up showed that the patient is referred for surgery on (b)(6) 2016. The voice hoarseness was stated to sometimes occur with stimulation on times. The left throat pain was occurring both with stimulation and without. It was stated that it is unknown if the increase in seizures is attributed to the high impedance but the level is approximately the same as baseline. It is unknown if the tinnitus, worsened mood, increased headaches, weight loss are attributed to vns therapy or high impedance. X-rays are not available for review.
 
Event Description
Patient had surgery on (b)(6) 2016. The lead had a complete break with multiple knots, indicative that the patient twisted the device. The patient also must have twisted the generator as it was no longer anchored to the fascia. It is believed that the patient's fall as well as manipulation contributed to the break. The lead was received for analysis on 04/21/2016. Product analysis is underway but has not been completed to date.
 
Event Description
Clinic notes received stated that the patient had complications of left vocal cord paresis and disconnection of leads from generator and had a new lead implanted. It appears that the vocal cord paresis that the patient had was likely related to the device failure. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5551724
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dennis100
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« Reply #127 on: August 22, 2018, 06:57:37 AM »

Model Number 302-20
Event Date 04/10/2014
Event Type  Malfunction   
Event Description
It was reported that the patient was going to be evaluated by another surgeon for a second opinion. The patient was referred for generator and lead replacement surgery. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator is not available to return to the manufacturer for analysis.
 
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Event Description
An implant card was received indicating that the vns patient was experiencing spasms and pain at the generator and lead sites prior to generator replacement surgery on (b)(6) 2014. The generator was replaced due to battery depletion.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon repaired two large tears in the lead with silicone. Since the surgery, the patient was having difficulty turning her neck. When she turned her neck, the patient became nauseous from pain in her throat. The patient was unable to eat due to the nausea and had lost weight. The patient was also experiencing tinnitus with her head turned and having daily headaches. The patient¿s device was recently programmed on. The patient previously had a surgical consult on (b)(6) 2013 for a possible lead migration. The surgeon determined there was no lead migration and stated that the patient¿s device was working well. Diagnostic results showed normal device function as of (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through 11/23/2011. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
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 patient has had multiple issues including pain and decreased appetite since the lead was repaired with silicone. The pain in the neck area was intense, and the patient kept ice applied and took medication as a result. The patient had lead replacement surgery on (b)(6) 2014. The patient reported on (b)(6) 2014 improved adverse symptoms and feeling much better since the surgery. The explanted lead is not being returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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dennis100
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« Reply #128 on: September 08, 2018, 12:44:04 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/24/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing pain in the ear, neck, and head due to the device twisting and turning, and the patient was referred for surgery due to the pain. It was reported that the patient was evaluated by a surgeon who attempted to manipulate the device and believed it was firmly in place. No relevant surgical intervention is known to have occurred to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7793690
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dennis100
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« Reply #129 on: October 01, 2018, 02:24:51 AM »

Model Number 105
Event Date 05/15/2013
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2013, it was reported that this patient was experiencing extreme pain and choking sensations that began after lead implant on (b)(6) 2013. (the lead revision is captured in mfr report #1644487-2013-01357). The patient had been experiencing pain and was under observation in the hospital for the pain and choking sensation. The patient was able to communicate that the pain was in her neck/ear area. The device was programmed on after the (b)(6) 2013 surgery. It was also stated that the patient was beginning to tolerate the pain and choking better than a few days prior and that the physician turned down the output current slightly to alleviate pain.
 
Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3194090
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dennis100
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« Reply #130 on: October 04, 2018, 04:13:17 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/01/2016
Event Type  Injury   
Event Description
Further information was received that the surgeon intended to perform surgical intervention for the lead when the generator needed to be replaced since at this time, the generator was still functional. No further relevant information has been received to date.
 
Event Description
Incoming information was received indicating the patient's device was to be upgraded and the patient was referred for surgery. Follow up with the patient stated that generator replacement was needed due to low battery. It was stated that the surgeon would also take a look at her lead as she reported that the lead was "all clumped up under her neck" and that when she turns her head to the right, she can see the wiring under the skin. She stated she could see the "clump" without turning her head. The patient also reported that her generator had migrated and the surgeon stated that when the generator was replaced, he would ensure the device was better secured in the pocket. It was further stated that the patient has near constant ear and toothache believed to be with stimulation and attributed to vns as she had seen both a dentist and ent. She reported a scratchy voice that worsens with stimulation and makes her feel like she has to gasp for air to continue conversations. It was noted that the patient otherwise has been doing well with vns and sees decrease in seizures with the device. The replacement surgery occurred. It was stated that the leads were not revised as they tested to be functioning within normal limits. Post-operation diagnostics showed the devices were functioning as intended. No device was expected for return per the hospital policies. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
It was reported that the patient was experiencing painful stimulation at her jaw. The patient also had pain in her neck and jaw which made it difficult to move. Therefore the patient was being referred for a possible lead revision due to the pain. Because of these symptoms the patient was experiencing issues with depression. No additional relevant information has been received. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6914216
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dennis100
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« Reply #131 on: November 10, 2018, 04:00:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2016
Event Type  Injury   
Event Description
It was reported by the patient through social media that she was experiencing voice alteration, breathing difficulties, and pain in the chest and ear. She stated that she wanted to have her device explanted. The explant surgery occurred. The reason for the explant was stated to be due to lack of efficacy and voice alteration. Programming history was reviewed and indicated that the device was functioning as intended, within normal limits. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7974765
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dennis100
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« Reply #132 on: January 20, 2019, 03:24:40 AM »

Model Number 302-20
Event Date 06/19/2012
Event Type  Injury   
Event Description
On (b)(4) 2012, the operative report was received from the patient's surgery on (b)(6) 2012. It was discovered that the patient only underwent a lead replacement not a full revision that day. The report stated that the patient had left ear pain with stimulation during the last year. The patient had a generator replacement on (b)(6) 2012, but the patient still had persistent left ear pain with stimulation. It was then decided that the patient needed prophylactic lead revision for patient comfort. During surgery the surgeon noticed extensive scar tissue around the leads and the surrounding jugular vein making dissection difficult. The generator was left implanted as it was just implanted in march. The generator was connected to the new leads and impedance was within limits. It was initially reported on (b)(6) 2011, by the physician that the vns patient is complaining of painful stimulation in the left side of his neck radiating up into the left ear. The patient's settings were a pulse width of 350usec and frequency of 20 hz. The last time diagnostics were performed they were within normal limits; specifics not provided. The manufacturer's consultant reported during a clinical visit with the patient on (b)(6) 2012, that the patient's current settings were output=0. 5ma/frequency=20hz/pulse width=250usec/on time=7min/off time=1. 1min/magnet output=1ma/magnet on time=60sec/magnet pulse width=250usec. A system diagnostics test showed results within normal limits; dcdc=3/eos=no. A normal mode diagnostics test was not performed. The pain is located in the left ear with stimulation which began in (b)(6) 2011. No trauma or manipulation occurred that is believed to have caused or contributed to the painful stimulation. There also has been no change in settings. The physician tried decreasing the patient's settings to try and help with the painful stimulation but the patient continued to feel the pain. The patient was having prophylactic generator replacement and a possible prophylactic lead revision surgery (if battery replacement doesn't improved the patient's pain). The surgery was for patient comfort. The patient was experiencing an increase in seizures, below pre-vns baseline levels, due to the lowering of vns settings.
 
Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when the patient underwent full revision surgery. The products could not be returned for product analysis as they were discarded by the hospital. Attempts for additional information from the physician have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient was scheduled for a generator and lead revision surgery. The lead revision was originally scheduled for prophylactic reasons. The patient was admitted to the hospital on (b)(6) 2012 for multiple seizures. The surgeon's office was unable to provide any additional information. On (b)(6) 2012, the neurologist's nurse practitioner reported that the patient was admitted to the icu on (b)(6) 2012 because, he had 25 seizures in 12 hours. The patient then had 9 more seizures while being admitted. The patient was discharged on (b)(6) 2012 and is being medically managed with iv medications and an adjustment of his po medications. The physician thinks that these seizures have been so uncontrolled and may be related to vns, which is why the patient will be undergoing a full revision instead of just a lead replacement. The nurse did not know the relationship of the increase in seizures to pre-vns baseline levels. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2650180
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dennis100
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« Reply #133 on: February 09, 2019, 02:02:56 AM »

Model Number 302-20
Device Problem Fracture
Event Date 10/14/2013
Event Type  Malfunction   
Event Description
It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8223185
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« Reply #134 on: February 22, 2019, 08:25:59 AM »

Model Number 102R
Event Date 08/17/2011
Event Type  Injury   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that the pt was experiencing painful stimulation in his ear and neck. The pt's vns was reportedly lowered and the pain resolved initially however the pt reported later that he was still experiencing pain. X-rays have been taken and sent to the manufacturer for review. No anomalies of the lead that could be the cause of the painful stimulation were observed. Vns diagnostics were not taken at the pt's office visit. Surgery to replace the pt's vns generator has occurred. The explanted generator has been returned and is currently undergoing analysis. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2276539
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« Reply #135 on: February 22, 2019, 08:26:36 AM »

Model Number UNKNOWN
Event Date 01/01/2010
Event Type  Injury   
Event Description
It was initially reported that the pt was experiencing loss of hearing on the left side. The pt's vns was disabled and the pt has been referred to an ent. No further details were immediately made available. Good faith attempts to obtain additional info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1841948
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« Reply #136 on: February 27, 2019, 08:32:51 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2015
Event Type  Injury 
Event Description
It was reported that the patient was seen in the clinic and had a fever since implantation. The neurologist was not sure if the fever was related to implantation and referred the patient to the surgeon. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
 
Event Description
It was reported that the vns patient had a seizure which may have opened up the electrode incision site on the neck. The patient was experiencing pain in this area. Additional information was received stating that the patient was hospitalized due to an increase in seizures. It was noted that patient had a high temperature which may have contributed to the increase in seizures. No further information relevant to the event has been received to date.

Event Description
On (b)(6) 2015 the physician's office reported that the patient was scheduled to see the physician but missed her appointment. The assistant stated that the patient was indeed referred for an ultrasound but the assistant stated she sees no indication that the patient had that done. She said that the patient cancelled her appointment with the physician and has not rescheduled any appointment.

Manufacturer Narrative
(b)(4).

Event Description
The patient reported on (b)(6) 2015 that after implant surgery she had an infection and sepsis. As a result, she had to spend a few weeks in the hospital. The issue was associated with her implant wound. Since then she has developed a "squishy lump area" on her chest, above the generator. The patient noted that she left the surgery receiving stimulation. Following her first titration she began to feel severe pain in her throat and her ear. She describes it as feeling "like stabbing". The generator had been turned from output=0. 50ma up to 0. 75ma when this issue began. She reported that the neurologist refused to turn her therapy level down upon her request and therefore she was upset with him. The patient again reported severe, unrelenting ear and throat pain with vns stimulation. She said she saw her primary care physician and he told her that she does not have an ear or throat infection or reason for the pain other than her vns stimulation. The patient saw her surgeon and they turned the stimulation down from output= 0. 75ma to 0. 5ma as requested by the patient. The nurse practitioner said that this helped the patient's comfort. The patient wanted to keep the device implanted. The physician ordered some blood work and an ultrasound to make sure that there was no infection. Diagnostics were ok at 3174 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872476
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« Reply #137 on: March 02, 2019, 04:29:37 AM »

Device Problem High impedance
Event Date 06/26/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient reported having painful stimulation in the neck after walking in front of an mri suite with the door to the magnet open. Thus, the manufacturer's sales representative interrogated the patient's device and completed a diagnostic test which revealed high impedance on the patient's vns system. Two more diagnostic tests revealed normal impedance following the initial high impedance result. The patient's device settings were subsequently lowered but the patient continued to experience the painful stimulation, this time in the chest pocket. Thus, the patient's device was programmed off. The pain in the patient's neck returned following the device being programmed back on (b)(6) 2015, characterized as a pulling sensation in the left neck and ear. Thus, the device was again turned off, with only magnet mode current remaining on. Device diagnostics were run again which revealed normal impedance. X-rays were reviewed by the neurologist which showed the vns leads were intact. There has been no reported trauma or manipulation. The physician does not know how this high impedance event began occurring. No known surgical interventions have been performed to date.
 
Event Description
Additional programming history was received and reviewed. The data obtained shows programming events from the date of the event, (b)(6) 2015, as well as a follow up visit with the treating physician on (b)(6) 2015. On (b)(6) 2015, the patient came in with the device disabled and left with device disabled as well. System diagnostic performed on (b)(6) 2015 resulted in normal impedance. The internal data decoded from the vns generator was reviewed as well. The data shows that impedance changed from 2356 ohms to 21822 ohms on (b)(6) 2015 from a 24-hour impedance measurement. System diagnostics performed later on (b)(6) 2015 showed an impedance change from 21822 ohms to 2089 ohms. Thus, the high impedance appears to have appeared and resolved all on (b)(6) 2015. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4936447
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dennis100
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« Reply #138 on: March 08, 2019, 01:52:35 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/08/2018
Event Type  Injury   
Event Description
Patient reported experiencing tightening of the lead wire with simulation which causes ear pain. The patient was referred for generator replacement due to low battery and lead replacement due to the pain. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8302844
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dennis100
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« Reply #139 on: April 06, 2019, 01:54:59 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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dennis100
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« Reply #140 on: April 07, 2019, 02:54:40 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/01/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was reporting ear pain and used his magnet to stop stimulation. According to the patient, this stopped the ear pain. When the patient returned to the office, the doctor decided to turn off and restart the titration from 0. 25 ma. When the adjustments were made, a high impedance message was noted. The physician asked for the patient to get "image tests" (likely x-rays). The patient's wife reported that a couple of weeks ago he had a severe seizure and fell flat on the floor. It's unclear if this may have caused the high impedance or if the seizure was a result of the high impedance. No additional information has been received to date and no known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8420858
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dennis100
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« Reply #141 on: April 07, 2019, 02:55:25 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/29/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had pain in their left ear all the time, but pain felt stronger during vns stimulation. It was reported that there was a lot of earwax removed, no inflammation, and that the pain is relieved when the patient lays down with a pillow against their ear. It was also reported that the patient experienced dyspnea and pain in left cheek and teeth. The physician decreased the patient's vns settings to prevent chronic nerve pain in the left cheek and teeth area. The patient's diagnostics were reportedly within normal limits. It was additionally reported that the pain occurred only during stimulation and became less severe. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8424598
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dennis100
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« Reply #142 on: April 07, 2019, 02:56:14 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2019
Event Type  Injury   
Event Description
It was reported from the patient¿s mother that he was having some troubles. The patient had a recent full replacement in january and now patient has had some adverse events. States was seen by pcp who started antibiotics and found inflammation in throat and both ears. Patient had "szs on and off all day", much different than his normal episodes, with actual convulsions and 15 min postictal period where he would sleep. It appears that the issues may be related to the recent surgery and that the seizures may be side effects of the medications provided but no additional information has been received to date for clarification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8433681
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dennis100
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« Reply #143 on: May 23, 2019, 11:22:01 PM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/16/2015
Event Type  Injury   
Event Description
It was reported that a patient was experiencing painful stimulation. At the patient's request, the neurologist referred the patient to a surgeon for lead revision surgery; however, the functionality of the lead is unclear. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The neurologist reported that the patient's painful stimulation began around 1. 5 years prior to the report. The patient reportedly felt the pain in her neck and all the way up into her ear. The neurologist did not believe the painful stimulation was caused by a lead fracture. The lead revision surgery that was planned as intervention for the painful stimulation was for patient comfort at the time of referral. Diagnostic test results from the date that the painful stimulation began were within the normal limits. No additional relevant information has been provided to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6546060
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dennis100
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« Reply #144 on: June 08, 2019, 06:25:08 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had experienced constant autostim stimulations, making him sweat, vomit, and causing a sore neck. The patient reported that he could not sleep, and that the pain went from his neck up to his ear, and his symptoms did not change according to what position he was in. Once the magnet was taped over the patient's generator, the symptoms went away. The patient visited his neurologist and the device was disabled. At the time the interrogation revealed nothing remarkable in terms of diagnostics. It was reported that the patient was feeling fine over the weekend and there was no reason to suspect that the autostim's frequent stimulation was due to the patient's heart rate being higher than normal. The device was turned back on later with autostim remaining disabled. Programming history was reviewed from the generator and no anomalies were seen. The amount of autostimulation per day was similar across the weekend of the event as compared to previous time periods. The amount of total stimulation per day was similar before the event and during the event. The patient was referred for replacement in order to have day night features, and due to the patient¿s belief that the autostim function of the generator was not working. Surgery is likely but has not occurred to date. No additional or relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8639935
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