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dennis100
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« on: July 13, 2018, 02:42:09 AM »

Model Number 302-30
Event Type  Injury   
Manufacturer Narrative
Information was incorrectly reported on the initial mfr. Report.
 
Event Description
It was reported the patient will have a vns generator replacement due to end of service, but the patient's mother would also like the lead replaced because she thinks the lead was compromised and is causing the patient jaw pain, head pain, and lower back pain. However, clinic notes from the physician were received and it was noted the patient has trigeminal neuralgia. The painful events are described as daily episodes lasting for hours. The pain starts in the patient's left lower jaw, where previously a tooth had been pulled, followed by midline low back pain, and frontal headache. The patient was seen in the epilepsy monitoring unit in 2013 and it was found that these events were not seizures. It was noted the patient does have trigeminal neuralgia, but replacing the lead will ensure the vns is not causing the pain. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
It was reported by the physician's office the patient's surgery will be for patient comfort. It was also noted the patient did not sustain any injuries from vns and trigeminal neuralgia is believed to be the cause of the patient's pain.
 
Event Description
It was reported by the patient's physician that the patient had transferred to a new neurologist. The new neurologist was contacted about the patient's issues and it was noted that the patient would not be referred for an additional surgery. It was also stated the pain is not related to vns and could be trigeminal neuralgia. The patient's vns was programmed off.
 
Event Description
It was reported the patient underwent generator replacement surgery on (b)(6) 2016. The explanted generator was confirmed to be neos = no. The lead impedance with the new generator was noted to be ok at 1408 ohms, which is within normal limits. It was noted that the surgeon only replaced the generator. It was later reported by the mother that the patient's vns was implanted for 12 years and it worked great. In 2011, the patient had a tooth on the left side that rotted and was removed. Two weeks after the tooth removal, the patient began having "episodes" of pain which began to occur daily. The patient was placed in the emu (epilepsy monitoring unit) and it was found these "episodes" were not seizures. The mother reported the physician thinks it is related to nerve damage. After the generator replacement on (b)(6) 2016 the patient reportedly had an "episode" which lasted 5 hours on (b)(6) 2016, and another which lasted 8 hours the next day. The mother believes the episodes are caused by vns and she wants her daughter to have a lead revision. It was noted the surgeon does not want to replace the leads without evidence there is a problem with the lead, since the diagnostics are currently ok. The mother stated she wants the patient's neck site opened to see if there could be anything affecting the lead. It was noted that a ct scan was performed, but it did not show any abnormalities. It was reported that the mother had also called the patient's physician and noted the patient is having severe jaw pain and has been seen in the er. Product analysis for the explanted generator was completed. The generator diagnostics were as expected for the programmed parameters. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
It was later reported that the patient used her magnet to turn off the device and the pain would go away. It was noted by the patient's mother that the settings were lowered from before and the patient's pain did subside. It was then that is was explained to the patient that the magnet could also be used to disable the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5633094
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dennis100
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« Reply #1 on: July 13, 2018, 02:43:02 AM »

Model Number 103
Event Date 09/13/2011
Event Type  Malfunction   
Event Description
It was reported that the patient came into the clinic recently and said that the vns is causing him severe voice alteration. It was confirmed that his voice was really hoarse such that he could barely speak. It was confirmed at the appointment that the device was turned off. The patient was told to see a throat specialist. This is an ongoing issue for the patient since 2013.
 
Manufacturer Narrative
Device history records were reviewed. Review of manufacturing records confirmed all quality tests were passed for the generator prior to distribution.
 
Event Description
The patient had an appointment at the neurologist's office on (b)(6) 2013. The device was interrogated and his device was confirmed to still be off. Although, it was noted that the patient complains of trigeminal pain but the device was confirmed to be off. (the trigeminal pain is captured in mfg report number: 1644487-2004-00719. ) the notes did not mention the patient reporting his vns setting off anti-theft devices or any adverse events associated with the vns believed to be on. It is unclear why the patient believed his device was on as the notes did not indicate the patient reported this but the nurse did indicate that this is not to say that the patient did not mention it at the visit. She further went on to state that it looks like the device was turned off in (b)(6) 2011 and then turned back on (b)(6) 2012. This past year it was officially turned off, but she did not provide the specific date upon request. The nurse did not have additional information.
 
Event Description
On (b)(6) 2013, the patient reported that his vns has spontaneously started constantly cycling on again since (b)(6) 2013. Follow-up showed that the device was off. The patient was noted to have psychiatric co-morbidities. The physician did not recommend the device be removed at this time.
 
Event Description
The vns patient reported on (b)(6) 2013 that his device was turned off (b)(6) 2012 due to trigeminal neuralgia which was previously reported in mfg report number: 1644487-2004-00719. He reported since that time he has noticed that at times his voice changes randomly and he thinks his vns is still cycling at times. He says it occurs randomly. He also alleged that his vns sets off the anti-theft devices when he goes in and out of department stores. The patient then reported on (b)(6) 2013 that he had his device disabled about a year and a half ago. He again explained that he believes his device had turned itself back on as he has been experiencing hoarseness of voice and feeling the device cycling on and off since (b)(6) 2013. The patient explained that he does not feel the cycling all the time and that it only happens sometimes. When this does occur, the patient indicated that it can stimulate for a few hours up to a whole day. The patient firmly believes that an anti-theft device at a department store had spontaneously turned the device on. The patient has an appointment scheduled in (b)(6) 2013 with the currently treating physician. Follow-up with the physician's office on (b)(6) 2013 revealed that the patient had not reported these events to them. Review of the device history records for the vns generator revealed that all quality tests were passed prior to final release. Review of the patient's programming history revealed that on (b)(6) 2011 the patient's device was programmed off. The device was remained off on (b)(6) 2012. However, there is no subsequent programming history available after this date. In the (b)(6) 2012 notes when the patient was last seen, it was indicated that the patient believed his device had been turned off "due to solar flares" which the nurse was not sure what he meant by this. She is unsure if the device was actually turned off but they plan to check his vns device on his follow up appointment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967448
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dennis100
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« Reply #2 on: July 13, 2018, 02:43:41 AM »

Model Number 302-20
Event Date 10/02/2014
Event Type  Malfunction   
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2014, it was reported that high impedance was observed that day for the patient during a system diagnostics test. The patient was sent for a chest and neck x-ray and the device was disabled. The patient was referred for a full revision. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received on (b)(6) 2014. Clinic notes dated (b)(6) 2014 indicate that the patient was having starring spell seizures almost daily and that swiping the magnet stopped his seizures. The patient¿s vns showed high impedance. It was noted that the patient would be referred for x-rays and surgery. Clinic notes dated (b)(6) 2014 indicate that the patient had several small seizures and that he was doing well with seizure control until his trigeminal neuralgia started. The neurologist stated that once his trigeminal neuralgia pain is resolved he thinks his seizure frequency will return to baseline levels.
 
Event Description
On (b)(4) 2014 it was reported that the patient was scheduled for a full revision surgery. Surgery took place on (b)(6) 2014. The explanted generator and lead were returned for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.
 
Event Description
On 12/08/2014 product analysis was completed on the lead. A portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Product analysis was completed on the generator on 12/11/2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4154445
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dennis100
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« Reply #3 on: July 13, 2018, 02:44:16 AM »

Model Number 300-20
Event Date 07/11/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, high impedance was observed during system diagnostics for the vns patient. The patient stated that the last time she had been seen and had her vns checked was in 2003. The patient reported that since (b)(6) 2012, she has felt a sharp pain in the left side of her face and down the left side of her neck. She stated that it started happening every 15-20 minutes, then every 10 minutes, and now it is occurring every 5 minutes for 5-10 seconds each time. The patient didn't know if it occurred with stimulation as she doesn't typically feel the stimulation. She further indicated that there was no recent trauma or manipulation that occurred prior to (b)(6) 2012 that may have caused or contributed to the pain or high impedance. The patient later stated that the pain is on the left side of her neck, a shocking sensation, only when the device is interrogated (more intense) and she also felt it when running diagnostics. She stated that she does not feel this pain at all at any other time. It was then confirmed with the physician that the pain she had been feeling in her face previously was found to be unrelated to vns as it was due to her neuralgia, which is being treated separately. The physician's office stated that the patient's vns is turned off, and the patient doesn't want replacement surgery at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2741379
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dennis100
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« Reply #4 on: July 13, 2018, 02:44:52 AM »

Model Number 302-20
Event Date 01/14/2009
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
It was reported that following lead revision surgery, a vns patient began experiencing neck pain when turning her neck from the left to right and upon tilting her chin back. During the surgery, the lead has been dropped on the floor. The surgeon soaked the lead in betadine and rinsed it off prior to implanting the lead in the patient. The vns device had not been programmed on after the surgery. There was some redness and swelling at the neck incision site which resolved with antibiotics. However, the patient continued to experience neck pain. The surgeon indicated there was no infection at that time. X-rays were sent to the manufacturer for review, and no discontinuities or anomalies were observed. An ultrasound report was received indicating that there was some fluid around the lead and at the generator site. The neurologist believes the ultrasound report suggests that the patient may have an infection. Both the neurologist and surgeon think the pain may be a neuralgia from the surgery, though this has not been confirmed. Both do not think the event is permanent in nature. The patient was treated with another round of antibiotics. Additional information revealed that the patient was evaluated by a different surgeon. Evaluation by that surgeon showed that the patient's pain in her neck has improved and there is currently no infection. Review of the manufacturing records show that the product was sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1336467
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dennis100
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« Reply #5 on: July 13, 2018, 02:45:26 AM »

Model Number 304-20
Device Problem No Known Device Problem
Event Date 05/15/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing some complications from her vns device and was referred for evaluation by the surgeon. The patient had acute spasmatic pain in the left neck and coughing lasting seconds whenever her magnet was swiped. However, the patient also experienced this 6-8 times per day spontaneously. The physician stated that there was no abnormality with the lead and that he suspected potential glossopharyngeal neuralgia. The physician prescribed gabapentin for the left neck paroxysmal pain. No surgery 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=7596790
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dennis100
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« Reply #6 on: July 13, 2018, 02:45:58 AM »

Model Number 102
Event Date 06/24/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, clinic notes from a vns treating physician were received through case mgmt. Review of the clinic notes revealed that on (b)(6) 2010, the pt was experiencing pain in their neck and shoulders on and off. The physician decreased the vns pulse width to see if it would help the pt. The physician also reported that on (b)(6) 2011 the pt had seizures at night, but did not try and swipe their magnet. In clinic notes dated (b)(6) 2011, the physician reports that the pt has a history of neck pain. The physician also reported that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. Due to the pt's flare of symptoms, the physician referred the pt for prophylactic battery replacement. In clinic notes dated (b)(6) 2011, the physician provides further info about the pt's history of neck pain, stating that it spreads into the occipital area in keeping with neuralgia. The physician again reports that the pt has recurring spells and it is unk whether these are breakthrough seizures or nonepileptic spells. The mfr's consultant later reported that the physician believes the pt's pain was not related to vns. Surgery has not yet been scheduled. Attempts for additional info regarding the pt's seizures have been made to the physician, but no further info has been received to date. When further info is received, it will be reported. A blc performed with the programming history in the mfr's programming history database which revealed negative yrs until eri = yes.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2180923
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