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dennis100
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« on: April 26, 2012, 01:22:29 PM »

Model Number 101
Event Date 10/01/2001
Event Type  Injury  
Patient Outcome  Life Threatening,Required Intervention,Hospitalization
Event Description
Initial report indicated that beginning at the end of august 2001/beginning of september 2001, the pt felt a cyclic pain in their teeth. Pt had two teeth extracted on 8/2001. Further investigation revealed that the pt's programmed settings were reduced on 9/01 in an effort to alleviate the tooth pain. Physician's notes indicated that the physician had "greatly reduced the output current", but there was no prior documentation of what the pt's output current was set at prior to the decrease. Further investigation revealed that on 2001, the pt was hospitalized for seizures. On that day, the pt suffered a grand mal seizure that lasted longer than usual. On 10/2001, programmed parameters were increased. It was reported that the pt has never really had improved seizure control since implant of the ncp system. Pt was released from hosp 15 days later and pt is reported to have improved seizure control after the parameter increase.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=363629
« Last Edit: February 13, 2015, 03:36:41 AM by dennis100 » Logged
dennis100
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« Reply #1 on: April 27, 2012, 11:13:08 AM »

Model Number 101
Event Date 01/01/2003
Event Type  Injury  
Patient Outcome  Required Intervention
Manufacturer Narrative
Report is incomplete because attempts to obtain additional info from treating neurologist have been unsuccessful to date. H. 6. Method: ncp system labeling lists pain, insomnia, tooth pain, dyspnea, choking sensation and increased coughing as potential adverse events possibly associated with surgery or stimulation.
 
Event Description
Reporter indicated that pt was experiencing decreased sleep, chest pain, severe tooth pain that prevents pt from sleeping and choking/dyspnea with stimulation. It was reported that the pt's neurologist had decreased device settings several times but that the pt has had little relief from the above symptoms. Further follow-up revealed that the pt was hospitalized during the first week of march 2003 due to dilantin toxicity and that the pt was having coughing with stimulation. Device settings were decreased while the pt was in the emergency room. The pt reports that pt told neurologist at their last office visit when device settings were increased that pt could not tolerate the device settings, but the neurologist would reportedly not decrease the settings at that time. The pt reports that now that device settings have been decreased pt has no side effects and is starting to have less seizures. Investigation to date has been unable to determine the severity of the reported adverse events.

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=448084
« Last Edit: February 13, 2015, 03:38:21 AM by dennis100 » Logged
dennis100
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« Reply #2 on: June 06, 2014, 05:18:52 PM »

Event Date 01/01/2006
Event Type  Malfunction   
Event Description
On (b)(4), 2012 it was reported that the vns patient was initially implanted with vns in the (b)(4) 2002 and began to feel ill with significantly more seizures and absence seizures in 2006. The patient's condition also worsened and he began to cough often and long and coughed until he threw up. The patient was reported to have seen the neurologist on several occasions. In (b)(4) 2009, the patient visited the dentist and the patient's teeth were ground and an ultrasound was performed. The patient 'jumped in the chest' and was hurt by the vns. It was noted that this was pain at the generator site. The patient had severe coughing, felt sick, and had trouble breathing when he left the dentist's office. When the patient came home, the patient's mother suspected that something was not right with the vns. When the settings of the vns could be adjusted by the hospital, the patient coughed hard and long, lost her breath, and turned blue in the face. It was reported that the physician had not been through something like this before. It was noted that this event occurred three times. In the (b)(4) 2010 it was reported that the manufacturer concluded that the vns was broken in the patient's body and the patient underwent revision surgery for a new vns to be implanted. It was reported that the explanted product had been previously been returned for product analysis however as the product information was not provided nor was additional patient identifying information, this could not be verified. Additional information has been requested from the physician but no further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2854670
« Last Edit: November 06, 2018, 07:38:24 AM by dennis100 » Logged
dennis100
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« Reply #3 on: July 03, 2014, 11:07:14 PM »

Model Number 302-20
Event Date 08/25/2009
Event Type Injury
Event Description
On (b)(6) 2015 the patient reported that his vns has been turned off for about 5. 5 months because of ¿several problems¿. It was later reported that the patient has had his device for a while due to painful stimulation. The patient will be proceeding with explant of the vns device. Although surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device manufacture date; corrected data: additional information was received that changes the product from the generator to the lead.

Event Description
Follow-up revealed that the vns patient¿s device was disabled on (b)(6) 2014. The patient underwent surgery on (b)(6) 2015 to explant his device due to pain and to pursue an alternative treatment option. During the procedure, the surgeon noted that the electrodes were not in proper alignment and had been implanted upside-down. Additionally, a tie-down had been placed on the electrode coil on the nerve. No other tie downs were observed. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.

Event Description
Initially, it was reported that the patient has experienced pain in the left jaw and teeth. The patient was evaluated by a dentist, but nothing was found wrong with the patient's mouth or teeth. The patient disabled the device with the magnet and the pain went away; however, when the magnet was removed the patient began choking and gagging. The patient reported that there appears to be muscles twitching in his neck area. The patient indicated that he is no currently followed by a treating physician and the patient was provided with vns treating physicians. It was later reported that the patient would be referred to surgeon for full vns revision surgery. Clinic notes dated (b)(6) 2014 note that the patient is having trouble with vns and the device was disabled and will likely require a full revision. No additional relevant information has been received to date. No surgical intervention has been performed to date.

Event Description
It was reported that the patient was turned up that day from 1. 0ma to 1. 25ma. Everything was fine while he was at the physician¿s office but when he got home he experienced pain in his jaw again. It only lasted a little bit. The physician stated that the patient is having the same pain in the jaw with the new generator. The patient used to be set at 1. 75ma, but now when they turn the current up to 1. 25ma the patient experiences instant pain when the device turns on. He also states that after a few hours of normal operation the pain gets worse. Settings are output=1-1. 25ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=5omin. Diagnostics are ok; impedance=2213ohms. The physician stated that they would try adjusting the pulse width and decreasing the duty cycle.

Event Description
It was reported that the patient underwent generator replacement. The lead was not replaced. Device diagnostics prior to and during surgery were within normal limits. It was reported that the explanting facility does not returned explanted devices for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845774
« Last Edit: December 19, 2015, 10:11:16 AM by dennis100 » Logged
dennis100
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« Reply #4 on: November 14, 2015, 12:51:34 PM »

Model Number 302-20
Event Date 07/19/2007
Event Type Malfunction
Manufacturer Narrative
X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to death or serious injury.

Event Description
Reporter indicated that both systems and normal mode diagnostic tests were performed on the vns patient's generator at a follow up visit and resulted in high lead impedance. It was also reported that the patient was experiencing painful stimulation to the left jaw and teeth on the left side. Further follow up and the treating physician revealed that there is not believed cause for the high lead impedance. X-rays were reviewed by the manufacturer and the strain relief did not appear to be adequate per manufacturers labeling. Additionally, a suspicious area in the lead body was observed where the first tie down is used for the strain relief bend. It is possible that a lead discontinuity is present at this point, but due to the shadows present and poor contrast, this could not be confirmed on the x-rays. The generator was programmed off. The patient had surgery to have the problematic lead removed and a new lead was implanted. The explanted lead has been returned to manufacturer and analysis is pending. Further attempts to obtain information regarding possible generator replaced have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=899074
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dennis100
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« Reply #5 on: January 13, 2016, 03:02:58 AM »

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

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

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

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

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

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

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880622
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dennis100
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« Reply #6 on: January 28, 2016, 12:21:23 PM »

Model Number 103
Event Date 05/21/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a vns patient was going to have their lead replaced. Follow up with the patient's treating physician's office: it was reported that the patient is happy with therapy, but when their settings were increased, they felt pain in their jaw/teeth and felt a pulling sensation when he turns his neck to the right. The surgeon decided to switch out their lead. The patient did not have any trauma reported preceding the events. On (b)(6), they were set at 1. 25 ma output current, which was decreased to 1. 0 ma. The patient was comfortable after their programming changes. Surgery was reported to be performed for patient comfort not to preclude a serious injury. Our consultant was present at the patient's surgery and during the removal of the lead the surgeon used electrocautery and disabled the generator. The implanting md was fully aware of the risk of using cautery prior to using it near their implanted generator but decided to use it anyway. The patient then had their generator replaced while in surgery as it had been pulse disabled. Their explanted generator was returned for analysis. Review of the data indicated that the pulse disabled byte was set to a value that does represent a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2679710
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dennis100
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« Reply #7 on: February 27, 2016, 07:02:15 AM »

Model Number 302-20
Event Date 06/23/2011
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that a vns pt who had recently undergone generator replacement surgery with a model 105 generator ((b)(6) 2011), began experiencing an unpleasant feeling on the left side of the neck (i. E. He feels that "a liquid run down along the lead), headache (left-sided), toothache and tinnitus (b)(6) after surgery (2. 5ma/20hz/250us/7s/0. 3min). Pt therapy settings were reduced on several occasions in attempt to alleviate these side effects, which were only temporarily successful and system impedance was noted to have increased gradually during each programming session. The pt indicated that he had almost the same symptoms in 2005, when he had a lead break and the symptoms increased gradually. The pt's treating vns therapy physician also indicated that prior to replacement, therapy settings were unable to be increased due to "a lot" of unspecified adverse events which resolved after decreasing the output current (to 2. 5ma) and pulse width (to 250 us). The reporting physician indicated that an emg was performed and the signal looked normal. Pt x-rays were rec'd and reviewed and no anomalies were identified. Pt emg testing was performed and no obvious anomalies were identified. The placement of the generator could not be fully assessed due to lack of a full ap chest view. The filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. The lead wires at the connector pin appeared to be intact. A second set of electrodes belonging to an explanted lead can be observed below the electrodes of the currently implanted lead. Neither lead breaks nor acute angle were observed in the assessed portions of the lead. At the moment good faith attempts to obtain add'l info have been unsuccessful to date. Revision surgery is likely but has not been scheduled.

Event Description
Further information was received from the reporting physician indicating the adverse events were constant and resolved with disablement of the device. At the moment revision surgery is likely and physician will consult with manufacturer at that time. No further information was provided by the physician.

Event Description
Analysis was completed on the returned generator which indicated no device issues. The explanted lead was not returned to the manufacturer for analysis; hence no commentary can be made regarding the reported lead issues.

Event Description
Additional information was received from the treating physician indicating the patient underwent generator and lead replacement surgery. The explanted lead was not returned to the manufacturer for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2358038
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dennis100
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« Reply #8 on: March 03, 2016, 04:20:31 AM »

Model Number 102
Event Date 07/04/2011
Event Type Injury
Manufacturer Narrative
Supplemental report 1 incorrectly left the event as a malfunction; however intervention has since been taken.

Event Description
A vns pt implanted for depression called and reported that a couple months ago, her psychiatrist changed two parameters on her generator but she did not know what those were. After this, about 3 weeks ago, she started experiencing pain in her neck around the electrode site and up further on her neck. The pt reported that the pain sometimes travels up around the left side of her head and in her jaw and teeth. It was the first time the pt had experienced this pain since implant. The pt had not had any fall or injury preceding the event and it only occurred when her device was on and did not occur during the off times. The pt had used her magnet to temporarily help the pain a couple of times but didn't leave the magnet there for an extended period of time. Their reported pain goes away when the magnet is taped over the device. The pt reported that their depression has gotten worse. It is unk if this is above or below their prevns rate. The pt was seen by a surgeon and they did not feel the vns was causing the pt's pain and that they did not require any kind of surgical revision. They have been referred to see a neurologist. No current device diagnostics have been received to confirm device function. Good faith attempts are underway to investigate the pt's reported events.

Event Description
Additional information was received from the patient indicating that the patient is still experiencing pain in her face, however an overall 80% improvement in her depression. The pain stated a couple of months prior to this report. The pain started as tooth pain. The patient then had to tooth removed and the pain was then being felt on the left side of the face radiating up to the skull. The pain reportedly occurs every 5 minutes for 1 minute, and there are no reported issues when disabled with the magnet. This is consistent with the on and off times of the patient's current settings. It was also reported that the patient's pulse width was lowered from 500usec to 250usec; however the date when this was done is unknown. The patient has since been seen by multiple surgeons. A ct scan and x-rays were performed but showed no abnormality. It is unclear if the x-rays will be sent to the manufacturer for review. One surgeon reported that he attempted different settings to determine if the patient still felt pain, and then programmed the patient off to see if she could feel the difference. The patient was able to tell when on versus off and reported intermittent pain in face. The surgeon feels that the patient may feel the stimulation and due to her other psychological issues, she may associate it with pain, even though the diagnostic test was normal. Specific diagnostic results were not provided. The surgeon also recommended that the patient go back to her treating neurologist to adjust settings. The surgeon ordered ct scans and will only re-position (exploratory) as a last option. Currently the patient leaves her device on for half of the day and disables the device with the magnet for the other half. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the surgeon indicating that the device was failing and no longer working for the patient. Diagnostics, performed since the onset of this issue, have been found to be normal, indicating that device failure is not suspected. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2255823
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dennis100
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« Reply #9 on: June 14, 2016, 09:27:52 AM »

Model Number 102
Event Date 04/25/2016
Event Type Injury
Manufacturer Narrative

Event Description
Clinic notes were received indicating that a vns patient was experiencing painful stimulation (a "shocking" sensation) for which the generator was disabled. It is stated that the painful stimulation stops when someone palms her in the back behind where the vns is placed. It is stated that when it shocks her it shocks her down her arm down to her elbow, in shoulder blade area, up into her neck, head, and teeth. She states that moving her left arm sets it off. The patient was then referred for generator replacement evaluation. Review of available data in the programming and history database revealed no anomalies. A battery life calculation performed with available data indicated the device has 8. 5 years remaining until neos = yes although the last 4 years of programming data is missing. Follow up with the provider indicated that the most recent device check was (b)(6) 2016 and when asked for battery status on that date the provider indicated the battery was "failing. " the provider indicated that vns was turned off until the battery could be replaced and increase seizure medication was prescribed until vns can be turned back on. The provider stated that the increase in anti-seizure medication was to preclude a serious injury since the vns device had been turned off awaiting generator replacement surgery although the patient had not actually experienced an increase in seizure. Further follow up with the provider indicated that while the clinic notes did not specifically indicate which battery indicator was observed the providers felt the patient's device was at neos or eos. The physician attributed the painful stimulation to the low battery condition and elected to disable the device output for patient comfort reasons. The provider submitted additional clinic notes containing device settings. An updated blc performed based on the newly submitted settings indicated that the device has approximately 8. 1 years remaining longevity. No device diagnostic data could be found in the clinic notes therefore the impedance status of the system was unknown. The device was subsequently evaluated and found not to be at eos and had normal lead impedance values in 3 different head/neck positions but the providers elected to proceed with generator replacement surgery on a prophylactic basis. The generator was successfully explanted and replaced on (b)(6) 2016 and normal impedance was observed with the new generator attached to the former lead (dc dc 2).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5689538
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dennis100
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« Reply #10 on: December 10, 2016, 07:50:49 AM »

Model Number 302-20
Event Date 08/05/2003
Event Type Injury
Event Description
It was reported by a nurse that a vns pt had vns removed on (b)(6) 2003 (the distal part of the electrode lead and the vagal nerve generator) due to the pt leads coming "unhooked" which were poking the pt and were palpable. Also the pt was reported to have no benefit noted from the vns. Additional info was received from the reporting nurse indicating it was unk if pt manipulation or trauma to the device could have caused the lead to be poking the pt and be palpable. Moreover, there was no documentation of high lead impedance being read due to the lead coming "unhooked". Furthermore, another nurse was involved and she found lead test normal at 3. The reporting nurse further stated that "unhooked" was an improper term used when reported the event. The nurse provided the surgical exam which stated: "the pt now has electrode leads in the subcutaneous tissue in his chest, which he says are painful and re certainly palpable and visible. I have told the pt that the options at this point are to remove the generator and leads, or to move them into a more satisfactory position on the chest wall. The pt says that because he has not had any change in the frequency of his generalized seizures, he would prefer to just have the device removed. His caretaker, who came with him today, agrees with this and feels it would be better to have this removed. She also states he has pain in his left teeth and his left ear whenever the stimulator is on, which the pt finds uncomfortable. " the surgical report was also provided and indicative of the following: "the previous incision was reopened by excising the previous scar and then extending the incision down through the subcutaneous tissue with bovie cautery until we identified the vagal nerve stimulator and the leads attached to it. The leads were quite adherent to the anterior pectoral sheath, and they were dissected free from this using bovie cautery. We then divided the lead using mayo scissors, and the generator and the distal part of the leads were removed from the wound and discarded. ".

Manufacturer Narrative
Age at time of event, date of birth; corrected data: an implant card was received indicating that the patient¿s date of birth was incorrectly reported on the initial manufacturer report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2009545
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dennis100
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« Reply #11 on: March 10, 2017, 04:44:22 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/12/2016
Event Type Injury
Manufacturer Narrative

Event Description
It was reported that a patient was having ear, jaw, and neck pain associated with stimulation. It was reported that the issues may also be psychological in nature. Follow-up to the company representative who was at the patient¿s appointment provided the physician attempted to change her duty cycle settings. It was reported she was in the office for over an hour and didn¿t like that cycle as well. She was still having sharp pain that comes from neck up to her ear and into her jaw, cheek and teeth. She has been to the dentist and her teeth are fine. Diagnostics were performed and were reportedly okay. Generator replacement surgery occurred on (b)(6) 2017. The explanted devices were discarded by the explant facility. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6296088
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« Reply #12 on: May 15, 2017, 12:43:30 AM »

Model Number 101
Event Date 07/21/2008
Event Type Injury
Event Description
It was reported that a vns pt was experiencing chattering in her teeth, left arm going up and down, whole body muscle spasms, and harshness with muscles in her throat with magnet mode stimulation. The pt was hospitalized and reported that she was overdosed on dilantin. Disabling the vns device with the magnet did not resolve the teeth chattering event. Good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1131063
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« Reply #13 on: June 01, 2017, 08:05:53 AM »

Model Number 302-20
Event Date 05/01/2004
Event Type  Malfunction   
Event Description 
As part of a retrospective complaint review associated with an investigation of low impedance events, the events in this complaint investigation were assessed for the possibility of a short-circuit condition in the implanted lead. Based on clinical symptoms and the diagnostic history of the patient's device, this file was found to be possibly related to a short-circuit condition. It was reported to manufacturer by the vns patient that the stimulation of the device did not feel as strong as it had previously, and that she had a recent increase in seizure activity as well as tooth pain. The patient further explained that she was involved in a physical altercation where she had been attacked and injured. The patient had been to see her neurologist following the incident, however, the altercation and subsequent adverse events that followed were not mentioned to the physician.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to death or serious injury.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1492071
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« Reply #14 on: July 08, 2017, 04:30:46 AM »

Model Number 302-20
Device Problem High impedance
Event Date 05/09/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient's vns system was found to have high lead impedance at a clinic visit upon diagnostics testing. Autostimulation was reported to be off. The patient was reported to be experiencing pain in her tooth. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604673
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« Reply #15 on: September 08, 2017, 11:17:41 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 05/18/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
A patient was experiencing horrendous pain in a tooth on the left side of his mouth and in the middle of his chest. The pain occurred only once initially, when the patient accidentally swiped his vns magnet over his generator. At a clinic visit 2 weeks prior, the patient's neurologist believed the device was operating normally, per the patient. The following month, the neurologist suspected that a problem with the patient's lead may have occurred based on the clinical symptoms that patient was experiencing. The neurologist ordered x-rays of the patient's vns system; however, the x-rays were not reviewed by the manufacturer. No device malfunction was reported at that time. Two months after his initial report, the patient stated that he felt like a woodpecker was hitting his chest when he turned onto his left side, and he continued to experience pain in his gums. The sensation occurred every 3 minutes with stimulation and went away when stimulation stopped. The patient was evaluated by his dentist, who stated that nothing was wrong with the patient's teeth or gums. The patient reported that though he initially felt stimulation when he was implanted, he stopped perceiving stimulation until his initial report of pain two months prior. The patient noted that the pain was impacting his sleep. The patient had taken pain medication to treat the painful stimulation, but the medication did not help. The patient was seen in clinic a week after the updated report, and device diagnostics were performed and returned results within the normal limits. The patient reported that magnet swipes made him feel as though he could not breathe in addition to the painful stimulation he was previously experiencing. The patient's settings were reduced as intervention for the painful stimulation and dyspnea. The patient was referred for surgery as the neurologist believed that the vns was clearly causing the patient's pain, despite diagnostics being within the normal limits. The surgery was reportedly both required to preclude a serious injury and for patient comfort. 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=6760034
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« Reply #16 on: October 19, 2017, 01:14:35 AM »

Model Number 103
Event Date 12/01/2011
Event Type Injury
Manufacturer Narrative

Event Description
On (b)(4) 2013 additional information was received from the rn. There were no precipitating events; the moc thinks the seizures were worse with teeth issues. The seizures were considerably worse in the months prior to the (b)(6) 2012 appointment than the pre-vns seizure frequency levels. The patient¿s multiple seizure types increased. There were no causal or contributory programming changes or medication changes that preceded the onset of the increase in seizures other than the ¿c/o teeth issues to seizure increases¿. It was later stated that because of the worsened seizures, the patient¿s vns settings and medications were increased.

Event Description
It was initially reported that the patient had in increase in seizures. The patient normal baseline is a seizure every week or two and the patient is having seizures almost daily. There were no precipitating events except that the patient¿s seizures get worse when he had issues with his teeth. The physician increased his topamax dose and vns settings. Attempts for additional information had been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3373724
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« Reply #17 on: December 31, 2017, 02:35:11 AM »

Event Type Malfunction
Event Description
It was reported by a patient that he had experienced "irregular stimulation" and painful stimulation with his vns device. The patient reported that the generator (unknown when implanted and reportedly explanted in (b)(6) 2016) caused him to have painful stimulation in the left neck and armpit, and the "irregular stimulation" to his vagus nerve caused his body to "forget how to breathe" while sleeping. The patient also reported that he had to then start using oxygen at night to make sure his body continues to breathe while he sleeps. Reportedly, the neurologist informed the patient that the irregular stimulation from the generator caused his nerve to become dependent on the stimulation to remember to breathe, so the neurologist continues to suggest that the patient be re-implanted with vns. However, the patient refused to be re-implanted after the third generator was explanted. The patient kept the third generator after explant, and the lead was left implanted. The patient also reported that vns did help reduce his seizures, but he has stress-induced grand mal seizures which were exacerbated by the painful stimulation and distress over having "defective vns devices. " he tried to hurt himself as well because of the painful stimulation and distress. No further relevant information has been received to date.

Manufacturer Narrative

Event Description
The patient reported that his third generator malfunctioned and shocked his jaw and teeth to the point where he had to get dentures. He reported that he could not get the lead removed where he lived due to the damage on his nerve from stimulation. Neither of the patient's previous surgeons were aware of a third generator being implanted. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6031775
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dennis100
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« Reply #18 on: April 04, 2018, 01:25:17 AM »

Model Number 302-20
Event Date 04/25/2012
Event Type  Malfunction   
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
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
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 #19 on: October 04, 2018, 04:10:27 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 #20 on: October 06, 2018, 05:23:52 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/13/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
Following a full revision surgery, patient stayed at the outpatient clinic overnight due to pain and vomiting. Vns was turned on after surgery and the patient also complained of tooth pain associated with stimulation cycle. The patient's device settings were later adjusted. The autostimulation feature was turned off and then the normal current was lowered and the patient reported feeling better. Per the surgeon, the pain was in the neck area and the lead revision and stimulation may have contributed to the pain. The vomiting is probably related to anesthesia per surgeon.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7856852
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« Reply #21 on: November 06, 2018, 07:39:14 AM »

Model Number 104
Event Date 03/26/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that the vns patient complained of having pain at her right eye and teeth during an office visit on (b)(6) 2014. The patient's device settings were decreased during an office visit on (b)(6) 2014. The patient subsequently reported having an increase in seizures above pre-vns baseline levels during an office visit on (b)(6) 2014. The patient¿s device output current and on-time were increased during this office visit. X-rays were taken during the office visit and reported to be normal. The physician stated that the increase in seizures was related to vns stimulation. Further follow-up revealed that all of the patient¿s seizure types had increased. There was no change to the duration of the patient¿s seizures or post-ictal period. The patient¿s device was reported to be functioning properly and her device off-time had been adjusted since her last office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800629
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« Reply #22 on: January 07, 2019, 03:31:39 AM »

Model Number 304-20
Event Date 01/05/2014
Event Type  Malfunction   
Event Description
It was reported that the patient's vns device had high lead impedance. Follow up with the physician found that the high lead impedance was observed on (b)(6) 2014. The vns device was programmed off to 0ma following the observation of the high lead impedance. The patient stated that she came into contact with a large magnet over christmas ((b)(6) 2013) and felt strange afterward. The physician will not provide any additional information. Ap and lateral chest and neck x-rays dated (b)(6) 2014 were received and reviewed by the manufacturer. The generator appears normally placed in the left chest. It cannot be assessed if the lead pin is fully inserted as the lead pin is not visible past the connector block. Feed thru wires appear intact. Lead wires appear intact at the connector pins. The lead coils behind the generator before routing upward to the left neck. The portion of lead behind the generator cannot be assessed. The electrodes appear aligned. A strain relief bend is present and appears to be per labeling. No strain relief loop is present. Two tie-downs are visible; however, the tie-downs are not placed per labeling as the first tie-down is not positioned laterally to the anchor tether. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. There are several slivers in the neck area near the electrode; however, these appear to be behind the lead body and not interacting with the lead. No other information has been provided.
 
Manufacturer Narrative
(b)(6).
 
Event Description
The patient reported via facebook comment in 2017 that the vns caused voice alteration and at a higher dose, she felt discomfort in her left neck, left lower tooth and left side of forehead for which her neurologist adjusted dose and time interval in response. She indicated that depending on the slant of her head, she felt that the vns was more intense. In addition, the patient reported brain freezes when she had to take her medications with cold water. She believed it was possible that the vns was going off at that time and causing it. The patient reported during follow-up with company representatives that her vns wasn't changed after high impedance a couple of months after having a cough. She said that she ended up getting pneumonia. The treating neurologist's nurse indicated that while the patient's pneumonia and the high impedance was noted in the patient's clinic notes, she didn't see anything connecting the pneumonia to the high impedance. The programming database and internal data of the patient's generator was reviewed. Per the data, it was found that the patient's generator was re-enabled. Also, it was found that the patient's impedance appeared to be fluctuating from high to normal until (b)(6) 2014, after which there was no further incidents of high impedance. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records 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=3622212
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dennis100
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« Reply #23 on: April 07, 2019, 02:50:34 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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« Reply #24 on: July 02, 2019, 01:20:54 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported by a physician that a vns patient¿s device was still firing even though the magnet was reportedly used to disable the device. The magnet was placed over the scar on the patient's chest, but the generator could not be felt. The physician reported that he could still see the device firing, which was determined by the patient clenching her teeth. The patient had multiple seizures during this time, which were attributed to the pain caused by the stimulation. It was reported that the seizures got worse and more frequent when the magnet was placed over the generator and that the patient had a neck muscle spasm during stimulations. The patient's device was communicated with the next day, which showed that the device was delivering therapy properly and that there had been no magnet activations during the times that the physician and patient stated that the magnet was used. The magnet was taped over the generator, and then the magnet activation was recorded properly. The physician reported that the generator was placed deep in the patient but could still be palpated, which could have caused the magnet to not activate. Follow-up was then received the next day reporting that, even with the magnet taped in place, the patient had neck and face spasms and tremors in the patient¿s cheeks during vns stimulation. Immediately following the symptoms that lasted up to 20 seconds, the patient went into a tonic seizure lasting 20-40 seconds. The patient's device was then programmed off. The patient was then referred for replacement of the device. Further follow-up indicated that the increase in seizures was not worse than before vns, but the device had been off for a week and the patient's seizures were back to one a day. The increase in seizures was stated not to be caused by vns therapy. The patient felt like the magnet didn't inhibit stimulation. The muscle spams, painful stimulation and increase in seizures resolved after the device was disabled, but the patient was still experiencing a subdermal burning sensation around the generator site. The patient had generator replacement surgery due to the painful stimulation. Diagnostics were within normal limits prior to surgery, and the surgeon found no visible anomalies with the devices prior to explant. The generator has not been received to date.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. Both interrogation and system diagnostic test were performed, with a distance of one and one-quarter inches between the device and the programming wand. Results were normal for all diagnostic tests performed. The pulse generator performed according to functional specifications. Proper functionality of the generator was successfully verified. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, 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. Magnet activations performed during output monitoring at a distance of one-inch from the generator, demonstrate the appropriate magnet output for the programmed settings. The generator diagnostics were as expected for the programmed parameters. Electrical evaluation showed that the device performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7594908
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« Reply #25 on: July 05, 2019, 11:20:52 PM »

Model Number 304-20
Device Problem High impedance
Event Date 05/24/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A report was received that a patient was complaining about painful stimulation in their neck, jaw, and teeth. Diagnostics revealed the patient's device had high impedance. The patient's device has been programmed off. The patient has not be referred for x-rays or replacement. Device history records were reviewed for the generator and lead, and both passed all functional specifications and quality tests and were sterilized prior to distribution. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8708030
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dennis100
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« Reply #26 on: August 10, 2019, 01:35:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2019
Event Type  Injury   
Event Description
It was reported that the patient was in the hospital with hoarseness, electrical pain in the back of throat going up to the patient¿s teeth, and hand spasms. The er (emergency room) physician indicated that he assumed the events were related to vns. Further information was received that the patient was seen the week prior to the hospitalization and per the neurologist the device was working fine. It was noted that impedance was ok, but that the exact value could not be recalled. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8776992
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