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dennis100
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« Reply #300 on: September 12, 2018, 02:24:00 AM »

Model Number 102R
Event Date 09/01/2009
Event Type  Injury   
Event Description
It was reported via clinic notes dated 10/28/2009 that the patient was hospitalized for 2 days due to a suicide attempt in (b)(6). The patient does have depression but it is not clear if this is a new onset or if the patient has a history of depression prior to vns. The patient was not receiving any treatment for her depression per the neurologist's knowledge. No changes were made to the patient's vns settings and the neurologist referred the patient to a psychiatrist for treatment of her depression. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2299164
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dennis100
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« Reply #301 on: September 14, 2018, 08:07:32 AM »

Model Number 102
Event Date 01/01/2008
Event Type  Injury   
Event Description
Reporter indicated that pt is experiencing an increase in depression. Diagnostics are within normal limits which indicates the device is functioning properly. Physician does not believe the increase in depression is related to vns but can't rule it out since she does not have any previous history on pt. Settings have been lowered and pt reports this is alleviating their depression.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1054093
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dennis100
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« Reply #302 on: October 15, 2018, 11:38:36 AM »

Model Number 102
Event Date 01/23/2009
Event Type  Injury   
Event Description
Initial reporter indicated that his wife, got implanted 2 years ago for depression and she has not received any benefit from the vns. He additionally reported that they have not noticed a difference in her mood. He stated "if anything it has gotten worse, she still cannot function properly in life. " it is unk if the pt's depression is above their pre vns rate. Good faith attempts have been made for further info and thus far no further info attained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1329208
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dennis100
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« Reply #303 on: November 01, 2018, 02:43:21 AM »

Model Number 103
Event Date 10/01/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2012 reported that the patient presented for the vns follow up visit complaining of an increase in seizures. It was also indicated that the patient feels very depressed, but there was no indication of an increase in depression. The patient was referred for generator replacement due to neos=yes. Attempts for additional information have been unsuccessful to date. The patient had generator replacement surgery occurred on (b)(6) 2012. Attempts for product return are in progress, but the generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2835948
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dennis100
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« Reply #304 on: December 02, 2018, 01:57:12 AM »

Model Number 102
Event Date 06/05/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 indicated that this vns patient¿s seizures have been fairly stable, but the patient¿s parents wondered if the patient was depressed. The patient slept for 15-16 hours per day and did not seem to be interested in doing things that he was interested in doing before. The caregivers wondered if the vns was working. The device was interrogated and was still doing well, per the physician. The physician indicated that it was possible that if the vns was not functioning right, it could allow some more depression symptoms to occur. Attempts for additional information have been unsuccessful. The patient has been referred for prophylactic revision. Surgery is likely but has not taken place.

Event Description
On (b)(6) 2013 it was reported that the patient underwent generator replacement that day. System diagnostics were noted to be performed without error. The explanted generator has not been returned for product analysis to date.

Event Description
On (b)(6) 2013, it was reported that the explanted generator was discarded.

Event Description
It was reported that the generator was not discarded and will be returned to manufacturer for analysis. The generator was received on (b)(4) 2013. The generator analysis was completed on (b)(4) 2013. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3223737
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dennis100
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« Reply #305 on: December 15, 2018, 02:25:17 AM »

Model Number 302-30
Event Date 09/01/2013
Event Type  Injury   
Manufacturer Narrative
Describe event or problem, corrected data: the supplemental report #2 inadvertently did not include this information.

Event Description
Additional information was received from the physician's office. The patient has a device that is misfiring, low battery, or completely out. This was detected in (b)(6) 2013. The device was disabled due to the feelings it was giving the patient. No other information was provided.

Event Description
It was reported that the patient went to the surgeon after being referred from her psychiatrist. The surgeon reported that he was unsure what the problem was and has no plans to follow-up with the patient. The patient reported that about a month ago she though her device stopped working because she felt like it wasn't working for her depression. The patient reported that her depression was not worse than it was pre-vns baseline. The patient reported that she saw her physician and the device was programmed off because she felt achy all over and her physician thought there may be an issue (short) with the lead. The patient was unsure if diagnostics had been performed at that time. The patient stated that the device will remain off for now and that she will only proceed with surgery if her insurance will pay for it because it is expensive.

Manufacturer Narrative
Manufacturer reviewed device history records. Review of the generator and lead device history records confirmed all quality tests were passed prior to distribution.

Event Description
It was reported the patient's device was programmed off in (b)(6) 2013.

Manufacturer Narrative

Event Description
Review of the manufacturer¿s in-house programming history revealed that on (b)(6) 2013 high impedance had been found on systems diagnostics. 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=3441194
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dennis100
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« Reply #306 on: December 18, 2018, 12:46:16 PM »

Model Number 102
Event Date 12/01/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that the patient had an increase in depression, above pre-vns baseline. The physician was unclear the relationship of the patient's increase in depression to vns. The patient reported consuming alcohol 4 times in (b)(6), but the physician was unsure if this increase can be attributed to that. The patient had his settings increase to see if that helped with his depression. No additional information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2430006
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dennis100
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« Reply #307 on: January 04, 2019, 09:06:59 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing an increase in depression due to the vns being ¿non-functional¿ for the past three years. It was clarified that the vns was thought to be non-functional due to the increase in depression and the patient not perceiving stimulation. It was stated that the patient would perceive stimulation for a while after the vns was interrogated, programmed, or had diagnostics performed, but after a couple of days, the patient would no longer perceive stimulation. Follow up with the physician revealed that the vns was checked the previous year and no problems were identified with the device functionality. The surgeon had offered to replace the vns, but the patient declined replacement. The patient was seen again recently and the diagnostics were within normal limits. It was noted that the patient had pretty severe depression and dementia. The dementia was not attributed to the vns. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175410
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dennis100
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« Reply #308 on: January 04, 2019, 09:07:55 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Malfunction   
Event Description
The patient reported that her depression was worsening and believed it to be due to her vns battery being low or depleted. A battery life estimation was performed and resulted in approximately 1 to 2 years until the neos status based upon the available programming data. Attempts for information have been made, but no additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8166609
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dennis100
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« Reply #309 on: January 05, 2019, 02:32:44 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/10/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was depressed and was referred to a psychiatrist. The patient's issues had subsided. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8139111
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dennis100
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« Reply #310 on: January 20, 2019, 03:05:20 AM »

Model Number 302-20
Event Date 05/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for surgery to explant his device due to discomfort and pain from a lead pulling sensation whenever he turned his head. The patient¿s device was disabled in 2011 due to lack of efficacy in treating the patient¿s depression. It was later determined that the patient did not have depression but was suffering from an anxiety disorder. The patient¿s generator and lead were explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Additional information was received stating that the vns patient underwent surgery for patient comfort and not to preclude a serious injury. The patient was a non-responder to vns therapy; therefore, the patient¿s generator was explanted and not replaced. Analysis of the returned generator and lead was completed. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the setscrew marks observed near the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The connector pin was inserted into the cavity of a test generator to verify a dimensional issue in the connector portion of the lead wasn¿t preventing the connector pin from being fully inserted into a generator. No obstructions were noted. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854239
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dennis100
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« Reply #311 on: January 21, 2019, 11:30:32 AM »

Model Number MODEL 250
Event Date 11/20/2009
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that during interrogation at an office visit on (b)(6) 2009 the patient¿s settings found were indicative of a faulted diagnostic test. The patient was implanted (b)(6) 2009. Based on the settings listed in programming/diagnostic history database the faulted system diagnostics test occurred on the day of implant, which caused the settings to change. Not all settings were corrected; however, and the magnet output current was at 1 ma. The patient is a depression patient and it is recommended that the magnet output current remain "off". No adverse events were reported. The settings were corrected on (b)(6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3942225
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dennis100
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« Reply #312 on: January 29, 2019, 07:25:16 AM »

Model Number 102R
Event Date 04/01/2014
Event Type  Injury   
Event Description
Additional information was received stating that the vns patient had a long history of depression with mood changes. The patient had severe depression and attempted suicide in (b)(6) 2014. The patient device was tested during an office visit in (b)(6) 2014 and diagnostic results showed normal device function. The patient's increased depression and suicide attempt were not believed to be related to vns.
 
Manufacturer Narrative
Additional information indicates that the event occurred in (b)(6) 2014.
 
Event Description
It was reported that the vns patient was admitted to behavioral center following a suicide attempt. The patient was reported to be doing better. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4092927
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dennis100
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« Reply #313 on: February 09, 2019, 02:07:20 AM »

Model Number 101 NCP PULSE GENERATOR
Event Type  Injury   
Event Description
Was implanted with cyberonics vns. They put in a recalled device and the //ong model. It would not stop going on and very quickly caused dramatic problems. I lost use of my vocal cords for over 8 months and then partially for many years, and began having laryngo spasms many times a day. After a long time, they have finally lessened a lot but still occur. They are quite terrifying as my throat is completely closed when they happen. No air can get in or out. Also, my oxygen levels dropped and stayed low, very low, and have remained on oxygen ever since. Was a straight a student moving through a doctoral program but could not complete due to inability to think and organize logically. I was always a very joyful person, but since the implant, i fight depression every day. Sometimes very serious depression, i was always interested in everything. Since the surgery, i mostly wait to die. It's been years since the device was implanted but it has taken this long to fight my way back to enough health to know to make this complaint. I can't take legal action because within the legal time limits i was fighting for my life and could not act. One of their neurosurgeons told me later that i was never a candidate for the implant and that i was nothing more than a customer to them.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8273950
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dennis100
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« Reply #314 on: February 09, 2019, 02:08:05 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
It was reported that the patient was experienced an increase in depressive symptoms and was being treated as an inpatient. It was suspected that the patient's battery had depleted which resulted in the increase in depression; however, a battery life estimation was performed with the data available to the manufacturer which did not support an end-of-service condition. Replacement surgery is being pursued. 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=8246369
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dennis100
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« Reply #315 on: February 11, 2019, 02:20:56 AM »

Model Number 102
Event Date 04/01/2009
Event Type  Malfunction   
Event Description
A vns pt's wife called and reported that her husband is implanted with the vns for depression. She called mfr for mri precautions. She reported that her husband had a seizure in (b)(6) of this year. He also lost (b)(6) pounds in the last 8 months and recently has had more seizures. Additionally reported that he is also experiencing left foot drop and left leg paralysis and that is why they need to do an mri. Good faith attempts are being made to determine if the reported events are related to their vns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577003
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dennis100
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« Reply #316 on: February 13, 2019, 02:56:43 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2018
Event Type  Malfunction   
Event Description
It was reported by the patient that she was experiencing an increase in depression and needed her vns checked. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8209942
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dennis100
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« Reply #317 on: March 01, 2019, 02:14:47 AM »

Model Number 303-20
Event Date 03/04/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for generator and lead replacement due to high impedance. Clinic notes dated (b)(6) 2015 note that the patient has experienced an increase in depression over the past 6 or 7 months thought to be due to progression of the patient's disease rather than vns failure. It was noted that the patient complained that this continued and device diagnostics were taken and found to be within normal limits (1841 ohms). It was reported that the patient underwent generator and lead replacement. The explanting facility does not return explanted devices; therefore, no product analysis can be performed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940265
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dennis100
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« Reply #318 on: April 06, 2019, 02:03:29 AM »

Model Number 101
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Malfunction   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in mfr report #1644487-2019-00429. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in this report, mfr report #1644487-2019-00428. Programming history was reviewed for the patient. The patient¿s device was disabled. No anomalies were seen. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401427
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dennis100
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« Reply #319 on: April 08, 2019, 02:34:05 AM »

Model Number 300-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/21/2002
Event Type  Injury   
Event Description
It was reported by a patient in medwatch mw5083309 that following their vns implant, they lost the use of her vocal cords for over eight months, and had partially lost the use of her vocal cords for many years. This is reported in this report. The patient also reported that their oxygen levels dropped and remained very low. The patient has remained on oxygen since then. The patient also reported that they have been depressed following the implant. They stated that it has been a very serious depression. This is reported in mfr report #1644487-2019-00428. Device history records were reviewed for the devices. The devices passed all specifications prior to distribution. Attempts for more information have not been successful to date. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8401443
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