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dennis100
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« Reply #450 on: November 10, 2018, 02:34:59 AM »

Model Number 300-30
Device Problem Corroded
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient stated that device did not work for him and the patient did want to replace the battery. Follow up with the physician's office revealed that the vns did not change to patient's seizure frequency. The patient did not elect to replace the vns. However, the patient was referred for and underwent full vns replacement surgery due to an end of service condition and the lead compatibility with the new generator. The explanted lead was received by the manufacturer. Lead product analysis is completed. The lead assembly was returned in four portions. What appeared to be rust-like deposits and pitting were observed on the unmarked connector pin surface. Set-screw marks were observed and indicated that proper mechanical contact was present. Scanning electron microscopy, or sem, was performed and identified evidence of pitting and surface irregularities. Continuity checks of the returned lead portions were performed with no discontinuities identified. Based on the findings in the pa lab, there is no evidence to suggest an anomaly with the returned portions of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7923517
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dennis100
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« Reply #451 on: November 10, 2018, 02:36:05 AM »

Model Number 304-20
Device Problem Fracture
Event Date 09/11/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient had a sore throat and it was believed to be due to the vns. The patient was seen by the physician and diagnostics revealed that the lead impedance was high. The patient was referred for full vns replacement surgery. Follow up with the company representative revealed that the patient's mother wished to have the vns explanted rather than replaced due to the sore throat and the belief that the vns did nothing for the patient. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7935816
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dennis100
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« Reply #452 on: November 11, 2018, 02:38:05 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7974765
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dennis100
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« Reply #453 on: November 11, 2018, 02:39:09 AM »

Model Number 302-20
Device Problem Fracture
Event Date 06/29/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was scheduled for explant due to lack of therapy. Additional information was received that the patient was explanted due to lack of efficacy. High impedance was observed on (b)(6) 2017 through a periodic device database review, and the device was disabled at this time. The facility at which the patient was explanted is historically a no return site no other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7985863
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dennis100
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« Reply #454 on: November 12, 2018, 07:47:20 AM »

Model Number 102
Event Date 09/12/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns explant. The reason for explant was reportedly lack of efficacy and migration due to weight loss. No further information is known at this time.
 
Event Description
Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2782964
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dennis100
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« Reply #455 on: November 14, 2018, 09:00:53 AM »

Model Number 302-20
Event Date 12/21/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2013, it was reported that the patient attended a surgery consult with her surgeon as the patient has possible nerve fibrosis. Clinic notes dated (b)(6) 2012, were received which indicated that the patient was noted to get a little hesitant with right rotation of her neck and appeared to be in some slight discomfort when the physician palpated the upper part of the lead, in the region where it attaches to the vagal nerve. The physician stated that it feels like she may have some fibrous tissue that has accumulated there but there is no redness anywhere over the device or along the lead. The patient's vns was disabled to evaluate the efficacy of the vns device. The physician later reported that he is unable to determine the date the discomfort and possible fibrosis was first observed. No trauma, causal or contributory programming or medication changes preceded the onset of the discomfort. Although surgery is likely, it has not occurred to date.

Event Description
On (b)(4) 2013, it was reported that the vns patient was scheduled for vns explant as the device was reported to have not helped the patient. Clinic notes dated (b)(6) 2013 were received which indicated that the patient has had no benefit from vns. One of the problems that the patient had with the device is that they believe it creates a great deal of pain for her to extend her neck due to tenting of the lead from the left neck to the preaxillary space. When extending the neck, this seems to cause her a great deal of extreme pain. They were not aware of any infection or automanipulation of the device on the part of the patient. An x-ray of the area was reported to have been taken demonstrating no obvious pathology or lead fracture. The physician stated that the lead was palpable under the subcutaneous layer but without excessive tenting. The physician later reported that the reason for lack of efficacy is that the patient is a non-responder to vns and it is unknown when this was first observed. The patient underwent explant of the vns on (b)(6) 2013. The explanted generator and partial lead were returned to the manufacturer for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed.

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted lead. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the cut end of the returned lead portion. No product related anomalies were observed with the single returned lead portion. Product analysis on the generator was completed on (b)(4) 2013. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2954686
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dennis100
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« Reply #456 on: November 26, 2018, 04:51:07 AM »

Event Date 03/01/2011
Event Type  Malfunction   
Event Description
It was reported by a neurosurgeon on (b)(6) 2011 that a patient was recently seen with high lead impedance. In (b)(6), the patient was seen by a neurologist, and the high impedance was observed. The patient is non-verbal; however the patient's father does not believe he is in pain. The patient's generator was left programmed on despite the observed high impedance; however the patient's settings are unknown. At this point, no revision is planned as the patient's father does not believe that the patient experienced efficacy from vns therapy. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2268028
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dennis100
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« Reply #457 on: December 01, 2018, 01:46:43 AM »

Model Number 304-20
Event Date 06/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 information was received from the reporter that the patient was scheduled to have surgery on (b)(6) 2013, either a lead repositioning or an explant. Follow-up confirmed that both the generator and lead were explanted on (b)(6) 2013. The primary reason for surgery had been reported that over time the white tie-downs that attached to the patient¿s lead had slowly moved to the surface of the skin and had begun to push through the skin. The surgeon, upon fixing the issue during surgery, then explanted the entire vns system due to a reported lack of efficacy in the patient. The patient and family had reported that there was no benefit of the vns and did not want the device replaced because the patient never received a therapeutic effect. The patient had no types of infections, complications, or any other issues with surgery. A review of the manufacturer¿s programming history database showed that there were no anomalies in the generator settings and also that no diagnostic tests had been performed. The explanted generator and lead products have been returned to the manufacturer for product analysis. Additional information is pending further attempts to the reporter and analysis of the products.

Event Description
Product analysis of the explanted generator and lead was performed. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions. A lead assembly was returned for analysis in four pieces with the lead connector portion still attached to the pulse generator. Abrasions were identified on the outer silicone tubing at multiple locations. The electrodes were damaged showing bends in the electrode ribbon and partial detachment of the electrode ribbon and suture from the silicone helix. This condition was most likely caused at explant. The lead assembly has remnants of what appears to be dry body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the cut ends of the returned lead portions. Based on the appearance of the returned lead portions, it is believed that the identified punctures, kinks, superficial cuts, etc. Were most likely caused during the explant procedure. Product analysis of the generator verified an end-of-service message was seen and was associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Follow up with the physician's office found that the physician stated the reason they had to do surgery was that the lead had eroded through the skin and the patient was not experiencing efficacy with the device. It was stated that "as far as we know" the patient was doing well since explant. No other information was provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3237070
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dennis100
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« Reply #458 on: December 06, 2018, 01:24:41 AM »

Model Number 105
Event Date 07/13/2014
Event Type  Injury   
Event Description
It was reported that the vns patient went to the er on (b)(6) 2014 because the patient was unable to disable her device. The patient was experiencing chest pain, voice alteration, and tightening of the chest. It was later determined that the reason why the patient was unable to disable her device with her magnet was likely due to improper technique. The patient stated she also had bradycardia while in the er. The patient¿s device was disabled, but the patient continued to experience voice alteration and shortness of breath. The physician stated that these issues were not related to vns. Ekg and ct were reported to be normal except for the bradycardia. The relationship between the bradycardia and vns is unknown. The patient was referred to see a cardiologist. The patient¿s device was disabled prior to being discharged. The patient¿s parent stated that the patient¿s blood work was abnormal; however, it is unclear what was abnormal with the blood work results. Attempts for additional relevant information have been unsuccessful to date.

Event Description
The explanting facility discarded the explanted device; therefore, no analysis can be performed.

Event Description
Clinic notes were received indicating that the vns patient was scheduled to undergo surgery on (b)(6) 2014 to explant her device. The patient had been hospitalized due to vomiting, diarrhea, sinus bradycardia, and voice hoarseness. The patient was given new medication and her device was disabled. It was noted that the patient¿s voice issues continued despite device disablement. The patient¿s device was tested and showed normal device function. The patient was seen by a cardiologist who determined that the patient had a history of nighttime bradycardia. The patient stated that she also had recently experienced bradycardia during the daytime. The patient had a history of chronic chest pain and was unable to tolerate stimulation at high settings due to the chest pain. The patient wanted her device explanted because it was uncomfortable and reportedly did not help with her seizures. Follow-up revealed that the patient¿s anxiety, nausea, voice alteration, vomiting and diarrhea were all related to vns stimulation. As the patient¿s device settings were increased, the patient¿s bradycardia had worsened and the patient was a non-responder to vns. The neurosurgeon stated that the patient did not have a prior history of cardiac events nor any pre-existing conditions susceptible to cardiac events. Additionally, the neurosurgeon indicated that the patient developed bradycardia following implant surgery. The patient underwent surgery on (b)(6) 2014 to explant her device. The explanted device has not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4013497
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dennis100
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« Reply #459 on: December 08, 2018, 01:49:38 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/16/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was in the hospital with a coma. The facility wanted to conduct an mri for the patient, and wanted to have the patient's device turned off. Additionally, it was stated that the patient had not seen any benefit from the vns device and the patient's family would like to have the vns device turned off indefinitely. Due to the patient being in a coma and needing and mri, physicians discussed the possibility of the device needing to be explanted. No other relevant has been received to date. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8051575
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dennis100
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« Reply #460 on: December 09, 2018, 03:38:00 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/26/2018
Event Type  Malfunction   
Event Description
This patient's mother reported that her daughter's parameter settings were increased at an appointment in (b)(6). It was stated that the patient now feels the device going off all the time and that when the device goes off the patient is having seizures. It was also stated that the patient's vns is not benefiting her and not helping her. Additional information was received from the patient's neurologist's office that the mother had called in stating that the vns keeps providing magnet stimulation with not magnetic field around, causing the patient to have seizures. The mother stated that the vns was not acting normal, and took the patient to the er but was unable to have the issue resolved. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8083923
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dennis100
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« Reply #461 on: December 09, 2018, 03:38:36 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2006
Event Type  Injury   
Manufacturer Narrative
Event Description
A patient reported through social media that vns did not work for her and that she also did not like that it made her voice hoarse. It was stated that the generator was disabled. Per the physician's assessment, the patient became seizure free after her second surgery for her brain recurrent brain tumor. It was noted that vns was placed after the patient's first surgery for the brain tumor. The device was disabled for lack of efficacy and because the patient was seizure free after removing her brain tumor. It was also reported that there was pain at the "nonfunctioning vns site". No diagnostics were provided. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8083811
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dennis100
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« Reply #462 on: December 09, 2018, 03:39:25 AM »

Model Number 303-20
Device Problems Corroded ; High impedance; Mechanical Problem
Event Date 05/15/2012
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient underwent generator and lead explant surgery due to lack of efficacy. The devices were returned for analysis. In the lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In the lead assembly returned for analysis, an abraded opening was noted on the silicone tubing resulting in portion of the positive coil being exposed. Scanning electron microscopy images of the connector pin and connector ring show that pitting or electro-etching condition have occurred on both the connector pin and connector ring exposed surfaces. An energy dispersive spectrometry analysis was performed on a sample of the deposits observed on the pin. The analysis showed the presence of elements present in stainless steel 316. The higher percentage of iron in this sample suggests oxidation may have occurred. Though it is difficult to state conclusively the observed condition of the connector pin mentioned above may confirm this to be a contributing factor for the reported ¿high impedance¿ allegation. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Internal investigation determined that in the event that the lead becomes compromised through wear or trauma (e. G. An abraded opening in the lead¿s silicone tubing), a charge imbalance may form at this location as a result of the alternate current pathway associated with the original model 105 generator design (e. G. Sn<20000). As a result of this charge imbalance and the low pitting potential of quadfilar coil, coil corrosion can occur resulting in a lead discontinuity.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8078971&pc=LYJ
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dennis100
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« Reply #463 on: December 10, 2018, 03:10:42 AM »

Model Number 100
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that this patient underwent explant surgery due to lack of efficacy, the need for an mri and the fact that the device bothers the patient. It was stated that the patient's device was completely dead prior to surgery. The explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8119963
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dennis100
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« Reply #464 on: December 12, 2018, 01:50:42 AM »

Model Number 300-20
Event Date 08/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
As the patient wanted to have an mri performed, diagnostics were run on the vns device which showed high impedance (output status = limit, lead impedance = high, dcdc = 7). Follow up with the physician found that x-rays were not performed. It is unknown if any patient manipulation or trauma occurred which may have caused or contributed to the high lead impedance. Additional programming and diagnostic history was unavailable. The vns device was explanted on (b)(6) 2013 to allow the patient to have an mri. The patient's device was previously disabled in (b)(6) 2002 to 0. 0 ma output current, per the patient's request, due to perceived lack of efficacy. Per the physician, the therapy was stopped because the therapy was ineffective for the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3360861
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dennis100
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« Reply #465 on: December 18, 2018, 12:39:55 PM »

Model Number 103
Event Date 03/01/2010
Event Type  Injury   
Event Description
It was reported that a patient wanted to have the device removed because it had migrated to one end and was protruding. The patient did not believe that it was effective in treating her depression. The patient's physician confirmed that the device did appear to be more visible in the patient's chest. There were no reports of trauma or manipulation of the device. The reason for the migration is unknown. The patient has been referred to a neurosurgeon. 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=1671173
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dennis100
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« Reply #466 on: December 22, 2018, 10:04:50 AM »

Type of Device:     STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Device Brand         VNS Therapy Pulse
Name:
Device                   CYBERONICS, INC.
Manufacturer's
Name:
Date of this            12/19/2014
Report:
(mm/dd/yyyy)
Describe the           The patient is a white male with intractable epilepsy. One month ago the patient
Event                     underwent removal of his vagal nerve simulator due to "pain," "burning," and
or Problem:            discomfort. The device did not prevent/reduce seizure activity as intended. This
                             particular generator and lead were implanted approximately three and a half years
                             ago. Of note, the patient underwent vagal nerve stimulator implantation originally
                             eight years ago. Of note, the patient initially underwent implantation of vagal nerve
                             simulator which was removed and replaced three times due over the course of five
                             years due to various reasons including pain, discomfort, infection and migration of
                             device due to weight loss.
the device(s) may
have                      Minor injury to the patient or health care provider
caused or
contributed to:

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=42681
« Last Edit: December 22, 2018, 10:32:11 AM by dennis100 » Logged
dennis100
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« Reply #467 on: December 26, 2018, 12:38:25 PM »

Model Number 102
Event Date 02/01/2012
Event Type  Death   
Manufacturer Narrative

Event Description
It was reported that the patient had recently passed away. The physician did not have any additional information at the time of the report but was attempting to learn more. The physician indicated that the patient's seizures were never controlled well with medication or vns therapy. The physician reportedly had several co-morbidities as well. Attempts for additional information and a copy of the death certificate are in progress. The funeral home indicated they were unsure if the patient's device was explanted prior to the patient's final disposition.
 
Event Description
Additional information was received as a copy of the death certificate that indicated the cause of death was suicide (b)(6). The patient was buried however it remains unknown if the vns was buried with him. The neurologist's office did not have any information on the patient's death and were not aware of the cause of death but felt that the patient's condition had been declining as his epilepsy did not respond to medication or vns therapy. The relationship of the patient's suicide to vns is unknown. An autopsy was performed however attempts for additional information from the medical examiner's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2480665
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« Reply #468 on: January 03, 2019, 08:40:16 AM »

Model Number 303-30
Event Date 09/09/2011
Event Type  Injury   
Event Description
On (b)(4) 2014, it was reported that the patient¿s generator and lead were explanted electively on (b)(6) 2014 as the patient reported no improvements to their seizure control since being implanted with the device and was experiencing some discomfort. The explanted lead and generator were returned for product analysis on (b)(4) 2014. The nurse later clarified that the discomfort the patient was feeling was in fact shortness of breath and numbness extending from the incision to the chin. The numbness was felt by neurosurgery to be due to injury to subcutaneous nerve during incision. The device had been disabled since (b)(6) 2012. The patient wanted the device off and refused parameter adjustment. The shortness of breath was due to device stimulation. It was stated that the explant surgery was not to preclude a serious injury. Diagnostics were not performed on the vns as the highest the patient was programmed to was an output of 0. 75ma. No causal or contributory programming or medication changes preceded the onset of the events. The nurse stated that she believed vns was not programmed to more therapeutic parameters due to poor tolerance and therefore was not effective. Product analysis was completed on the generator on (b)(6) 2014. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis of the lead is still underway.
 
Event Description
Analysis of the lead was completed on (b)(6) 2014. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3637198
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« Reply #469 on: January 05, 2019, 02:30:51 AM »

Model Number 1000
Event Date 10/18/2018
Event Type  Death   
Event Description
Reporter states her son had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours as his rhythm was stop and go. He was pronounced dead at 11am. A few weeks prior to this event, the pt had an mri done, in which his vns was turned off and the on again by a different neurologist. After the exam, the vns would constantly turn on and off on its own and started to affect his vocal cords. Her son mention he believed the neurologist may have turned the vns up too high and he wanted to have it explanted. She reports the device wasn't helping him and his seizures were getting worse, increasing to 6 violent episodes a month. She also notes her son was agitated and had horrible heartburn the day before he died which literally "knocked him forward. " the autopsy came back negative for any abnormal tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8155362
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« Reply #470 on: January 07, 2019, 03:07:05 AM »

Model Number 103
Event Date 09/05/2013
Event Type  Injury   
Event Description
The physician does not believe that the increase in seziures and changes in seizure patterns are related to vns therapy. The physician reported that the patient recently changed medications and he is trying to see what works for the patient. The physician feels that the vns system is working properly and does not plan to make any changes. It was reported that the patient will continue to assess the patient.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013, note that the patient is experiencing more seizures. It was noted that the patient suffered a severe seizure and sustained a large laceration on her right hand. The patient's family feels that the vns is not helpful and it was noted that they are in the process of decreasing the level of device stimulation. The notes indicate that ativan would be replaced with onfi. Clinic notes indicate that interrogation showed the generator battery is running low. Clinic notes dated (b)(6) 2013, note that the patient's recent seizure was milder, with a quicker return to baseline and that they seem better in that regard. Attempts to obtain additional information are underway, but no additional information has been received to date. The patient has not been seen by physician since (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3622657
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dennis100
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« Reply #471 on: January 09, 2019, 08:59:00 AM »

Model Number 102
Event Date 07/01/2008
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the nurse suggested replacing the vns patient¿s device, but the patient¿s parent did not want the device touched at the time. The generator was previously programmed off. Additional information was received stating that the patient was programmed off prior to her visit with her neurologist in 2012. The patient¿s parent believed that vns was not helping the patient and that the patient¿s seizures were better without vns. In (b)(6) 2008, the neurologist discovered that the patient experienced a 50% decrease in seizure frequency during that summer although interrogation of the device at the time revealed the device was reportedly not working. The neurologist decided not to replace the device. The patient was referred for surgery to explant the device, but the surgeon decided that surgery could be dangerous and left the device implanted as it was not causing harm to the patient. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2008.

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dennis100
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« Reply #472 on: January 10, 2019, 02:03:50 AM »

Model Number 302-20
Event Date 04/02/2014
Event Type  Malfunction   
Event Description
Clinic notes were received indicating that the vns patient¿s increase in seizures was due to a fall that occurred in april 2012 which hospitalized the patient. The patient¿s seizures had increased since the fall occurred so the neurologist adjusted the patient¿s medications. The patient¿s device was previously programmed off in 2012 due to lack of efficacy. No known surgical interventions have occurred to date.
 
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to lead fracture. Further follow-up revealed that the generator was replaced prophylactically. The explanting facility retains explanted product and does not return for product analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient reported that the device initially work well, but that after a period of time it was no longer effective. The physician reported that the device would be programmed off. The patient was referred for surgery. No surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed 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=3782180
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dennis100
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« Reply #473 on: January 11, 2019, 02:37:47 AM »

Type of Device:                     stimulator, autonomic nerve, implanted for epilepsy
Device Brand Name:              VNS Therapy
Device Manufacturer's Name: Cyberonics
Date of this Report:               02/24/2011
(mm/dd/yyyy)
Describe the Event                 Vagus Nerve Stimulator (VNS) lead & generator exhibited "Lack of
or Problem:                           Efficacy." The explanted lead was a 2.0mm and the generator was
                                            Model 103.
the device(s) may have                   
caused or contributed to:        Potential for patient harm

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/Medsun/medsun_details.cfm?ID=23782
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dennis100
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« Reply #474 on: January 13, 2019, 04:09:54 AM »

Model Number 106
Event Date 02/17/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient¿s device was disabled on (b)(6) 2014. It is unclear when the device was disabled as the patient¿s device settings while hospitalized indicate that the device was programmed on.
 
Event Description
An adverse event form for a study patient was received indicating that the patient experienced vomiting and diarrhea possibly related to implant and device stimulation. It was noted that the device was programmed off and the patient has since exited the study. It was reported that the patient was admitted to the hospital on (b)(6) 2014 for vomiting and diarrhea. The treating physician reported that it was moderately severe and occurred intermittently. It was reported that the patient had previously complained about gastrointestinal discomfort, but no specific action was taken because the cause of the vomiting and diarrhea was unknown or thought to be related to the complicated drug therapy or the patient's depression. It was reported that the patient lost approximately 15kg of body weight over the last year. It was reported that since the patient did not feel that vns therapy made any difference in the seizure frequency or severity, it was decided to program the device off during the hospitalization. It was reported that a few days after the device was programmed off the patient stopped complaining about the diarrhea and vomiting. The patient recovered and was discharged from the hospital on (b)(6) 2014.

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dennis100
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« Reply #475 on: January 15, 2019, 03:39:38 AM »

Model Number 302-30
Event Date 04/25/2014
Event Type  Malfunction   
Manufacturer Narrative
Date of event; corrected data: additional information indicates that the date of event was (b)(6) 2014.
 
Event Description
It was reported that the vns patient was referred for surgery due to high impedance and end of service. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2010.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received indicating that the vns patient was tested multiple times during an office visit on 04/25/2014 and diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The neurologist was unaware of any trauma that may have caused or contributed to the reported high impedance. The patient was referred for surgery but the patient declined replacing her device. According to the patient¿s husband, the patient never received efficacy with vns. The husband stated that the patient had been seizure free for two months using a new medication. According to the neurologist, there was no lack of efficacy with vns for the patient. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3826482
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dennis100
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« Reply #476 on: January 15, 2019, 03:40:37 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Injury   
Event Description
It was reported that clinic notes on (b)(6) 2013 note that device diagnostics were within normal limits. The patient's wife indicated that vns therapy did not help the patient and that the patient's arm was sore near the implant site. The patient requested to have the vns explanted.
 
Manufacturer Narrative

Event Description
It was reported that the explanted devices are not available for return to the manufacturer for analysis.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2013 to explant his generator and lead due to a painful lead pulling sensation on the left side of his neck. The patient¿s device had previously been disabled in (b)(6) 2013 due to lack of efficacy. The painful lead pulling sensation continued with the device disabled. The generator and lead were explanted because the presence of the device was causing the pain and the patient never received efficacy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3813078
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dennis100
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« Reply #477 on: Today at 03:09:44 AM »

Model Number 302-30
Event Date 04/17/2014
Event Type  Malfunction   
Event Description
An implant card was received indicating that the patient underwent generator and lead replacement due to battery depletion and lead discontinuity. Further follow-up revealed that high impedance was observed by the surgeon prior to the surgery. The generator was received for analysis. Analysis of the generator was completed on (b)(4) 2014. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The lead was not received for analysis. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received from the neurologist stating that the vns patient was a non-responder to vns therapy. However, it is unclear why the patient was re-implanted if he was a non-responder. It is possible that the neurologist was unaware of the lead discontinuity which would have affected the effectiveness of the device. No x-rays were taken. The surgeon could have elected to replace the patient¿s device generator and lead rather than explant once lead discontinuity was observed. However, no definitive conclusions can be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3895238
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