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[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/01/2018
Event Type  Injury   
Event Description
It was reported that the patient had been referred for vns replacement surgery, and follow up with the patient's neurologist determined that this was due to an increase in seizures. The neurologist suspected this was due to a depleted battery; however, no confirmation of an end-of-service battery status has been received and a battery life estimation performed with the available programming data did not support an end-of-service status. It was reported that the device was checked in july and was noted to be stable. 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=8250731

[dennis100]

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/18/2018
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the physician that the patient had passed away due to sudden unexpected death in epilepsy (sudep). The patient's mother indicated that the vns contributed to the patient's passing; however, the physician reported that was not the case. The physician indicated that the patient's death was not attributed to vns. The last system diagnostics known for the patient were within normal limits. The mother reported that on the day of the patient's death he had a slight seizure around 8 am and his heart stopped. The emt worked on him for several hours but he was eventually pronounced dead at 11 am. The patient's mother additionally reported that the patient's vns had been turned off for an mri a few weeks before the patient's passing and was turned on by a different neurologist. The mother reported that the son thought the neurologist had turned on the stimulation too high and wanted the generator explanted. She reported that the patient's generator would constantly turn on and off, and that it affected the patient's vocal cords. She reported that the patient's device was not helping him and that there was an increase in seizure frequency. She also reported that the patient had horrible heartburn and was agitated the day before he passed away. The patient's autopsy came back negative for any abnormal tests. The suspect product has not been received to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242124

[dennis100]

Model Number 103
Event Date 01/01/2014
Event Type  Injury   
Event Description
Additional information with device settings were received. The vns duty cycle was adjusted on (b)(6) 2014.
 
Manufacturer Narrative
Adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event. Outcomes attributed to adverse event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being updated to show that intervention was taken. Type of reportable event, corrected data: additional information was received that intervention was taken for the increase in seizures; therefore, this field is being corrected to adverse event.
 
Manufacturer Narrative

Event Description
It was reported that the patient has been experiencing an increase in seizures. It is unknown if the seizures are above the patient's pre-vns baseline frequency. Attempts to obtain additional information will be made, but no additional information has been received to date.
 
Event Description
Attempts for additional information were unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3657689

[dennis100]

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

[dennis100]

Model Number 106
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 via clinic notes received by the manufacturer that the patient was experiencing an increase in seizures, approximately 2-3 a week, and migration of the vns generator. The patient underwent prophylactic vns generator replacement surgery. The explanted generator has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8210610

[dennis100]

Model Number 103
Event Date 02/23/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed an ifi condition after being implanted for approximately two years and the patient was experiencing an increase in seizures. The ifi condition is believed to be premature battery depletion. A battery life calculation using the available programming history showed approximately 1. 3 years remaining. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4638131

[dennis100]

Model Number 104
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient's seizures are worse at times, but it is unknown whether or not the increase is above the patient's pre-vns baseline frequency. The patient believes that the generator battery is low. The patient reported that she still feels device stimulation, but that the seizures are changing and are more frequent at night. The patient reported that she has not been seen by the physician for a year and needs to find a new physician to have the device checked. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient had scheduled an appointment with a new physician to check the device but then cancelled the appointment. The patient has not been seen by a physician to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4627745

[dennis100]

Model Number 103
Device Problem Use of Incorrect Control Settings
Event Date 01/01/2013
Event Type  Injury   
Event Description
Information was received from the patient's neurologist. He did not know when the settings were adjusted, but there was an increase in seizures after the adjustment. He stated that this increase in seizures was not related to vns. He also stated that programming changes, medication changes, or other external factors did not cause or contribute to the increased seizures.
 
Manufacturer Narrative

Event Description
Clinic notes were received indicating that the vns patient was not doing well following adjustments to device settings. The patient's device settings were programmed back to previous settings during an office visit on (b)(6) 2013. The patient's device was tested and showed normal device function at the time. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5007921

[dennis100]

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Information was received that the patient's seizure increased from (b)(6) to (b)(6) 2017. Vns was returned to original settings by april after being turned off for surgery few months back. Yet the seizures are still worse currently. Per the physician, the relation of the seizures to vns is unclear. Patient's magnet swiping technique was observed to confirm that it is effective in initiating magnet stimulation. Normal mode diagnostic test results were provided with a dcdc - 5. Patient's device was disabled for patient's hysterectomy. Following that, the settings were titrated up to 2. 75 ma. The patient experienced pain in the throat which went away when the settings were decreased to 2. 5 ma. Since then the patient noticed that vns has not helped with her seizures and wanted it removed. Patient saw a neurosurgeon, who recommended that the vns be programmed off to see changes in seizures before removing. The patient did receive benefit from vns initially but has had a lot of stress. The nurse practitioner mentioned that she can't say the increase in seizures is directly related to vns. The seizure rate in comparison to pre-vns baseline is unknown.
 
Manufacturer Narrative

Event Description
Per the neurologist's note, patient is receiving benefit from device. No known surgical interventions to remove the vns has occurred to date.
 
Event Description
Clinic notes were received for patient, who would like to have her device removed, because she feels she no longer is receiving efficacy from the therapy. Notes dated (b)(6) 2017 indicate that patient's seizure frequency is worse than before over the last several months. Patient reported that the use of the magnet has had no effect in reducing seizure frequency or aborting seizures. Since patient's visit in (b)(6), patient has ben seen several times for vns adjustment. In (b)(6) visit, patient noted that she had increased frequency of seizures and that she has had multiple different types including drop events, convulsions, and starring/spacing. Patient cannot identify any changes in her life or medication use to correspond with this worsening. Patient also tried cbd oil and found it to be somewhat helpful. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6822371

[dennis100]

Model Number 103
Event Date 11/18/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported from clinic notes received on 01/22/2016 that the patient had a change in seizure pattern in (b)(6) 2015. Notes dated (b)(6) 2015 state that the patient has worsened since last visit. Follow-up with the physician showed that impedance values were within normal limits at the time of the worsening seizures. The physician indicated that the worsening seizures were not worse in frequency but more in intensity and her generalized tonic clonic seizures have involved more widespread body regions and are more severe. The physician increased the current on (b)(6) 2015 because of this condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6864304

[dennis100]

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital for increased seizures and one episode of status, which was not normal for patient. The patient also experiences a tingly feeling in their neck. Patient's generator could not be interrogated at the time of report. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542540

[dennis100]

Model Number 102R
Event Date 08/01/2009
Event Type  Injury   
Event Description
It was reported that a patient experienced a significant increase in seizures over the past 2 to 3 months. Device diagnostics were performed and were within normal limits. The patient's programmed settings were adjusted in an attempt to help with seizure control. 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=1543771

[dennis100]

Model Number 102R
Device Problem Battery Problem
Event Date 07/20/2015
Event Type  Injury   
Event Description
Additional information received from the treating physician indicates that the onset of the increase in seizure duration was in (b)(6) 2015 and is likely related to vns therapy. The treating physician indicated that medication change was undertaken to preclude a serious injury. The physician is planning to have the patient's device replaced prophylactically with a new device which offers more therapeutic treatment options. The physician indicated that the planned replacement procedure is being undertaken to preclude a serious injury. No known surgical interventions have occurred to date.
 
Event Description
Information was received indicating that a patient underwent prophylactic explant and replacement of his pulse generator and lead. An implant card received indicates that the generator had not reached near end of service. The explanting facility discarded the explanted devices; therefore, no analysis can be performed.
 
Manufacturer Narrative

Event Description
Clinic notes received from a provider indicated a patient's family voiced concern that the patient's seizures were becoming more prolonged. The notes state the patient was stabilized on the vns and moderately high dose of valproate but the patient has had a recent deterioration. The physician speculated that the vns device may nearing battery end of service. It is stated that his vns has been implanted for approximately 5 years at higher settings and has been helpful in the past. The physician suggested elective vns battery replacement in the next 3-5 months. The patient's medications were altered and follow-up was scheduled for 3 months later. A physician order was sent to have the vns device replaced in (b)(6) 2015. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4973089

[dennis100]

Event Type  Injury   
Manufacturer Narrative

Event Description
An article titled "vns lead removal or replacement surgical technique, institutional experience and literature overview" was published on 09/03/2015 which included adverse events involving 7 vns patients. One patient presented vocal cord paralysis and underwent lead replacement. Two patients presented lead fractures, lack of efficacy and paresthesia and they underwent explant. Two patients presented increased seizures and underwent vns replacement. Two patients suffered small laceration of the internal jugular vein which was repaired with a suture and which occurred during lead explant surgery due to lack of efficacy without replacement of the lead. The manufacturer report # 1644487-2015-05981 involves the patient who presented vocal cord paralysis. The manufacturer report # 1644487-2015-05982 involves the first patient who presented lead fracture, lack of efficacy and paresthesia. The manufacturer report # 1644487-2015-05983 involves the second patient who presented lead fracture, lack of efficacy and paresthesia. This report involves the first patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05985 involves the second patient who presented increased seizures and underwent replacement. The manufacturer report # 1644487-2015-05986 involves the first patient who suffered small laceration of the internal jugular vein. The manufacturer report # 1644487-2015-05987 involves the second patient who suffered small laceration of the internal jugular vein.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5116358

[dennis100]

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
Analysis of the generator was completed on 10/29/2015. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition. Analysis of the lead was completed on 11/06/2015. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative

Event Description
It was reported that a patient's vns generator was explanted. The patient felt vns was making her seizures worse and was causing her pain in the neck. It is unknown if this pain was associated with stimulation. The patient also felt that vns did not help her seizures. Attempts for additional relevant information have been unsuccessful to date. The explanted generator has not been returned to the manufacturer for analysis to date.
 
Event Description
Further follow-up revealed that the physician indicated the increase in seizures was not related to vns. The seizures were not an increase above the patient's pre-vns baseline frequency. Clinic notes on (b)(6) 2015 note that the patient would like her vns removed because it is more trouble than it's worth. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5115756

[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The physician reported that the patient experienced increased seizures, body twitching, numbness in the right arm, and occasional left leg weakness. The physician attributed these events to the vns generator being at a low battery status. The physician clarified that the patient's current increased seizure levels are at/below pre-vns levels. The patient has been referred for vns replacement surgery due to these events. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8380159

[dennis100]

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
Patient reported that vns therapy did not decrease his seizures and had increased his seizures due to the stress from continuous voice alteration and not being able to sing with vns therapy. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8348790

[dennis100]

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/25/2019
Event Type  Malfunction   
Event Description
The patient reported that they have had a recent increase in seizures, and they also wanted to know if the vns generator could move. The patient noted that there are no causal factors for suspected generator migration and increased seizures. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8372209

[dennis100]

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an increase in seizures. Low sodium levels, and pneumonia. The pneumonia and low sodium levels were not alleged to be related to vns. Livanova operating room support specialist checked the patient¿s device, and it was found to be operating as expected. No other information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8301454

[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/07/2019
Event Type  Injury   
Event Description
It was reported via clinic notes received by the manufacturer that the patient was experiencing seizures about every other day, which was an increase. The patient felt that her memory had gotten worse with the increase in seizures. It was noted that the vns was still functioning but the battery life was beginning to wane. The patient was referred for vns replacement surgery. 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=8303438

[dennis100]

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/21/2014
Event Type  Malfunction   
Event Description
It was reported in clinic notes that the patient had an increase in seizures. The patient had recently been released from prison and while they had good seizure control while incarcerated, they had some increased seizure activity upon release. The programming history was reviewed and no anomalies at the time of the event were seen. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8331996

[dennis100]

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/27/2018
Event Type  Injury   
Event Description
During follow up with the physician's office for an increase in seizures reported in mfg. Report #1644487-2019-00054, it was reported that the patient apparently experienced an increase in seizures following the replacement surgery. It was reported as above the pre-vns baseline and the physician was unable to provide an assessment on whether it was related to vns. It was stated that the patient's autostim mode was activated and the patient's vns settings were reduced back to those on the previous m103 generator. The diagnostics from the doi were within normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8321729

[dennis100]

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Malfunction   
Event Description
It was reported by the patient's caregiver that since the patient's last scheduled settings change on (b)(6) 2019 the patient has had 4 seizures. It was indicated that with the prior settings changes the patient only experienced one seizure between (b)(6) 2018 until (b)(6) 2019, indicating an increase in seizure frequency with the most recent programmed settings. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8323332

[dennis100]

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/06/2018
Event Type  Malfunction   
Event Description
It was reported that the patient had an increase in seizures in (b)(6) 2018. The patient's generator was disabled in 2009 per our records, however the patient's device may have been turned on since then. At the time, it was believed that the patient¿s generator was at end of service (eos), and that it was not providing therapy. It was reported by the patient that they were feeling more stimulation than normal in (b)(6) 2019. The patient had called in for help in getting a new magnet, and had mentioned that she feels more stimulation than normal. This allegation indicated that the device was not at end of service in march, and had likely been turned back on. A battery life calculation was performed for the patient, and there was only data present from the patient¿s date of implant. There were no anomalies seen. The battery life calculation does not support the patient having an increase in seizure due to end of service. Attempts for more information have been unsuccessful to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8325954

[dennis100]

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/02/2019
Event Type  Injury   
Event Description
It was reported from a patient that she was feeling pain after settings were increased for her seizures. The patient later saw her neurologist who turned the settings down, however the patient was still feeling the pain. It was clarified that the patient was not feeling pain with stimulation, although she only began feeling the pain after settings were previously increased. An update was received stating that the constant pain was occurring behind the patient's electrode site on the neck. It was noted that the patient had been taken to the er due to increased seizures and intolerable pain in her neck. She stated that her vns was "not working" and that she wanted it removed. The patient was still experiencing pain after decreasing settings. Follow up with the physician's office confirmed that when the patient was last seen, the output current was decreased due to pain and swelling in the neck and throat after previously increasing settings. It was unknown what the cause of the pain, swelling, and increased seizures were at this time. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8320621

[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
It was reported the patient was referred for prophylactic replacement due to experiencing an increase in nocturnal seizures which resulted in hospitalization. Per the physician, the nocturnal seizures are idiopathic. The patient's generator was later replaced. The device is being returned by the explanting facility but has not been received to date. Attempts for further information have been made. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8328954

[dennis100]

Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
The physician reported that a patient's mother is concerned that the vns battery is near end of service. The patient's mother told the physician the patient has had an increase in seizure frequency. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8338745

[dennis100]

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/07/2019
Event Type  Malfunction   
Event Description
It was reported that the patient has had several seizures since having a vns generator replacement, and that the patient has had drastically more seizures with the new generator than with the previous generator which had a dead battery. Multiple attempts for follow up were performed with the patient's neurologist but no additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8351249

[dennis100]

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/04/2018
Event Type  Injury   
Event Description
It was reported that the patient was experiencing a change in seizure patterns. It was unclear what change had occurred at the time of the initial report. The physician was inquiring about vns involvement. Follow up with the physician's office revealed that the change in seizure patterns had begun since the vns was implanted. It was stated that the patient was experiencing longer seizures of 10-15 seconds compared to the pre-vns baseline of 3-5 seconds and that the patient was experiencing more seizures in the morning after waking up and more rescue medication has been given in the mornings. It was stated that the seizure frequency had remained the same as the pre-vns baseline. The physician did not know the relation between the change in seizure patterns and vns. The autostimulation threshold was adjusted and the patient was referred for blood work and an emu stay. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8350858

[dennis100]

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/26/2019
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized due to an increase in seizures and status epilepticus. The reason for the increase in seizures is unknown. Clinic notes were received and reviewed for the patient¿s generator replacement. Programming data was reviewed. The battery life calculation does not support the increase in seizures being due to low battery. No anomalies were seen. The patient¿s generator was replaced, and has not been received by livanova. No other information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8359286