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dennis100
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« Reply #480 on: March 08, 2019, 01:54:11 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/25/2019
Event Type  Injury   
Event Description
It was reported on vns therapy (b)(6) by a patient¿s mother that her son had vagus nerve damage that caused gastro paresis as a side effect of vns therapy. No patient could be identified, and no further information was received despite reaching out to the reporter. No additional information is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8348620
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dennis100
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« Reply #481 on: March 09, 2019, 03:02:16 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2016
Event Type  Injury   
Event Description
The physician reported that they had to program the vns off due to the patient experiencing vomiting and weight loss as a side effect of the vns. The physician also notes that the patient's vomiting has resolved and that the patient has also gained weight. Further follow up with the physician confirmed that both vomiting and weight loss were thought to be caused by vns stimulation. The physician notes that this patient had an extensive work up including assessment from the physician's mental health and gi colleagues who could find no organic cause for these symptoms. The physician also notes that there has been no documented changes in medication or other treatments. The physician mentioned that device disablement was both for patient comfort and to avoid serious injury. The physician notes that by the time the vns was turned off the patient's weight loss was 9 kg and they were experiencing daily vomiting. The physician notes that the patient's vomiting has resolved since the device was disabled and that the patient has also gained weight. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8331367
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dennis100
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« Reply #482 on: March 14, 2019, 06:26:47 AM »

Model Number 304-20
Event Date 10/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during a vns repositioning surgery for placement of a gastrostomy tube unrelated to vns, the surgeon pulled on the lead and it appeared to have broken while he tugged on it from its location at the upper incision. An implant card was also received indicating the lead was "fissured" during surgery when the lead was pulled back for repositioning. The generator was previously in the abdomen due to the patient's small size. The physician wanted to salvage the lead and replacement was not intended. They needed to re-tunnel for the lead so both incision sites were opened. The physician tugged the lead back, towards the neck. It was reported that the lead had frayed and broken near the lead pin and occurred while the physician was pulling on it very hard by hand. No surgical instruments were used on the lead. Diagnostics after the break were high. It was noted that the case was very difficult based on the patient铠size and complication due to the gastrostomy tube. It was reported that diagnostics were reportedly within normal limits prior to surgery. The generator was replaced as the battery was reported to be at near-end-of-service. The lead was discarded at the end of the procedure. The explanted generator has not been received to-date. No additional information has been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5190183
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dennis100
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« Reply #483 on: March 20, 2019, 11:13:10 AM »

Model Number 303-20
Event Date 03/30/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient stomach was twitching which was suspected to a suspected lead fracture. The patient's device was subsequently disabled. However, the patient's device was tested and showed lead impedance within normal limits (impedance value - 2500 ohms). Additionally, x-rays were provided to the manufacturer for review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Additional information was received stating that the patient's device had been programmed back on to evaluate stimulation on-times by evoked potential monitoring. The recording were provided to the manufacturer for review. Based on the recordings, the patient's lead was suspected to be fractured as it appeared device stimulation was not being delivered. The patient's device was again disabled. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5225087
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dennis100
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« Reply #484 on: March 23, 2019, 01:44:54 AM »

Model Number 104
Event Date 12/01/2015
Event Type  Injury   
Event Description
On (b)(6) 2015 it was reported by the patient's mother that the patient has had recent unusual seizure activity that started over the last few months (that she thinks are simple partial seizures) and thinks are possibly related to the device function. She wants the patient to see the physician to check the vns device. The patient's mother went to the physician's office and reported that she wants the vns "worked on". Per the nurse, the mother did not report any change in the patient's seizures. The patient's mother later reported that the patient was having an increase in partial seizures and that the vns generator was not delivering the appropriate amount of therapy. She stated that she thinks the physician "switched the battery to save settings. " the mother feels that the increase in seizures is above pre-vns baseline levels. The patient's mother stated that there is a change in behavior; the mother described this as stiffening of arms and right side of body, quick arm and hand movements, incontinence, and unusual desire for excessive water. She said these were all things that were well controlled and are now occurring more frequently. The mother indicated that there has been no change in medication.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5304878
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dennis100
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« Reply #485 on: March 27, 2019, 06:57:21 AM »

Model Number 106
Event Date 01/31/2016
Event Type  Death   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient passed away on (b)(6) 2016. The on-call physician that pronounced the patient's death reported that the cause of death was sepsis due to clostridum difficule colitis. The patient underwent generator replacement surgery on (b)(6) 2016. Following the surgery, the patient was prophylactically prescribed the antibiotic clindamycin. The patient subsequently developed an infection of clostiridum difficule. The funeral home reported that the patient had an extensive medical history and was "very sick. " the patient was buried with the generator still implanted. No additional relevant information was received. Manufacturer device labeling indicates that it is important to follow infection control procedures. It is recommended in labeling to administer antibiotics postoperatively at the discretion of the physician. A review of device history records showed that both the lead and generator were sterilized and passed all inspections prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5461592
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dennis100
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« Reply #486 on: March 27, 2019, 06:58:16 AM »

Model Number 103
Event Date 01/22/2016
Event Type  Injury   
Event Description
The patient reported that she has facial droop which she resolves with her magnet. The patient also reported that she taped the magnet over the generator to disable device stimulation and she was no longer experiencing tachycardia. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician reported that the facial droop, tachycardia, and voice alteration are not related to vns. The physician reported that voice alteration was not noted. The physician also reported that since the patient relates that when the device is off there are no voice changes, the device was programmed off; however, magnet mode stimulation was left on. The physician indicated it is unclear when and why the patient's complaints originated.
 
Event Description
The patient continues to complain of vocal issues. She indicated that she was seen by an ent. The patient indicated that the ent believed the wire may have gotten tugged during a neck surgery where a steel plate was placed in the patient's neck that may be causing the patient's issues. The patient also reported that she is experiencing vocal dystonia and gastroparesis. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
The physician¿s office indicated that the patient has been treated for dystonia for a while at another clinic and it was not believed to be related to vns. The notes found that the patient was seen on (b)(6) 2016 and the vns was functioning as intended. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5470661
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dennis100
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« Reply #487 on: March 28, 2019, 08:19:23 AM »

Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012. The physician reported that high lead impedance was first observed on (b)(6) 2012. It is unknown if a copy of the x-rays will be provided as the physician reported that the patient needs to request them from medical records. The physician stated that no patient manipulation or trauma occurred that was believed to have caused or contributed to the high lead impedance. The physician also reported that on (b)(6) 2011, he interrogated the patient's vns and the settings were found to be as follows: output current 2. 25ma, signal frequency 20hz, pulse width 250 microseconds, signal on time 30 seconds, signal off time 1. 1 minute, magnet current 2. 50 ma, magnet on time 30 seconds, magnet pulse width 250 microseconds. Diagnostics were performed which showed the device was working properly with the lead impedance =ok, dcdc=2, and neos=no. No changes were made to the patient's settings. He further reported that on (b)(6) 2012, he interrogated the patient's vns and the settings were found to be as follows: output current 2. 25ma, signal frequency 20hz, pulse width 250 microseconds, signal on time 30 seconds, signal off time 1. 1 minute, magnet current 2. 50 ma, magnet on time 30 seconds, magnet pulse width 250 microseconds. Diagnostics were performed which showed there was high lead impedance, dcdc=7, and neos=no. The patient's signal off time was decreased from 1. 1 minutes to 0. 8 minutes. Due to this high impedance, the patient was referred to surgery and seen by the surgeon on (b)(6) 2012. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported on (b)(6) 2012, that the patient was seen at a follow up visit and had high impedance. He was referred to a surgeon. A chest x-ray was also ordered. Additional information was received on (b)(6) 2012, indicating that the patient was seen by the surgeon. The physician's notes indicted that lead impedance was high and the dc/dc code was 7 when diagnostics were run, however it doesn't indicate which diagnostics (system or normal mode) this was observed on. Additionally the generator was not at end of service. When the high impedance was observed, the neurologist changed the patient's off time, but no other settings were changed. The x-rays were reviewed by the surgeon and he indicated that there were no obvious lead breaks. It is unclear if the x-rays will be sent in for review by the manufacturer. The patient was referred for a full revision. Revision is likely, but has not occurred to date.
 
Event Description
On (b)(6) 2013, it was reported that this patient may have been having pseudoseizures. Surgery is likely but has not taken place.
 
Event Description
It was reported that this patient was seen on (b)(6) 2013. The physician stated that the patient's non-epileptic spells that are currently intractable.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On 08/12/2013, additional information was reported that the patient was seen on (b)(6) 2013. The patient¿s non-epileptic events were still occurring, but his seizures at night with incontinence were worse. The patient¿s family sated that the device never worked; however, the physician¿s notes indicated that the patient had an initial benefit prior to the device not working due to high impedance. The device was checked again on, and high impedance was still seen. The patient had not responded well to medications. The patient has presumed non-epileptic events and frontal lobe seizures. Surgery is likely but has not taken place.
 
Event Description
An implant card was received which indicated that the patient underwent lead replacement due to "lead malfunction". The lead impedance with the new lead was marked as "ok". It was reported that the lead was discarded on the day of surgery and will not be returned to manufacturer for analysis.
 
Manufacturer Narrative
This information was inadvertently left off of mfr. Report #01.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2714078
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dennis100
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« Reply #488 on: March 28, 2019, 08:20:25 AM »

Model Number 102
Event Date 04/08/2012
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2012 found that the patient had experienced "four episodes of limpness and unresponsiveness lasting up to 45 minutes," which was "completely atypical for her. " the patient's mother confirmed the change in seizure pattern on (b)(6) 2012 as she reported that the patient was experiencing incontinence during seizures which the patient had not prior to vns in 2007, and that recently the patient became unresponsive while experiencing seizures. The patient's mother also reported that the patient's seizures had increased in frequency; however, she stated that this frequency was the same frequency level the patient had prior to vns. The patient's mother reported that the patient had been to the emergency room three times in the past few months and that the "unresponsive" behavior started on (b)(6) 2012 while the incontinence had been occurring for the past eight months. Clinic notes dated (b)(6) 2012 further detail the patient's change in seizure pattern. The patient's unresponsiveness lasts 4-5 minutes. The patient also experiences clusters of eye rolling up fluttering, which leads to difficulty seeing. Nine of these events were experienced on (b)(6) 2012 from 0650 to 0745, and three more events were experienced while the patient was in school. In addition, it was noted on (b)(6) 2012 that the patient is in pain when using the magnet. It is unknown where this pain is located and how long it has been occurring. Clinic notes dated (b)(6) 2012 verify that the patient's seizures had become worse and that she was in the hospital that day due to the number of seizures. The physician states in the notes that he believes the patient needs a prophylactic battery replacement as the battery is greater than six years old and the rapid cycling settings the patient is set on is using up the battery more quickly. Notes dated (b)(6) 2012 again state that a vns battery change is needed, and the patient underwent replacement surgery on (b)(6) 2012. Attempts have been made for additional information; however, they have been unsuccessful. Attempts will be made for product return so product analysis can be performed. No additional information is available.
 
Event Description
Clinic notes dated (b)(6) 2012 indicate that the patient had about ten seizures per day, which was pretty good control for her. Clinic notes dated (b)(6) 2012 additionally noted that the physician was concerned about the recent episodes the patient had. The physician stated that the patient's mother told him that the patient is out of it for 45 minutes and can sleep up to 18 hours. Apparently a teacher at school thought the patient was faking this although the physician stated it is unclear to him how the patient could fake that length of sleeping. Per the physician, the patient does not typically have this type of seizure and this is a change for her, so before making medication adjustments, it was planned to take a 24 hours video eeg to see if there aware any changes from her last eeg which was several years ago. Clinic notes dated (b)(6) 2012 indicate that the patient was weaned off of topomax.
 
Manufacturer Narrative
Date of event, corrected data: incorrect date inadvertently written in initial mdr. Describe event or problem, corrected data: information from clinic notes inadvertently not included in initial mdr. Relevant tests/laboratory data, including dates, corrected data: information inadvertently not included in initial mdr.
 
Event Description
Follow up with the physician's office found that the patient's device was turned back on again on the same day of the surgery - (b)(6) 2012. The explanted device has been discarded/destroyed. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2858364
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dennis100
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« Reply #489 on: March 28, 2019, 08:21:12 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury   
Event Description
It was reported that after a change in stimulation off time settings from 3. 0 minutes to 1. 8 minutes, the patient experienced two cases of fecal incontinence, tiredness, and possibly increased seizures. The diagnostics were noted to be within normal limits and the patient's settings were changed back to the original duty cycle settings. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7992173
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dennis100
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« Reply #490 on: March 28, 2019, 08:22:09 AM »

Model Number 102
Event Date 08/16/2013
Event Type  Death   
Event Description
It was reported by the physician that the patient had died. Follow up found that the date of death was (b)(6) 2013. It was reported that the aptient was found in the bathroom after an apparent seizure. The patient had incontinence. The family was insistent that the patient had not missed any medication and there was no known cause for a seizure. They do not plan for an autopsy. Good faith attempts have been made; however, they have been unsuccessful. No additional information has been provided.
 
Manufacturer Narrative
Date received by manufacturer; corrected date: previously submitted mdr inadvertently provided a wrong date for this field (08/25/2014). The correct date for this field is 09/02/2014. This report is being submitted to correct this date.
 
Event Description
Additional information was received indicating that the vns patient had passed away from "natural causes¿. The coroner noted bruising on the left eyelid and bruising and swelling of the tongue, which indicates that the patient possibly had a seizure and bit his tongue prior to death. An autopsy was not performed and a blood sample was not ordered. The cause of death was listed as ¿seizure¿. The coroner¿s report noted that the patient had a history of seizures and was implanted with a vns device. It is believed that the patient¿s device was not explanted prior to burial; therefore, no analysis can be performed. With the available information, an internal classification has determined that the death may be possible sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3350634
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« Reply #491 on: April 04, 2019, 01:45:53 AM »

Model Number 102R
Event Date 01/22/2013
Event Type  Death   
Event Description
It was initially reported that the patient passed away and the cause of death was unknown. The physician was uncertain of the cause of death she just knew that the patient had passed away. No further information was provided. Follow-up with the funeral home indicated that the patient was likely buried with the generator and lead. Good faith attempt for additional information and the death certificate have been unsuccessful to date.
 
Event Description
Additional information was received that the cause of death was hospital acquired pneumonia, respiratory distress hypoxia due to (or as a consequence of) seizure disorder, severe gerd, hypothyroidism and mental retardation. There was no autopsy performed and the manner of death was natural. Based on an internal classification based on the available information the death is not sudep.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3092878
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dennis100
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« Reply #492 on: April 04, 2019, 01:46:34 AM »

Model Number 302-20
Event Date 01/07/2010
Event Type  Injury   
Event Description
It was reported by a nurse that a vns pt experienced a loss in weight and had to decrease the pt's vns settings due to the pt losing weight. The event of loss in weight started last yr. Further info from the nurse indicated the pt was also complaining of severe neck and left lateral chest pain which was positional. Additional info was received from the treating nurse indicating the cause of the pt's loss of weight was related to vns pain in the throat as the pt could not eat due to pain. The nurse did not know a cause for the pt's positional pain as the pt stated that the event has been ongoing since vns placed. Interventions planned are to have a second opinion and replace vns as it significantly improves the pt's seizures. Additional info was received through clinic dated (b)(6) 2011 notes indicating the pt's seizures are worse due to lack of rest, pt is experiencing painful stim, cannot swallow, increase in acid reflux allegedly due to vns, device disabled (b)(6) 2011 - pain stopped as a result of device being disabled. Interventions taken were to increase meds as vns is disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1999589
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dennis100
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« Reply #493 on: April 04, 2019, 01:47:13 AM »

Model Number 102R
Event Date 03/07/2013
Event Type  Death   
Event Description
It was reported that a vns patient passed away on (b)(6) 2013. Their death was not related to their vns device but sudep is suspected to be the cause of their death. The pt weighed (b)(6), the etiology of their seizures: iatrogenic hypoglycemia secondary to insulin in the nursery. The patient had quadriparesis, cortical blindness dysphagia and gerd. The patient had seizure reduction with the vns. They were receiving vns therapy treatment at the time of death. They were set to 2. 00 ma,20 sf ,250 pw ,7 seconds on time,30 seconds off time ,2. 25 ma ,60 seconds on time ,250 pw. No products were explanted at the time of death. No autopsy performed, their death was not witnessed. The patient was found pulseless in the am, cold, lying in bed and no signs of a struggle. The patient did have a history of nocturnal seizures. The patient does have a history of mild aspiration with no recent pneumonia at time of death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3035470
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dennis100
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« Reply #494 on: April 04, 2019, 01:48:02 AM »

Model Number 302-20
Event Date 04/16/2012
Event Type  Injury   
Event Description
On (b)(6) 2012, clinic notes were received through case management. Review of the clinic notes dated (b)(6) 2012, revealed that the patient was in the emergency room twice the night before with seizures. The emt taped the magnet to her vns and the device was turned off. The patient was referred for battery replacement due to a low battery. It was reported that the patient has not been feeling stimulation over the last 5-6 months. The patient was noted to have an increase in seizures over the last months. The patient has multiple seizure types; psychomotor, gtc, and dualistic with aura. The patient was noted to have a past medical history of acute myocarditis, respiratory failure, gerd, cardiomyopathy, lymphadenitis, and a family history of lung cancer and diabetes. It was later reported that although a dcdc of 4 was observed during a system diagnostics test on (b)(6) 2012, high impedance was not observed. The increase in seizures was first observed 2-3 months ago. The physician believes the increase in seizures is due to loss of therapy and stress. The patient has been scheduled for prophylactic battery change. The increase in seizures is below pre-vns baseline levels. All the patient's seizure types have increased. It was unknown if any causal or contributory programming changes, medication changes, or other external factors preceded the onset of the increase in seizures. No causal or contributory programming or medication changes precede the onset of the stimulation not perceived. No patient manipulation or trauma occurred that is believed to have caused/contributed to the stimulation not perceived. The patient underwent prophylactic battery replacement on (b)(6) 2012. Pre-operative system diagnostics showed output=ok/lead impedance=ok/dcdc=2/eri=no. The patient's settings were output=2. 25ma/frequency=25hz/pulse width=250usec/on time=30sec/off time=3min/magnet output=2. 5ma/magnet pulse width=250usec/magnet on time=60sec. The generator was replaced and system diagnostics showed the system to be functioning properly with output=ok/lead impedance=ok/dcdc=2/eri=no. Attempts for the return of the explanted generator have been made but have been unsuccessful.
 
Event Description
On (b)(6) 2012, it was reported that the hospital could not find the explanted generator; it was reported that it might have been disposed of. It was later reported that the hospital did indeed have the generator and would be returning it to the manufacturer for product analysis. The explanted generator was returned to the manufacturer on (b)(6) 2012. Product analysis is still underway and has not yet been completed.
 
Event Description
Additional information was received on (b)(6), 2012 when product analysis was completed on the explanted generator. In the pa 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. The generator performed according to functional specifications; there were no anomalies found with the pulse generator.

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« Reply #495 on: April 04, 2019, 01:49:11 AM »

Model Number 102
Event Date 12/13/2012
Event Type  Injury   
Event Description
Reporter indicated that during a ventral hernia repair surgery, a vns patient had an episode of bradycardia. The patient did not have a history of cardiac events, but the patient's father did have a history of cardiac events. The patient has pre-existing medical conditions of hypertension, depression, asthma, gerd, and tmj. The arrhythmia experienced was bradycardia; normal heart rate was 72, during event it was 39. Preoperative bp was 128/74, bp during event was 56/27 at the lowest. The vns generator was programmed on for the surgery. Interventions taken for the intraoperative bradycardia event were done to preclude a serious injury. The bradycardia has not recurred. Follow up with the reporter revealed '"pt presented for ventral hernia repair on (b)(6) 2012. Pt had eventful preoperative course, and no issues with induction of anesthesia. 1 hour into the case, during extensive lysis of adhesions in the abdomen [using electrocautery], the patient became profoundly bradycardic and hypotensive. Pt's anesthetic was decreased and he was given 100% o2, phenylephrine 600 mcg total, glycopyrrolate 0. 1 mg, atropine 0. 8 mg, calcium 0. 5 mg, magnesium 1 gm, and a total of 1. 7 mg epinephrine over the course of about 30 minutes during the severe bradycardia. A magnet was also placed over the [vns] device intraoperatively and transcutaneous pacing was used during the event. The case was aborted and the patient was subsequently extubated and taken to pacu and then the icu for overnight monitoring. He experienced no abnormal sequelae and returned several weeks later for the procedure without complication. " it was felt the combination of the extensive electrocautery used and the vns stimulation may have caused the bradycardia event per the reporter.

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« Reply #496 on: April 05, 2019, 10:09:06 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/26/2019
Event Type  Injury   
Event Description
It was reported that the patient had abdominal pain and nausea and the physician questioned if the patient¿s electrodes had been placed correctly. The patient was at 0. 75ma output current, and was asked to practice with the vns magnet providing 1ma stimulation once or twice a week. When the patient practiced with the magnet she experienced massive abdominal pain. The patient was ramped up to normal output current 1ma. Two weeks later, the patient had reduced continuous abdominal pain. The duty cycle was changed. Two weeks after that, the patient stated that the pain was reduced further but still not gone. The frequency was lowered from 30 hz to 20 hz. After a month, the patient still had pain and developed symptoms of diarrhea and no appetite. The patient¿s general practitioner had no assessment of the symptoms. The patient¿s device was disabled at the request of the patient and the pain resolved. X-rays were received and reviewed for the patient. Per the x-rays, the generator placement appeared to be normal in the left axillary chest area. Complete pin insertion was confirmed as the pin can be seen coming through the second connector block. The feed through wires, and the lead wire continuity appeared normal. The lead was observed in the neck and chest. Part of the lead appears to be behind the generator and could not be assessed. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. The electrodes are placed correctly, as there is a single wire present on the top electrode, and double wires present after the second electrode, indicating proper orientation. Note that the presence of a micro fracture and/or a lead discontinuity cannot be ruled out in the portion of the lead that is not visible in the provided images. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8445038
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« Reply #497 on: April 05, 2019, 10:09:48 PM »

Model Number 302-20
Device Problem High impedance
Event Date 02/20/2019
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Patient underwent generator replacement and impedance was noted to be ok post-operative. Two days later, the patient began to experience a scratchy voice and coughing. The patient was seen by a neurologist and high lead impedance was observed. The patient was seen by the surgeon and x-rays were performed. The surgeon reviewed the x-rays and noted that nothing was wrong with the device. The patient was seen by the neurologist's nurse practitioner. Upon interrogation, lead impedance was ok. The patient was programmed to the same settings prior to device replacement and began to experience coughing, gagging, crying, and dry heaving. The patient's settings were decreased until the patient was stable. By the end of the programming session, high impedance was again observed. 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=8444541
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dennis100
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« Reply #498 on: April 06, 2019, 02:27:40 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/04/2019
Event Type  Injury   
Event Description
It was reported that the patient consulted with a surgeon for removal of the vns due to breathing issues at night and vomiting. The patient now has to use a cpap. It was reported that the patient¿s pcp suspected the issues may be related to vns, but was unsure since the patient¿s lab results were normal. The patient reported having a decrease in seizures from vns therapy and has been working with a neurologist to adjust therapy. Clinical notes were later received which reported the patient experienced the stomach flu and had several vns adjustments by the neurologist. 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=8464223
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dennis100
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« Reply #499 on: April 07, 2019, 03:18:33 AM »

Model Number 1000
Device Problem High impedance
Event Date 08/06/2018
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
High impedance was found during an internal programming history review. Design history records were reviewed for the generator. The device passed all functional specifications prior to distribution. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generators compared to those reported by model 103-106 generators. As indicated in the physician's manual, high lead impedance (>/=5300 ohms), in the absence of other device related complications, is not an indication of a lead or generator malfunction. The patient's physician has reported that the family feels that the patient has experienced behavior side effects and also urinary incontinence and blamed the vns for these events, despite the physician explaining that the vns may not be causing those events. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425237
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« Reply #500 on: April 07, 2019, 03:19:19 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/21/2019
Event Type  Injury   
Event Description
It was reported that the patient was experiencing pain and caused the patient to vomit. Consequently, the device was turned off and it was noted that the patient felt better immediately. Information was received that the system diagnostics for the patient's vns generator were within normal limits. No other relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8444513
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dennis100
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« Reply #501 on: April 16, 2019, 01:17:47 AM »

Model Number 104
Event Date 06/08/2015
Event Type  Injury   
Event Description
It was reported from a vns patient that he had an esophageal tear from intubation. This occurred during the patient's replacement surgery when the suspect device in this report was explanted. No intervention was reportedly taken on the tear and the patient healed with no issues noted. The explanted generator was returned for product analysis to the manufacturer. The analysis verified that the generator performed according to all functional specifications and passed all electrical tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5972949
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dennis100
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« Reply #502 on: May 10, 2019, 01:48:21 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's fiancé reported that the vns was turned up too high at the generator replacement surgery. It was noted that the patient's quality of life is not good, and at the "higher" output current the patient was feeling dizzy, nauseous, and "felt like having seizures", and she "felt like she is being overmedicated". Further follow up confirmed that the patient's generator output current was reduced as a result of the patient's symptoms, and that the patient's symptoms resolved after the parameter adjustment. The physician noted that the patient was feeling "poorly" due to pain and feeling like they were getting too strong of a stimulation. The physician reported that the patient experienced increased seizures due to being very stressed and very much in pain/discomfort, which stemmed from the vns output current being set too high. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8556724
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« Reply #503 on: May 11, 2019, 02:49:25 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/01/2018
Event Type  Injury   
Event Description
Clinic notes were received for patient referral for replacement. Notes indicated the reason for referral was due to low battery. They also indicated that the mother reports the patient has had a dry cough from vns and the mother wanted the battery checked because of this. The mother also reported that since november about every three weeks the patient has gi upset leading to vomiting or stomach ache. The patient was put on prilosec and this has helped a bit. Notes state he is now having side effects including coughing when the device fires and perhaps some gi issues and painful at times. It is unclear if the patient's referral for replacement is related to the adverse events he has been experiencing. No additional information has been received to date. Surgery has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8554701
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dennis100
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« Reply #504 on: May 14, 2019, 01:17:59 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury   
Event Description
It was reported through social media that a patient experienced gastric paresis as a side effect of vns. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8547840
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« Reply #505 on: May 23, 2019, 11:17:55 PM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2011
Event Type  Injury   
Event Description
Clinic notes were received in regards to a vns explant referral. Within the clinic notes it was stated the patient is interested in having her vns removed. It was noted the vns had been programmed off since 2011, but the patient continues to have physical discomfort. Attempts for additional relevant information have been unsuccessful to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient's pain after disablement is suspected to be at the generator site. The cause of the pain remains unclear. Both the generator and as much of the lead as possible will be removed. The removal is for patient comfort and to improve quality of mri to evaluate for breast cancer. The breast cancer was not reported as an allegation against vns therapy. Per notes, patient has a family history of breast cancer and is going for mri screening for breast cancer. Patient also experienced pain at generator site. The painful stimulation in the chest occurred after patient had gastric bypass surgery when vns was turned back on. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Report source, corrected data: health professional and company representative. Supplemental mdr #2 inadvertently did not include the report source. Date received by manufacturer, corrected data: 03/02/2018. Supplemental mdr #2 inadvertently did not include the date received by manufacturer.
 
Event Description
Patient underwent explant surgery to remove the vns. Explanted devices will not be returned per hospital policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6551029
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dennis100
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« Reply #506 on: June 08, 2019, 06:59:06 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2019
Event Type  Injury   
Event Description
It was reported that the patient has had a fever, severe vomiting, and weight loss following vns replacement surgery. The patient was hospitalized, and the patient reported that the physicians believe that the patient has acute gastritis caused by damage to the vagus nerve. The device was not turned on following replacement. The patient was later released for the hospital. During the full replacement surgery, it was reported by a sales representative that there wasn¿t anything abnormal. The lead impedance was normal and the device was not programmed on. Device history records were reviewed for the generator and lead. There were no unresolved non-conformities, and the devices passed all specifications prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8637187
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dennis100
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« Reply #507 on: June 09, 2019, 01:54:27 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/11/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, (b)(4).
 
Event Description
It was reported that the patient had an infection at both the lead and generator site. The patient was initially implanted approximately a month prior to the report. The manufacturer's device history records were reviewed and it was verified that the lead and generator were sterilized prior to distribution. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.
 
Event Description
It was reported that the patient's generator and lead were explanted. The patient reportedly had a tuberculosis infection. The patient reported that she went to the er on (b)(6) 2017 vomiting, swelling, and a feeling like she had something "pressing against her trachea. " the er told her that her post-operative swelling was normal. The neurologist prescribed iv fluids and zofran. Then, she woke up with purulent discharge from her neck incision and she went to the er on (b)(6) 2017 where she was treated with antibiotics and after 24 hours was referred for explant and transferred via ambulance, she was diagnosed with a postoperative infection and treated. On (b)(6) 2017 they lavaged her device but on (b)(6) 2017 took her to the hospital and explanted her vns. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6854331
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« Reply #508 on: June 09, 2019, 01:55:47 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/25/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient had experienced constant autostim stimulations, making him sweat, vomit, and causing a sore neck. The patient reported that he could not sleep, and that the pain went from his neck up to his ear, and his symptoms did not change according to what position he was in. Once the magnet was taped over the patient's generator, the symptoms went away. The patient visited his neurologist and the device was disabled. At the time the interrogation revealed nothing remarkable in terms of diagnostics. It was reported that the patient was feeling fine over the weekend and there was no reason to suspect that the autostim's frequent stimulation was due to the patient's heart rate being higher than normal. The device was turned back on later with autostim remaining disabled. Programming history was reviewed from the generator and no anomalies were seen. The amount of autostimulation per day was similar across the weekend of the event as compared to previous time periods. The amount of total stimulation per day was similar before the event and during the event. The patient was referred for replacement in order to have day night features, and due to the patient¿s belief that the autostim function of the generator was not working. Surgery is likely but has not occurred to date. No additional or relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8639935
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dennis100
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« Reply #509 on: June 14, 2019, 06:22:06 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was hospitalized due to nausea, vomiting, double vision, and tremors attributed to the vns surgery. A hospital discharge form for the patient notes that the symptoms were caused by peak dose effect of medication and dehydration and poor oral intake in the immediate aftermath of his surgery. It was stated that there is no relationship to any vns malfunction as the device was not turned on, but there is a clear relationship of the adverse events to the after effects of the surgery and anesthesia. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8658323
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