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dennis100
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« Reply #30 on: September 11, 2018, 02:47:40 AM »

Model Number 103
Event Date 09/21/2011
Event Type  Injury   
Event Description
It was initially reported that the pt was to undergo a battery replacement surgery, though she had recently been implanted. However, later information from the physician indicated that the pt's mother had noted swelling over the generator site, which was said to be "not getting worse and there [had] been no drainage or redness at the site. " later, though, there was a large fluid collection at the site. Over time, there was no gross change in the appearance. The pt was intubated due to seizures and had a fever. There was concern of a low grade infection given the wound's state. The physician commented that they would remove the generator, collect cultures, and wash the wound, leaving the lead intact for a future replacement the surgery was completed as planned, and the product was returned to the manufacturer for analysis. Information from the physician showed that the cultures indicated a seroma, and the pt had been set to 0. 5 ma prior to explant. The pt was medicated with iv ancef. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2307846
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dennis100
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« Reply #31 on: September 11, 2018, 02:49:48 AM »

Model Number 302-20
Event Date 02/10/2011
Event Type  Injury   
Event Description
It was reported by a surgeon that a vns patient had extrusion of a lead connector which was removed in february (mfr. Report # 1644487-2011-00435) and a sensitive staph grew on broth culture. She then had an admission for vns site infection in june with high wcc but no organism isolated. Patient also presented with redness and swelling around the vns and had been treated with fluciox and cephalexin.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2308197
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dennis100
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« Reply #32 on: September 12, 2018, 02:27:58 AM »

Model Number 102
Event Date 09/05/2011
Event Type  Injury   
Event Description
Further information from physician reveals that the infection was believed to be due to vns, but patient manipulation or trauma occurred "immediately post op" that may have contributed to the infection. No cultures of the would were taken. The patient was put on antibiotics and the issue resolved.
 
Event Description
It was reported that one week after the vns implanted surgery, the pt had redness and swelling at the generator site. He tried cleaning the wound, and on the day he was supposed to go for a follow-up visit with his neurologist, it appeared that the wound was opening up. On the same day, the physician referred the pt back to the surgeon. The pt was put on antibiotics. The pt explains that he saw the surgeon and was told the infection is getting better, and the pt can return to "light" or "limited" work. Attempts for further information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the lead and generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2307851
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dennis100
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« Reply #33 on: September 12, 2018, 02:28:36 AM »

Model Number 102
Event Date 09/16/2011
Event Type  Injury   
Event Description
Additional information was received indicating that surgery to replace the patient's generator has occurred. The explanted generator has been returned and undergone analysis. The generator performed to specifications and no anomalies were found.

Event Description
It was reported via clinic notes received dated (b)(6) 2011 that the patient was experiencing more frequent breakthrough seizures after being seizure free for almost 3 years. The physician indicated that the vns battery may be nearing end of service; however, diagnostics were normal and did not indicate the generator was near end of service. The notes state that the patient is still experiencing intermittent hoarseness with stimulation indicating the patient is still feeling stimulation. After 1 seizure that resulted in a fall, it was noted that the left side of the patient's chest appeared more swollen and the patient's wife expressed concern that the generator may have shifted position. The physician stated that there was a possibility that the reduction of the pulse width from a previous visit may be a contributing factor. Attempts for further information have been unsuccessful to date. Surgery to replace the patient's generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2308207
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dennis100
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« Reply #34 on: September 12, 2018, 02:29:16 AM »

Model Number 103
Event Date 11/13/2010
Event Type  Injury   
Event Description
Reporter indicated vns revision surgery was tentatively planned for (b)(6) 2012. The patient later had vns generator and lead replacement surgery performed on (b)(6) 2012. The explanted generator has been returned and is pending analysis. The explanted lead was discarded by the hospital.
 
Event Description
Manufacturer follow-up with the surgeon's office revealed the patient has scheduled and cancelled her surgical consult appointment for the vns generator migration and pain three times. Due to the multiple cancellations, the surgeon's office will no longer see the patient for a surgical consult. All attempts to the reporter for additional information have been unsuccessful to date.
 
Event Description
Reporter indicated a patient was being referred for a surgical consult due to the vns generator migrating in the chest and causing pain. Attempts for further information are in progress. Surgery to reposition or replace the generator appears likely. The patient previously had generator repositioning surgery on (b)(6) 2011 due to migration; the surgery was done for patient comfort only and not to preclude a serious injury.
 
Event Description
Product analysis was completed on the returned vns generator. No anomalies were identified, and the generator performed per specifications.
 
Event Description
Reporter indicated the patient presented to the office on (b)(6) 2012 complaining of painful stimulation on her left side and when lying down. Vns diagnostics were reported as ok, and the vns output current is set to 0. 5ma. The patient then reported to the manufacturer on (b)(6) 2012 that she was having pain in her neck and chest. Before the pain started, the patient had been in a physical domestic dispute, and was assaulted. There is also swelling at the generator site per the patient. The patient was referred back to her treating physicians, who were also notified of the events by the manufacturer. The patient has been referred for vns lead and generator revision surgery, but a consult has not occurred to date.
 
Event Description
Reporter indicated the patient was seen in clinic on (b)(6) 2011 and vns diagnostics were normal and the patient is doing well at this time. Surgical intervention is no longer planned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2288147
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dennis100
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« Reply #35 on: September 12, 2018, 02:29:59 AM »

Model Number 302-20
Event Date 09/01/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2011, a vns treating physician's nurse reported that they saw the vns patient on (b)(6) 2011, because the patient was experiencing an increase in seizures, below pre-vns baseline levels, for the past (b)(6) weeks. When diagnostics were performed in the office visit, high impedance was discovered. The physician did not disable the device. The patient was still able to perceive stimulation and did not report any changes in the way it felt. The nurse then reported that the patient's generator was implanted very auxiliary, but now the device has migrated almost to the center of her chest. The patient has not reported any trauma or manipulation. The physician believes the generator migration has something to do with the high impedance. On (b)(6) 2011, the patient's spouse reported that when the patient's generator migrates, it causes the patient excruciating pain. Additionally he stated that she only randomly feels stimulation now and it is not as consistent as it was before. On (b)(6) 2011, the patient's x-rays were received by the manufacturer. Based on the x-ray review there was a suspect area in the lead near the electrodes, in the strain relief bend. However a lead break was unable to be confirmed at this location due to poor contrast of the x-rays. Also, an unpronounced lead fracture could not be ruled out. On (b)(6) 2011, the vns patient's husband reported that they have been having a lot of problems with the patient's increased seizures and her neck swelling. A worst case blc was performed with the patient's limited programming history which revealed 10. 4 years until eri=yes. Attempts for additional information have been made to the physician, but no further information has been received to date. Although surgery is likely, it has not yet occurred.
 
Event Description
On (b)(6) 2011, additional information was received when it was discovered that the vns patient was scheduled for a revision surgery in october. The physician later reported that the generator migration and decreased perception of stimulation were first noticed on (b)(6) 2011. The physician also provided clinic notes dated (b)(6) 2011, which reported that the patient has had some breakthrough seizures. The clinic notes also state that the generator has been mobile and the patient has some pain associated with this. The patient reported that she can still feel vns firing. The physician referred the patient for x-rays but they were apparently not sent to the manufacturer for review. The patient went for a full revision surgery on (b)(6) 2011 and although good faith attempts for product return have been made, the explanted product has not been returned to the manufacturer to date. The lead was replaced due to the high impedance but it is unknown why the generator was replaced at this time. Attempts for further information are underway, but no additional information has been received to date.
 
Event Description
On (b)(6) 2011, additional information was received when the manufacturer's consultant reported that the patient's generator had been replaced due to prophylactic reasons when the lead was replaced due to high impedance on (b)(6) 2011.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2284091
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dennis100
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« Reply #36 on: September 13, 2018, 01:57:42 AM »

Model Number MODEL 250
Event Date 05/14/2014
Event Type  Malfunction   
Event Description
Analysis of the returned handheld device was completed. The cause for the reported allegation is associated with a defective main battery. During testing, it was also identified that the main battery was unable to power the handheld, giving further indication that it is defective. Further analysis identified that the handheld would not power on. The cause for the anomaly is associated with the swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing it from powering on. No further anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the handheld device¿s battery was damaged. The handheld device would only work when plugged into its power adaptor; however, the handheld device would frequently restart and display the following warning message: ¿the battery latch was opened. The system was put into sleep mode. ¿ the battery latch was reported to be fine, but the battery was puffed up and was pushing up against the battery latch. The handheld device was returned to the manufacturer where analysis is currently underway.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the handheld device passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3856628
« Last Edit: January 19, 2019, 03:35:47 AM by dennis100 » Logged
dennis100
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« Reply #37 on: September 14, 2018, 08:16:55 AM »

Model Number 102
Event Date 07/16/2011
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
All further attempts to the reporter for additional information have been unsuccessful to date. The explanted vns generator has been returned and is currently pending product analysis.
 
Event Description
Product analysis of the vns generator was completed. No anomalies were identified during the analysis and the generator performed per specifications. The generator was not at end of service.
 
Event Description
Reporter indicated a patient had vns generator migration, neck, shoulder, and chest pain, swelling over the generator site, erratic vns stimulation, and increased seizures. The vns generator was also reported to be nearing end of service and not working at full power. The patient had vns generator replacement surgery performed on (b)(6) 2011. A battery life estimation for the generator performed by the manufacturer yielded approximately 2. 69 years remaining, but 1. 5 years of programming history was missing. Attempts for further information and return of the explanted generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2330300
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dennis100
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« Reply #38 on: September 18, 2018, 08:30:14 AM »

Model Number 102
Event Date 10/04/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6) 2012, additional information was received when it was discovered that the hospital did not have the explanted product to return to the manufacturer and therefore, must have been discarded.
 
Event Description
On november 8, 2011, clinic notes from a vns treating nurse practitioner were received through case management. Review of the clinic notes dated (b)(6) 2011 revealed that the patient felt that the vns was making her left neck twitch with stimulation. The patient reported that she would like to have the device explanted as she does not feel that it has helped with her seizure control. The physician also stated that the patient has not tolerated the stimulation well and therefore, he has not been able to increase her settings past an output current of 0. 5ma. The physician decreased her output current from 0. 5ma to 0. 25ma and her magnet output current from 0. 75ma to 0. 5ma. The physician doesn't feel that she is getting much stimulation from the device with these low settings. The physician also reported that he encouraged her to consider battery replacement since he is not so sure that her seizure control has not improved some over time with the device. On november 8, 2011 the nurse practitioner reported that the patient wants her device explanted and the physician agreed to refer her because the patient was not happy with the device but it was unclear as to why the patient was unhappy. The nurse stated that the patient has been experiencing some issues with her lymph nodes swelling and that the patient¿s primary care physician has indicated that the patient may want to remove the vns device in order to treat the swelling. The patient¿s last system diagnostics were on july 19, 2011 and the results showed output=ok/lead impedance=ok/dcdc=3/eri=no. A battery life calculation was performed which revealed 5. 83 years until eri=yes. Good faith attempts for additional information from the nurse have been made but no further information was received to date. Although surgery is likely, it has not yet occurred.
 
Event Description
Additional information was received on (b)(4) 2011 when it was discovered that the patient was scheduled for explant surgery. The surgery took place on (b)(6) 2011 and attempts will be made for the return of the explanted product.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2355579
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dennis100
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« Reply #39 on: September 18, 2018, 08:31:08 AM »

Model Number 302-20
Device Problems Break; High impedance
Event Date 04/16/2009
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Initial reporter indicated that their pt had high lead impedance. It was reported that in dec a box fell on the pt's neck and since that time the pt had not felt her vns stimulation and had hoarseness after talking on the phone for an hour that would resolve over time and was transient. The pt had full revision surgery and it was noted in the operating room that the pt's vagus nerve appeared swollen and was reported to have been injured by the pt's box injury in dec. No interventions were planned to treat the pt's vagus nerve injury. During surgery a gross lead break was noted prior to replacement of the vns system. Lead break was additionally noted on x-ray review prior to surgery. The pt's lead break was reported to have been related to their injury with the box falling on their neck in dec. It is unk the cause of the pt's inner silicone tubing abraided opening. The lead assembly was returned in two portions with one loose and one tie down attached. The green (-) electrode inner silicone tubing appeared to be abraded open approximately 6mm from the end of the electrode bifurcation and the quadfilar coil appeared to be broken in this area. During the visual analysis of the returned 331mm portion the green (-) electrode quadfilar coil appeared be broken in several areas. Visual analysis was performed and identified one of the areas as being thin which prevented identification of the coil fracture type with evidence of electro-etching on the surface. The add'l coil break was identified as having evidence of being melted with pitting on the surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1459521
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dennis100
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« Reply #40 on: September 20, 2018, 10:37:14 AM »

Model Number 303-30
Event Date 07/20/2011
Event Type  Injury   
Event Description
Analysis of the returned generator was completed. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current 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.
 
Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the supplemental report #3 inadvertently reported the date the information was received by the manufacturer incorrectly. The correct date field was (b)(4) 2013.
 
Event Description
Further information was received indicating the patient was scheduled for full vns re-implant. The surgery took place on (b)(6) 2013.
 
Event Description
The generator was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
The previously submitted mdr incorrectly reported this information. The suspect device was not returned to the manufacturer for analysis. The previously submitted mdr incorrectly reported this information. The suspect device was not returned to the manufacturer for analysis.
 
Event Description
Review of the manufacturer in house programming database revealed that system diagnostics on (b)(6) 2011 were within normal limits, indicating proper device function.
 
Event Description
An implant card was received which reported the patient was re-implanted with vns therapy system on (b)(6) 2013.
 
Event Description
Additional information was received from the physician on (b)(6) 2012. He stated the swelling, edema, and vocal cord paralysis were addressed with antibiotics and remove of the vns. The swelling, edema, and vocal cord paralysis are due to the presence of the device (infection). There were no reports of trauma or manipulation. He did not know if the paralysis occurred with stimulation on times only. It was unknown if there were any programming or medication changes prior to the onset of the edema or vocal cord paralysis. The patient does not have a history of either edema or vocal cord paralysis. Good faith attempts to obtain additional information from the physician including dates of removal of the device and more details on the infection were unsuccessful to date. The dhrs for the lead and generator were reviewed and sterility prior to device distribution was confirmed.
 
Event Description
Additional information was received on (b)(4) 2012 where it was reported that the patient had the generator and lead explanted but not replaced on (b)(6) 2011. Follow up with the physician who treated the patient for the infection revealed that the patient (b)(6) infection that was found in (b)(6) 2011 and later had the device removed over concerns for continued infection. The patient also had a laryngoscopy on (b)(6) 2011 which was said to be unremarkable. It was believed that the patient may have had some difficulty swallowing due to possible upper tracking of infection from the vns lead. The patient was given doxycycline prior to removal of the device. The neck and larynx were negative for any abscess during a ct scan. The cause of the infection was unknown.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2011 that a vns patient was having symptoms of inflammation and mild edema at the lead site, and left side vocal cord paralysis. It was unknown when these issues began. 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=2417107
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dennis100
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« Reply #41 on: September 20, 2018, 10:38:36 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Injury   
Event Description
Upon further follow up with the nurse, it was revealed that the patient is experiencing pain and a "shocking sensation in chest due to wires being bunched up". The lead appears to be protruding from mid-neck to the collarbone with a "knot" felt at the lead body. The only intervention taken to date is assessment by the surgeon. Both the surgeon and the treating vns physician tested the device, and it was reported to be working okay. The patient's severe body spasms are believed to be the likely cause of the lead protrusion and caused the extreme pain and feeling of being shocked. No other physiological changes are believed to have contributed to the lead protrusion. Since the surgeon is afraid the lead wires may break if not replaced and due to the length of implant, the patient is referred for full revision surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported on (b)(6) 2013, that the patient is experiencing lead wires "bulging" accompanied with tension/pain in the neck that occurred right after she had a severe episode of body spasms about 10 days prior. The patient has a variety of physical illnesses, one of which includes these body spasms. The treating rn believed the body spasms may have been experienced as an extreme case due to stress as the patient was on her way to her brother's funeral. She also thought that the protrusion was due to the spasms that the patient experienced. The rn also mentioned that the patient's depression had been worsening recently, but that she believes that the patient's stress (brother passing away, dog being ill) have contributed to this recent increase in depression. The patient was evaluated again by the treating vns psychiatrist on (b)(6) 2013. Diagnostics on the patient's vns are within normal limits. The psychiatrist reports that the lead "bulging out a little bit like a vein" but was unsure if this bulge has always been there all along. Later, it was reported that the patient has also been experiencing pain and swelling in the tongue due to little cuts on her tongue which occurs with stimulation, and the surgeon believes this is related to vns. The patient has been experiencing this for a while; however, it has worsened lately with the other events. The treating rn did not have further details at that time. Clinic notes from the surgeon dated (b)(6) 2013, indicate that the patient complains of tension/pain in the left neck/leads and had been worsening over the past few years. The surgeon indicated in the notes that he can offer operation for lead revision for severe excess lead tension and generator change for end of life which the patient agreed. The patient was scheduled for surgery for possible generator and lead revision due to pain and swelling with stimulation. The surgeon reportedly believes the patient does not need an x-ray because he can see the wires bunched "where it goes into the vns. " as of (b)(6) 2013, the rn reported the patient indicates that she has a "white line in her skin going along the vagal nerve" and a knot at the electrode site which the patient and physician can feel. The rn also indicated that the patient has a lot of accompanying medical, physical and psychological problems. Although surgery is likely, it has not occurred to date. Attempts for additional information from the treating psychiatrist's office ( rn) have been unsuccessful to date. Follow up with the surgeon's office revealed that per the psychiatrist's notes, the patient "denies any pain or discomfort from vns. She has been diagnosed with major depression disorder and major psychotic disorder which may be a psychotic manifestation of her symptoms. Would like to rule out psychotic or psychological disorder. " the nurse indicated that the surgeon appears to be due to not to preclude a serious injury as the notes indicate that she denies pain or discomfort and the symptoms appear to be thought to be related to her other mental/physician illnesses. However, it remains unclear at this time.
 
Manufacturer Narrative

Manufacturer Narrative
The initial report inadvertently reported the age incorrectly as the date of event was listed incorrectly. The initial report inadvertently reported the event date incorrectly as it was reported that the tension and pain in the neck was worsening over the past couple of years.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3027374
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« Reply #42 on: September 21, 2018, 01:31:36 PM »

Model Number 102
Event Date 03/12/2016
Event Type  Death   
Event Description
Additional information was received that the patient had passed away on (b)(6) 2016. The patient's devices were explanted on (b)(6) 2016 by the medical examiner's office but have not been received to date. Patient was re-admitted in to (b)(6) hospital around (b)(6) 2016 due to experiencing seizures. After seizures, patient clutches the generator site and complained of pain. According to the treating physician, this has occurred several times. The hospital requested the device be checked and a field representative performed interrogation and diagnostics. The physician was informed about using the magnet to disable the patient's device and was asked to contact the patient's neurologist for further instruction. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep. The autopsy results were requested from the medical examiner's office but were not received to date as the autopsy is not yet completed.
 
Event Description
Death certificate and the autopsy results were received indicating that the patient's immediate cause of death was hypertensive cardiovascular disease. The manner of death is natural. The patient died while in hospice care. Patient's medical history is significant for congestive heart failure, liver and kidney failure, (b)(6), mental retardation and dementia. Patient also has a clinical history of seizure disorder. Per the autopsy results, the heart is markedly enlarged and globular with four-chamber dilatation and diffuse endocardial fibrosis of the left ventricle. The lungs are edematous, and the right lower lung lobe is collapsed, the liver is mottled. The right kidney has marked cortical pitted scars consistent with remote infarction or possible chronic pyelonephritis. A vagus nerve stimulator is in place. As such, the cause of death is hypertensive cardiovascular disease. Hepatitis c is a contributory cause.
 
Manufacturer Narrative

Event Description
The explanted devices were received for analysis on 05/02/2016. Since a significant 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 anomalies were identified in the returned lead portion. Analysis of the generator is underway and has not been completed to date.
 
Manufacturer Narrative
Additional manufacturer narrative and/or corrected data: supplemental report #1 inadvertently omitted the identifiers of the corrected data fields, which were (describe event or problem) and (relevant tests/laboratory data, including dates) regarding details of the patient¿s hospital admission and device diagnostics respectively.
 
Event Description
It was reported that the patient was admitted to the icu due to seizures. The nurse at the icu reported that the patient grabs at the area of vns but is unable to communicate the issue due to pre-existing conditions. Due to this, a device issue is suspected and the nurse was informed about the use of magnet in disabling the stimulation and referred to patient's neurologist who can disable the device. Additional information was received from the nurse at the icu about patient's admission on (b)(6) 2016 due to nausea and vomiting. On (b)(6) 2016, patient experienced seizures. At night around 1 pm on (b)(6) 2016, patient grabbed the left chest at the generator site and reported pain. Patient was given pain medication and the magnet was not used to disable the device. On (b)(6) 2016, patient reported pain again around 4 pm. Patient was reported to have been discharged after (b)(6).
 
Event Description
In the (b)(4) 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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. Analysis in the (b)(4) lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5549413
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dennis100
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« Reply #43 on: September 23, 2018, 02:58:33 AM »

Model Number 104
Event Date 12/13/2011
Event Type  Malfunction   
Event Description
Reporter indicated the increased seizures the patient experienced were due to the high lead impedance. The seizures were not above pre-vns baseline level and the seizure type was not known.
 
Manufacturer Narrative
Describe event or problem, corrected data: information regarding the increased seizures was inadvertently omitted from follow-up mdr #1.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Per the patient's caregiver, on (b)(6) 2012, the patient's incision sites appeared purple and the patient had debridement and irrigation of the vns generator area, and the generator was moved to a new pocket. The patient then had vns prophylactic generator and lead replacement surgery performed on (b)(6) 2012, due to desiring a newer vns model. The vns may have been placed in the right chest due to the patient's continued wound healing problems and possible infection. An implant card was received indicating the vns generator and lead had been replaced due to "malfunction". The explanted vns generator and lead remnant were received for analysis on (b)(6) 2012 and are pending analysis. The vns generator was interrogated successfully in the product analysis lab and did not display any abnormalities upon interrogation. Attempts for further information regarding the wound healing and possible infection are in progress.
 
Event Description
Reporter indicated the new vns generator was implanted in the right chest due to the previous poor healing issues in the left chest incision area. The new lead was tunneled diagonally across the chest. It was unknown what to attribute the poor wound healing to, as the patient had no trauma and it was not felt there had been any device manipulation by the patient. The patient was last seen on (b)(6) 2012, and has been released back to the care of her neurologist, with instructions to call the surgeon's office if issues arise. There have been no calls about the patient since she was seen on (b)(6) 2012. There was no infection present in the wound, but the lead was extruding through the skin prior to the (b)(6) 2012 surgery. The cause of the poor wound healing is unknown, and there was no known trauma or device manipulation by the patient. Additional manufacturer follow up with the treating neurologist's office revealed, the patient is doing well since the surgery, and there have been no issues with the wound healing. Product analysis of the explanted lead and generator was completed. Note that since the majority 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. Scanning electron microscopy images of the unmarked connector pin show that pitting or electro-etching conditions have occurred on the pin surface. However, the generator and lead were received connected together, and the generator was programmed on; the generator was outputting to an open load. Other than the above mentioned observations and the typical wear and explant related observations, no product related anomalies were identified in the returned lead portion. Results of generator diagnostic testing and monitoring indicated the device was operating properly and that the battery was at an "ifi = yes" condition. Electrical test results showed that the pulse generator performed according to functional specifications. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Manufacturer Narrative

Event Description
Reporter indicated a patient presented on (b)(6) 2011, with swelling around the vns generator site, increased seizures, and high lead impedance with vns diagnostics testing. The patient recently had vns generator replacement surgery performed on (b)(6) 2011, and all vns diagnostics were normal at the surgery. The patient had vns lead pin reinsertion surgery performed on (b)(6) 2011, which resolved the high lead impedance. It was noted during the surgery that one of the lead pins had "popped out" of the generator header. The lead pins were then secured appropriately into the generator header. Vns diagnostics following the lead pin reinsertion were within normal limits. Attempts for further information are in progress.
 
Event Description
Reporter indicated the patient's vns generator site incision had opened up (wound dehiscence), and the vns lead was visible within the wound. There was not an infection present, and it is unknown why the wound opened up. There was no trauma, and it is not felt the patient manipulated the vns, though she is developmentally delayed. There does not appear to be any hygiene issues, as it was felt the patient was very well cared for at home by her mother. The patient had exploratory surgery performed on (b)(6) 2012. The patient is on antibiotics because she had an open wound. At the (b)(6) 2012, surgery, the wound was washed out and debrided and closed, but no devices were explanted. The patient was seen on (b)(6) 2012 and is doing well.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2408227
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« Reply #44 on: September 26, 2018, 05:37:38 AM »

Model Number 102
Event Date 08/29/2011
Event Type  Injury   
Event Description
Additional information was received from the surgeon who reported that the patient's reported additional health problems are not related to vns. The patient has been referred to a vascular specialist, but the patient has not followed up.
 
Manufacturer Narrative
The supplemental report #1 inadvertently did not include that the patient now reportedly has seven blood clots.
 
Event Description
It was reported that the patient has seven blood clots and has swelling in the legs and left arm, and the patient did not have these blood clots and swelling prior to vns. Attempts for additional information from the surgeon's office have been unsuccessful to date.
 
Event Description
It was reported that the patient had the generator and lead explanted on (b)(6) 2014. The explanted products have not been received by the manufacturer to date.
 
Event Description
The patient reported that the patient wants to the vns device explanted because it caused him to have blood clots. The patient indicated that he has had the device disabled 'for a period of time. ' the patient is reportedly now on coumadin, and continues to report that his health has declined with vns. He plans on reducing coumadin in anticipation of vns explant. Attempts for additional information on the device disablement have been unsuccessful to date.
 
Event Description
It was reported by the explant hospital that the explanted products were discarded.
 
Event Description
Additional information was received from the epileptologist's office which revealed that they are unable to provide an assessment regarding the relationship of the patient's heart conditions to vns. It was noted that the patient's vns system has been working properly and no changes have been made to the patient's medication or the vns settings. They are unaware if any interventions have been planned or if the patient had a medical history of blood clots or heart problems. The surgeon's office reported that the patient's blood clots, swelling and heart valve problems are not related to vns. The patient has been referred to a vascular specialist regarding these events. No causal or contributory medication changes precede the onset of these events, and the patient does not have a medical history of these events. Patient manipulation or trauma may have occurred to have caused/contributed to the swelling. No additional information was provided by the surgeon. The patient further reported that he has seven blood clots, and has swelling in his legs and left arm, which he didn't have before vns. The patient says that with vns, he is having more health problems than what he wants. Attempts for additional information from the surgeon have been unsuccessful to date.
 
Manufacturer Narrative
Date of birth, corrected data: the initial report inadvertently reported the date incorrectly. Date received by manufacturer, corrected data: the supplemental report #7 inadvertently reported the date incorrectly. It should have reported the date as 10/24/2014.
 
Event Description
It was reported that a vns pt had swelling in his arms and legs around the time of vns implant on (b)(6) 2011 through (b)(6) 2011. The pt went to the er in (b)(6) 2011, and the physicians found that he had a blood clot in his arm and one in his leg. He was hospitalized at that time. During this hospitalization, the pt was diagnosed with one of his heart valves not opening. The pt indicated that he thinks these events are all related to vns. The pt has reportedly not had his vns checked in a while and probably will not until the blood clots and heart valve problem resolve. Attempts for add'l info from the physician have been unsuccessful to date.
 
Event Description
Information was received from the neurologist¿s office that in clinic notes dated (b)(6) 2012, it was documented that the device was off. The nurse was unable to find when it was first turned off. An additional attempt for information has been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2465251
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« Reply #45 on: September 29, 2018, 03:57:11 AM »

Model Number 102
Event Date 01/01/2011
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

Manufacturer Narrative
Event description, corrected data: previously submitted mdr inadvertently omitted information received during follow-up. This report is being submitted to correct this information.

Event Description
Information was received that the patient was seen on (b)(6) 2013 for consult. The notes indicated that the patient¿s pain in the chest was not consistent with vns. It was stated that the (b)(6) event was a recurrent infection ((b)(6)), but it is unknown when this started as this information was provided by the patient. There was no documentation was available regarding the ¿heart problems¿; however, it was documented that the patient was negative for murmurs or gallops. No additional information or x-rays were available. Attempts for product return have been unsuccessful. An implant card indicated that the patient was explanted due to painful stimulation.

Event Description
On (b)(6) 2013, this patient underwent generator revision. The product has not been returned to date.

Event Description
On (b)(6) 2013, it was reported that this patient's device has shifted due to weight loss beginning in 2011. This was not causing the patient pain that began four days prior. For the past month, the patient had been observing a lump over the generator site, and since then, it has tripled in size. There was no manipulation/trauma and no medication changes or programming changes. The patient stated that she was last seen two months prior by her vns physician, and her device was found to be functioning properly. Additional information was received indicating that the a little over a month ago, a quarter-sized nodule was noticed near her generator. Now the area is swollen from the left side of her sternum to her arm pit, approximately the size of a hand. The outline of the generator is visible. The area is painful and bruising. There is no drainage or opening in the incision area, and there was no trauma to the area. Vns had controlled her seizures as she has gone from 15 per day to 2 to 3 per month. Clarification was given that the generator migrates from mid-left ribs to under the arm pit settings and diagnostics from (b)(6) 2013 were provided. The patient was referred for prophylactic replacement and pocket revision additional information was received that there may be a disc in the patient's neck that is out of place. (the left side of her neck had been swollen for several months, and she has limited movement on her left side. ) this is not related to vns. It was also suggested that the patient had heart problems, and the patient is a (b)(6) carrier. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069093
« Last Edit: November 18, 2018, 04:36:28 AM by dennis100 » Logged
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« Reply #46 on: October 01, 2018, 02:27:11 AM »

Model Number 302-30
Device Problem Migration or Expulsion of Device
Event Date 01/01/2014
Event Type  Injury   
Event Description
It was reported that the team of physicians elected to proceed with a generator replacement in an attempt to resolve the complaint of intermittent radiating pain. Surgery was performed on (b)(6) 2015. A diagnostic test was performed which showed the device was working as intended prior to explant. During the surgery, the physician noticed inflammation surrounding the generator site that he thought to be caused by the original placement of the device. Upon closing the patient, the surgeon witnessed a small break in the lead about an inch away from the lead pin. A full revision was performed, having the lead and generator both replaced. A diagnostic test was run with the newly implanted device which still showed normal impedance levels. The explanted lead and generator were sent to the pathology department of the hospital. It was also found by the surgeon during surgery that the explanted lead did not appear to be attached to the correct nerve. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
The surgeon later described the inflammation found during surgery. He stated the lead insulation was torn with exposed wires at the generator site. The surgeon also stated the patient's pain has resolved since the vns revision surgery. No additional relevant information was received.
 
Manufacturer Narrative
Evaluation, corrected data: this information was inadvertently left off of supplemental #02 mfr. Report.
 
Event Description
It was reported that the patient's generator has migrated and is causing constant pain at the chest site. Device diagnostics were within normal limits. The patient was referred for x-rays. The physician believes that the migration is a result of weight change and growth since implant. It was reported that surgery will be required to reposition the device. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
 
Event Description
It was reported by the physician that the patient has had chest pain, in the form of an intermittent shocking pain, for over a year. It was reported this pain radiates to the neck and epigastric regions. It was reported that deactivation of the vns system does not help. The patient's x-rays appeared normal and system diagnostics all appeared normal. The patient has been referred for replacement. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Brand name; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Type of device; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Model#, serial #, lot#, exp. Date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report. Device manufacture date; corrected data: this information was inadvertently not updated on supplemental #02 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4341541
« Last Edit: October 14, 2018, 12:21:06 PM by dennis100 » Logged
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« Reply #47 on: October 02, 2018, 12:30:46 AM »

Model
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« Reply #48 on: October 02, 2018, 12:31:32 AM »

Model Number 302-20
Event Date 11/20/2007
Event Type  Malfunction   
Event Description
It was reported to mfr that a sys diagnostic test performed on the vns pts device revealed high lead impedance with output status ok. A second system diagnostic test performed at the same office visit revealed high lead impedance with the out put status at the limit. The pt presented at the physicians office with continuous neck pain and extreme coughing during stimulation of the device, which began the previous day. The pt reported having had pulled his left neck muscle the day prior. Additionally, the physician stated that the pt is a truck driver and does "a lot of movement in his neck, so he may have stretched the leads". It was recommended to set the normal mode and magnet mode output current ot 0ma, however the physician opted to decrease the settings from 1ma to 0. 75ma decrease the pulse width from 500usec to 250usec. The coughing and the pain improved with the setting change. The pt was referred to the implanting surgeon to have the device replaced. Preoperative interrogation of the device revealed that at some point the device output current had been set to 0ma. During surgery, it was observed that the negative coil was a "burnt yellowish color" and that the "nerve was burnt at the site where the negative electrode was in contact with the nerve". The area above and below the burnt area on the nerve was swollen. The entire lead, including the electrodes was removed,and a new lead was implanted. The generator was replaced prophylactically. Additionally, the surgeon reported that the pt was experiencing hoarseness prior to the device being removed. Attempts to obtain the explanted devices for analysis have been made, but have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2998029
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« Reply #49 on: October 02, 2018, 12:32:27 AM »

Model Number 103
Event Date 06/12/2012
Event Type  Malfunction   
Event Description
On (b)(6), 2012, the patient's explanted generator was returned for product analysis. Product analysis was approved on (b)(6), 2012. The generator was returned for a reported demipulse eos and failure to program condition. The reported failure to program was not duplicated in the pa lab. Results of diagnostic testing indicate the battery status shows neos=yes in the pa lab. The battery was found to be partially depleted and at ifi and neos.
 
Event Description
On (b)(4) 2012, it was reported that this vns patient would be undergoing surgery for an unknown reason. Follow up on (b)(6) 2012 with the patient's physician revealed that the patient was last seen on (b)(6) 2012, and the patient's device indicated ifi = yes. The patient had a surgical consult on (b)(6) 2012, and it was reported that the patient's battery was completely depleted. The device could not be interrogated; however, as the generator is a model 103 generator, interrogation should be possible regardless of battery status. The programming system was ruled out as the reason for the failure to communicate. The reporter was unsure as to the color of the ifi indicator from (b)(6) 2012. It was also stated that the patient had an increase in seizures. The relation of this increase seizures to the pre-vns seizure frequency is unknown; however, it was stated that the increase in seizure is attributed to the depleted battery. Surgery is likely but has not occurred to date.
 
Manufacturer Narrative
Description of event, corrected data: previously submitted mdr inadvertently omitted information that the patient's generator implanted and explanted on (b)(6) 2012 was received. This report is being to correct this information.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
On (b)(6) 2012, confirmation of surgery on (b)(6) 2012, was received for this patient. Additional information was received on (b)(6) 2012, that there were complications during the surgery and high impedance was seen. The high impedance report is captured in mfr report #1644487-2012-01923 follow up with the physician on (b)(6) 2012, revealed that on (b)(6) 2012, diagnostics were normal and ifi=yes was seen. High impedance was seen on (b)(6) 2012 and diagnostics showed that the device was at end of service. Operative notes were also received on (b)(6) 2012. The notes indicated that in the surgery, the old generator was removed and a new generator was replaced and secured. Multiple attempts with integrity testing with the eef lab technician were unsuccessful, deeming a lead failure. The notes reported that dissection down through the subcutaneous tissue encountered quite a bit of scarring and inflammatory response, but there were no signs of infection. The internal carotid artery was identified, as was the jugular vein which was large for his size. The vagus nerve was identified with the vns device on the vagus nerve a, and it was quite enlarged, consistent with some inflammatory response around the device and the nerve. While trying to dissect up above the device, there was a small tear created in the jugular vein and immediately quite a bit of blood was noted to be coming from the wound. Due to the blood loss and the ongoing inflammatory response in the neck, it was decided that the patient¿s surgery would be postponed until another day. The device was amputated in the chest, and with careful inspection, there was a question of whether there was a crack about four centimeters from the insert of the generator. The tear in the jugular vein was due to the adhesion to vagal nerve stimulator lead. The device was reportedly returned to the manufacturer for review; however, it has not been received. The notes stated that the plan would be to obtain authorization to have the entire device, lead and generator, replaced on (b)(6) 2012, confirmation was received that this patient had undergone generator and lead implant surgery on this date. Attempts for product return have been unsuccessful.
 
Event Description
The patient was re-implanted on (b)(6) 2012.
 
Event Description
Product analysis for the generator implanted on (b)(6) 2012 and explanted on (b)(6) 2012 was approved on (b)(6) 2012. The device was returned at shipping settings indicating that the device was not programmed on. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. (this generator was returned along with the suspect medical device - generator on (b)(6) 2012. ) design history files for the explanted m103 generator (suspect medical device) were reviewed and showed that the device passed all functional tests prior to distribution.
 
Manufacturer Narrative
Describe event or problem, corrected data: previously submitted mdr stated that the patient was re-implanted on (b)(6) 2012; however, the patient was actually re-implanted on (b)(6) 2012. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2615021
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« Reply #50 on: October 02, 2018, 12:33:15 AM »

Model Number MODEL 250
Event Date 02/13/2015
Event Type  Malfunction   
Event Description
Information was provided by the company representative on 05/14/2015 that the handheld device¿s main battery was swollen. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
It was reported that the programming system was unable to performed diagnostic tests on the vns patient¿s device despite being able to successfully interrogate and program the device. The wand battery was replaced and the handheld was confirmed to be unplugged from the power adaptor; however, the issues continued. The patient¿s generator was noted to be in normal placement and not deep in the patient¿s breast tissue. No sources of emi were identified. The programming system was able to perform diagnostic tests on other generators at the same location in the office. Another programming system was used and was able to perform diagnostic tests without any issues. The components of the suspect programming system were tested with the known working programming system and the issue appeared to be isolated to the handheld device of the suspect programming system. The suspect handheld device has not been returned to date.
 
Event Description
Product analysis was completed for the handheld device on 06/10/2015. No anomalies associated with the serial cable were identified during the analysis. Visual analysis of the handheld was able to verify that the main battery was swollen. Additionally, it was identified that the handheld would not power on. The cause for the anomaly is associated with the swollen main battery. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). No further anomalies were identified. Cause of the swollen battery is not known but may be related to wear and/or usage of battery. Product analysis was completed for the software flashcard on 06/10/2015. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, 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=4691121
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« Reply #51 on: October 02, 2018, 12:34:24 AM »

Event Date 05/29/2001
Event Type  Injury   
Event Description
An article about the histological appearance of a chronically stimulated vagus nerve in a pediatric reporter indicated vns therapy moderated a patient's atonic episodes, but the patient experienced "occasional hospitalizations for status epilepticus. " the patient passed away due to asphyxiation (reported on medwatch 1644487-2008-02703). The vns therapy system was explanted with "1. 5 cm of unstimulated nerve superiorly and inferiorly. " the electrodes were dissected from the nerve "revealing grossly normal nerve above and below the stimulator. " "abundant inflammatory cells were present around the stimulated nerve section. " "severe myelin loss and occasional myelin digestion chambers were seen in the nerve fibers. With modified trichrome and luxo fast blue stains, this loss was estimated to be nearly 90%. " good faith attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Article: histological appearance of chronically stimulated vagus nerve in a pediatric patient. Pediatr neurosurg 2001, 35:99-102 2001 r shane tubbs. Et al.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=1241164
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« Reply #52 on: October 04, 2018, 04:03:41 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/02/2017
Event Type  Injury   
Event Description
A report was received from a physician stating that one of his younger patients who returned for a visit a few weeks after initial implant and swelling was noted at the generator site. The wound was washed out and the generator was removed. An infection was noted at the site. No further relevant information has been received to date.
 
Manufacturer Narrative
Device evaluated by manufacturer, additional information: analysis of the device is not required because the adverse event is not related to the delivery of vns stimulation.
 
Manufacturer Narrative
Date received by manufacturer - corrected information: in supplemental report #2 the date received by the manufacturer should have been 06/18/2018.
 
Event Description
A review of the device history records showed that both the lead and generator were sterilized prior to distribution.
 
Event Description
The product information was received for the patient in relation to the reported events.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6740281
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« Reply #53 on: October 04, 2018, 04:04:26 AM »

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
A report was received stating that the patient has swelling in the left breast (described as gynecomastia left, hall grade 2, tanner b2-3). The physician stated that it was difficult to tell if there is connection to vns and the swelling as he has never seen this before with other patients.
 
Event Description
Patient has a left-sided painful breast enlargement with no secretion. The doctor palpated the enlargement of the glandular body just above the nipple. A mamma-sonography was performed and it identified an unilateral gynecomastia without malignancy. There is no pre-existing testicular diseases, abdominal surgery or thromboembolic events in the history. There are no indications of endocrine disruption as the cause. In particular, hyperprolactinemia was excluded. Total testosterone is slightly more detectable but there are no indications for an androgen or estrogen excess. Patient was prescribed medication. Surgical option was also discussed. However, no known surgical interventions have occurred to date. Patient was also recommended an ultrasound examination and to visit an urologist / andrologist. The physician reported that they do not see a connection between the scalp/enlargement and the vagus nerve stimulator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7528145&pc=LYJ
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« Reply #54 on: October 05, 2018, 12:30:11 PM »

Event Date 12/19/2005
Event Type  Injury   
Event Description
In (b)(6) 2005, i had a vagus nerve stimulator implanted for treatment resistant depression by a dr (b)(6) at (b)(6) medical center in (b)(6). (dr (b)(6) subsequently worked at (b)(6) medical center). Afterwards, i felt as if i were fighting off an infection. I informed the surgeon, but blood work revealed no infection. About three weeks later, however, my chest began puffing out like a balloon, and i was rushed to the hosp. According to my medical records, i was treated for an (b)(6) infection. I did not find that out until i requested the medical records some time later. The device was removed, and i was kept at (b)(6) med ctr for several days on iv antibiotics. Then i took iv antibiotics at home for a few more weeks, with a nurse coming over to replace the iv syringe in my hand every few days. Two months later, another vagus nerve stimulator was implanted by the same surgeon, who damaged my recurrent laryngeal nerve, leaving me unable to speak for a year. I will report that incident separately. (i assumed these adverse events were reported by the healthcare providers, and i was too severely depressed for years to even attempt to report these incidents myself. But now, years later, i want to be sure you know about these incidents). And i will file another report concerning severe sleep apnea caused by the second vagus nerve stimulator (which i cured in (b)(6) 2013 by having to demand that the neurologist adjusting the settings on the device turn it off, after suffering significant sleep apnea even on a bipap machine. At that point, i had found the studies revealing higher settings on these devices cause severe sleep apnea, severe depression, and cardiac arrest during sleep. But again, i will file separate reports for each of these incidents that contributed to the destruction of my health, disability, and having to live off ssdi since 2011. Of course, i do not have the first vagus stimulator that was removed in (b)(6) 2005. At the time the device was implanted, i was suffering from severe, unremitting depression because a psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania as a side-effect of sertraline, but not otherwise. Vns had no effect on my depression at the time, but the second vagus nerve stimulator nearly caused me to commit suicide because it was causing sleep apnea with an apnea hypoxia index of 47. On (b)(6) 2006, i had a second vagus nerve stimulator implanted for treatment-resistant depression after the first one had to be removed in (b)(6) 2006, because the surgeon infected me with (b)(6) while the first stimulator was implanted (i have submitted a report concerning that adverse event already). I have also submitted a report concerning damage to my recurrent laryngeal nerve when the second device was implanted, leaving me unable to speak for a year. Over the years, my psychiatrist, and then a neurologist, increased the output of the device. I had no risk factor for sleep apnea. I had been running literally 49 miles per week before i began to experience severe depression, in part as a result of settings for the device. I had a cpap sleep study on (b)(6) 2011, which revealed that i was not breathing between 10 and 30 seconds every minute of the night. My apnea hypoxia index (api) was 47. 4. The doctor who diagnosed me with sleep apnea told me that on a scale of 1 to 10 in severity, with 10 as most severe, he rated my sleep apnea as a 9. The settings on the vagus nerve stimulator as of (b)(6) 2011 were: parameters output current (ma): 1. 5, signal frequency (hz): 2. 0, pulse width (usec): 250, signal on time (sec): 30, signal off time (min): 5, magnet output current (ma): 1. 75, magnet on time (sec): 60, magnet pulse width (usec): 250, lead test/normal mode test output status (ok or limit): ok, lead impedance (ok or high): ok, dc-dc converter code (0-7): 3 eri flag (yes or no): no. Even using a bipap machine, my api fluctuated at scores from 8 to 40 until (b)(6) 2013. On that date, i brought several studies to my neurologist's office that proved indisputably that vagus nerve stimulation causes severe sleep apnea, severe exacerbation of depression and cardiac arrest during sleep. I was waking up for years feeling as though somebody had beaten my body with a baseball bat. The neurologist reluctantly turned the device off. That evening, and every subsequent evening since then, i have experienced no sleep apnea. I still have the product, but it is still implanted, and turned off. I do have the product packaging. Because i have the packaging, i will answer below that i do have the product. I weighed approximately (b)(6) pounds in (b)(6) 2011, as opposed to my weight listed in two other reports related to implantation of this device and a prior implantation of a vagus nerve stimulator. Lyme neuroborreliosis since 1980. Babesia microti infection since 1980, severe, unremitting treatment-resistant major depression from late 2003 to late 2006 because psychiatrist took me off medications i was taking for depression and put me on lamictal, zyprexa, etc. Merely because i experienced mild hypomania five days per month as a side-effect of sertraline; severe-to-extreme treatment-resistant depression from (b)(6) 2008 to present because a doctor caused extreme excitotoxicity by provoking a severe inflammatory immune response for an entire year while treating me far too aggressively for lyme disease, and also caused by vagus nerve stimulation. I was not able to reduce the depression to the moderate range until i discovered that buprenorphine acts synergistically with ketamine to reduce depression, and prevents tolerance to ketamine; i took the same dose of both medications for six years. I was able to get off 300mg intramuscular ketamine daily in six weeks, with no withdrawal symptoms, and with better results treating depression 1. 5 years ago when i began treating the cerebral cortex with a 30 watt, 810 nanometer (near infrared) laser that emits a collimated beam, in continuous wave mode for 50 minutes each evening. My nightly readings on my bipap machine, which i have saved, prove that when the vagus nerve stimulator was turned off, i no longer experienced sleep apnea that severely exacerbated my depression, and which caused extreme physical pain. After a vagus nerve stimulator had been implanted in (b)(6) 2015 and removed on (b)(6) 2015, a second vagus nerve stimulator was implanted by a dr. (b)(6) at (b)(6) medical center in (b)(6), on (b)(6) 2006. During the surgery, my left recurrent laryngeal nerve was damaged. I was unable to speak for an entire year. The surgeon casually told me that he did not know whether i would ever be able to speak again. For an entire year, i had to use as much energy as it takes to scream at the top of one's voice merely to make a rasping sound that was barely intelligible. I have a videotape with audio made about six months after the device was implanted, demonstrating the extent of impairment. I still have that video in digital format. The product itself is still implanted but turned off. Since the surgical procedure, not the product itself, caused the damage, and since the product is still implanted but turned off, i will answer below that i do not have the product so that you can evaluate it. I assumed at the time that the manufacturer or surgeon reported this, and then became too severely depressed as a result of sleep apnea caused by the vagus nerve stimulator (and also as a result of medical incompetence of a doctor treating lyme disease and babesia microti) that i was incapable of reporting it. A psychiatrist misdiagnosed me with bipolar disorder merely because i experienced mild hypomania five days per month as a side-effect of sertraline, but not otherwise. He took me off of sertraline and adderall, and put me on medications such as lamictal and zyprexa. In (b)(6) 2006, i finally felt capable of going to another doctor and asking to be put back on the medications i had been taking before i began seeing the psychiatrist who caused the three-year episode of severe depression. Within a week of being put back on those medications, i was not suffering from depression or mild hypomania. But the vagus nerve stimulator was implanted while the psychiatrist was causing me to suffer a three-year episode of severe, unremitting depression that was not responsive to ect.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910123
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dennis100
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« Reply #55 on: October 06, 2018, 05:08:49 AM »

Model Number 106
Event Date 07/13/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that vns study patient injured herself near her generator site. The patient subsequently developed a hematoma and began experiencing swelling and pain. As result, the patient¿s device was disabled. The events were attributed to the implant of the device. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3988339
« Last Edit: January 26, 2019, 04:05:02 AM by dennis100 » Logged
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« Reply #56 on: October 06, 2018, 05:09:26 AM »

Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area
Event Date 05/01/2018
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported that this patient had high impedance which the doctor believed the high impedance suggested a break in the wiring. Additional information was received from the patient¿s mother who stated that the patient is having uncomfortable stimulation and the device is pulsating in the patient¿s neck. The patient¿s device was turned down to 0. 75ma. The patient¿s mother also stated that the patient has migraines, nausea, and vomiting, and feels that his heart speeds up since receiving the m106. Clinic notes were received which stated that the patient feels that his vns is not working and he is still having seizures, mostly under stress due to living conditions. The neighborhood they live in is quite violent. It was stated the patient¿s spells began 3 months ago, and the patient feels they are worsening. The doctor stated that the patient had an increase in seizures, although this was felt to be due to vns malfunctioning. Additional information was received from the patient¿s mother stating that the patient's left neck began to swell and the patient went to the er. They had no way to program the device off. Steroids were administered and the swelling as since subsided. The patient's device was disabled shortly after this and the patient is doing slightly better. This patient received a lead and generator replacement. 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=7842002
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dennis100
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« Reply #57 on: October 06, 2018, 05:10:07 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2018
Event Type  Injury   
Event Description
It was reported that the patient's vns lead wire was extruding from his neck. The physicians wanted to explant the device as a result. Follow up by the tc revealed that there was no trauma or patient manipulation that could have contributed to the event. The physician's office believed that the patient was allergic to the vicryl sutures placed after surgery as the patient has been in almost weekly since the date of implant due to his body rejecting the sutures and pushing them out of his skin. It was stated that this caused abscess type problems around the generator and neck and that the patient has been back in previously to remove the sutures and clean the surgery site. It was later reported that the patient responded well to vns therapy, but had significant swelling around the generator and approximately 2 inches of the lead was protruding. The surgeon decided to explant the whole vns system and give the patient time to recover from the infection. A review of device history records revealed that the generator and lead were sterilized and passed quality control inspection prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7877560
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dennis100
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« Reply #58 on: October 07, 2018, 03:12:05 AM »

Model Number MODEL 250
Event Date 10/01/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld was no longer working. The battery appeared to be swollen and the case would not close. A new programming tablet was provided to the physician. The physician had another programming system available so no patient care was affected. The handheld and flashcard were received for analysis. Analysis of the handheld was completed on 10/23/2014. As result of the swollen battery, it was identified that the handheld would not power on. The swollen battery bent the battery cover causing the battery latch switch to register that the latch was unlocked, thus preventing the handheld from powering on (this condition can also cause the handheld to power off intermittently). No further anomalies were identified. Analysis of the flashcard was completed on 10/23/2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, 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=4209541
« Last Edit: January 31, 2019, 02:32:33 AM by dennis100 » Logged
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« Reply #59 on: October 08, 2018, 01:38:42 PM »

Model Number 103
Event Date 03/19/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that a seizure caused the dehiscence. The patient underwent another revision on (b)(6) 2014. The physician indicated that a resection of a neuroma in both the generator site and electrode site occurred. The patient later underwent explant of both the generator and lead. No additional relevant information has been received to date.
 
Event Description
The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2014 due to inflammation, dehiscence, and extrusion of the lead at the generator site. In (b)(6) 2014, the patient presented with drainage at the generator site. The surgeon stated that no infection had developed and attributed the event to vns implant surgery. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4012570
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