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dennis100
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« Reply #120 on: February 18, 2018, 02:42:55 AM »

Model Number 102
Event Date 11/01/2008
Event Type Injury
Event Description
Initial reporter indicated that they had been implanted with the vns for about three years and was losing weight again like last time. Pt reported that when they lose weight they get depressed and "will think about committing suicide. " the last time the pt lost weight "someone went over to the dr's office and did something to the device. It was not known what they did, but afterwards, he started gaining weight again and all the other things went away. " no changes in medication, lifestyle, or diet reported. Pt has vns programming titrations. Reported the pt had not had a programming change for at least six months. The pt was also feeling a shocking in his neck and hoarseness when the device stimulates. Good faith attempts are being made at the pt's treating physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1266293
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dennis100
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« Reply #121 on: February 27, 2018, 02:45:59 AM »

Model Number 302-20
Event Date 12/28/2011
Event Type Injury
Event Description
Additional information was received indicating that the patient's lead is now extruding. This event will be reported under manufacturer's report # 1644487-2012-00663.

Event Description
The patient underwent generator replacement surgery on (b)(6) 2013. The new generator was connected to the existing lead.

Event Description
Further follow-up revealed that the generator was discarded by the explanting facility and will not be returned to device manufacturer for analysis.

Event Description
It was reported on (b)(6), 2012 that the patient's generator has migrated again due to (b)(6) of weight loss. Additionally, it was reported that the patient was going to be scheduled for surgery to prevent future lead problems. It was reported that the surgeon plans on replacing both lead and generator to free up more lead if necessary. Further follow-up revealed that the surgeon used non-absorbable suture during the last surgery to secure the generator to the fascia. It was also reported that no trauma or patient manipulation occurred which could have caused or contributed to the generator migration. Surgery is planned, but not yet scheduled.

Event Description
It was initially reported that the patient was experiencing some adverse events including pain in her ear that would radiate down her neck, pain while swallowing, and lead protrusion. However the patient did indicate that she had been seizure free for 8 months. Additional information was received indicating that the protrusion was related to weight loss, and that the patient's pain was related to generator migration. The physician reported that the generator had migrated approximately 3-4 inches which was causing a lead pulling sensation and the pain. The pain was reported as constant and the patient was referred to a surgeon. Diagnostics were provided and were said to be within normal limits with a impedance of 2957ohms. The physician attempt to lower the patient's setting however this did not have an effect on the pain that the patient was experiencing. X-rays were performed and sent to the manufacturer for review. The generator could be seen in the left chest. The lead was intact at the lead pins. The lead pin could be visualized past the connector block and therefore appeared to be fully inserted. The filter feedthru wires were intact. There was a portion of the lead behind the generator that could not be assessed. Although a strain relief bend appeared to be present, the presence of a strain relief loop could not be assessed. Also, based on the quality of the image provided, proper placement of the visualized bend could not be determined. Two tie-downs were present. There were no acute angles or lead discontinuities seen in the visible portions of the lead body. The lead body did not appear taut across the patient's chest. Based on the x-ray images provided, a cause for the patient's pain, migration and lead pulling sensation could not be determined. Additionally generator migration could not be assessed as x-ray images prior to the reported migration were not received. Also, as the entire lead could not be assessed, an undisclosed issue in the non-visible portion of the lead could not be ruled out. Additional information was received from the surgeon indicating that he would try to reposition the generator and lead before proceeding with the replacement. The patient underwent surgery on (b)(6) 2012. During the procedure it was noted that the tie-downs did not appear to have been sutured appropriately and the surgeon did not feel that non-absorbable sutures were used when the patient was initially implanted. The surgeon freed a large portion of the lead in the neck that was taught. He utilized two new tie downs, and also re-secured the generator in the pocket. Diagnostics after the procedure were still within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2435669
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dennis100
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« Reply #122 on: March 11, 2018, 01:33:34 AM »

Model Number 105
Event Date 09/09/2014
Event Type Injury
Event Description
It was reported that the recently implanted vns patient was hospitalized on (b)(6) 2014. The patient was experiencing coughing, breathing issues, nausea, vomiting, and chest pain at the generator site. Patient also stopped eating and had lost weight. The patient¿s caregiver wanted the patient¿s device explanted as the events began when the device was programmed on a week after vns surgery. The patient¿s seizures had increased and patient was on more seizure medications than prior to vns therapy. However, the surgeon and neurologist stated that the patient is fine. The patient is diabetic and was admitted with a very high blood sugar level. The patient¿s physician believed the events were due to the patient¿s high blood sugar levels as well as vns stimulation. Following revealed that the patient¿s device was disabled on (b)(6) 2014. Attempts for additional relevant information have been unsuccessful to date.

Event Description
On (b)(6) 2015, it was reported that the patient was scheduled for explant surgery as part of the incision site had opened and some of the generator is visible and exposed. The patient underwent removal of the vns on (b)(6) 2015. The explanted generator has not been returned for product analysis to date.

Event Description
It was reported that the hospital discards explanted devices and therefore the explanted generator cannot be returned for product analysis.

Manufacturer Narrative

Event Description
It was reported that the patient has been referred for surgery. The physician does not believe the events are related to vns therapy. No surgical interventions have been performed to date.

Event Description
Clinic notes were received stating that the patient was hospitalized due to reaction to the vns device. The patient¿s symptoms were reported to have been stable.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4194303
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dennis100
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« Reply #123 on: March 11, 2018, 01:34:21 AM »

Model Number 103
Event Date 03/19/2013
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient presented with history of chest pain radiating to left arm, with shortness of breath since four months. After the sixth titration, on (b)(6) 2013, the patient had loss of appetite and difficulty in eating due to burning pain while eating. The patient also feels nauseous after eating. This resulted in less intake of food and loss of weight and weakness. The patient has lost about 7 kg of weight and has giddiness. In view of this, the amplitude and duration of the titration were decreased. The subject is under observation and the outcome of the event is considered not resolved. As per the opinion of the private investigator (based on the patient not having these symptoms prior to the sixth titration), the event is not related to implantation and definitely related to stimulation. The patient was admitted for infection and loss of weight on (b)(6) 2013. Upon investigation, it was determined that the patient had dengue fever, which was not related to vns. The infection was similarly not related to vns. The patient was managed conservatively and was discharged on (b)(6) 2013. Additional information was received that concomitant medications and heart failure could not be a cause of the loss of appetite, difficulty in eating, nausea, or weight loss. The loss of appetite and nausea were not due to psychological reasons. The difficulty in eating due to burning pain while eating is the cause for the poor intake of food. As the weight loss was marked related to stimulation, the difficulty in eating due to burning pain while eating and feeling nauseated after eating are related to implantation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3414002
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dennis100
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« Reply #124 on: March 12, 2018, 01:45:41 AM »

Model Number 102
Event Date 05/30/2012
Event Type Injury
Event Description
Additional information was received on (b)(6) 2012. It was indicated that the migration was first noted on (b)(6) 2012. There was no trauma or manipulation however; the patient may have lost some weight which might have contributed. Attempts for additional information have been unsuccessful to date.

Manufacturer Narrative

Event Description
Information received on (b)(6) 2012, indicated that the patient underwent a generator re-positioning surgery on (b)(6) 2012, to resecure the generator. No devices were replaced at that time.

Event Description
It was reported by the surgeon's office that the patient's generator has migrated and is causing the patient arm discomfort. The patient has been referred for surgery to reposition the generator. Follow up was performed with a nurse at the surgeon's office, but she was unsure if there had been any manipulation or trauma to the device. She also was unable to determine if a non-absorbable suture was used during implant to secure the generator. Attempts for additional information have been unsuccessful to date. Surgery is likely but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2649568
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dennis100
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« Reply #125 on: March 13, 2018, 01:34:11 AM »

Event Date 01/01/2009
Event Type Malfunction
Event Description
Voluntary report # (b)(4) was received indicating that the patient began experiencing increased neck and shoulder pain as well as increased seizures. The report date of the voluntary report was indicated as (b)(6) 2012. The physician reportedly indicated that they believed this was arthritis and referred the patient to a pain specialist. The device could reportedly be seen migrating and had "disconnected". The report indicated that the physician "decreased the voltage". The vns was reportedly removed 6 months following the initial complaint however it was not indicated if this refers to the vns lead, generator, or both. It was noted keppra and vimpat were added to the patient's treatment plan and she was already taking dilantin and gabapentin. The patient reportedly developed anorexia and is losing weight. There is a comment indicating "she is now (b)(6)" however it is not indicated what this is referring to. It was also noted that the patient is having trouble walking and has developed tremors however the patient reportedly feels these are related to the medication but it is indicated that drug levels have not been taken in some time despite requests from the patient.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2721027
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dennis100
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« Reply #126 on: March 22, 2018, 12:46:06 AM »

Model Number 103
Event Date 08/20/2012
Event Type Injury
Manufacturer Narrative

Event Description
Additional information was received on (b)(4) 2013 when it was reported that the patient had a follow-up visit with her nurse practitioner that day. The first interrogation of the device indicated that the device was "off, the output current was 0. 0ma, however the magnet output current was at 0. 25ma. The vomiting has "slowed up some" since (b)(6) 2012 and the patient has lost 40 pounds and has little appetite. There were 3,746 magnet activations captured on the device. The device was then programmed "on" to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 5ma/magnet pulse width=500usec/magnet on time=60sec. System diagnostics were "ok" and the ohms was noted to be 3,580ohms.

Event Description
It was reported that shortly after the patient's vns stimulation was enabled immediately following initial vns implant surgery, the patient began vomiting. The physician indicated that he was unsure if the vomiting was occurring with stimulation, but he indicated it was likely. The patient was noted as not vomiting when the family swipes the magnet over the generator to activate extra stimulation to abort a seizure. The patient's family believes the patient is having a sensation in his stomach however the patient is nonverbal. The patient's vns was disabled for 3-4 days however when the stimulation was re-enabled, the patient was vomiting so much he became dehydrated and had an increase in seizures requiring hospitalization as a result. Vns diagnostics had not been run since surgery which were noted as within normal limits at that time. The patient's vns has been turned back off for the time being. Follow-up with the patient's neurologist found the patient has a dental abscess which she and the surgeon believe may be contributing to the vomiting with stimulation. They have asked the patient to have resolved and then they will resume vns stimulation. No medication changes were believed to have caused or contributed to the events. Attempts for the missing product information are in progress.

Event Description
Additional information was received on (b)(6) 2013 when it was reported that the vns patient has lost 40 pounds and is vomiting. The patient's device was shut off except for the magnet settings. The physician questioned whether the leads could possibly be placed upside down. The patient was stated to have profuse vomiting when the device is on. It was reported that the patient's device has sporadically been on and off based on the patient's vomiting events. Currently the physician is thinking about turning the magnet mode off as well.

Event Description
Additional information was received on (b)(6) 2013, when it was reported that the patient had the vns device turned off over a month ago by the surgeon because of vomiting. There are no plans to turn it on until the patient sees a gastro physician.

Event Description
It was again reported that since his vns implant, the patient has had serious stomach issues and has lost a considerable amount of weight. The patient, however, has had an improvement in seizure reduction. The patient was noted to have had persistent vomiting, changes in appetite, and weight loss.

Event Description
On (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time.

Manufacturer Narrative
Describe event or problem; corrected data: inadvertently stated "on (b)(6) 2012, the physician's office reported that they did have any additional information on this patient at this time" instead of "on (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time" on supplemental report #1.

Event Description
On (b)(6) 2012, the physician's office reported that they did not have any additional information on this patient at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2766219
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dennis100
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« Reply #127 on: March 28, 2018, 02:01:35 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type Malfunction
Event Description
It was reported by the patient that the device was causing her pain in her neck due to the tie-down protruding. She said that she had lost some weight about a year ago and the tie-down was starting to protrude about then. Over the last few weeks it has been causing pain when it was touched or when she turns her neck. The patient indicated that she had wanted the device removed a year ago, which per the physician was due to unsubstantiated lack of efficacy. The patient current feels that the device is malfunction and wants it removed. The patient saw a surgeon the prior year and the surgeon indicated that she did not require surgery. No additional information is known at this time.

Event Description
Manufacturer follow up with the patient's physician revealed the physician has not seen the patient in several years, and no questions were able to be answered.

Manufacturer Narrative
The incorrect lot number was inadvertently reported on the initial mdr. The correct lot number is provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2880147
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dennis100
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« Reply #128 on: April 02, 2018, 01:18:59 AM »

Model Number 302-20
Event Date 12/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure is occurred but did not cause or contribute to a death or serious injury.
 
Event Description
A/p and lateral views of the chest and neck, dated (b)(6) 2013, were received and reviewed. The generator was visualized in normal orientation in the patient¿s left chest area. The lead appeared to be intact at the lead pin and the filter feedthru wires appear intact. The lead pin could not be seen past the second connector block in the image, therefore it could not be assessed if the lead pin was fully inserted. A portion of the lead appeared behind the generator and could not be assessed. The lead was seen in the left side of the patient¿s neck. A strain relief loop was observed; however, a strain relief bend did not appear to be present. No sharp angles were observed in the portions of the lead that could be visualized; however, a possible lead discontinuity was seen in the lead body. Based on the x-ray images, it is possible that the high impedance is due to a lead discontinuity. Additionally, micro-fractures in the lead cannot be ruled out. No further interventions have been taken since the last report. No additional information has been provided.
 
Event Description
It was reported that the generator was explanted on (b)(6) 2014.
 
Event Description
On (b)(6) 2012, it was reported that high impedance was seen in regards to this patient's device. After the first interrogation, the output current was reduced by 0. 25 ma, and the pulsewidth was reduced from 500 usec to 250 usec. Another diagnostic test was performed with high impedance results. The patient was last seen on (b)(6) 2011. Programming history was also provided. Per the patient's mother, the patient manipulated the device often. The generator was described as very superficial and palpable. Follow-up showed that patient manipulation was believed to have caused or contributed to the high impedance events. The device was not disabled. It was unknown when the device protrusion began, but the patient had lost weight within the last year, which may have contributed to the protrusion. The physician did not allege that the body was rejecting the device. No interventions were taken for the protrusion event. The weight loss was the cause of the excess of manipulation of the generator by the patient. A/p and lateral views of the neck and a/p view of the chest were reviewed. The reported events are high lead impedance and generator protrusion. The generator was visualized in the patient's left chest. The lead appeared to be intact at the lead pin and the lead pin was seen past the connector blocks indicating complete lead pin insertion. The integrity of the filter feedthru wires could not be assessed due to the angle of the x-rays provided. For the same reason, it could not be confirmed whether or not there was any lead behind the generator. The lead was seen in the left side of the patient's neck. No sharp angles were seen in the portions of the lead that could be visualized; however, there was a portion of the lead by the generator that could not be seen due to the angle of the x-ray images provided. A lead discontinuity was seen in the lead bifurcation. Follow-up showed that the weight loss was not believed to be related to vns. The patient did not often go to appointments, so the weight loss was only noticed at a recent appointment. The patient's mother indicated that the weight loss began one year ago. No interventions for this were taken. Surgery is likely but has not taken place.
 
Manufacturer Narrative
New information received corrects the date of explant.
 
Event Description
Additional information was received indicating that the physician believed that the generator battery depleted too quickly. A battery life calculation (results previously reported) and review of programming history showed normal battery depletion.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 157mm portion quadfilar coil 1 appeared to be broken approximately 5mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 157mm portion quadfilar coil 2 appeared to be broken approximately 15mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum and calcium. 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. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Additional information was received from the distributor stating that the vns patient was being scheduled for surgery to have the generator and lead explanted, and the generator had reached end of service. Additionally, it was reported that the patient will not be re-implanted with a new device for reasons unknown. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Attempts to obtain the date the devices were explanted are underway.
 
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=2925866
« Last Edit: July 05, 2018, 07:53:37 AM by dennis100 » Logged
dennis100
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« Reply #129 on: April 10, 2018, 01:09:54 AM »

Model Number 304-20
Event Date 07/23/2016
Event Type  Injury   
Event Description
It was reported that a patient was having dyspnea and voice alteration. The symptoms occurred even between stimulations. Diagnostics were within normal limits. The physician decided to disable the device to see if the symptoms get better. The patient was still experiencing vocal cord problems even with the generator programmed off. The vocal cord issue did not start until later into the titration phase and did not resolve with the disablement, so the physician believed that the nerve was inflamed and wanted to wait and titrate the device up again. The patient later reported that her implant surgery took two times as long as it should have because the surgeon had difficulty implanting the lead. While in recovery, she choked on water and could not swallow. The patient lost a large amount of weight because she could not swallow food. She also reported that she was diagnosed by an ent with left vocal cord paralysis, spasms in the trachea and esophagus, and damage to the swallow and sensory nerves. Due to these issues, she could not talk, breathe, or sleep. The left side of her face was also reportedly paralyzed. The patient was having speech and swallow therapy, but she was told that this would not help. The physician considered disabling the patient's device to allow inflammation at the nerve to go down, but the patient was receiving efficacy from vns therapy. The physician decided program the patient's device to low settings for all modes of stimulation. No further intervention was taken. No additional information has been received to date.
 
Event Description
The patient's device was programmed off, and the patient reportedly had unspecified issues caused by her battery. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6150194
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dennis100
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« Reply #130 on: April 12, 2018, 12:29:01 AM »

Model Number 302-20
Event Date 04/10/2014
Event Type  Malfunction   
Event Description
The explanted generator is not available to return to the manufacturer for analysis.
 
Event Description
It was reported that the patient has had multiple issues including pain and decreased appetite since the lead was repaired with silicone. The pain in the neck area was intense, and the patient kept ice applied and took medication as a result. The patient had lead replacement surgery on (b)(6) 2014. The patient reported on (b)(6) 2014 improved adverse symptoms and feeling much better since the surgery. The explanted lead is not being returned to the manufacturer for analysis.
 
Event Description
It was reported that the patient was going to be evaluated by another surgeon for a second opinion. The patient was referred for generator and lead replacement surgery. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturing device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator replacement surgery on (b)(6) 2014, the surgeon repaired two large tears in the lead with silicone. Since the surgery, the patient was having difficulty turning her neck. When she turned her neck, the patient became nauseous from pain in her throat. The patient was unable to eat due to the nausea and had lost weight. The patient was also experiencing tinnitus with her head turned and having daily headaches. The patient¿s device was recently programmed on. The patient previously had a surgical consult on (b)(6) 2013 for a possible lead migration. The surgeon determined there was no lead migration and stated that the patient¿s device was working well. Diagnostic results showed normal device function as of (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through 11/23/2011. No known interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
An implant card was received indicating that the vns patient was experiencing spasms and pain at the generator and lead sites prior to generator replacement surgery on (b)(6) 2014. The generator was replaced due to battery depletion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3838722
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« Reply #131 on: April 12, 2018, 12:29:55 AM »

Event Type  Injury   
Manufacturer Narrative
Vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis. Aburahma, samah k. Et al. Seizure - european journal of epilepsy.
 
Event Description
An article titled ¿vagus nerve stimulation therapy in a developing country: a long term follow up study and cost utility analysis¿ was received which included the vns patient adverse events. Two patients experienced post-operative infections that were treated with iv antibiotics, one of which required device explant. One patient had wound dehiscence one week following surgery that was surgically treated. One patient had to undergo surgery to reposition the device due to protrusion. One patient underwent surgery due to a lead issue. Five patients were noted to have experienced significant weight loss due to decrease in appetite. Analgesics did not improve oral intake in the noncommunicative patients, and in one patient decreasing the stimulation intensity did help. Two patients were non-responders but experienced significant weight loss that required either device removal or disablement. This manufacturer report involves the device protrusion which required surgery to reposition the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377788
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« Reply #132 on: April 18, 2018, 01:07:23 AM »

Model Number 102
Event Date 02/06/2012
Event Type  Injury   
Manufacturer Narrative
Date of event, corrected data: initial report inadvertently listed wrong date. Event date is (b)(6) 2012.
 
Event Description
Additional information was received from the physician which indicated that the migration was first observed on (b)(6) 2012. The surgeon was also contacted and stated that the suture used during the vns generator implant was absorbable. Manufacturer labeling recommends non-absorbable suture to be used to attach the generator to the fascia.
 
Event Description
It was reported that the patient lost weight and the vns generator slipped in the pocket. The patient underwent surgery and the surgeon repositioned and sutured the vns generator higher in the pocket.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3056142
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« Reply #133 on: April 22, 2018, 01:11:26 AM »

Model Number 304-20
Event Date 02/18/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that this vns patient was hospitalized after implant surgery due to a cough. The patient¿s device was not programmed on at the time. Follow-up showed that the condition was not pre-existing and not occurring with stimulation at the present time; however, it could not be determined if the event was related to vns. Currently, the coughing was not occurring with stimulation. It was stated that on occasion, the patient would cough and have a little bit of blood in her sputum. The patient also reported lead protrusion in the neck when turning her head to the right. The patient was seen and the lead appeared very tight when the patient turned her head. The generator was placed in the upper chest, under the clavicle, but the lead just may have been too short. The patient was referred to a surgeon for evaluation but this was for patient comfort. Surgery is likely but has not taken place.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient's device is off, but she is complaining of pain "radiating throughout her whole body," the patient was scheduled to have either a lead revision or vns removal. Additionally, the patient claims that the lead going up to her neck is "too tight" and her device is flipping over. The patient showed the physician how she can manually manipulate it to "flip over. " additionally, it was also reported that the device could easily be manipulated in the pocket. The patient's device was explanted on (b)(6) 2013. The explanted device was discarded by the hospital after the surgery. Attempts have been made for additional information; however, they have been unsuccessful.
 
Event Description
Further follow-up revealed that the patient's device was explanted "because she has had several problems since the device was placed. The physician's office also reported that the patient experienced excessive nausea, vomiting, tightness of the lead, choking sensations, coughing, and burning pain at the generator site. It was reported that the neurologist recommended removal of the vns system because the neurologist felt that the amount of problems the patient experienced did not seem to outweigh the benefits of having vns therapy. Attempts to obtain additional information have been unsuccessful to date. Attempts to have the explanted devices returned for analysis have been unsuccessful to date.
 
Event Description
It was reported that the patient was seen by another physician for a second opinion. It was reported that the patient had experienced a weight loss of 35 pounds due to the nausea, vomiting following vns implant surgery. The patient¿s device was programmed on in approximately (b)(6) 2013. System diagnostics were reportedly within normal limits (lead impedance ok and approximately 3,500 ohms. The patient reported that her symptoms have not changed since the device was programmed on. The physician believes that the symptoms are probably due to trauma to the nerve during the implantation as the surgery lasted approximately 5 hours. The physician felt that time will probably alleviate the symptoms. The physician informed the patient to come back in if the symptoms persist in 3-6 months.
 
Event Description
Follow up with the physician found that he did not believe the choking was related to the vns. The choking was not associated with or occurring with stimulation. During explant, the patient's generator was found to be sutured to the fascia at implant with a non-absorbable suture. The physician believes the patient was manipulating the device. It did not appear that the device had migrated since implant. It was unknown when the device was turned off. The explant surgery was taken for patient comfort. The patient also felt the device was causing "electrical disturbances" in her house. The symptoms have improved since explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125097
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« Reply #134 on: April 22, 2018, 01:11:55 AM »

Model Number 302-20
Event Date 01/01/2012
Event Type  Injury   
Event Description
On (b)(6) 2013, it was stated that this patient was referred to the surgeon to preclude a serious injury. On (b)(6) 2013, this vns patient complained of discomfort because the lead protrudes from her neck when she leans her head backwards. Follow-up showed that the pain began 1. 5 years prior. The patient put on about 40 pounds then lost about 50 pounds in less than 1 year. Diagnostics were unchanged from the previous visit, but these were not provided. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3124748
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« Reply #135 on: May 04, 2018, 01:13:33 AM »

Event Date 01/01/2009
Event Type  No Answer Provided   
Event Description
Rptr began to have increased neck and shoulder pain and increased seizures. The dr said it was arthritis and sent her to a pain specialist. It could be seen migrating, the device had disconnected. Decreased the voltage. Rptr finally had it removed 6 mos after her initial complaint. She was placed on additional anticonvulsants keppra and vimpat. She was already on dilantin and gabapentin. Rptr has developed anorexia and is losing weight. She is now (b)(6). She also is having trouble walking and has developed tremors. She feels it is from the medication and expresses concern that it has taken her physician so long to take drug levels when she has been wanting them done. Now he wants to take a battery of lab tests.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2666397
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« Reply #136 on: June 04, 2018, 12:20:16 AM »

Model Number 102
Event Date 07/01/2009
Event Type  Injury   
Event Description
It was reported to the mfr that the vns pt has been experiencing weight loss. The pt's device was programmed off and the pt was able to gain weight. The weight loss has been determined to be related to vns therapy by the pt's physician. Diagnostics performed on the pt's device at implantation surgery were within normal limits. The pt's device has been explanted with no plans for replacement due to intolerance. The explanted products have been returned to the mfr for product analysis. Product analysis is currently pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1558561
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dennis100
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« Reply #137 on: July 31, 2018, 03:40:53 AM »

Model Number 102
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was initially reported through clinic notes that the patient's vns is "sticking out" which requires the patient to wear a sports bra to stabilize it. Patient's grandmother stated that the patient has lost (b)(6) due to which her skin is pulling so thinly that the generator is surfacing causing her pain. Pt was referred to a plastic surgeon to help her with the issue. The plastic surgeon indicated that the vns generator is in the breast tissue and needs to be moved before he can do anything. He believed that once the vns is moved, it will stop the pain. No add'l info is received. Good faith attempts to obtain add'l info has been unsuccessful till date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1894919
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« Reply #138 on: August 11, 2018, 12:51:07 AM »

Model Number 106
Event Date 06/23/2018
Event Type  Injury   
Event Description
Due to excessive throat irritation, my daughter was taken to the emergency room after not eating for over a week. She was diagnosed with dehydration through blood work at the hospital. Required two large iv bags of fluid. My daughter was unable to eat for about two weeks total and lost a lot of weight.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7681233
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dennis100
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« Reply #139 on: October 05, 2018, 12:20:51 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/04/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluated by mfr?, device evaluation is not necessary as the migration is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator has shifted in the chest pocket since they have lost over (b)(6) of weight. The patient would like to have surgery to revise the migration. Multiple attempts for relevant information were made, but no information has been received to date. No other relevant information has been received to date. Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7909876
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dennis100
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« Reply #140 on: November 10, 2018, 03:08:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/09/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported through social media that the vns was "not working" for the patient as it was reportedly provoking brain seizures causing the patient to not be able to wake up for 3 days. It was further reported that since being implanted, the patient has been feeling more sick, has lost about 40 pounds since implant (about a month), and could not go to the bathroom on his own. The patient had been hospitalized as a result, and it was stated the device would be disabled and explanted soon. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7936172
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« Reply #141 on: November 10, 2018, 03:10:01 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2018
Event Type  Injury   
Event Description
It was reported that the patient was feeling painful, erratic stimulation throughout the left side of her neck where the lead is located. The lead was previously not visible, but was reported to now be protruding against the patient's neck. It was reported that the patient had lost some weight. Lead impedance was reported to be normal with multiple diagnostics being performed. It was also stated that the patient was unable to sleep due to the stimulation. It was reported that the physician had ordered x-rays; however, these have not been reviewed by the manufacturer to date. The patient's device was later disabled, and the patient was referred to a surgeon for surgery. The neurologist reported that the erratic stimulation was believed to be related to a possibly disconnected lead, and that the cause of the protrusion was not known. The neurologist indicated that the surgical consult was not due to or to preclude a serious injury. No known surgical intervention has 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=7949664
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dennis100
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« Reply #142 on: November 10, 2018, 03:10:53 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/10/2018
Event Type  Injury   
Event Description
It was reported that the patient was admitted to the hospital due to issues including dysphagia, ataxia, weight loss of 10 pounds since (b)(6) 2018 (implant month of current vns generator), an increase in general tonic-clonic seizures and changes in neurological status: lethargy and muscle weakness. The patient's device was turned off to see if symptoms improved. The doctor believed that the patient may have an allergy to titanium. No known surgical intervention has occurred to date. No further relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939263
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dennis100
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« Reply #143 on: January 04, 2019, 09:10:05 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/01/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient had been losing weight. Caregiver stated that the patient would only want to eat once a day and had lost 30 pounds. Per neurologist, the patient gained 30 pounds in the past 3 years until the most recent vns surgery. After the surgery, the patient lost 30 pounds. Patient does not have any history of eating disorders. The neurologist stopped a medication as it might have contributed to the weight loss but the patient's weight did not increase despite this change. Neurologist also added a new medication to help stop the weight loss but this was not effective. Due to the very close temporal relationship between implant surgery and onset of weight loss, the neurologist believes that there is a causal effect with vns therapy. Vns settings have been significantly reduced to see if that helps increase appetite. A review of device history records for the generator shows that no unresolved non-conformances were found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8180824&pc=LYJ
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« Reply #144 on: January 05, 2019, 02:42:49 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/14/2018
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as extrusion is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient had their generator explanted due to extrusion. The generator was explanted to preclude a serious injury and to prevent an infection, as the generator was physically visible through the skin. A medical professional indicated that the patient did lose a lot of weight and then gained the weight back prior to the extrusion. The device history records were reviewed and indicated that the generator and lead were sterilized according to specifications and passed functional specifications prior to distribution. Device evaluation not necessary as extrusion is not related to the functionality or delivery of therapy of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8131284
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« Reply #145 on: January 16, 2019, 02:33:37 AM »

Model Number 304-20
Event Date 04/15/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the vns patient was scheduled for surgery to replace his generator due to end of service on (b)(6) 2014. During the procedure, it was determined that the patient¿s device was not at end of service so the generator was not replaced at the time. The surgeon noted during the procedure that the patient¿s lead was extruding from his neck. Intervention was required to prevent any adverse events as the lead was exposed. The surgeon buried the lead medially and secured it with a suture. Further follow-up revealed that the patient may have been manipulating the lead but the patient denied any manipulation or trauma had occurred. The patient did not have any physiological changes that may have caused or contributed to the reported event. It was noted that the patient had lost 10 kg since his last revision surgery in 2012.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3803231
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« Reply #146 on: February 08, 2019, 01:03:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/28/2018
Event Type  Injury   
Event Description
It was reported that post surgery, the patient had not been eating and had been vomiting. The patient also had a higher number of autostimulations than prior to their replacement. Further information received indicated that it was unknown if the patient¿s generator had died prior to replacement. The physician did not believe that the vomiting and weight loss is related to an illness or to compromised immune system post surgery. The patient saw a gastroenterologist, and had a v-tube and bypass to the duodenum and was placed on a feeding tube. It was indicated that there was a gastric issue; however, it is unknown if that is the sole cause of the nausea and vomiting, or if there was additional factors. The physician was concerned to disable the device because the patient is on many medications and has gone into status in the past. The physician also questioned if the patient¿s nerve had been pulled during the recent replacement surgery. The sales representative present at the surgery denied the surgeon having pulled on the nerve, and stated that surgeon believed the vomiting was unrelated to vns. The patient was hospitalized and his device was disabled. Per the physician, the patient immediately improved when the device was disabled. No additional or further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8222113
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« Reply #147 on: February 11, 2019, 02:15:04 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1577003
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« Reply #148 on: March 09, 2019, 02:20:29 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury   
Event Description
Patient reported in social media that they have lost much weight since their first vns implant. Patient is currently implanted with their third device and it is disabled (turned off). While receiving vns therapy, patient's weight decreased from (b)(6) pounds to (b)(6) pounds. After turning device off, patient's weight increased to (b)(6) pounds. No additional relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8298269
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« Reply #149 on: March 10, 2019, 02:14:08 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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