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dennis100
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« Reply #600 on: April 22, 2018, 01:08:53 AM »

Model Number 102
Event Date 04/15/2013
Event Type  Malfunction   
Event Description
The surgeon reported that a non-absorbable suture used to secure the generator to fascia during implantation of the device on (b)(6) 2012.
 
Manufacturer Narrative
Review of manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.
 
Event Description
It was initially reported that the patient reported to the neurologist that her generator migrated to the left axillary area. The neurologist¿s office reported on (b)(6) 2013 that they were referring the patient back to the implanting surgeon as they suspect that the lead has come disconnected from the generator, and the patient was having an increase in seizures since the early part of the prior week. Additionally, the neurologist¿s office was unable to interrogate the generator on (b)(6) 2013. It was unknown by the nurse at the neurologist¿s office if patient manipulation or trauma occur that is believed to have caused/contributed to the generator migration. The patient later reported on (b)(6) 2013 that she is considering having her device removed. She reported that three days after implanted, the patient began to experience frequent chest pains, shortness of breath, and difficulty speaking; these events are captured in mfg report number: 1644487-2013-01474. She also reported experiencing hot flashes. She reported that her seizures have reduced from daily to 5 times in the last year. The last vns dosing adjustment was (b)(6) 2013, in which she reported that the neurologist turned the vns settings up. However, this has not been confirmed by the neurologist to date. Attempts for information from the neurologist have been unsuccessful. Additionally, attempts to the surgeon regarding type of suture used to secure the generator to the fascia during implant surgery have been unsuccessful to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3123691
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dennis100
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« Reply #601 on: April 23, 2018, 01:03:44 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Garci´a-navarrete e, et al. Long-term results of vagal nerve stimulation for adults with medication-resistant epilepsy who have been on unchanged antiepileptic medication. Seizure: eur j epilepsy (2012), http://dx. Doi. Org/10. 1016/ j. Seizure. 2012. 09. 008.
 
Event Description
An article entitled ¿long-term results of vagal nerve stimulation for adults with medication-resistance epilepsy who have been on unchanged antiepileptic medication¿ was received. Forty-three patients were followed. After implant, patients were evaluated on a monthly basis increasing stimulation 0. 25 ma at each visit, up to 2. 5 ma. Medication was unchanged for at least 18 months since the stimulation was started. Of the 43 operated patients, 63% had a simulation or great than 50% reduction in seizure frequency. Differences in the responder rate according to stimulation intensity, age at onset of epilepsy, duration of epilepsy before surgery, previously epilepsy surgery, and seizure type, did not reach statistical significations. Most side effects were well tolerated. One patient reported an increase in the duration and intensity of his seizures. Twenty-two patients experienced side-effects. The most common were mild, consisting in hoarseness, neck tingling or occasional coughing at the time when the signal was on, all of which were usually well tolerated. Two patients had intermittent dyspnea, and another patient experienced occasional episodes of dysphagia with stimulation. Irritability was reported by two families, in the context of a general improvement in the level of alertness. Five had severe side effects, requiring their vns generators to be inactivated or explanted. Three of the 5 patients that stopped receiving stimulation had been responders. Reasons for explanation were infection in two patients, and odynophagia, in one patient. One patient had an exacerbation of a previous behavior disturbance, with severe aggressiveness, which improved when the stimulator was inactivated. Seizure reduction was maintained after the stimulation was stopped. Another stimulator was removed at family request, owing to a persistent abdominal pain. One explant due to infection is captured in this report: mfr report# 1644487-2013-01450. The other explant due to infection is captured in mfr report #1644487-2013-01453. The explant due to odynophagia is captured in mfr report #1644487-2013-01449. The explant due to abdominal pain is captured in mfr report #1644487-2013-01447. The report of increased seizure duration and intensity is captured in mfr report #1644487-2013-01444.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3120504
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dennis100
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« Reply #602 on: April 23, 2018, 01:04:34 AM »

Event Date 01/01/2012
Event Type  Injury   
Manufacturer Narrative
Ryzi m, brazdil m, novak z, chrastina j, oslejskova h, rektor i, et al. Long-term vagus nerve stimulation in children with focal epilepsy. Acta neurol scand. 2012. http://Http://www. Ncbi. Nlm. Nih. Gov/pubmed/22994298.
 
Event Description
An article entitled ¿long-term vagus nerve stimulation in children with focal epilepsy¿ was received. The article reviewed one and two year efficacies of 15 patients implanted with a therapy system. Of the 15 patients, 7 were responders at one year after implant, nine were responders at two years after implant, and nine were responders at five years after implant. Initial settings were provided. The output current was increased in two week increments of 0. 25 ma to a target intensity of 01. 50 ma to 2. 0 ma depending on efficacy and the presence of side effects. Rapid cycles (on time: 3. 0 seconds, off time: 1. 8 minutes and on time: 7 seconds, off time: 18 seconds) was used in all patients who were classified as non-responder at one year. Medications were kept unchanged during the first six months. The article concluded that vagus nerve stimulation is an effective method of treating children with refractory focal epilepsy. It led to a substantial decrease in the number and duration of urgent hospitalizations. The article indicated that one patient experienced severe adverse effects requiring explant of the device. The patient experienced repetitive attacks of cardiac asystolia, sometimes associated with syncope at the time when the device was switched on. The syncopes started after more than one year of stimulation. The asystole was strictly related to the on status of the device and was not related to patient seizures. ¿ this was provided by video-eeg monitoring. The patient did not response to vns; therefore, the output current was not adjusted. The discontinuation of vns led to the complete cessation of these symptoms. The cardiological investigations performed on this patient both pre-operatively and post-operatively (during the off times) revealed no abnormalities. Other severe adverse effects were not observed. The explant due to cardiac events is captured in mfr report #1644487-2013-01439. Urgent hospitalizations were also reported for nine patients in the post-operative period. This was defined as hospitalization because of an increase in seizure frequency with a change or adjustment in the long-term aed treatment or because of an adverse event, a complication of the epilepsy itself, or an aed treatment that lead to any permanent therapeutic treatments. This report captures the urgent hospitalization for an increase in seizure frequency for patient 5 of 9. Additional reports are captured in mfr report #1644487-2013-01490, mfr report #1644487-2013-01491, mfr report #1644487-2013-01493, mfr report # 1644487-2013-01494, mfr report #1644487-2013-01496, mfr report #1644487-2013-01497, mfr report #1644487-2013-01498, mfr report #1644487-2013-01499 the article also noted that cough, hoarseness, and mild dysphagia were observed in 12 of the 15 patients reviewed. In none of these patient¿s was the severe effect a reason for discontinuation of vns, and the effect resolved completed by the next visit.
 
Event Description
Additional information was received that all of the reported adverse events (except for the cardiac event) were mild, temporary, and overall in line with the experience.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3122253
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dennis100
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« Reply #603 on: April 24, 2018, 01:07:25 AM »

Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
It was reported that interrogation of the device resulted in high impedance >10,000 ohms. It was reported that the patient underwent generator replacement in (b)(6) 2012. The patient has been experiencing an increase in seizures and behaviors. The patient is being evaluated for replacement surgery. The patient was sent for neck and chest x-rays which were reviewed by the radiologist. The radiologist's review noted that the patient was experiencing neck pain. The review identified that the lead appears to be intact over the left lateral chest. The lead was coiled and was difficult to evaluate. Clinic notes dated (b)(6) 2013 noted that the patient's seizures have increased since the last visit in (b)(6) 2012. It was reported that the did well for several months following the last visit; however, 2 months ago she started experiencing an increase in seizures up to three to four generalized tonic-clonic seizures per week. It was also noted that the patient's mother reported that the patient's speech seems to have deteriorated and that the patient is having severe behavioral problems. The notes indicated that the recent increase in seizure frequency may be secondary to the vns malfunction. The notes indicate that the physician reduced the patient's settings from 1. 5ma/1. 8 min off to 1ma/3 min off. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely; however, has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent surgery on (b)(6) 2013. During the surgery after the patient was anesthetized, diagnostic tests resulted in normal impedance readings. The patient's head was turned in different orientations to rule out positional high impedance which were all within normal limits. Different programming systems were also used which also resulted in normal readings. The surgeon decided that he will not replace the lead since diagnostics were within normal limits. The surgery was aborted and the patient taken to recovery.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/09/2016. Supplemental mdr #7 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 7 is 09/09/2016. Date received by manufacturer (mo/day/yr), corrected data: 10/26/2016. Supplemental mdr #8 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 8 is 10/26/2016.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
The explanted generator and lead were received on 10/26/2016. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of; ¿fracture of lead(s) / explanted / due to lead break / high impedance¿ (lead section) and ¿pain¿ (lead section) were confirmed. A condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The ¿increased seizures¿ (patient section) allegation is beyond the scope of activities performed in the pa laboratory environment: however, the observed discontinuities may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During the visual analysis abraded openings were observed on the outer and inner silicone tubes and the quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break (found at 99mm) and identified the area on three 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 strand was identified as being mechanically damaged with no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the areas on the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 160mm portion quadfilar coils 1 and 2 appeared to be broken. Scanning electron microscopy performed on the quadfilar coil 1 coil break identified the areas on the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. Scanning electron microscopy performed on the quadfilar coil 2 coil break identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strand. 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 and the cut ends that were made during the explanted process, 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 on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. With the exception of the discontinuities and abraded openings, the condition of the returned lead portions is consistent with those 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 discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to support the ¿fracture of lead(s) / explanted / due to lead break / high impedance / low impedance / low impedance message, short circuit condition¿ allegations.
 
Event Description
On (b)(6) 2016, it was reported that low impedance with <600 ohms was observed on patient's device. Possible causes were discussed and patient manipulation was ruled out. X-rays were planned to be sent for review. Programming history for the device was reviewed. The device was temporarily disabled sometime after (b)(6) 2012 till (b)(6) 2013 due to high impedance. It is suspected that the current low impedance may be related to the previous high impedance observed in 2012. No known product replacements have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices have not been received to date.
 
Event Description
Clinic notes were received for patient's full revision surgery referral. Notes dated 7/15/2016 indicate that the lead impedance was greater than 10,000 in 2013 and patient was referred to surgeon for a lead revision. On the day of surgery on (b)(6) 2013, intraoperative device showed that the lead impedance was not over 10,000 but rather was okay at 3069ohms. The surgeon tested the device several times with the different programming systems but all of the tests showed the lead impedance was okay and the lead impedance values ranged from 3060 to 3179 ohms. As a result, the surgeon did not revise the lead at that time. More recently, patient was seen by the neurologist and the lead impedance was less than 600 ohms, and so patient was referred back to surgeon for evaluation and management. A chest x-ray was performed, which showed a lead fracture. According to caregiver, patient's seizures have been increasing in frequency. Patient had done quite well over the past couple of years, but more recently, within the past six months, experienced an increase in seizure frequency. Patient has had no real behavioral concerns until just recently likely related to the vns not working because of the lead fracture. Lead revision is planned but has not occurred to date.
 
Manufacturer Narrative
Describe event or problem: supplemental mdr #3 incorrectly reported that the high impedance was observed in 2012, when in fact, it was only observed in 2013.
 
Event Description
Lead product information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3115964
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dennis100
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« Reply #604 on: April 29, 2018, 01:58:03 AM »

Model Number 302-20
Event Date 05/06/2013
Event Type  Malfunction   
Event Description
On october 3, 2013, the manufacturer received a letter from the food and drug administration (fda) providing a report from the fda's medwatch program. Based on the nature and timing of the reported pain, dyspnea, and muscle spasms, it is possible that the event is related to the high impedance event. Below is the quoted event description from the medwatch report (mw5031542): "volun 27-aug-2013: i had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013. ".
 
Event Description
On (b)(6) 2013 it was reported that the lead impedance after surgery was noted to be ¿ok¿. Attempts were made for the return of both the lead and generator but neither product has been returned for product analysis to date.
 
Event Description
On (b)(6) 2013 ap neck and chest and a lateral chest x-rays were received for review. The images were dated (b)(6) 2013. The generator was seen in normal orientation in the left chest area. The filter feedthru wires and lead at the connector pin appear intact. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator. A portion of the lead appeared to be present behind the generator. The electrodes were observed in the neck and appeared to be in proper alignment. Based on the x-ray images provided, the cause of the high impedance is unknown; however, it could be related to a possible lead pin insertion issue. The presence of additional micro-fractures in the lead also cannot be ruled out.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. The lead pin could not be seen past the second connector block, indicating that it may not be fully inserted into the generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2013 the nurse reported that pa and lateral chest x-rays have been performed and will be sent for review; however they have not been received by the manufacturer to date. The nurse also stated that around the time the patient started to notice voice changes and tightness with stimulation, her seizure frequency increased from 1-2 times per week to once per night. During this time the patient was also not sleeping well therefore it was unclear what was causing the increase in seizures. The surgeon noted that he suspects a malfunction of the vns as her chest x-ray revealed the vns to be in continuity. The patient underwent a full revision surgery on (b)(6) 2013. Attempts were made for the return of the explanted generator but it has not been received by the manufacturer.
 
Manufacturer Narrative
Follow-up report #1 should have stated that attempts were made for the return of both the lead and generator, instead of just the generator.
 
Event Description
On (b)(6) 2013 it was reported that the vns patient was experiencing tightness and in her neck that started about two weeks ago. The nurse also stated that the patient has been experiencing an increase in seizures that started around the same time, two weeks ago. The device was interrogated on (b)(6) 2013 and the settings were output=0. 75ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=1ma/magnet on time=30sec/magnet pulse width=500usec. High impedance was observed on (b)(6) 2013 with output=limit/lead impedance=high/dcdc=7/eos = no. The patient¿s vns was disabled due to the high impedance. The nurse stated that almost immediately after the device was disabled, the tightness that the patient was experiencing improved. There has not been any recent trauma and the patient denied any device manipulation. X-rays were ordered and the patient was referred for surgery. It was reported that the patient previously was followed by a different physician but that physician has left the practice. The patient was last interrogated in (b)(6) 2012 and per the patient¿s chart, device diagnostics were not performed at that time. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The nurse later reported that the patient had also been experiencing voice changes during the same time as the tightness in the neck. She stated that they do not have a copy of the patient¿s x-rays but that the patient might have a copy that could be sent to us; she stated she would follow-up with the patient regarding this. No further information has been provided to date. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3167236
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dennis100
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« Reply #605 on: April 30, 2018, 01:37:57 AM »

Model Number 300-20
Event Date 05/10/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that the vns patient has been experiencing painful stimulation for the last couple of weeks that has been off and on; one day it will occur and the next it wouldn¿t. When the patient came into the office on the previous friday, high lead impedance was seen on diagnostics; output=limit/lead impedance=high. The patient has been getting efficacy from the therapy so the physician was hesitant on disabling the device, but stated he would call her in for the disablement. The physician did ask the patient if there had been any specific trauma/fall recently, but the only thing noted was that she uses the treadmill for exercise. The physician also noted that this patient is new to his office so it is unclear when she was last evaluated. The patient was referred for surgery. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Clinic notes dated (b)(6) 2013 indicated that the patient was having significantly more pain and hoarseness. The patient¿s vns was disabled that day. Although surgery is likely, it has not occurred to date.
 
Event Description
On (b)(6) 2013 it was reported that the patient underwent a full revision surgery that day. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed. The physician¿s assistant reported that no x-rays were taken and that there was no report in the physician¿s notes of where in the body the painful stimulation was felt. No further information was provided.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death.
 
Event Description
Generator analysis was approved on (b)(4) 2013. The generator was explanted/returned for prophylactic reasons. The generator septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Pa of the lead was approved on (b)(4) 2013. An analysis was performed on the returned lead portions. During the visual analysis of the returned 212 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 33 mm and 35 mm from the connector bifurcation. Scanning electron microscopy was performed on the coil break found at 33 mm and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the coil break found at 35 mm and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface 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 (+) marked connector inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. For the observed (-) unmarked connector inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuity, 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 pins 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the reported allegation. The abraded openings observed on the outer and (+) marked connector inner tubing sections have the potential for contributing to the painful stimulation allegation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3156500
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dennis100
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« Reply #606 on: May 01, 2018, 12:58:08 AM »

Model Number 103
Event Date 05/04/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
It was initially reported that after the patient did fine in post op after being implanted with vns, until post op day 4, when the patient possibly stretched his neck and became hoarse. For the first three days after surgery, the patient was fine and had no voice issues. However, after this date, the patient became hoarse and had pain over the vagus surgical site. There was no suggestion of infection. The surgeon stated that he would have the patient see an ear nose throat doctor for a laryngoscopy to check the patient's vocal cords. Follow up with the physician found that the patient had vocal cord paralysis on day 4 of post op. The event was not associated with stimulation, as the vns device had not been programmed on yet. No programming or diagnostic history was therapy was never initiated. The device was explanted as an intervention. Additional follow up was performed; however, no additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3249296
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« Reply #607 on: May 02, 2018, 01:51:40 AM »

Model Number 102
Event Date 11/07/2009
Event Type  Malfunction   
Manufacturer Narrative
Additional information was received which changes the product the report is reported on.
 
Manufacturer Narrative
Review of device history records. Review of lead device history records confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was performed on the returned generator. The pulse generator diagnostics were as expected for the programmed parameters. No obstructions were observed in the header lead cavity or connector blocks. A bench lead inserted past the connector blocks. In addition, the in-line cavity go gauge test passed. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿painful stimulation¿). In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
The patient reported on (b)(6) 2013 that he felt his vns device was ¿not working right¿ because he was feeling his stimulation since a couple of days prior which he had never experienced before. He started to feel his device turn on and can feel it pulsating in his neck where his scar is which had never happened previously. He reported that the treating neurologist did increase the vns settings a few weeks ago, but he did not notice any problems then. He reported that he believed everything was fine at his last visit. The patient denied any trauma or event that would have initiated the symptoms. Later, the vns company representative attended the patient¿s follow-up appointment on (b)(6) 2013 with a treating vns physician to assess the patient¿s symptoms and check the vns device. The patient reported about six months prior, the patient started feeling pain with stimulation by his clavicle and that about a month ago, the painful stimulation got more intense and he described it as a ¿spreading pain¿ which began in the clavicle area. The patient also started experiencing intense voice alteration with stimulation and was not able to talk when the device was stimulating. Upon performing diagnostics on the patient¿s device on (b)(6) 2013, high lead impedance was obtained with impedance value greater than 10,000 ohms. Therefore, the patient¿s device was disabled on this date, per manufacturer labeling recommendations. Clinic notes from (b)(6) 2013 reported that the patient¿s output current was increased on (b)(6) 2013 from 2. 25ma to 2. 5ma. The patient continued to complain of a ¿vibrating sensation in the left cervical region which would be consistent with the area of the lead. ¿ the physician notes that ¿it appears the patient¿s lead is faulty and therefore the device is being turned off. ¿ the patient was referred for replacement surgery. However, the surgery has not occurred to date. The cervical spine and pa/lateral views of the chest x-ray report dated (b)(6) 2013 reported no anomalies regarding the vns device. Attempts for a copy of the x-rays and additional information have been unsuccessful to date.
 
Manufacturer Narrative
Date of event; corrected data: this information was inadvertently left off of supplemental mfr. Report #1.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s surgery ended up just a battery replacement. The surgical team could visually inspect that the lead pin was not fully inserted and full of fluid. When the pin was dried off and reinserted, the system diagnostics showed results within normal limits. On (b)(6) 2013 further details were received when it was reported that the patient¿s revision surgery was underway when the surgeons noted the pin on the generator was not fully inserted. The pin was cleaned and reinserted and the surgeons noted the pin came loose very easily when unscrewing the set screw. After pin reinsertion, the device was within normal limits with no high impedance observed. The surgeons, by referral from the neurologist, went forth with a prophylactic generator replacement. Again, diagnostics showed all systems within normal limits. The surgeons elected to not move forward with a lead revision at this point. The explanted generator was returned for product analysis on july 29, 2013. Product analysis is underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3199351
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« Reply #608 on: May 03, 2018, 01:31:20 AM »

Event Date 01/01/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(4) 2013 an article titled ¿endoscopic laryngeal patterns in vagus nerve stimulation therapy for drug-resistant epilepsy¿ was reviewed. The article stated that the objective was to evaluate laryngeal patterns in a cohort of patients affected by drug-resistant epilepsy after implantation and activation of a vagus nerve stimulation therapy device. There were 14 consecutive patients that underwent a systematic otolaryngologic examination between 6 months and 5 years after implantation and activation of a vagus nerve stimulation therapy device. The article reported that they observed three different laryngeal patterns; four patients showed left vocal cord palsy at the baseline and during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02125, this report, 1644487-2013-02126, and 1644487-2013-02127), seven showed left vocal cord palsy at the baseline and left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02128, 1644487-2013-02129, 1644487-2013-02130, 1644487-2013-02131, 1644487-2013-02132, 1644487-2013-02133, and 1644487-2013-02134), and three patients showed a symmetric pattern at the baseline and constant left vocal cord adduction during vagus nerve stimulation (captured on mfr. Report # 1644487-2013-02135, 1644487-2013-02136, and 1644487-2013-02138). The article stated that the vast majority of patients (12/14) reported mild immediate dysphonia after implantation of the vns device, however only 4/14 patients remained dysphonic at the time of their laryngeal examination that occurred between six months and five years after surgery. One patient reported dysphonia at more than one year after surgery. All four patients showed left vocal cord palsy at the time of the examination. It was stated in the article that for the group of patients that showed left vocal cord palsy both at rest and during phonation with the vns both armed and disarmed (4/14 patients), only one of these patients reported dysphonia at the time of examination. It was stated that this laryngeal pattern seems related to iatrogenic damage to the vagus nerve, which is unable to conduct physiological or supraphysiological stimuli. The second group (7/14 patients) that showed left vocal cord palsy at the baseline both at rest and during phonation and persistent left vocal cord adduction during the whole vns stimulation period; only three reported dysphonia persisting at the time of examination, showing good right vocal compensation. The third group of patients (3/14 patients) that showed a symmetrical laryngeal pattern at rest and during phonation at baseline and left vocal cord adduction during the entire vns stimulation period had no patients that reported dysphonia at the time of examination. It was stated that the nerve is not completely damaged in these patients.
 
Event Description
On (b)(6) 2013 the physicians (authors of the paper) stated that they solved their patient¿s side effects some months after implant. They said they have no time to give any further information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3229051
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« Reply #609 on: May 03, 2018, 01:32:11 AM »

Event Date 06/18/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 a copy of the patient¿s x-rays was reviewed. The generator appears in the upper left chest in a normal placement. The filter feed-through wires appeared to be intact. The lead connector pin was fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the x-rays images, the cause for the high lead impedance could not be determined.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Additional information was received regarding the date of birth and age for the patient.
 
Event Description
On (b)(6) 2013, it was reported that dcdc=7 was seen. There was no known trauma, and the patient was still feeling stimulation and experiencing voice alteration. X-rays were to be taken but have not been received. The patient was a good responder to vns therapy. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place. It was also stated that the patient underwent lead revision in (b)(6) 2012 due to high impedance. This is captured in mfr report #1644487-2013-02117.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3227240
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« Reply #610 on: May 05, 2018, 12:16:55 AM »

Model Number 105
Event Date 06/25/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
Follow up with the physician found that the hoarseness the patient experienced had resolved. No other information was provided on the previously reported events.
 
Event Description
The patient was implanted with a vns device on (b)(6), 2013. On (b)(6) 2013, it was reported that the patient would potentially be having a stent placed and pacemaker implanted on (b)(6) 2013. It was additionally reported that the ekg strip from the operating room revealed that the patient had an event during intraoperative testing. The neurologist described this as an asystole event. Attempts are underway for additional information; however, no additional information has been provided.
 
Event Description
Additional information was received. The physician indicated at one point that the arrhythmia was related to stimulation and another point indicated that the arrhythmia is not related to stimulation but that is exacerbated or co-currently contributed to the arrhythmia. It was also indicated that the patient was never programmed on at the time of the arrhythmia. It was believed that the patient already had arrhythmia and his last event was more likely cardiogenic epileptic event. Manipulating the vagal nerve during place the lead could have worsened the arrhythmia.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3309060
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« Reply #611 on: May 06, 2018, 01:54:17 AM »

Event Date 07/10/2013
Event Type  Injury   
Manufacturer Narrative
Article citation: roldan p, brell m, perla ypc, moreno a, barcelo i, martinez ab, et al. [vagal nerve stimulation treatment in patients with drug resistant epilepsy: son espases university hospital experience]. Neurocirugia (astur). 2013. [epub ahead of print]. (b)(6). http://Http://www. Ncbi. Nlm. Nih. Gov/pubmed/23850134.
 
Event Description
The abstract for the article, "vagal nerve stimulation treatment in patients with drug resistant epilepsy: son espases university hospital experience" was received and reviewed by the manufacturer. The study was a retrospective analysis of patients operated from january 2004 until december 2012. Interviews and tests completed by outpatients and principle caretakers were evaluated. : fifteen patients were included, with a mean postoperative follow-up of 4. 41 (0. 5-8) years. Mean age at implantation was 25 (10-50) years. The article reports that two patients had the vns device removed due to refractory headaches. This report is for the first patient and manufacturer report number 1644487-2013-02448 reports on the second patient. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been received. Abstract objective: to present our experience in treating drug-resistant epilepsy with vagal nerve stimulation in our centre, evaluating its impact on disease control and on different aspects related to the patients and main caretakers' quality of life. Materials and methods: results: fifteen patients were included, with a mean postoperative follow-up of 4. 41 (0. 5-8) years. Mean age at implantation was 25 (10-50) years. Over 66% of the patients perceived a reduction greater than 25% of their crisis intensity. Forty-seven percent of the patients experienced a decrease greater than 50% in the number of crises. As undesired adverse events, one patient presented persistent dysphonia, another self-limited cough and cervical discomfort and another, persistent cervical discomfort. The device had to be removed in 2 patients due to refractory headaches. There were no complications derived from the surgical procedure. Conclusions: vagal nerve stimulation is an effective treatment for reducing crisis frequency and intensity. The patients as well as their caretakers experience a subjective improvement in their quality of life. Despite its economic cost, it seems to reduce their care needs to a certain degree and its use may therefore be justified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3293520
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« Reply #612 on: May 06, 2018, 01:54:59 AM »

Model Number 102
Event Date 03/29/2013
Event Type  Injury   
Event Description
Operative notes from the patient¿s (b)(6) 2013 surgery were received. Surgical diagnoses included painful malpositioned vagal nerve stimulator lead. During surgery, robust fibrotic scar tissues was found with suture tie downs dislodged. The note stated that the patient tolerated the initial implant procedure well; however, he began to complain of left neck superficial pain at the site of palpable scar tissue and lead. Initial non-operative management included massage and external repositioning, which were both unsuccessful. X-rays reportedly showed no fracture of the lead. During surgery, the suture tie-downs were noted to have become dislodged. The suture tie-downs were temporarily removed, and the lead was freed as much as possible and then re-secured. The lead course was re-routed to allow gentle curve with strain relief loop recreated and suture tie downs secured to muscular fascia. Scar tissue was revised.
 
Event Description
Attempts for additional information did not provide information regarding the events. The only information returned was that the patient did not have a history or diagnosis of osa.
 
Manufacturer Narrative

Event Description
Operative notes from the patient¿s (b)(6) 2013 implant surgery were received. The procedure was completed with minimal blood loss. No adverse events or complications were noted in the operative report. It was noted that the programming wand was used to interrogate and test the generator and lead, and they tested well.
 
Event Description
Clinic notes dated (b)(6) 2013 indicates that the patient was seen for follow up after vns placement performed on (b)(6) 2013. The patient reports hoarseness that waxes and wanes, and is concerned about "feeling the wiring up in the lower neck". The patient had some throat, tongue, and perioral numbness a couple of days ago, but it resolved. The notes also mention that the patient has a past medical history or sleep apnea. Clinic notes dated (b)(6), 2013, indicate that the patient feels like something is "stuck in his throat when the vns is on" and feels like he is choking while eating. The patient went in for revision surgery on (b)(6) 2013, where the lead, and possibly the generator, were revised or repositioned. The devices were not removed and no new devices were implanted. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

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« Reply #613 on: May 07, 2018, 01:12:21 AM »

Model Number 302-20
Event Date 07/11/2013
Event Type  Injury   
Event Description
On (b)(6) 2013, it was reported that the patient was scheduled for a prophylactic battery replacement that day and in the or before the surgery, it was noted that the consent form showed lead replacement as well. The surgeon stated that the patient and her husband had requested to have the lead replaced due to side effects. Interrogation of the system found the impedance dcdc code was 2; however, both the output current and magnet output current were programmed to oma. A review of the patient's programming history found data from (b)(6) 2012. Follow up with the surgeon's office found that the side effects referred to the patient experiencing throat tightening and hoarseness with stimulation on times. The surgery was performed for these reasons as the patient "wanted it out. " the device was replaced. It was unknown if the surgery was for patient comfort or to preclude a serious injury. It was additionally unknown if there were any causal or contributory programming or medication changes which preceded the event. It was stated that the neurologist would need to be contacted for this information and no additional information was provided. Attempts to the neurologist for additional information were made; however, they were unsuccessful. No additional information has been provided.
 
Manufacturer Narrative

Event Description
It was reported that the explanting facility discarded the explanted device.
 
Event Description
Follow up with the neurologist found that the patient was not under his care when first implanted with the vns and his old records do not allow him to clarify any of the questions asked better. No other information was received.
 
Event Description
Attempts to obtain additional information from the patient's original treating physician identified that the physician is now retired. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3267176
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« Reply #614 on: May 08, 2018, 02:12:50 AM »

Model Number 302-20
Event Date 06/13/2008
Event Type  Injury   
Manufacturer Narrative

Event Description
The vns device was replaced on (b)(6) 2013. The device has not been returned to the manufacturer.
 
Event Description
On (b)(6) 2013, this patient reported that the lead has been close to the vocal cord since implant. There was no pain. The patient experienced voice alteration with magnet activation. The patient was referred for revision. The patient indicated that the device settings could not be increased because it causes her to have difficulties breathing. When the magnet is used, she has problems catching her breath for awhile. She also cannot make but a "raspy squeak" for a short while after magnet use. At the current device settings, the patient did not experience difficulty breathing. Attempts for additional information have been unsuccessful. Surgery is likely but has not taken place.

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« Reply #615 on: May 09, 2018, 01:41:04 AM »

Model Number 103
Event Date 01/08/2013
Event Type  Injury   
Event Description
Product analysis was completed on the generator on 02/17/2015. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the expected low battery voltage. The battery, 2. 564 volts, shows a neos=yes condition. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 607 volts. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. No anomalies exist and the end-of-service (eos) condition is an expected event. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Additional information was received stating that the vns patient¿s device showed an end of service condition during an office visit on (b)(6) 2014. The patient is not expected to undergo replacement surgery due to lack of efficacy.
 
Event Description
Clinic notes dated (b)(6) 2014 were received which indicated that the patient is having an increase in seizures, very frequent each day. The patient was referred for a battery replacement and the physician reported that the device has reached end of battery life. The patient underwent generator replacement on (b)(6) 2014. Attempts have been made for the return of the explanted generator but it has not been received to date.
 
Event Description
On (b)(6) 2015 the explanted generator was received for product analysis. Product analysis is still underway and has not yet been completed.
 
Manufacturer Narrative

Event Description
Clinic notes were received which indicated that the patient's father called the physician's office and stated that the patient is having break through seizures. Per the note, it seems that the patient will have several one day and then go weeks without any activity. The patient's father wanted to know if he could increase the patient's medication and was advised an increased medication dosage amount. The date of this note is unknown. Notes dated (b)(6) 2013 indicate the patient had an increase in seizures and then increase felbamate. The patient's vns was checked and diagnostics indicated that the battery is near end of life. Notes dated (b)(6) 2013 indicate the patient had breakthrough seizures tuesday evening at 5pm that stopped at 6pm. The patient had a lot of facial twitching and fell down once. Otherwise, the patient has done well for months. Clinic notes dated (b)(6) 2013 additionally note the break through seizures, which occurred on (b)(6) 2013. The patient had a breakthrough seizure and fell down the stairs and broke arm. The patient will go for a few days to a week with no seizures, then usually in the morning will see eyes roll back and fall, with some facial twitching. The father noticed an increase in stuttering and stated that the patient is getting worse. Follow up with the physician found that upon interrogating the vns, it was seen to be near end of service. The physician believes the increase in seizures and lack of efficacy was due to the device nearing end of service. Since starting the vns, the patient's seizures have decreased. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the event. No additional information was provided.

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« Reply #616 on: May 10, 2018, 01:04:55 AM »

Model Number 302-20
Event Date 08/12/2013
Event Type  Malfunction   
Event Description
On (b)(6), 2013, it was reported that the patient is experiencing pain in the chest area. The patient first experienced it a few weeks ago and went to the emergency room where they concluded that it was not a heart problem. The last time the patient had diagnostics performed on the vns was a month prior, which showed the device was fine. The pain was not occurring with stimulation and seems to be happening mostly at night, not necessarily only with stimulation. The pain is in the left upper chest only and no were else. The physician stated that he could think of no other reason for the pain besides vns. The patient is no longer having voice hoarseness and can no longer feel the device stimulation. The patient tried placing the magnet over the device to turn it off; however, this did not change the pain. The patient does not feel as though the device is working. Interrogation and diagnostics of the patient's device was performed on (b)(6), 2013, which showed high impedance. The patient said that he did not want to have the device replaced at this time and would prefer to just have it explanted. However, the physician does not want to explant the device at this point and decided to turn the device off and assess in a month if it should be explanted or replaced. The patient did not want to take x-rays so none were taken. The physician stated that if the patient experiences an increase in seizures while the device is off, they will likely replace the device. No surgery has been performed to date. The vns battery status was fine and it was reported that the high impedance happened due to a fall the occurred recently. And the pain started occurring after the fall. It is likely the pain is associated with the high impedance and fall. The patient has had voice alteration since implant and it was heard again on the (b)(6), 2013 visit. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2015 the physician reported that the patient had undergone explant surgery in february. He stated that the patient¿s pain was from ¿broken leads¿. He provided the name of the hospital where the explant occurred but that hospital discards explanted devices and therefore the generator will not be returned for product analysis.
 
Event Description
On (b)(6) 2014, it was reported that the patient is insistent that he wants his vns removed. Although surgery is likely, it has not occurred to date.
 
Event Description
The patient underwent explant of the device. It was unknown when and where the surgery occurred, despite attempts to the physician. No product return attempts can be made at this time since when and where the surgery occurred is unknown.
 
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3390789
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« Reply #617 on: May 10, 2018, 01:06:08 AM »

Model Number 102
Event Date 01/01/2013
Event Type  Injury   
Event Description
Clinic notes dated (b)(6) 2013 note that the patient's last seizure has been a while. It was noted that vns was interrogated and diagnostic routines were run. It was noted that adjustments were made in stepwise fashion. An eeg was performed on (b)(6) 2013 which showed no evidence of any ongoing seizure activity. No evidence of any clearly defined seizure activity was seen at any time.
 
Event Description
It was reported that the patient experienced some seizures and that the medications were changed. It was reported that the patient's seizures were the same as before.
 
Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2013 notes that the patient has started having breakthrough seizures. It was noted that device diagnostics were within normal limits and that the end of service indicator was negative. It was noted that the lead impedance was ok. The physician increased the device output current to 1. 25ma and the magnet output current to 1. 5ma. The patient reported feeling the stimulation and a voice change was noted. It is unknown whether or not the increase in seizures is above the patient's pre-vns baseline frequency.

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« Reply #618 on: May 21, 2018, 01:39:47 AM »

Model Number 302-20
Event Date 01/19/2013
Event Type  Injury   
Event Description
On (b)(4) 2013 a referral was received for replacement of the vns due to it ¿failing¿. It was stated that the vns had been turned off the psychiatrist due to severe pain on the vagus nerve. It was reported that the patient has a possible lead fracture.
 
Event Description
On (b)(6) 2013 the patient mentioned that she had a device malfunction in january and subsequent device disablement since the event. The nurse later reported that the vns patient had a device failure because the patient developed severe pain/discomfort at the electrode site. It was stated that diagnostics were performed that indicated the device is not near end of service and that the lead impedance was ¿ok. ¿ the nurse stated that she feels that there is an issue with the lead despite the diagnostic results due to the patient¿s clinical symptoms. X-rays were also reported to have been taken, which didn¿t show anything. The device was disabled temporarily and it did get better about two weeks after the device was disabled. She stated that diagnostics were even taken with the patient in different positions and while the device functioned properly during all of these tests, she still believes that there is an issue that is causing the patient¿s events. The patient was referred to the surgeon for revision. Although surgery is likely, it has not occurred to date. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
On (b)(6) 2013 the nurse practitioner reported that over the past weekend the patient started feeling pain in her neck at the lead site that radiates up to her jaw and neck and down her left arm and left leg. The patient stats that the pain is with stimulation but she feels a soreness in the area all of the time. The patient denies any trauma but the patient is raising a child that can sometimes be combative and has hit her in the head but she doesn't remember anything specific at the time she felt the pain. The patient's settings were output = 1. 75 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. The patient was programmed off to output = 0 ma/frequency = 20 hz/pulse width = 250 usec/on time = 30 sec/off time = 5 min. She states the patient said the pain went away but she was still feeling the soreness. She states before she turned the patient off she did system diagnostics and all was ok with dcdc of 2 and neos = no. She is not sure at this point where she will proceed from here. The manufacturer's consultant later stated that he spoke with the patient on (b)(6) 2013 and she reported to him that on (b)(6) 2013 that she was having heart palpitations, along with nausea and vomiting that she thought was the onset of a migraine. Later the patient wasn't still "feeling right" so she decided to disable the device for the rest of the night. In the morning on 01/20/2013, the patient removed her magnet and she then started vomiting. She was also having tingling and numbness on her left side, so she again disabled the device with her magnet, which resolved the issues. The patient also noted that since this weekend, she was also feeling tightness where the electrodes are located and a lead pulling sensation in her neck when she uses her right arm to blow dry her hair. She said that she typically doesn't feel stimulation with the on-times, but does get voice alteration during the stimulation. The patient noted that she has a (b)(6) daughter that does like to jump on her. The patient is also getting efficacy from the therapy and is fearful that she is going to get worse because the nurse disabled the device on (b)(6) 2013. The patient's nurse practitioner indicated that the patient was implanted for treatment resistant depression in 2006 but also has a diagnosis of schizophrenia. The nurse stated that she recently had to turn the patient's device to zero as the patient began having pain in lead/generator area that radiated up to her jaw and down her left arm and leg. She stated all diagnostics were normal. The patient was going to be seen for follow-up on (b)(6) 2013 and the nurse has decided to keep the device turned off until that day. The patient is also considering meeting with her primary care physician to have her throat evaluated due to the feeling in her throat. The patient later indicated on (b)(6) 2013 that the constriction feeling in her neck was continuing to increase the previous night and the numbness in her extremities was disturbing, with an intolerable migraine type headache in forehead area with significant pressure at the base of the back of her head. She said the physician seems to think initial irritation of the vagus nerve is possibly consistent with the intermittent issues he has seen with devices nearing end of battery life. X-rays were taken and a ct with no visual concern. The diagnosis was painful neuropathy and migraine. The patient was given iv fluids, steroids to reduce inflammation, iv phenergan, and a prescription of neurontin. The patient stated that on (b)(6) 2013 there is less constriction in the neck, the migraine persists, and neuropathic pain. The patient stated that the discomfort is more tolerable without the constricting feeling in the neck. On (b)(6) 2013 the manufacturer's consultant stated that he met with the patient and the nurse practitioner that day and the patient has been through a lot of psychological issues. He started with a summary of the events saying that on (b)(6) 2013 the patient's symptoms got so bad (constriction in her neck), that she had to go to the emergency room and at that time felt a tingling in her extremities and pain in her left arm and up to the electrodes in her neck. The emergency room doctor said he had never seen anyone with vns but has seen patients with other similar devices and thought maybe vns caused damage to the nerve. Therefore, he gave her steroids to treat nerve pain. With these iv steroids all the events went away. Now the patient's symptoms are completely gone and the device is disabled. The patient also reported that the week of (b)(6) 2013 she lost her voice; she had virtually no voice and said it was as if the stimulation was on all of the time based on her losing her voice. As of today, the patient's depression is still better than pre-vns levels but the patient is starting to get anxious that the vns is not on. The consultant stated he will get x-rays and the emergency room report and will send that to the manufacturer for review. The nurse practitioner stated that with the device being disabled, all the events resolved except for the neuropathic pain and tingling in the extremities/discomfort. It was reported that it was thought that the emergency room diagnosed the event as neuropathic pain to get insurance to pay for it but the patient is not having any events now. The nurse practitioner believes that all of the patient's events are due to vns. She did report however, that the heart palpitations, tingling, numbness, and vomiting/nausea are not occurring with stimulation. No causal or contributory programming or medication changes precede the onset of the events. The patient does not have a medical history of any of these events (pre-vns). The patient's device was disabled but since the patient is desperate to have vns working, they want to have a full revision surgery as they believe the vns is causing the patient's symptoms. On (b)(6) 2013 the device was programmed back on to output = 1 ma/frequency = 500 usec/on time = 30 sec to run system and normal mode diagnostics; which were within normal limits. The system diagnostics showed dcdc = 3/eri = no and normal mode showed dcdc = 2/eri = no. The patient was then disabled again. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received on (b)(6) 2013 when it was reported that the patient recently had her device turned off on (b)(6) 2013 due to pain in the neck. This pain started on (b)(6) 2013 and the patient had disabled the device herself by using her magnet which helped. The patient also started vomiting when she removed the magnet. The reporter also explained that when the patient uses her right arm to blow-dry her hair, she feels a tightening feeling around the electrodes in the left side of her neck. She explained that she was seen in the er and the er physician informed her that she is experiencing irritation to the vagus nerve which he has seen previously when other implanted devices were nearing the end of their service life. She stated that x-rays had been taken and she was placed on iv fluids as well as steroids to help with the adverse events she was experiencing. The patient was anxious about what may happen as far as her depression since the nurse practitioner had turned off her device. Since the device has been off the patient has felt a lot of anxiety and is not sleeping hardly at all; she stated that it is like "time has no meaning". The reporter also mentioned that she had seizures prior to implant which stopped after being implanted. It was later reported that the patient's device appeared to be functioning normally when queried but she had significant discomfort and developed neuropathy. She was treated with steroids and neurontin for that and it resolved. Clinic notes were received. Review of the notes dated (b)(6) 2013 state that this was an emergency session to adjust the vns settings due to palpitations and discomfort. The patient had pain in left side of jaw with radiation down left arm that had worsened since that weekend. The pain was reported to be intolerable. The patient felt discomfort all down the left side and since the vns was turned off with the magnet she felt better. The patient was anxious and mildly paranoid. Diagnostics showed the device to be functioning properly. Clinic notes dated (b)(6) 2013 indicate that the patient was being treated for neuropathy in the neck and is feeling better physically. Clinic notes dated (b)(6) 2013 indicate that the patient's device is now "failing" and is trying to get a replacement. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
Generator analysis was approved on (b)(4) 2014. The generator was returned with output currents set to 0 ma. Analysis showed that the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.
 
Event Description
Information was received that the patient was scheduled for a generator replacement on (b)(6) 2013. Three diagnostics were performed, which confirmed that there were no issues with the lead, so the lead would not be replaced. It was later confirmed that the replacement surgery took place on this day. The explanted generator was returned to the manufacturer on (b)(4) 2013.
 
Event Description
On (b)(6) 2013 it was reported that the patient¿s illness is rapidly progressing as she waits for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient developed neuropathy on the left side of her neck and that her discomfort was severe. It was reported that the device was programmed off and the patient required treatment with steroids to resolve the pain. The nurse reported that x-rays were not helpful in identifying the problem. The nurse indicated that there was no high impedance and the device is not at end of service. The nurse reported that the patient experienced successful response to vns when the device was programmed on and that attempts to have the surgery performed are underway.
 
Event Description
It was reported that the patient was seen for a consult appointment to have the vns generator removed. The patient states that she is afraid of having it replaced and then having difficulty getting it replaced again in the future. However, the physician believes the patient should still stay implanted for now as he wants the patient to get a new generator and believes having a separate explant surgery would cause too much scarring. Additional follow up found that the patient saw the neurologist and everything was within normal limits (specifics not provided). It was noted that the patient's device was disabled and the patient complained of pain when interrogation, but physician said it was only during interrogation and he didn't think it was the device. The patient was referred back to the epilepsy center for epilepsy evaluation. It was unclear if the diagnostics were actually performed and if the patient may have felt pain during the diagnostic.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2966248
« Last Edit: September 01, 2018, 10:25:49 PM by dennis100 » Logged
dennis100
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« Reply #619 on: June 08, 2018, 02:51:49 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 06/21/2017
Event Type  Injury   
Manufacturer Narrative
Patient problem :(b)(6).
 
Event Description
It was reported that a vns patient who is still in titration began to experience dyspnea upon exertion when the vns output current was increased. The patient was implanted one month prior, and they stated they may be titrating too fast for her. The patient later reported to the company representative that she was experiencing pain in the neck area of vns. She stated that if the pain continued she was going to tape the magnet down to see if it helped with the pain. Information was later received that follow-up was received providing that the physician had lowered the frequency setting. The patient¿s pain subsided however it still "bothers" her voice. The physician wants to increase the current but tolerability for the patient had been an issue. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7537765
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« Reply #620 on: June 09, 2018, 02:15:26 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 06/11/2008
Event Type  Injury   
Event Description
It was reported in 2012 that the patient's father called asking for the patient's records from time of implant until when the device was turned off. He believed that the vns almost killed her. Per the father, the patient had aspiration pneumonia and had been admitted to the emergency department. When follow-up was conducted with the physician¿s office in 2012, the physician¿s office stated that the patient had a past history of problems with aspiration even prior to the vns, so they didn¿t believe it was related to the vns or stimulation. The vns was turned off at the family¿s request approximately two months after implant. In 2018, further information from the father was received. He reported that the patient was now in respiratory failure and had had quite a few aspiration and pneumonia events. He stated that the patient hadn¿t had aspiration events prior to the vns. The father believed that one instance of aspiration pneumonia, that had occurred ¿a while ago,¿ had been caused by a feeding tube that he said was needed because the patient couldn¿t swallow due to the vns. Since then, the patient had had multiple instances of aspiration pneumonia due to influenza, which the father did not suspect were related to the vns. Later he indicated that the patient had had multiple aspiration pneumonia events due to the vns. The father reported that the patient had issues with the vns such as throat pain, inability to speak, and inability to swallow food. He said that the patient¿s vns had been disabled permanently between 2012 and 2014 because the patient¿s ent had attributed the dysphagia to the vns. Per the father the ent had looked at the patient¿s throat while the magnet was swiped and the patient¿s throat did not close. Per the father, because the patient¿s throat remained open, fluid and other things could get into lungs, leading to pneumonia. Finally, the father reported that the patient¿s physician had told him that there had never been any problem with the vns. Further follow-up with the physician¿s office found that this father frequently reported this complaint to them and that the patient was recently admitted to the hospital with pneumonia. The physician indicated that he couldn¿t provide an assessment of the events reported by the father until he saw the patient again. 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=7497099
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« Reply #621 on: June 09, 2018, 02:16:11 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 03/13/2017
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient's mother reported that her son was implanted last year and after the surgery he was not able to walk, lost control of his upper and lower limbs, and at times could not hold his posture. It was explained he continues to need help walking as the patient is very ataxic. The patient also sometimes needs help feeding himself and he no longer talks, walks independently, and interacts less. The patient was previously diagnosed with autism, but it has declined significantly since the vns procedure. It was noted the neurologist completed testing of the system to verify everything was working correctly, and it was. No one had an explanation for the patient's decline. It was also stated that the patient has been diagnosed with tuberous sclerosis which can contribute to developmental delays including physical ones. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7493765
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« Reply #622 on: June 10, 2018, 12:54:35 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/27/2018
Event Type  Malfunction   
Event Description
It was reported that the patient was experiencing increased seizures up to 20 seizures per day, increased seizure intensity, and a status epilepticus event following vns implantation. Per the physician, the cause of these events was unknown. It was also reported that the patient had hoarseness and food swallowing complications when the magnet was used. Settings changes were made for the patient's increased seizures, increased seizure intensity, status epillepticus event, hoarseness, and food swallowing issues. It was later reported that the patient was doing better following the settings changes. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7488128
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« Reply #623 on: July 06, 2018, 10:55:09 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 03/12/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It experienced constant voice hoarseness since implant which was present prior to stimulation. The patient was also admitted due to shortness of breath but no treatment was initiated and no physical problem with respiration was found. However the device was disabled. Information was later received from the physician's office. The patient was seen and while there was no written information about the ent visit as their electronic system does not have any record of his ent visit, the patient reported that he has been told he has paralysis. He also reported that his voice is getting better and would like to restart vns therapy. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7570885
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« Reply #624 on: July 06, 2018, 10:55:53 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 01/12/2018
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a patient was experiencing laryngeal problems after vns stimulation began. It was stated that voice alteration began about three months after surgery and persisted after stimulation was turned off. An ent evaluation concluded laryngeal immobility, "meaning a recurrent damage". It was suspected that the problems were due to stimulation, and not surgery. Follow up from the physician's office provided a timeline of events. The vns device was implanted with ok diagnostics. Two weeks later, the device was titrated up to 0. 25ma. About three weeks after this titration, the patient was titrated up to 0. 5ma. Since this titration, there was a report of pain at the generator site. The vns was checked and was found to be ok. A week later, it was reported that the patient was vomiting with intense pain radiating along the neck, and the vns was turned off as a result. Voice alteration was confirmed to have been noted in mid (b)(6) and to have persisted after the device was turned off. The device was checked in mid (b)(6) and confirmed disablement. No device malfunction or impedance issue was noted from this visit. An ent assessment then found vocal cord paralysis. The physician believed the events were due to vns stimulation, and planned to have the device explanted. No surgery has occurred to date. No further additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7650798
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« Reply #625 on: July 07, 2018, 04:28:11 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
Report received that a patient had a sudden increase in seizures. The device was said to be dead starting a few months prior to this increase in seizures. At the time, the patient elected to not obtain a replacement because she was seizure-free and had experienced swallowing and speech issues with vns. After the seizures returned, she was referred for a replacement. An internal battery life calculator supported the end-of-service condition. Clinic notes were later obtained that included office visits from six to eight months prior to the increase in seizures. These notes showed that the device was able to be interrogated. The device was found to be on. There were notes from both visits indicating that the device diagnostics were abnormal with the battery at end of service. The generator was later replaced and stated to be done prophylactically. Follow-up determined that the device was at near-end-of service and had not been pulse disabled. The impedance was found to be normal prior to the replacement. Further information was received that the physician stated that the diagnostics were abnormal due to the battery reaching end of service. It was also reported that a possible cause of the increase in seizures was the patient being non-compliant with her medications. The replaced generator was reportedly discarded. No additional relevant information has been obtained to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7562538
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« Reply #626 on: July 22, 2018, 02:11:36 AM »

Model Number 101
Event Date 06/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
On (b)(6), 2012 clinic notes dated (b)(6), 2012 were received from a vns treating physician. Review of the clinic notes revealed that the patient¿s mother stated the patient was recently hospitalized from (b)(6), 2012- (b)(6), 2012 due to a stroke and a hole in her heart told to her by cardiology. No outpatient cardiology has been set up at this time per the patient's mother. The patient has residual speech difficulty and right upper and lower extremities weakness. The patient has been provided with speech, occupational, and physical therapy. The patient is currently on asa 81mg per day. No new stroke-like symptoms have been reported since then. The patient's blood pressure was noted to be 124/76. The patient's assessment includes stroke/cerebral thrombosis with cerebral infarction. Attempts for further information have been made to the physician but have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=2665067
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« Reply #627 on: August 10, 2018, 04:04:59 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/01/2018
Event Type  Injury   
Event Description
It was reported that a patient was to have her device replaced due to pain at the site. Clinic notes were received indicating that patient has had severe left neck pain, dysphagia and hoarseness with stimulation. The device had been turned off and the patient had experienced an improvement of symptoms since having the device off. It was indicated the patient previously had a left thyroid lobectomy. It was noted from a recent office visit that the patient felt pain in her neck and throat that radiated into her jaw and left face. The patient had difficulty swallowing and had been eating less as a result. She stated she had been to the er at least once for the pain. The device output was lowered, and the patient still felt pain. Both output and magnet current were turned off. Diagnostics indicated no issues and battery life ok. The physician plans to have the battery replaced and possibly lead revised. From follow up with the neurologist, it was stated that the patient had not experienced any trauma to the site or other events that may have led to the adverse events. No surgery has occurred to date. No other additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7709600
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« Reply #628 on: August 11, 2018, 01:24:37 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/19/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient was experiencing voice alterations at his last office visit so normal mode and autostim output currents were disabled. The physician wanted to try just magnet mode. The patient came back at a later date and the patient's device was interrogated and resulted in high impedance, and adjusting the current down to 0. 75 resulted in an impedance of 4700 ohms which was seen as normal. A programming history review was performed for the patient's generator which showed normal impedance values since the time of implant; however the impedance values through history where on the higher end of normal ranges. At this time it is unclear why the impedance is fluctuating between high impedance and normal impedance values. Design history record for the lead was reviewed. The lead passed all specifications prior to release into the field. No additional or relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7687311
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« Reply #629 on: August 11, 2018, 01:25:06 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2011
Event Type  Injury   
Event Description
It was reported that the patient wanted the vns device to be explanted due to voice hoarseness and device not working (lack of efficacy). The patient complained of hoarseness and feels like she is getting a sore throat at times, so she uses the magnet to turn it off. Settings were adjusted to help with the hoarseness follow-up with the physician reveals that the hoarseness and sore throat are related to vns stimulation. No causal or contributory programming or medication changes precede the onset of the events. No patient manipulation or trauma occur that is believed to have caused or contributed to events. No known surgical intervention have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7692430
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