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Author Topic: Painful Stimulation  (Read 18056 times)
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dennis100
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« Reply #420 on: February 05, 2019, 03:33:27 AM »

Model Number 302-20
Event Date 09/24/2014
Event Type  Malfunction   
Event Description
Additional information was received stating that the high impedance was first observed (b)(6) 2014.
 
Event Description
It was reported that the vns patient was sent for x-rays due to concerns with her device lead impedance. X-rays were taken and were reported by the physician to be unremarkable. Follow-up revealed that the patient¿s concerns with lead impedance were due to pain occurring with magnet mode stimulation on-times. The patient¿s magnet output current was subsequently reduced. Patient manipulation or trauma is not believed to have caused or contributed to the event. Follow-up revealed that the patient¿s device was tested and diagnostic results revealed high impedance (dc dc ¿ 6). X-rays dated (b)(6) 2013 and (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin cannot be confirmed to be fully inserted into the generator connector block with the images provided. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause of the high lead impedance remains unknown. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. 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=4230225
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dennis100
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« Reply #421 on: February 06, 2019, 03:06:37 AM »

Model Number 102
Event Date 11/20/2014
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
On (b)(6) 2016, it was confirmed that the patient's device was able to be interrogated. Patient was seen at the neurologist's office due to recent increase in seizures to evaluate her for continuation of her vns therapy or replacement since her device disablement on (b)(6) 2008 due to seizure freedom. A diagnostic test was performed and patient was able to feel vns stimulation. During the stimulation period of the diagnostic test, patient experienced pain with stimulation in neck area pulled away before the test was completed. Additional information was received that the patient's diagnostic test results were not available as they could not be completed.
 
Event Description
It was reported that the patient's generator was unable to be interrogated. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4330779
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dennis100
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« Reply #422 on: February 06, 2019, 03:07:29 AM »

Model Number 103
Device Problem Migration or Expulsion of Device
Event Date 10/30/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2015 it was reported through clinic notes dated (b)(6) 2015 which indicate that the patient is considering re-implant of the vns device after having it removed due to irritation in (b)(6) 2014. Although re-implant surgery is likely, it has not occurred to date.
 
Event Description
Initially, it was reported that the patient was seen in the emergency room with complaints of device migration and painful device stimulation. The patient was seen on (b)(6) 2014 to program the device off while the issues were being addressed. A chest x-ray confirmed proper positioning of the device. The nurse practitioner indicated that there is no belief that the reported issues are related to vns. It was later reported that the pain occurred approximately three times a day for approximately thirty minutes each occurrence. It was also reported that the patient has lost twenty pounds which caused the device migration. The device output current was decreased from 2. 25 ma to 0. 50 ma and then later programmed off. The patient continued to report pain despite the device being programmed off. The patient';s father reported that the patient was scheduled for vns explant due to her discomfort and pain with the migration. It was reported that the vns has helped with the patient's seizures, but that the generator would not be replaced for now. The physician reported that the surgery was being performed for patient comfort. The patient's generator was explanted. No additional relevant information has been received to date.
 
Event Description
The patient's generator was returned for analysis on 01/21/2015. Product analysis for the generator was completed and approved 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. The battery, 2. 936 volts as measured during completion of the final electrical test, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that in two weeks since the patient¿s vns surgery, she has made a complete turnaround. It was noted that she has not had any seizures and her father feels that the seizures were due to hormonal changes occurring due to puberty. She will likely not be re-implanted and will instead continue medications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4338510
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dennis100
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« Reply #423 on: February 07, 2019, 02:47:37 AM »

Event Date 01/01/1998
Event Type  Injury   
Event Description
A case study titled ¿optimizing outcomes in refractory childhood epilepsy with vns therapy¿ was presented which included a vns patient who was experiencing painful stimulation and choking sensations months following vns implant surgery. The patient¿s device settings were very low and not high enough to perform system diagnostics. In (b)(6) 2013, an evoked potential test was performed but no abnormalities were observed. The patient underwent generator and lead replacement surgery on (b)(6) 2014. During the procedure, the surgeon noted that the vagus nerve was located more anteromedial to the common carotid arteries than expected possibly due to the large amount of fibrosis. The surgeon did not observe any issues with the patient¿s lead but noted that the electrodes were implanted more proximal to the nerve. The patient¿s physicians determined that the patient¿s issues were due to the electrodes being implanted too high and the nerve being superficial to the larynx. It was noted that the patient had been doing well with vns following the procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4461163
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dennis100
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« Reply #424 on: February 07, 2019, 02:48:19 AM »

Model Number 103
Event Date 12/24/2014
Event Type  Malfunction   
Event Description
The patient reported on (b)(6) 2016 that he believed that the generator was turned on (magnet mode only) because the generator was activated by the detectors at the doors of a large retail store, which caused the patient to have painful stimulation from his left neck to his ear, which made him drop to the floor. His stitches also came out because of the fall to the floor. The patient and his mother believed that the device was defective due to the electro-magnetic interference with the device. The patient had the generator explanted due to the painful stimulation, and the patient reported that the generator was analyzed by a vns technician that was certified by the state and had documentation that the device was defective. The patient did not know where the analysis was done. However, the device was returned to the manufacturer and analysis was performed. There were no anomalies identified with the generator other than the septum being cored. There was no bodily fluids inside the septum, though, so there would not have been a path for stimulation to reach the patient body. The patient also reported feeling the painful stimulation in the neck and ear, which is not near the patient generator. Therefore, the painful stimulation can reasonably assumed to not be related to the cored septum. The device performed according to specifications. No further relevant information has been received to date.
 
Event Description
Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The septum was cored but no bodily fluid remnants were observed in the header septum cavity. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430571
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dennis100
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« Reply #425 on: February 07, 2019, 02:49:09 AM »

Model Number 304-20
Event Date 11/06/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2014 it was reported that the patient was experiencing shocking pain with stimulation and was in the emergency room. The patient was admitted to the hospital and was still there the next day, though the use of the magnet did stop the shocking. It was noted that the patient¿s treating neurologist had retired. It was reported on (b)(6) 2014 that the patient has high lead impedance. The patient said that this may have occurred because he took a fall and hit his chin pretty hard about a month prior. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4285947
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dennis100
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« Reply #426 on: February 07, 2019, 02:49:53 AM »

Model Number 300-20
Event Date 11/03/2014
Event Type  Malfunction   
Event Description
Analysis of the returned lead portions were completed. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portions were performed, and no discontinuities were identified. Note that since the electrode array section was not returned for analysis, an evaluation cannot be made on that portion of the lead.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to lead discontinuity. The explanted device were returned to the manufacturer for analysis. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. The device performed according to functional specifications. Analysis of the returned lead is currently underway.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation in her neck. The patient¿s device was tested and system diagnostic results revealed high impedance. The patient¿s device was not subsequently disabled. X-rays were taken and reported to show a gross lead fracture next to a tie-down. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, 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=4295204
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dennis100
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« Reply #427 on: February 07, 2019, 02:50:35 AM »

Model Number 103
Event Date 09/28/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing nausea and pain at her electrode site during stimulation on-times. The patient was later diagnosed with gastroparesis and it was determined that her stomach was not producing enough gastric juices to promote digestion. Endoscopy and colonoscopy were performed and adjustments to the device settings were planned. Attempts for additional relevant information will be made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4296768
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dennis100
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« Reply #428 on: February 07, 2019, 02:51:43 AM »

Model Number 300-20
Event Date 11/10/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high impedance (impedance value ¿ 6102 ohms) and an ifi condition during an office visit on (b)(6) 2014. Clinic notes were received indicating that the patient device was working well on (b)(6) 2014. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
Additional information was received stating that the vns patient had a bad seizure and was subsequently hospitalized. The patient had also been experiencing painful stimulation in the neck region.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.
 
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=4318275
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dennis100
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« Reply #429 on: February 07, 2019, 09:20:04 PM »

Model Number 102R
Event Date 09/01/2014
Event Type  Injury   
Event Description
Clinic notes were received for review which were dated (b)(4) 2014 and indicated that the patient was having painful stimulation from her vns. Normal mode diagnostics showed a dcdc of 4. The patient was also experiencing an increase in seizures frequency since the patient¿s last visit. The patient was observed in the clinic without any signs of pain or intolerance associated with her settings. The patient was noted to now be experiencing baseline seizure frequency. The physician indicated that since te patient is experiencing an increase in seizures and in (b)(6) 2014 reported isolated painful stimulation, this suggests her current battery is nearing end of service although the battery has not flagged ifi=yes. Therefore the patient was referred for surgery. Clinic notes dated (b)(4) 2014 were also received which indicated that the patient has been experiencing an increase in auras, not progressing into seizures at that time. The patient¿s normal mode diagnostics had increased to a dcdc of 4 and the patient was noted to be experiencing sporadic isolated painful stimulation. The physician indicated that due to the sporadic painful stimulation that started a couple of weeks prior and the diagnostics testing, she referred the patient for generator replacement. Clinic noted dated 06/06/2014 also indicate an increase in auras not progressing into seizures. Although surgery is likely, it has not occurred to date.
 
Event Description
It was reported that the patient underwent prophylactic generator replacement on (b)(6) 2015. The physician¿s assistant attributed the patient¿s increase in seizures to the device nearing end of service, per the battery life calculation on the generator. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the events. It was noted that the patient hasn¿t been seen by the physician¿s assistant since the generator replacement. The patient¿s generator was discarded after surgery by the hospital and therefore cannot be returned for product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4401771
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dennis100
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« Reply #430 on: February 07, 2019, 09:21:08 PM »

Model Number 103
Event Date 11/11/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient experienced episodes of syncope two times following device implant in (b)(6) 2014. It was reported that one incident occurred in (b)(6) 2014. It was reported that the patient also experienced pain with device stimulation and that the device was programmed off and the pain did not resolve. It was reported that the patient has a familial history of cardiac disease and is having blood work performed. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4427468
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dennis100
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« Reply #431 on: February 07, 2019, 09:21:46 PM »

Model Number 304-20
Event Date 12/01/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was experiencing severe pain with device stimulation. The device was programmed off and the patient was referred to an ent for evaluation. It was reported that the patient may undergo surgery to prevent a serious injury. No additional relevant information has been received to date. No known surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4413014
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dennis100
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« Reply #432 on: February 09, 2019, 03:20:49 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
Information was received that the patient's device was spontaneously going into magnet mode whether the device was enabled or disabled the patient was reported have painful stimulation and tightness at the generator site. It was also reported that the device was cycling every seven seconds despite parameter changes. Diagnostics from the physician was reported to be fine. Information was later received that the patient's generator was replaced. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8265182
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dennis100
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« Reply #433 on: February 09, 2019, 03:21:28 AM »

Model Number 302-20
Device Problem Fracture
Event Date 10/14/2013
Event Type  Malfunction   
Event Description
It was reported that a patient had been experiencing pain around her generator site since her last generator replacement. The pain was noted to have increased in frequency and severity over the course of the 5 years, and it was stated that she recently began having severe sharp pain at the site that worsens when trying to lift heavier items. The physician had instructed her to not pick things up. The patient now feels pain all the time and also experiences tingling in her hands and feet and pain in her ears. She was unsure if the newer events are related to vns. The patient stated not having any sort of trauma to the site. The pain is constant and seemed to be related to the placement of the device. The physician was recommending the newer device with the tachycardia detection as he believed it would benefit her seizure control. The patient further reported that she was experiencing sharp pains with vns stimulation. It was stated that she had issues with pain in the past and had settings adjusted at her last appointment, however the pain had now returned. At the patient's follow up appointment, it was noted that the patient's device was showing high impedance as observed from two different programming systems. The patient did not report any trauma that may have led to damage of the lead. It was further stated that after the device was disabled for the high impedance, the patient's painful stimulation resolved. Clinic notes were received also indicating that the patient was having more seizures with vns. Battery status was noted to be ok. No surgery has occurred to date. No additional relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=822318
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dennis100
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« Reply #434 on: February 10, 2019, 04:01:41 AM »

Model Number 103
Event Date 12/01/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing pain and arm jerking with stimulation on-times. The patient had also been having some increased seizure activity. The patient¿s device was tested and showed an end of service condition. It was noted that patient harms himself and that there was scarring at the neck. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Event Description
The patient underwent a battery replacement on (b)(6) 2015. The device has not been received for analysis to date.
 
Manufacturer Narrative

Event Description
The patient's m103 device was returned for analysis on 02/12/2015. Product analysis of the generator was completed and approved on (b)(6) 2015. 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a neos=yes condition. The electrical performance of the generator, as measured in the product analysis lab, will be used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377344
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dennis100
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« Reply #435 on: February 10, 2019, 04:02:48 AM »

Model Number 302-20
Event Date 10/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s device showed high impedance (impedance value >= 10,000 ohms) during an office visit on (b)(6) 2014. The patient device was disabled. The patient had been experiencing painful stimulation since (b)(6) 2014 and experienced in increase in seizure intensity. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
X-rays dated (b)(6) 2015 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377444
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dennis100
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« Reply #436 on: February 10, 2019, 04:03:43 AM »

Model Number 302-20
Event Date 12/04/2014
Event Type  Malfunction   
Event Description
The generator was returned for analysis on 1/12/2015. Product analysis was completed on 2/9/2015. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 949 volts as measured during completion of test parameter of the final electrical test, shows an ifi=no condition. Here were no performance or any other type of adverse conditions found with the pulse generator. The decoder spreadsheet shows that there was high impedance greater than 10,000 ohms seen prior to explant on (b)(6) 2014.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance and painful stimulation. Follow-up revealed that the patient began experiencing the painful stimulation on (b)(6) 2014. No causal or contributory programming or medication changes preceded the onset of the painful stimulation. Patient manipulation or trauma is not believed to have caused or contributed to the event. It was noted that the patient¿s device battery was depleted and that surgery was scheduled to preclude a serious injury and to continue seizure treatment. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4392277
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dennis100
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« Reply #437 on: February 10, 2019, 04:04:47 AM »

Model Number 103
Event Date 12/08/2014
Event Type  Injury   
Event Description
On 04/29/2016, it was reported that the patient's pain that was first thought to be from the migration (so reported last year) was just recently clarified to be painful stimulation radiating down the jawline with magnet swipes. The patient had not followed up between the report last year and now so this was not known until now. Once the pulse width was adjusted this pain resolved. For the patient's reported migration, he stated there was no reported trauma so they think that the non-absorbable suture may have broken. It was stated that the implanting surgeon does always use non-absorbable sutures. The migration is less painful and more so just an inconvenience as it pops out and moves when she is in different positions. Notes also mention that vns is sticking out. He also noted that the patient's battery was below 50%, so the generator was being replaced prophylactically, though the primary reason for replacement seems to be the migration. Notes state vns moves when she moves left arm and has pain. Clinic notes dated (b)(6) 2016 state that the battery mobility in her chest and its prominence as well as the prominence of the electrode coils in her neck bother her significantly. Inspection of her neck shows fairly prominent positioning of her battery and cervical electrode loops without any skin erosion, erythema, or signs of infection. There is no known cause of the protrusion except normal physiology.
 
Event Description
Implant card was received on 06/13/2016. The patient underwent generator replacement on (b)(6) 2016. The explanted device was discarded and is unavailable for analysis.
 
Event Description
It was reported that the vns patient was referred for surgery due to chest pain and potential generator migration. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4391038
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dennis100
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« Reply #438 on: February 10, 2019, 04:05:40 AM »

Model Number 103
Event Date 12/10/2014
Event Type  Injury   
Event Description
Product analysis for the generator m103 was completed and approved on (b)(6) 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. However, the battery, 2. 763 volts as measured during the final electrical test, shows an ifi=yes condition. There was no programming history available for this generator. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative

Event Description
The patient's generator was replaced on (b)(6) 2015 due to prophylactic, ifi-yes. The device was received for analysis on 1/21/2015. Analysis is currently underway but has not been completed to date.
 
Event Description
It was reported that the vns patient was scheduled for surgery due to painful stimulation in the neck. The physician believed that replacement of the generator would resolve the patient¿s painful stimulation. The patient¿s device was tested and showed normal device function. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4397002
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dennis100
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« Reply #439 on: February 10, 2019, 04:06:28 AM »

Model Number 103
Event Date 12/05/2014
Event Type  Injury   
Event Description
Additional information was received that the patient underwent generator replacement on (b)(6) 2015. The explanted generator is suspected to have been discarded by the explanting facility and will not be returned to the manufacturer; therefore, no product analysis can be performed.
 
Event Description
Additional information was received that the patient¿s explanted generator will be returned to the manufacturer but the explanted product has not been received to date.
 
Event Description
Clinic notes were received indicating that the vns patient was experiencing pain in the neck, throat, jugular, and chest during stimulation on-times. The patient described it as a choking feeling. It was also noted that the patient¿s apnea had worsened since vns. The physician did not decrease the patient's device settings due to potential effects of the decrease in therapy. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4377482
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dennis100
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« Reply #440 on: February 10, 2019, 04:07:01 AM »

Model Number 103
Event Date 12/05/2014
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing pain in her neck and chest during stimulation on-times and was constantly sore at areas around the lead. The patient¿s lead was found to be visible in the patient¿s neck where it previously was not visible. The patient¿s device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 3062 ohms). Patient trauma is not believed to have caused or contributed to the high impedance. The physician believed that the issues were related to an end of service condition with the patient¿s device. A battery life calculation using the available programming history showed approximately 7. 4 years until near end of service. The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4397157
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« Reply #441 on: February 11, 2019, 02:30:05 AM »

Model Number 102
Event Date 11/01/2014
Event Type  Injury   
Manufacturer Narrative
 
Event Description
On (b)(6) 2015 the physician reported that the patient is unable to tolerate an output current of 0. 5ma and therefore diagnostics have not been performed.
 
Event Description
On (b)(6) 2015 it was reported that the patient underwent explant of the vns device due to painful stimulation and coughing. It was noted that the patient¿s settings could never be increased due to these adverse events and so the patient did not have efficacy with the vns. The device was disabled on (b)(6) 2014 and then explanted on (b)(6) 2014. It was reported that the hospital no longer returns explanted products and therefore the explanted generator could not be returned for product analysis. Additional information was requested from the physician but no further information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4475189
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« Reply #442 on: February 11, 2019, 02:30:56 AM »

Model Number 105
Event Date 01/01/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient experienced painful device stimulation at the neck every 5 minutes. Device diagnostics were performed which showed high impedance. The patient was referred to surgeon. There was no known trauma that may have caused or contributed to the high impedance. X-rays were performed and the x-ray review was sent to manufacturer. X-rays do not indicate a lead discontinuity. Surgical office notes dated (b)(6) 2015 not that there is a questionable microscopic lead break and new lead and generator are needed. It was noted that the patient's symptoms are worse at work and stop when the patient is home. No known surgical intervention has been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received stating that the patient's painful stimulation began occurring about four to five months following (b)(6) 2014 generator replacement surgery. X-ray review by the surgeon reported no conclusive results. The lead pin was stated to be fully inserted during the (b)(6) 2014 surgery, as verified on x-rays, and no lead fracture was visualized. Device diagnostics taken after this (b)(6) 2014 revision were stated to be normal. The surgeon also reported he did not believe the patient's neck pain was related to vns. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a prophylactic generator replacement surgery (b)(6) 2015. The patient's device was seen to have been programmed off prior to surgery. Pre-operative diagnostics were run and showed normal impedance readings. Thus, only the generator was replaced and incomplete lead pin insertion was believed to be the cause of the previous intermittent high impedance result. Complete pin insertion was verified with the surgeon. A system diagnostic test indicated normal impedance upon being run three times. An implant card was received which confirmed the high impedance as the reason for the generator replacement being scheduled. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4481386
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« Reply #443 on: February 12, 2019, 03:31:29 AM »

Model Number 102R
Event Date 01/30/2015
Event Type  Injury   
Event Description
Clinic notes state that the patient has had an increase in the number of seizures. It is stated that he has had a few more than usual. Patient does not know when last vns dosing was. The patient¿s depakote dose was increased. The patient was referred for battery change / possible revision due to painful stimulation. Good faith attempts for further information from the physician have been unsuccessful to date.
 
Manufacturer Narrative

Event Description
Further information from the nurse stated that she did not know the exact reason for the onset of seizures. She had no diagnostics results available to provide. The nurse stated that clinic notes dated (b)(6) 2015 state that the patient was dosed but experienced coughing during titration but again diagnostics were not noted. The nurse was unable to comment on the location of the painful stimulation. The patient underwent full revision on (b)(6) 2015. Prior to replacement the device was interrogated and showed that the device was set to 0ma. A system diagnostic test was ran but was interrupted as the patient reacted to the stimulation as it was painful. It was also reported that the patient then went into surgery and a systems diagnostic was performed again after the patient had been sedated and the patient's body shook when the diagnostic was run. The diagnostic test was run pre-op and showed dcdc code 2 was seen there didn't appear to be any issues. Attempts for product return have been made but the product has not been received to date.
 
Event Description
It was reported that the patient's explanted lead and generator were discarded after surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4541097
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« Reply #444 on: February 12, 2019, 03:32:22 AM »

Model Number 103
Event Date 02/03/2015
Event Type  Injury   
Event Description
It was reported that the vns patient went to the er for a cardioversion. Following the procedure, the patient began experiencing bradycardia, pain, and syncope occurring with stimulation on-times which caused the patient to pass out. It was described that the patient¿s heart rate dropped for 30 seconds every five minutes which caused the patient to have pain and pass out. The patient¿s device was subsequently disabled. Diagnostic results showed normal device function. The patient did not have any issues with vns prior to the cardioversion. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4554432
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« Reply #445 on: February 13, 2019, 03:09:01 AM »

Model Number 304-20
Event Date 01/03/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Additional information was received that the patient is undergoing ent procedures to treat painful stimulation in the neck and head, voice alteration, and coughing that he has been experiencing since early january. However, the device being disabled has also helped diminish these symptoms as they were thought to be related to stimulation during high impedance. No known vns surgical interventions have occurred to date.
 
Event Description
Additional information was received that the patient underwent a recent brain surgery and the vns is still disabled. The patient's previous neurologist has no additional information to provide. No known surgical interventions have occurred to date.
 
Event Description
It was reported that device diagnostics resulted in high impedance (6592 ohms). Previous device diagnostics on (b)(6) 2015 were within normal limits (2736 ohms). X-rays were taken and did not identify any obvious discontinuities with the vns system. The generator was programmed off and the patient was referred to surgeon. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4516986
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« Reply #446 on: February 14, 2019, 02:28:57 AM »

Model Number 304-30
Device Problems Tube; Break; Lead
Event Date 10/19/2015
Event Type  Injury   
Event Description
Additional information was received from the physician stating he believes vns stimulation was causing the patient's pain. It was also noted that prior to the event, the patient had a seizure, fell, and then began complaining of pain with stimulation. The physician stated the device might have been affected by the fall.
 
Event Description
The neurologist indicated that the cause of the pain is unknown, but that has resolved since explant. The patient is pursuing medication therapy. The physician is unsure what caused the patient's pain since diagnostics were fine, but that the pain resolved when the device was explanted.
 
Event Description
It was reported that the patient was experiencing intermittent pain at the generator site. The physician instructed the patient to use the magnet to disable the device to see if the pain was related to device stimulation. The patient was later seen in the emergency room due to the pain and the mother claimed she could feel the device stimulation when touching the patient's chest. The nurse indicated that this may be muscle spasms. It was reported that the physician programmed the device off and then the patient suffered a seizure. The patient was referred to surgery for consult and then scheduled for surgery as the surgeon feels the device needs to be evaluated. The patient underwent exploratory surgery where a break in the lead tubing was identified. The surgeon indicated that there was fluid visible in the tubing. Device diagnostics were within normal limits. The neck incision was opened; however, the surgeon indicated that the vagus nerve was heavily scarred. The lead was cut and explanted along with the generator. The surgeon felt that the nerve was too scarred to implant another vns system and the patient's mother opted not to proceed with reimplant. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 01/04/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 01/12/2016. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the lead assembly appeared to have dried remnants of what appear to have once been body fluids inside the outer silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 98mm-100mm from the end of the connector boot. The inner silicone tubes and quadfilar coils appeared to be looped and pulled thru the opening. The abraded opening found on the outer silicone tubing 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 inside the outer silicone tubing. With the exception of the abraded opening found on the outer silicone tubing, the condition of the returned lead portion is consistent with that which typically exists 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 portion were performed, during the visual analysis, with no discontinuities identified.
 
Manufacturer Narrative

Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5307942
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« Reply #447 on: February 14, 2019, 02:30:06 AM »

Model Number 102R
Event Date 01/26/2013
Event Type  Injury   
Event Description
Clinic notes were received for prophylactic replacement. Clinic notes indicate that the patient experienced coughing, dysphagia, and vomiting with vns stimulation. Patient also experiences some lead pulling sensation that is tolerable. Additional information was received stating that the patient experienced painful stimulation in the neck and throat when vns settings were increased. As a result, the settings were decreased again. It was reported that the patient's painful stimulation began 2 years ago.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4645633
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« Reply #448 on: February 15, 2019, 04:05:08 AM »

Model Number 103
Event Date 02/25/2015
Event Type  Injury   
Event Description
It was reported that both the neurosurgeon and neurologist spoke with the er physician and informed him that the device position was normal and that it had not moved from it's original implant site. No known interventions occurred for the reported chest pain.
 
Manufacturer Narrative

Manufacturer Narrative
X-rays showed that the vns was not in place.
 
Event Description
It was reported that the patient was seen on (b)(6) 2015 and the postoperative wounds appeared normal. The reason for the visit was noted to be chest pain with vns stimulation. X-rays showed that the vns was no in place and could be causing the chest pain. An exam by another physician identified that the surgical sites looked good and there was some excoriation of skin of the end of the left chest incision. The patient was seen by the neurologist who concluded the incisions were healing well. The patient had no longer experienced any chest pains. Device diagnostics were within normal limits.
 
Event Description
Initially, it was reported that the patient was experiencing problems with incisions following vns implant. It was reported that the patient had been seen in the emergency room twice with chest pain. It was also reported that device migration was noted. Further follow-up with the physician identified that the patient was doing great and the incisions were healing. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4632705
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« Reply #449 on: February 16, 2019, 03:11:16 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2015
Event Type  Injury   
Event Description
The physician reported that the nocturnal seizures were unusual for the patient, however she has still experienced an overall decrease in her seizures compared to before vns. She also said that there was no way of telling if these seizures are related to vns or not and that they were not witnessed.
 
Event Description
It was reported that the patient began feeling pain and a pulling type sensation in her neck. It was noted that there was no trauma. X-rays were taken and sent for review. Per the x-rays, the generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appear in proper alignment. Strain relief bend was present but not per labeling. No strain relief loop was present. Two tie-downs were observed but were not placed per labeling. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Part of the lead was behind the generator and could not be assessed. The presence of a micro-fracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Based on the x-rays received, the cause for the pain and lead pulling sensation could possibly be due to the lack of proper strain relief. The patient was seen by the physician and the diagnostics (systems and normal mode) read normal. The doctor upped the output current to 1. 0ma and reduced the pulse width to 250 to see if it would help with the side effects she was having. It was noted that the patient had been experiencing pain in her chest and a ¿pulling¿ sensation when the device is on. Since the doctor saw her last, she had a cluster of nocturnal seizures and now she is noticing more effect on her voice and pain when the device is on. She went to see an ent who investigated and was able to determine that her vocal cord was not moving when the device was on. The patient doesn¿t want to turn the device off, as she feels it is really helping with her seizures and she is able to ¿tolerate¿ the effects. The physician also mentioned the patient also has horners syndrome on the left side.
 
Manufacturer Narrative

Event Description
The ent could not tell if the device was stimulating or not during his evaluation of the patient, so he could not comment on any dynamic changes in vocal cord function. The physician stated that the improvement in vocal cord function may have been due to the decrease in output current or because the device was not stimulating at the time of evaluation. The ent felt that it was reasonable to keep the patient's vns on and doubted that there would be any progressive decline in vocal cord function. No further relevant information has been received to date.
 
Event Description
On (b)(4) 2015, it was reported that the patient's painful stimulation is worsening (erratically, and more noticeable when active) as well as her voice hoarseness becoming worse and sometimes painful. This has been noticeable over the last 4-5 months. She also reports that since this time, she has noticed that several times, she has had a jolt from the stimulation and it feels like it takes her breath away. This most recently happened in (b)(6) 2015. The nurse mentioned that the diagnostics back in (b)(6) 2015 were within normal limits.
 
Event Description
An update was received on 06/24/2016 regarding the patient's voice issues. The patient was still experiencing voice issues, which were also occurring during off-times. The ent was concerned about possible vagus/laryngeal nerve damage because the issue is still occurring when the device was not stimulating. The patient's previous settings were decreased two separate times to alleviate the voice issues. The patient did not want to try a temporary disablement due to the possibility of an increase in seizures. The ent consult notes stated that the patient's laryngeal function was affected by vns, but the function and voice was improving. The notes did not explicitly mention laryngeal nerve damage. The patient's settings were recently adjusted to help with tolerability. The patient also reported having painful stimulation with magnet mode, but she has had fewer and milder seizures than pre-vns and is overall happy with vns therapy. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4620110
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