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Author Topic: Painful Stimulation  (Read 21030 times)
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dennis100
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« Reply #450 on: February 16, 2019, 03:12:40 AM »

Model Number 105
Event Date 01/15/2015
Event Type  Injury   
Event Description
It was reported that a recently implanted patient is having a hard time tolerating stimulation at around 0. 25mv - 0. 5ma. The patient experiences tightness in the chest, throat pain, and voice alteration and tachycardia associated with vns stimulation. Additional clinic notes were received for the patient. Clinic notes indicate that the patient was able to stop 3 seizures by swiping the magnet. When vns settings were increased from 0. 5 ma to 0. 75 ma, on (b)(6) 2015 the patient experienced mild palpitations and hoarseness of the voice with the increase but was reported to be able to tolerate it at the current level. Due to patient's concerns regarding discomfort with stimulation routinely (voice hoarseness, palpitations (tachycardia), chest discomfort and throat pain), the physician made a decision to decrease settings back to previous settings on (b)(6) 2015. Additional system diagnostic results was received. It was also reported that the patient continues to experience dysphagia when vns output current is increased to 0. 5 ma.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4583522
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dennis100
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« Reply #451 on: February 16, 2019, 03:13:21 AM »

Model Number 302-20
Event Date 02/01/2015
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
An implant card was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanting facility discarded the explanted devices; therefore, no analysis can be performed. Follow-up with the physician revealed that the patient had been experiencing painful stimulation. The device was disabled and the painful stimulation resolved. X-rays were taken and were reported by the physician to be unremarkable. It was noted that the patient benefited from vns.

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dennis100
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« Reply #452 on: February 17, 2019, 06:30:15 AM »

Model Number MODEL 250
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient complained of intermittent pain at the generator site. The physician believes that the generator was depleting or nearing end of service and referred the patient for generator replacement. No additional relevant information will be provided due to hippa policy at the facility. No known surgical interventions have been performed to date.
 
Event Description
The explanted generator was returned for product analysis. The analysis found that the generator performed according to functional specifications with no anomalies found. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified and the device had not reached eri or eos. The pulse generator diagnostics were as expected for the programmed parameters. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Visual examination noted tool marks/dents on the pulse generator case. The header had tool marks on it. The marks are most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). Signs of discoloration are evident on the pulse generator case, which is consistent with the adhered remnants of dried body fluids following an explant process.
 
Event Description
During review of the in-house programming/diagnostic history database, it was observed that during the office visit on (b)(6) 2015 the patient's settings were different than what were programmed at the previous office visit on (b)(6) 2009. The generator was found to be programmed off and the settings found were indicative of a faulted diagnostic test however the database did not contain a faulted test. There was a gap in history from (b)(6) 2009-(b)(6) 2015 and due to this gap it is not known how long the generator was programmed off. The generator was then programmed on and the patient reported painful stimulation. The generator was then programmed off again in response to the painful stimulation. It appears that the patient's reported painful stimulation that is related to the device being programmed off for an undetermined amount of time and then being programmed back on. No additional relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The patient underwent generator replacement. It was reported that the patient is no longer experiencing pain. The explanted generator is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577713
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dennis100
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« Reply #453 on: February 17, 2019, 06:31:10 AM »

Model Number 103
Event Date 02/01/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Patient age; corrected data: the previously submitted mdr inadvertently provided an incorrect patient age. Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Event description; corrected data: the previously submitted mdr inadvertently did not include all of the information available regarding the event. Date of explant; corrected data: the previously submitted mdr inadvertently provided the wrong explant date of the device.
 
Event Description
Information was received indicating that the patient¿s device was explanted on (b)(6) 2015 due to pain. The pain was first observed in (b)(6) 2014 in the throat and at the electrode site. The physician decided to disable the device in (b)(6) 2014 for patient comfort. The physician later attempted to program the patient¿s device back on and the patient was unable to tolerate the minimal device settings. The patient reported a burning sensation at the site of implantation, which recurred every five minutes during stimulation on-times. She also complained of dysphonia and tension of the platysma muscle. The patient¿s seizure frequency remained the same. Mri was performed with the purpose of finding an epileptogenic lesion (which was actually found in that study). It was indicated that programming changes/ medication changes/ other external factors did not cause or contribute to the pain. The patient had no prior history of this particular pain prior to vns. Product analysis was completed for the generator. There were no performance or any other type of adverse conditions found with the generator. Product analysis was completed for the lead. Other than typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
It was reported that the vns patient underwent surgery to explant her device on (b)(6) 2015 due to painful stimulation. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4577017
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dennis100
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« Reply #454 on: February 18, 2019, 01:28:30 AM »

Model Number 105
Event Date 10/28/2013
Event Type  Injury   
Event Description
It was reported that the patient had surgery on (b)(6) 2015. The patient¿s spouse reported that the lead was replaced, and the surgeon made a new pocket for the generator to be placed in. It was reported that the generator was not replaced, only repositioned. It was reported that the patient was doing okay. The explanted lead has not been received by the manufacturer to date.
 
Event Description
Analysis was completed on the explanted lead. A punctured opening was identified in the outer silicone tubing. Although difficult to state conclusively this condition was most likely caused during manipulation of the lead at implant/ explant related to surgeon use and not a device malfunction. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious opening was noted on the inner silicone tubing other than the end of the returned lead. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
A vns implant card was received reporting that the patient had lead replacement surgery on (b)(6) 2015 due to "lead discontinuity, electrode failure. " the patient's spouse reported that they learned that the lead wiring continued bubbles and/or other irregularities under the coating. Good faith attempts for additional, relevant information from the surgeon have been unsuccessful to date. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was later reported on (b)(6) 2015 that the patient was scheduled for a lead replacement and generator repositioning surgery. The patient had previously had generator repositioning surgery in (b)(6) 2014 due to irritation at the clavicle area. At that time, surgery was performed for patient comfort reasons. It was later reported in (b)(6) 2015 that the patient continued to feel pain and tenderness at the generator site during weight bearing activity. As the patient is wheelchair bound, she has to use her upper body for wheelchair transfers quite a bit and experiences pain at the generator site with every transfer with weight bearing activity. She also reports feeling a sensation that the generator moves while turning in bed or during exercises in physical therapy. At that time, it was noted that generator placement posteriorly (on the scapular area) might be considered due to the patient¿s pain to reduce chest muscle sensitivity. It was also reported at that time that the patient experienced painful stimulation at the neck if output current is increased above 0. 5 ma. As a result, the device was temporarily disabled and turned on again on (b)(6) 2015. However, the neurologist felt this is not a therapeutic level of therapy. The patient was referred for replacement surgery, as it was reported that the patient continues to feel a ¿taser-like¿ sensation at 0. 5ma current. Pulse width was adjusted from 250usec to 130usec which reportedly worsened the sensation. The pulse width was then adjusted up to 500usec which again worsened the sensation. The painful stimulation was in the throat, along the jaw line and neck which had reportedly been present since being programmed on three days after implant. The treating physician and patient determined to have the lead completely revised as this sensation has been present since the date that the device was first programmed on. The patient¿s device was turned off until she can have lead revised as the therapeutic level cannot be tolerated and the side effect is too uncomfortable even at 0. 5ma. It was reported that a 4. 0-maxon suture (absorbable) was used to suture device to tissue. However, the device does move within the pocket and it creates considerable discomfort. The plan was for the patient to discuss with the surgeon to either place the device on the right chest wall or on the upper back. Clinic notes dated (b)(6) 2015 reported that the device was turned off (b)(6) 2014. The patient no longer had the ¿shocking pain¿ in the left neck and throat region. However, she still had pain in the left anterior chest wall due to the generator. On the clinic visit on (b)(6) 2015, the neurologist proceeded with turning the device on to low setting per surgeon request, but the patient still felt the shocking sensation with stimulation. Lyrica was added for the pain management. The surgeon assessed on (b)(6) 2015 that the lead could have been placed on the wrong nerve or the lead insulation could have been damaged. He assessed that the solution for the painful stimulation is revision of the leads. The surgeon recommends lead revision and repositioning the generator in the left chest. The patient was referred for surgery. Diagnostics have reportedly been within normal limits. Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative

Event Description
The surgeon reported that the patient had been reporting painful stimulation prior to surgery. During surgery on (b)(6) 2015, no obvious insulation breaks were noted, but it was reported that there was fluid and air bubbles inside electrode insulation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4566036
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dennis100
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« Reply #455 on: February 19, 2019, 03:49:30 AM »

Model Number 302-30
Event Date 03/01/2015
Event Type  Malfunction   
Event Description
Analysis was completed for the generator on 05/15/2015. Other than typical explant procedure related observations, no surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. The device performed according to functional specifications of the current automated final test. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis was completed for the lead assembly on 05/21/2015. Abraded openings were noted on the outer silicone tubing. The reported lead fracture was not verified within the returned lead portions. Note that since a portion was not returned for analysis, an evaluation cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.
 
Event Description
Initially, it was reported that the patient was scheduled for generator replacement due to end of service. It was later reported that the patient was also scheduled for lead replacement due to painful stimulation in the electrode site that had begun the month prior. It was reported that there was no known device malfunction and that last known diagnostics were within normal limits. An implant card was obtained which indicates that the generator was replaced prophylactically and the lead was replaced due to painful stimulation and visual confirmation of lead fracture. A company representative was present during the surgery and confirmed that the surgeon identified a lead fracture. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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. Corrected data: adverse event. Corrected data: outcomes attributed to adverse event: required intervention to prevent permanent impairment/damage.

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dennis100
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« Reply #456 on: February 19, 2019, 03:50:08 AM »

Model Number 102
Event Date 08/27/2011
Event Type  Injury   
Manufacturer Narrative
Review of the available programming and diagnostic history.
 
Event Description
It was reported that the vns patient underwent surgery on (b)(6) 2011 to explant her device due to painful stimulation. The explanting facility discarded the explanted device; therefore, no analysis can be performed. No further information relevant to the event has been received to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2009.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4724831
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dennis100
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« Reply #457 on: February 19, 2019, 03:53:23 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type  Injury   
Event Description
It was reported by a psychiatrist that a vns patient experienced pain going up the left side of the neck and down into the left shoulder with stimulation. Patient's current settings were 1. 75/20/500/30/5 and treating psychiatrist stated that diagnostics were all ok (no specifics) and have been in the past. The patient denies any trauma to the area. Additional information was received from the patient indicating that she is still experiencing painful stimulation only when her head is turned to the left. Patient stated that when her head is straight there is no pain. The patient stated she would like to see a surgeon to see if he can offer any solutions to the reported pain. However, at the time no interventions have been scheduled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919376
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dennis100
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« Reply #458 on: February 20, 2019, 12:20:46 PM »

Model Number 103
Event Date 01/12/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient experienced pain and chest discomfort with vns stimulation when magnet was swiped. Interrogation of the generator showed that the patient¿s magnet mode output current was set higher (3. 0 ma) than what was previously programmed (2. 75 ma). The pulse width and the normal mode on time were also changed. The physician questioned about the possibility of vns settings automatically changed without the physician programming the device. The patient also mentioned that no other physician changed the vns settings. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received that the patient's vns device was programmed by a different physician on (b)(6) 2015 to the settings observed on (b)(6) 2015. It was noted that the pulse width had been decreased from 250 to 130.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4702201
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dennis100
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« Reply #459 on: February 20, 2019, 12:21:29 PM »

Model Number 300-20
Event Date 03/25/2015
Event Type  Injury   
Manufacturer Narrative
Evaluation codes: device failure occurred, but did not result in a death.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to jaw pain which occurred during magnet mode stimulation on-times. Clinic notes were received indicating that the patient¿s magnet mode output current was increased from 1ma to 1. 5ma during an office visit on (b)(6) 2015. The physician also attempted to increase the normal mode output current of the device from 1ma to 1. 25ma but was unable to keep this setting due to patient tolerability issues. Attempts for additional relevant information have been unsuccessful to date. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analyses of the returned generator and lead have been completed. Analysis concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. The positive coil was found to be protruding out (still within the outer tubing) from the inner silicone tubing at what appear to be abraded/tear openings. Also, an abraded opening was noted on the inner tubing of the negative coil. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4704217
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dennis100
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« Reply #460 on: February 20, 2019, 12:22:13 PM »

Model Number 302-20
Event Date 03/21/2015
Event Type  Malfunction   
Event Description
Analysis was completed for the generator on 04/23/2015. The generator performed according to functional specifications, and there were no performance or any other type of adverse conditions found with the generator. Analysis was completed for the returned lead portion on 04/28/2015. The electrodes were not returned for analysis and therefore, a complete evaluation could not be performed on the entire lead product. Abraded openings were found on the outer and inner silicone tubes. The dried remnants of what appeared to have once been body fluids were found inside the outer and inner silicone tubes. With the exception of the observed abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies, beyond the outer and inner tubing openings, 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
Evaluation : device failure occurred, but did not cause or contribute to a death.
 
Event Description
Initially, it was reported that the patient was experienced spasms and pain at the generator site with device stimulation on time. It was reported that device diagnostics were within normal limits (dc dc code - 2). It was reported that the pain and discomfort had been present for a few days. Device settings were adjusted. It was later reported that the patient and discomfort were not any better with a decrease in device settings and frequency, so the patient was referred for surgery. The device was programmed off pending the surgery. There were no changes in medications or trauma or falls that may have caused or contributed to the pain and discomfort. The patient underwent surgery for patient comfort. The surgeon identified a break in the outer lead tubing in two places therefore, the patient underwent generator and lead replacement. Device diagnostics with the new vns system were within normal limits. The lead and generator were received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4713766
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dennis100
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« Reply #461 on: February 21, 2019, 02:08:09 PM »

Model Number 102
Event Date 06/11/2012
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported by the vns treating physician that the patient¿s device was turned off on (b)(6) 2012 to prep for mri and not due to the pain. However, it was reported to be left off to preclude a potential serious injury. On (b)(6) 2012, the patient reported throat discomfort during stimulation on-times. The patient then reported on (b)(6) 2012, some chronic mild throat pain in the contact of allergies with congestion and sneezing (not related to vns). The vns device was turned off in preparation for mri, not to manage throat pain. It was reported that the patient was experiencing "stabbing" pain in anterior throat during stimulation on-times following increase vns to 1. 50ma on (b)(6) 2011. The patient requested adjustment after two weeks. On (b)(6) 2011, the physician decreased settings for patient comfort (1. 0ma). On (b)(6) 2012, the physician further decreased output current to manage the pain.

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« Reply #462 on: February 21, 2019, 02:09:05 PM »

Model Number 302-20
Event Date 11/18/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
Implant card was received stating that the patient underwent generator and lead replacement due to painful stimulation. High impedance was also marked on the implant card. The explanted devices were discarded after surgery.
 
Event Description
It was reported on (b)(6) 2014 that the patient began having neck burning pain with each vns discharge starting a couple of days prior. The patient shut off the device himself and the pain improved. The device was set him to 0ma current that day since he had pain relief with vns off and sent him for x-rays. Follow-up showed that the patient underwent generator replacement on (b)(6) 2015. The device was discarded after surgery. No relevant additional information has been received to date.
 
Event Description
Additional information was received from the implanting surgeon that high impedance was not observed during this patient's surgery. Diagnostics were reported to be within normal limits following the replacement. It was further confirmed that the high impedance was marked incorrectly on the implant card.
 
Manufacturer Narrative
Brand name, corrected data: lead model 302. New information received changes the information in this field. Type of device, name, corrected data: lead. New information received changes the information in this field. Model, corrected data: 302-20. New information received changes the information in this field. Serial #, corrected data: (b)(4). New information received changes the information in this field. Lot #, corrected data:1609. New information received changes the information in this field. Expiration date, corrected data: 04/30/2009. New information received changes the information in this field. If implanted, give date, corrected data: 10/05/2006. New information received changes the information in this field. Device manufacture date, corrected data: 04/06/2006. New information received changes the information in this field. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #463 on: February 22, 2019, 08:18:46 AM »

Model Number 302-20
Event Date 03/12/2015
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Adverse event or product problem; corrected data: the previously submitted mdr inadvertently provided incomplete information, as it did not specify that the event was both an adverse event and product problem. Outcomes attributed to adverse event; corrected data: the previously submitted mdr inadvertently provided incomplete information.
 
Event Description
It was reported that device diagnostics resulted in high impedance. The patient reported pain in the chest area during device stimulation. The device was programmed off after observing the high impedance. The patient was referred for x-rays. The patient has been referred for surgery. No known surgical interventions have been performed to date. Attempts to obtain additional relevant information have been unsuccessful to date.
 
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 underwent lead and generator replacement on (b)(6) 2015. It was reported that a keloid had developed around the explanted lead. The generator was replaced prophylactically. It was reported that the explanted lead was discarded. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted devices have not been returned to date.

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« Reply #464 on: February 22, 2019, 08:19:39 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient¿s generator had migrated to the left armpit which was causing discomfort and pain. Clinic notes were received indicating that the physician observed the generator migration during an office visit on (b)(6) 2014. Diagnostic results from the office visit showed normal device function at that time. Follow-up revealed that the patient returned to the office on 04/06/2015 due painful stimulation that began approximately two week before the visit. The patient¿s device was tested and diagnostic results revealed high impedance. The patient¿s device was subsequently disabled and the pain subsided. The patient continued to have discomfort and stated that he could feel the device poking him under his skin. 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 underwent generator and lead replacement surgery on (b)(6) 2015. The explanted devices have not been returned to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
The explanted lead and generator were received, and analysis is underway but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contributed to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2015. Electrical test results showed that the pulse generator performed according to functional. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 385mm portion quadfilar coil 1 appeared to be broken approximately 12mm from the electrode bifurcation. During the cleaning process a coil strand became detached from the electrode (mating) end of the quadfilar coil 1 coil break. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 12mm) and identified the area on three of the broken coil strands as being mechanically damaged with pitting which prevented identification of the coil fracture type. Evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of these broken coil strands. The fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Pitting was observed on the coil surface. 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. 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. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #465 on: February 22, 2019, 08:20:38 AM »

Model Number 102
Event Date 03/01/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes reported that at the patient's visit on (b)(6) 2015 the patient was experiencing pain with vns stimulation. As a result, vns settings were decreased. At the next appointment with neurosurgery on (b)(6) 2015, the device was disabled to assess what was causing the painful stimulation. After the device was disabled, the sternal pain resolved. No additional relevant information has been received to date.
 
Event Description
Generator replacement surgery occurred. The explanted device has not been received by the manufacturer to-date.
 
Event Description
It was reported that the patient complained of left shoulder and neck pain with vns stimulation on-times. The pain originated in the shoulder. Chest x-rays were ordered and the patient was referred for generator replacement. Good faith attempts for additional relevant information have been unsuccessful to date. No known surgical intervention has been performed to date.
 
Manufacturer Narrative

Event Description
It was reported that the patient was referred for full vns replacement. No known surgical intervention has been performed to date.
 
Event Description
The explanted generator was received for analysis which was completed on 02/14/2017. The device output signal was monitored for more than 24-hours in a simulated body temperature environment. Results showed no variation in the output signal and demonstrated the expected level of output current for the entire monitoring period. The diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.

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« Reply #466 on: February 25, 2019, 02:39:18 AM »

Model Number 103
Event Date 03/23/2015
Event Type  Injury   
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2015 due to pain and painful stimulation. At that time, the physicians reported that the surgery was for patient comfort reasons and not to preclude a serious injury. The implant card reported that lead impedance was okay after replacement surgery. Additional information was later received that patient complained of pain after the surgery. Initially at post-op appointment on (b)(6) 2015, the notes recorded no post-operative complications and no patient complaints. The scars/incision sites were reported to be healed nicely. Later on (b)(6) 2015, the notes reported that the patient reported having continued problems with a burning sensation and a sensation of electricity around the vns site. The pain/discomfort did not improve after full replacement surgery. She could not tolerate this continued problem. The clinic notes from (b)(6) 2015 reported that the patient presented after full replacement complaining of pain in the area of the vagus nerve stimulator and neck. The patient reported that the pain was persistent if the device was not on. As a result, she wanted the device removed. The patient's device was programmed off due to the pain, and the physician assessed that it needs to be removed due to pain experienced even with the device off. The patient was referred for removal of the vns. The manufacturer¿s field clinical engineer attended the explant surgery on (b)(6) 2015. Explant of the generator and lead occurred on (b)(6) 2015, and the explanted devices were discarded. As a result, product analysis is unable to be performed.
 
Event Description
It was reported that the patient has had pain in the vns region of the neck since the first date of initial implant. Therefore, it was felt that since the patient was still complaining of pain with the replacement vns system, that the physician did not see any reason for it to remain implanted. It was felt to be removed more for patient comfort reasons.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Describe event or problem: the initial report inadvertently did report this information.

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« Reply #467 on: February 25, 2019, 02:40:06 AM »

Model Number 302-20
Event Date 04/14/2015
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient had presented with increased seizures and painful stimulation. System diagnostics were run on the vns system on (b)(6) 2015 and they returned a dcdc code 0. Normal mode diagnostics were run on the vns system on (b)(6) 2015 and they returned a dcdc code 0. The pulse generator was disabled. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. A battery life estimation for the implanted generator returned 0 years expected until near end of service. Programming history data was reviewed though (b)(6) 2012. The device was last programmed to a 16% duty cycle. The last parameters recorded were 2 ma/30hz/500usec/30sec/3min, magnet mode 2. 25ma/60sec/500usec. Diagnostic history data revealed that system diagnostics recorded on (b)(6) 2012 returned a lead impedance result within normal ranges. Normal mode diagnostics were run on (b)(6)2012 recorded on (b)(6) 2012 returned a lead impedance result within normal ranges. Magnet mode diagnostics recorded on (b)(6) 2012 returned a lead impedance result within normal ranges. Further information was received indicating that the patient had presented pain at the generator implant site. It was also indicated that the patient had undergone a generator replacement the previous year. X-rays were taken and reviewed at the healthcare facility. It was reported that review by the healthcare professional had not found any lead break or disconnection of the lead. Review of the x-showed that 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 seemed to be fully inserted into the generator connector block. The electrodes appeared normally placed on the vagus nerve. It is difficult to assess if the strain relief bend and loop were used. The tie downs were used but it is unclear, if those were used as indicated in the labeling, due to the picture quality. Part of the lead was behind the generator. No sharp angles or lead breaks were visible on the assessed lead parts. Based on the x-rays, the cause of the reported low impedance remains unknown. Further information was received stating that the seizure frequency was above the pre-vns seizure rate, with complex partial and tonic-clonic seizures. No manipulation of the vns system was suspected. The patient had undergone battery replacement in (b)(6) 2014. On (b)(6) 2015 system diagnostics returned a dcdc code 0, low impedance result. The patient presented mild painful stimulation with a strange sensation near the generator. No known surgical interventions have occurred to date.

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« Reply #468 on: February 26, 2019, 02:30:36 AM »

Model Number 102R
Event Date 04/01/2015
Event Type  Injury   
Event Description
The explanted generator was received for analysis. The returned product form indicated that the generator was explanted prophylactically due to ifi - yes. Analysis is underway, but has not been completed to date. Further follow-up revealed that the pain only occurs with diagnostic testing when the device settings are changed. There was no patient manipulation or trauma that is believed to have caused or contributed to the pain with diagnostic testing. The pain is located at the patient's neck. No interventions were performed for the pain. Clinic notes dated (b)(6) 2015 note that because the device has been implanted for greater than 10 years and due to the pain the generator will be replaced. It was noted that there may be a malfunction of the device and x-rays would be performed. Device diagnostics on (b)(6) 2015 were within normal limits. No additional relevant information has been received to date.
 
Event Description
Initially, it was reported that the patient was scheduled for generator replacement. It was later reported that the generator replacement was prophylactics, but that the patient was experiencing a lot of pain with device interrogation and that there may be a malfunction in the generator or lead. The patient underwent generator replacement. Device diagnostics were within normal limits with the new generator and existing lead. The explanted generator has not been received for analysis to date.
 
Manufacturer Narrative

Event Description
Analysis of the generator was approved on 06/29/2015. At decontamination and initially on the test bench the device did not communicate, which analysis in the pa lab determined, most likely, was caused by the microprocessor being in an unknown state. Visual evidence of burn marks on the generator case indicates that the state of the microprocessor, most likely, was adversely impacted by the electrocautery procedure. Post can open, the device performed according to functional specifications. Other than the noted failure to communicate before post can open, which was most likely due to the electrocautery process at explant, analysis in the pa lab concluded proper functionality of the pulse generator.

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« Reply #469 on: February 26, 2019, 02:31:45 AM »

Event Date 03/06/2015
Event Type  Injury   
Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently lacked the required evaluation codes. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.
 
Event Description
It was reported that a patient with a partially explanted vns system (approximately 6 cm of lead remaining implanted) experienced a hot, painful sensation in the left side of the neck and was getting stuffy while having an mri performed on (b)(6) 2015. The scan was interrupted but then started back up again. After the mri was completed, the patient was hoarse and experienced coughing and choking for the next few days. The neurologist couldn¿t find anything that could be contributing to these events. The patient had an ent evaluation where it was found that the patient had decreased sensitivity of the larynx however; the vocal cord movements were intact. The ent evaluation was performed on (b)(6) 2015. It was concluded that there was significant heating of the vagus nerve during the mri. Follow-up revealed that the scan was performed according to the new vns guidelines however, the ¿old¿ low sar epilepsy protocol was followed. The gradients are increased quickly which may be the cause of the issues the patient experienced. The physician indicated there was a stimulation of the vagus nerve because a stream is going to run in the remaining leads under the influence of rapid changes in the diffusion gradient despite the short duration of the series (approximately 1 minute). It is suspected that perhaps the spatial gradient field may have exceeded 720 gauss/cm. No additional relevant information has been received to date.
 
Event Description
X-rays images were received by the manufacturer. Review of the images revealed a 6cm portion including the electrodes still implanted in the patient. Further information was later received indicating that the facility uses an mri rx/tx head coil which has been successfully used on vns patients previously.

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« Reply #470 on: February 27, 2019, 08:45:22 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/04/2015
Event Type  Injury 
Event Description
It was reported that the patient was seen in the clinic and had a fever since implantation. The neurologist was not sure if the fever was related to implantation and referred the patient to the surgeon. Attempts to obtain additional information have been unsuccessful to date.

Manufacturer Narrative
 
Event Description
It was reported that the vns patient had a seizure which may have opened up the electrode incision site on the neck. The patient was experiencing pain in this area. Additional information was received stating that the patient was hospitalized due to an increase in seizures. It was noted that patient had a high temperature which may have contributed to the increase in seizures. No further information relevant to the event has been received to date.

Event Description
On (b)(6) 2015 the physician's office reported that the patient was scheduled to see the physician but missed her appointment. The assistant stated that the patient was indeed referred for an ultrasound but the assistant stated she sees no indication that the patient had that done. She said that the patient cancelled her appointment with the physician and has not rescheduled any appointment.

Manufacturer Narrative
(b)(4).

Event Description
The patient reported on (b)(6) 2015 that after implant surgery she had an infection and sepsis. As a result, she had to spend a few weeks in the hospital. The issue was associated with her implant wound. Since then she has developed a "squishy lump area" on her chest, above the generator. The patient noted that she left the surgery receiving stimulation. Following her first titration she began to feel severe pain in her throat and her ear. She describes it as feeling "like stabbing". The generator had been turned from output=0. 50ma up to 0. 75ma when this issue began. She reported that the neurologist refused to turn her therapy level down upon her request and therefore she was upset with him. The patient again reported severe, unrelenting ear and throat pain with vns stimulation. She said she saw her primary care physician and he told her that she does not have an ear or throat infection or reason for the pain other than her vns stimulation. The patient saw her surgeon and they turned the stimulation down from output= 0. 75ma to 0. 5ma as requested by the patient. The nurse practitioner said that this helped the patient's comfort. The patient wanted to keep the device implanted. The physician ordered some blood work and an ultrasound to make sure that there was no infection. Diagnostics were ok at 3174 ohms.

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« Reply #471 on: February 27, 2019, 08:47:14 AM »

Model Number 104
Device Problem Battery Problem
Event Date 04/27/2015
Event Type  Injury 
Event Description
Information was received from the neurologist. She was unaware of the relationship between the increase in seizures and vns, if any. The patient is not having more seizures than prior to vns implant. She indicated that replacing vns is an intervention for the increased seizures. Information was received that the patient¿s generator was explanted and replaced on (b)(6) 2015. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently did not include the information which was provided by the neurologist.

Manufacturer Narrative
 
Event Description
Clinic notes were received for the vns patient¿s office visit on (b)(6) 2015 indicating that the patient had been experiencing an increase in seizures since her previous office visit on (b)(6) 2015. The seizures included gtc seizures which were noted to be previously rare, but the patient had been having several of these seizures per week which commonly lasted an hour in duration. The patient also had a gtc seizure a few days prior to the office visit which lasted four hours. At the (b)(6) 2015, the patient also began having an increase in falling episodes from clusters of small seizures. The patient¿s legs subsequently weakened and the patient was unable to walk for up to 45 minutes following the cluster seizures. The notes indicate that the majority of the seizures were small and would last up to a minute in duration, but clusters of these seizures sometimes lasted up to an hour up to 2-3 times per day. It was noted that the patient did not use the magnet in the past three years due to painful stimulation; however, the physician stated that magnet mode stimulation was frequently activated. The patient¿s medication levels were checked and the dph level was found to be 2. 8 so the physician increased the dosage which provided initial improvement. The patient¿s device was tested and showed normal device function and an ifi condition. The physician indicated that the patient¿s events may be due to the depleting battery of the device or due to medication levels. The patient was referred for surgery but no known surgical interventions have occurred to date. Attempts for additional relevant information have been unsuccessful to date.

Event Description
Product analysis was completed for the generator on 07/22/2015. The data downloaded from the generator supports the infrequent use of the magnet function, which shows three magnet swipes since the final electrical test. In addition, magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. No evidence of body fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an if=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Event description; corrected data: the previously submitted mdr inadvertently did not include all product analysis details.

Event Description
Further review of the product analysis results indicated a battery voltage of 2. 804 volts when the generator was initially received. The generator was received with the output current disabled. Time with the output current disabled allows the battery voltage to recover slightly. This supports a previously observed ifi or neos flag as stated in the clinic notes.

Event Description
Additional clinic notes were received and reviewed by the manufacturer. Within the clinic notes it was stated the patient also experienced an increase in seizure severity prior to the vns replacement which occurred in 2015.

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« Reply #472 on: February 27, 2019, 08:48:19 AM »

Model Number 101
Device Problem Failure to Interrogate
Event Date 01/01/2005
Event Type  Malfunction 
Event Description
Further follow-up revealed that the device was programmed off in 2005 due to painful stimulation which resolved after the device was programmed off. The patient does not want to undergo generator replacement or have the device programmed back on due to the pain he experienced with the device stimulation prior to it being programmed off.

Manufacturer Narrative
 
Event Description
Initially, it was reported that the patient was referred for generator replacement due to end of service. It was later reported that the surgeon's office was unable to interrogate the generator, but that the patient was feeling painful stimulation indicating that the device was still functioning and was not at end of service. The patient reported that device replacement will not be pursued as the device was not helpful in controlling the patient's seizures. Attempts to obtain additional relevant information have been unsuccessful to date.

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« Reply #473 on: February 28, 2019, 03:39:59 AM »

Model Number 302-20
Event Date 08/01/2014
Event Type  Malfunction   
Event Description
On (b)(6) 2015, patient's vns device was disabled due to painful stimulation and lack of efficacy. Patient experienced headache, pain in the chest, neck and radiating pain in the left ear with stimulation. Systems diagnostics were performed and high impedance was observed. On (b)(6) 2015, the patient came back and wanted the device turned on. The patient had reported initially that she did not receive much benefit from vns. Once the device was disabled, the patient returned and said that she did receive benefit from it and therefore the vns was turned back on. Patient was referred for x-rays but it is unknown of the device was turned on again. Patient had previously reported headaches, painful stimulation in the neck and face and pulsating at the generator site since (b)(6) 2014. 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 or serious injury.

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« Reply #474 on: February 28, 2019, 03:41:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
Follow-up from the provider indicated the reason for explant was that the patient did not think the vns helped.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on follow-up report #2.
 
Event Description
It was reported that a vns patient was experiencing painful and erratic stimulation for about three months prior to an appointment on (b)(6) 2016. She stated that her autostimulations were going off "constantly and painful" at times, particularly at night. The provider changed device settings comfort measures. The device was then disabled. It was later provided that explant surgery was scheduled. No known surgery has occurred to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.

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« Reply #475 on: March 02, 2019, 04:35:51 AM »

Device Problem High impedance
Event Date 06/26/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient reported having painful stimulation in the neck after walking in front of an mri suite with the door to the magnet open. Thus, the manufacturer's sales representative interrogated the patient's device and completed a diagnostic test which revealed high impedance on the patient's vns system. Two more diagnostic tests revealed normal impedance following the initial high impedance result. The patient's device settings were subsequently lowered but the patient continued to experience the painful stimulation, this time in the chest pocket. Thus, the patient's device was programmed off. The pain in the patient's neck returned following the device being programmed back on (b)(6) 2015, characterized as a pulling sensation in the left neck and ear. Thus, the device was again turned off, with only magnet mode current remaining on. Device diagnostics were run again which revealed normal impedance. X-rays were reviewed by the neurologist which showed the vns leads were intact. There has been no reported trauma or manipulation. The physician does not know how this high impedance event began occurring. No known surgical interventions have been performed to date.
 
Event Description
Additional programming history was received and reviewed. The data obtained shows programming events from the date of the event, (b)(6) 2015, as well as a follow up visit with the treating physician on (b)(6) 2015. On (b)(6) 2015, the patient came in with the device disabled and left with device disabled as well. System diagnostic performed on (b)(6) 2015 resulted in normal impedance. The internal data decoded from the vns generator was reviewed as well. The data shows that impedance changed from 2356 ohms to 21822 ohms on (b)(6) 2015 from a 24-hour impedance measurement. System diagnostics performed later on (b)(6) 2015 showed an impedance change from 21822 ohms to 2089 ohms. Thus, the high impedance appears to have appeared and resolved all on (b)(6) 2015. No additional relevant information has been obtained to date.

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« Reply #476 on: March 02, 2019, 04:36:46 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/29/2015
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient would like the vns device explanted due to swelling in the area of the generator and extreme pain in the left side of the neck and jaw. It was noted that the pain increased when the vns device was stimulating; therefore, the vns device was programmed off sometime in 2008. No known surgical interventions have been performed to date.
 
Event Description
It was further reported that the patient has decided not to have her vns explanted at this time.

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« Reply #477 on: March 03, 2019, 11:12:40 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/15/2015
Event Type  Malfunction   
Event Description
The explanted lead and generator were received on (b)(4) 2015. Analysis of the generator was completed on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed on (b)(4) 2015. The reported allegation of "abraded insulation" was verified. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were found.
 
Manufacturer Narrative

Event Description
It was reported that the vns patient was referred for exploratory surgery due to an increased perception of stimulation which was described as painful and erratic. The patient's device was tested and showed normal device function. The patient's device was temporarily disabled using the magnet and the painful stimulation resolved. The physician decreased the programmed device settings and the patient tolerated the adjustment well. It was noted that painful stimulation issues began after the patient experienced a drop seizure. The patient underwent exploratory surgery on (b)(6) 2015. The lead was found to have an abraded opening in the silicone tubing and was replaced. The generator was replaced prophylactically. The explanted devices have not been returned to date.

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« Reply #478 on: March 03, 2019, 11:13:45 AM »

Model Number 105
Event Date 06/23/2015
Event Type  Injury   
Event Description
It was reported that the vns patient was experiencing an increase in seizures and painful stimulation. Follow-up revealed that the patient visited the office on (b)(6) 2015 due to painful stimulation in her neck. The physician decreased the device output current from 1. 5ma to 0. 25 ma and the patient subsequently began having an increased seizures during the visit. The physician reprogrammed the output current back up to the original settings and believed that this would resolve the patient¿s issues.

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« Reply #479 on: March 03, 2019, 11:14:55 AM »

Model Number 302-20
Device Problems High impedance; Inappropriate Shock; Battery Problem
Event Date 09/01/2014
Event Type  Malfunction   
Event Description
Analysis of the generator was completed 07/27/2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the explanted lead was completed on 08/12/2015. The reported allegation of high impedance was not confirmed. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
It was reported that the patient was experiencing a shocking sensation from the vns. It was reported that the patient was scheduled for generator replacement because the patient's neurologist did not know why the shocks were occurring. Clinic notes dated (b)(6) 2014 note that the patient had been complaining of left side electrical sensations when turning his neck to the left. Clinic notes dated (b)(6) 2015 note that the patient is feeling shocks and misfiring and that the vns is not working. It was noted that the patient feels a pulling on the left side of his neck and that he has been having a few seizures; however, it was also noted that the patient has not been taking medications prescribed at the last visit. Clinic notes dated (b)(6) 2015 note that the patient complains of the generator shocking him to the point of tears. The patient was seen the day prior at which time device settings were lowered which was noted to have worked to decrease the shocking sensation. It was noted that the generator is shorting out and the battery was malfunctioning and the patient would be referred for surgery to replace the battery. Further follow-up revealed that the patient was standing in his kitchen two weeks prior when he felt the device begin to stimulate. The patient reported that he normally has a choking sensation with stimulation, but this instance it did not go away. The patient reported since that time he experienced severe choking and painful stimulation. During the surgery, pre-operative diagnostics resulted in high impedance. Both the generator and lead were then replaced. The explanted devices were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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