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dennis100
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« Reply #1170 on: March 03, 2019, 11:04:35 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4922100
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dennis100
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« Reply #1171 on: March 06, 2019, 02:02:24 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; High impedance
Event Date 07/17/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery. The pain began occurring following a settings increase. Thus, the settings were decreased which helped the pain. The pain was thought to perhaps have been caused by the detached electrode. No additional relevant information has been obtained to date.
 
Event Description
Analysis was completed on the patient's explanted generator. Analysis showed that the generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. No 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, and no discontinuities were identified.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the device evaluation.
 
Manufacturer Narrative

Event Description
Clinic notes were received and indicated that the patient had experienced pain associated with stimulation. There was also a report of a settings adjustment which helped with the pain. The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015. However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system. Thus, the lead was replaced as well. It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached. No lead fractures were noted. It was unknown how the lead had become partially detached form the nerve. The diagnostics were normal following the generator and lead replacement. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5002392
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dennis100
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« Reply #1172 on: March 06, 2019, 02:03:20 AM »

Model Number 304-20
Device Problems Fracture; Lead
Event Date 11/11/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Initially, it was reported that the patient underwent device explant for an unknown reason. Further follow-up revealed that the vns system was explanted because the device had been programmed off for some time because it was painful when the device was on. It was noted that during explant there was a lead fracture visualized by the surgeon near the neck area. The patient was not reimplanted. The explanted lead and generator were received for analysis. 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 lead was completed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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, and no discontinuities were identified.
 
Event Description
Follow-up revealed that the patient first reported painful stimulation in the neck during an office visit on (b)(6) 2013. The device was subsequently disabled. No diagnostic tests were performed that day. The last diagnostic test was performed on (b)(6) 2013 which showed normal device function at that time and the device had not been tested since device disablement.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5000874
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dennis100
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« Reply #1173 on: March 07, 2019, 02:10:08 AM »

Model Number 300-20
Event Date 07/15/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 it was reported that the patient has high impedance. Normal mode diagnostics were performed which showed a dcdc of 7 and output=limit. The patient also reported painful stimulation. His report of the location of pain varies, but it does appear to occur when the device turns on. He reported that it's in his neck, then his head, and then his chest. They didn't want to perform system diagnostics due to the patient's report of painful stimulation at settings lower than the system diagnostic test settings. It was also noted that the patient has voice alteration when the device cycled on. The vns device was left on at the patient's request. The patient was referred to a surgeon. Although surgery is likely, it has not occurred to date. The physician reported that no patient manipulation or trauma occurred. She noted that a ct scan had been performed on the patient but not x-rays.
 
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=4959601
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« Reply #1174 on: March 08, 2019, 01:49:10 AM »

Model Number 302-20
Device Problem High impedance
Event Date 02/05/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had high impedance at their appointment. The patient had reportedly heard a pop and felt vibrations in their neck that had since resolved. The patient later reported that they had felt pain in their neck and chest. Per the patient, no trauma had recently occurred to the neck or chest. Surgery is likely but has not occurred to date. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8379553
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dennis100
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« Reply #1175 on: March 09, 2019, 02:58:47 AM »

Model Number 303-20
Device Problem Detachment of Device or device Component
Event Date 01/03/2019
Event Type  Malfunction   
Event Description
It was reported by a company representative that the patient experienced a shocking feeling in their neck soon after lead and generator placement surgery. The physician indicated that x-rays were taken that indicated the electrodes were not securely placed on the nerve. The physician indicated that the patient underwent a generator and lead replacement surgery. The suspect product (lead) was reportedly not available for return. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8296459
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dennis100
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« Reply #1176 on: March 09, 2019, 02:59:25 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/10/2019
Event Type  Injury   
Event Description
It was reported that the patient experienced painful stimulation/shocking in the neck when the magnet was swiped over the generator and their pain management physician requested information about explanting the patient's generator. It was reported that the patient had been strangled and that the nurse believed the patient's lead may be broken due to the reported assault. It was additionally reported that the patient's lead was bent and was "poking out. " clarification from the medical professional indicated that the device was not coming out of the skin. The patient no longer felt the vns cycle like she had in the past. No known surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8302654
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« Reply #1177 on: March 09, 2019, 03:00:03 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/02/2019
Event Type  Injury   
Event Description
It was reported from a patient that she was feeling pain after settings were increased for her seizures. The patient later saw her neurologist who turned the settings down, however the patient was still feeling the pain. It was clarified that the patient was not feeling pain with stimulation, although she only began feeling the pain after settings were previously increased. An update was received stating that the constant pain was occurring behind the patient's electrode site on the neck. It was noted that the patient had been taken to the er due to increased seizures and intolerable pain in her neck. She stated that her vns was "not working" and that she wanted it removed. The patient was still experiencing pain after decreasing settings. Follow up with the physician's office confirmed that when the patient was last seen, the output current was decreased due to pain and swelling in the neck and throat after previously increasing settings. It was unknown what the cause of the pain, swelling, and increased seizures were at this time. No known surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8320621
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« Reply #1178 on: March 09, 2019, 03:00:38 AM »

Model Number 304-20
Device Problem Fracture
Event Date 01/01/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's vns. The patient's vns was programmed off and the patient was referred for a consult. A review of device history records revealed that the generator and lead passed quality control inspection prior to distribution. The patient underwent vns lead replacement surgery due to an observed lead fracture. The patient also had reported feeling painful stimulation in his neck. The explanted lead has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8298975
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dennis100
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« Reply #1179 on: March 10, 2019, 02:26:47 AM »

Model Number 302-20
Device Problem High impedance
Event Date 01/09/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was seen again after a lead pin reinsertion surgery, and high impedance was observed. Diagnostics further noted that the output current was not delivering and the patient was complaining of a shocking sensation to her neck. The patient was sent for x-rays and was to be referred for possible lead revision surgery. Clinic notes from the office visit were received and reviewed. It was stated that since the patient's last visit, the patient was experiencing an intermittent "shocking" sensation at the left side of the neck, coughing more, and had chocked while eating three times, one of which became cyanotic and required a heimlich maneuver. The noted diagnostics confirmed the high impedance and low output current delivered that was reported. It was stated that x-rays of the chest and neck showed no apparent lead break. Settings were decreased for the adverse event of painful stimulation, coughing, and choking. Ap and lateral chest and neck x-rays were received for review. The generator placement appeared to be normal in the left axillary chest area. Due to the quality and angle of the images provided, complete lead pin insertion and feed-through wire integrity could not be assessed. The lead was observed in the patient¿s neck appeared to be routed toward the patient¿s left chest. Due to the quality and angle of the image, strain relief and integrity of the lead could not be assessed. A portion of the lead is routed behind the generator. Based on the images provided, no obvious cause of the adverse events or high impedance was identified. Note that the presence of a gross fracture in the portion of the lead excluded from the images or a micro-fracture along the lead body cannot be ruled out. Revision surgery occurred and it was noted that the explanted product was not expected to be returned for analysis as the hospital discards products after surgery. It was specified that only the lead was revised, with the replacement lead placed on the left vagal nerve. Pin reinsertion was not tested. No device was received to date. No additional relevant information was received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8300514
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« Reply #1180 on: March 16, 2019, 02:01:56 AM »

Model Number 303-20
Device Problems Circuit Failure; Loss of Power
Event Date 09/07/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient had pain in the neck and throat, and swollen spot in the neck. It was reported that short circuit was suspected, as the dcdc value dropped from 6 to 5, to 3, to 2 and now 0. The generator was switched off. It was reported that the x-rays will be taken then sent to the manufacturer for review. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that both lead and generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.
 
Event Description
It was later reported that the vns patient had eating disorder, hoarseness, dysphagia and protrusion. Review of the available programming and diagnostic history received from the nurse showed normal diagnostic results through (b)(6) 2012. The x-rays were taken and sent to the manufacturer for review. 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 seems to be fully inserted into the generator connector block. The electrodes placement seems to be normal. One tie-down, strain relief bend were used to secure the implanted lead but not as indicated in the labeling. Part of the lead was behind the generator. No lead breaks or sharpe angles were visible on the assessed lead parts.
 
Event Description
Further information received indicating that the patient underwent a full revision. The lead was replaced due to lead function issue (low impedance) and the generator was replaced likely due to battery depletion. No explanted devices return is expected at ths time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5123049
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dennis100
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« Reply #1181 on: March 19, 2019, 01:32:59 AM »

Model Number 300-20
Device Problem High impedance
Event Date 10/01/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that this patient is experiencing painful and erratic stimulation at an unspecified location. The pain only occurs at night for the patient. At a recent clinic visit high impedance was found on system diagnostics. The patient denies any incident that may have caused the high impedance. The physician was instructed to turn off the device or lower the device settings. The patient will likely receive a m106 to replace her existing system. Clinic notes state over the past month or more she has been having intermittent sensations of her device going off where as she had not really felt it come on at all in the past year. When she swipes her magnet she has no stimulation. Surgery is likely but has not occurred to date.
 
Event Description
The explanted devices were discarded after surgery and will not be received for analysis.
 
Event Description
The patient had a full replacement on (b)(6) 2015. The explanted devices have not been received for analysis to date.
 
Event Description
The patient reported muscle spasms (a fluttering feeling) in her neck and down into her left shoulder which the patient states began around the time of the high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5232625
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dennis100
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« Reply #1182 on: March 19, 2019, 01:33:44 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/22/2015
Event Type  Malfunction   
Event Description
It was reported by a physician that a patient's vns showed high lead impedance on diagnostics at a clinic visit. Additional relevant information has not been received to-date. No known surgical intervention has occurred to-date.
 
Event Description
Follow-up to the physician revealed a chest x-ray was taken and showed that the device migrated down near the left breast and medial to the original location. The x-rays were not sent to the manufacturer for review. The patient reported the migration had occurred over the past three years. The patient reported pain due to the migration which was explained by the physician as mechanical from the patient's bra rubbing on the unit. The last systems diagnostics in (b)(6) 2015 were reportedly fine. The physician did not know whether the sutures were non-absorbable or the relationship of the sutures to the migration. It was reported the patient has not had any significant changes in weight. The physician believes that the high impedance and the migration are related and that the high impedance is the result of the migration of the generator. The device was not turned off, and the settings were not changed.
 
Event Description
Operative notes for the implant surgery were received and indicated that a stitch was used to secure the generator, but the type of suture was not indicated. For the lead, two loops were formed and were stated to be secured with stitches. The type of suture used to secure the loops of the lead was not indicated.
 
Event Description
Clinic notes from a visit on (b)(6) 2016 were received providing that the patient had her generator disabled on (b)(6) 2016 due to discomfort, however she experienced an increase in frequency and more violent seizures since it was turned off. The patient had the device turned back on (b)(6) 2016. Diagnostics on (b)(6) 2016 showed high lead impedance. Follow-up to the physician revealed that the additional discomfort was experienced in the neck due to stimulation and resolved after the device was turned off. The pain at the chest was specified to be in the left superior chest and did not resolve after the device was turned off. Re-enabling the device did not resolve the increase in seizures.
 
Event Description
An implant card was received 05/24/2016 indicating the generator was replaced prophylactically and the lead was replaced due to lead discontinuity. The explanted devices were reported to have been discarded and are unable to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5237219
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« Reply #1183 on: March 21, 2019, 01:26:16 AM »

Model Number 304-20
Event Date 09/24/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2015 it was reported that the patient has a neck incision complaint and that the patient is seeing the surgeon on (b)(6) 2015. The physician¿s office reported that the ¿neck incision complaint¿ was an infection at the neck site; there was some bruising or hematoma and slight swelling and discoloration. The nurse said that it was from the vns surgery. They decided to wait to turn the vns on since the patient was having the infection. They did not do cultures; they just prescribed the patient antibiotics. They are not going to do any other interventions besides the antibiotics. They saw the patient again recently on (b)(6) 2015 and she was much better, the bruising had gone down, and they decided to turn the vns on. The manufacturing records for both the lead and generator were reviewed and it was confirmed that the devices were sterilized prior to shipment.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5206821
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« Reply #1184 on: March 22, 2019, 02:31:55 AM »

Model Number 302-30
Device Problem High impedance
Event Date 11/12/2015
Event Type  Malfunction   
Event Description
It was reported that a patient felt a shocking pain in her left chest up into her neck. Diagnostics were performed, and high impedance was identified. X-rays were performed, but a lead break was not visualized. The patient was referred for revision surgery. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently left off that the patient did not feel stimulation and did not have voice alteration, which indicated that the patient was not receiving therapy due to the high impedance.
 
Event Description
The patient did not feel stimulation and did not have voice alteration, which indicated that the patient was not receiving therapy due to the high impedance. The physician temporarily disabled the generator on (b)(6) 2015 due to the high impedance. The patient had lead revision surgery on (b)(6) 2016 due to the shocking pain in the chest and high impedance. There was high impedance during pre-op. Generator diagnostics were performed to rule out the generator as the cause of the high impedance, and the results were within normal limits. After testing the generator, the original lead was inserted back into the generator to ensure the high impedance was not due to a connection issue, but the impedance was still high. The lead was replaced, which resolved the high impedance. The explanted lead was received on 01/12/2016. Analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5331002
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« Reply #1185 on: March 25, 2019, 02:00:57 AM »

Model Number 303-20
Device Problem High impedance
Event Date 12/23/2015
Event Type  Malfunction   
Event Description
It was reported that a patient, who was recently implanted with vns, experienced discomfort when the device was initially programmed on. Diagnostics showed that high impedance was present. The physician programmed the patient's generator off and ordered x-rays. The physician's office evaluated the chest x-rays that were taken on (b)(6) 2015, and they did not see anything that looked wrong. The x-rays were not available for livanova to evaluate. The patient had lead revision surgery on (b)(6) 2016. The surgeon did not test the lead impedance during surgery. He did not test the connection of the existing lead to the generator prior to replacing it. Therefore, it cannot be determined if there was incomplete lead pin insertion. The explanted lead is expected for return, but it has not been received to date.
 
Manufacturer Narrative
Udi of suspect device: (b)(4). Brand name, corrected date: initial report inadvertently reported the incorrect brand name of the suspect device. Model #, corrected data: initial report inadvertently reported the incorrect model of the suspect device.
 
Event Description
The patient felt pain in the left neck when her vns was turned on. The explanted lead was received on 02/02/2016. Analysis has not been completed to date.
 
Event Description
Analysis was completed on 03/01/2016. The entire lead was evaluated. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. The high impedance was most likely related to a lead pin insertion issue since the lead did not have any anomalies that would have caused the high impedance. Since the pain the patient felt was in the neck area, it would not have been related to the high impedance, which only would have caused painful stimulation at the generator site.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5371512
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« Reply #1186 on: March 26, 2019, 02:45:20 AM »

Model Number 304-20
Device Problem High impedance
Event Date 12/17/2015
Event Type  Malfunction   
Event Description
It was reported that a patient's device had high impedance. The patient also reported painful stimulation at the electrode site. The physician disabled the device on (b)(6) 2015, and the patient was referred for full revision surgery. The physician did not believe that there was any trauma that could have caused the high impedance. However, the patient had an appointment with a different physician on (b)(6) 2016, and diagnostics were performed. System diagnostics and normal mode diagnostics were all within normal limits, and there was no high impedance present. The patient's device was programmed on temporarily during the appointment, and the patient reported feeling painful stimulation at the generator site. Once the device was disabled again, the painful stimulation resolved. The physician planned on programming the patient's device back on if he saw her again. It is unknown if the physician originally ran normal mode or system diagnostics on (b)(6) 2015, so it cannot be determined if there was intermittent high impedance or if the high impedance was due to the physician running normal mode diagnostics. Attempts for further programming history from the original appointment on (b)(6) 2015 have been unsuccessful to date.
 
Event Description
The patient was referred for generator replacement surgery, even though high impedance was not present. A company representative was present at the surgery on (b)(6) 2016, and system diagnostics were performed with the patient's neck extended in different positions. The diagnostic results were all within normal limits, and there was no indication of a device malfunction. The generator was replaced prophylactically, and the lead impedance was still within normal limits once the new generator was attached to the existing lead. Therefore, the lead was not explanted. The physician that reported the high impedance most likely ran normal mode diagnostics, and did not run system diagnostics to properly identify if high impedance was present. The generator replacement surgery was not done in response to the painful stimulation that the patient reported to be experiencing in the neck.
 
Event Description
The generator was returned for product analysis. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5360491
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« Reply #1187 on: March 27, 2019, 07:00:13 AM »

Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient has reported left vocal cord dysfunction. The onset of the event is unknown. The patient has consulted with an ent surgeon on whether or not any intervention needs to be taken.
 
Event Description
It was reported that the patient saw a local ent and the neurologists have yet to see the patient in the office. She was not complaining at all when they previously saw her. Further follow-up showed that the patient has been wheezing, having shortness of breath, and difficulty walking short distances. She thought her asthma was flaring up so she saw her primary physician. He noticed that the wheezing was coming from her throat. She was sent to ent and had further testing done. She was told she has vocal cord dysfunction most likely from the vns.
 
Event Description
(b)(6) 2016 notes state that the patient is here to have the vns settings decreased. Since having her duty cycle increased in august, she has been experiencing problems related to her vns. She has been wheezing, has shortness of breath, and cannot tolerate walking short distances or going up a flight of stairs. She saw an ent and was told she has vocal cord dysfunction. The md decreased duty cycle from 35% to 29%. (b)(6) 2016 -patient left to do stairs and walk briskly; came back and is still having problems with wheezing and shortness of breath. Turned device off and repeated, wheezing and shortness of breath gone totally. She feels much better. But with device off feels like she is having muscle spasms near vagus nerve, could feel the quiver of left neck which also affected her speech. Device was then decreased to 0. 5 ma then back to 1. 5 ma. So patient was set back to 1. 5 ma and will be seen in a few weeks to reduce if necessary. (b)(6) 2016 notes state the home pulmonary and ent specialists state that the wheezing while exercising is related to vns. When the vns was stopped she was able to exercise quite well without difficulties. They state that may indicate significant airway obstruction related to vagus nerve stimulation. Notes state they will get her down to 1 ma and cycle 30 sec on and 5 min off and see if that becomes more manageable in terms of her breathing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5341090
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« Reply #1188 on: March 28, 2019, 08:16:26 AM »

Model Number 105
Device Problem Insufficient Information
Event Date 10/14/2015
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the nurse practitioner the patient developed a hematoma on his neck which appeared to be associated with vns surgery. It was noted that fatty tissue had to be removed during the patient's implant surgery, which caused the hematoma. The hematoma is now reported to be resolved. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
A call was placed to the nurse practitioner and she stated that system diagnostic were run, no flags were observed, and the impedance value on (b)(6) 2016 was 3280 ohms, which is within normal limits. The nurse practitioner also stated that she was able to see the charts from all of his following heath care professionals and she noted that the patient had not reached out to anybody since (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5434839
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« Reply #1189 on: March 28, 2019, 08:17:23 AM »

Model Number 106
Event Date 01/05/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient's mother that there was bruising around the incision site after the vns generator and lead were implanted. An additional phone call was later placed by the patient's mother. The patient's mother explained that the patient initially had a decrease in seizures right after surgery, from about 30 seizures/day down to about 5 seizures/day until (b)(6) 2016. On (b)(6) 2016, the patient had approximately 30 seizures, on (b)(6) 2016 the patient had greater than 50 seizures, and on (b)(6) 2016 the patient had nearly back to back seizures. The patient was taken to the er and the patient's following neurologist came down to the er and programmed the patient's vns on. The patient tolerated the stimulations. It was also reported the patient's mother had used the vns magnet to activate the vns several times on (b)(6) 2016 and noted the patient had done ok with the magnet stimulations. However, it was noted that the patient had some blotchiness on her face, neck, and chest but the cause of the blotchiness was unknown. The blotchiness was noted to come and go with seizures, but not all seizures. The dhrs for both the lead and the generator were reviewed and confirmed the devices passed all testing and were sterilized prior to distribution. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Adverse event and/or product problem; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of reportable event; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
Additional information was received showing the patient was actually hospitalized for 2 weeks, due to the increased seizures, beginning on (b)(6) 2016. It was also noted the vns magnet was used to temporarily disable to the device; however, it is currently unknown why this disablement occurred. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Additional information was received from the physician who stated the bruising, increase in seizures, and blotchiness were not related to vns, and the office has since made titrations with no recurrence of the issues.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5446622
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« Reply #1190 on: April 01, 2019, 01:01:02 AM »

Model Number 302-20
Event Date 01/19/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient was experiencing painful stimulation and felt like his vns wires were unconnected. The patient had an appointment on (b)(6) 2016, and high impedance was confirmed to be present. The patient was referred for x-rays. No gross fractures were identified in the visible portion of the lead. The electrode portion of the lead could not be assessed as they were not included in the provided images. The presence of a microfracture could not be ruled out. No surgical intervention has occurred to date.
 
Event Description
The patient had full revision surgery on (b)(6) 2016 due to high impedance. The explanting facility does not return product to the manufacturer. Therefore, no analysis could be performed.
 
Event Description
Clinic notes were received with further information regarding the high impedance of the patient's device. The patient experienced pain in the chest and neck and coughing with magnet activation. A chest x-ray was performed, and the physician stated that he could see the lead wire going over the sternum and beyond the left border of the sternum. The physician could not feel the lead wire beyond the left border of the sternum even though the lead wire and generator were very superficial, above the pectoralis muscle on the right side of the chest. The physician believed that the lead wire was disconnected either over the sternum or at the are of connection to the "old wire," which was most likely referencing the electrodes on the vagus nerve. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5687518
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« Reply #1191 on: April 02, 2019, 01:34:08 AM »

Model Number 103
Event Date 04/05/2016
Event Type  Injury   
Manufacturer Narrative

Event Description
Clinic notes were received for patient's prophylactic replacement referral due to ifi=yes. Notes mention that the patient feels the device shocking him similar to when his battery has gotten low in the past and seizures are increased in the last 2 weeks. Additional relevant information has not been received.
 
Event Description
Additional information was received from the neurologist that the patient has experienced neck pain with stimulation several times when the (vns) battery is weakening. The patent has not had more seizures compared to pre-vns baseline level. There were no known changes to medications, vns settings or other external factors which preceded the onset of the increase in seizures. Patient underwent prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. The explanted generator was received on 06/02/2016. Analysis is underway but has not been completed to date.
 
Event Description
The pulse generator was explanted/returned due to "prophylactic replacement. " although the reported allegations of "increased seizures" and "painful stimulation" cannot be evaluated in the pa laboratory setting, proper functionality of the pulse generator in its ability to provide appropriate programmed output currents can be verified. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. This was successfully verified in the pa lab. In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generatoroutput signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The reported allegation of "low battery" was not duplicated in the pa lab. The battery, 2. 818 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5660851
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« Reply #1192 on: April 03, 2019, 01:23:09 AM »

Model Number 302-20
Event Date 03/21/2016
Event Type  Malfunction   
Event Description
High impedance (>10,000 ohms) was observed for patient's generator during a routine follow up appointment on (b)(6) 2016. Patient's device was checked on (b)(6) 2016 prior to the visit and diagnostics were within normal limits at that time. Patient did not fall. Patient was referred for x-rays and possible surgical consult. No known surgical intervention has occurred to date.
 
Event Description
Additional information was received that the patient's generator was disabled on (b)(6) 2016 upon seeing the high impedance message. Patient's x-rays were provided and reviewed. The generator appears normally placed on the left chest. The connector pin appears to be fully inserted inside the connector block. There does not appear to be any damage to the generator. The lead is seen routing up to the neck. The electrodes appear to be aligned at the nerve but placement is difficult to visualize. Based on the images seen, the lead appears intact and there are no gross discontinuities on the lead or at the generator that could be visualized but a microfracture cannot be ruled out. As an incomplete pin insertion was ruled out as the cause of high impedance, fracture within the lead is suspected. No known surgical intervention has occurred to date.
 
Event Description
Patient was seen by a surgeon for her neck issues and underwent explant surgery on (b)(6) 2016. The explanted device was not received to date and the explant hospital was reported to discard all implants after pathology.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5760034
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« Reply #1193 on: April 03, 2019, 01:24:07 AM »

Model Number 304-30
Event Date 05/07/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a patient had high impedance at about 9,000 ohms. The patient also reported feeling discomfort in her neck periodically with stimulation. The patient's device was noted to have been left on. There were no reported causes for the impedance issues or when the last known diagnostics were performed at the time of the call. The patient was being referred for full replacement surgery. The generator was going to be replaced due to the patient's desire for the newer model. No surgical intervention has occurred. No further relevant information has been received to date.
 
Event Description
The explanted generator had product analysis completed. Product analysis of the generator confirmed proper generator functionality. The generator confirmed its ability to provide appropriate programmed output currents. Additionally, a comprehensive automated electrical evaluation showed that the generator performed according to all functional specifications. There were no performance or any other type of adverse condition found with the generator.
 
Event Description
The patient had full replacement surgery on (b)(6) 2016. The explanted lead and generator were returned to the manufacturer for analysis. A section of the lead assembly was returned for analysis in one piece. Setscrew marks were seen on the connector pin providing evidence that proper contact between the setscrew and the connector pin existed at least once. Also, the connector ring had scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. Abrasions were noted on the connector boot and on the outer silicone tubing at multiple locations. The outer silicone tubing had a compressed appearance at multiple locations. A suspected coil break was identified at the end of the negative coil. The negative coil also had a discolored appearance in the vicinity of the broken end. Scanning electron microscopy images of the positive coil showed that pitting or electro-etching conditions had occurred at the break location. The returned lead assembly had kinks in at least one of the coils in two locations. The lead assembly had dried remnants of what appeared to have once been body fluids in the small o-ring boot location inside the inner silicone tubing. Scanning electron microscopy of the positive coil showed that pitting or electro-etching conditions had occurred at the coil end, showing evidence suggestive of a stress-induced fracture. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5763552
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« Reply #1194 on: April 03, 2019, 01:24:59 AM »

Model Number 302-20
Event Date 01/30/2016
Event Type  Malfunction   
Event Description
It was reported that the patient铠lead experienced high impedance. He was scheduled for a full revision surgery. The patient also reported painful stimulation in the neck, and the device was disabled in relation to the high lead impedance. Surgery has not been reported to occur to date. Additional pertinent information has not been received to date.
 
Event Description
The patient's vns system was fully replaced on (b)(6) 2016. The impedance value of the replacement system was within normal limits. The explanting facility does not return explanted devices, so product return of the explanted generator or lead is not expected. No additional pertinent information has been received to date.
 
Event Description
The explanted generator and lead portion were received and underwent product analysis. It was noted that the lead was still inserted into the generator when it was received. A continuity check was performed on the lead and setscrew of the generator which verified proper contact between the lead pin and setscrew. Analysis on the lead found a kink in the lead coils however no discontinuities were identified in the returned portion of the lead. It was noted the portion of the lead with the electrode segment was not returned. Therefore it could not be evaluated and its role in the reported high impedance could not be determined. During analysis on the generator various impedance loads were attached to the generator and the subsequent diagnostic tests resulted in the accurate resistance measurements in all instances. The generator found that it performed to functional specification. The internal data of the generator was reviewed and noted the last >25% change in impedance occurred on (b)(6) 2016 when the prechange value was 2460 ohms and the postchange value was 11807 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5639498
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« Reply #1195 on: April 05, 2019, 01:44:38 AM »

Model Number 302-20
Event Date 05/19/2016
Event Type  Malfunction   
Event Description
It was reported on 05/23/2016 that this patient's device is showing high lead impedance. The lead has been implanted since 2007 but the generator has only been implanted since (b)(6) 2015, so until x-rays or surgery occurs, it is unknown if pin insertion is the cause of the high impedance or a lead fracture. The patient has not yet had x-rays although they are requested. No surgical intervention has occurred to date.
 
Event Description
Clinic notes were received on 10/27/2016. Notes mention the broken lead and that the patient has decreased tolerance for stimulation. Surgical intervention has not occurred to date.
 
Event Description
It was indicated that the decreased tolerance in stimulation was reported to be painful stimulation at the patient's neck.
 
Event Description
On (b)(6) 2017 an implant card was received indicating that the patient had a full replacement on (b)(6) 2017. Explant products have not been received to date.
 
Event Description
The explanted devices were discarded after explant and are not available for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5720883
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« Reply #1196 on: April 05, 2019, 10:13:47 PM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/06/2019
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by the patient that their vns generator had migrated and that they experienced a burning feeling in their ear, on their arm, and up their neck. The patient indicated that they wanted the replacement generator to be implanted on the right side due to "too much scar tissue. " another report was received by the patient that their eyes were constantly fluttering and that the vns magnet swipe helped the eye fluttering. The patient was referred for an urgent generator and lead replacement and a letter was received by the surgeon indicating that the generator had migrated and caused the patient severe pain, burning sensations, and limited use of their arm. It was reported that the patient's generator was replaced and a company representative indicated that the patient experienced pain at the generator site that may have been caused by the scar tissue due to the number of replacements the patient has had. The patient experienced neck pain and pain when the turning her neck. The surgeon assessed that the cause of that pain was due to the generator migration which caused the strain relief loop to be too small and cause the pulling when the patient's head turned. The surgeon repositioned the tie downs and made a larger relief loop in the leads. The hospital reported that the explanted generator could not be released and therefore, return of the suspect product is not expected to date. No further information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404293
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« Reply #1197 on: April 06, 2019, 01:50:15 AM »

Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/05/2019
Event Type  Injury   
Event Description
The physician referred a patient for revision surgery due to a suspected lead break. The patient reported that there was no trauma to check or chest; however, they woke up one morning with left neck pain and swelling. The physician reported that that x-rays were reviewed, and that there appeared to be a lead break where the wire for the coils connect to the main wire. The physician ordered an additional x-ray and a ultrasound of the neck to determine the cause of the issue. After reviewing the x-ray and ultrasound, the physician believed that the lead was 100% broken. The physician believes that the left neck pain and swelling are related to the reported lead break. The physician reportedly suspects either the lead was not on the vagal nerve originally or that a small blood vessel in the area spontaneously burst and caused the sudden swelling and lead break. It was noted that the patient has been doing excellent with the vns since, and that the patient's seizures had been significantly reduced. It was noted that the patient's device was turned off and that the patient has seen an increase in seizures as a result. The ap and lateral neck and chest x-rays were received and reviewed by the manufacturer. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the lead pins were fully inserted. The device was placed in the patient¿s left chest per labeling. The lead was observed in the neck and chest. The lead wires appeared intact at the connector pins. In the portions of the lead visible, no gross lead fractures or other anomalies were observed. Additionally, four electrode coils were observed in the x-ray, two coils from a previously implanted lead and two coils from the current lead. The previous lead appears to have been explanted around 2-3 inches from the previous electrode coils. The previous and newly implanted electrode coils do not appear to be both implanted in the same location. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8465274
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« Reply #1198 on: April 07, 2019, 02:44:48 AM »

Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/16/2000
Event Type  Injury   
Event Description
The patient's generator was disabled after 6 months of use reportedly due to lack of benefit. It was reported that the patient's generator was explanted due to considerable irritation on the left site of their neck where the electrodes were located, which worsened when they turned their head. It was reported that prior to explant the patient's skin was puckered and that an anchor tether, part of the lead body, had poked through their skin. Another reason for explant was indicated as scar tissue, likely at the electrode site caused by chronic irritation. While the patient's generator was implanted they reported having tightened neck muscles due to vns stimulation, likely related to the lead extrusion and scar tissue. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8425064
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« Reply #1199 on: April 07, 2019, 02:45:42 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/05/2019
Event Type  Injury   
Event Description
It was reported that a patient was experiencing pain in the neck. Follow up was received indicating that the pain was extreme and was not associated with any injuries or seizure, although the patient's last seizure was in (b)(6) 2018 and the patient noted that she may have hit her face during the seizure. It was noted that the patient had not had any recent changes in medication. Per the physician, the patient's device had been programmed off. The pain had become mild and her neck was sore at the lead location. Diagnostics were within normal limits. Settings were adjusted to mitigate the painful stimulation. It was stated that the patient felt as if the nerve was irritated or sore likely due to the painful stimulation. The patient's device was then programmed on, initially to 0. 75 ma. However, the patient could not tolerate the stimulation at this current. The settings were then reduced further and the patient was left at reduced settings and no other medical intervention was reported. An implant card was received indicating that the patient underwent a replacement surgery due to "unexplained neck pain". No additional, relevant information was received to date. No device was received for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8413663
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