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dennis100
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« Reply #60 on: December 20, 2017, 03:03:11 AM »

Model Number 106
Event Date 05/26/2016
Event Type Malfunction
Event Description
Product analysis was completed on the returned generator on 07/07/2016. Review of the internal device data ¿sensecontrol¿ memory location showed that all tachycardia functions were enabled. External visual examination showed only observations consistent with the device explant procedure. Both interrogation and system diagnostic test were performed with expected results. The observed battery status was ifi=no. The pulse generator was placed in a final test fixture. A waveform generator setup was used for the basic stimulus to test the tachycardia detection feature. Heart beat sensitivity setting 5 was evaluated. The pulse generators sensing response showed sense delay starts of 17. 8 seconds with a no load condition and 8. 8 seconds with a 2k load condition. The pulse generator was opened. Possible contaminates were observed on the trimmed edge of the pcba (tab removed). The pulse generator module was subjected to a postburn electrical test. Results show that the pulse generator module failed several electrical tests associated with the identified contaminants. No additional pertinent information has been received to date.

Event Description
It was reported that the intended m106 replacement generator was unable to detect the heart rate within surgery. A reading of ¿?????¿ was present in the heart rate field on all sensitivity settings. No pre-surgical evaluation was performed. Device diagnostics were within normal limits. The programmed currents were turned off during attempts to verify heart rate. All available sensitivity values were cycled through and the issue persisted. Recommendations were given to mitigate emi, to reposition in the pocket, and reposition the wand. A different generator was ultimately implanted without reported issue. The generator device history record was reviewed and found all specifications met prior to distribution. In particular, all functional specifications, including r-wave verification, were completed prior to distribution. The internal device data of the generator was reviewed. The three available lines of interrogation and diagnostics with the tachycardia detection enabled showed that a sensitivity setting of 5 was used. The detected foreground heart rate values were 81. 2, 81. 2, and 118. 7 bpm. There were no anomalies with impedance or battery voltage noted. The suspect generator was received by the manufacturer on 06/13/2016 and is undergoing product analysis.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5735609
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dennis100
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« Reply #61 on: December 20, 2017, 03:04:04 AM »

Model Number 106
Event Date 06/02/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the physician had a patient who he could not get results from the heart rate detection feature. Some initial troubleshooting steps were performed, including attempting sensitivity settings 4 and 5, but this did not resolve the issue. The patient did not have pre-surgical evaluation done at the time of implant. The generator dhr was reviewed and found that all specifications were met prior to distribution. No additional pertinent information has been received to date.

Event Description
It was later reported on (b)(6) 2016 that the patient's vns system was recently interfaced with to troubleshoot the heart rate verification feature. This was after the previous reported attempt on (b)(6) 2016. The output currents were disabled on the generator. The heart rate verification was attempted and showed a stable heart rate value. No issues of difficulties were encountered while registering the heart rate. The generator's output currents were turned back on after the testing. No changes were made to the sensitivity setting throughout the testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5752705
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dennis100
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« Reply #62 on: December 21, 2017, 02:11:04 AM »

Model Number 106
Event Date 05/13/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported to a company representative that a surgeon reported a failure to detect a heart rate with a model 106 generator. The patient had a successful pre-screening. It was determined that a sensitivity of 1 was appropriate. During the implant, the surgeon tried all the sensitivity settings and could only get "????" and a brief heartrate detection. The rate displayed for a few brief seconds before the "????" appeared again. The device was not implanted. A second generator was used and the impedance upon diagnostics was indicated to be within normal limits. The generator has been received for analysis, which is underway, but has not been completed to-date. Additional relevant information has not been received to-date.

Event Description
Analysis was completed for the returned generator. The report of undersensing was duplicated in the lab. The pulse generator was placed in a final test fixture. The stimulus (waveform generator) and pulse generator were connected to an oscilloscope for visual confirmation of pulse generator sensing the stimulus. Heart beat sensitivity setting two (as received) was evaluated with a no load and 2k load conditions. The pulse generator's sensing response observed showed sense delay starts of 8. 2 seconds with a no load condition and 6. 0 seconds with a 2k load condition. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The pulse generator was opened. Possible contaminates were observed on the trimmed edge of the printed circuit board assembly. The battery was removed. The pulse generator module was subjected to an electrical test. Results show that the pulse generator module failed several electrical tests; supply current 2ma/normal, supply current off, supply current off sense, trim diagon current. The pulse generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse. This synch pulse is received by the tablet and used to calculate the heartbeat rate. Test results of the synch pulse revealed a longer delay (from initiation of the hb detection algorithm until hb synch pulses occur) than what is expected. Remaining residual material on the printed circuit board assembly edge after the ¿test tab¿ removal during the manufacturing process may have been the contributing factor for the report of undersensing. Review of the downloaded data revealed no anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5708939
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dennis100
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« Reply #63 on: December 21, 2017, 02:11:48 AM »

Model Number 106
Event Date 05/19/2016
Event Type Malfunction
Event Description
It was reported that there was an inability to get a reading for the generator¿s heartbeat detection during implant surgery. Troubleshooting was attempted, including attempting different sensitivity values and moving the generator closer to the heart, but did not succeed. The case was completed with the auto-stimulation mode disabled. Follow up revealed that the pre-surgical evaluation to establish candidacy for the auto-stimulation mode was not performed. During the surgery, the current modes were not disabled. Lead impedance was within normal limits. A review of programming history from the surgery showed that sensitivity values 3, 4, and 5 were attempted. As there were no device interrogations or diagnostics performed while the heartbeat detection was enabled, it is not expected that review of the interval device data would yield pertinent information at this time. The generator device history record was reviewed and found all specifications were met prior to distribution, including the r-wave detection functional testing.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5721834
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dennis100
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« Reply #64 on: December 21, 2017, 02:12:50 AM »

Model Number 106
Event Date 05/13/2016
Event Type Malfunction
Manufacturer Narrative
Additional details regarding the troubleshooting session were inadvertently not provided in the initial report.

Event Description
During the troubleshooting session on (b)(6) 2016, different sensitivity levels were attempted with version 11. 0 software but the heartrate would return as "*****" then show as "?????" regardless of the sensitivity level selected. Then the device was interrogated and it was ensured the device was off with version 9. 0 software. The pre-surgical evaluation indicated to use a sensitivity level of 4. It was attempted to use heartrate sensitivity levels of 4 and 5 but the difference between the baseline heartrate and the vns programmer was too high. Time was provided for the heartrate to level out and testing was repeated and adjusted the sensitivity to 3 with an acceptable difference of 0 to 1. The manufacturer's in-house programming history was reviewed, which provided settings and diagnostics for the date of 05/31/2016.

Event Description
It was reported to a company representative that a surgeon reported a failure to detect a heart rate with two model 106 generators (the first generator has been reported in mfr report# 1644487-2016-01293). The patient had a successful pre-screening. It was determined that a sensitivity of 1 was appropriate. During the implant, the surgeon tried all the sensitivity settings and could only get ¿????¿, and a brief heartrate detection. The rate displayed for a few brief seconds before the ¿????¿ appeared again. The first generator was not implanted. A second generator was used and the surgeon reported that he had the same issues sensing the heartrate with the second generator. However, he elected to implant it and leave the autostimulation feature off. The surgeon reported no other difficulties communicating with the device and impedance upon diagnostics was within normal limits. Follow-up by the company representative to the patient¿s mother revealed that the device was still unable to sense the heartrate at the patient's first dosing session with the neurologist. Follow-up was received from the company representative after speaking with the surgeon further, the heartbeat sensing was reported to be ¿all over the place¿ and was providing wide ranges of numbers inconsistent with the baseline heartrate measured for the patient. The surgeon decided to place the device subpectoral to see if it worked. It was stated that it worked better in that location, but was still providing wide ranges of heartbeat detection that the surgeon considered unreliable. During surgery, the heartbeat was given 10 seconds to attempt to stabilize while detecting. Another 10 seconds after the detection would show asterisks, and another ten seconds it would show a wide range of numbers. A sensitivity level of 2 was tried and was better but did not resolve the issue. A troubleshooting appointment was scheduled for the patient¿s appointment on (b)(6) 2016. Another surface ecg was performed, and it was determined to use a sensitivity level of 3. It was noted that the r-wave detection reduces when the patient is laying down. Using software version 9. 0, heartrate sensing was able to be achieved with no issues. Additional relevant information has not been received to-date.

Manufacturer Narrative
Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the reporting number assigned for the actions for the reported event.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5709146
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dennis100
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« Reply #65 on: December 23, 2017, 01:20:39 AM »

Model Number 106
Event Date 06/24/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient was seen in an appointment on (b)(6) 2016. At the beginning of the appointment, the generator had settings on a sensitivity level of 3 and threshold of 40%. Autostimulations were noted in the office visit data. The sensitivity setting was attempted to be lowered to values of 1 and 2, but heartbeat was not detected. After placing the sensitivity setting back to 3, the heartbeat was unable to be verified. The output currents were not programmed off prior to attempting to detect the heart rate. The heartbeat verification was reportedly completed successfully in the implant surgery of the generator. The generator dhr was reviewed and found all specifications were met prior to distribution. The review of operations in the dhr showed the generator was a mechanically routed device. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5814718
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dennis100
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« Reply #66 on: December 23, 2017, 01:21:44 AM »

Model Number 106
Event Date 06/22/2016
Event Type Malfunction
Event Description
It was reported on 06/22/2016, during the implant surgery, that the m106 impedance was checked and found to be within normal limits. During testing for the tachycardia, the device would not pick up the patient's heart rate. Heart rate detection attempts were made multiple times at on sensitivity settings 1 through 5, the tablet was rebooted, and the wand was tested 3 times. Additionally, the wand was disconnected and re-connected several times. A back up m106 was then opened and implanted. The implanted generator was able to pick up the patient's heart rate right away, and was tested several more times to ensure proper functionality. Review of decoded data shows that on the date of surgery ((b)(6) 2016) for the first m106 generator sn: (b)(4), tachycardia detection was programmed on and sensitivity levels 1-5 interrogation were performed and showed 60 bpm were observed. A system diagnostic test was performed and also showed 60 bpm. All output currents (normal and autostimulation) were programmed off during the testing. The suspect m106 generator was received by the manufacturer for analysis. Analysis is expected but has not been completed to date.

Event Description
Product analysis (pa) for the returned generator was completed. It was noted that in pa, both interrogation and system diagnostics were performed. The device measured 2809 with the test resistor and an ifi = no condition. Communication was ok, and lead impedance, along with current delivered, were normal for all diagnostic tests performed. However, the output waveform, observed from a bench oscilloscope, was abnormal to what is typically observed in the pa lab. In addition, the output waveform voltage measured approximately 3. 0v (approximately 4. 0v expected ¿ 1ma x 4kohms) and the impedance value (2809 ohms and 2870 ohms) was lower than anticipated (approximately 4000 ohms expected). Additional system diagnostics were performed during the analysis of the generator. The atypical output waveform and diagnostic results were only observed on the first and second system diagnostic tests that were performed in the pa lab. The atypical waveform and diagnostic results were not replicated on any of the system diagnostic tests thereafter. A cause for the initial observations could not be determined; however, it resolved on its own during subsequent diagnostic testing. The stimulus (waveform generator) and the generator were connected to an oscilloscope for visual confirmation of the generator sensing the stimulus. The stimulus was connected to the generator case and out2. Heart beat sensitivity settings 1-5 were evaluated with no load and 2k load conditions between out2 and out1. The generator¿s sensing response observed in the pa lab showed sense delay starts of 2. 2 to 3. 0 seconds with no load and 2k load conditions. The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. The generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The generator diagnostics were as expected for the programmed parameters. The generator was placed in a temperature chamber, which was cycled between 55 degrees celsius and -20 degrees celsius, with a 30 minute dwell at each mad and min limit, for 5 cycles. Heart beat sensitivity setting 5 was evaluated; post temperature cycle, with no load and 2k load conditions between out2 and out1. The generator¿s sensing response observed in the pa lab showed sense delay starts of 3. 0 seconds with a no load condition, followed by delays of 11. 8 and 2. 8 seconds with a 2k load condition. However, the heart beat sensitivity settings 1-5 were re-evaluated, post temperature cycle, with no load and 2k loads between out2 and out1. The generator¿s sensing response observed in the pa lab showed sense delay starts of 2. 0 to 3. 0 seconds with no load and 2k load conditions. A comprehensive automated electrical evaluation showed that the generator performed according to functional specifications. The generator was opened. Possible contaminates were observed on the trimmed edge of the pcba. Heart beat sensitivity settings 1-5 were evaluated, post open can, with no load and 2k load conditions between out2 and out1. The generator¿s sensing response observed in the pa lab showed sense delay starts between. 20 and 2. 92 seconds with no load and 2k load conditions. Despite the pcba routed edge observations, no adverse sensitivity delays were encountered during this stage of testing. The battery was removed. The pulse generator module was subjected to a postburn electrical test. Results show that the pulse generator module failed magnet related electrical tests; test:7_9_1, test description: magnet detection normal, value: 0=go, low limit: 0. 0, high limit: 0. 0, measured: 1. 0; 7_9_3, magnet response, 0=go, 0. 0, 0. 0, 1. 0. The magnet detection normal and magnet response test results are due to the need for updates to the test software. The updates will support use of the pa module tab-less test fixture (m105/m106) to help compensate for the distance between the electromagnet coil (on the test fixture) and reed switch (on the pcba). In the meantime, fet (final electrical test) or bench test results will ensure proper reed switch operation. The reported allegation of ¿undersensing no r-wave detected¿, listed in the remetrex issue file, was not duplicated in the pa lab. The pulse generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse. This synch pulse is received by the tablet and used to calculate the heartbeat rate. Test results of the synch pulse in ¿as-received¿ condition yielded sense delays of between 2. 2 and 3. 0 seconds. Other than the noted event (initial diagnostic test results), there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5815280
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dennis100
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« Reply #67 on: December 23, 2017, 01:22:56 AM »

Model Number 106
Event Date 06/29/2016
Event Type Malfunction
Event Description
It was reported that the patient underwent initial vns implant surgery on (b)(6) 2016. During the surgery, it was reported that the heartbeat verification was not successful and that the company representative received question marks instead of the heart rate on the patient's generator. The output currents were off and the patient's heart rate setting was correct. All of the sensitivity settings were tried and the question marks persisted. The impedance was 1320 ohms, 1272 ohms, and 1242 ohms during separate system diagnostics and no issues were observed during normal interrogation or diagnostics. The patient was implanted with the intention of following up later on this issue. A pre-surgical evaluation was not performed to determine the implant location prior to surgery. The surgeon was informed of the importance of performing the pre-surgical evaluation, which is needed to verify whether the implant location is suitable for heart beat sensing or not. Additional troubleshooting information was received that the wand battery life was tested and that the green light of wand stayed on for >25 seconds. The generator was not suspected to have been exposed to high energy discharge due to electro cautery. During the heartbeat verification, ???? kept appearing and the heart beat could not be detected even briefly. The generator was implanted in between the armpit and the sternum but not too close to the armpit. There was no attempt to reposition the generator in the pocket and the device was left implanted without replacement. The device history record was reviewed and was found to be complete. The device passed all testing, including the r-wave verification and the dc leakage-sense delay. Additional relevant information has not been received.

Manufacturer Narrative
Relevant tests/laboratory data, including dates, corrected data: (b)(6) 2016 11:09:54 (system diagnostics) td: on, sensitivity: 5, foreground heart rate: 67 bpm. Supplemental mdr 1 inaccurately listed foreground heart rate for (b)(6) 2016 11:10:35 as 60 bpm instead of 67 bpm.

Manufacturer Narrative
(b)(4).

Event Description
At heartbeat detection sensitivity setting 5, 67 beats per minute was observed. The 67 bpm value appears to indicate that the device did sense r-waves just prior to the tachycardia detection being programmed off. However, the programming data shows that verify heartbeat detection was not attempted during this time when the generator was sensing. It is possible that the generator was shifted slightly prior to this interrogation which placed it in a better location for detecting r-waves. Based on the final interrogation, evidence suggests that the generator may be accurately sensing heart rate at this time on setting 5.

Event Description
Programming and decoder data was reviewed for the patient's device. On (b)(6) 2016, tachycardia detection was programmed on and the autostim threshold was 60%. Sensitivity levels 1 - 5 were attempted. All output currents were programmed off during and after the testing. Tachycardia detection was programmed off at the end of the troubleshooting. Additional relevant information has not been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5817518
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dennis100
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« Reply #68 on: December 24, 2017, 02:39:41 AM »

Model Number 106
Event Date 06/14/2016
Event Type Malfunction
Event Description
It was reported on (b)(6) 2016 that the patient had a prophylactic generator replacement that day. The patient was implanted with a m106 and systems diagnostics were normal with impedance of 2405 ohms with the new generator in the or. However, in the operating room (or) the patient's heartbeat was unable to be detected. All sensitivity settings were tried, but only ????s were observed. The surgeon had declined to do the ekg surface assessment. They did not replace the generator but just programmed it on to the same settings as the explanted 102. The design history records was reviewed and the generator passed all functional tests. R-wave verification passed prior to distribution as well. All testing (final r-wave twice, pcba level r-wave, and the sso sensing delay/leakage current tests) show that this device had the ability to sense within its specification in manufacturing. It was confirmed that the generator and lead electrodes were implanted very close to each other in a single incision fashion. The patient was seen for post-op appointment on (b)(6) 2016. Heartbeat detection was again tried but only ???? at settings 1-4 were seen. At setting 5 there were able to intermittently detect a heartrate at times (maybe 30-40% of the time). This heartrate was very erratic. It was over 200 bpm, around 89-91 bpm, and also around 45-50 bpm at different times. The patient's pulse was around 90. Since the hr detection was intermittent and inconsistent, the physician decided to leave the autostim current off (0. 0ma). He did leave tachycardia detection on at a sensitivity of 5 with a 40% threshold. His thought was to capture the data on what the device was detecting. The patient's device is currently programmed with an off time of 0. 5 min and this has been very effective for her.

Manufacturer Narrative
(b)(4).

Event Description
The patient had a follow-up appointment on (b)(6) 2016. A 2-position assessment was done for the generator site. R-waves while standing were barely discernible with < 0. 2v amplitude. R-waves while the patient was laying on her left were 0. 1-0. 2v magnitude, still significantly less than 0. 4v. Conclusion of the assessment was that inadequate r-wave amplitudes are present based on the implant location. The alternate placement measured at the axilla would be a good choice for a future replacement device if autostimulation mode is needed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5777706
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dennis100
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« Reply #69 on: December 25, 2017, 01:54:41 AM »

Model Number 106
Event Date 06/17/2016
Event Type Malfunction
Event Description
Analysis was performed on the generator. Heart beat sensitivity setting 4 (as received) was evaluated with a no load and 2k load conditions between out2 and out1. The pulse generators sensing response observed in the (b)(4) lab showed sense delay starts (sense drop out, no load condition) of 29. 0 seconds with a no load condition and 22. 6 seconds with a 2k load condition. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The pulse generator was opened. Possible contaminates were observed on the trimmed edge of the pcba (tab removed). The battery was removed. The pulse generator module was subjected to a postburn electrical test. Results show that the pulse generator module failed several electrical tests including: r2 verification, supply current 2ma/normal, supply current off, supply current off sense, and trim diag on current. The pulse generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse. This synch pulse is received by the tablet and used to calculate the heartbeat rate. Test results of the synch pulse revealed a longer delay (from initiation of the heartbeat detection algorithm until heartbeat synch pulses occur) than what is expected. This delay may have been interpreted by clinicians, as non-detection of a heartbeat signal, causing them to attempt detection at a different gain setting or location on the patient. Therefore, the allegation of, undersensing delayed/intermittent heartbeat verification, may have been verified. Remaining residual material on the pcba edge after the 'test tab' removal manufacturing process may have been the contributing factor for the reported allegation of "undersensing delayed/intermittent heartbeat verification. ".

Event Description
During the replacement of the generator, the physician was unable to confirm hr verification during the verification process so they had attempted various troubleshooting steps. He attempted heartbeat detection at all 5 settings twice but was unable to get the heartbeat and only got question marks. Interrogation was successful and the programming system was not suspected to have caused any issues. Diagnostics were performed with no issue (around 2100 ohms), however pre-op testing was not done to confirm the appropriate location for the generator. The importance of the pre-surgical evaluation prior to surgery was discussed with the surgeon. The surgeon was able to move the generator around some in the pocket, but noted the generator was closer to the midline than an axillary position. He also said that he went through every sensitivity with no success and was only getting question marks at that the time. He then decided to replace the device with another model 106 generator and the heartbeat verification was successful with this device with no significant efforts. The suspect device was received on 07/06/2016. Analysis is underway but has not been completed to date. Additional relevant information has not been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5788276
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dennis100
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« Reply #70 on: December 26, 2017, 02:23:56 AM »

Model Number 106
Event Date 07/27/2016
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Serial #, corrected data: (b)(4). Initial mdr inadvertently did not list the product serial #. Lot #, corrected data: 203490. Initial mdr inadvertently did not list the product lot #. Expiration date (mo/day/yr), corrected data: 02/18/2017. Initial mdr inadvertently did not list the product expiration date. Device manufacture date (mo/day/yr), corrected data: 05/26/2016. Initial mdr inadvertently did not list the device manufacture date. (b)(4).

Event Description
Additional information was received that the patient has the generator implanted in the right chest and electrodes implanted on left vagus nerve. The physician inquired if the placement of the devices would contribute to problems with the heart rate sensing of the m106 as the neurologist was unable to get the hb detection to perform. The patient¿s generator was implanted on the right since the patient has a pacemaker implanted on the left. Per labeling, the implant location of the model 106 pulse generator critically affects its ability to properly sense heart beats. Improper implant location and/or heartbeat detection sensitivity setting could (b)(6) impact r-wave detection performance results.

Event Description
Product information was received on 08/08/2016. A review of device history records for the generator shows that no unresolved non-conformances were found. The r-wave verification step was successful per the device history records. The generator is not a laser routed device. Additional relevant information has not been received to date.

Event Description
It was reported that the surgeon had to implant the m 106 generator on the right chest of the patient on (b)(6) 2016 and that the heartbeat verification was unsuccessful. It is unknown if a pre-surgical evaluation was performed and if all the troubleshooting steps were completed. Attempts for additional relevant information were made but no additional relevant information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5890558
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« Reply #71 on: December 27, 2017, 01:25:44 AM »

Model Number 106
Event Date 07/05/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Manufacturer Narrative
Additionally, it can be seen that during a 14 day period, the vns was able to detect 661 times where a stimulation would have been provided, indicating the device was working as expected. This information was inadvertently incorrectly reported on supplemental #01 mfr. Report. This information was inadvertently incorrectly reported on supplemental #01 mfr. Report.

Event Description
It was reported that the surgeon was unable to detect the patient's heartbeat during the surgical procedure. It was noted that the vns therapy was programmed on while trying to detect the heartbeat. The dhr for m106, sn (b)(4) was reviewed. The dhr was found complete and the m106 passed all testing, including the r-wave verification and the dc leakage-sense delay. Attempts for additional information have been unsuccessful to date.

Event Description
Additional information was received from the surgeon's vns programming system and it was found that the patient's output currents had been programmed on while the surgeon was trying to test the heart beat detection of the device. It should be noted the output currents should be programmed off while trying to test the heart beat detection. Additionally, it can be seen that during a 14 day period, the vns was able to detect 661 times where a stimulation would have been provided, indicating the device was working as expected.

Event Description
It was found during review of the (b)(6) 2016 that two seizures had been detected, but since autostim was programmed to 0ma, not stimulations were delivered. A valid heart ware was detected on (b)(6) 2016 appointment. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5846616
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« Reply #72 on: December 30, 2017, 01:41:26 AM »

Model Number 106
Event Date 08/16/2016
Event Type Malfunction
Event Description
Memory data extracted from the patient's device were provided to the manufacturer and reviewed. They indicated the following: on (b)(6) 2016, heart rate was initially unable to be sensed by the generator. However, once the device was interrogated at sensitivity 4, a foreground heart rate of 90. 1 bpm was detected. When the patient came back on (b)(6) 2016, it appears that there was again evidence of heart rate (82. 7 bpm). Given this information, it appears that the generator was able to accurately sense at higher sensitivity levels (4-5). However, one reason why the programmer may not have been able to display the value (showed ????) on (b)(6) 2016 could be because the output current was programmed on, which is known to interfere with picking up this value during stimulation. It appeared also that on (b)(6) 2016, the settings were tested on 2 and 5 with outputs disabled. At this time, however, based on the information we have the generator was at least intermittently sensing.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that the vns patient's device was unable to verify heartbeat detection during an office visit on (b)(6) 2016. Using heartbeat sensitivity level 1 to 5, the device could not displayed heartbeat but it showed bpm - ?????. It was reported that the device was implanted in (b)(6) 2016 but the pre-surgical evaluation could have not been performed. It was reported that they could interrogate the device and the system diagnostic test was ok on the office visit on (b)(6) 2016. It was reported that the tablet device and the wand was functioning properly and the autostim was disabled. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Additional information was received indicating that the patient's generator is located in the chest at 9cm from the lead placement. It can not be confirmed that the heartbeat verification was performed the day of implant. No additional information was provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5927512
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« Reply #73 on: January 01, 2018, 02:03:45 AM »

Model Number 106
Event Date 09/22/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
Product analysis on the generator found that it could be successfully interrogated and diagnostic testing was performed. The battery voltage was measured after the can was opened and the voltage was 2. 975v. The generator performed according to functional specifications during product analysis however it was noted that the sense amplifier appeared to be too sensitive during testing. While there is not a lower limit for the minimum detected amplitude during testing, the results were noted to be lower than expected. Additionally, these values deviated significantly from those detected during initial manufacturing test. The internal data on the generator showed that the last recorded background heart rate was 95 bpm. These findings support the possibility that the generator was oversensing heart rate in the field based on these low amplitudes however the root cause of the oversensing could not be determined based on these results. Upon further review of the manufacturing records it was noted that while the generator passed r-wave configuration testing at all five gain settings for amplifier b, the recorded minimum sensing values were near the maximum allowed; particularly for setting #1. It was also noted that the generator initially failed final electrical test during manufacture when the generator became detached from the fixture during the test. The device was placed back on the fixture and retested where it passed final electrical testing. It was noted however that heartbeat verification was not performed again after the device became detached from the test fixture. This was based on the device previously passing heartbeat verification.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that during implant surgery the surgeon was experiencing difficulties getting the generator to properly detect the heartbeat. A pre-surgical evaluation was performed which indicated that the sensitivity setting should be set to 1 with the generator near the axillary position and approximately 5+ inches from the neck site. It was also noted during the pre-surgical evaluation that the patient's hr was 72 bpm. Initially the lead and generator were connected and the diagnostic results were within acceptable limits. However when the sensitivity level was set between 1-4 the heartbeat detection resulted with an error message, "????". The "????" error message indicates a loss of or no communication. A company representative then aided in troubleshooting attempts. The sensitivity level was then increased in 5 and the heartbeat detection measured heartbeats ranging from 197-212 bpm. It was confirmed that the programming system was functioning appropriately and the data receive light was flashing with the heart rate. Then the surgeon irrigated the nerve and set the sensitivity settings to 1. After this the heartbeat detection was correct with 71-73 bpm however it started to climb to 143-146bpm and eventually resulted in an error message "????". The surgeon made multiple attempts to adjust the sensitivity setting however each time the heartbeats detected would increase and eventually present with the "????" error message. It was noted that the patient was overweight and there was concern that this could be contributing to the heartbeat detection issues. However since a pre-surgical evaluation was completed this appears unlikely. Due to the heartbeat detection issues the surgeon decided to implant another generator. The suspect generator has been received and is pending product analysis. The manufacturing records of the suspect generator were reviewed and they indicated that the generator passed quality control inspection.

Event Description
Additional testing was completed on the generator. The generator's printed circuit board assembly was modified in order to be connected to the testing equipment. During testing gain settings #2 and #5 were out of specification for being oversensitive while gain settings #1 and #3 were under sensitive. It was noted that during the initial testing previously reported, all settings were overly sensitive. The generator was then tested again using the tests methods from initial product analysis testing. During this test only gain settings #1 and #3 did not meet specification due to undersensing. The results from the initial product analysis were not duplicated. The reason for the variation in results between testing is unknown. However a few potential causes were determined. Firstly, the battery was not removed until after the initial product analysis testing. It is possible that the generator was previously latched in to an unstable condition which cleared itself after a power cycle. Secondly, the printed circuit board assembly had several wires soldered onto it during the testing. It is possible that the mechanical handling and/or thermal cycling may have contributed to the generator's performance in subsequent testing. The cause of the oversensing that was initially observed could not be determined since the original behavior was not repeated in subsequent testing.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6021258
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« Reply #74 on: January 03, 2018, 01:39:40 AM »

Model Number 106
Event Date 11/30/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported during device implantation that the device could not detect heart rate. A pre-operative assessment to evaluate whether the patient was a good candidate for tachycardia detection was not performed. All sensitivity settings were used to try to verify the heartbeat, diagnostics were normal, and the battery of the programming wand being used was confirmed to be functioning. The wand was reportedly held still during verification and was reportedly communicating well with the generator. Additionally, the patient's generator was reported to be implanted close to the heart in the left chest. Throughout the surgery the patient's heart-rate was 60-62 bpm. The surgeon did not want to try moving the generator to a different location to test if this solved the issue. A review of the device history records confirmed that the suspect device passed all quality inspections prior to release internal data was reviewed. It was determined that the device was turned on prior to heartbeat verification and could have been stimulating during verification, which could cause have caused interference. Only one interrogation was taken after heartbeat detection was turned on. It captured a foreground heart-rate of 60, which is the default value shown during interrogations when the device is not sensing a heart-rate. Therefore, it was likely that a valid heart rate had not yet been detected. No further relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6179378
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« Reply #75 on: January 06, 2018, 03:05:16 AM »

Model Number 106
Device Problem No Known Device Problem
Event Date 11/01/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
Report received that a patient has felt his vns auto-stimulations more frequently than expected. The patient had reportedly been working with a robot in school and since then, the number of auto-stimulations have increased and the patient had felt more fatigued. The physician reportedly indicated that the auto-stimulation activations did not align with the patient's increase in heart rate. The physician decreased the vns heart rate detection sensitivity which reportedly decreased the number of activations. Further information was received that after the heart detection sensitivity was decreased, the patient presented with an increase in seizures. Diagnostics were reportedly okay, but results were not provided. The patient's mother was concerned that the robot had damaged the vns. No further relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7077344
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« Reply #76 on: May 04, 2018, 11:31:52 PM »

Model Number 1000
Device Problem Oversensing
Event Date 03/21/2018
Event Type  Malfunction   
Event Description
During an implant procedure, it was reported that the generator's heartbeat detection feature was consistently sensing twice the patient's heart-rate. Various heartbeat detection sensitivity levels were tried, but these did not resolve the issue. System diagnostics and settings were reported to be normal. A review of device history records for the generator shows that no unresolved non-conformances were found and the device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7430532
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« Reply #77 on: May 29, 2018, 02:47:57 AM »

Model Number 106
Device Problems Device operates differently than expected; Programming issue
Event Date 07/29/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Review of available programming history revealed a systems diagnostics which was within normal limits. All output currents remained programmed off during the time of the undersensing event. Follow-up to the physician after the patient's first dosing appointment revealed the unit was activated with no ill effect to the patient. Heart-rate detection was not noted at the visit. Diagnostics from the appointment were not available. No additional information has been received to-date.
 
Manufacturer Narrative
Evaluation codes, corrected data: the previously submitted manufacturer report inadvertently reported the results and conclusions codes incorrectly. Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the internal reporting number assigned for the actions for the reported event.
 
Event Description
It was reported that during an initial implant surgery an m106 was unable to sense the patient's heart rate after trying each sensitivity setting. Pre-surgical ekg testing was not performed. Sensing was able to be achieved at level 1 but only for 10 seconds after which the unable to sense error message appeared intermittently. Follow-up to the company representative who was at the surgery revealed the generator was tried in various positions and could not detect. The programming computer was not plugged in, tachycardia detection was set to on. He stated that the programming wand was not turning off during the detection. It was verified that the detection level was being changed at each change of settings the generator was not being manipulated at the time of each sensing attempt. The device history record was reviewed for the suspect device, and the generator passed all functional specification and electrical tests. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
A company representative attended the patient's appointment and performed heartbeat testing for the patient's device. The patient's heart rate was verified to be detected by the generator. The pre-operative assessment was performed without issue. All 7 ecg positions were performed without issue. Readings were found and it was determined the patient should be at a sensitivity of 1. It was reported the patient would continue to be titrated. Programming history review was performed 01/18/2016. Review of the patient's in-house programming history revealed data from (b)(6) 2015. Data was available from the clinic visits on 08/(b)(6) 2015, where the patient was titrated to higher settings. Autostimulation was programmed on (b)(6) 2015.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5036836
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« Reply #78 on: May 29, 2018, 02:48:35 AM »

Model Number 106
Device Problem Device inoperable
Event Date 08/04/2015
Event Type  Malfunction   
Event Description
Upon conclusion of the investigation of this event, it was determined that the cause of the undersensing was the movement of the programming system by the company representative during the implant surgery. The device functioned properly.
 
Event Description
It was reported that a company representative was unable to obtain a heart rate reading from the generator that was being implanted in the patient. The implanting surgeon did not perform the pre-operative evaluation to determine if the placement of the generator was optimal to detect the patient's heart rate. System diagnostics were normal at the time the generator was implanted. Troubleshooting was performed, including changing the position of the wand and generator and adjusting the sensitivity setting, but the heart rate was still unable to be detected by the generator. The company representative noted that the loss of heart rate signal seemed to correlate with her moving around the patient in the operating room. The device history record was reviewed for the suspect device, and the generator passed all functional specification and electrical tests. Programmer data from the company representative's programming system indicated that no heart rate was steadily detected. The data from the physician's programming system was requested, but no relevant information has been received to date.
 
Event Description
The patient had generator replacement surgery due to premature battery depletion (reported in mfr. Report #1644487-2016-01943). Analysis of the generator identified that there were contaminates on the trimmed edge of the printed circuit board assembly (pcba), which was caused by the manufacturing method of removing the tab from the pcba. This was the cause of a delay in producing a heartbeat detection synch pulse. This synch pulse is received by the programming tablet and used to calculate the heartbeat rate. Test results of the synch pulse revealed a longer delay than what is expected. This was most likely the cause of the undersensing that occurred during the patient's implant procedure.
 
Event Description
The programming data from the company representative's programming system was further reviewed, and the data showed that the generator did detect foreground heart rates, which were within the range that the company representative reported to be read off the heart rate monitor in the or. The patient has not scheduled a follow-up appointment with their treating physician to date, so no further data is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5035033
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« Reply #79 on: February 28, 2019, 03:11:20 AM »

Model Number 106
Device Problems Image Display Error / Artifact; Device Inoperable
Event Date 07/02/2015
Event Type  Malfunction   
Event Description
It was reported that during the patient's generator implant, the heart rate detection feature kept alternating between asterisks and question marks during testing of the device after it was placed in the patient, indicating interruptions in communication and an inability for the function to accurately detect heart rate. All sensitivity levels were reportedly tested several times, and the feature worked intermittently at a sensitivity of 5. It was verified that the generator was in the pocket. Tachycardia detection was on. System diagnostics were performed and were within normal limits. The generator was repositioned farther from the lead, and then closer to the heart, with sensitivity alterations and measurements being taken throughout. The surgeon completed the implant of the device in the position originally planned based on the pre-surgical screening. The patient was reported to have successfully completed the pre-or heart rate detection screening. The sales representative was present at the pre-surgical evaluation and indicated that there were no interruptions or complications. Pre-surgical evaluation was completed in all 7 positions, with a reported average amplitude of greater than 0. 6mv. Results were not able to be analyzed as they were reportedly shredded after implant. Output current was programmed off while attempting to detect heart rate. The wand was reportedly held steady so there are no suspected communication issues according to the sales representative. The device history record for this generator was reviewed and showed that there were no non-conformances associated with this device prior to shipment. No additional relevant information has been obtained to date.
 
Event Description
Additional information was received that the patient's heartbeat was still unable to be detected at a follow up visit on (b)(6) 2015, though all heartbeat detection sensitivity settings were tested. The patient's diagnostics were reportedly normal. No additional relevant information has been obtained to date.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.
 
Manufacturer Narrative
Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the recall reporting number assigned for the actions for the reported event.
 
Event Description
Additional information was received that the vns heart rate detection feature for the patient is still no functioning properly.
 
Event Description
Programming history was reviewed for this patient's implanted generator. Review of programming history shows data from the implant surgery as well as follow up visits on (b)(6) 2015. The programming data revealed that the generator was picking up heart rate.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4957686
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« Reply #80 on: March 05, 2019, 07:30:53 AM »

Model Number 106
Device Problem Device Stops Intermittently
Event Date 08/10/2015
Event Type  Malfunction   
Event Description
As a part of a field action, a company representative performed heartbeat testing for the patient's device with the permission of the physician. Initially, the patient's heartbeat detection function was confirmed to be faulty, with the patient's output current programmed off, resulting in "????" on the display. However, during troubleshooting, the patient's heart rate was verified to be detected by the generator both seated and standing at a sensitivity setting of 3. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient's generator may actually have been turned on during the implant procedure, which may have contributed to heartbeat detection functionality. No additional relevant information has been obtained to date.
 
Event Description
It was reported that following the patient's initial implant procedure on (b)(6) 2015, the new generator was showing "????" intermittently at multiple sensitivity settings (3 through 5) for the heartbeat detection test. It was noted that the sensitivity of '3' was pulling up the correct heart rate some of the times. Additional information was received that, during the heart rate detection test during surgery, "*****" were seen first for a couple seconds and then it switched to "????" for 20 to 30 seconds then back to "*****" before a heartbeat reading was detected. It was also reported that a pre-surgical evaluation was performed with the patient but that the surgeon only took a reading with the patient in the supine position, and received an appropriate reading on the ekg. The pre-surgical evaluation results were not available for review. During the surgical heartbeat detection test, the device was programmed to the most sensitive setting (5) and the same result occurred with "*****" and then "????" for a long time. The generator output current was programmed off while attempting to detect heart rate as instructed, and the programming wand was held steadily over the generator without communication loss. The final device locations post-implant were the same as those determined through the pre-surgical evaluation. Additional information was received that diagnostics for this patient were normal. The programming system was unplugged from a wall outlet to prevent emi. The wand may have been pressing down on the generator during the detection test, which may have caused some communication issues, although this cannot be confirmed and the readings were successful for two other cases that same day. No additional relevant information has been obtained to date.
 
Manufacturer Narrative
Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the recall reporting number assigned for the actions for the reported event.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Device manufacturing records were reviewed and found all specifications were met prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5046878
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« Reply #81 on: March 06, 2019, 01:38:06 AM »

Model Number 106
Device Problem Device Stops Intermittently
Event Date 07/21/2015
Event Type  Malfunction   
Event Description
Patient was seen by the physician on (b)(6) 2015. Further troubleshooting was attempted on patient¿s vns device. Heart rate was detected but only for 2-3 seconds. At setting 3, the heart rate was accurate (87bpm), but displayed for only a couple seconds before ¿???¿ appeared. All sensitivity settings were checked again. At setting 1, only ¿???¿ was received. At setting 2, heart rate of 135 beats per minute was seen. At setting 4, 103 beats per minute was observed. At setting 5, 137 beats per minute was observed. Data from the tablet shows that the generator had 1400 heart rate detections since (b)(6) 2015. An ecg was not performed because they were in a clinic and had no access to an ecg unit. The physician agreed to order an ecg test for the pre-surgical evaluation to verify that the current generator location is ideal. Review of the decoder data showed that the device was able to sense the patient¿s foreground heart rate. (the foreground heart rate is a continuously updating 10-second average of the patient¿s instantaneous heart rates. ).
 
Event Description
It was reported that the patient's newly implanted m 106 device was only intermittently able to detect heart rate at sensitivity level 3 during surgery on (b)(6) 2015. Pre-op ekg was performed and resulted in optimal sensitivity level 3. On setting 3, intermittent signals of heart rate were displayed. The correct heart rate was displayed right after starting the hr detection test and was visible for just a few seconds before being replaced with "????" indicating lost or no communication. Other sensitivity levels were attempted but the only "????" was observed. Troubleshooting was attempted to reposition the wand and reduce electromagnetic interference (turned off the lights, turned off potential interfering devices) but the issue did not resolve. The surgeon did not want to reposition the generator to attempt to get better signals. The surgeon was properly trained on the pre-operative/implant procedure and the pre-surgical evaluation was completed in entirety without difficulty prior to surgery. The generator was implanted in the position determined by the pre-surgical evaluation of optimal heart rate detection. There were no other communication issues experienced during device interrogation, programming and diagnostic testing. The device was programmed off while attempting to detect heart rate.
 
Manufacturer Narrative
Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the internal reporting number assigned for the actions for the reported event.
 
Event Description
Additional information was received that the pre-surgical evaluation was completed but the results were unknown and there is no ekg printout that could be found. Heartbeat detection was attempted again in the follow up appointment but the same results were received. When the heart rate detection is activated " ****????" was observed at sensitivity setting 3. It was confirmed that the tablet was not plugged into the wall and that the wand's power light was on when he was communicating with the device. A battery test on the wand was also performed and the light stayed on for 25 seconds. It was confirmed that the wand was being held steady over the device. A system diagnostics was performed and the impedance was 2588 ohms. At sensitivity setting of 5, "****???" was observed initially, followed by a brief reading of "191" bpm, followed again by ***????. At setting to 4, "***???", "170" bpm, and "***???" were observed. At setting 3, "***????", "91" bpm, "***????" were observed. It was confirmed that 91bpm is the patient's heart rate. The patient's generator was able to be communicated with when diagnostics were performed and when the generator was programmed to the sensitivity settings. The patient's autostim was left on, at on current of 0. 0ma, and a threshold of 40%.
 
Manufacturer Narrative

Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data, corrected data: the suspect device udi was inadvertently left out of the initial mdr.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5000512
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« Reply #82 on: March 07, 2019, 01:47:06 AM »

Model Number 106
Device Problem Failure to Sense
Event Date 08/28/2015
Event Type  Malfunction   
Event Description
The patient was seen for a troubleshooting appointment. The generator was found to properly detect the heartrate with the appropriate heart beat detection feature. The physician programmed the heart beat detection feature on at the completion of the troubleshooting.
 
Manufacturer Narrative
Suspect device udi: (b)(4).
 
Event Description
It was reported that during initial implant surgery, the vns patient¿s device was unable to verify heartbeat detection except for a couple brief moments during the procedure. The pre-surgical assessment found the r-wave amplitude measurements ranged from 0. 4-0. 9 mv. It was noted that the r-wave amplitude was not measured with the patient in the prone position. The patient¿s device was unable to verify heartbeat detection at each heartbeat sensitivity level. The wand battery was replaced heartbeat detection was tested again but was unsuccessful. The device showed bpm - ????? or *****. When tested at sensitivity levels 3 and 5, the device was briefly able to detect heartbeat (bpm ¿ 74 and 190, respectively) but then showed bpm - ?????. The patient¿s generator was repositioned and the data transfer indicator of the programming wand was noted to be on when attempting to communicate with the device. There were no issues programming the device. The patient¿s device was tested and showed lead impedance within normal limits (impedance value ¿ 2035 ohms). The surgeon elected to complete the procedure and verify heartbeat detection at the follow-up appointment. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The patient had an office visit on (b)(6) 2015 and the device still was unable to verify heartbeat detection except for two brief moments during testing. Heartbeat detection was tested using sensitivity 5 and the patient¿s heartbeat was measured as approximately 100 bpm for about a second then the screen showed bpm - ?????. The wand then powered down so the wand battery was checked and confirmed to be functioning normally. Heartbeat detection was tested again at sensitivity 5 and the same thing happened. The patient¿s device was tested and showed lead impedance within normal limits (impedance value ¿ 3326 ohms). Normal mode and magnet mode were programmed on and auto stimulation was left disabled. Tachycardia detection was left programmed on at heartbeat sensitivity level 5 and autostim threshold ¿ 40%. The patient returned to the office on 09/21/2015. The device tachycardia detection log was downloaded and showed approximately 1800 entries. The autostim threshold was subsequently increased from 40% to 70%. The neurologist elected not to test heartbeat detection during the office visit as he did not believe it would be successful, and planned to use to the tachycardia detection logs to manually calibrate the tachycardia detection device settings. No further information relevant to the event has been received to date.
 
Event Description
Based on the information available to date, the cause for the reported intermittent heart rate detection may be related to the leakage paths on the side of the pcb created by removal of the tab from the pcb during the manufacturing process.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5106011
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« Reply #83 on: March 18, 2019, 01:41:33 AM »

Model Number 106
Device Problems Generator; Device Displays Incorrect Message ; Device Operates Differently Than Expected
Event Date 09/14/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2015, the vns patient's replacement generator was unable to verify heartbeat detection. The generator was programmed to heartbeat sensitivity level 2 and the device briefly showed 63 bpm before it showed bpm - ?????. It was noted that the patient's heartbeat was actually 53 bpm. The programming wand was tested and the battery was verified to be functional. The power indicator of the programming wand remained on when attempting to verify heartbeat detection, but the data received indicator was not on during this time. Sensitivity levels one through five were attempted but the issues continued. A backup generator was used and was able to verify heartbeat detection (bpm - 53) without any issues. The opened but unused generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator evaluated the entire range of heartbeat verification sensitivity settings. Various delays in the start of sensing were observed, up to 40. 4 seconds. Additional testing is currently underway.
 
Event Description
The pulse generator can was opened, and possible contaminates were observed on the edge of the printed circuit board (pcb) that is cut during the manufacturing process. The pulse generator showed no sense delays or sense drop outs after the pcb was cleaned. The contaminates were determined to be conductive material deposited on the edge of the printed circuit board (pcb) as a result of a laser cutting process during manufacturing. Further evaluation of this device showed that the delay and intermittency observed was due to leakage paths between various traces on the pcb edge caused by the minimal amount of conductive material. Because of the leakage, the device demonstrated intermittent sensing while sync pulse was being transmitted. However, when the sync pulse communications used by the verify heartbeat detection feature were terminated, sensing resumed and was stable. The sync pulse communications occur during use of the verify heartbeat detection in the operating room during initial implant and at the physician's office during follow-up appointments. At all other times when implanted in the patient, heartbeat sensing, and thus the autostim feature, operate as intended. No adverse events have occurred as a result of this event. After the pcb trimmed edge was cleaned and the pulse generator was reassembled, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

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« Reply #84 on: March 19, 2019, 12:30:05 AM »

Model Number 106
Device Problems Unable to Obtain Readings ; Programming Issue
Event Date 09/18/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during implant surgery there was significant difficulty trying to perform the pre-surgical evaluation. It was noted that the ekg technician had difficulty getting the correct format required to perform the screen to allow for choosing the optimal sensitivity level. Ultimately, only the supine position was able to be done due to the time taken with the ekg technician attempting to configure the format correctly. The heart beat was unable to be detected during the surgery, but the sensitivity was set to level 3, and the device was implanted. Attempts for additional relevant information have been unsuccessful to date. Review of the generator device history records confirmed that all quality specifications were passed prior to distribution.
 
Manufacturer Narrative
Remedial action initiated; corrected data: the previously submitted manufacturer report inadvertently did not include the actions taken for the reported event. Action reported to fda; corrected data: the previously submitted manufacturer report inadvertently did not include the recall reporting number assigned for the actions for the reported event.
 
Manufacturer Narrative
Describe event or problem; relevant tests/laboratory data; corrected data: inadvertently did not include this information on the follow-up report #1.
 
Event Description
It was reported that the physician does not plan on doing the ecg workup. He provided a copy of his programming history for the patient for review. It contained programming history from (b)(6) 2015 through (b)(6) 2015. Diagnostic results were all within normal limits; last one was on (b)(6) 2015. Tachycardia detection was programmed on. Heartbeat sensitivity levels three through four were attempted to verify heartbeat detection. Review of data shows that on follow-up appointment (b)(6) 2015 for the m106 generator sn: (b)(4), tachycardia detection was programmed on and tested at sensitivity settings 3 and 4. A follow-up appointment on (b)(6) /2015 showed that the tachycardia detection was still on and set to sensitivity level 4. A follow-up appointment on (b)(6) 2015 showed that the tachycardia detection was still on and set to sensitivity level 4. A follow-up appointment on (b)(6) 2015 showed that the tachycardia detection was still on and set to sensitivity level 4.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr); corrected data: on follow-up report #1, inadvertently listed date as 11/09/2015 instead of 12/04/2015.
 
Event Description
The patient was seen for follow-up and the device was able to be programmed. Although the surface ecg assessment was unable to be performed due to the patient refusing, the patient's heart rate was verified as being accurately captured at a sensitivity setting of 4 via use of an external monitor.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=515038
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dennis100
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« Reply #85 on: March 20, 2019, 10:23:45 AM »

Model Number 106
Device Problems Device Operates Differently Than Expected; Device Sensing Problem
Event Date 10/15/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that there were some heartbeat detection issues experienced during the patient's (b)(6) 2015 implant surgery. An m106 device was only intermittently detecting the correct heart rate for the patient, even after following troubleshooting which involved nerve irrigation and moving the device in multiple different locations among other steps. At this point, the generator was removed from the patient and a different generator was implanted. The opened but unused generator has been received by the manufacturer for analysis. However, analysis has not been completed to date. Review of programming history shows data from the implant date (b)(6) 2015. All output currents remained programmed off for the duration of surgery, except for the final diagnostics and interrogation. Diagnostics were within normal limits (3097 ohms and 3098 ohms). In the course of surgery, sensitivity settings 1-5 were attempted, but foreground heart rate could only be obtained for settings 1, 3, and 4.
 
Event Description
Analysis of the opened but unused generator was completed. Sense settings one through five were evaluated with a no load and 2k load conditions between out2 and out1. Various sense delay starts were observed (3. 6 seconds to 31. 4 seconds). The pulse generator was opened. Possible contaminates were observed on the pcb trimmed edge of the pcb (tab removed). With the pulse generator case removed and the battery still attached to the pcb, the supply current off (8. 0ua) and supply current off sense (10. 5ua) measured at the pa bench were not in specification (high limit for supply current off 5ua and high limit for supply current off sense 8ua). Results of the electrical test show that the pulse generator module failed several electrical tests. After cleaning the trimmed edge of the pcb with high grit sand paper and isopropyl alcohol to remove the suspected contaminates, the pulse generator performed according to functional specifications. The pulse generator was reassembled (with the original battery, case, and header). Sense settings one through five were re-evaluated with a no load and 2k load conditions between out2 and out1 to determine to what effect the removal of the contaminates from the lasered edge of the pcb would have on the pulse generators sensing abilities. The pulse generator showed no sense delays (2. 0 seconds to 3. 0 seconds) after the lasered edge of the pcb was cleaned. The generator was instrumented in order to evaluate the delay in producing a heartbeat detection synch pulse. This synch pulse is received by the tablet and used to calculate the heartbeat rate. Test results of the synch pulse revealed a longer delay (from initiation of the hb detection algorithm until hb synch pulses occur) than what is expected. This delay may have been interpreted by clinicians, as non-detection of a heartbeat signal, causing them to attempt detection at a different gain setting or location on the patient. Therefore, the allegation of under-sensing may have been verified. The removal of the tab from the pcb during the manufacturing process may have been the contributing factor for the reported allegation of "undersensing no r-wave detected. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5209728
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dennis100
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« Reply #86 on: March 24, 2019, 02:03:55 AM »

Model Number 106
Device Problem Communication or Transmission Problem
Event Date 11/09/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during vns replacement surgery on (b)(6) 2015, the heartbeat testing for a m 106 generator was unsuccessful. During the heart beat testing, "????" was observed. It was reported that no pre-surgical evaluation was done and no communication problems were observed during the procedure. The heart beat sensitivity test was done twice at sensitivity setting 2 and 3 with 30 sec interval. During each attempt, only "????" was displayed on the tablet. The surgeon did not want to try sensitivity 4 as he never had to go up more than 3 in the past. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient was seen again at the clinic and the heart beat sensitivity testing was successful. The heart rate was picked up instantly at the first testing. It was reported that the device diagnostics were also fine (2822 ohms) and the device was functioning correctly. No patient adverse events were reported. The programming history, provided to the manufacturer for review, indicates that no output current was programmed until the patient left the or. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5272976
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dennis100
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« Reply #87 on: April 26, 2019, 06:21:55 AM »

Model Number 106
Device Problem Under-Sensing
Event Date 12/05/2016
Event Type  Malfunction   
Event Description
It was reported to a company representative that a during implant surgery a surgeon was having difficulty obtaining a heartrate with an aspire generator. The company representative stated that the output current may have been turned on before the heart rate was determined as the surgeon tends to do that to save time, which would interfere with the ability to detect the heartbeat. He provided that he reminded them to make sure the device output is off to evaluate the heart rate as it can cause issues detecting heartrate. Follow-up from the company representative who attended the patient¿s follow-up appointment with the neurologist provided that heartrate detection was active and was working. The device was turned on prior to arriving at the neurology clinic. The diagnostics were reported to be normal. Additional relevant information has not been received to-date.
 
Event Description
Review of manufacturing records revealed the generator met all specifications prior to distribution.
 
Event Description
Operative notes were received indicating the device was interrogated and functioning properly at the time of surgery (b)(6) 2016 and the impedance was okay and the device was programmed to previous settings. It also stated that the tachycardia monitoring was interrogated. This was functioning on a setting of #1. The autostimulator was set at 2. 5 level of stimulation". Later it was stated the device interrogated appropriately. Lead impedance is okay. However, on notes from a post-operative follow-up (b)(6) 2016, tachycardia monitoring did not pick up his heart rate at a setting of 1, 2, 3, 4, or 5. At the time of the surgical procedure cardiac monitoring/tachycardia monitoring was functioning on a setting of #1. Today tachycardia monitoring was not picking up his heart rate even at a setting of sensitivity of #5. The device was left set at #5. " lead impedance was ok. Cardiac monitoring functioning was not detecting his heart rate at a setting of 1, 2, 3, 4, 5. It was left set at #5.
 
Event Description
A review of the manufacturer¿s in-house programming history database was performed. And revealed data during the implant surgery. The normal mode and magnet mode output current were programmed on prior to the autostimulation and seizure detection parameters being turned on. The diagnostics test was within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6239216
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dennis100
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« Reply #88 on: May 11, 2019, 01:01:03 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/13/2019
Event Type  Injury   
Event Description
It was reported that upon initial implant, the epileptologist came to the operating room to program tachycardia detection and when do so, the patient¿s heart rate doubled that of baseline. The physician decided to leave detection off until post operative appointment. Sensitivity level was set at 3. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8487574
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dennis100
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« Reply #89 on: June 12, 2019, 02:16:53 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/07/2017
Event Type  Injury   
Event Description
The patient contacted the manufacturer to ask questions about the tachycardia detection feature of the m106 generator. While asking for more information the patient reported that a little over a week post implant surgery, she had developed shortness of breath, pneumonia and an increased heart rate which caused her to go to the hospital. The patient was placed on two antibiotics and referred back to her primary care physician for the treatment of the pneumonia & shortness of breath. A review of manufacturing records showed that both the lead and generator were sterilized prior to distribution. No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; this information was inadvertently left off on mfg. Report #0.
 
Event Description
During the communication with the patient there was no allegation that the elevated heart rate, shortness of breath or pneumonia were related to the vns implant procedure or the vns device. The patient reported these symptoms during the communication to provide context to her questions regarding the tachycardia detection feature the vns generator and not to make an allegation against vns.
 
Manufacturer Narrative
Corrected data: unique identifier (udi); this information was inadvertently reported incorrectly on mfg. Report #0.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6934594
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