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dennis100
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« on: January 19, 2016, 12:31:25 PM »

Model Number 103
Event Date 06/01/2012
Event Type Injury
Manufacturer Narrative
Describe event of problem, corrected data: information inadvertently not included in supplemental mdr 1.

Event Description
Product analysis was performed on the returned generator. Visual examination, performed at the pa test bench, showed tool marks/dents on the pulse generator case and tool marks on the pulse generator header. These tool marks are most likely associated with manipulation of the device during the explant procedure as the observed markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electrocautery tool. The septum was not cored. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. The pulse generator was opened. A visual assessment on the pcb, performed at the pa test bench, revealed no visual anomalies. The reported increase in seizures could not be evaluated in the pa laboratory setting. However, the depleted battery may have been a contributing factor. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. An end-of-service warning message was verified in the pa lab and found to be associated with the pulse disabled by the pulse generator. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 1. 966 volts, indicating a depleted battery. The data in the diagaccumconsumed memory locations revealed that 119. 305% of the battery had been consumed. With the exception for capacitor c4 out of specification, the post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. This is not expected to have an adverse effect on battery longevity. The cause for the out of specification capacitor, c4, (v cpu) value is likely associated with component aging.

Event Description
Additional information from the physician found that the increased seizure frequency was above pre-vns levels due to the patient not being at the same programming levels he was on previously. The relationship of the event to vns was no change and no other interventions were performed besides surgery. After the surgery the device was reprogrammed and turned back on. No other information was provided on the outcome of the surgery. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the event.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(4) 2012 found that the patient had an increase in seizures (b)(6) 2012. Of the patient's multiple seizure types, it was noted that there was an increase in grand mal and partial complex seizures. In particular, the patient experienced two grand mal seizures and one partial complex seizure in (b)(6), two grand mal seizures and one partial complex seizure in (b)(6), and one grand mal seizure and four partial complex seizures in (b)(6). Testing of the device found that it was at end of life, and a replacement surgery was scheduled for (b)(6) 2012. The battery was returned for analysis and is pending product analysis. Follow up with the neurologist's office found that they did not have any further information beyond what was found in the clinic notes. The date the increase in seizures was first observed was noted as being over (b)(6) in reference to (b)(6) 2012. No date or month was provided, so (b)(6) 2012 is being used as the event date unless more information is given in the future. Diagnostic information was not known and no further information was provided. Follow up with the surgeon similarly indicated that additional information beyond that in clinic notes or from the neurologist was unavailable. The surgeon indicated that he did not know the relationship of vns to the increase in seizures and that the patient's family came to him due to the recurrence of seizures. Prior diagnostic information was not known; however, the surgeon stated that he programmed the patient's device to 0ma after surgery in order to allow the neurologist to reprogram to desired settings. The patient was seen again on (b)(64) 2012 and the surgeon stated that the patient expressed interest in going back to work right away. He stated that the patient and his family did not mention the seizures during the appointment, so he assumed they were not an issue. No additional information was provided. A programming history review was performed which showed data from the implant date, (b)(6) 2009 to (b)(6) 2010. No anomalies were observed in the data. At this time we do not know if the increase in seizures was above or below pre-vns baseline levels. In addition, the relationship of the increase in seizures to vns is unknown.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2826972
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dennis100
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« Reply #1 on: January 19, 2016, 12:32:02 PM »

Model Number 302-20
Event Date 07/27/2012
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
During generator revision surgery for this vns patient on (b)(6) 2012, high impedance was seen. It was reported that diagnostics were run prior to surgery with no high impedance. During surgery, a break in the lead casing was seen; however, it could not be determined if the break occurred during surgery or at another time. The lead was revised in addition to the generator. Post-operative diagnostics indicated ok impedance. The generator revision is captured in mfr report # 1644487-2012-01850. The explanted lead was received on (b)(6) 2012 and is currently undergoing product analysis. On (b)(6) 2012, follow-up with the patient's physician was performed. The physician stated that high impedance was not seen prior to surgery. Impedance values and settings from additional appointments were provided.

Event Description
The explanted generator, in addition to the lead, was received on (b)(6) 2012 and is currently undergoing product analysis. Follow-up on (b)(6) 2012, also revealed that the patient's device was last interrogated in (b)(6) 2011 and low battery was seen (one-quarter to one-third of battery life remaining). When the patient was seen for follow-up, it was noted that the battery was dead. The increase in seizures was attributed to the battery being dead. The physician believed the battery depleted very quickly from (b)(6) 2011 to (b)(6) 2012. The patient's device was turned on after surgery. The patient was seen post-operatively on (b)(6) 2012, with ok impedance at 3059 ohms. The patient was doing okay with modest seizure control, and the patient's settings were provided. It was stated that the settings would be gradually increased to their previous values. (the exact values were not provided).

Event Description
Product analysis was approved on (b)(6) 2012. The lead assembly was returned for analysis due to the following allegation high impedance. A break in the lead casing was seen during the surgery, but they could not determine if the break occurred during surgery or at another time. A discontinuity was identified in the positive coil. Scanning electron microscopy images of the positive coil showed that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in one of the coil ends. Although, not conclusive, it appears this observed condition is the result of the explant procedure. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Manufacturer Narrative
Description of event, corrected data: previously submitted mdr inadvertently omitted information. This report is being submitted to correct this information.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2714386
« Last Edit: January 28, 2016, 12:29:42 AM by dennis100 » Logged
dennis100
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« Reply #2 on: January 21, 2016, 08:42:46 AM »

Model Number 103
Event Date 01/17/2011
Event Type Malfunction
Event Description
Product analysis for this explanted generator was approved on 02/10/2015. In the product analysis lab, an end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 431 volts, indicating a near end of service condition. Data in device memory locations revealed that 44. 953% of the battery had been consumed. With the pulse generator case removed, the battery measured 2. 431 volts. However, the pulse generator was reporting an eos and pulsedisabled condition. Looking at various signals from the microprocessor found that two pins and were at different logic states compared to a bench device. The pins were re-soldered to the substrate, and a hard reset was performed. The hard reset did change the logic states of the pins but did not clear all of the latch conditions; therefore, the pulse generator still reported an end of service and pulsedisabled condition. The battery was removed from the substrate. The pulse generator module was connected to a bench power supply and set to voltage levels while system diagnostics were performed. The pulse generator module reported the correct battery condition to the corresponding voltage level set on the bench power supply. Once the battery was removed from the substrate the latch condition was resolved. A battery life calculation with incomplete programming history resulted in 7. 5 years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. In addition, the previously reported device issue may have contributed to the disparity between the end of service condition and 44. 953% battery capacity that had been consumed based on the device¿s internal eos projection system. The device was explanted and replaced on (b)(6) 2014 due to battery depletion.

Event Description
Additional information was attained that the patient did not have any procedures performed or events that they know of to disable their device.

Manufacturer Narrative

Event Description
During review of our internal programming history it was noted that upon interrogation on (b)(6) 2011, the patient's generator had been disabled due to "vbat

Manufacturer Narrative
Analysis identified that the vmonitor (circuitry involved in measuring battery voltage) was being loaded down by the microprocessor. The cause was not able to be identified. 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=2808775
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dennis100
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« Reply #3 on: January 22, 2016, 08:53:06 AM »

Model
« Last Edit: March 17, 2018, 11:57:45 AM by dennis100 » Logged
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« Reply #4 on: January 22, 2016, 08:53:55 AM »

Model Number 104
Event Date 10/10/2012
Event Type Malfunction
Event Description
Visual examination performed at the bench revealed burn marks on the returned pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated the device was operating properly. Following a re-enabling of the device output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 1. 317% of the battery had been consumed.

Event Description
The generator was returned on (b)(6) 2013 and is pending product analysis. No additional information has been provided.

Manufacturer Narrative

Event Description
On (b)(6) 2012, the surgeon placed the electrocautery too close to the patient's newly implanted replacement generator during surgery. Upon final interrogation, the battery was found to be completely depleted and a new generator needed to be used. Using an electrocautery device too close to a pulse generator may damage or disable the device. It is recommended to not use electrocautery near an implanted device and to keep the electrosurgery electrodes as far away as possible from the device. Training has been provided to the implanting surgeon in regards to cautery usage and the vns. The depleted generator will not be returned to the company as the hospital does not return explants without signed patient consent. Since the generator was depleted before use, a programming history review cannot be performed as there is no data available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2802277
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dennis100
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« Reply #5 on: January 23, 2016, 04:50:52 AM »

Model Number 105
Event Date 04/02/2013
Event Type Malfunction
Event Description
A consultant attended an implant surgery and it was reported that a patient's generator was replaced for eos she states system diagnostics was done outside of the pocket and all ok with 1900 ohms. She states that the surgeon used electrocautery after the 1st diagnostic testing was performed she saw a spark. He remembered that he should not have done that afterwards but the battery on the m105 was saying eos yes on diagnostics at that point. He replaced the m105, sn (b)(4) generator with another m105, sn (b)(4). The explanted generator will not be returned for analysis. User error caused event.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3072767
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dennis100
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« Reply #6 on: January 28, 2016, 12:30:13 AM »

Model Number 103
Event Date 10/16/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
The reported application-specific integrated circuit (asic) latch-up condition was confirmed. Review of the data from the generator indicated that the pulse disabled byte was set to a value that does represent a vbat

Event Description
It was reported that during a generator replacement surgery electrocautery had been used during the implant, and the new m103 sn (b)(4) generator had interrogated fine outside of the pocket, but once inside, it was interrogated several times and vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2821021
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dennis100
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« Reply #7 on: January 28, 2016, 04:57:53 AM »

Model Number 300-20
Event Date 04/16/2012
Event Type Malfunction
Event Description
The company representative reported that the surgeon pulled the lead when installing the new generator, making the lead taut. After closing the patient and waking her, the patient was in pain as a result of the tautness when she turned her head to the right. The surgeon opted to take the patient back in to surgery to correct. Surgeon used electrocautery and cut the lead at that time. The surgeon noticed that he had cut the lead immediately and damage was visible. The surgeon noted that no injury to the vagus nerve was observed. He did not opt to perform full revision. Therefore, the patient's device was disabled and was never programmed. The patient was referred to a different facility for full revision. The physician noted that patient was a little hoarse following surgery which is believed to be related to surgery, but there was no paralysis believed to be present. No serious injuries occurred, and no interventions were taken to preclude a serious injury. The hospital discards products in surgery, so attempts for product return of the explanted generator on (b)(6) 2012, were unsuccessful. The patient had generator and lead replacement surgery on (b)(6) 2012. Pre-op system diagnostics indicated high lead impedance. The surgeon displayed the x-ray in the operating room, and a lead discontinuity was visible near the generator area. Two system diagnostics on the newly residing generator (one out-of-pocket and one in-pocket) indicated okay results. The field clinical engineer confirmed that the generator was replaced for compatibility to the single pin lead. The explanted generator and lead on (b)(6) 2012, were received by the manufacturer. Product analysis for the generator and lead was completed. The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. Analysis of the lead identified a coil discontinuity in the positive coil. Scanning electron microscopy images of the positive coil suspected broken ends show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in both coil ends. The suspected coil break is located at approximately 8. 3cm from the end of the connector bifurcation. This was most likely caused during the implant/explant procedure, as reported by the company representative who attended the surgery. Also, the positive coil has what appears to be wear (flat surfaces) in the vicinity of coil discontinuity. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred on the coil in the vicinity of the identified flat surfaces. The outer silicone tubing has what appears to be an imprint at approximately 8. 3 cm from the end of the connector bifurcation. The exact reason for this imprint is unknown. Also, the inner silicone tubing of the positive coil has what appears to be tearing at this location. The unmarked connector pin has what appears to be pitting in the vicinity of the setscrew marks. The inner silicone tubing of the positive coil is abraded open at approximately 8. 1-8. 4 cm from the end of the connector bifurcation. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies (besides an abraded inner tubing opening) were identified in the returned lead portion.

Manufacturer Narrative
Device failure occurred, 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=2697273
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dennis100
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« Reply #8 on: January 28, 2016, 12:16:59 PM »

Model Number 103
Event Date 05/21/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a vns patient was going to have their lead replaced. Follow up with the patient's treating physician's office: it was reported that the patient is happy with therapy, but when their settings were increased, they felt pain in their jaw/teeth and felt a pulling sensation when he turns his neck to the right. The surgeon decided to switch out their lead. The patient did not have any trauma reported preceding the events. On (b)(6), they were set at 1. 25 ma output current, which was decreased to 1. 0 ma. The patient was comfortable after their programming changes. Surgery was reported to be performed for patient comfort not to preclude a serious injury. Our consultant was present at the patient's surgery and during the removal of the lead the surgeon used electrocautery and disabled the generator. The implanting md was fully aware of the risk of using cautery prior to using it near their implanted generator but decided to use it anyway. The patient then had their generator replaced while in surgery as it had been pulse disabled. Their explanted generator was returned for analysis. Review of the data indicated that the pulse disabled byte was set to a value that does represent a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2679710
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« Reply #9 on: January 30, 2016, 11:39:50 AM »

Model Number 103
Event Date 05/22/2012
Event Type Malfunction
Event Description
On (b)(6) 2012, attempts were completed for the return of the explanted product but were unsuccessful.

Manufacturer Narrative

Event Description
Additional information was received on (b)(6) 2012, when the explanted generator was returned for product analysis. Product analysis confirmed an end-of-service warning message in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status indicated ok. The battery voltage value stored within the generator (2. 925 volts) suggests the device is not at neos condition. With the exception of the "as-received" pulse disable condition, there were no additional adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
On (b)(6) 2012, it was reported that during the patient's battery revision surgery due to eos on (b)(6) 2012, a new generator was implanted and then explanted that same surgery due to the device reading end of service. It was later reported that the surgeon used electrocautery during the surgery. When he went to place the new generator in the pocket, the pocket was too small, so he took the generator out of the pocket and used electrocautery to make the pocket larger. It was after the electrocautery that the generator read eos. The surgeon then connected another new generator and the flag read eos=no. Attempts for product return are underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2641648
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dennis100
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« Reply #10 on: January 31, 2016, 01:01:42 PM »

Model Number 103
Event Date 05/15/2012
Event Type Malfunction
Event Description
All attempts to the reporter for vns programming history have been unsuccessful to date. The available information indicates the most likely cause of the vbat eos disabled condition of the vns generator is due to electrocautery. A mastectomy with breast reconstruction is a major surgical procedure usually requiring at least two surgeons (plastics and general). In addition, breast tissue is highly vascular and requires cautery use to control bleeding. As the left breast was removed and then reconstructed, and the surgical area is immediately superior to the generator area, electrocautery was most likely the cause of the vbat disabled condition (asic latch-up).

Event Description
Reporter indicated a patient's vns was interrogated and found to be disabled on (b)(6) 2012; a vbat

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=2614007
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« Reply #11 on: February 02, 2016, 06:25:29 AM »

Model Number 103
Event Date 02/01/2012
Event Type Injury
Event Description
On (b)(6) 2012 the patient reported that she has a "knot" in her neck. The patient also indicated that the lead is still protruding from her neck.

Event Description
Additional information was received on (b)(6) 2012, when it was discovered that the vns patient had been scheduled for prophylactic battery replacement surgery that day. The patient was complaining of lead poking the skin by the generator. System diagnostics were performed prior to surgery and the impedance was within normal limit of 3757 ohms. Upon re-positioning of the generator, the surgeon touched the generator with the electrocautery in error. When system diagnostics were then performed after, the device alerted to eos when it had previously not been at eos. The generator was then replaced. A system diagnostics test after replacement showed the device to be functioning properly at 2471 ohms. The explanted generator could not be returned to the manufacturer for product analysis as the hospital does not return devices.

Event Description
Additional information was received on (b)(6) 2012, when the operative report was received from the patient's surgery on (b)(6) 2012. Preoperative diagnostics showed that device to be working well with appropriate impedance and a battery swipe appeared to be functioning according to the notes. The notes further state that once they got the patient's chest open, they removed the generator and reattached it and cleaned out the generator pocket to have a better position for it. When they re-tested the generator after this, diagnostics showed the generator was at end of life. The surgeon stated that this may have been exposed to electrocautery. They tested the device several times and it would not function. The generator was therefore replaced and diagnostics showed results within normal levels of 2500 ohms. The patient's settings were reset to the previous settings without difficulty and the device was rechecked with good results. The notes also indicate that prior to surgery the patient was having good benefit from vns but this was starting to be less functional as the generator itself appeared to may have rotated and was causing her some discomfort at the incision site. The patient was also reported to have not believed the battery was working well. The patient later indicated that sometime around (b)(6) 2012, she contacted her neurologist because she was having pain around her generator; under her arm and in her neck. The patient also indicated that her magnet was not working and her lead was protruding from the neck and catching on clothing which caused pain. She was also short of breath. The physician then ordered x-rays to rule out bronchitis or pneumonia since she was short of breath. The x-rays showed nothing so the physician assumed it was a problem with her vns device and referred her to the surgeon.

Manufacturer Narrative

Event Description
On (b)(6) 2012, a vns implanting surgeon the vns patient's generator had migrated and the lead was pulling. On (b)(6) 2012, the neurologist reported that the vns patient was complaining of pain around the generator site close to her underarm and neck for a couple of months. The patient stated that the areas are tender and painful but is not particular to stimulation. She also says that the lead is protruding at the neck site. The physician referred the patient to a surgeon regarding the protrusion. The patient also reported that she doesn't feel stimulation when she swipes her magnet. The patient's seizures however were actually doing better. The neurologist later reported that the patient's generator has actually flipped on its side in the patient's chest so instead of lying flat and flush it is sticking out which is causing the pulling the patient feels on the lead. The patient has been referred to a surgeon for prophylactic replacement due to the migration and to alleviate the potential for infection. The patient denied any manipulation or trauma that could have caused the device to have moved to its side. The patient stated that the generator is able to be interrogated but she still does not feel any magnet stimulation when she swipes the magnet. The reason the patient was not feeling magnet stimulation was not due to becoming accustomed to the magnet settings according to the manufacturer's consultant. Attempts for further information were made but no additional information was received from the physician. Although surgery is likely, it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2574353
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« Reply #12 on: February 25, 2016, 06:19:20 AM »

Model Number 103
Event Date 11/10/2011
Event Type Malfunction
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. The high energy exposure from electrocautery equipment during the patient's double mastectomy is the most likely cause for disabled output condition. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status indicated ok. The battery voltage value stored within the generator, 3. 330 volts, suggests the device is not at near-end-of-service condition.

Manufacturer Narrative

Event Description
On (b)(6) 2011, a vns treating neurologist reported that he was seeing the patient for the first time after a double mastectomy due to cancer. The physician reported that the cancer was not related to vns. The physician interrogated the patient's generator and received an error message that said the pulse was disabled due to vbat less than end of service (eos). The physician stated that the surgeon used electrocautery over the vns during the double mastectomy surgery which must have damaged the vns. System diagnostics were performed and the message that vbat was less than eos was again received. The patient's device was then disabled and the patient was referred for battery replacement. Although battery replacement surgery is likely, it has not yet occurred.

Event Description
Additional information was received on (b)(6), 2011 when it was discovered that the vns patient had battery replacement surgery on (b)(6) 2011 due to battery depletion from electrocautery. The explanted generator was returned to the manufacturer for product analysis on (b)(4), 2011 that has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2359338
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« Reply #13 on: March 02, 2016, 02:59:16 AM »

Model Number 104
Event Date 08/05/2011
Event Type Malfunction
Event Description
It was reported that during surgery to replace the patient's vns generator due to end of service, electrocautery was used that resulted in a pulse disabled condition on the new generator. A back-up generator had to be implanted. Attempts for the return of the disabled generator have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2264162
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« Reply #14 on: March 06, 2016, 10:45:06 AM »

Model Number 103
Event Date 04/10/2009
Event Type Malfunction
Event Description
A review of pt programming data revealed that during the pt's initial follow up visit ((b)(6) 2009) after implant surgery ((b)(6) 2009) a "vbat < eos threshold" warning message was received indicating that the pt's demipulse generator was likely in the presence of electrocautery causing an asic latch-up condition during the implant procedure. As a result of this exposure the capacity of the generators battery was altered leading to an atypical depletion state. The generator was returned and reported in mdr # 1644487-2011-01531 due to a premature eos allegation. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications. There was a capacitor that was measured to be out-specification but had no adverse effect on device functionality. The battery is depleted, 1. 56 volts as measured with the can removed and battery still attached to the pcb. The data in the memory locations revealed that 34. 928% of the battery had been consumed.

Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data. Follow-up report #1 inadvertently listed the aware date as (b)(6) 2011, which was the aware date for the initial report. The correct aware date for the follow-up #1 report should have been (b)(6) 2011.

Event Description
Attempts were made for operative notes for the implant and explant of the generator however they will not be provided as it is against their policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2211867
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« Reply #15 on: March 06, 2016, 10:45:40 AM »

Model Number 103
Event Date 09/15/2010
Event Type Malfunction
Manufacturer Narrative
Analysis of programming history. No anomalies were observed in the available history, however the use of electrocautery during implant is still likely.

Event Description
It was reported by a neurologist that he received an error message when trying to interrogate pt's vns device which indicated that generator was disabled. The surgeon likely used electrocautery during implantation of the generator which led to this malfunction. The surgeon has been notified regarding the usage of the electrocautery. Surgery to replace the generator is likely.

Event Description
A review of available programming history from the date of implant, (b)(6) 2010, was performed. The "vbat < eos threshold" warning message was not observed in the available data. However, electrocautery was likely used after the time of the last available programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2211889
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« Reply #16 on: March 10, 2016, 04:50:25 AM »

Model Number 103
Event Date 05/11/2011
Event Type Malfunction
Event Description
It was reported by a nurse that a vns pt had an "impedance problem. " pt underwent surgery on (b)(6) 2011 and replacement of the generator resolved the high impedance issue. X-ray images were taken but they were not reviewed by the mfr. However, the radiology report stated that "vns is disconnected. " reinsertion of the pin into the generator showed the device being at end of service. The reason for eos = yes is apparently due to the usage of electrocautery for making an incision but this has not been confirmed yet. Also, there was no trauma or manipulation to the generator. Good faith attempts to obtain the product for product analysis have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2188681
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« Reply #17 on: March 10, 2016, 04:51:04 AM »

Model Number 103
Event Date 02/03/2011
Event Type Malfunction
Manufacturer Narrative
Medwatch report number 1644487-2011-01020 contains information surrounding this event.

Event Description
The vns patient's generator was explanted on (b)(6) 2011, due to end of service. Product analysis of the generator was completed on (b)(6) 2011. Product analysis verified that an end of service warning message appeared in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Diagnostic testing indicated the estimated time to eos was 10. 0 years. The generator history revealed that the pulse had become disabled on (b)(6) 2011. This event was previously reported in mdr 1644487-2011-01020; however, further review indicates that the event requires a separate mdr; therefore, this mdr is being submitted. It is suspected that electrocautery damaged the generator; it is addressed in labeling that electrocautery during surgery can cause the pulse generator to become disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2187625
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« Reply #18 on: March 10, 2016, 04:51:45 AM »

Model Number 103
Event Date 05/04/2011
Event Type Malfunction
Event Description
A physician reported that during a generator implant, the demipulse model stimulator unexpectedly reached end-of-service (eos). The generator had been placed on the leads and "tested" initially, which showed the device to be properly functioning. It was again tested before the patient was closed, and it showed that it was at eos. The physician indicated that electrocautery had been used. The physician stated he would be using another generator to implant the patient, and the other would be removed. Attempts for further information have been unsuccessful 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=2118866
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« Reply #19 on: March 10, 2016, 04:52:18 AM »

Model Number 103
Event Date 05/06/2011
Event Type Malfunction
Event Description
It was reported by the surgeon that during surgery to replace the patient's generator prophylactically, electrocautery was used that disabled the pulse generator. The surgeon stated that he was not aware of the safety alert issued to implanting surgeons concerning the use of electrocautery, however, this has now been provided to him. The surgeon indicated that a back-up generator was implanted instead of the disabled one. Attempts for the return of the disabled generator are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2117679
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« Reply #20 on: March 10, 2016, 01:03:02 PM »

Model Number 104
Event Date 04/25/2011
Event Type Malfunction
Event Description
It was reported that during the surgery to replace the pt's generator as noted in mfr report # 1644487-2010-02439, the pt's generator was disabled by electrocautery. The surgeon was advised on the precautions concerning the use of electrocautery during implant surgery. The disabled generator has been returned and is currently undergoing analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107780
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« Reply #21 on: March 11, 2016, 05:42:00 AM »

Model Number 103
Event Date 04/22/2011
Event Type Malfunction
Manufacturer Narrative
Review of manufacturer programming history was performed.

Event Description
It was reported that the an intensified follow-up (ifi) warning was received on the patient's device in (b)(6) 2014. No known surgical intervention has occurred to date.

Event Description
It was reported that the physician used electrocautery during a pt's initial vns implant. This resulted in the vns generator being disabled. A back-up generator was not available to replace the disabled generator so the surgeon chose to leave the generator implanted and would likely replace the generator at a later date. The surgeon is aware of the mfr precautions on the use of electrocautery during surgery. Surgery to replace the generator is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2102411
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« Reply #22 on: March 17, 2016, 11:46:27 PM »

Model Number 103
Event Date 01/13/2011
Event Type Malfunction
Event Description
During an initial implant for a vns pt, it was reported by the implanting surgeon that a generator was connected and had diagnostic testing performed outside of the implant pocket, with results indicating no end-of-service (eos) condition. After the device was inserted into the pocket, diagnostics were performed again, but eos was now indicated. The likely scenario of the generator's being hit by electrocautery was explained to the surgeon, but he did not believe electrocautery was used after the testing outside of the pocket was completed. The potential cause of electrostatic discharge was also explained to the surgeon. The product was not implanted and has been returned to the manufacturer for analysis. However, analysis has not been completed to date. The pt was implanted with another generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1997246
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« Reply #23 on: March 22, 2016, 02:08:40 AM »

Model Number 103
Event Date 11/09/2010
Event Type Malfunction
Event Description
It was initially reported that during the initial implant of the patient, the eos projection showed 0 years remaining. The operating room stated that they had introduced the pulse generator into the sterile field and monopolar electrocautery had been used thereafter. The patient was then implanted with a new pulse generator. The unused pulse generator was returned to the manufacturer for analysis, which has yet to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1921027
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« Reply #24 on: March 22, 2016, 02:09:11 AM »

Model Number 103
Event Date 10/22/2010
Event Type Malfunction
Event Description
It was initially reported that during the initial implant of the patient's vns device that the pulse generator was disabled after testing when in the pocket. First diagnostics performed outside the pocket were within normal limits. When the generator was put into the generator pocket, the "vbatt disabled" warning message was observed. The surgeon was confirmed to be using electrocautery after the generator was inside the pocket. The unused pulse generator was returned to the manufacturer for analysis, nut has yet to be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1917583
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« Reply #25 on: March 22, 2016, 02:09:39 AM »

Model Number 103
Event Date 10/28/2010
Event Type Malfunction
Event Description
Reporter indicated that electrocautery was used against advisement from the mfr's rep during surgery to re-insert the vns lead pin. The electrocautery disabled the vns generator and the generator had to be replaced. The explanted generator has been returned and is currently undergoing analysis. Attempts for lead info are currently in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919093
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« Reply #26 on: March 23, 2016, 08:25:20 AM »

Model Number 103
Event Date 07/01/2008
Event Type Malfunction
Event Description
Pt had his generator explanted on (b)(6) 2010. Explanted generator was returned to mfr for analysis. Analysis was completed on the generator and an end of service warning message was observed and found to be associated with the output being disabled by the pulse generator. This was likely due to the use of electrocautery in the operating room while performing the explant. Output monitoring revealed some variation in the device output when programmed to pt settings. Other than the observed conditions, there were no add'l adverse functional, mechanical, or visual issues identified with the returned generator. Follow up with the surgeon's nurse revealed that an electrocautery was used in the operating room during the explant surgery. It was informed to the nurse to let the surgeon know about not using electrocautery in the operation room during vns surgery as this causes malfunction in the generator.

Manufacturer Narrative
Device failure occurred, but did cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1889539
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« Reply #27 on: March 24, 2016, 06:55:24 AM »

Event Date 08/30/2010
Event Type Malfunction
Event Description
Reporter indicated that an unknown patient who had recently been implanted with a vns was nearing end of service. The reporter questioned if the end of service could have been affected by electrocautery. Attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1865275
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« Reply #28 on: March 26, 2016, 08:53:45 AM »

Model Number 103
Event Date 06/17/2010
Event Type Malfunction
Event Description
Reporter indicated that during a patient's vns generator replacement surgery, the new 103 generator's eos status changed from 10 years remaining to 0 years. Systems diagnostics with the resident vns lead and new 103 generator were normal, with 1696 ohms. Monopolar cautery was used in the generator incision pocket after the new generator was attached to the resident lead, but the cautery tip did not touch the generator. Another generator was used to complete the implant surgery. The 103 generator has been returned and is currently in product analysis.

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=1773471
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« Reply #29 on: March 26, 2016, 08:54:36 AM »

Model Number 101
Event Date 07/06/2010
Event Type Injury
Event Description
Explanted products were returned to the manufacturer and underwent analysis. Upon analysis, no anomalies were found with the generator. The lead had an abraded opening with fluid leak in the outer tubing only, but no other anomalies were noted with the returned lead portions.

Event Description
It was reported that the patient underwent a prophylactic generator replacement surgery. The lead was also replaced as there was a tear in the silicone tubing which the surgeon thought he had caused due to the use of the electrocautery. Product has been requested, but has not been returned to manufacturer to date.

Event Description
It was reported that a patient was experiencing an increase in seizures and would be referred for generator revision. Follow up with the physician revealed that he believed the increase in seizures to be related to decreased output current of the device. There were no causal or contributory medication changes, programming changes, or other external factors that preceded the onset of the increase in seizures. Good faith attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1782828
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« Reply #30 on: March 28, 2016, 01:17:59 PM »

Model Number 103
Event Date 03/01/2010
Event Type Malfunction
Event Description
It was initially reported by the surgeon that he used electrocautery while performing a lead revision surgery on the pt. When the surgeon hooked up the new lead to the generator implanted, he received generator passed end-of-service. Surgeon went ahead and replaced the generator as well. Diagnostics performed were within normal limits once the new lead and the generator were implanted. Old generator was returned to manufacturer for analysis. Analysis is currently pending on the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1662862
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« Reply #31 on: March 29, 2016, 05:10:47 AM »

Lot Number 3714
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the pt went in for generator replacement surgery on (b)(6) 2010. The surgeon dissected down to the generator using electrocautery and system diagnostics were run prior to disconnecting the old generator. System diagnostics showed high lead impedance, but the surgeon was not prepared to do a full revision at that time, so the device was left implanted. System diagnostics were not performed prior to surgery and the last good diagnostics were obtained in (b)(6) 2009. The surgeon felt that the electrocautery would not cut the lead, but it is known that the electrocautery can potentially cut the lead. Surgeon stated he could not visualize a break in the lead at the time of surgery. The cause of the high impedance is currently unk. No x-rays were taken of the device and no trauma or manipulation was reported. The pt underwent a second surgery on (b)(6) 2010 to replace both the generator and leads. Product was returned to the mfr, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1652989
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« Reply #32 on: March 30, 2016, 07:46:23 AM »

Model Number 104
Event Date 01/19/2010
Event Type Malfunction
Event Description
It was reported that a surgeon received the message of "battery is past eos" while performing generator replacement surgery on a vns patient. The surgeon stated that after performing diagnostics, the message regarding the battery was received followed by a high lead impedance message. The generator had not been programmed on at the time of the event and re-running diagnostics indicated the issue prevailed. Further information from the surgeon revealed he had used electro-cautery while the reported generator was in the sterile field. The likely cause for the received high impedance is due to the event of asic latch up as a stored impedance value was read prior to programming the generator. Further information from the surgeon revealed he re-implanted the vns patient and impedance value was ok.

Manufacturer Narrative
Device malfunction 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=1613596
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« Reply #33 on: March 31, 2016, 06:17:08 AM »

Model Number 103
Event Date 11/03/2009
Event Type Malfunction
Event Description
It was reported that during a generator replacement surgery, when a new demi-pulse generator was connected to the implanted lead, and system diagnostic tests were performed outside the pocket, the results were within normal limits. The surgeon used electrocautery to make the generator pocket and when a system diagnostic test was performed after the generator was placed inside the pocket, the following message appeared: "pulse generator is past predicted eos, if vns to be continued it is suggested that generator be replaced". Upon interrogation following the placement of generator in the pocket, the estimated time to eos is noted as 0 months. The generator was not implanted, and has been returned to mfr, where analysis is currently underway. A new demi-pulse generator was connected to the same lead and implanted with no further issues.

Manufacturer Narrative
Analysis of programming and diagnostic history. Analysis of programming and diagnostic history revealed the estimated time to eos = 0 months.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1570345
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« Reply #34 on: April 02, 2016, 03:26:09 AM »

Model Number 104
Event Date 09/23/2009
Event Type Malfunction
Event Description
It was reported that a model 104 generator resulted "disabled" while performing a battery replacement of a 102r generator with a model 104. The pt's model 104 generator was interrogated outside of the sterile field and the eos projection at the time was 10 years. The surgeon stated he performed a generator diagnostic using the test resistor at this time which also resulted in a 10 year eos projection. The pt's settings were programmed and the eos projection was then 7. 1 years. The leads were attached to the model 104 generator and monopolar cautery was used to "stop a bleeder" while the generator was out of the pocket. System diagnostics were ran again to check connection between generator and lead which resulted in "pulse generator disabled" message due to "vbatt less than eos threshold. " the surgeon then re-attached the old generator model 102r to existing leads and verified that lead impedance was still ok. At the moment the root cause of the reported event is unk as good faith attempts to obtain add'l info have been unsuccessful to date. The model 104 generator and 102r generator were returned to the mfr and are currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1514169
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« Reply #35 on: April 02, 2016, 03:26:43 AM »

Model Number 103
Event Date 09/17/2009
Event Type Malfunction
Event Description
It was reported that the patient was having surgery to reposition the generator on (b)(6) 2009. Physician stated that diagnostics were performed before and after the surgery which revealed the end of service (eos) projection was 10 years. While patient was in recovery later that day, the generator was reinterrogated and showed eos projection of 10 years. The patient then swiped the magnet a few times and the device was re-interrogated. Upon interrogation following magnet swipes, they received a message saying "vbatt less than threshold". They also saw that the eos projection was now 0 years. It was then reported that on (b)(6) 2009, the physician was unable to establish communication with the generator using two separate programming systems and the patient was not feeling stimulation. Patient was seen again on (b)(6) 2009 at which time the device was interrogated and the eos projection was 10 years. At this time, there are no interventions planned as the device appears to be working. Reporter stated that monopolar cautery was used to re-open the patient's chest incision during surgery. Cyberonics labeling cautions that electrocautery should not be used during surgery as it may compromise the generator's battery life.

Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1516743
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« Reply #36 on: April 07, 2016, 09:28:35 PM »

Model Number 304-20
Event Date 03/04/2016
Event Type Injury
Event Description
It was reported that during the initial implant surgery the patient's nerve was damaged and the physician had to use electrocautery to stop the bleeding. The lead was placed over the damage without issue. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5532389
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« Reply #37 on: April 10, 2016, 03:15:45 AM »

Model Number 103
Event Date 04/22/2014
Event Type Malfunction
Event Description
It was reported by a surgeon that the patient experienced sharp pain with stimulation prior to replacement in the left neck, left shoulder and back of scapula accompanied by stomachache.

Manufacturer Narrative
Only the generator was replaced.

Event Description
Good faith attempts for further, relevant information have been unsuccessful. It was reported that the patient is a complex medical case, and there are a lot of other factors, such as psychiatric issues.

Event Description
Additional information was received stating that the medical staff believed the vns patient¿s generator was fried due to cautery. The explanted generator was returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description
Analysis of the generator was completed on (b)(4) 2014. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator. It was reported that the surgeon told the patient that the generator was "fried". It was reported that the surgeon interrogated the generator after removing it from the patient after electrocautery was used. Since diagnostics prior to surgery were within normal limits, it appears that the surgeon caused the premature end of service with the electrocautery. An implant card received confirmed that only the generator was replaced.

Event Description
It was reported that after going through airport security, the vns patient was experiencing increased headaches and auras, pain at her generator site, and issues with her magnet. The patient felt five constant jolting sensations at her generator site every few minutes. The patient¿s magnet had to be swiped at least three times to activate magnet mode stimulation. Prior to the event, the patient¿s magnet always activated magnet mode stimulation immediately. At airport security, the patient did not go through the metal detector but was within 10 feet from the airport security wand. The patient taped her magnet over her generator but continued to feel pain and jolting sensations. The patient went to the er on (b)(6) 2014 due to pain at her generator site that radiated through her arm and armpit every three minutes. When the magnet was placed over the patient¿s device, the patient had a burning pain and her generator site turned red. The magnet was removed and the patient¿s device was disabled as of (b)(6) 2014. The pain and redness subsequently resolved. The patient device was tested and diagnostic results showed lead impedance within normal limits (impedance value ¿ 2870 ohms). The patient was admitted to the hospital due to pain, erratic stimulation, increase in seizures and lack of magnet control. The patient stated that she experienced severe pain in her shoulder whenever her device was tested and did not have the same seizure control since her generator was replaced in (b)(6) 2013. Since her device was disabled, the patient experienced six generalized seizures. The patient underwent generator and lead replacement surgery on 05/20/2014. The patient¿s family believed there was an issue with the patient¿s lead and that her generator was fried due to cautery. The explanted devices have not been returned to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3845253
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« Reply #38 on: April 30, 2016, 12:08:15 AM »

Model Number 300-20
Event Date 01/01/2008
Event Type Malfunction
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that pt had an anterior spinal fusion, and the surgeon used electrocautery. The device was turned off prior to surgery. When the device was turned back on and diagnostics were performed, it resulted in high lead impedance on system and normal mode diagnostics. X-rays were received and reviewed by cyberonics. No obvious acute angles or lead discontinuities were observed on the visible lead portions. However, the contrast on the films fade further down towards generator. Due to this poor image contrast near the generator, the lead could not completely be assessed. Based on the x-ray views received, no cause for the high impedance could be determined. Physician is wanting to wait until the pt recovers completely from the back surgery before doing the revision.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1096204
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« Reply #39 on: May 05, 2016, 02:43:08 AM »

Model Number 105
Event Date 03/16/2016
Event Type Malfunction
Event Description
It was reported that the patient¿s generator was implanted on (b)(6) 2016. It was verified following surgery to not have a depleted battery. Later that day, the device was interrogated and found to have an neos battery status. In a patient appointment on (b)(6) 2016, the device could not be interrogated. Troubleshooting by using two programming systems and verifying function of the programming systems with a demo generator confirmed the generator was likely at non-communicative eos. The generator was explanted on (b)(6) 2016. The device was interrogated upon removal and found to have a normal battery indicator, but had a vbat's eos warning flag activated. This indicates the battery voltage fell below eos and later rebounded to a normal voltage prior to explant. The generator device history record was reviewed and found all specifications were met prior to distribution. All functional testing was completed and within specifications. The generator was received by the manufacturer for product analysis. Product analysis was completed on 03/30/2016. Burn marks were observed on the pulse generator case, indicating that the pulse generator was likely exposed to an electrocautery tool. Other than the noted burn marks and explant-related observation, no other visual anomalies were noted. Review of the data downloaded from the generator indicated that the pulsedisabled bit was set to a value that represents a vbat's eos threshold condition. After resetting the pulsedisabled bit in the generator memory, was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse successfully interrogated at multiple orientations adjacent to the programming wand. In 24-hour monitoring simulated environment, the generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed an ifi=no condition. Other than the noted pulsedisabled condition, there were no additional performance or any other type of adverse condition found with the pulse generator. No additional pertinent information has been received to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5564762
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« Reply #40 on: May 05, 2016, 02:43:38 AM »

Model Number 106
Event Date 03/09/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
During the replacement surgery on (b)(6) 2016, the surgeon decided to replace the generator because he used electro-cautery when removing the old battery that resulted in damaging the device. The generator was unable to be interrogated after electro-cautery was used showing that the device had premature end of life. There were no signs of physical damage to the device just battery depletion. The device was discarded after surgery. This event was previously reported on supplemental mdr #1 in mfr report #1644487-2015-06515 on (b)(6) 2016. However, in order to more thoroughly and accurately report the event and suspect device and device information, this initial report was created.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5589312
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« Reply #41 on: June 05, 2016, 06:54:12 AM »

Model Number 302-20
Event Date 07/01/2014
Event Type  Malfunction   
Event Description
The suspect device is the lead and diagnostics available at that time were within normal limits. No suspected malfunction of the generator exists, and as such, the follow-up report #1 should not have referenced that product analysis of the generator is underway as it is irrelevant information.
 
Event Description
Analysis of the returned lead was completed. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portions. Incisions in the silicone tubing of the lead coils were necessary to perform proper inspection of the lead. A high impedance condition was identified in the positive coil. Openings were noted on the outer and the inner silicone tubing in the vicinity of the coil discontinuity. Scanning electron microscopy images of the outer silicone tubing suggest the tubing was in contact with some type of electro-cautery tool. Scanning electron microscopy images of the positive coil ends at the coil discontinuity location show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires in one of the coil ends. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the returned generator is currently underway.
 
Manufacturer Narrative
Describe event or problem; corrected data: the suspect device is the lead and diagnostics available at that time were within normal limits. No suspected malfunction of the generator exists, and as such, the follow-up report #1 should not have referenced that product analysis of the generator is underway as it is irrelevant information.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2014, the vns patient¿s replacement generator was tested with the existing lead and diagnostic results revealed high impedance (dc dc ¿ 7). The lead pin was reinserted into the generator header and diagnostic results continued to show high impedance. The patient¿s lead was replaced during the procedure. Pre-operative diagnostic results showed lead impedance within normal limits. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3958499
« Last Edit: January 20, 2019, 12:47:39 AM by dennis100 » Logged
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« Reply #42 on: June 06, 2016, 12:59:52 AM »

Model Number 106
Event Date 03/24/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that during prophylactic generator replacement, the new generator showed near end of service after being placed in the chest pocket. It was reported that prior interrogation outside of the chest pocket was within normal limits. It was reported that electrocautery was not used after the chest pocket was opened. A new generator was implanted without issues and the generator showing near end of service was returned for analysis. Analysis of the generator was completed on 04/14/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Review of the device decoder identified that the memory locations show a value of 1. 797 volts indicating an eos condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the attempted implant procedure, which may have been a contributing factor. Other than the noted eos condition, there were no performance or any other type of adverse condition found with the pulse generator. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5591468
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« Reply #43 on: June 06, 2016, 01:00:30 AM »

Model Number 105
Event Date 01/29/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The patient was referred for surgery to reposition her generator. After the surgical procedure was closed, the patient's generator was interrogated and appeared to be unexpectedly nearing end of life. Follow up with the surgeon indicated that electrocautery was used in the procedure and the generator was likely struck, inducing an asic latch-up condition. Further communication established that the battery indicator changed to not show an end of life, which is an expected event for generators which experience this condition. No surgical interventions have occurred to date. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5464488
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« Reply #44 on: June 06, 2016, 01:01:24 AM »

Model Number 104
Device Problem Device operates differently than expected
Event Date 10/24/2014
Event Type Malfunction
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results and an ifi condition during an office visit on (b)(6) 2015. A battery life calculation using the available programming history showed approximately 6. 9 years remaining. Review of internal device data showed that a vbat < eos threshold condition was observed at the first post-operative interrogation on (b)(6) 2014. The battery voltage was 3. 541v with 2. 351% battery capacity used. The device was subsequently programmed on. The ifi condition was observed on (b)(6) 2015 and the battery voltage was 2. 761v with 18. 563% battery capacity used. This data indicates that the patient's generator was hit by electrocautery during implant which caused pre-mature battery life.

Manufacturer Narrative

Event Description
It was reported that the vns patient's device tested and showed lead impedance within normal limits and an ifi condition. The patient's device did not show an ifi condition when it was last tested in (b)(6) 2015 and was not expected to have reached an ifi condition based on programmed settings. It was noted that the patient wore his magnet on a necklace and the device showed approximately 3900 magnet activations since implant. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5331374
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« Reply #45 on: June 07, 2016, 12:20:33 AM »

Model Number 103
Device Problem Premature discharge of battery
Event Date 10/06/2015
Event Type Malfunction
Event Description
It was reported that the patient's generator was showing 25% battery status indicator when check on (b)(6) 2015. The device was recently implanted on (b)(6) 2015. The patient had burr hole surgery (on her brain) on (b)(6) 2015. The company representative programmed the device off prior to the surgery, and everything was reportedly okay with the patient's vns (battery status and impedance). It was noted that electrocautery was used during the burr hole surgery. It was reported that the electrocautery did not directly strike the device, but depending on the location/proximity of the grounding pad, it may have likely made some contact. No known surgical intervention has occurred to date. No additional relevant information has been received to date. Mfr report # 1644487-2015-05676 captures a report of high impedance with this generator.

Event Description
The patient had generator replacement on (b)(6) 2015. Lead impedance was okay pre-operatively and post-operatively. Pre-operatively, the battery status was ifi-yes. The generator will not be returned for analysis per hospital policy. Additional programming and diagnostic data was assessed. From (b)(6) 2015 (burr hole surgery date) and (b)(6) 2015. There was no evidence of premature battery depletion on these dates. No additional relevant information has been received to date. Mfg report # 1644487-2015-05676 captures a report of high impedance with this generator.

Event Description
Operatives notes from the (b)(6) 2015 surgery were received. There was no mention of the type of fashion that the chest was opened during surgery on that date (e. G. Cautery, etc. ), so this did not provide any information that may have been able to clarify the sudden drop in battery voltage after the surgery.

Manufacturer Narrative
(b)(4).

Event Description
Additional programming/diagnostic data was reviewed for the patient's device. There was an interrogation and system diagnostic test performed on (b)(6) 2015. Lead impedance was within normal limits (1932 ohms and 2008 ohms). The battery status dropped to 25%, which occurred when the battery capacity passed 7. 5% consumed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5193811
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« Reply #46 on: June 08, 2016, 01:41:59 AM »

Model Number 103
Device Problems Premature discharge of battery; Device displays error message
Event Date 06/01/2015
Event Type Malfunction
Event Description
Analysis was completed on the returned vns generator. Analysis showed burn marks on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool. In the analysis lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. No additional relevant information has been received to date.

Event Description
Additional information was received that the patient underwent generator replacement surgery on (b)(6) 2015 due to premature battery depletion. It was reported that the patient's device was seen to show ifi=yes on pre-operative interrogation and then ifi=no on pre-operative diagnostics. Programming history was reviewed and showed normal device functionality on (b)(6) 2014. However, the patient then reportedly had a corpus callosotomy surgery in (b)(6) 2015. The next time the patient was seen appears to be (b)(6) 2015 at which time the device was interrogated and displayed a vbat

Event Description
Additional information was received that the patient's nurse practitioner was concerned that the patient's generator may have been struck by electro-cautery during a corpus colostomy procedure in (b)(6) 2014. It was stated that a couple of weeks after the procedure the patient was set to have an mri, so the device was to be disabled. However, it was reported that at that time the patient's device was already turned off and was giving errors (thought to be end of service errors). Additional information was received from the nurse who interrogated the patient's device in (b)(6) 2014. She stated that the patient came in for a follow-up appointment on (b)(6) 2014 to have the device disabled for an mri, but the devices normal and magnet currents were already set to 0ma. She also stated there was an error message telling her to contact the manufacturer. She stated that she then titrated the patient back up to 1. 25ma normal and 1. 5ma magnet output current. System diagnostics were within normal limits. The patient tolerated the titration well. No additional information has been received to date.
Manufacturer Narrative

Event Description
It was reported that the patient's generator was showing about 25% battery life remaining per battery icon upon interrogation when a few months prior the generator was showing a 100% on the battery icon. It was noted that in (b)(6) 2015, the patient went in for an mri and at that time it was said that the device had "turned itself off" per the family as communicated to them. Additionally there was mentioned" errors when interrogated" but it was not clear on what was visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5177701
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« Reply #47 on: June 08, 2016, 01:42:44 AM »

Model Number 103
Device Problem Premature discharge of battery
Event Date 02/14/2014
Event Type Malfunction
Event Description
Programming data was received on 12/01/2015. The data was from 03/04/2014 to 10/06/2015. The first interrogation that was performed after surgery showed that the generator was pulse disabled (vbat < eos threshold). The battery voltage also depleted more quickly than compared to the battery life calculation that was performed. These pieces of information suggest that the device may have been in contact with an electrocautery device or static discharge during the implant procedure on (b)(6) 2014, which would have caused the battery to deplete much quicker than expected. These events are addressed in labeling. All diagnostic results were within normal limits. No known replacement surgery has occurred to date.

Manufacturer Narrative

Event Description
The patient decided to have his vns explanted instead of having replacement surgery due to an unknown reason. Attempts for further information were unsuccessful to date. No surgery has occurred to date.

Event Description
It was reported that a patient's generator battery status was at near end of service in (b)(6)2015. However, the patient had his generator replaced on (b)(6) 2014. The physician was concerned that the battery was depleting more quickly than expected. Programming data was requested, but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5191318
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« Reply #48 on: June 08, 2016, 01:43:26 AM »

Model Number 105
Device Problem Device inoperable
Event Date 09/17/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery, the surgeon nicked an artery and had to use bovie cautery to seal the wound. In doing so, the surgeon noted that he hit the generator which was to be implanted with electro cautery and it resulted in the generator becoming disabled. The plan was to replace the patient with another m105 generator. It is not known if another generator was implanted that day. Attempts for additional relevant information have been unsuccessful to date. The generator has not been received by the manufacturer to date.

Event Description
Follow-up revealed that a back-up generator was used to complete the replacement procedure. The explanting facility discarded the opened but unused generator; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5146320
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« Reply #49 on: June 08, 2016, 01:44:18 AM »

Model Number 105
Device Problem Device inoperable
Event Date 09/15/2015
Event Type Malfunction
Event Description
It was reported that during generator implant surgery, cautery was used in the sterile field causing the generator to immediately go to an end of service condition. The patient was implanted with a backup generator. The suspect generator has not been received by the manufacturer to date.

Manufacturer Narrative
(b)(4). The previously submitted mdr inadvertently did not include the udi for the suspect device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5142489
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« Reply #50 on: June 18, 2016, 06:57:04 AM »

Model Number 105
Event Date 04/28/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported on 04/28/2016 that during a replacement surgery on (b)(6) 2016 (replacement housed in file (b)(4)). The or specialist called to return a generator that was opened but not used during the replacement surgery. It was stated that the generator was opened in the or, interrogated, programmed, put in the patient, re-interrogated and was the battery was dead. The surgeon was using cautery. The generator was received for analysis on 05/10/2016. Product analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5673693
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« Reply #51 on: July 21, 2016, 01:34:43 AM »

Model Number 103
Device Problems Device inoperable; Device displays error message
Event Date 07/14/2015
Event Type Malfunction
Event Description
It was reported that during vns implant surgery the generator showed an end of service message after being sutured in place. A new generator was then implanted. The generator showing end of service that was not implanted is expected to be returned for analysis, but has not been received to date. Further follow-up revealed that following attaching the generator to the lead device diagnostics did not show end of service. The surgeon then sutured the neck and chest area and at the completion of that the device was rechecked and then showed end of service. The patient was taken to icu and the device was checked again after one hour which again showed end of service. The generator was then replaced. It was reported that electrocautery was used during the implant procedure. The device programming history was received and reviewed that confirmed that the generator appeared to have been hit with electrocautery causing the end of service warning.

Event Description
The generator was received for analysis. Analysis of the generator was completed on 09/23/2015. Burn marks were observed on the can indicating an asic latch-up electrocautery issue. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted event (pulsedisabled), there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4974206
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« Reply #52 on: November 29, 2016, 02:15:45 AM »

Model Number 104
Event Date 03/10/2016
Event Type Malfunction
Event Description
A physician reported that a generator was at end of service a few months after implant. The physician believed the generator was damaged during implant by a bovi (electrocautery). The generator was reportedly completely dead during interrogation. No further relevant information has been received to date. No surgical intervention has occurred to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6002946
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« Reply #53 on: November 29, 2016, 02:16:29 AM »

Model Number 106
Event Date 09/13/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that during replacement surgery on (b)(6) 2016, cautery was introduced into the sterile field after the generator was introduced and the generator experienced a cautery strike. As a result, an alternative generator was implanted due to premature end of service. The surgeon was instructed that this is not proper process and the generator should not be in the sterile field with a cautery tool. The generator was received for analysis on 09/19/2016. Product analysis was completed and approved on 10/04/2016. The pulse generator performed according to functional specifications. However, the data, battery voltage minimum shows a value of 1. 839 volts, indicating an eos condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6001310
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« Reply #54 on: November 29, 2016, 02:17:13 AM »

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

Event Description
A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 103, shows an ifi=no condition. The reported allegation of ¿premature end of life (eol eos = yes)¿ was not duplicated in the pa lab. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

Event Description
During a prophylactic replacement surgery on (b)(6) 2016, it was noted that a new m 106 generator was showing eos indicator. During the surgery, the company representative first interrogated the new m106 inside of its packaging, programmed the patient's initials into the generator, and did not note the generator to be at eos. The generator was later removed from the sterile packaging and connected to the patient's lead. The generator was interrogated and observed to be at eos within the surgical field. The problem was persistent even when the test resistor was connected to the generator. A system diagnostics was performed and device was re-interrogated but the eos indicator persisted. It was confirmed that electrocautery was not used in the sterile field after the generator was introduced, and that the torque screwdriver's metal part was not touched by the doctor during ratcheting of the lead pin. As the eos status did not resolve, a different generator was implanted for the patient instead. The suspect generator was received on 09/28/2016. Analysis is underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6035772
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« Reply #55 on: November 29, 2016, 02:17:58 AM »

Model Number 105
Event Date 08/05/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status was ok. Other than the noted condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported that the patient had surgery on (b)(6) 2014 for device repositioning due to patient discomfort, with no replacement planned. It was then reported that during this generator repositioning, a plasma blade accidently made contact with the generator. Diagnostics run in the or then revealed and end of service status, which was not seen prior to surgery. The generator was therefore replaced. Device manufacturing labeling indicates user of electrosurgery [electrocautery or radio frequency (rf) ablation devices] may damage the generator. The product was returned. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4055889
« Last Edit: January 31, 2019, 02:06:16 AM by dennis100 » Logged
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« Reply #56 on: November 29, 2016, 10:34:44 PM »

Model Number 103
Event Date 09/02/2016
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative

Event Description
It was noted during repositioning a repositioning surgery that the generator showed vbat disabled and was no longer providing stimulation. The company representative stated she had spoken with the surgery about the electro cautery precautions, but it is suspected the device was hit with electro cautery. A new generator was placed during the surgery. The device was interrogated before the surgery and was confirmed to be working correctly. Lead impedance was within normal limits. The device is expected to be returned for analysis, but has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5984716
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« Reply #57 on: December 09, 2016, 07:39:36 AM »

Model Number 304-20
Event Date 11/01/2016
Event Type Malfunction
Event Description
A patient was undergoing a lead repositioning surgery due to comfort reasons. During the surgery, a lead discontinuity and an abrasion in the insulated tubing were both reportedly identified by the surgeon. Pre-operative and post-operative impedance values were both reportedly within normal limits. The lead was potentially struck with electrocautery during this surgery. This affected the generator's battery, which is reported in mfr. Report # 1644487-2016-02707. The surgeon opted to replace the lead the next day even though diagnostics from the prior day were within normal limits. The lead has been returned to the manufacturer, but analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6120760
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« Reply #58 on: December 10, 2016, 07:47:10 AM »

Model Number 103
Event Date 02/04/2011
Event Type Malfunction
Event Description
It was reported that during an initial implant surgery, the physician used electrocautery near the vns generator causing it to be disabled. A back-up generator had to be implanted. A mfr rep was present at the surgery and cautioned the surgeon prior to the surgery on the use of electrocautery. Attempts for the return of the disabled generator are currently in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2030806
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« Reply #59 on: February 07, 2017, 01:18:09 AM »

Model Number 103
Event Date 01/17/2013
Event Type Malfunction
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
It was initially reported that while implanted a new generator diagnostics indicated eos=yes. Electrocautery was use during the surgery but not while the generator was in the sterile field. A company representative was present at the surgery and did not witness any cautery being used near the generator and the generator was not placed in to the sterile field until after the cautery was removed. The generator was not implanted and a back-up generator was implanted instead. The new generator which was showing eos=yes was returned to the manufacturer for evaluation. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 2. 841% of the battery had been consumed. Burn marks were also observed on the pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2964329
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« Reply #60 on: February 12, 2017, 08:34:41 AM »

Model Number 102
Event Date 12/13/2012
Event Type Injury
Event Description
Reporter indicated that during a ventral hernia repair surgery, a vns patient had an episode of bradycardia. The patient did not have a history of cardiac events, but the patient's father did have a history of cardiac events. The patient has pre-existing medical conditions of hypertension, depression, asthma, gerd, and tmj. The arrhythmia experienced was bradycardia; normal heart rate was 72, during event it was 39. Preoperative bp was 128/74, bp during event was 56/27 at the lowest. The vns generator was programmed on for the surgery. Interventions taken for the intraoperative bradycardia event were done to preclude a serious injury. The bradycardia has not recurred. Follow up with the reporter revealed '"pt presented for ventral hernia repair on (b)(6) 2012. Pt had eventful preoperative course, and no issues with induction of anesthesia. 1 hour into the case, during extensive lysis of adhesions in the abdomen [using electrocautery], the patient became profoundly bradycardic and hypotensive. Pt's anesthetic was decreased and he was given 100% o2, phenylephrine 600 mcg total, glycopyrrolate 0. 1 mg, atropine 0. 8 mg, calcium 0. 5 mg, magnesium 1 gm, and a total of 1. 7 mg epinephrine over the course of about 30 minutes during the severe bradycardia. A magnet was also placed over the [vns] device intraoperatively and transcutaneous pacing was used during the event. The case was aborted and the patient was subsequently extubated and taken to pacu and then the icu for overnight monitoring. He experienced no abnormal sequelae and returned several weeks later for the procedure without complication. " it was felt the combination of the extensive electrocautery used and the vns stimulation may have caused the bradycardia event per the reporter.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3023649
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« Reply #61 on: February 16, 2017, 01:08:07 AM »

Model Number 103
Event Date 02/28/2011
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
During a prophylactic replacement surgery for a vns pt, a system diagnostic test was performed with the generator outside of the implant pocket. Then, surgeon implanted the generator and closed the skin and performed another system diagnostic test. This latter test revealed an end-of service (eos) condition. Therefore, it was suspected that electrocautery damaged the generator during implant. Later information showed that the surgeon used electrocautery in the implant pocket to clear away a "knob" of tissue. The generator was approx 5 inches away at the time. The affected generator has been returned for analysis, but the analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2061819
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« Reply #62 on: February 17, 2017, 01:13:44 AM »

Model Number 302-20
Event Date 02/23/2011
Event Type Malfunction
Event Description
Reporter indicated a pt had high lead impedance readings with systems and normal mode diagnostics tests. It was recommended to program the vns off and obtain x-rays. The pt had no known trauma, but did have a surgical procedure performed on (b)(6) 2011 in which electrocautery was used in the vicinity of the vns system. The pt later had attempted vns replacement surgery, however; high lead impedance was received with the resident lead and new generator. The surgeon elected not to replace the lead or generator at that time and no devices were explanted; the new generator was removed and returned to the mfr for analysis. The plan of care was to refer to another surgeon. The vns was left programmed off. As high lead impedance was still occurring after inserting the lead pin into the new generator, a lead fracture is suspected. Attempts for further info are in progress.

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=2064041
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« Reply #63 on: February 20, 2017, 07:39:42 AM »

Model Number 103
Event Date 01/31/2011
Event Type Malfunction
Event Description
Mfr was notified that pt underwent surgery for migration of vns device, reported in mdr # 1644487-2011-00391. Pre-operation diagnostics were within normal limits, however, after surgery was completed the neurosurgeon rec'd a message that the device was at end of service. It is suspected that the surgeon used electrocautery however, this cannot be confirmed. Good faith attempts to obtain add'l info are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2024862
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« Reply #64 on: March 04, 2017, 01:08:25 AM »

Model Number 103
Event Date 01/07/2014
Event Type Malfunction
Event Description
No additional information has been obtained to date.

Event Description
Implant card was received stating that the patient had their generator explanted on (b)(6) 2015. No attempts for product return were made as the explanting facility does not return explanted product. Therefore, no product analysis can be performed.

Manufacturer Narrative

Event Description
It was reported that the patient was going to undergo surgery that was unrelated to vns and electrocautery precautions were requested. The physician was provided these precautions and the surgery was started. It was reported that the generator was interrogated prior to surgery and diagnostics were within normal limits. At the completion of the surgery device diagnostics showed eos = yes, pulse disabled indicating that the device had come in contact with electrocautery. The lead impedance was ok with 1647 ohms. The reporter was informed that generator replacement would most likely be required for the patient to continue vns therapy. Attempts to obtain additional information will be made, but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3602524
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« Reply #65 on: March 10, 2017, 05:19:05 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 01/23/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery, the new generator was attached to the lead and upon interrogation an end of service warning presented. System diagnostic tests and interrogations were subsequently performed and the end of service condition was observed again. The surgeon confirmed that electro-cautery tools were used during the procedure however he was unaware if the electro-cautery tool being close or coming into contract with the generator. It was noted that the generator was not interrogated until it was attached to the lead and prior to the surgery the generator had been stored at room temperature. A different generator was then implanted without incident. The suspect generator has not been received to date. Manufacturing records for the generator were reviewed and it indicated that the device passed quality control inspection prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6338820
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« Reply #66 on: April 30, 2017, 01:24:11 AM »

Model Number 103
Event Date 01/07/2014
Event Type Malfunction
Event Description
No additional information has been obtained to date.

Event Description
Implant card was received stating that the patient had their generator explanted on (b)(6) 2015. No attempts for product return were made as the explanting facility does not return explanted product. Therefore, no product analysis can be performed.

Manufacturer Narrative

Event Description
It was reported that the patient was going to undergo surgery that was unrelated to vns and electrocautery precautions were requested. The physician was provided these precautions and the surgery was started. It was reported that the generator was interrogated prior to surgery and diagnostics were within normal limits. At the completion of the surgery device diagnostics showed eos = yes, pulse disabled indicating that the device had come in contact with electrocautery. The lead impedance was ok with 1647 ohms. The reporter was informed that generator replacement would most likely be required for the patient to continue vns therapy. Attempts to obtain additional information will be made, but no additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3602524
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« Reply #67 on: April 30, 2017, 01:24:52 AM »

Model Number 105
Event Date 01/03/2014
Event Type Malfunction
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
On (b)(6) 2014, the patient underwent surgery for a mastectomy of a tumor in the left breast that was unrelated to vns, per the physician. Prior to surgery, system diagnostics showed the vns device was ok with over half the battery life left. However, after surgery, diagnostics showed the device was at end of service (eos = yes). The vns generator was therefore replaced during the surgery. It was found that the surgeon used electrocautery during the tumor excision. No other information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3594974
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« Reply #68 on: May 04, 2017, 12:16:28 AM »

Model Number 103
Event Date 06/27/2014
Event Type Malfunction
Event Description
Analysis of the returned generator was completed. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The device showed a non-ifi condition. Other than the noted event, there were no performance or any other type of adverse condition found with the pulse generator.

Manufacturer Narrative

Event Description
It was reported that the recently implanted vns patient¿s device was interrogated during an office visit on (b)(6) 2014. The device showed a message stating ¿vbatt < eos threshold. ¿ the neurosurgeon stated that electrocautery was not used during the implant procedure. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3963735
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« Reply #69 on: May 05, 2017, 02:16:50 AM »

Model Number 103
Event Date 05/30/2014
Event Type Malfunction
Event Description
On (b)(4) 2014 product analysis was completed on the explanted generator. Review of the data indicated that the pulse disabled byte was set to a value that represents a vbat

Manufacturer Narrative

Event Description
The unused generator has been returned to the manufacturer where analysis is currently underway.

Event Description
It was reported that during lead replacement surgery on (b)(6) 2014 due to high impedance, the vns patient¿s replacement generator was interrogated and showed pulse disablement. The generator was not used and a different generator was implanted. The pulse disablement is believed to be due to electrocautery that was used during the procedure. The unused generator has not been returned to date. The high impedance was reported in manufacturer report # 1644487-2014-01214.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892636
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« Reply #70 on: May 05, 2017, 02:18:04 AM »

Model Number 300-20
Event Date 05/19/2014
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description
Additional information was received indicating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

Event Description
Additional information was received stating that the vns patient¿s device was not disabled following the high impedance observation. No patient trauma was reported. X-rays were taken but information regarding the images in relation to vns was not provided. The patient was referred for surgery but no known surgical interventions have occurred to date.

Event Description
Analysis of the returned generator and lead was completed. There were no anomalies found with the pulse generator. The generator performed according to functional specifications. A partial lead discontinuity was identified in the positive coil. Scanning electron microscopy images of the positive coil verified that the coil was exposed to some type of electro-cautery tool as indicated by the appearance of the coil wires resulting in a discontinuity of at least three strands at one location. Note that since portion of the lead electrodes were note returned an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.

Event Description
It was reported that the vns patient¿s device was tested on (b)(6) 2014 and diagnostic results showed high impedance (dc dc ¿ 7). The patient was referred for surgery but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3903237
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« Reply #71 on: May 05, 2017, 02:19:43 AM »

Model Number 105
Event Date 05/27/2014
Event Type Malfunction
Event Description
Additional information was received that product analysis on the generator was completed. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

Manufacturer Narrative

Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to patient adverse events. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Event Description
It was reported that the patient reported status seizures and device diagnostics showed eos: yes. It was reported that the patient had recently had the generator repositioned and electrocautery was used. The patient was scheduled for generator replacement. The relationship of the status seizures to vns therapy is unknown. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3892377
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« Reply #72 on: May 07, 2017, 01:02:57 AM »

Model Number 304-20
Event Date 03/19/2014
Event Type Malfunction
Event Description
Analysis of the generator and lead were completed. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the noted condition there were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead identified a break in the negative coil. An abraded opening was noted in the outer tubing. Also, openings in the outer and the inner silicone tubing were identified at the lead body with an appearance which suggests the tubing was in contact with some type of electro-cautery tool. Scanning electron microscopy images of the coils at the inner tubing openings suggest the coils were in contact with some type of electro-cautery tool as indicated by the appearance of the negative coil. Scanning electron microscopy images of the negative coil at the fifth portion of the returned lead show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, surface contamination and/or mechanical distortion (smoothed surfaces) the fracture mechanism cannot be ascertained. Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the vns patient¿s device showed high impedance. The patient¿s last normal diagnostic results were reported to be from (b)(6) 2013. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted products have not been returned to date.

Event Description
It was reported that the generator and lead were being returned for analysis. The generator and lead were received. Analysis is underway, but has not been completed to date.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. 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=3857064
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« Reply #73 on: May 07, 2017, 07:39:42 AM »

Model Number 302-20
Event Date 04/01/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received for review that reported over the past few months there has been an increase in seizures, although the actual frequency is not clear. Lead impedance appears to be satisfactory; however, there is tenting of the skin over the lead. The patient was scheduled for surgery to find out if the lead needs to be replaced or if it can be freed up. Their vns was interrogated at that time but no changes were made to the settings on account of low battery reserve. The patient clinic visit (b)(6) 2012 a lead test was performed that showed output status ok, lead impedance ok, dcdc 2, eri no. Then later in notes says patient device interrogated and battery shows near end of service and needs to be replaced. The patient's seizures were at baseline and not a change in seizure type and were being attributed to their low battery. The patient had surgery for patient comfort not to preclude an serious injury. The patient's vns battery needed replacing soon based on time implanted not actual battery voltage. They were not at eos but soon so going to the o. R. For that and assessing the other issue with tenting over the lead at that time. The patient went to surgery and had their generator replaced and lead. Their lead was a prophylactic replacement. No cause of the tenting was noted in the or other than patient growth. The patient was implanted with their vns when 11 and now 18. It is possible patient growth has attributed to the reported tenting over the lead body. Implanted for over 7 years. Impedances were within normal limits reported at the time of explant. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. A coil break was identified in the negative coil. Scanning electron microscopy of the negative coil show that pitting or electro-etching conditions have occurred at the end of the coil. However, due to metal dissolution the fracture mechanism cannot be determined. Scanning electron microscopy images of the positive coil; show that the coil was most likely cut using some type electro-cautery tool as indicated by the fused coil wires at the coil end. Also, scanning electron microscopy images of the positive coil at 1. 1cm and 1. 4cm past the electrode bifurcation verified that the coil was exposed to some type electro-cautery tool as indicated by the appearance of the coil wires. These conditions were most likely caused during the explant procedure. This cannot be verified. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. The patient's explanted generator was returned for analysis. In the analysis lab, the device output signal was observed on an oscilloscope while programmed to the last known parameters from the vns programming history database (no as-received parameters). The generators calculated output voltage was 10. 0 volts (4k ohms x 2. 50ma), with an allowable +/- 10% tolerance. The generators output voltage measured 8. 51 volts. The pulse generator could not maintain the programmed output due to a depleted battery. The reported allegation of "end of service", was duplicated in the laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module 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=2851904
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« Reply #74 on: May 07, 2017, 07:40:25 AM »

Model Number 103
Event Date 03/09/2014
Event Type Malfunction
Event Description
It was reported that during surgery while opening the patient that electrocautery was used and burned the generator at that point. An eos=yes message appeared. The generator was returned to the manufacturer for evaluation. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 012 volts shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 6. 381% of the battery had been consumed. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. Other than the noted condition, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Device failure occurred, 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=4108291
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« Reply #75 on: May 07, 2017, 07:41:03 AM »

Model Number 103
Event Date 08/17/2014
Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative
Additional information indicates that the event occurred on (b)(6) 2014.

Event Description
Additional information was received stating that the vns patient铠emergency surgery was a shunt malfunction that occurred on (b)(6) 2014.

Event Description
It was reported that the vns patient recently underwent emergency surgery not related to vns. The patient¿s device subsequently showed a low battery condition during an office visit on (b)(6) 2014. It is believed that during the patient¿s non-vns surgery, electrocautery was used which hit the generator and depleted the battery. An implant card was received indicating that the patient underwent generator replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4095602
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« Reply #76 on: May 07, 2017, 07:41:52 AM »

Model Number 103
Event Date 08/11/2014
Event Type Malfunction
Event Description
The explanted generator was returned to the manufacturer for analysis. Review of the internal device data indicated that the pulsedisabled byte was set to a value that represents a vbat

Event Description
It was reported that during generator replacement for near end of service the new generator was connected to the existing lead and interrogation identified that the new generator battery showed end of service. The generator was explanted and another new generator was implanted. The generator is expected to be returned for analysis, but has not been received to date. It is likely that the generator was exposed to electrocautery during the implant surgery. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4077843
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« Reply #77 on: May 08, 2017, 11:00:01 AM »

Model Number 300-20
Event Date 10/06/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). The patient was sent for x-rays. No known surgical interventions have occurred to date.

Event Description
Analysis of the lead was completed on 12/15/2014. Scanning electron microscopy images of the positive coil exposed portion show that the coil was exposed to some type-of electro-cautery tool. Scanning electron microscopy images of the negative coil ends at the first and second portion of the lead show that the coil was exposed to and cut using some type of electro-cautery tool as indicated by the fused wires. Review of the 'as-received' photograph taken prior to decontamination shows the lead connectors reversed with the marked connector inserted in the negative terminal/cavity of the pulse generator and the unmarked connector inserted in the positive terminal/cavity of the pulse generator header. Note that since a portion of the lead (including the electrode helices) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. Analysis of the generator was completed on 12/16/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. No performance or any other type of adverse conditions were found with the pulse generator.

Event Description
It was reported that the patient underwent generator replacement due to lead discontinuity. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

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=4221731
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« Reply #78 on: May 09, 2017, 12:26:22 AM »

Model Number 103
Event Date 09/30/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during lead revision surgery to move the lead to a different location due to discomfort, the surgeon used electrocautery and when the generator was interrogated it showed end of service. The generator was then replaced. The explanted generator was received for analysis. Analysis was completed on 10/23/2014. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device explant, which may have been a contributing factor. In addition to the burn marks noted above visual examination showed tool marks on the pulse generator case and header. These tool marks are most likely associated with manipulation of the device during the explant procedure as the observed markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. Other than the noted event (pulsedisabled), there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4204003
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« Reply #79 on: May 09, 2017, 12:27:18 AM »

Model Number 103
Event Date 09/09/2014
Event Type Malfunction
Event Description
It was reported that during prophylactic generator replacement the surgeon used electrocautery after connecting the new generator to the existing lead and placing the generator in the pocket. Interrogation of the new generator after electrocautery was used resulted in the generator being at end of service indicating that the generator had been hit by the electrocautery. No replacement generator was available at that time so the patient was scheduled for generator replacement at a later date. The patient later underwent generator replacement. The explanted generator has been received for analysis. Analysis is underway, but has not been received to date.

Event Description
Analysis of the returned generator was completed. The generator was returned with the pulse disabled byte set to a value that represents a vbat's threshold condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool, which may have been a contributing factor. Other than the noted event, there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4154898
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« Reply #80 on: May 10, 2017, 12:20:41 AM »

Model Number 103
Event Date 10/23/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool.

Event Description
It was reported that the vns patient underwent non-vns related spinal surgery in which electrocautery was used. Following this procedure, the patient¿s device was reported to be pulse disabled. Post-operative diagnostic results showed an end of service condition. The patient underwent generator replacement surgery on (b)(6) 2014. The explanted generator was returned to the manufacturer for analysis. Review of the as-received decoder showed that the generator was not pulse disabled and not at end of service with the battery measured at 2. 762v. 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 condition found with the pulse generator. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4268901
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« Reply #81 on: May 10, 2017, 12:21:36 AM »

Model Number 105
Event Date 10/22/2014
Event Type Malfunction
Manufacturer Narrative
(b)(4). Corrected data: inadvertently did not include the udi on the initial report.

Event Description
It was reported that during initial implant surgery, the device diagnostics were run with the generator in the pocket and resulted in vbat less than eos. It was reported that two device diagnostics performed prior to closing the generator pocket were within normal limits, but that after the generator pocket was closed the vbat less than eos message appeared. It was reported that the generator was likely exposed to electrocautery during the surgery. The surgeon replaced then replaced the generator. The explanted generator was received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Event Description
Analysis of the returned generator was completed which confirmed an output pulse disabled condition due to a perceived low battery voltage. Analysis concluded that the event may be related to high energy exposure during surgery. The pulse generator performed according to functional specifications after output was re-enabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4255773
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« Reply #82 on: May 21, 2017, 04:54:26 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type  Injury   
Event Description 
It was reported that a pt with a mass on her neck (near electrode site) would undergo electrocautery to have it removed. Good faith attempts to obtain additional info from the pt's treating physician such as cause of the mass and relationship to the device have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1309904
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« Reply #83 on: June 22, 2017, 12:25:04 AM »

Model Number 103
Event Date 05/27/2010
Event Type Malfunction
Event Description
It was reported that a surgeon obtained fluctuating eos projections while performing systems diagnostics during an initial implant. The first systems diagnostics resulted in 10 years to eos; however, when the generator was in the pocket and the skin was closed, the eos projection was 0 months. The physician had used monopolar cautery (grounding pad on the pt's right thigh) during the implant procedure because there was some bleeding at the bottom of the generator pocket. The surgeon did not have back of products available, therefore, the generator was left in the pt. The surgeon was cautioned against using electrocautery in the past. The surgeon has referred the pt back to the neurologist. Good faith attempts to obtain a copy of the flashcard to confirm the events are currently being made.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1740263
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« Reply #84 on: June 23, 2017, 01:11:21 AM »

Model Number 104
Event Date 03/01/2010
Event Type Malfunction
Event Description
It was initially reported by the surgeon that the pt is having his battery replaced due to eos. Pt's eri status showed that only two months is remaining. Explanted generator was returned to mfr for analysis. Analysis was completed by the mfr. Product analysis of the returned generator revealed that an end of service warning message was rec'd and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, the reported demipulse eos condition was duplicated during diagnostic testing, using parameters from the programming history, which indicated that the generator was approaching eos, (2 month at the returned parameters). There were no adverse functional, mechanical, or visual issues identified with the returned generator. Good faith attempts to obtain add'l info has been unsuccessful till date. Further investigation determined that the root cause of the eos warning messages as being as asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1733194
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« Reply #85 on: June 27, 2017, 01:19:48 AM »

Model Number 303-20
Event Date 04/01/2010
Event Type Malfunction
Event Description
It was reported to manufacturer that a vns pt had their leads replaced prophylactically and the explanted leads were returned to manufacturer for product analysis. During analysis, an opening in the silicone tubing was identified exposing a portion of the negative coil showing that the lead coil was exposed to some type of electro-cautery tool. Pitting or electro-etching conditions also were observed. The electrode array portion was not returned for analysis. No other anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1767907
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« Reply #86 on: July 02, 2017, 01:04:01 AM »

Model Number 103
Event Date 09/01/2010
Event Type Malfunction
Event Description
It was initially reported during the lead revision surgery as previously reported in mfr report number 1644487-2010-00812, that pulse generator prior to replacement was showing eos=10 years. When the new leads were in place, the pulse generator showed vbat<0, eos=0 months. The pulse generator at that time had been only implanted for a couple months. Electrocautery was used to open the generator during the lead replacement. Troubleshooting was performed on the pulse generator and was still showing eos=0 months, so it was replaced at that time. She acknowledged and performed a generator diagnostics using a test resistor on the device with high impedance and eos=0 months. A new battery was used and resulted in eos=10 years with an impedance value of 1401 ohms. The explanted pulse generator has been returned to the mfr for analysis, which has yet to be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1859777
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« Reply #87 on: July 03, 2017, 01:09:31 AM »

Model Number 103
Event Date 09/27/2010
Event Type Malfunction
Event Description
It was reported that while performing system diagnostics, a surgeon obtained eos message with 0 months while replacing the pt's previous generator due to end of service. A company rep indicated the surgeon was using bovie but unk if the generator was in the sterile field while bovie was used. At the moment good faith attempts to obtain add'l info have been unsuccessful to date. The reported generator was returned to the mfr and is currently undergoing analysis.

Manufacturer Narrative
Device failure occurred, 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=1889535
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« Reply #88 on: July 05, 2017, 10:53:15 AM »

Model Number 103
Event Date 10/06/2010
Event Type Malfunction
Event Description
It was initially reported that the pt was receiving an initial vns implant. When the pulse generator was connected to the lead inside the pocket first and resulted 0 years remaining until eri-yes. The surgeon got the same results when diagnostics were performed outside the pocket. Electrocautery was used at the lower end of the sterile field, but the surgeon was said to be "very careful about being near to electrocautery. " when the generator was replaced, diagnostics were again performed, which resulted in 10 years remaining until eri=yes. The generator not used during the surgery was returned to the manufacturer for analysis, but has yet to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1899687
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« Reply #89 on: July 11, 2017, 03:36:26 AM »

Model Number 104
Event Date 09/22/2010
Event Type  Malfunction   
Event Description
It was initially reported by a materials person at a hospital that a vns pt underwent generator replacement surgery due to unk reason. A return product form was received by the mfr and indicated the generator was explanted due to suspected end of service. The explanted generator was returned to the mfr and underwent product analysis. Analysis of the generator revealed that an end of service warning was received during analysis and found it to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within spec. Other than the output disable condition, there were no add'l adverse functional, mechanical, or visual issues identified with the returned generator. F/u was made with the surgeon's office and indicated the generator was explanted using bovie. The new generator was implanted and interrogated properly. Re-iteration was made to the surgeon's office the importance not to use electro-cautery for the explant and implant of model 103/104 as it disables the output current.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1949144

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« Reply #90 on: July 24, 2017, 12:49:24 AM »

Model Number 102R
Event Date 03/31/2011
Event Type  Injury   
Event Description
On (b)(6) 2011, it was reported by a vns implanting surgeon to the case manager that the vns patient was seen on (b)(6) 2011, complaining of a "burning sensation" in her neck. The patient's generator had been recently replaced and the generator was placed in her axilla region instead of the clavicular region. The patient is having discomfort with the generator in her axilla region, especially when she sleeps at night, therefore, she was referred to the surgeon for repositioning of her generator. No diagnostics were performed. On (b)(6) 2011, the surgeon moved the patient's generator to just under the clavicle. However, the surgeon used electrocautery to open up the patient. The manufacturer's consultant was advised that there is a safety alert regarding the use of electrocautery with vns because it could possibly disable the generator or affect the battery life. The consultant was informed that he needed to review the safety alert with the surgeon. It was reported that they were able to communicate with the generator and everything was fine after the surgery. Good faith attempts for further information from the patient's physician have been to no avail thus far. If additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2070197
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« Reply #91 on: July 28, 2017, 06:42:07 AM »

Model Number 103
Event Date 03/03/2011
Event Type  Malfunction   
Event Description
It was initially reported by the attending neurologist that during the exploratory revision surgery for the pt, that the pulse generator was showing to be at eos. The pt's device was recently implanted, so was not expected to be at an eos condition. The pt's revision surgery was unrelated to the generator and not due to any device malfunction or pt serious event, but was to remove the tie-downs placed during the initial implant. It was noted by the neurologist that the surgeon did use electrocautery while opening the pt's generator pocket. The neurologist indicated that the device was able to be communicated with prior to the surgery. The pulse generator was replaced at that time and returned to the mfr for analysis, which has yet to be completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2050204
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« Reply #92 on: August 05, 2017, 08:15:55 PM »

Model Number 104
Event Date 04/18/2011
Event Type  Malfunction   
Manufacturer Narrative
Review of programming history.
 
Event Description
Additional information was received on (b)(6) 2013 when the physician reported that the patient's device is showing vbatt

Event Description
Additional information was received on (b)(6) 2013 when product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during surgery. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The battery, 2. 586 volts as measured during completion the final electrical test, shows an n eos condition. The exposure to an electrocautery tool may have been a contributing factor for the "asic latch-up condition" and "premature end of life" conditions.
 
Event Description
Additional information was received on (b)(6) 2013 when the explanted generator was returned to the manufacturer for product analysis. Product analysis is still underway and has not yet been completed.
 
Event Description
The patient was again seen for follow up on (b)(6) 2012. The generator had not yet reached end of service. Revision, when the generator reaches end of service, is likely but has not occurred to date.
 
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Event Description
During review of internal programming history it was noticed that there was a vbat < eos threshold in the data for (b)(6) 2011 at 12:52. During review of the programming history, it was noticed that the pt was programmed on during their implant procedure. Given the data available the pt was not programmed off during that visit. On (b)(6) 2011, however during the initial interrogation, the pt was programmed off. Analysis of a decoder spreadsheet which displays settings off their generator the interrogation performed (b)(6) 2011 on 12:52pm shows that the device was disabled previously due to vbat < eos threshold. This is most likely due to the use of electrocautery during their implant surgery. Teaching was provided to the implanting surgeon on manufacture recommendations in regards to using cautery. Investigation determined that the likely root cause of this event is due to an application-specific integrated circuit (asic) latch-up condition resulting from the generator receiving an electrical transient during surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). The emi and/or esd causing the asic latch-up can be attributed to the use of electrocautery in direct contact with the generator, electrocautery in close vicinity to the generator or a major electrostatic discharge. No further interventions have been reported to be planned for the pt. No serious injury reported from event. Cyberonics labeling cautions that electrocautery should not be used during surgery as it may compromise the generator's battery life.
 
Event Description
Additional information was received indicating that the patient's generator had received the intensified follow-up indicator (ifi) = yes flag upon interrogation on (b)(6) 2012. This ifi=yes condition is believed to be premature, likely related to the asic latch-up condition which resulted from the use of electrocautery during implant. Based on the patient's current settings the generator would be expected to reach the ifi= yes flag in approximately 5 years if the asic latch-up condition had not occurred. No interventions are currently planned, however, the patient appears to be following up with her physician more frequently as she was seen again on (b)(6) 2012 and is scheduled to follow up again in one month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2255849


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« Reply #93 on: August 05, 2017, 11:10:56 PM »

Event Type  Malfunction   
Event Description
It was reported by a physician's office that an unk pt's generator "had a problem with arcing while using bovie during surgery. " the device was later able to be turned on. Attempts for further info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2258034
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« Reply #94 on: August 11, 2017, 08:02:53 AM »

Model Number 103
Event Date 08/16/2011
Event Type  Malfunction   
Event Description
It was reported by the physician that the pt's device had been "moved" by a surgeon on (b)(6) 2011. The pt then came into the office as the magnet was not functioning, and the office was not able to communicate with the generator on (b)(6) 2011. The site attempted to use multiple programming systems that were known to be functional, and communication was still not possible. The pt had been last seen by the physician on (b)(6) 2011 and communication was possible then, but no diagnostics were listed on this date. Later info showed that a company rep went to the site and was able to communicate with the pt's generator on his third attempt. His wand was rotated each time the communication failed until it was successful. The rep received an end-of-service message, though the battery icon was completely full, indicating the generator was likely damaged by electrocautery during the surgery where the surgeon moved the generator. No equipment had been replaced during this surgery, and no vns software was used in the surgery to ensure proper device function throughout the procedure. A copy of the hand-held info from the site was obtained and showed that on (b)(6)2011 the pt's device has a pulse disable command due to the battery voltage being less than the end-of-service (eos) threshold. However, the voltage measurement on this date was 3. 059 v. A revision surgery in the future is likely.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2278699

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« Reply #95 on: August 16, 2017, 03:56:17 AM »

Model Number 103
Event Date 08/05/2011
Event Type  Malfunction   
Manufacturer Narrative
Initial report inadvertently indicated that the suspect medical device had been discarded however the information received was erroneous since the generator has been received by the manufacturer. Initial report inadvertently indicated conclusion code "70" for "device discarded unable to follow up" however the information received was erroneous since the generator has been received by the manufacturer.
 
Event Description
The explanted generator was received by the manufacturer and underwent analysis. Analysis confirmed the pulse disabled condition as-received. Once the output was re-enabled, the generator was subjected to electrical testing and performed according to specifications. Review of the generator source code revealed the stored impedance value was likely the residual value from initial manufacturing (>10,000ohms). In addition there was no change in impedance observed from the date of surgery. Though the data from the handheld computer that was used during the initial implant surgery has not been received to date, this stored impedance value suggests that a diagnostic test was not completed during the surgery. Though it was confirmed through analysis that the pulse was disabled, likely a result of the generator being in the vicinity of electrosurgical equipment prior to implant.
 
Event Description
Additional programming history was received confirming the pulse disabled condition being present the date of surgery. A self-check of the generator on the date prior to surgery showed normal battery voltage however on the date of surgery, the battery voltage had dropped to 1. 826 volts as measured by a system diagnostics test during surgery. This further suggests that electrocautery likely damaged the generator resulting in the pulse disabled condition. Due to the pulse disabled condition, the generator does not take a new measurement of the impedance value resulting in the continued observation of the high impedance value. The impedance value never changed from the value used during manufacturing.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
It was reported that during the initial implant of the patient's vns lead and generator, electrocautery was used that resulted in a pulse disabled condition on the new generator. Diagnostics also indicated high impedance. Generator diagnostics were performed on the generator and the same results were confirmed. The generator reportedly did not indicate end of service or a pulse disabled condition prior to implant. A back-up generator was implanted that showed normal diagnostics. Attempts for the return of the disabled generator and test resistor used during the generator diagnostics have been made however they have reportedly been discarded. Attempts for programming history are in progress.
 
Event Description
Attempts for additional programming history have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2264160
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« Reply #96 on: September 06, 2017, 08:15:44 AM »

Model Number 103
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The three model 2183 cfx battery cells were returned to the battery manufacturer from the vns generator manufacturer for evaluation for premature battery depletion. These cells were compared to three beginning of life control samples provided by the battery manufacturer. Analysis of the three cells for premature battery depletion was performed. There were no visual anomalies noted, and there were no apparent component defects were noted during x-ray analysis. The device history records and electrical burn-in test results were reviewed. No abnormal or defective conditions were noted during the manufacture of the cells. All of the battery manufacturer and generator manufacturer specifications for shipment were met. The capacity verification testing analysis test performance for the three returned cells and three beginning of life cells (controls) was reviewed. In conclusion, the performance of the two groups, in terms of complex impedance and capacity verification, with a depth of discharge range from 76% to 86%, did not reveal any differences that account for premature battery depletion.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of device manufacturing records confirmed that all quality tests were passed prior to distribution. Method and results, corrected data: the previous report inadvertently did not include this information.
 
Event Description
Follow-up with the neurologist's office found that they had no record of any medical procedures or mris between (b)(6) 2010, that could have possibly resulted in the pulse disabled condition. The site indicated that the pulse disabled condition was believed to be related a static shock the patient received from her clothes dryer between (b)(6), however a static shock would likely not have enough energy to result in an asic latch-up condition.
 
Event Description
It was reported that the patient underwent generator replacement surgery due to generator end of service. The explanted generator was returned to the manufacturer and underwent analysis. The reported demipulse predicted eos, and low battery allegations were duplicated in the pa lab. Results of diagnostic testing verified the neos battery status. The data in the diagaccum consumed memory locations revealed that 43. 931% of the battery had been consumed. The battery is partially depleted, at 2. 381 volts, as measured during execution of the final electrical test. The premature battery depletion may be the result of elctrocautery use at explant, as evident by the burn marks on the generator can. While reviewing decoder data for the generator, it was identified that on (b)(6) 2011, the initial interrogation of the patient's generator had been disabled due to "vbat eos threshold" at which time battery voltage was noted to be 3. 008 volts. No anomalies were noted during the patient's previous office visit ((b)(6) 2010). As the patient's settings were increased during subsequent office visits it was also noted that the generator battery began to deplete at an accelerated rate (2. 891v to 2. 804v 1 month). During the analysis of the device, burn marks were noted on the can, though the device was not received in a pulse disabled condition. Thus it is unknown when this burn could have occurred. Pulse disabled events associated with vbat eos threshold prior to device eos were previously investigated for which the off-label use of electrocautery and esd were determined to be the source of an asic latch-up condition which occurred with these devices and in turn impacted the capacity of the generator battery. Given the proximity of this event to the implant procedure (2 years after implant) and the lack of evidence which would support the occurrence of a secondary surgical procedure, the pulse disabled event is unexpected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2437363

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« Reply #97 on: September 15, 2017, 01:15:29 AM »

Model Number 103
Event Date 03/20/2012
Event Type  Malfunction   
Event Description
The patient's generator was replaced on (b)(6) 2012. As reported in manufacturer report # 1644487-2012-00590, the patient was having surgery due to high impedance with suspected possible incomplete pin insertion in the generator. Pre-operatively, the battery indicator was full (ifi=yes). The resident made the incision and used electrocautery to achieve hemostasis at the incision. When he proceeded deeper into the pocket he used bi-polar cautery. The generator was removed, and the pin was disconnected. The pin was inspected, cleaned, and reinserted. System diagnostics were performed with a result of high lead impedance and eos=yes. The test was repeated several times with the same result. The surgeon decided to open a new generator at this time. Device diagnostics were performed following generator replacement and resulted with okay results. Product analysis of the generator was completed on (b)(6) 2012. Product analysis verified that an end of service warning message appeared in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Diagnostic testing indicated ifi=no. There is sufficient information to indicate that the device was disabled on the date of surgery due to the use of electrocautery during surgery which damaged the generator. This is addressed in labeling that electrocautery during surgery can cause the pulse generator to become disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585324
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« Reply #98 on: September 20, 2017, 12:49:29 AM »

Model Number 103
Event Date 06/14/2012
Event Type  Malfunction   
Event Description
It was reported by a vns implanting md that in the operating room the generator was inconsistent on interrogation - sometimes he could get a baseline read on the settings, and other times he would get an eos warning, or no response. Based upon this he replaced the generator with a new m103. A cautery was used in the operating room but reported to be after this programming event. It was noted that on review of programming history on the operating room handheld that several faults were noted likely from a break in communication with the generator. One successful interrogation was noted. It is unknown if the cautery damaged the generator. Good faith attempts were made to have the generator returned for analysis. Thus far it has not been returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2655127
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« Reply #99 on: September 21, 2017, 12:16:10 AM »

Model Number 103
Event Date 03/16/2012
Event Type  Malfunction   
Event Description
Reporter indicated that the vns generator was able to be reprogrammed following the vbat
 
Event Description
Reporter indicated a vbat

Manufacturer Narrative
Describe event or problem, corrected data: information regarding the patient not feeling stimulation when the vns generator was disabled due to asic latch-up was inadvertently omitted from the initial mdr report.

Event Description
All attempts to the reporter for vns programming history have been unsuccessful to date. The available information indicates the most likely cause of the vbat< eos disabled condition of the vns generator is due to electrocautery used during the (b)(6) 2012 surgery. As the surgical area was the generator area, electrocautery was most likely the cause of the vbat disabled condition (asic latch-up). Reporter indicated the patient did not feel stimulation since the (b)(6) 2012 surgery, when the vbat

Manufacturer Narrative
Describe event or problem, corrected data: information regarding reprogramming the vns was inadvertently omitted from the initial mdr report.
 
Manufacturer Narrative
Analysis of programming history. Electrocautery is suspected to have caused the vbat-eos/asic latch-up condition which disabled the generator.
 
Event Description
Additional vns programming history for the patient was obtained and reviewed. The vns was noted to be disabled upon interrogation on (b)(6) 2012. The vns settings were corrected this day. The last time the vns was noted to be programmed 'on' was on (b)(6) 2012, which was 3 day prior to the (b)(6) 2012 surgery date. It is likely the vbat-eos disabled condition was due to electrocautery used during the (b)(6) 2012 surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2637558
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« Reply #100 on: October 01, 2017, 12:11:40 AM »

Model Number 104
Event Date 11/09/2012
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results and diagnostic test demonstrated that the pulse generator was operating within specification. Burn marks were also observed on the pulse generator can and header, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Product analysis confirmed an output pulse disabled condition due to a perceived low battery voltage; may be related to high energy exposure during explant process.
 
Event Description
On (b)(6) 2012 it was reported that during the patient's surgery that day to move the patient's lead, electrocautery was used. Diagnostics were performed on the generator prior to surgery which showed the device to be functioning properly with neos=no. After surgery diagnostics showed neos=yes. The patient's settings were output=1. 75ma/frequency=30hz/pulse width=130usec/on time=60sec/off time=1. 8min and the patient had been implanted in (b)(6) 2011. The surgeon confirmed that the generator was in the sterile field when he used electrocautery. The patient underwent generator replacement that day due to the electrocautery affecting the battery life. The generator was received by the manufacturer for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2856702
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« Reply #101 on: October 03, 2017, 12:29:02 AM »

Model Number 103
Event Date 11/14/2012
Event Type  Malfunction   
Event Description
Reporter indicated the vns generator replacement was planned prior to the surgery, and was prophylactic.
 
Manufacturer Narrative

Event Description
During a replacement surgery for high impedance (captured in manufacturer's report # 1644487-2012-03355), it was reported that the generator was explanted due to end of service. Product analysis was completed on the returned generator and an end-of-service warning message was verified which was found to be associated with the output being disabled by the pulse generator. Physical evidence on the case exterior (burn marks) suggest the device was subjected to a high energy source such as electro-cautery equipment. Once the output was re-enabled, results of diagnostic testing indicated the device was operating properly and electrical test results showed that the pulse generator performed according to functional specifications with approximately 53% of the battery consumed. Based on the burn marks observed on the generator, it appears that electrocautery was used during the surgery which caused an asic latch-up condition in the generator. Other than the burn marks on the can and resulting pulse disable condition, there were no additional adverse functional, mechanical, or visual issues identified with the returned generator. As the generator was not found to be at end of service, it is currently unknown if the generator was explanted due to the end-of-service warning message that was received or if the replacement of the generator was planned prior to the start of surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2916781

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« Reply #102 on: October 04, 2017, 12:10:33 AM »

Model Number 103
Event Date 11/27/2012
Event Type  Malfunction   
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Event Description
Reporter indicated the vns lead was removed due to infection on (b)(6) 2013, but the generator remained in the patient. The patient was implanted with a new generator and lead on (b)(6) 2013. The generator was replaced as it was felt it had been damaged by electrocautery use during the (b)(6) 2013 lead removal surgery. The explanted generator was returned on (b)(4) 2013 and is pending analysis. The explanted lead was not returned.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for the generator prior to distribution. The lead information is currently unknown; as such a review of the lead manufacturing records is not possible.
 
Event Description
The return product form indicates the generator was explanted due to "vbat < eos threshold". Product analysis was performed on the returned generator. The premature eol (end of life) was duplicated in the product analysis lab. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccum consumed memory locations revealed that 6. 035% of the battery had been consumed. No additional information has been provided.
 
Event Description
Reporter indicated a patient developed a wound infection at the vns generator site pocket in the chest on approximately (b)(6) 2012. The patient had been recently implanted with the generator on (b)(6) 2012. The wound was noted to be open on (b)(6) 2012. The vns lead was visible at the height of the left breast. The vns generator was performing as intended and working properly. Oral antibiotics were given, and the patient had wound debridement and irrigation surgery performed with high-pressure iodum solution. Antibiotics are to continue. The cause of the infection may be due to the recent implant surgery, but the patient may have also had trauma/device manipulation that may have contributed to the infection.

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« Reply #103 on: October 05, 2017, 12:35:24 AM »

Model Number 104
Event Date 01/01/2012
Event Type  Malfunction   
Event Description
Product analysis was completed on the returned generator. In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery showed to be at 2. 709 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test and, shows an ifi condition. The data in the diagaccumconsumed memory locations revealed that 21. 053% of the battery had been consumed. Review of the downloaded data from the pulse generator showed that, as-received, the pulsedisabled byte was not set to a value that represents a vbat-eos threshold condition as it had been programmed back on. However; the pulse generator may have been exposed to an electrocautery tool during implant based on burn marks observed on the pulse generator case. The cause for the 'premature end of life (eol) indicator' and 'asic latch-up condition' conditions is unknown. However, the exposure to an electrocautery tool may have been a contributing factor. Teaching has been provided to the implanting surgeon on electrocautery usage in the or since this event. A review of manufacturing records confirmed that the device passed all functional tests prior to distribution.
 
Event Description
A vns programming physician reported that one of their patients had a vns replacement performed on (b)(6) 2012. It was felt to be a routine replacement without complications with the device programmed at her pre-op settings right at the time of surgery. However, when i saw the patient for her 1st follow-up appointment in (b)(6) 2012, interrogation gave an error message of the device being 'disabled due to vbat less than eos' indicating it was not supplying stimulation. The patient was also having a clear worsening in seizure control. The device was turned on at the (b)(6) visit with setting re-titrated upwards over the next couple of months. Unfortunately, the patient has continued to have a higher than typical seizure frequency over the last year. In addition, at her office visit on (b)(6) 2013, interrogation of the vns suggested the battery was declining quickly, already reaching need for ifi, intensified f/u. The patient is (b)(6) woman with a past medical history significant for medically refractory epilepsy, developmental delay, and status post vagal nerve stimulator placement. Complicated by the device being disabled after replacement. She has had to undergo re-titration of her vagal nerve stimulator settings due to this. In the recent past, there has been some worsening in her seizure control. When she was last seen in the (b)(6), seizure frequency was continuing to be higher than typical baseline. She is experiencing anywhere from 2-4 generalized tonic-clonic seizures per month. In addition, most months she is having multiple clusters of her eyelid flutter spells requiring doses of the rescue medication lorazepam to assist with aborting these. In the interim since the last visit, the patient does continue to experience a higher than her previous baseline seizure frequency but is fairly similar compared to when she was last seen in september. Her mother estimates that in the last 3 months she has had 9 of the larger convulsive seizure, but these have not actually been visually witnessed. Instead, the 9 larger seizures have all occurred directly out of sleep in the early morning and have been heard by her mother but not seen. They have occurred between 5:30 and 7:00am. Out of sleep and will consist of a crying vocalization and loss of awareness. They last about 20 seconds. By the time her mother arrives in the room, the seizure itself is over and she has some postictal sleepiness. She will usually simply fall back asleep for minutes or hours afterwards and then is back to her baseline. There have been 9 such events in the last 3 months. She is not having any of her larger convulsive seizures during the daytime. The only daytime events that have been happening in the last 3+ months are her eye flutter spells. These may last seconds at a time but usually occur in clusters of events lasting minutes or sometimes up to 30 minutes at time off and on. In general, she has the larger, more prolonger clusters lasting up to 30 minutes about 2-3 times per month, and these will be aborted by 1 mg dose of lorazepam. However, in the last week since christmas the patient has had 6 such episodes. When these occur, however, they really do no have any impact on the patient's level or alertness or interaction. In addition, when she takes the dose of lorazepam it does successfully abort the activity but does not have an impact on her level of functioning. She is tolerating her current medication combination quite well without significant side effects. She is tolerating vagal nerve stimulation well without complaints. She has not had any lab studies done since (b)(6) 2012. She remains on polytherapy with vimpat, lamictal, zonegran, ethosuximide, and dilantin. Unfortunately, over this last year she has continued to experience higher than previous baseline degree of seizure frequency. This continues to be the case despite polytherapy with a total of 5 separate antiepileptic drugs and with vagal nerve stimulator. Given her ongoing seizure frequency,they may consider some adjustments with her medication regiment. However, prior to doing so it would be beneficial to further define seizure types and seizure frequency with video eeg monitoring to determine the best medication options. The vagal nerve stimulator was interrogated during their visit. No changes were made in settings. The patient tolerated this well. The settings at the end of the visit include an output current of 2. 00, signal frequency 30, pulse width 500, signal on time 14, signal off time 1. 8, magnet current 2. 25, magnet on time 30, and magnet pulse width 500. System diagnostics suggest that the battery life is declining, with need for intensified follow-up. Their physician reported that it was their understanding from speaking to someone last spring is that the initial error message and disabling of the device may have suggested exposure of the generator to conditions surgically or pre-surgically which could have drained battery life significantly. The issue now is that the patient's vns will need to be replaced again, possibly less than one year after the last surgery. There is also concern that it may not have been functioning to full capacity, judging by the patient's clinical response. The patient has been referred for a battery replacement. With a proposed date of 2/12/2013. Good faith attempts will be made for their explanted generator to be returned once surgery occurs.
 
Event Description
An implant card was received on (b)(4) 2013 confirming that the generator was replaced on (b)(6) 2013. It was also noted that the generator was replaced due to the battery depletion, near eos = yes. The lead impedance with the new generator was marked "ok".
 
Manufacturer Narrative

Event Description
The patient had their generator replaced on (b)(6) 2013. It has been returned for analysis and completion is pending. Further information was received from the patient's neurology clinic. The first date the patient experienced an increase in seizures was (b)(6) 2012. Reported to be related to their vns as in may have been malfunctioning and with rapid decline to the battery needed a replacement. Multiple seizure types increased.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2957154
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« Reply #104 on: October 11, 2017, 01:48:30 AM »

Model Number 104
Event Date 06/01/2012
Event Type Malfunction
Event Description
Analysis of the generator was completed on (b)(6) 2013. The end of service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. The event has been previously investigated by the device manufacturer. The battery was found to be depleted and at eos. During a diagnostic test attempt, the voltage dropped to 1. 750 volts, which shows that the battery is depleted when the device attempts to enter a functional mode. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications.

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Manufacturer Narrative

Event Description
It was reported that upon interrogation of the patient's generator a warning message ""vbat < eos" was received indicating that the generator was disabled due to end of service. It was reported that no diagnostics or interrogations had been performed on the device since implant. The patient's mother believed that the battery didn't last as long as she felt it should have and indicated that she feels that the device was damaged by electrocautery during the patient's left shoulder surgery in (b)(6) 2012. No diagnostics were able to be performed due to the device being disabled. Additionally, it was reported that the patient has not experienced any seizures since (b)(6) 2012. The patient underwent generator and lead replacement on (b)(6) 2013. The implant card was received which confirmed that the generator and lead replacement occurred on (b)(6) 2013. It was noted that the generator was replaced due to end of service. The generator was returned to device manufacturer on (b)(6) 2013 for analysis. Analysis of the generator is underway; however, has not been completed to date.

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« Reply #105 on: October 11, 2017, 01:49:29 AM »

Model Number 103
Event Date 03/14/2013
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported during surgery to only revise the patient generator pocket that the surgeon used electrocautery while opening the patient's pocket. The electrocautery affected the generator causing the generator to show eos=yes when previously it was not at end of service. Prior to surgery it was not planned for the generator to be replaced however due to the use of electrocautery replacement was required. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been complete.

Event Description
Additional information was received that product analysis was completed on the generator. Review of the data indicated that the pulsedisabled byte was set to a value that represents a
vbat

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« Reply #106 on: October 11, 2017, 01:50:33 AM »

Model Number 105
Event Date 03/14/2013
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected to have been caused by user error with electrocautery.

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
Reporter indicated that during a vns prophylactic generator replacement surgery, a new model 105 generator was displaying an end of service warning message. Electrocautery was being used in the vicinity of the generator, and it is suspected the electrocautery may have caused an asic/latch up condition of the new generator to occur. The reporter used a different vns generator to complete the surgery. The unused model 105 generator has been returned and is pending analysis.

Event Description
Product analysis was completed on the returned vns generator. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

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« Reply #107 on: October 12, 2017, 12:30:28 AM »

Model Number 103
Event Date 05/02/2013
Event Type Injury
Event Description
On (b)(4) 2013 additional programming history was received for the patient from date of generator explant ((b)(6) 2013). Product analysis on the explanted generator was completed on (b)(6) 2013. In the pa lab, the device output signal was monitored for more than (b)(4), while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications as received, the generator output was not disabled due to a perceived vbat

Manufacturer Narrative

Event Description
On (b)(6) 2013 it was reported that surgery was done that day to reposition the patient¿s generator in her chest cavity. The patient¿s generator was reported to have protruded in her chest cavity every time she slept on her side. It was not generator migration, it seemed like the generator pocket had gotten enlarged. During the surgery, the generator was confirmed to still be sewn to the fascia by the surgeon. During surgery the generator ended up having to be replaced due to end of service even though it had only been implanted since (b)(6) 2012. The generator had been interrogated during surgery and the device presented a warning stating that it was at eos and that ¿the programmed current was not being delivered because the pulse was disabled. ¿ a timeline of the events was provided and it was stated that at 7:58am the first interrogation of the generator took place pre-operatively and the patient¿s settings were output=0. 75ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3min/magnet output=1ma/magnet pulse width=500usec/magnet on time=60sec. Lead impedance was ok and ifi flag was no. The manufacturer¿s consultant then programmed the patient¿s output current to 0. 00ma prior to the surgery. The patient was then prepped and opened and the cut in the chest area was made. The device was interrogated again at 8:00am and the parameter settings were as follows: output=0. 00ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=3. 0min; ifi flag was no. The output current was at 0. 00ma because he had disabled the device prior to the surgery. At 9:38am the generator was interrogated outside of the pocket and everything still looked good; the ifi flag was no again. A system diagnostic test was then performed immediately after this and that was when the eos flag showed yes and the warning message appeared indicating that the ¿programmed current was not being delivered because the pulse was disabled. ¿ at 9:40am, two minutes later, the device was interrogated again outside of the pocket and the eos flag showed yes again. The manufacturer¿s consultant stated that he had visualized an electrocautery pad that was placed on the patient¿s right hip and that this event is indicative of electrocautery being used during surgery. A new generator was implanted and tested prior to closing the patient back up and all test results were within normal limits for the new device. It was later reported that it was unknown when the protrusion was first observed; the patient had reported it ¿flipped¿ approximately 45 degrees when she moved to her side. The surgeon stated that the patient appears to be a ¿twiddler¿ and that the pocket enlargement was typical of manipulation by the patient. Patient manipulation was suspected by the physician but was not confirmed with the patient or caregiver. No physiological changes were reported which may have contributed to the protrusion. The surgeon¿s pa confirmed that the surgeon used bi-polar electrocautery in the surgery. The explanted generator was returned for product analysis on (b)(6) 2013. Product analysis is still underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3131663
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« Reply #108 on: October 12, 2017, 12:31:58 AM »

Model Number 103
Event Date 01/23/2012
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the generator met all final testing requirements prior to distribution.

Event Description
Reporter indicated that it was felt a patient¿s vns generator had reached an ifi = yes condition (8-18% battery capacity remaining) prematurely. The patient has been implanted with the vns since (b)(6) 2012. The patient has been at the same settings (2ma/20hz/250 pulse width) and 29% duty cycle. The reporter confirmed that the patient had no recent surgeries in which electrocautery was used. All attempts for additional programming history from the reporter have been unsuccessful to date.

Event Description
The generator analysis was completed on (b)(6) 2013. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. The calculated (from ram and flash data) vbat voltage was found to be lower than the actual battery voltage (as measured with a dmm while the battery was still attached to the pcb). The low vbat resulted in the device replacement notifications (ifi = yes, neos, etc. ) even though the actual battery voltage was above the warning level, this is most likely related to the exposure from electro-cautery use.

Manufacturer Narrative
Corrected data: additional information shows that the event date is the date of implant; therefore, the patient age at the time of the event is being updated. Date of event, corrected data: additional information shows that the event date is the date of implant.

Event Description
It was reported that the patient's generator was replaced on (b)(6) 2013 due to premature end of service. Tje device was returned and is pending product analysis.

Event Description
Review of additional decoder data from (b)(6) 2012 to (b)(6) 2013 shows that the device was first interrogated on (b)(6) 2012 at eos pulse disabled (0/30/500/30/5/0/500/60). This indicates that the device was likely hit with electrocautery during device implant. This would account for the decreased in generator longevity. A previous investigation concluded that devices hit with electrocautery would experience a 48% decreased in battery life: this is consistent with this suspect medical device.

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« Reply #109 on: October 12, 2017, 12:33:11 AM »

Model Number 105
Event Date 03/06/2013
Event Type Malfunction
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed device met specifications prior to distribution.

Event Description
Additional information was received on (b)(4) 2013 when product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The reported ¿premature end of life (eol)¿ allegation was not duplicated in the pa lab, although the pulse disable condition did exist in the received generator. The output was re-enabled in the pa lab in order to perform additional testing. The measured battery level was 3. 072 volts during completion of the final electrical test, which is a non-ifi condition. The generator performed according to functional specifications after output was re-enabled.

Event Description
On (b)(6) 2013 it was reported that during the vns patient's battery replacement, the newly implanted generator showed that it was at near end of service even though it was just implanted that day. During interrogation and when diagnostics were performed, both showed neos=yes. The manufacturer's consultant stated that electrocautery was used but it did not come in contact with the vns system. Diagnostics were performed three times but each time the device showed neos=yes. It was reported that another generator would therefore be implanted in the patient. This was implanted with no problems. The manufacturer's consultant stated that she had interrogated the device prior to surgery to program in the patient data but doesn't recall seeing a battery status message then and the device did not give any neos warnings. The next time the device was interrogated was once the device was passed through the sterile filed. Upon interrogation, the generator gave a neos message and neos=yes was observed on three different diagnostics tests after that. The generator had been received by the hospital either the day before the surgery or the morning of surgery. The generator was stored on a shelf in the or and the manufacturer's consultant mentioned that it was 'freezing' in that room. The surgeon stated that he was concerned about this generator showing neos=yes as he did not do anything wrong during surgery. The manufacturing records for the generator were reviewed. During manufacturing they had to remove excessive adhesive per header touch up but the device was re-welded and met all specifications prior to distribution. The generator was received for product analysis on (b)(4) 2013. Product analysis is still underway but has not yet been completed.

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« Reply #110 on: October 16, 2017, 12:06:57 AM »

Model Number 105
Event Date 06/26/2013
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.

Manufacturer Narrative

Event Description
Both the initially implanted model 102 generator and replacement model 105 generator were returned on (b)(4) 2013. Model 105 product analysis results: an end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were also observed on the back side of pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status indicated ok. The battery voltage value stored within the generator (3. 017 volts reported during fet) suggests the device is not an neos condition. With the exception of the burn marks and disabled output condition there were no other adverse functional, mechanical, or visual issues identified with the returned generator. Model 103 product analysis results: product analysis found that the elective replacement indicator (eri) was set. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. No other information has been provided.

Event Description
It was initially reported during a generator replacement that new generator indicated that it was near end of service. The new generator was connected to the lead and there were no any unusual flags or warnings. The surgeon preformed systems diagnostics, inside and outside the pocket and the ¿neos¿ warning was received. The surgeon indicate that there was no electrosurgery in the sterile field while the generator was present or during the procedure and did not do any adjustments on the lead pin/setscrew to possibly cause electro-static discharge. There was no back-up product available and the surgeon decided to leave the generator implanted. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator to distribution. Good faith attempts for more information have been unsuccessful to date.

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« Reply #111 on: October 16, 2017, 12:07:59 AM »

Model Number 104
Event Date 07/02/2013
Event Type Malfunction
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
It was reported that the patient was in the operating room under anesthesia for prophylactic generator replacement, it was observed that the replacement model 104 device was at ifi (intensified-follow-up condition) with ifi=yes observed during when pre-operatively, the device was at 100% battery capacity. Therefore, the model 104 replacement device was also explanted, and not used. Troubleshooting was performed during surgery. The company representative observed the surgeon use electrocautery during the original explant, but was unable to verify if it was used with the replacement model 104 device was placed. The surgeon reported that he was not sure if he used electrocautery in the vicinity of the replacement device, as surgery is a complicated process. No other issues were reported from the surgery. The patient was implanted with another generator successfully. The unused generator was returned to the manufacturer for analysis. However, product analysis has not been completed to date. Additionally, a copy of the programming/diagnostic data from the surgery was copied by the company representative, but the data has not been uploaded/reviewed to date. If electrocautery was used in the vicinity of the replacement generator, the asic latch-up condition may have occurred where the errrant end of service conditions may be due to the asic remaining in a trickle charge state when an undeliverable output current is programmed.

Event Description
Analysis of the generator was completed on (b)(6) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the attempted implant. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications.

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« Reply #112 on: October 19, 2017, 12:15:48 AM »

Model Number 103
Event Date 08/28/2013
Event Type Malfunction
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
Review of programming history shows that the device was interrogated 3 times prior to any system diagnostic being performed. Three system diagnostics all indicated high impedance and eos-yes. A decoder was reviewed. Based on the discrepancy in battery voltage versus % battery consumed, it appears that the device reached the pulse disabled state most likely due to the presence of electrocautery.

Event Description
On (b)(6) 2013, the patient was implanted with a new generator and lead. Prior to implant, the generator was interrogated pre-operatively and found to be disabled with ifi (intensified follow-up indicator) showing "no". At 11 am, the device was interrogated before the system diagnostic test was performed and seen to be at the same settings and ifi flag. The bovie was in the plastic protector on the side of the bed more than 12 inches from the incision, wand, and device. The scrub had the generator on her mayo prior to keep it off the field. The surgeon and scrub were aware of no cautery and took precautions as mentioned, with the generator not near the bovie and the bovie in a plastic protector more than 12 inches from incision site. There were no cords or other electromagnetic interference (emi) on field or near generator or wand noted at testing time. System diagnostics were performed on the generator when it was inside the pocket with the skin open. The diagnostics showed both end of service (eos) = "yes" and high lead impedance. The lead pin was reinserted and a second system diagnostics was run which showed the same results. A generator diagnostic test was performed which again showed high lead impedance and eos = yes on the generator. The generator was removed and a back-up generator was implanted into the patient. Final diagnostics of the back-up generator confirmed it was within normal limits with normal impedance and ifi = "no". Follow up with the nurse confirmed that all electrical equipment was away from the generator and nothing came close to it when it "flipped" from ifi = no to eos = yes. The new generator was tested three times and final diagnostics tests confirmed it was within normal parameters. Product analysis was performed on the generator that went to eos during surgery. The reported end of life and high impedance events were not duplicated in the product analysis lab. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 071 volts, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 0. 326% of the battery had been consumed. However, review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

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« Reply #113 on: October 19, 2017, 12:17:05 AM »

Model Number 105
Event Date 01/09/2013
Event Type Malfunction
Event Description
Additional information was received stating that the generator was being returned to the manufacturer. The generator was returned to the manufacturer on (b)(4) 2014 where analysis is currently underway.

Event Description
It was initially reported that a new generator was able to be communicated with prior to implant but once in the sterile field and system diagnostics were attempted a ¿checksum¿ error occurred, which is a communication error. Diagnostics were attempted three times and each time the communication error was received. The test resister was inserted in to the generator and on interrogation the same message was received. Troubleshooting was performed with the programming system confirming that the programming system was functioning and able to interrogate generators outside the sterile field both before and after the communicate problems. Another generator was opened and was able to be interrogation and communicated with off the sterile field but once in the sterile field it was unable to be communicated with. The surgeon was asked to turn off the electrocautery and the communication still could not be established with the generator with the electrocautery off. A third generator was opened and was successfully able to be communicated with and was implanted in the patient. The surgeon was asked to turn the electrocautery off and remove it from the sterile field prior to the third generator being opened. There was electrocautery that was present in the sterile field but was reported to have been 8 inches away. Electrocautery being on in the sterile field is against safety precautions and could disable the generator but it the generator should still be able to be communicated with. The operating room that the surgery was in was the mri room but the issue had not occurred before. Further information was received from the hospital that the generators showed eos during surgery prematurely during implant surgery. The surgeon¿s notes stated that he was very conscious of electrocautery and generators and all power sources and sources of rpf were kept out of the area. A nurse had called and stated at in a recent generator replacement surgery where the new generator "checked out fine" until the incision was closed. It was reported that once the incision was closed the new generator then displayed end of service upon device testing. During the communication when this was reported she stated that this was the third time this had occurred referring to the generators opened for this patient¿s surgery. The recent case was reported in medwatch 1644487-2013-02351. Attempts have been made to have the generators returned for analysis; however, the hospital will not release the generators. This file houses the medwatch for one of the generators and medwatch # 1644487-2013-02392 houses the medwatch for the second generator.

Manufacturer Narrative

Event Description
Analysis of the generator was completed on (b)(4) 2014. Diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed all quality tests were passed prior to distribution.

Event Description
Additional information was received which indicates that there is an rf device present in the operating room during vns surgeries which may create radiofrequency in the room. It was stated that this device appears near the end of surgery when they are closing the patient. No additional information has been provided.

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« Reply #114 on: October 21, 2017, 12:33:07 AM »

Model Number 103
Event Date 09/18/2013
Event Type Malfunction
Event Description
On (b)(6) 2013 it was reported that the patient went to see the physician to have the device turned on; however, upon interrogation, diagnostics showed an end of service condition. The physician stated that the only cause for this she could think of, was electrocautery. Follow up found that battery life was showing as ok on (b)(6) 2013 and electrocautery was only used before the generator was placed in the pocket. Attempts were made for additional information; however, they were unsuccessful. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3412904
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« Reply #115 on: October 22, 2017, 01:06:04 AM »

Model Number 104
Event Date 10/28/2013
Event Type Malfunction
Event Description
Analysis of the generator was completed on (b)(4) 2013. Electrical tests results showed that the pulse generator performed according to functional specifications. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications.

Event Description
Review of the available programming and diagnostic history showed that the vns patient¿s generator was programmed to the same settings as those as-received. Therefore, the device was likely delivering therapy at these settings from (b)(6) 2012 to (b)(6) 2013. Using the generator battery longevity table at the patient¿s last known programmed settings, the approximate battery life from beginning of life (bol) to end of service is 1. 8-2. 1 years. Given the output current and duty cycle, it appears that the battery depleted at a normal, expected rate. Review of the decoder data showed normal battery consumption. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description
Review of the available information shows that cause for the premature end of life allegation is due to the device being hit with electrocautery during initial implant. There is a chance in which the asic latch-up condition could escape detection. Escape would require the following to occur while the asic is latched: the implanting surgeon does not perform a system diagnostic test, and the device does not perform a daily (24 hour) diagnostic test, both within the 23 hour latch window. If this scenario were to occur, the asic latch would remain undetected and result in the ~48% reduction of battery life. It appears that this is the situation for this device. The available programming history shows that the only one system diagnostic test was performed on the date of implant, and it is likely that this was performed once the generator was in the pocket. It appears that electrocautery may have been affected the generator following this diagnostic test. In addition, no internal 24-hour check occurred until after 23 hours. The rough blc performed with the available data shows that the device should have taken ~2 years from bol to ifi: in the field, this took ~1 year which is consistent with a 48% decrease in battery life. Furthermore, burn marks were observed on the generator. These marks were determined to not be from device explant; therefore, they would likely be from device implant, supporting that the device was exposed to electrocautery from the time of implant.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

Event Description
Review of the dhr for this generator shows that the final electrical test (fet) on (b)(6) 2012 failed resulting in the generator not being re-programmed to off settings. The next fet from (b)(6) 2012 was successful, and the device was programed off at the conclusion of this test. However, the generator likely stayed in this high output state for months before being subjected to fet again, effectively programming the generator off. During the time in between fet tests, the generator is believed to have used a significant amount of battery capacity. This, in addition to the electrocautery exposure, contributed to the premature end of life indicator.

Manufacturer Narrative
Device manufacturing records, available programming and diagnostic history, and decoder data were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

Event Description
It was reported that the patient's generator was showing ifi = yes and the physician feels like that is sooner than expected. It was reported that the device settings are 3. 25/20/130/21/0. 5. The last interrogation was in (b)(6) 2013 with ifi=no. It is unknown if the physician has undergone any other surgeries since device implant. The patient was referred for surgery. The patient underwent generator replacement on (b)(6) 2013. The generator was received for analysis on (b)(6) 2013. Analysis is underway, but has not been completed to date.

Manufacturer Narrative
Device history records reviewed. No device failure occurred; however, the device did reach an end of life condition earlier than expected due to the generator remained programmed to a high output state during manufacturing. The event did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3489496
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« Reply #116 on: October 27, 2017, 07:05:32 AM »

Model Number 103
Event Date 02/18/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to battery depletion. Electrocautery was used in a port-a-cath procedure on( b)(6) 2014 that caused the generator battery to drain. The explanted generator has been returned to the manufacturer where analysis is currently underway.
Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

Event Description
It was reported that during an unrelated surgery the patient's generator was repositioned to the patient's right chest. The surgeon wanted to verify that the generator was working properly. The physician performed diagnostics which showed the generator was at neos. The surgeon confirmed that electrocautery was performed. The patient had not been prior consented for generator replacement; therefore, the generator could not be replaced at that time. It was later reported that the patient would be referred for generator replacement. Surgical intervention has not occurred to date.

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« Reply #117 on: November 01, 2017, 12:24:44 AM »

Model Number 105
Event Date 05/09/2014
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during lead replacement surgery on (b)(6) 2014 due to high impedance, the vns patient¿s device showed near end of service (neos) so the generator was also replaced during the procedure. The patient¿s device was tested on (b)(6) 2014 and diagnostic results showed a non-ifi condition. It is likely that electrocautery was used during the replacement procedure which caused a premature neos message to appear; however, no definitive conclusions can be made with the available information. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. The high impedance was reported in manufacturer report #1644487-2014-01364.

Event Description
Analysis of the generator was completed on (b)(4) 2014. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse condition found with the pulse generator.

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« Reply #118 on: November 05, 2017, 02:42:01 AM »

Model Number 103
Event Date 08/22/2014
Event Type Malfunction
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

Event Description
It was reported that during generator re-implant surgery on (b)(6) 2014, the vns patient¿s replacement generator showed an end of service condition after being placed into the generator pocket. The generator was not tested prior to implant. Another generator was used for the case. The surgeon claims that cautery was not used when the generator was presented into the field. The unused generator has not been returned to date.

Event Description
Additional programming history was reviewed and decoded which showed that initial interrogation of the device showed 3. 272 volts. Subsequent diagnostics found the device at 1. 937 volts and showing vbat < eos indicating that electrocautery likely struck the device causing it to disable.

Manufacturer Narrative

Event Description
The explanted generator was returned to the manufacturer for analysis. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Diagnostic testing indicated the device was operating properly and showed a non-ifi condition. The eos condition was not duplicated once the output was re-enabled. The cause of the eos condition was not determined. Other than the eos condition, there were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4102486
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« Reply #119 on: November 05, 2017, 02:42:52 AM »

Model Number 103
Event Date 03/01/2014
Event Type Injury
Manufacturer Narrative

Manufacturer Narrative
Sex; corrected data: the initial mdr inadvertently reported the patient¿s sex incorrectly.

Event Description
It was initially reported that the patient had a generator replacement (b)(6) 2014. The patient picked at the incision site and had a sore on the left side of incision. The surgeon wanted to go in and re-center the generator. During surgery while repositioning the generator it was determined during system diagnostics that the generator was at end of service. As the patient was recently implanted the end of service condition was likely due to use of electrocaudary. The generator was replaced that day. Attempts for additional information have been unsuccessful. The generator malfunction related to the electrocadary will be reported on medwatch 1644487-2014-02494.

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« Reply #120 on: November 11, 2017, 02:08:07 AM »

Model Number 104
Device Problem Battery issue
Event Date 10/06/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that this patient's device was showing to have a battery status indicator of 25%, which the doctor did not expect, as the generator was only implanted a few months ago. Electrocautery was reported to have been used during the patient's previous replacement generator surgery. The device history record of the generator was reviewed, and it shows that no unresolved non-conformances were found. Data from the patient's device was reviewed and it confirms that the battery depleted more quickly than expected. 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=6991698
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« Reply #121 on: November 14, 2017, 01:50:12 AM »

Model Number 105
Event Date 01/26/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery on (b)(6) 2015 due to an increase in seizures, the vns patient¿s replacement generator was tested with the existing lead which showed normal device function and battery status. After the patient was closed, the device was tested again and showed an end of service condition. The patient was reopened and another generator was used for the procedure. Follow-up revealed that electrocautery was used for the subcutaneous tissue during the procedure while the generator was inside the generator pocket. There was no indication that electrocautery had contacted or damaged the generator upon removal. Gloves were worn throughout the surgery to prevent potential static discharge to the generator. The suspect generator has been returned to the manufacturer where analysis is currently underway. The increase in seizures event was reported in manufacturer report # 1644487-2014-03183.

Event Description
Analysis of the returned generator was completed. Review of the downloaded data indicated that the pulse disabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4532198
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« Reply #122 on: November 14, 2017, 01:51:06 AM »

Model Number 103
Event Date 01/23/2015
Event Type Malfunction
Event Description
It was reported that during generator replacement surgery device diagnostics with the new generator and existing lead were within normal limits both inside and outside of the generator pocket and once the incision was closed device diagnostics showed ifi - yes. It was reported that electrocautery was not brought back into the field during incision closure; however, it was on the table near the patient which may have discharged during incision closure. A new generator was then implanted. A device programming decoder showed that the battery voltage changed from 3. 354v to 2. 022v between 9:04:31 and 10:00:41 on (b)(6) 2015. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Manufacturer Narrative

Event Description
Analysis of the returned generator was completed. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant or explant. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The battery of the returned generator was measured as 3. 095 volts showing an ifi=no condition. The downloaded data revealed that 1. 629% of the battery had been consumed. Other than the observed pulse disablement and burn marks, 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=4532316
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« Reply #123 on: November 14, 2017, 01:51:52 AM »

Model Number 103
Event Date 01/28/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4). The initial mdr inadvertently did not include the suspect device udi. This report is being submitted to correct this data.

Manufacturer Narrative

Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was hit by electrocautery which resulted in a low battery condition of the device. The surgeon elected the implant the device. Follow-up revealed that the patient¿s device was functioning normally.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4536309
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« Reply #124 on: November 15, 2017, 01:29:42 AM »

Model Number 103
Event Date 11/17/2014
Event Type Malfunction
Event Description
Additional information was received from the neurologist stating that the patient did not have any surgeries since implant during which the generator may have been struck by electro-cautery. However, the neurologist did state that the patient swipes her vns magnet excessively which he believes may have contributed to the premature battery depletion. Additional information was received that the patient's device was showing ifi=yes during a follow up appointment (b)(6) 2015. The patient then underwent a generator replacement surgery on (b)(6) 2015 due to neos=yes. The explanting facility discarded the explanted device; therefore, no analysis can be performed. Programming data was received. Review of the received programming data revealed that upon the initial follow up appointment following the patient's (b)(6) 2014 generator replacement surgery, the generator was seen to be pulse disabled with a pulse disabled error message being seen. The eos pulse disabled condition found upon the first follow-up visit after implant surgery suggests that the device was likely hit with electro-cautery during device implant. This would account for the decreased in generator longevity. Based on the data received, the patient's recorded magnet swipes did not appear to be excessive.

Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to near end of service. Clinic notes were received indicating that the patient¿s device battery indicator showed 100% battery life remaining during an office visit on (b)(6) 2015; however, during an office visit on (b)(6) 2015, the battery life indicator showed 20% battery life remaining. Attempts for additional relevant information have been unsuccessful to date.

Manufacturer Narrative

Manufacturer Narrative
Review of the available programming and diagnostic history was performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4622778
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« Reply #125 on: November 16, 2017, 02:16:40 AM »

Model Number 105
Event Date 02/16/2015
Event Type Malfunction
Event Description
Analysis of the returned generator was completed. Review of the data indicated that the generator reached end of service condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the end of service condition. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 3. 234 volts, shows an ifi=no condition. No signs of manipulation of the returned setscrew were present (socket not stripped) and the septum was not returned for evaluation. The header septum cavity meets the specified requirements. Therefore, a root cause for the condition could not be determined. Additionally, the lead replacement surgery that occurred on (b)(6) 2015 was also reported in manufacturer report # 1644487-2014-01974.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Describe event or problem. Corrected data: the manufacturer report number for the lead replacement surgery was inadvertently left out of the initial report.

Event Description
During a lead replacement surgery, the septum plug from the generator came out. The septum plug was reinserted into the generator with no issues. However, after connecting the lead to the generator, diagnostics indicated that the newly implanted generator was near end of service. The use of the hex screwdriver during the placement of the septum plug is suspected to be cause of the premature battery depletion of the generator. The generator was replaced and returned to manufacturer on (b)(6) 2015. Analysis is underway but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4595931
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« Reply #126 on: November 19, 2017, 01:13:21 AM »

Model Number 103
Event Date 04/13/2015
Event Type Malfunction
Event Description
It was reported that during initial implant surgery on (b)(6) 2015, the vns patient¿s device was tested after the lead pin was tunneled from the neck incision site to the generator pocket and system diagnostic results showed an end of service condition. The device was tested prior to tunneling the lead which showed battery status as ok. Another generator was used for the implant and the procedure was completed. Review of the internal device data shows that battery voltage was measured at 3. 243v and pulse enabled during a system diagnostics test performed on (b)(6) 2015 at 01:11:34 pm. Another system diagnostic test was subsequently performed at 01:29:13 pm which measured the battery voltage at 1. 941v and pulse disabled due to vbat < eos threshold. The explanted generator has been returned to the manufacturer where analysis is currently underway.

Manufacturer Narrative
(b)(4). Review of the available programming and diagnostic history.

Event Description
Analysis of the returned generator was performed and burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The battery of the returned generator was measured as 3. 048 volts showing an ifi=no condition. The downloaded data revealed that 0. 938% of the battery had been consumed. Other than the observed pulse disablement and burn marks, there were no performance or any other type of adverse conditions found with the pulse generator. The cause for the reported premature battery depletion was due to electromagnetic induction (emi) or electrostatic discharge (esd) transients. Premature battery depletion can result from the use of electrocautery during surgery or an electrostatic discharge imparted to the generator through the torque wrench used.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4757606
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« Reply #127 on: November 20, 2017, 02:40:16 AM »

Model Number 103
Device Problems Premature end-of-life indicator; Defective item; Device displays error message
Event Date 06/10/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
An user facility medwatch was received on 10/05/2015 reporting an unspecified error during device replacement requiring a second procedure. The medwatch report date was 07/07/2015 via the fda's medwatch program and report # was mw5044181.

Event Description
It was reported that the patient had generator replacement on (b)(6) 2015, and was seen post-operatively to turn on the replacement device, but a near end of service (neos) message was observed upon interrogation. The surgeon reported that electro-cautery was not used in proximity to the generator during surgery. He felt that the generator was defective. The generator was subsequently replaced the same day. The explanted generator has not been received to date by the manufacturer for analysis. The hospital¿s policy is to keep explanted devices. Good faith attempts for additional, relevant information have been unsuccessful to date.

Event Description
It was reported that the company representative observed end of service vbat < eos message on two different programmers. The hospital registered nurse reported that it is possible that the resident used bovie electrocautery. If electrocautery comes in contact around the generator, this is a known cause for premature end of service of the battery.

Event Description
A copy of the programmer data from the surgery was reviewed. The device was interrogated on date of implant and was set to 1. 5ma. The battery status indicator was already revealing near end of service (neos) = yes. It was reported that the device was off at time of implant. Review of the generator device history record was performed and confirmed that all quality specifications were passed prior to distribution. No anomalies were observed during the manufacturer process, and the device was confirmed to be set to 0ma at time of manufacturer release.

Manufacturer Narrative
The user facility medwatch report received was identified to be related to the event previously reported within this manufacturer report which reported the events and device information previously. (b)(4). Based on the investigation, the premature end of life of the generator is suspected asic latch-up as a result of electrocautery during implant surgery. However, a definitive conclusion cannot be made, as the explanted generator was not received by the manufacturer for analysis. Good faith attempts for product return have been unsuccessful. This event is addressed in labeling and is due to asic latch-up. Per section 1. 6. 4. 1 of the vns therapy system physician's manual (u. S. ), "use of electrosurgery (electrocautery or radio frequency [rf] ablation devices) may damage the pulse generator. During the vns implantation procedure, do not use electrosurgical equipment after the pulse generator has been introduced to the sterile field. [. ] electrostatic discharge (esd) may damage the pulse generator. Care should be taken when using the hex screwdriver to avoid touching the metal shaft when the screwdriver is engaged with the setscrew of the pulse generator. This shaft can serve as a path to conduct electrostatic discharges into the device circuitry. ".

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« Reply #128 on: November 21, 2017, 02:08:49 AM »

Model Number 103
Event Date 05/22/2015
Event Type Malfunction
Event Description
It was reported that during generator replacement surgery a vbat

Event Description
Analysis of the explanted generator was completed on 06/17/2015. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were also observed on the pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status indicated ok. The battery voltage value stored within the generator (3. 051 volts reported during fet) suggests the device is not at a near end-of-service condition.

Manufacturer Narrative
Suspect device udi: (b)(4).

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« Reply #129 on: November 22, 2017, 03:14:15 AM »

Model Number 103
Event Date 05/12/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
The generator was received for analysis. Product analysis was completed on 06/29/2015, which revealed that the complaint of high impedance was not duplicated in the product analysis laboratory. Various electrical tests were performed and results of the diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. No obstructions were observed where the lead inserts into the generator, and a bench lead was able to be fully inserted into the header. The output signal was monitored and results showed no signs of variation in the generator's output signal and demonstrated that the device provided an expected level of output current. It was found that the generator performed according to functional specifications. There is sufficient evidence to support that the high impedance was caused by user error. Since the replacement of the generator resolved the high impedance, product analysis showed there were no anomalies with the generator, and the generator had been implanted for less than a year, it can logically be concluded the high impedance was caused by the lead pin not being fully inserted into the generator.

Event Description
It was reported that the patient was referred for surgery due to high impedance being observed. The generator was programmed off after observing the high impedance. During surgery, the surgeon indicated that he inadvertently hit the generator with electrocautery when opening the generator pocket. The surgeon opted to implant a new generator without first checking the existing generator. A new generator was placed and device diagnostics were within normal limits with the new generator connected to the existing lead. The explanted generator was checked with the test resistor which showed that the generator was performed as intended. The explanted generator has not been received for analysis to date.

Manufacturer Narrative
Device available for evaluation; corrected data: this information was inadvertently left off of the initial mfr. Report.

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« Reply #130 on: November 23, 2017, 01:40:53 AM »

Model Number 105
Event Date 06/18/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during the patient's exploration surgery, electrocautery was used and may have touched the patient's generator, causing an asic latch-up condition, resulting in premature end of battery life. Pre-operative diagnostics yielded neos=no, but after the generator was re-positioned in the patient, diagnostics read neos=yes. The surgeon stated that he did not strike the generator with electrocautery. The generator was replaced. The explanted generator has been received by the manufacturer for analysis. However, analysis has not been completed to date.

Event Description
Analysis of the explanted generator was completed. Review of the data downloaded from the generator indicated that the pulse had been disabled by the generator. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device explant, which may have been a contributing factor. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 139 volts as measured during completion of the final electrical test, shows an ifi=no condition. Other than the noted pulse disabled event, there were no additional performance or any other type of adverse condition found with the pulse generator. An fda medwatch 3500a form was received by the manufacturer from the user facility regarding this event, stating that the device did not perform as intended (uf/importer report # 3902560000-2015-8031).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4902167
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« Reply #131 on: November 23, 2017, 01:41:46 AM »

Model Number 105
Event Date 06/15/2015
Event Type Malfunction
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015. The generator was near end of service but was unable to be interrogated at the time of the procedure believed to be due to end of service. The lead was replaced prophylactically. During the procedure, the surgeon replaced the patient's generator and subsequently used electrocautery to replace the lead. When the device was tested after the device replacements, the replacement generator showed an end of service condition. The device was tested prior to the use of electrocautery and the device showed battery status as ok. Another generator was used to complete the procedure. The explanted devices and the opened but unused generator were returned to the manufacturer for analysis. The end of service condition and failure to program with the explanted generator was the result of normal, expected battery depletion. The device performed according to functional specifications. Analysis concluded that no abnormal performance or any other type of adverse condition was found. Review of the data from the opened but unused generator indicated that the pulse disabled byte was set to a value that represents a vbat

Event Description
Analysis of the returned lead portion was completed. The condition of the returned lead portion were consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4905425
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« Reply #132 on: November 23, 2017, 01:42:47 AM »

Model Number 103
Device Problem Device operates differently than expected
Event Date 06/26/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient's generator showed neos-yes. The device was recently implanted on (b)(6) 2015. The patient had scheduled surgery on (b)(6) 2015 due to events reported in mfg report #: 1644487-2015-05282. The surgeon for the surgery on (b)(6) 2015 felt that the generator was most likely depleted due to electrocautery coming into contact with the generator during implant. The generator was replaced on (b)(6) 2015. The explanted product has not been received by the manufacturer for analysis to date. Good faith attempts for additional, relevant information have been unsuccessful to date.

Event Description
The patient had surgery on (b)(6) 2015 due to high impedance, as captured in mfg report #: 1644487-2015-05282. The generator was reported to have shown end of service pulse disabled message on that date. As a result, the generator was replaced on (b)(6) 2015. It was reported that the generator showed near end of service upon system diagnostics, and the surgeon felt that this was most likely depleted due to electrocautery coming into contact with the generator during implant. No additional relevant information has been received to date.

Event Description
It was reported that the explanted device is not being returned to the manufacturer per hospital policy. As a result, analysis is unable to be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4936810
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« Reply #133 on: November 23, 2017, 01:43:51 AM »

Model Number 103
Device Problem Device displays error message
Event Date 07/01/2015
Event Type Malfunction
Event Description
Analysis was completed for the returned generator. Review of the generator data indicated that the device was at end of service and was in a pulse disabled condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device surgery which may have been a contributing factor. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. Other than the generator premature end of service condition due to electrocautery usage near the presence of the device, there were no adverse conditions found with the pulse generator.

Manufacturer Narrative

Event Description
It was reported that during repositioning surgery reported in manufacturer report # 1644487-2014-03433, the vns patient's generator incision site was created using electrocautery and the generator subsequently showed an end of service condition. The surgeon replaced the device during the procedure. A battery life calculation using the available programming history showed > 10 years remaining. The explanted generator has been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940160
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« Reply #134 on: November 23, 2017, 01:44:41 AM »

Model Number 104
Event Date 06/30/2015
Event Type Malfunction
Event Description
Analysis was completed on the generator. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

Manufacturer Narrative

Manufacturer Narrative
Suspect device udi: (b)(4). The initial report inadvertently did not report this data.

Event Description
During planned generator replacement, it was reported that a replacement generator reached premature near end of service condition. This condition was suspected to be due to the surgeon using electrocautery during the procedure. Another replacement generator was then successfully implanted. The unused generator was received by the manufacturer. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4940244
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« Reply #135 on: November 28, 2017, 01:42:17 AM »

Model Number 302-20
Device Problem High impedance
Event Date 07/29/2015
Event Type Malfunction
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
If follow-up, what type; corrected data: the suspect medical device should have been changed to the model 105 generator serial number (b)(4) on follow-up report #2 but it wasn't changed until follow-up report #3. Therefore, follow-up report #3 should have been marked as a correction mdr for section.

Event Description
On (b)(6) 2016 it was reported that during pre-op for the surgery for the patient, he checked the patient's device and received high impedance, >10,000ohms, and the battery was completely full. They took the patient into surgery and opened up the pocket. The surgeon was able to see that the leads were not all the way in, so he took it out and put it back in making sure that the pins were in and the setscrew was tightened till it clicked. Then when they did the diagnostics, the impedance was all fine, however now has a message stating battery is near eos (neos=yes) and the battery icon only has a small line of red showing. Electrocautery was used to open up the pocket. Therefore, the generator was replaced as well.

Event Description
It was reported that the patient was referred for exploration surgery to try and reinsert the lead pin into the generator. Although surgery is likely, it has not occurred to date.

Event Description
A copy of the patient's x-rays were received for review. The filter feedthru wires were intact. The connector pin does not appear to be fully inserted inside the connector block, as the pin was not visualized to pass completely through the connector block. The lead wire was intact at the location of the connector pin; however there was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities in the portion of the lead that could be visualized near the generator. The electrode placement was performed as per labeling. Strain relief is present but is not per labeling as there is no strain relief loop. Three tie downs appear to be present. There were no obvious discontinuities with the lead; however, a micro-fracture in the lead cannot be ruled out.

Event Description
It was later reported on (b)(6) 2015 that x-rays were ordered. They have not been received for review by the manufacturer to date.

Event Description
On (b)(6) 2015 it was reported that the patient has high impedance on both normal mode and system diagnostics that was found on (b)(6) 2015; lead impedance-high/output-limit. There was no trauma to the area and the physician stated that there were no apparent causes. She referred the patient for revision surgery. The physician reported that x-rays were not taken. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4964498
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« Reply #136 on: November 30, 2017, 02:17:32 AM »

Model Number 104
Device Problem Device operates differently than expected
Event Date 08/18/2015
Event Type Malfunction
Event Description
On (b)(6) 2015 it was reported that during the prophylactic generator replacement, the surgeon was closing the pocket for the new generator and he needed to use the cautery on the tissue. After that, the generator was interrogated and diagnostics were performed, which both revealed the warning of "vbat>eos. " it was confirmed that the generator was interrogated before, outside the field, to program the patient initials and was confirmed to be at eos= no. The backup generator was used with no further issues. The surgeon is aware of the precautions but was thinking that because the pocket was closed it wouldn't be an issue. The surgeon was informed of the precautions regardless of the procedure being performed, which he understood. The generator was returned for product analysis. Product analysis is still underway and has not yet been completed to date.

Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data: inadvertently did not include udi on initial report.

Event Description
Product analysis was completed on the generator on (b)(4) 2015. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5072958
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« Reply #137 on: December 01, 2017, 02:07:33 AM »

Model Number 103
Device Problems Premature discharge of battery; Device displays error message
Event Date 06/01/2015
Event Type Malfunction
Event Description
Analysis was completed on the returned vns generator. Analysis showed burn marks on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool. In the analysis lab, the device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. No additional relevant information has been received to date.

Event Description
It was reported that the patient's generator was showing about 25% battery life remaining per battery icon upon interrogation when a few months prior the generator was showing a 100% on the battery icon. It was noted that in (b)(6) 2015, the patient went in for an mri and at that time it was said that the device had "turned itself off" per the family as communicated to them. Additionally there was mentioned" errors when interrogated" but it was not clear on what was visualized.

Event Description
Additional information was received that the patient underwent generator replacement surgery on (b)(6) 2015 due to premature battery depletion. It was reported that the patient's device was seen to show ifi=yes on pre-operative interrogation and then ifi=no on pre-operative diagnostics. Programming history was reviewed and showed normal device functionality on (b)(6) 2014. However, the patient then reportedly had a corpus callosotomy surgery in (b)(6) 2015. The next time the patient was seen appears to be (b)(6) 2015 at which time the device was interrogated and displayed a vbat

Manufacturer Narrative

Event Description
Additional information was received that the patient's nurse practitioner was concerned that the patient's generator may have been struck by electro-cautery during a corpus colostomy procedure in (b)(6) 2014. It was stated that a couple of weeks after the procedure the patient was set to have an mri, so the device was to be disabled. However, it was reported that at that time the patient's device was already turned off and was giving errors (thought to be end of service errors). Additional information was received from the nurse who interrogated the patient's device in (b)(6) 2014. She stated that the patient came in for a follow-up appointment on (b)(6) 2014 to have the device disabled for an mri, but the devices normal and magnet currents were already set to 0ma. She also stated there was an error message telling her to contact the manufacturer. She stated that she then titrated the patient back up to 1. 25ma normal and 1. 5ma magnet output current. System diagnostics were within normal limits. The patient tolerated the titration well. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5177701
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« Reply #138 on: December 01, 2017, 02:08:45 AM »

Model Number 106
Device Problems Device displays error message; Battery issue
Event Date 09/29/2015
Event Type Malfunction
Event Description
Product analysis was completed on the returned vns generator. Review of the data download from the vns generator indicated that the device was set to an eos (end of service) condition. However, burn marks were observed on the pulse generator case indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant which may have been a contributing factor to the eos pulse disabled condition. The vns generator was reset to allow for an output to once again be provided by the vns generator for subsequent testing. Additionally, review of the downloaded data from the generator suggests that a diagnostic test was performed and an acceptable impedance value was found on (b)(6) 2015. During product analysis, the premature end of life condition was not duplicated. The generator diagnostics were as expected for the programmed parameters. Electrical testing showed that the generator performed according to functional specifications. The battery voltage showed an ifi = no condition. The sensing functions of the vns generator performed according to specifications. Other than the noted vns generator pulse disabled event, there were no performance or any other type of adverse condition found with the generator.

Manufacturer Narrative
(b)(4).

Event Description
It was reported by the physician that the m106 generator was interrogated prior to surgery. It was noted that once the m106 generator was attached to the lead and interrogated once more, it was found the generator had the eos (end of service) message and the battery was showing the red x. No electrocautery was used after the generator went into the sterile field. However, it is unknown if the surgeon touched the metal shaft of the hex screwdriver, which could have possibly caused electrostatic discharge. A new m106 generator was used and implanted. The new m106 generator was interrogated, diagnostics results were good, and the generator was able to pick up heart rate. The dhr for the m106 generator was reviewed and found complete. No anomalies were noted and all tests were passed. The m106 generator was received by the manufacturer. Product analysis is expected, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5181489
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« Reply #139 on: December 06, 2017, 02:07:15 AM »

Model Number 104
Device Problem Failure to advance
Event Date 10/09/2015
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
It was reported that during generator replacement for end of service, the surgeon needed to reposition the generator pocket after placing the new generator in the device pocket. The surgeon was informed that using electrocautery while the generator was in the pocket was not advised. Device diagnostics then showed that the generator was at vbat >eos indicating that the generator may have been struck by electrocautery. The generator was not implanted and a new generator was placed with no issues. The generator was received for analysis. Analysis is underway, but has not been completed to date.

Event Description
Analysis of the generator was completed on 11/09/2015. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status indicated ok and the impedance value was normal. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the pulse disabled condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5199220
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« Reply #140 on: December 06, 2017, 02:08:15 AM »

Model Number 103
Device Problems Improper or incorrect procedure or method; Device displays error message
Event Date 10/09/2015
Event Type Malfunction
Event Description
Analysis was completed on the generator. Review of the data indicated that the pulse-disabled byte was set to a value that represents a vbat

Manufacturer Narrative
(b)(4).

Event Description
During a generator replacement surgery on (b)(6) 2015, electrocautery was used on the new generator that was to be implanted. The new generator showed a "vbat < eos" message and was replaced during the same surgery. Labeling indicates that the use of electrocautery may damage the pulse generator and warns not to use electrosurgical equipment after the pulse generator has been introduced to the sterile field. The suspect generator was received on 10/14/2015. Analysis is underway but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5194731
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« Reply #141 on: December 11, 2017, 01:35:53 AM »

Model Number 105
Event Date 01/22/2016
Event Type Malfunction
Event Description
During initial implant surgery on (b)(6) 2016 the generator showed the warning message of "vbat < eos" during interrogation after the lead was connected. It was confirmed that at initial interrogation, it didn't show an end of service (eos) condition and was programmed successfully with no issues. It was also noted that the generator was in the hospital for at least 45 minutes before use, so temperature was not an issue. He indicated that this warning happened after the device was in the sterile field and with the use of cautery while the generator was in the sterile filed. A back-up generator was therefore implanted. Attempts were made for return of the generator but it has not been received to date.

Event Description
On (b)(6) 2016 the explanted generator was returned for product analysis. Product analysis completed on the generator confirmed an output pulse disabled condition due to a perceived low battery voltage. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant/explant, which may have been a contributing factor. There were no additional performance or any other type of adverse condition found with the pulse generator.

Manufacturer Narrative

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5437224
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« Reply #142 on: December 25, 2017, 01:37:54 AM »

Model Number 106
Event Date 08/10/2016
Event Type Malfunction
Event Description
The explanted generator and lead were received on 09/8/2016. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Review of the data downloaded from the generator indicated that the ¿pulse disabled¿ byte was set to a value that represents a "pulse watchdog timeout" condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulse disabled bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The reported allegations of ¿energy output to patient tissue incorrect¿ and ¿output current low¿ were not duplicated 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. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 3. 039 volts, shows an ifi=no condition. The reported allegation of ¿premature end of life (eol)¿, was not duplicated in the pa lab. The data in the ¿diagvbat¿ (as received, ram and flash data) memory locations shows a value of 2. 904 volts. However, the data in the ¿diagvbat_min¿ memory locations show a value of 1. 788 volts on (b)(6) 2016, indicating an eos condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the explant procedure, which may have been a contributing factor. Other than the noted events (¿pulse disabled¿ and eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

Manufacturer Narrative
(b)(4).

Event Description
Patient underwent surgery on (b)(6) 2016 for high impedance as reported in mfr report # 1644487-2016-01850. During the surgery, the surgeon had attempted multiple pin re-insertions and this did not resolve the high impedance. No fractures can be visualized in the lead body but the lead was revised. The generator was removed from pocket and placed on the table. After the lead was revised, the generator was connected to the new lead. Diagnostics showed that the impedance was within normal limits but the battery was showing neos - yes. Per company representative who was present during the surgery, the battery life of the generator was good prior to surgery and during the surgery prior to lead revision. After the lead was revised, the generator was connected to the new lead. Diagnostics showed that the impedance was within normal limits but the battery was showing eos. It is suspected that electrocautery use or something else cause the battery depletion during the lead revision surgery. Per implant card, the lead and generator were replaced due to "lead discontinuity" and "battery showed eos. " the programming history for the generator was reviewed from the day of surgery. Several system diagnostics were performed as shown below. The first four tests are believed to have been performed before the lead was revised. The last two tests were performed after the lead revision and possible use of electrocautery. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5916383
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« Reply #143 on: December 27, 2017, 01:41:20 AM »

Model Number 106
Event Date 07/07/2016
Event Type Malfunction
Event Description
Analysis of the generator was approved on 08/09/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 966 volts as measured, showed an ifi=no condition. The data in memory locations revealed that 0. 639% of the battery had been consumed. The measured battery voltage showed a value of 3. 267 volts. However, the minimum battery voltage showed a value of 1. 607 volts, indicating an end of service condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (end of service condition), there were no performance or any other type of adverse condition found with the pulse generator.

Event Description
It was reported that a patient was undergoing full revision surgery to get the newest model generator and single pin lead. Diagnostics were performed with the generator outside of the pocket, and everything was ok. After the generator was implanted and the site was sewn up, the generator was interrogated and showed neos = yes. Diagnostics were performed multiple times over a span of about 10 minutes, which all resulted in neos = yes. The physician decided to replace the generator. The physician stated that he was almost positive that he had not utilized cautery. The device history record for the affected device was reviewed and no unresolved non-conformances were noted. Programming data indicated that the battery voltage of the generator was at an expected level at the start of the surgery, but the voltage dropped substantially during the surgery. The generator was received on 07/21/2016. Analysis has not been approved to date.

Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5837281
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« Reply #144 on: December 27, 2017, 01:42:28 AM »

Model Number 106
Event Date 07/13/2016
Event Type Malfunction
Event Description
The pulse generator performed according to functional specifications of the final configuration r-wave test). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 095 volts, shows an ifi=no condition. The data in the ¿diagvbat¿ (as received, ram and flash data) memory locations shows a value of 3. 533 volts. However, the data in the ¿diagvbat_min¿ memory locations show a value of 1. 789 volts, indicating an eos condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

Manufacturer Narrative
Suspect device udi: (b)(4).

Event Description
During the generator replacement surgery for patient, the new m106 that the physician was attempting to implant was found to be eos upon implant. The physician ended up using a backup m106 device for the implant as a result. A review of device history records for the generator shows that no unresolved non-conformances were found. The suspected device was received on 07/19/2016. Analysis is underway but has not been completed to date. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5851516
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« Reply #145 on: December 30, 2017, 01:17:08 AM »

Model Number 302-20
Device Problems Fluid leak; Fracture; Mechanical issue
Event Date 08/12/2016
Event Type Malfunction
Event Description
Abraded openings were noted on the outer and the inner silicone tubing of the lead coils resulting in portions of the lead coils being exposed. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends show what appears to be wear (flat surfaces) on the coils strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break. Also, scanning electron microscopy images of the lead coils at the suspected torn ends of the first portion of the returned lead show appearance suggesting that the coils were exposed to some type of electro-cautery tool (most likely at explant). One strand shows appearance suggesting that the coils were torn. Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description
Additional programming data was received.

Event Description
Patient underwent generator replacement on (b)(6) 2016 and the lead impedance at the time of implant was 687 ohms. The patient had a follow up visit on (b)(6) 2016 and after interrogation, the impedance shown was below 600 ohms, indicating low impedance (< 600 ohms). No known interventions were taken since the patient is receiving efficacy. The impedance will be monitored during each clinic visit.

Manufacturer Narrative

Event Description
Patient underwent lead revision surgery on (b)(6) 2016. The generator was tested with the resistor pin and the impedance was 3246 ohms. The lead wire was noticeably frayed and thus a new lead was implanted. Impedance on new lead when connected to the existing generator was 1029 ohms. The explanted lead was received on 11/28/2016. Analysis is underway but has not been completed to date.

Event Description
Additional programming data was received.

Manufacturer Narrative
Relevant tests/laboratory data, including dates; corrected data: (b)(6) 2016 09:19:46 am: diagvinitialprechange ¿ 483 ohms / diagvinitialpostchange ¿ 650 ohms / time of change detection ¿ (b)(6) 2016 16:17 estimated occurrence (implant (b)(6) 2016). Initial mdr inadvertently indicated the implant date to be (b)(6) 2016 instead of (b)(6) 2016.

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« Reply #146 on: December 31, 2017, 01:45:34 AM »

Model Number 106
Event Date 09/19/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
The generator was received for analysis on 10/26/2016. Product analysis is currently underway but has not been completed to date.

Event Description
Product analysis for the m106 sn: (b)(4) was completed and approved on 11/22/2016. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

Event Description
It was reported on (b)(6) 2016 that during a case for a model m106 implantation, the device was interrogated prior to the case and the patient¿s initials were entered with no problems. The device was connected to the lead outside the pocket and diagnostics were performed. The lead was ok but a low battery message, neos-yes was received. No cautery was used when the device was in the field. System diagnostics were performed again and still a low battery message was received. A backup generator was advised to be used. A review of the design history record showed that the generator passed all functional tests prior to distribution into the field. The device has not been received for analysis to date.

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« Reply #147 on: January 01, 2018, 02:17:58 AM »

Model Number 105
Event Date 09/28/2016
Event Type Malfunction
Manufacturer Narrative
Suspect device udi number: (b)(4). Initial reporter phone number: (b)(6).

Event Description
The generator had product analysis completed and it was unable to be interrogated and diagnostics were unable to be performed in the lab. Contaminates were identified on the trimmed edge of the printed circuit board assembly (pcba). The pcba was subjected to a postburn test where it failed several electrical tests. After the trimmed edge of the pcba was cleaned and the contaminates were removed, the pcba passed the postburn test and performed according to functional specifications. The battery voltage with the case removed and the generator battery attached to the pcba confirmed the end of service condition.

Event Description
Additional programming data was provided and did not show any indication of electrocautery usage during implant. The patient's generator was explanted on (b)(6) 2016 and was not able to be communicated with during surgery. The generator was reportedly sent for analysis, but has not been received to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a physician was unable to change a patient's settings. The patient had recently been implanted. Later follow-up found that the following message was identified when the generator was interrogated on (b)(6) 2016: vbatt < eos threshold. The device had been disabled (set to 0ma). The interrogation prior (on (b)(6) 2016) showed an expected value for the battery voltage. All diagnostics showed impedance values within normal limits. The patient had reportedly not undergone any surgeries and was not exposed to any electrical discharges between these two interrogations no known surgical intervention has occurred to date.

Event Description
The generator was returned to the manufacturer and is currently undergoing product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6064569
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« Reply #148 on: January 02, 2018, 02:01:12 AM »

Model Number 106
Event Date 10/27/2016
Event Type Malfunction
Event Description
Analysis completed on the suspect generator resulted in : the data in the ¿diagvbat¿ ((as received, ram and flash data)) memory locations show a value of 3. 432 volts ((b)(6) 2017 estimated last automeasure). However, the data in the ¿diagvbat_min¿ memory locations show a value of 1. 716 volts ((b)(6) 2016 estimated time of occurrence (one day after implant attempt (b)(6) 2016)). Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. The reported allegation of ¿asic latch-up condition¿ could not be verified in the product analysis laboratory. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that an incident occurred during battery replacement. The new generator was checked outside the pocket and everything was fine. After been placed inside the pocket, the generator test showed eos flag. No diagnostics were performed at this point, another generator was implanted in patient. Return of suspect generator opened but not to the manufacturer is expected, but it has not been received to date. It was queried if electrocautery was used at some point, but the nurse could not confirm this. Review of manufacturing records confirmed all tests passed for the generator prior to distribution.

Event Description
The suspect faulty generator was received by the manufacturer. Analysis of the device is underway, but it has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6116165
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« Reply #149 on: January 05, 2018, 03:18:43 AM »

Model Number 103
Device Problem Premature end-of-life indicator
Event Date 01/30/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
Programming history was reviewed with the data from the date of implant through 1. 5 years after implant. There was no indication that the battery was depleting quicker than normal, and there was no evidence that the device had come into contact with an electrocautery tool after implant surgery. It was reported that the patient had generator replacement surgery. The reason for replacement was indicated as premature battery depletion/ifi yes. The explanted generator was not interrogated nor were diagnostic tests performed prior to surgery. A second decoder was performed using data from 1. 5 years after implant through the date of the event. A comparison of the charge consumed and the corresponding voltage showed that the generator voltage was dropping quicker than normal. The generator was received, but analysis has not been approved to date. No additional information has been provided to date.

Event Description
It was reported that a patient's device was at ifi = yes during a clinic visit. The patient had only been implanted for 3 years and was not at high settings, so the physician's assistant was concerned that the ifi flag appeared prematurely. The patient was referred for replacement surgery. It was later reported that the patient had an upper endoscopy performed 7 months after implant. The type of tools used during the endoscopy are unknown. A programming history review revealed no anomalies in the available programming history. No additional information has been provided to date. No surgical intervention has taken place to date.

Event Description
Analysis was approved for the generator. When received, the data was downloaded from the generator and reviewed. Burn marks were observed on the pulse generator can and header, which indicated that the pulse generator may have been exposed to an electrocautery tool; however, it could not be determined if these marks were implant or explant related. Programming history did not indicate a low battery at the time of the implant. No other surface abnormalities were noted on this device. The generator was opened. A visual assessment of the internal circuitry revealed no visual anomalies. The generator was subjected to radiographic examination. No visual anomalies of the circuitry were noted during examination. A system diagnostic test performed yielded results within the normal limits and showed the device was at ifi = yes. The generator performed according to functional specifications. The ifi battery status showed that the battery was partially depleted, as measured during electrical testing. The battery voltage was measured, and results showed that the measurement circuit was operating properly. The manufacturing device history was reviewed. No anomalies were noted during review and all steps met specification. The cause of the premature battery depletion could not be determined; however, the battery depletion appears to possibly be premature based on the downloaded data. The battery has been sent to the vendor for further analysis, but no further information regarding the analysis has been received to date. The patient was noted to have undergone a generator repositioning surgery 1 year after implant; however, it is unknown if electrocautery was used during the surgery. The patient's implanting physician did not have any programming data available from the date of implant as the surgeon does not have a programming system. No additional relevant information has been provided.

Manufacturer Narrative

Event Description
Additional analysis of the generator battery was performed externally by the battery manufacturer, and the results of testing were returned. The open circuit voltage, mid-cell thickness, impedance and microcalorimetry measurements of the battery component are all consistent with a beginning to middle of life cell. The cathode separator was thoroughly inspected at two different magnifications. No defects were noted in the cell assembly. The internal glass-to-metal seal was also thoroughly inspected. The cell exhibited an acceptable pin to lid resistance value. Additionally, the header assembly passed leak testing. No defects were identified during the destructive analysis that would account for the early depletion of the cell as noted by the vns manufacturer. No additional relevant information has been provided to date.

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« Reply #150 on: January 26, 2018, 02:26:23 AM »

Event Date 08/30/2010
Event Type Malfunction
Event Description
Reporter indicated that an unk pt who had recently been implanted with a vns was nearing end of service. The reporter questioned if the end of service could have been affected by electrocautery. Attempts for further info have been unsuccessful to date.

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« Reply #151 on: January 28, 2018, 01:50:05 AM »

Model Number 103
Event Date 09/03/2010
Event Type Malfunction
Event Description
Reporter indicated that during a vns lead replacement surgery, the generator was interrogated and found to have zero years remaining on the battery with a "vbat disabled" message. The lead was being replaced due to the pt being in a fight which caused trauma to the vns lead, and the generator was not previously at end of service. It is suspected that cautery used near the generator during the surgery, damaged the generator. A new generator was implanted and the suspect generator was returned for analysis. Analysis of the generator is pending.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #152 on: February 09, 2018, 10:57:47 AM »

Model Number 106
Device Problem High impedance
Event Date 12/15/2017
Event Type Malfunction
Event Description
A patient underwent generator replacement surgery. Diagnostics on the explanted device were within the normal limits. The existing generator was then explanted, and the new generator was introduced into the field. The physician then used electrocautery to resize the pocket. The new generator was connected to the existing lead and high impedance was observed. The lead pin was removed and reinserted into the generator, and the high impedance message was observed again. The lead was then connected to the previous generator, and impedance was within the normal limits. The lead was then connected to the new generator and high impedance was observed again. A test resistor was then inserted into the new generator, and high impedance was observed during a generator diagnostic test. Finally, a third generator was connected to the lead, and normal impedance was observed. The third generator was implanted in the patient, and the generator displaying high impedance was returned to the manufacturer for analysis. Analysis has not been approved for the returned generator to date. The company representative present at the surgery confirmed that both the lead pin and test resistor pin were fully inserted into the generator each time the device was tested, and she noted that two clicks were heard, confirming that the setscrew had been tightened adequately. The company representative reported that the generator was not dropped at any time, but she was unsure if the electrocautery present in the field may have affected the performance of the generator. No additional relevant information has been received to date.

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« Reply #153 on: February 10, 2018, 01:54:32 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 10/05/2017
Event Type Malfunction
Event Description
It was reported that product analysis had been completed on a patient's generator that had been explanted due to battery depletion. Product analysis showed the generator had reached end of service and could not be interrogated. Data from the generator showed that only about 18. 703% of the battery had been consumed at that point. Burn marks were also observed on the generator case, indicating possible exposure to an electro-cautery tool. Postburn electrical tests were run on the generator and multiple tests failed. Product analysis found remaining residual material on the pcba edge which originated from the test tab removal process. This resulted in excess current consumption. A review of the device history record indicated the generator had been manufactured using the laser-routing process which is known to produce conductive debris and result in current leakage pathways. No other relevant information has been received.

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« Reply #154 on: March 08, 2018, 02:19:00 AM »

Model Number MODEL 250
Event Date 05/23/2012
Event Type Malfunction
Event Description
Further investigation was performed in-house, however the event could not be replicated.

Event Description
It was reported from a neurologist's office that during the interrogation of the patient's generator, an ifi flag warning was observed on the patient's device. This was the first time the physician's office had ever observed the warning. When the button was selected, it would repeatedly appear and with no progression to the programming menu. The handheld computer being used was a (b)(4). A hard reset was then performed, and the patient's device was reinterrogated and the issue would repeat with no progression to the programming menu. After the hard reset, the warning appeared approximately 8-10 times before another (b)(4) handheld computer was used. After interrogation, the same event occurred. Then, a (b)(4) handheld computer was used which confirmed an ifi flag, but the site was able to click to proceed only three times before progressing to the programming menu. The patient's device was able to be successfully programmed at that time with the (b)(4) computer. Attempts for a copy of the flashcards from the neurologist's office and the handheld used at the surgeon's office are in progress, but the copied programming history has not been received to date. The issue with the other (b)(4) handheld computer and its related software is reported in manufacturer report number: 1644487-2012-01507.

Event Description
The implant card was received and confirmed the generator replacement surgery on (b)(6) 2013 was due to battery depletion with near end of service=yes.

Manufacturer Narrative

Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's referral for generator replacement. The notes indicate that the generator is now showing "end of service: yes" upon interrogation. Although surgery is likely, it has not occurred to date. The notes also mentioned that the patient continues to average 4-6 small seizures per month.

Manufacturer Narrative

Event Description
It was reported on (b)(6) 2013 that the patient had generator replacement surgery on (b)(6) 2013 due to battery depletion. The generator was returned to the manufacturer, however product analysis has not been completed to date. The return product form indicated the reason for replacement was due to end of service with eri=yes.

Event Description
Analysis of the explanted generator was completed. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicates that the pulse generator may have been exposed to an electro-cautery tool, as captured in mfg report number: 1644487-2010-01474. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The reported premature end of life and asic latch-up condition allegations were duplicated in the pa lab (associated with the pulsedisabled by the pulse generator). With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 377 volts, indicating a near end of service condition. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. Other than the noted errors, there were no performance or any other type of adverse conditions found with the pulse generator.

Manufacturer Narrative
Type of report, corrected data: the initial report inadvertently did not report that this is a '30 day report. '.

Event Description
Additional information received that now the generator is indicating neos = yes which the physician believes is premature however it is already known that the generator has been hit with electrocautery which will impact the battery capacity. Clinic notes dated (b)(6) 2012 were received for the patient who has been referred for generator replacement surgery due to neos=yes. The notes also indicated that the patient was experiencing breakthrough seizures, but the frequency appeared to be the same as previously noted and related to poor medication compliance. Although surgery is likely, it has not occurred to date. Manufacturer report number 1644487-2010-01474 captures the asic latch-up condition as a result of using electrocautery during implant surgery.

Event Description
Copies of the physician's flashcard and flashcard data from the date of surgery was received and analyzed via decoder spreadsheet where it was confirmed that on (b)(6) 2012, the battery voltage was 2. 679 confirming ifi = yes. However, the used charge accumulation was 17. 952% indicating that the battery was not depleting at an expected rate. Further review of a previous report where it was reported that during the patient's initial implant, a "vbat

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« Reply #155 on: March 13, 2018, 12:26:53 AM »

Model Number 302-20
Event Date 07/26/2012
Event Type Malfunction
Event Description
Analysis of the generator was previously completed on (b)(6) 2012, but mistakenly not included on the previous report. Analysis found the generator performed to specifications and no anomalies were found. Additional information was later received as an implant card indicating the reason for replacement was "lead discontinuity" and "prophylactic generator replacement". The lead impedance following the surgery was noted as "ok".

Manufacturer Narrative

Event Description
It was reported that the vns patient was scheduled for a lead revision due to high impedance. Additional information was received indicating that surgery to replace the patient's lead as well as replace the patient's generator prophylactically has occurred. The explanted products have been returned for analysis. Analysis of the lead has been completed. The electrode portion of the lead was not returned. A discontinuity was observed in the negative coil and a partial discontinuity was observed in the positive coil at the same location however the discontinuities appear to be related to electrocautery being used during surgery. Based on the pitting present at the site of the discontinuities, it is likely that the discontinuity was present with stimulation for some time. It is unknown whether the electrocautery damage occurred during the previous generator replacement on (b)(6) 2011 or at the recent replacement surgery on (b)(6) 2012. The generator is still undergoing analysis. Attempts for additional information have been unsuccessful to date. No adverse events have been reported.

Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently indicated that the "generator is still undergoing analysis" however analysis had been completed at that time.

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« Reply #156 on: March 15, 2018, 01:46:20 AM »

Model Number 105
Event Date 08/22/2012
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during surgery to replace the patient's vns generator, the generator indicated eos after being placed in the pocket. Diagnostics prior to placing the generator in the pocket were normal. A company representative present at the surgery indicated electrocautery had been used; however, it was not used near the generator. A back-up generator was implanted. The faulted generator was returned and underwent analysis. Analysis confirmed the generator was returned in a pulse disabled condition due to a perceived low battery voltage. After the output was re-enabled, the generator performed to specifications. No burn marks such as those created by use of electrocautery were observed on the generator can. Review of generator source code from the surgery indicates the generator was functioning normally until an event occurred resulting in a sudden drop in the battery voltage such as exposure to electrocautery or an electrostatic discharge. The cause of the pulse disabled event is unknown. No adverse events have been reported as a result of the issue.

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« Reply #157 on: March 25, 2018, 01:34:10 AM »

Model Number 304-20
Device Problems Unintended collision; Improper or incorrect procedure or method; Device displays error message; Extrusion
Event Date 10/01/2015
Event Type Injury
Event Description
It was reported that the vns patient was picking at the neck incision site and subsequently caused extrusion of the lead. The patient underwent surgery on (b)(6) 2015 and the patient's lead was replaced prophylactically. During the procedure, the patient's generator was inadvertently hit by electrocautery and the device subsequently showed a vbat < eos threshold message. Battery status prior to surgery showed ok. The generator was also replaced during the procedure. The explanted lead has been returned to the manufacturer where analysis is currently underway. Analysis of the returned lead will be reported in this manufacturer report. The explanted generator was returned to the manufacturer for analysis which was reported in manufacturer report # 1644487-2015-06497.

Manufacturer Narrative

Event Description
Analysis of the returned lead was completed. Scanning electron microscopy images of the lead coils at the exposed portions and at the cut ends show that the coils were exposed some type of electro-cautery tool. Based on the appearance of the returned lead this was most likely caused at explant. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Note that since the electrode array portion was not returned for analysis, an evaluation cannot be made on that portion of the lead.

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« Reply #158 on: March 28, 2018, 12:35:43 AM »

Model Number 104
Event Date 11/29/2012
Event Type Malfunction
Event Description
Additional information was received that product analysis was completed on both generators. The premature eol was duplicated in the product analysis lab for the new generator with the suspected issue. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Despite the lack of physical evidence on the case exterior, high energy exposure is a likely cause. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing (following a reset of the pulse disable bit) indicated the device was operating properly. Electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 1. 564% of the battery had been consumed. The second generator was returned due to prophylactic replacement and low battery ifi=yes. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the product analysis lab. The battery is partially depleted, 2. 805 volts (near ifi) as measured. The data in the diagaccumconsumed memory locations revealed that 91. 045% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

Event Description
Additional information was received that it was confirmed that electrocaudary was used while the generator was in the sterile field.

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Manufacturer Narrative

Event Description
It was initially reported while the patient was having a generator replacement there was an issue with the new generator. Diagnostics were run on the generator prior to implant outside the pocket and they were within normal limits. Once the patient was implanted and the generator was in the pocket the generator was showing eos-yes. A resident was performing the surgery under the supervision of vns implanting physician. It is unclear if electrocautery was used during the surgery near the generator but is possible. The patient was implanted with a different generator and all diagnostics were within normal limits. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

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« Reply #159 on: April 21, 2018, 12:27:37 AM »

Model Number 103
Event Date 03/08/2011
Event Type  Malfunction   
Event Description
It was reported that the patent had generator replacement surgery on (b)(6) 2013. The explanted generator was received by the manufacturer on (b)(6) 2013. However, product analysis has not been completed to date. Attempts for additional information have been unsuccessful to date.
 
Event Description
During this review of the vns programming history database for this vns generator on (b)(4) 2013, it was identified that the device was in a pulse disabled state due to "vbat

Event Description
Analysis of the generator confirmed the output pulse disabled condition. The reported asic latch-up condition allegation was duplicated in the laboratory. Based on the vns programming history database and the as received condition of the generator suggest that exposure to an electro-cautery tool (as burn marks were observed on the generator) which may have been a contributing factor. The device performed according to functional specifications after output was re-enabled. A non-operating crystal oscillator was also observed most likely related to high energy exposure. In the lab, the generator would not interrogate. The generator was opened. With the pulse generator case removed and the battery still attached to the pcb, the battery measured 2. 591 volts, indicating an neos condition. The generator could not be interrogated with either the handheld or (b)(4) software. When the crystal was checked for oscillation, with the oscilloscope probe, communication with the generator was possible. The post burn-in electrical test results showed that the pulse generator module performed according to functional specifications. The calculated (from ram and flash data) vbat voltage did not reflect the bench-measured vbat voltage of the pulse generator (post open can). Analysis of the generator showed that monitor was being loaded down. A cause for the electrical loading could not be determined, but it may be related to the electro-cautery exposure.
 
Event Description
The return product form indicated the reason for generator replacment as battery depletion with eri=yes.
 
Event Description
The implant card confirmed that the patient had generator replacement surgery on (b)(6) 2013 for battery depletion with near end of service condition.
 
Manufacturer Narrative

Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.
 
Manufacturer Narrative
Review of the manufacturing records performed. Review of the generator manufacturing records confirmed all quality tests were passed prior to distribution.

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« Reply #160 on: April 30, 2018, 12:20:49 AM »

Model Number 304-20
Event Date 08/20/2012
Event Type  Injury   
Event Description
It was reported that the patient had vocal cord paralysis as determined by an ear nose and throat doctor. The vocal cord paralysis began shortly after implant surgery. It was stated that the patient's device was turned on, and that as of (b)(6) 2013, the patient's voice issues have improved since initially noted after the replacement. Follow up with the neurologist's office found that the vocal cord paralysis was observed in (b)(6) 2012. Hoarseness and pain in the vocal cord area were also observed around this time after implant surgery. Per the neurologist's office, the ent checked the patient and found that the left vocal cord was immobile. As of the last visit, the patient had a scope done and the left vocal cord was still immobilized. In regards to intervention, it was only known that the patient was taking speech therapy. The hoarseness and vocal cord paralysis is constant and not with stimulation. It is unknown if the pain was with stimulation. The patient has been programmed on since surgery to previous settings. The following parameters were provided - output current = 0. 5ma, pulsewidth = 30 microseconds, magnet output current = 1ma. It was unknown if the patient has a medical history of vocal cord paralysis; however, it was stated that the paralysis occurred shortly after surgery. In particular, it was stated stated that the vocal cord paralysis occurred due to the patient being burnt with the leads. It was stated that the burn occurred while transferring the battery and replacing the leads. The physician's staff stated that, per the notes, a new set of leads were connected into the generator and no impedance issues were found. The area was irrigated. No other information was provided to clarify what was meant by the patient was burnt as this was all the information that was available. It was unknown if the burn referred to electrocautery or if electrocautery was used during surgery. It was said that a video swallow study was performed which was negative for aspiration. Diagnostics were all ok. No other information was provided. Attempts have been made for additional information; however, no additional information has been provided.

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« Reply #161 on: May 06, 2018, 01:09:47 AM »

Model Number 103
Event Date 07/31/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013, it was reported that the generator "shorted out" during the initial implant surgery. Prior to implant surgery, the generator was checked and confirmed to be functioning properly. However, during implant surgery, the manufacturer's representative observed that electrocautery was used in the pocket while the generator was in the pocket. Diagnostics were then run and found eos=yes (pulse disabled). The patient was implanted with a different generator and the "shorted out" generator was returned for product analysis. No other information has been provided.
 
Event Description
The generator analysis was completed on (b)(6) 2013. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor. A reset of the pulsedisable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Other than the noted condition, there were no performance or any other type of adverse condition found with the pulse generator.
 
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

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« Reply #162 on: May 09, 2018, 12:30:48 AM »

Model Number 103
Event Date 07/12/2013
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's device was explanted due to premature end of life. Product analysis of the explanted generator was performed on (b)(6) 2013. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the surgical procedure. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications. The data in the diagaccumconsumed memory locations revealed that 6. 035% of the battery had been consumed.

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« Reply #163 on: June 04, 2018, 12:09:06 AM »

Model Number 103
Event Date 09/30/2009
Event Type  Malfunction   
Event Description
It was reported to the mfr that the vns pt went through a prophylactic generator replacement. The explanted generator was returned to the mfr for product analysis. Diagnostics performed on the pt's device prior to the surgery were within normal limits, indicating proper device function. Upon interrogation in the product analysis lab, the following message appeared: "pulse generator is currently disabled due to v-bat less than eos threshold". This event was found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within spec. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Discoloration was observed on the can of the generator which is an indication that some sort of electrical energy source may have been used on the device during the explant procedure. The reported eos condition was not verified during the pa analysis; however, the output therapy was disabled due to a perceived low voltage threshold crossing. Investigation determined that the likely root cause of this event is due to an application-specific integrated circuit (asic) latch-up condition, resulting from the generator receiving an electrical transient during surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). The emi and/or esd causing the asic latch-up can be attributed to the use of electrosurgery in direct contact with the generator, electrosurgery in close vicinity to the generator or a major electrostatic discharge.

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« Reply #164 on: June 06, 2018, 01:50:31 AM »

Model Number 103
Event Date 11/09/2009
Event Type  Malfunction   
Event Description
It was reported that a vns pt's generator was explanted due to pain at the generator site. The explanted generator was returned to the mfr and underwent product analysis. Product analysis performed on the returned generator revealed an end of service warning message which was associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The reported eos condition was not duplicated during the pa analysis. Capa (b)(4) further investigated the eos condition of the generator and revealed the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge. The pain event is further reported in mfr report # 1644487-2009-02675 along with the product analysis of the generator.

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« Reply #165 on: June 08, 2018, 02:19:43 AM »

Model Number 106
Device Problem Premature end-of-life indicator
Event Date 05/02/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was undergoing generator replacement surgery, and the new lead was connected to the lead outside of the pocket. Diagnostics were within normal limits at that time. The surgeon then placed the generator in the pocket, and the device was communicated with again. The battery was at end of service, even though it had full battery prior to being placed in the pocket. The company representative that was present at the surgery could not see if electro-cautery equipment was in the field while the generator was being implanted or if the metal part of the hex screwdriver was touched while screwing the set screw in. Data from the surgery was reviewed, which showed that the device was functional prior to the surgery and then, within three minutes, the generator was at end of service. This is possibly indicative of the device being hit with electro-static discharge, but there is not enough evidence at this time to determine if that was the definitive cause of the malfunction. The device history record of the generator was reviewed, and the device performed to specification prior to release. The generator has been received, but analysis has not been approved to date.

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« Reply #166 on: June 09, 2018, 12:59:44 AM »

Model Number 104
Device Problem Energy output to patient tissue incorrect
Event Date 04/24/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient was scheduled for a generator replacement surgery due to battery depletion. Diagnostics was performed on the replacement generator while still in the packaging and the diagnostics were within normal limits. However, upon connecting the replacement generator to the implanted vns lead, high impedance was observed and the vns generator battery was at vbat < eos. The high impedance was reported in mfg. Report #1644487-2018-00804. The diagnostics also indicated that a high output current status was observed, which is reported in this mfg. Report. The surgeon stated that he may have touched the metal part of the torque screwdriver. The company representative stated that electrocautery was present in the field when the new generator was being implanted. A backup generator was implanted and a full vns replacement surgery occurred. The suspect generator was received by the manufacturer and is pending product analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7524130

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« Reply #167 on: July 06, 2018, 08:14:40 AM »

Model Number 104
Device Problem Premature end-of-life indicator
Event Date 02/15/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient¿s generator settings spontaneously changed to 0ma and the physician reports that the patient¿s battery was only 25% and the device was implanted less than one year ago. Data from the patient's device was received and reviewed. It was seen that the device was set to vbat < eos threshold when the device was interrogated on (b)(6) 2018. All outputs at this time were set to 0 ma including the magnet output. Lead impedance was within normal limits. The device was then programmed back on to desired settings. From reviewing the data, the generator is functioning properly and thus the only explanation for why the generator was at settings of 0ma upon interrogation is that the generator was likely in contact with some form of electrocautery on or around (b)(6) 2018. This may have been caused by event non-invasive procedure where possible electrocautery or radio frequency tools were used. As far as the generator¿s performance right now, all impedance values are within normal limits and the voltage of the battery (battery longevity) appears normal and was not significantly affected by this electrocautery use. No additional or relevant information has been received to date.

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« Reply #168 on: September 04, 2018, 08:21:21 AM »

Model Number 302-20
Event Date 06/03/2011
Event Type  Malfunction   
Event Description
Reporter indicated no x-rays were performed. The explanted lead and generator were returned for analysis. No anomalies were identified with the generator and the generator performed per specifications. A break in the positive lead coil was identified near the anchor tether helical area. An abraded opening was identified in the inner tubing of the negative coil (at approximately 0. 7-0. 9 cm past the electrode bifurcation). Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However; due to metal dissolution and surface contamination, the fracture mechanism cannot be determined. Also, scanning-electron microscopy images of the exposed area of the negative coil indicate the coil was exposed to some type of electro-cautery tool. Other than the above mentioned observations and typical wear and explant related observations, no additional anomalies were identified within the returned lead portions. Review of the decoder programming history for the returned generator revealed high lead impedance occurred on (b)(6) 2011. On this date, the ohms value increased from 2338 to 13124.
 
Manufacturer Narrative
Model #, lot #, expiration date, corrected data: the initial manufacturer report incorrectly reported this information. This report is being submitted to correct this data. Manufacture date, corrected data: the initial manufacturer report incorrectly reported this information. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Reporter indicated a patient had high lead impedance with vns diagnostics testing. It was not known if any trauma had occurred. The patient later had vns generator and lead replacement surgery performed. Attempts for return of the explanted devices are in progress.
 
Manufacturer Narrative
Date of event, corrected data: the correct event date is provided. Device failure occurred, 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=2225433
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« Reply #169 on: October 11, 2018, 06:03:23 AM »

Model Number MODEL 250
Event Date 05/23/2012
Event Type  Malfunction   
Event Description
Clinic notes dated (b)(6) 2012 were received for the patient's referral for generator replacement. The notes indicate that the generator is now showing "end of service: yes" upon interrogation. Although surgery is likely, it has not occurred to date. Surgery will be captured in manufacturer report number: 1644487-2012-01508. The notes also mentioned that the patient continues to average 4-6 small seizures per month.
 
Event Description
Copies of the physician's flashcard and flashcard data from the date of surgery was received and analyzed via decoder spreadsheet where it was confirmed that on (b)(6) 2012, the battery voltage was 2. 679 confirming ifi = yes. However, the used charge accumulation was 17. 952% indicating that the battery was not depleting at an expected rate. Further review of a previous report where it was reported that during the patient's initial implant, a "vbat
 
Manufacturer Narrative

Event Description
Additional information received that now the generator is indicating neos = yes which the physician believes is premature however it is already known that the generator has been hit with electrocautery which will impact the battery capacity. Clinic notes dated (b)(6) 2012, were received for the patient who has been referred for generator replacement surgery due to neos=yes. The notes also indicated that the patient was experiencing breakthrough seizures, but the frequency appeared to be the same as previously noted and related to poor medication compliance. Although surgery is likely, it has not occurred to date. Manufacturer report number 1644487-2010-01474 captures the asic latch-up condition as a result of using electrocautery during implant surgery.
 
Manufacturer Narrative
Type of report, corrected data: the initial report inadvertently did not report that this is a '30 day report.'.

Event Description
Further investigation was performed in-house, however the event could not be replicated.
 
Event Description
It was reported from a neurologist's office that during the interrogation of the patient's generator, an ifi flag warning was observed on the patient's device. This was the first time the physician's office had ever observed the warning. When the "proceed" button was selected, it would repeatedly appear and with no progression to the programming menu. The handheld computer being used was a (b)(4) x5. A hard reset was then performed, and the patient's device was reinterrogated and the issue would repeat with no progression to the programming menu. After the hard reset, the warning appeared approximately 8-10 times before another (b)(4) x5 handheld computer was used. After interrogation, the same event occurred. Then, a (b)(4) x50 handheld computer was used which confirmed an ifi flag, but the site was able to click to proceed only three times before progressing to the programming menu. The patient's device was able to be successfully programmed at that time with the (b)(4) x50 computer. Attempts for a copy of the flashcards from the neurologist's office and the handheld used at the surgeon's office are in progress, but the copied programming history has not been received to date. The issue with the other (b)(4) x5 handheld computer and its related software is reported in manufacturer report number: 1644487-2012-01508.

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« Reply #170 on: October 31, 2018, 01:17:05 AM »

Model Number 103
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
During a repositioning surgery a recently implanted generator was found to be at end of service. It is believed that electorcaudary was used during the surgery and caused the end of service condition. The generator was replaced that day as a result. Attempts for additional information have been unsuccessful. The repositioning surgery and the events leading to it will be reported on medwatch 1644487-2014-02493.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Model #, serial #, lot#, expiration date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect. Device manufacture date; corrected data: previously submitted mdr inadvertently provided product information that was incorrect.
 
Event Description
It was reported that the generator was discarded during surgery; therefore, no product analysis can be performed.

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« Reply #171 on: December 07, 2018, 08:55:42 AM »

Model Number 105
Event Date 07/15/2013
Event Type  Malfunction   
Event Description
An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were also observed on the pulse generator can and header, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Results of diagnostic testing indicated that the battery status was ok. Other than the noted condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.

Event Description
It was reported that during generator replacement surgery the new generator "checked out fine" until the incision was closed. It was reported that once the incision was closed the new generator then displayed end of service upon device testing. The new generator was then replaced with another new generator which was tested and was within normal limits. It was reported that no electrocautery was used after the first generator was implanted and that the surgeon is very conscious of electrocautery use and the generators. Attempts have been made to have the generator returned for analysis; however, the generator has not been received to date.

Event Description
Additional information was received which indicates that there is an rf device present in the operating room during vns surgeries which may create radiofrequency in the room. It was stated that this device appears near the end of surgery when they are closing the patient. No additional information has been provided.

Event Description
It was reported that the generator would be returned for analysis. The generator was received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #172 on: January 04, 2019, 08:57:50 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/27/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient underwent a surgery to move the patient's port to the opposite side from the vns. Prior to the procedure the patient's device was turned off and the battery status showed the 75% indicator. After the procedure, the device showed the neos battery status and a message was seen stating that output current was low. It was stated that bovie (electrocautery) was used during this port surgery. The patient later underwent a vns generator replacement surgery and it was found that the battery status was no longer depleted. System diagnostics at this replacement surgery were reported to be normal. The generator was replaced and has been received by the manufacturer. An analysis is underway but has not been completed to date a review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. No additional or relevant information has been received to date.

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« Reply #173 on: January 20, 2019, 01:44:44 AM »

Model Number 103
Event Date 03/31/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery. No other relevant information has been received to date.
 
Event Description
It was reported that diagnostic tests were taken on the generator prior to implanting of device outside of the pocket and after device was in the pocket. The test before implant showed the battery was not at near end of service condition, but the test after the generator was in the pocket showed that the device was at end of service condition. It was reported that the generator was not cold prior to implant. The physician decided to continue implanting the generator. The manufacturer's or specialist that attended the surgery did not see cautery come in contact with the generator, but the cautery device was lying on the patient when the generator was introduced. The surgeon also submerged the generator in a tray with antibiotic solution prior to implant. The manufacturer investigated the programming data available from surgery. The voltage dropped from 3. 287v to 1. 884v during the surgery. The initial interrogation (before implant) and system diagnostics were at ifi = no, and the subsequent diagnostics (after implant) measured between 1. 884v and 1. 988v. The drop in voltage is an indicator that the device likely came in contact with an electro-cautery device or an electrostatic discharge, causing the asic latch-up condition. Electro-cautery is known to potentially cause battery depletion and its usage is warned against in labeling. No known surgical intervention has occurred to date.

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« Reply #174 on: January 31, 2019, 02:07:19 AM »

Model Number 106
Event Date 09/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery the new generator was connected to the lead and the device was interrogated when a low battery vbat's eos message. The generator had been interrogated while still in the packaging and an end of service warning did not present. The generator was then detached from the lead a new generator was implanted. It was noted that electro-cautery equipment was present in the sterile field while the generator was present. The physician was informed by a company representative that the manufacturer does not recommend keeping electro-cautery equipment in the sterile field once the new generator has been introduced to the sterile field. The manufacturing records of the premature end of service generator were reviewed and found that the generator passed quality inspection prior to distribution. Programming data from the day of the attempted implant was reviewed and it confirmed that prior to implant the battery voltage was not at end of service. However a subsequent diagnostic test found that the battery voltage was at end of service. Additionally it was noted that the generator's temperature had increased when the end of service warning was observed. The suspect generator has not been received to date.
 
Event Description
Product analysis was completed on the m106 generator. During visual analysis noted that the generator had burn marks which indicate that the generator was exposed to electro-cautery. Upon initial interrogate the generator was in a eos = yes pulse disabled condition. The pulse disabled byte was reset and the generator was interrogated. The battery indicator was then eri = no. The generator then performed to functional specification. Based on the burn marks on the generator's case and the report that electro-cautery was used during the surgery. It appears that the premature battery indicator was the result of coming into contact with electro-cautery during the implant procedure.
 
Event Description
The generator has been received and is currently pending product analysis.

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« Reply #175 on: February 06, 2019, 02:34:11 AM »

Model Number 103
Event Date 11/12/2014
Event Type  Malfunction   
Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the generator was connected to the lead and system diagnostic results showed normal device function. The generator was disconnected and the surgeon began creating the generator pocket. The generator was reconnected and placed in the generator pocket; however, subsequent diagnostic results showed a near end of service condition. At the patient¿s follow-up appointment, the patient¿s device showed a pulse disabled message. The physician elected to program on the patient¿s device. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported the patient¿s device had reached the intensified follow-up battery status indicator. Diagnostics were reported to be normal.
 
Event Description
Follow-up was received from the patient¿s new neurologist that the patient was referred for replacement as the battery was low. A review of the manufacturer¿s in-house programming history was performed. On the date of implant (b)(6) 2014, systems diagnostics showed the impedance was within normal limits and the battery voltage was 3. 261 volts. Upon a second diagnostics test during implant surgery the generator showed an end-of-service condition, and the battery voltage dropped to 1. 897 volts. On (b)(6) 2016 diagnostics testing showed the voltage had recovered, and impedance values were within normal limits. The battery voltage reached the 25% indicator on diagnostics performed on (b)(6) 2016 with a voltage of 2. 846 volts. It had been reported by the company representative that electrocautery was used near the generator during the implant surgery. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Manufacturer Narrative

Event Description
Replacement surgery occurred. The explanted device was provided to be discarded by the hospital.

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« Reply #176 on: February 13, 2019, 01:34:22 AM »

Model Number 103
Device Problems Device Displays Incorrect Message ; Battery Problem
Event Date 01/19/2015
Event Type  Malfunction   
Event Description
It was reported that during generator replacement surgery on (b)(6) 2015, the vns patient¿s replacement device was implanted and programmed on to previous device settings. The patient¿s device was then tested and showed a near end of service condition. Electrocautery was not used during the procedure. Pre-operative diagnostic results of the replacement generator showed ok battery status. The patient¿s device was tested again the next day and showed pulsedisabled due to ¿vbat
 
Manufacturer Narrative
 
Event Description
Analysis was completed on the explanted generator and shows a pulse disabled condition had occurred and confirms the pulse generator was programmed out of the event on (b)(6) 2015 (implant (b)(6) 2015). The battery, 2. 701 volts as measured during completion of test parameter (measured diagvbat) of the final electrical test, shows an ifi=yes condition. The data in the diag accum consumed memory locations revealed that 18. 203% of the battery had been consumed. A battery life calculation resulted in 4. 9 (minimum 4. 0) years remaining before the near-end-of-service (neos) flag would be set to a neos=yes condition. Other than the noted event (pulse disabled), there were no performance or any other type of adverse condition found with the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the hardware reset condition. No device failure found during product analysis, the premature end of life condition was confirmed by product analysis as due to the pulse disabled event from an electro-cautery tool usage at implant.
 
Event Description
Additional information was received that at the follow up visit on (b)(6) 2015 the battery was showing 100% of charge; on the (b)(6) 2015 that battery was showing 30% of charge remaining. Review of the decoder data provided showed on the interrogation on (b)(6) 2015 the battery voltage (vbat) was 3. 545volt; however the "pulse disabled" incorrectly showed vbat< eos threshold which was not the case as the currently measured vbat 3. 545v is > to 2. 0v. The battery status indicator is 100%, in line with the measured vbat 3. 545v. On the next programming step on (b)(6) 2015, the measured voltage was the same, vbat 3. 545v with "pulsedisabled" showing "enabled" with no eos flag. No further eos flag showed on the next visits.
 
Event Description
Further information was received indicating that the patient underwent revision surgery on (b)(6) 2015. It was reported that the generator was explanted due to device failure. The explanted generator was returned to the manufacturer on 12/15/2015. Analysis is underway but it has not been completed to date.

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« Reply #177 on: March 04, 2019, 08:07:04 AM »

Model Number 104
Event Date 06/16/2015
Event Type  Malfunction   
Event Description
It was reported that during the patient's generator replacement, a new generator was opened and attached to the patient's leads. However, when diagnostics were run, it was reported that the new device showed both high impedance (>10,000 ohms) and end of service. A generator diagnostics was also performed with the test resistor in the generator, which also reportedly showed high impedance and eos. Thus, a new generator was taken from inventory and successfully implanted in the patient with normal impedance and battery status. The opened but unused generator has been returned to the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis of the explanted generator was completed. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device implant/explant. Review of the ram/flash data downloaded from the generator showed that no diagnostics were performed on the pulse generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 096 volts as measured during completion of the final electrical test, shows an ifi=no condition.
 
Manufacturer Narrative
(b)(4).

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« Reply #178 on: March 19, 2019, 01:13:37 AM »

Model Number 103
Event Date 10/26/2015
Event Type  Malfunction   
Event Description
It was reported that the vns patient was picking at the neck incision site and subsequently caused extrusion of the lead. The patient underwent surgery on (b)(6) 2015 and the patient's lead was replaced prophylactically. During the procedure, the patient's generator was inadvertently hit by electrocautery and the device subsequently showed a vbat < eos threshold message. Battery status prior to surgery showed ok. The generator was also replaced during the procedure. The explanted devices were returned to the manufacturer for analysis. An end-of-service warning message was displayed by the pulse generator and found to be associated with the output being disabled. Burn marks were also observed on the pulse generator can, which indicated that the pulse generator may have been exposed to an electro-cautery tool. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. The data in the diagaccum consumed memory locations revealed that 4. 621% of the battery had been consumed. Other than the pulse-disabled condition there were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the returned lead is currently underway and will be reported in manufacturer report # 1644487-2015-06498.

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« Reply #179 on: March 19, 2019, 01:14:18 AM »

Model Number 302-20
Event Type  Malfunction   
Event Description
It was reported on 10/28/2015 that this patient has high impedance. The patient had a recent generator replacement on (b)(6) 2015. The impedance when the new generator was connected was ok at 1187 ohms. The patient was doing some work, lifting shingles on her roof a couple of days ago and it is unknown if this may have caused the issue. No further relevant information has been obtained to date.
 
Event Description
The patient's generator and lead were both replaced on (b)(6) 2016. During the replacement, pin reinsertion was not performed and the surgeon simply proceeded with the replacement. The high impedance resolved with lead replacement, but the surgeon decided to replace the generator because he used electro-cautery when removing the old battery that resulted in damaging the device. The sales representative did re-train the surgeon on the importance of not using electro-cautery when the generator is not being explanted. The explanted devices were discarded after surgery.
 
Manufacturer Narrative
Describe event, corrected data, a new mfr. Report was created to house all further events for the generator premature eol.
 
Event Description
Mfr. Report # 1644487-2016-00837 created to house the report of electro-cautery being used when removing the old battery that resulted in damaging the device. All follow-up information for that depleted generator battery will be housed in that mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5243110
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« Reply #180 on: April 07, 2019, 02:14:54 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 02/27/2019
Event Type  Malfunction   
Event Description
It was reported that during a battery replacement surgery, impedance was fine after implant. After the patient was closed, impedance was checked again and showed to be within normal limits, but with near end of service=yes condition flagging. It was stated that a photon blade was used in the area of the m102 being replaced due to calcification. It was further clarified that electrocautery was still used a little after the generator was implanted. It was unknown if anyone had touched the metal shaft of the generator when attaching the lead. Device history records were reviewed and noted that the device was sterilized and passed all quality inspections prior to distribution. No additional, relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8443819
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« Reply #181 on: April 09, 2019, 12:33:45 AM »

Model Number 103
Event Date 05/09/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A report was received indicating that following pocket closure during a device implant an end of service message was observed. Diagnostics performed prior to pocket closure revealed normal battery status and normal lead impedance. It was stated that electrocautery was not used between the first and second diagnostic measurements. The device was then successfully explanted and replaced with no issues. Manufacturing records were reviewed for the device and no unresolved nonconformances were identified prior to device distribution. Data from the programmer used at implant has been obtained and is currently under review. The explanted device has been returned to the manufacturer and is currently undergoing product analysis.
 
Event Description
Data obtained and decoded from the user's programming system confirmed that an end of service indicator had been observed following normal readings. An end-of-service warning message was verified during testing and was found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator was likely exposed to an electro-cautery tool during device implant/explant. A reset of the pulsedisabled bit in the pulse generator memory was performed to allow for an output to once again be provided by the pulse generator for subsequent testing. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 066 volts as measured during testing shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 3. 082% of the battery had been consumed. Other than the noted event (pulsedisabled), there were no additional 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=5697599
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dennis100
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« Reply #182 on: April 10, 2019, 01:23:39 AM »

Model Number 106
Event Date 05/09/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2016 that the patient who was implanted with a model 106 in (b)(6) 2015 already has 1/3 of battery life remaining. It was indicated that system diagnostics have been performed and the battery is coming back with less than 1/3 battery life left. There are no events reported which could explain the depleted battery life like additional exposure to cautery or other types of electrical exposure. A battery status indicator is visible which shows a battery level consistent with a 2. 74v < vbat = < 2. 87v range considered to be in the bottom 25% of the generator's battery life. The battery gauge is green, indicating pre-ifi status. The design history record for the m106 was reviewed on 06/02/2016. Records shows that the generator passed all functional tests including r-wave configuration prior to distribution into the field.
 
Event Description
It was reported on (b)(6) 2016 that the generator was replaced on (b)(6) 2016. The decoder was reviewed on 06/29/2016 for the patient's m106 device. History was available on (b)(6) 2015, (b)(6) 2016. From the decoder, on 1(b)(6) 2015 the device had consumed 2. 645% of the battery and the diagvbat was at a value of 3. 359 volts. On (b)(6) 2016 the device had consumed 4. 257% of the battery and the diagvbat was at a value of 3. 347 volts. On (b)(6) 2016 the device had consumed 10. 174% of the battery and the diagvbat was at a value of 2. 793 volts. Based on the battery gauge status for m105/m106, the battery voltage from (b)(6) shows 2. 793 which falls in the range of 2. 74v< vbat<= 2. 87v which would show a 25% remaining green indicator on the battery gauge. The explanted generator was received for analysis on 07/06/2016. Analysis is underway but has not been completed to date.
 
Event Description
Product analysis for the model 106 generator was completed and approved on 08/08/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 783 volts as measured during completion of test parameter of the final electrical test, shows an ifi=yes condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during the implant procedure, which may have been a contributing factor. Other than the noted event (eos condition), there were no performance or any other type of adverse condition found with the pulse generator. Updated decoder with implant date information was reviewed: no new information showing electrocautery usage is seen from the decoder. It is still possible that cautery was used after this data was obtained.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5695118
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« Reply #183 on: April 21, 2019, 03:37:46 AM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 11/01/2016
Event Type  Malfunction   
Event Description
It was reported that after a surgery that was taking place for lead repositioning purposes, the generator was found near end of service. The generator was not near end of service before the surgery. Electrocautery was reportedly used in the lead repositioning surgery. Due to the generator being found at near end of service after the lead repositioning surgery, the generator was explanted during that surgery. A lead discontinuity was identified during this surgery. The lead discontinuity has been reported under mfr. Report #1644487-2016-02708. System diagnostics both pre-operatively and post-operatively were within normal limits. The explanted generator has not been received to date.
 
Event Description
The explanted generator was received for product analysis. Analysis has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The generator was returned and had product analysis completed. The generator data was reviewed and showed that the pulse disabled byte had been activated. Additionally, the generator had visible burn marks on its case. The pulse disabled byte was reset and the generator was able to adequately provide the intended therapy when it was monitored in a simulated body environment for a period of over 24 hours. The generator diagnostics were as expected for the programmed parameters and a comprehensive electrical evaluation showed that the generator performed according to functional specifications. The measured battery voltage and the measured charge consumed did not indicate an end of service condition.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6120646
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« Reply #184 on: May 11, 2019, 01:23:25 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/15/2019
Event Type  Malfunction   
Event Description
It was reported that, during a generator replacement surgery, a new m106 generator showed an ok battery status prior to being placed in the patient; however, after being placed in the patient the battery status was low. The generator was not left implanted as it was replaced. The physician reported that electrocautery was used during the surgery. Diagnostic tests from the surgery confirmed an end-of-service (eos) battery status. A review of device history records for the generator shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. Given that the device was at neos/eos, the low output current from both generator diagnostics test is an expected event due to the low battery. Additionally, the neos is likely due to the battery voltage increasing very slightly during the surgery, but again reaching the eos status after programming and diagnostics testing which is expected to further drain the battery. The suspect generator has not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8496073
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« Reply #185 on: June 17, 2019, 04:18:30 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/21/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a vns patient was referred for replacement due to battery depletion however the device had not been implanted for a full year at the time of referral. The downloaded programming data was reviewed. The data on (b)(6) 2017 shows that the voltage dropped to 2. 105 volts from 3. 378 volts and displayed a near end-of-service-condition. The voltage was then shown to have recovered on (b)(6) 2017 to 3. 445 volts and was no longer at a near end-of-service-condition. The lead impedance was within normal limits at 2,144 ohms and 1,205 ohms (b)(6) 2017 and (b)(6) 2017 respectively. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Generator replacement surgery occurred. The explanted device was discarded by the hospital.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on the initial report that the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017. Event codes, corrected data: the event codes were inadvertently provided incorrectly on the initial report.
 
Event Description
From review of the data available, the cause of the premature depletion was most likely the result of the use of electrocautery during surgery on (b)(6) 2017.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7135315
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« Reply #186 on: June 18, 2019, 12:31:46 AM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 11/29/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported during an initial implant surgery that upon interrogation, the new generator was found to be depleted. The surgeon mentioned that prior to implant, he did not recall the device being depleted and that the end of service indicator was observed after multiple interrogations and diagnostics. Impedance of the new generator was within normal limits. A backup generator was used for the implant. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The explanted device has not been received by the manufacturer to-date. No additional relevant information was received to date.
 
Event Description
The generator was received by the manufacturer and product analysis is underway but has not been completed to date. No additional or relevant information was received to date.
 
Manufacturer Narrative

Event Description
Product analysis was performed and approved for the explanted generator. Burn marks were observed on the generator case, indicating that the generator may have been exposed to an electrocautery tool during the implant procedure. The minimum voltage measured showed 1. 786 v, estimated from the day of surgery, confirming the report of the "end of service" indicator. Decoded data from the generator indicated that 1. 090% of the battery had been consumed. Battery voltage measured 2. 964 during testing, indicating an intensified follow-up indicator = no (ifi=no) indicator. Testing performed on the device showed the generator performed according to functional specifications. Other than the noted "end of service" event, there were no additional performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7140641
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« Reply #187 on: July 27, 2019, 12:22:08 PM »

Model Number 106
Device Problems Premature End-of-Life Indicator; Device Contaminated during manufacture or shipping
Event Date 06/16/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's generator battery reached the 25% remaining battery status quicker than expected. It was also reported that the patient had a surgery or procedure that may have used electro-cautery. The device history records of the generator were reviewed, and indicated that the device was subjected to laser routing during the manufacturing process, which could have caused the generator battery to depleted prematurely. A battery life calculation was performed to estimate remaining battery life and the results did not estimate that the device would have reached low battery at this time, based on the available data. Data from the patient's device was reviewed and premature battery depletion was identified. However, the causation and when the premature depletion began was unable to be identified as data was only reviewed from one date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8341142
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