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dennis100
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« Reply #270 on: April 04, 2019, 12:36:37 AM »

Model Number MODEL 250
Event Date 05/31/2016
Event Type  Malfunction   
Event Description
It was reported that the surgeon's programming system was giving errors several times during a vns patient's implant. It was believed the error code was error code 374. The physician reset the buttons on the wand twice and it continued to give an error. He also reportedly used a resistor and that showed the lead was okay, but it could not be determined if this meant the programming system was successfully used at some point in the procedure. Follow up from a company representative attempted to resolve the errors. Standard troubleshooting steps were taken, including verifying that the programming computer was not plugged into the wall ac power, checking the wand 9v battery, and verified connections were tight. Communication with a demo generator was not successful. Several combinations of the existing components and known working components were not successful. The combinations tested aimed to identify a suspect device; however, the results were inconclusive due to inconsistent results. Because the known working components also had mixed success based on the operating environment, electromagnetic interference is suspected to have interfered with the troubleshooting procedure. The suspect device has not been returned to the manufacturer to date. Attempts for additional pertinent information have not been successful to date.
 
Event Description
The programming system tablet and wand were received by the manufacturer on 07/06/2016. Product analysis was completed on the returned wand on 07/11/2016. Other than normal wear related observations, no external visual anomaly was identified with the serial data cable or case. Internal visual inspection of the printed circuit board assembly and associated components revealed no anomaly. Continuity testing of the serial data cable and the battery cable passed. Furthermore, the returned battery was at a functional voltage level. The device met the specification requirements of the final electrical test and performed according to functional specifications. Product analysis is underway for the returned suspect tablet. Follow up with the physician's office showed that they could interrogate the patient's generator despite the inordinate difficulties in doing so. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned tablet on 07/29/2016. The tablet was received with an ac adapter, sd card, and with the main battery depleted. The tablet was received without a usb to db9 adapter cable. Visual inspection identified no anomalies. No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications. The serial adapter cable was reportedly discarded; therefore, product analysis cannot be completed on the unreturned portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5747848
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dennis100
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« Reply #271 on: April 07, 2019, 01:30:30 AM »

Model Number 1000
Device Problem High impedance
Event Date 02/25/2019
Event Type  Malfunction   
Manufacturer Narrative
Voluntary medical device correction (remedial action) was initiated by the manufacturer on 11/16/2018 via physician notification letter.
 
Event Description
It was reported that during an initial implant high impedance was seen. The or representative indicated they did irrigate the nerve, and tried reinserting the pin. He stated the surgeon rechecked around nerve, and when the new lead was used they did not have problems. He was asked if a generator diagnostics was performed at all while attempting to troubleshoot the problem and he said no. He did note that when the surgeon took the lead out he had to cut the lead and then implant the new one and part of the lead was left in the body still. He was asked if when the new lead was implanted and they did system diagnostics the first time, if they saw good impedance and he said yes, about 1500 ohms. The or rep did state that a system diagnostics test was run after troubleshooting on the first lead and generator used and not just interrogation. Internal investigation identified that a change in the timing of the impedance test may result in higher impedances for model 1000 generator compared to those reported by model 103-106 generator. As indicated in the physician¿s manual, high lead impedance (>/=5300 ohms), in the absence of other device-related complications, is not an indication of a lead or generator malfunction. Existing recommendations, as described in the physician¿s manual, should still be followed. Additional investigation is underway. Device history record for the m1000 was reviewed. The generator passed all specifications prior to release for distribution. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8441552
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dennis100
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« Reply #272 on: April 08, 2019, 02:01:24 AM »

Model Number MODEL 250
Event Date 05/10/2016
Event Type  Malfunction   
Event Description
On (b)(6) 2016 it was reported that the usb cable is "loose" at the connection port and intermittently working. The device has not been returned for product analysis to date.
 
Manufacturer Narrative
Initial mdr inadvertently omitted information known prior to submission of the mdr.
 
Event Description
It was reported that the operating room specialist that she attempted to use a second cable on the tablet and the connection worked but was still a little loose. Information received on 07/06/2016 indicated that multiple cables have been used and these are also loose at the connection port. She has to orient the cable in a certain way in order for the tablet and usb connection to work. The tablet is expected to be returned but has not been received to date.
 
Event Description
The company representative's tablet was received on 09/29/2016 and product analysis was performed on it. Product analysis found no anomalies with the tablet. The loose cable could not be replicated. No anomalies were found with the accessories of the tablet either. The company representative's claim of a loose cable could not be confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5700547
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dennis100
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« Reply #273 on: April 15, 2019, 12:10:49 AM »

Model Number 304-20
Event Date 09/06/2016
Event Type  Injury   
Event Description
It was reported through an implant card that patient underwent a full revision due to strong fibrosis and stimulation of the muscle. Company representative was present in the or. The plan was a lead replacement but after the connection of the new lead to the generator a "near end of service" flag was observed. They decided to replace the generator as well. Company representative indicated that the follow up physician has the patient in visit in (b)(6) 2016 for the last visit before the intervention took place. No product failure was reported or suspected. It was reported that no explanted devices are available for the return.
 
Event Description
Further follow up indicated that the surgeons saw the fibrosis on the mri, and so they decided to perform new lead implantation. It was reported that sometimes the patient felts the stimulation because the muscle twitched. This is more a physiological process by the patient. The available programming history data was reviewed, this review showed that the diagnostic test was recorded only on two dates: on (b)(6) 2012 the impedance value was 1864 ohms and on (b)(6) 2012, the lead impedance was 3473 ohms. Those values support the reported fibrosis. Further attempts, to obtain more information about this incident, were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5989722
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dennis100
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« Reply #274 on: April 16, 2019, 12:07:17 AM »

Model Number MODEL 250
Event Date 08/25/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a field clinical engineer was having trouble interrogating a patient in the operating room. The manufacturer's clinical engineer performed troubleshooting on the programming system and verified there were tight connections between the programming wand and the serial cable, the tablet was not plugged in, the wand had sufficient battery, and there was limited emi in the room. The generator was removed from the patient's pocket and interrogation was still unsuccessful. A hard reset on the tablet was performed and the communication issues then resolved. Later in the day, after the hard reset, the nurse stated that there were issues with the tablet's touch screen. The touch screen display was reportedly not lined up correctly. A tablet calibration was then performed and the issues reportedly resolved. The sales representative provided later follow-up stating that there were still tablet screen issues occurring a month later and these issues could not be resolved through resets or troubleshooting. The tablet has not been received by the manufacturer to date. No further relevant information has been received to date.
 
Event Description
The tablet was returned without the rf adapter, the usb serial adapter, or the power supply. The tablet was analyzed and the reported issue could not be re-created in the product analysis lab. No anomalies were identified with the analysis of the tablet and the tablet was able to perform according to all functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5973058
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dennis100
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« Reply #275 on: April 24, 2019, 12:36:27 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported by a medical professional that a vns patient presented in clinic with hoarseness which has come on with stimulation recently. He also has high impedance upon system diagnostics. The patient reports he has had no falls and no impacts. The only physical activity he has performed lately has been lifting boxes at work. He does not attribute the current lead issues to any particular event. It was provided that when the patient moves his head to the left the lead impedance value was normal and the lead impedance value is high when his head is turned to the right. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred on (b)(6) 2017. Follow-up to the company representative who attended the surgery provided that pre-operative diagnostics were within normal limits when the patient¿s head was facing forward, however when diagnostics were performed with the patient¿s head turned to the right, the impedance was high at 7,500 ohms. She stated that after the lead had been removed upon visual examination, it was apparent that the lead coil was broken and ¿bent¿ and the outer tubing was split open. The explanted generator was received by the manufacturer and analysis is underway, but has not been completed to-date. The explanted lead was not returned to the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were tested and results demonstrated accurate resistance measurements were obtained in all instances. Proper functionality of to provide appropriate output currents was successfully verified and the septum was not cored eliminating the possibility of an unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator¿s output signal and the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed the generator performed according to functional specifications. The battery measured 3. 075 volts and did not show an end-of-service indicator. The downloaded data revealed that 22. 513% of the battery had been consumed. 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=6188111
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dennis100
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« Reply #276 on: May 11, 2019, 12:27:51 AM »

Model Number 103
Device Problems Energy Output To Patient Tissue Incorrect; Adverse Event Without Identified Device or Use Problem
Event Date 03/22/2017
Event Type  Malfunction   
Event Description
It was reported by the physician's office that during the initial interrogation of the patient's vns, he received a message he had not seen before warning that he wanted to increase the output current more than recommended, which obscured the settings. When this message eventually disappeared, the recorded output current was a 0ma and the output current in the reprogram column showed he wanted to change the settings to 2. 25ma, which he noted was the patient's output current at her previous interrogation. The physician explained he believed the next 2 settings were also 0ma, with the patient's previously programmed settings showing up in the column. The physician noted he reprogrammed the device and the settings reverted back to the appropriate column and the settings were then as they had been at the last appointment. It was further reported the patient was fine and experienced no issues.
 
Manufacturer Narrative
Describe event or problem; corrected data: "the patient was referred for generator replacement due to normal battery depletion. The ifi = yes condition (intensified follow-up indicator) was observed by the physician approximately one month prior to the reported unintended settings. " this information was inadvertently left off of the initial mfr. Report.
 
Event Description
The patient was referred for generator replacement due to normal battery depletion. The ifi = yes condition (intensified follow-up indicator) was observed by the physician approximately one month prior to the reported unintended settings. The company representative attended the patient's vns generator replacement surgery and noted the device was completely depleted on the surgery date. She also noted she was able to checked the physician's programming system and found that the system diagnostics showed the device was working as intended. Based on the information received, it is believed that the vns generator had simply further depleted to the pulsedisabled state on the date the physician reported the changed settings. During the pulsedisabled state, the device can still communicate, but has programmed itself to no longer deliver therapy as the battery has depleted. This explains the reason the physician observed that the settings were programmed to 0ma. Additionally, though the generator is disabled and no longer providing therapy (as intended) the battery will continue to deplete normally to the point of no communication. This condition was experienced by the company representative on the date of surgery. No device malfunction is suspected. The device is expected to be returned for analysis, but has not been received to date.
 
Event Description
The vns generator was received by the manufacturer for analysis. While product analysis is expected, it has not been completed to date.
 
Event Description
Product analysis was completed on the returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. With the generator opened, no visual anomalies were found on the printed circuit board. During the bench interrogation, the generator was found to be pulse-disabled and at end of service (eos). The circuit board was subjected to electrical testing. All tests required for proper generator function passed. The battery measured 1. 929 volts, confirming an eos condition. The cause of the end of service condition was normal current consumption. The internal device data showed that 114. 323% of the battery had been consumed. Review of the internal device revealed no anomalies. Other than the expected end of service condition, there were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503210
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dennis100
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« Reply #277 on: May 11, 2019, 12:28:43 AM »

Model Number 304-20
Device Problem Fracture
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
The patient's neurologist had reported that they believed that the there was a lead issue as the impedance was around 800 ohms. It was explained to the neurologist that while the impedance is within normal limits, a representative would attend the surgery. While in surgery, the surgeon was able to see that the lead was exposed and the silicone cover was damaged, and the procedure was updated from a prophylactic generator replacement to a full revision. It was stated that there was a short circuit condition. The patient's lead and generator were replaced. The devices were not returned to livanova 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=8470989
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dennis100
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« Reply #278 on: May 11, 2019, 12:29:25 AM »

Model Number 304-20
Device Problem High impedance
Event Date 03/23/2019
Event Type  Malfunction   
Event Description
The patient underwent full revision surgery due to battery depletion and high impedance. The sales representative present at surgery informed that the high lead impedance was discovered during an appointment with the patient's neurologist. The sales representative noted that they first switched out the generator to see if the high impedance resolved. The lead showed to have high impedance after the generator was replaced, so the lead was replaced as well. Further follow up with the neurologist confirmed that the reason for high lead impedance is unknown. The neurologist noted that in the operating room, the lead did not appear to be fractured. The sales representative received the explanted generator for return. The explanted product has not been received to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8530162
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dennis100
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« Reply #279 on: May 23, 2019, 10:43:51 PM »

Model Number 102
Device Problems Low Battery; Adverse Event Without Identified Device or Use Problem
Event Date 04/28/2017
Event Type  Injury   
Event Description
Clinic notes indicated that a patient was experiencing an increase in nocturnal seizures. The physician later referred the patient for generator replacement surgery since the patient's device had been implanted for over seven years. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery due to reported battery depletion. A company representative present at the surgery reported that the patient's explanted device was unable to be interrogated to due reaching end-of-service. The explanted generator was discarded after surgery and is unavailable for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6665798
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dennis100
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« Reply #280 on: June 01, 2019, 03:08:28 AM »

Model Number 303-30
Device Problems Corroded ; Fracture
Event Date 01/20/2017
Event Type  Malfunction   
Event Description
Clinic notes mentioned that high impedance was observed on a patient's device. The patient's device was not programmed off during the clinic visit, per the patient's request. The patient was referred for revision surgery. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent lead and generator replacement surgery due to the high impedance. The company representative present at the surgery indicated that the generator, which had been implanted 2 years prior, was the cause of the high impedance since the lead was initially replaced but did not resolve the high impedance. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received by the manufacturer, but analysis has not been approved on the devices to date. No additional relevant information has been received to date.
 
Event Description
Analysis was approved for the generator. When received, the data was downloaded from the generator and reviewed. On (b)(6) 2017, a >25% increase in impedance was observed. The impedance value increased from normal impedance to high impedance. The next >25% change in impedance was observed on the date of explant from high impedance to normal impedance. The generator was interrogated, and system diagnostic tests were performed and returned results within the normal limits, indicating that there were no impedance issues with the generator. The generator performed according to functional specifications. Analysis was also approved for the lead. The lead was returned for analysis in two pieces. Three set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. A lead break was identified in the positive coil, but the fracture mechanism could not be determined. Microscopy images of the positive coil show evidence of pitting at the lead break location. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6732554
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dennis100
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« Reply #281 on: June 03, 2019, 04:17:35 AM »

Model Number 102
Event Date 09/19/2011
Event Type  Injury   
Event Description
It was reported by the pt that she had not felt stimulation for a month prior to the report and had 7 gran mal seizures the day prior. The pt's previous neurologist and passed away and she was needing a new physician. She noted that she had not had her vns checked in over a year. The pt was referred for vns replacement which has occurred. A manufacturer representative present at the surgery indicated that there were no medication or programming changes that are believed to have caused or contributed to the increased seizures. Diagnostics at the time of the surgery were normal with dcdc=2. Attempts for further information and the return of the pt's vns generator are currently in progress.
 
Event Description
The explanted generator has been received and undergone analysis. The generator performed to specifications and no anomalies were found. Follow-up with the site found that the physician is not sure what to attribute the patient's seizures to. The patient has not been seen for follow-up at this time so it is unknown if the patient's seizures have resolved since replacement. The site is still attempting to obtain the patient's medical records and medical history from the patient's previous physician.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2307815
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dennis100
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« Reply #282 on: June 07, 2019, 04:39:44 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/12/2019
Event Type  Injury   
Event Description
It was reported that the patient was hospitalized and referred for vns battery replacement on (b)(6) 2019. The patient underwent replacement due to battery depletion. The operating room representative who attended the surgery indicated that when he arrived at the case, the patient was already prepped on the table followed by a quick battery change. The surgeon and team were hurried with another case to follow and did not get a chance to obtain pre-op diagnostics and clarification for battery change. The generator has been received for analysis which has not been completed to date. Information was received from a nurse at the neurosurgery department. It was stated that the patient was hospitalized due "mental status changes" after falling in the shower. She stated the patient's vns was interrogated during normal work up and found to have low battery. She stated they thought the patient may have had a seizure, but are not sure the patient had a seizure, why the patient fell in the shower, or the cause of the potential "seizure". She stated the patient was also found to have pneumonia, unrelated to the vns, which also could have caused the "seizure". The nurse was unsure if the low battery was alleged to be the cause of the seizure. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8588240
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dennis100
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« Reply #283 on: June 08, 2019, 12:33:37 AM »

Model Number 1000
Device Problem High impedance
Event Date 04/16/2019
Event Type  Malfunction   
Event Description
It was reported that when the patient's lead was first connected during an initial implant surgery, impedance showed ok at 3000-4000 ohms. The surgeon was not comfortable with this impedance value so reinserted the pin which again showed an impedance value of 3000-4000 ohms. After the patient was closed up, impedance showed >9,000 ohms several times. Output current was always ok. The next day, the patient's generator was interrogated. The device output currents remained off the day of and day after surgery but sensing was enabled. The day of surgery. Per the attending company representative no electrosurgical equipment was used during the surgery. The manufacturer's device history records of the generator and lead were reviewed and the devices passed final quality and functional specifications prior to release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8600755
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dennis100
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« Reply #284 on: June 10, 2019, 12:14:01 AM »

Model Number 102
Device Problems Communication or Transmission Problem; Adverse Event Without Identified Device or Use Problem
Event Date 09/21/2017
Event Type  Injury   
Event Description
It was reported via clinic notes that the patient's battery had become depleted. The patient was referred for replacement surgery. It was later reported that the patient had experienced psychotic breaks and an increase in seizures that may have been related to the battery depletion. A battery life calculation using data from the month of implant through the next two years indicated that the patient's device was estimated to have more than 10 years life remaining until it had become depleted. The physician believed the psychotic breaks and increased seizures were related to battery depletion. The last known settings and system diagnostic test results were unavailable because the patient's device could not be interrogated at her first clinic visit with the physician nor subsequent visits. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent generator replacement surgery. The company representative present at the surgery was able to communicate with the generator and observed that the device had not yet reached an end-of-service condition. Intraoperative diagnostics for the explanted device were within the normal limits. The explanted generator was not available for return to the manufacturer for analysis. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6986144
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« Reply #285 on: June 11, 2019, 12:13:47 AM »

Model Number 106
Device Problem High impedance
Event Date 09/26/2017
Event Type  Injury   
Event Description
It was reported that a patient was hospitalized due to a rash of seizures. Upon doing system diagnostics, the physician reported he saw high lead impedance. He would like this patient to be expedited for a lead revision due to the increase in seizure activity. Revision surgery occurred. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative who attended the surgery provided that during the surgery the lead pin was re-inserted. The impedance was shown to be normal after the lead pin re-insertion, however the surgeon elected to replace the lead anyway. There was no fracture or break identified in the surgery.
 
Event Description
It was reported that the explanted lead was discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6967577
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« Reply #286 on: June 12, 2019, 02:14:22 AM »

Device Problem Fracture
Event Date 09/27/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient had high impedance after a fall in (b)(6) 2017, and the patient has had an increase in seizures. The patient was referred for x-rays and surgery. The x-rays have not been received by the manufacturer to-date. Full revision surgery occurred. The company representative who attended the case provided that when systems diagnostics were performed with the replacement generator high impedance was observed. The surgeon tried irrigating the nerve as well as reconnecting the generator, and confirmed the lead was correctly on the nerve, neither resolved the problem. The surgeon connected the test resistor and there was not high lead impedance with diagnostics. The lead was then changed and the high lead impedance was resolved. The explant facility does not return devices to the manufacturer and the explanted devices have not been received. Additional relevant information has not been received to-date.
 
Event Description
Information was received which indicated that the lead had been implanted earlier than originally reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6967783
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« Reply #287 on: June 17, 2019, 04:05:24 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as protrusion of the generator is not related to the functionality or delivery of therapy of the device.
 
Event Description
It was reported that the patient's generator was protruding under the scar with no extrusion. It was thought that this could be due to the patient's physiology as he was a small child. Later, it was reported through clinic notes the patient was having trouble with tissue erosion. The generator was implanted under the pectoralis muscle but on the medial border the skin was thinning out again. The generator had not eroded through but the skin was very thin and fixed at that spot. The surgeon was not sure of the cause, but referred the patient to electively move the generator laterally and superiorly, possibly to a new pocket. The generator's device history records were reviewed. All final quality specifications were passed prior to distribution. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient underwent generator replacement. The attending company representative believed that the pocket was revised. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7139288
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« Reply #288 on: June 22, 2019, 03:09:45 AM »

Model Number MODEL 250
Event Date 09/20/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that a company representative's tablet was having trouble doing heartbeat detection during at least three surgeries. She was able to interrogate and do diagnostics in each case without issue, but she could not do the heartbeat verification because it would just keep going and going without any heartbeat shown. She had not tried doing heartbeat verification outside of the operating room. In each case, she switched out her tablet for the surgeon's but kept the same serial cable and wand, and there were no issues with the heartbeat detection with the surgeon's tablet. Further information was received indicating that she had tried moving to different areas of the operating room, but the heartbeat verification did not work. She did report that the serial cable felt loose inside the usb port of the tablet. The company representative attended another surgery on (b)(6) 2016, and she was unable to communicate with the patient's generator at all. She was holding the serial cable in the tablet tightly and moved the tablet away from the operating table as far as possible, but she was still unable to communicate with the generator. Once the patient was in post-op, she was able to communicate with the patient's generator and perform heartbeat verification, using the same programming system, without any problems. During another surgery around (b)(6) 2016, the company representative was unable to communicate with another generator. She then switched out her serial cable and wand with known good ones, and she still was unable to communicate with the generator. Then, after the surgery was complete, her programming system was able to communicate with the patient's generator in post-op without issue. A new tablet was then provided to the company representative because the tablet had been identified as the most likely cause of the communication issues. The faulty tablet has not been received to date.
 
Event Description
The tablet was received, and analysis was approved. No anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6029169
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dennis100
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« Reply #289 on: June 26, 2019, 05:44:43 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 12/18/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A company representative who attended a patient¿s vns replacement surgery provided that when she connected the new generator to the lead systems diagnostics showed low impedance. A second diagnostics test also showed low impedance. The test resistor was connected to the generator and the impedance was ok. Pre-operative diagnostics were unable to be obtained as she was unable to interrogate the previous device. The physician then connected the lead to the new generator and performed system diagnostics two more times and the impedance was ok, both times. The lead was not replaced. The explanted device was discarded by the hospital. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7244353
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dennis100
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« Reply #290 on: June 27, 2019, 11:42:23 AM »

Model Number 106
Event Date 12/17/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was initially reported by the neurologist that he was unable to accurately detect the heart beat for the patient. It was noted he tried sensitivity settings 1 through 5, but only received. Troubleshooting was performed and it was found that the vns programming wand was working correctly, but that the data received light was not observed at all. The neurologist noted that upon initial interrogation of the patient's vns system, he was able to see the flickering of the data received light. The neurologist decided to program the autostim feature off, but left the normal mode and magnet mode programmed on. It was later noted by the company representative, who attended the vns implant surgery, that she was able to pick up the patient's heart beat right away, indicating the device was working properly. The company representative reached out to the neurologist to schedule an appointment where she would be able to help the neurologist with some troubleshooting. After the troubleshooting appointment, the company representative reported the issue of not being able to detect the patient's heart beat was repeated. The company representative tried changing rooms to eliminate possible sources of emi (electromagnetic interference). She verified all connections with the programming system were connected properly, turned off the lights, and checked the programming wand's battery life. The wand was also repositioned on the patient to try communicating from a different angle. Sensitivity settings 1 through 5 were all checked and it was verified that at the time of testing for the heart beat, the output current was programmed off. None of the troubleshooting resolved the issue. It was noted the device showed a heart beat once for a short period of time at setting 4, but went to all after. The programming history from the date of implant was reviewed and there were no anomalies noted which could have caused or contributed to the reported event. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Review of the decoded data shows that on the date of the implant ((b)(6) 2016) for the m106 generator, sn: (b)(4), tachycardia detection was programmed off and sensitivity levels 1, 2, and 3 were tested. Interrogations were performed and showed 0 bpm, which would be expected with the tachycardia detection programmed off. System diagnostics were also performed, but the td was programmed off at the time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5427568
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dennis100
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« Reply #291 on: June 28, 2019, 10:04:02 PM »

Model Number 1000
Device Problem Detachment Of Device Component
Event Date 03/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported during a generator replacement surgery, that the replacement generator connected to the lead was displaying high impedance. High impedance was still observed after multiple attempts to reinsert the lead pin. A second accessory pack was opened for a different screwdriver, and the replacement generator was tested with the test resistor. Impedance was within normal limits and the device was functioning as intended. Upon unscrewing the test resistor, the set screw component fell out, though it was unclear if this was due to user error or the component being loose. A new replacement generator was connected to the lead with another third screwdriver, and diagnostics indicated impedance was within normal limits. Device history records were reviewed for the replacement generator and indicated that the device was sterilized and passed all quality inspections prior to distribution. The generator was returned for analysis, however no analysis has been completed to date. Further update from the company representative at the surgery indicated that the high impedance was found through both interrogations and multiple system diagnostics. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7456217
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dennis100
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« Reply #292 on: July 01, 2019, 12:50:08 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/19/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
Clinic notes were received for a replacement referral. The notes provided that the patient reported increased seizure activity. The vns was interrogated and has reached end-of-service, but the specific battery status was not provided. The patient was referred for battery replacement. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
The patient had generator replacement surgery due to battery depletion. The company representative who was present at the surgery reported that the battery was completely depleted. The generator was discarded. The physician believed that the increased seizures may have been related to the battery status of the device. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7516894
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dennis100
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« Reply #293 on: July 02, 2019, 12:34:55 AM »

Model Number 102R
Device Problem Detachment Of Device Component
Event Date 05/03/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient¿s m102r device could not be interrogated and he is going to have the device replaced. After the replacement it was noted that the explanted generator was not attached to the header. There was no evidence of lead fracture and normal impedance was recorded with the new implanted generator. The or specialist reported that the detachment was noticed when the surgeon opened the pocket. She was unable to interrogate the device pre-op due to battery depletion. The explanted generator has been disposed of and is not available for return. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7542255
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« Reply #294 on: July 04, 2019, 12:02:42 AM »

Model Number 1000
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 05/10/2018
Event Type  Injury   
Manufacturer Narrative
 
Event Description
It was reported that a patient was implanted in (b)(6) 2018 and his device was not turned on until recently due to scheduling issues. The patient was programmed to 0. 25ma. The patient returned today complaining of burning at the generator site. The patient was sent for x-rays, and the device was disabled. Ap and lateral x-rays of the neck and chest were available that displayed complete view of the neck and chest. Based on the images provided, the feedthrough wires appeared intact at the connector pins, and the generator was placed in the upper left chest, as expected. However, based on the angle of the image, the connector pin does not appear to be fully inserted past the connector block. The lead was observed in the patient¿s neck and was routed toward the patient¿s left chest. A strain relief bend and loop are present and placed per labeling. Two tie downs are present. Both tie downs appear to be securing the strain relief loop per labeling but no tie down appears to be securing the bend. No obvious fractures or sharp angles were found in the images. Note that a portion of the lead was routed behind the generator so it could not be assessed. Based on the images provided, the patient¿s painful stimulation may be related to incomplete lead pin insertion. Note that the presence of micro-fractures could not be ruled out. Patient was referred to surgery for consult. No additional or relevant information has been received to date.
 
Event Description
At the patient's follow-up visit, high impedance stated to have been seen on the device and the patient was scheduled for a lead pin reinsertion. Pre-op testing found high impedance. The surgeon attempted pin reinsertion and impedance was still high, so they tested the generator with a test resistor and diagnostics indicated ok at 4100 ohms. At this point, the surgeon was not comfortable with the high reading, so he decided to open a new generator. The new generator was connected to the lead and diagnostics indicated 5444 ohms. A test resistor was not used to test this new generator at this time. The surgeon decided it was probably the lead that was defective, and he performed a revision of the old lead. The old lead was extracted and a new lead was implanted. The new lead was connected to the new generator and impedance indicated 9000 ohms. A second test was run indicating 9000 ohms. The or representative stated that at this point in the surgery, he rebooted and double checked his programmer and reran the diagnostic test. Impedance still indicated 9000 ohms. This was likely incomplete pin insertion as well. The original generator was still present in the operating room, so the surgeon decided to insert the new lead into the original generator. Impedance showed 1878 ohms. The new generator was then tested with a test resistor, and impedance was 4074 ohms. The surgeon made the decision to implant the original generator with the new lead as long as diagnostics were consistently ok. Three more diagnostics were run and showed impedances of 6189 ohms, 1716 ohms, and finally 1689 ohms. The first high reading was due to pin insertion which was corrected. With this, the surgeon felt comfortable using the original generator with the new lead, and the patient was closed up. The explanted devices have not been received for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7567346
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