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Author Topic: Efficacy With High/Low Impedance  (Read 2418 times)
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dennis100
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« Reply #30 on: March 31, 2019, 07:14:47 AM »

Event Date 02/11/2014
Event Type  Malfunction   
Event Description
During an internal review of programming and diagnostic data, it was found that a vns patient's device was tested on (b)(6) 2004 (adjusted to (b)(6) 2014) and system mode diagnostic results revealed high impedance (dcdc code 7). On (b)(6) 2004 (adjusted to (b)(6) 2014), system mode diagnostics were repeated and high impedance persisted. The device was not disabled. Further information from the physician indicated that, after the initial vns implant the patient's seizures were reduced by up to 50%. The patient was only suffering approximately 2 major seizures per month since 2003. In 2009, the generator was replaced and the device parameters were modified due to side effects; the frequency was reduced to 20hz. No change in seizure pattern occurred. On (b)(6) 2014, high impedance dcdc code 7 was observed; however, no change in seizure pattern occurred: still only 2 grand mal seizures per month. Therefore, it was decided to not turn the device off, but observe if seizure pattern changes when battery runs out. The device settings were left unchanged. It was reported that the patient was last seen in (b)(6) 2016. The device continued to show high impedance dcdc code 7, however, no change in seizure pattern. The physician decided to wait until the battery runs out. If no change in seizure pattern will be observed, no lead replacement will be performed but only a replacement of the battery. It was reported that the patient will be seen again in (b)(6) 2016, where x-rays will be taken. No further information was provided to date. No known surgical interventions have occurred to date.
 
Event Description
Additional information was received from the physician indicating that the patient was initially implanted with vns in 1998. That device was replaced in 2003 due to end of service. Another replacement took place in (b)(6) 2009 due to the unit reaching the end of its life. It was reported by the physician that the reported side effects, which occurred in 2009 after the implant of the current device, were due to patient tolerability; therefore it resulted in reducing the pulse frequency. No further details were provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5497176
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dennis100
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« Reply #31 on: April 04, 2019, 12:55:43 AM »

Model Number 302-20
Event Date 05/23/2016
Event Type  Malfunction   
Event Description
It was reported by a physician that diagnostics for a patient showed low impedance. The physician stated the device still seems to be working and the patient is not having seizures. Follow-up by the company representative to the physician revealed there was no trauma or manipulation around the lead or generator. No adverse events have been experienced. There were no previously recorded issues with the device diagnostics. X-rays were planned to be taken, but have not been received by the manufacturer for review. Additional relevant information has not been received to-date.
 
Event Description
Follow-up by the company representative who attended the patient's follow-up visit revealed that the patient's generator is low in the back area below the ribcage which was requested due to cosmetic reasons. The patient reported it felt like it would "catch or feel funny, like it was caught on something". Two diagnostics at the time indicated high lead impedance. The output current was lowered to 1. 0 (from 1. 75ma the lead impedance upon diagnostics registered as high. Diagnostics performed after output current reduction to 0. 5ma resulted in high lead impedance. The patient was reprogrammed to 1. 0ma and was referred for revision surgery. No known surgery has occurred to-date.
 
Event Description
Revision surgery occurred on (b)(6) 2016. Prior to surgery, system diagnostics showed high impedance. An incision was made to remove the generator, the pin was removed and reinserted three times which showed high impedance each time. The test resistor was inserted and generator diagnostics were performed showing impedance values were within normal limits with the resistor in place. Lead revision was performed. The generator was not replaced. Lead impedance was tested out of the pocket and inside the pocket and was within normal limits. The lead was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5735989
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dennis100
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« Reply #32 on: April 11, 2019, 02:13:20 AM »

Model Number 304-20
Device Problem High impedance
Event Date 06/15/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that high impedance was observed during device diagnostics with an impedance value of 5897 ohms. At the recent implant of the lead and generator the impedance was noted to be 2948 ohms. The physician then left the patient programmed at 0. 25ma since the patient was not experiencing painful stimulation and she had been receiving efficacy from vns. Further follow-up with the physician found that patient manipulation or trauma are not suspected to have contributed to the high impedance. Instead the physician suspects the lead pin may have shifted which has caused the high impedance. The patient was sent for x-rays however they have not been reviewed by the manufacturer to date. The manufacturing records of the lead and generator were reviewed and found that both devices passed qc inspection prior to distribution. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was seen by the physician at a follow-up appointment and the high impedance warning message was still presenting. During the appointment the patient reported experiencing painful stimulation in her chest. The generator was then disabled. X-rays were received and reviewed by the manufacturer. There did not appear to be any obvious lead discontinuities in the portion of the lead that could be visualized and the connector pin appeared to be fully inserted. However the presence of a micro-fracture in the lead cannot be ruled out. The x-rays did show that the lead did not have adequate strain relief as described in labeling. The implanting physician was then retrained on proper lead placement. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery. A system diagnostic test was performed during pre-op which showed high impedance 10,000 ohms. The generator was then detached from the lead and the generator was tested on it's own. This generator diagnostic test resulted within acceptable limits. The lead was then replaced and the new lead was connected to the existing generator. A system diagnostic test with the new lead and existing generator resulted in an acceptable lead impedance. The explanted lead has not been received to date.
 
Event Description
It was reported that during the lead revision surgery on (b)(6) 2016 the surgeon attempted to re-insert the existing lead into the generator. However the high impedance did not resolve therefore the lead was replaced.
 
Manufacturer Narrative
This information was inadvertently reported incorrectly on mfg. Report #2.
 
Event Description
A company representative reported that the explanted lead was discarded by the hospital following the replacement surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5780375
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dennis100
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« Reply #33 on: April 13, 2019, 04:02:40 AM »

Model Number 303-20
Event Date 07/28/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that low impedance was observed on vns patient's system implanted on (b)(6) 2015. The impedance was already found to be low some times before, but when the patient's device was checked in (b)(6) 2016, 3 system diagnostic tests were performed which showed impedance values of 600 ohms, 3000 ohms and again less than 600 ohms. X-ray was taken and sent to the manufacturer for review. The generator appears on the x-ray to be placed in upper chest in normal arrangement. The filter feed-through wires appears to be intact. The pin connector appears to be fully inserted. The electrodes appeared to be placed in normal arrangement. It is unable to assess the presence of the strain-relief bend and loop and if they were placed as specified by labeling. One tie-down is visible to secure the implanted lead. A portion of lead behind the generator could not be assessed. A clear lead discontinuity is visible, near the clavicle. A sharp angle is visible in the chest near the generator block connection and in that area, the lead appears to be twiddled. Based on the x-ray image, the cause for low impedance could be a short circuit in the lead part that appears to be twiddled. Further information was received from the nurse, indicating that no loss of efficacy yet but the patient recently could not perceive stimulation in magnet or normal mode. It was reported that no trauma was noted. The nurse indicated that it's unlikely that twiddling occurred as the generator is fairly deep and under a large breast. It was reported that the patient suffers from anxiety. Review of manufacturing records confirmed that both, the generator and the lead, passed all functional tests prior to distribution. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An implant card was received which indicated that the patient underwent lead revision surgery. The explanted lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5892846
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dennis100
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« Reply #34 on: April 14, 2019, 01:13:57 AM »

Model Number 302-20
Event Date 07/07/2016
Event Type  Malfunction   
Event Description
Clinic notes were received for surgery referral due to high impedance which was observed during a clinic visit on (b)(6) 2016. Diagnostics showed high lead impedance was present. On the (b)(6) 2016 visit it was stated the patient had not had seizure activity lately, with the last seizure in (b)(6) 2015. As of 07/02/2015 the patient's seizures were stated to be controlled. No adverse effects were mentioned by the physician. 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) 2016. The explant facility reported that they do not return explants per policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5870132
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dennis100
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« Reply #35 on: April 24, 2019, 01:07:07 AM »

Model Number 304-20
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
The patient was referred for a prophylactic generator replacement when it reported that low impedance had been observed for quite some time on the generator, the exact date of first observance was not known. X-rays had been performed and the results were reviewed by the physician. Since no lead discontinuity was observed by the physician he decided to leave the lead implanted and only replace the generator. After the new generator was implanted the low impedance continued to be observed. Further follow-up with the physician found the patient felt stimulation at higher settings and the patient's seizure condition were under good control. Additionally, the physician noted that the x-rays did not show any signs of a short circuit condition in the lead. Therefore the physician felt that it was reasonable to leave the system implanted and to only replace the generator when the battery expired. The x-rays have not been reviewed by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6176718
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dennis100
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« Reply #36 on: April 26, 2019, 06:25:25 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/28/2016
Event Type  Malfunction   
Event Description
High impedance was observed for patient's device on system diagnostics on (b)(6) 2016. Patient was also reported to be seizure free. Surgery is planned but no known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The explanted lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6254878
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dennis100
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« Reply #37 on: April 26, 2019, 06:26:10 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/14/2015
Event Type  Malfunction   
Event Description
It was reported by the nurse that high impedance was observed on the patient's vns. The nurse stated that the patient has responded well to vns and he isn't in any pain or discomfort and that the vns has been effective for the patient at low settings. The physician decided to leave the patient's device programmed on as the patient seemed to still be gaining benefit from the vns and was not experiencing any adverse events. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
It was later reported x-rays were ordered due to the high impedance; however, the x-rays were unable to be released to the manufacturer for review. Attempts for additional relevant information have been unsuccessful.
 
Event Description
Product information and programming history data became available. X-rays were taken but a lead break was not identified. The output is set at 0. 50 ma and the patient is seizure free. As the device does not cause the patient any harm, the device was not disabled.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6252863
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dennis100
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« Reply #38 on: May 03, 2019, 12:38:31 AM »

Model Number 300-20
Device Problem Low impedance
Event Date 03/07/2017
Event Type  Malfunction   
Event Description
Information was received indicating that a low impedance message had been observed with the patient's generator. The patient who has developmental delays was not able to communicate whether there was an altered perception of stimulation. The physician elected to keep the patient's generator programmed on because the benefit would outweigh the risk. It was reported that the patient was experiencing isolated seizures but better than before. No surgical intervention has occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6451422
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dennis100
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« Reply #39 on: May 03, 2019, 12:39:25 AM »

Model Number 300-20
Device Problem Fracture
Event Date 03/07/2017
Event Type  Malfunction   
Event Description
Information was received indicating that high impedance was observed on the patient's new generator during a replacement surgery. The surgeon verified proper pin insertion and orientation, but system diagnostics showed that high impedance persisted. The lead pins were removed and reinserted multiple times, which did not resolve the impedance issue. A test resistor was used and confirmed that the generator was function as expected. The surgeon was not comfortable completing a revision of the lead so the patient's new generator was programmed off. Impedance values prior to surgery were not available since the patient's previous generator was at end of service. A programming history database review was completed for the patient's previous generator to determine when high impedance was present. Based on the available information, no high impedance was detected as of (b)(6) 2009. To date, no known surgery to revise the lead has occurred. No additional relevant information has been received.
 
Event Description
The patient's family reported that the patient's mood had been affected by the loss of vns therapy from the high impedance. The patient's seizures were controlled. No surgical intervention has occurred to date.
 
Event Description
The patient's treating physician reported that the impedance was still high, so x-rays were performed. The x-rays were sent to the manufacturer for review. The lead pins were both inserted past the connector blocks. The generator appeared placed normally per labeling in the left chest, and the feedthru wires were intact. There appeared to be a gross fracture in one of the lead wires below the electrode bifurcation. However, the quality of the image was very low, so the presence of the fracture could not be confirmed. No lead revision has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6447298
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dennis100
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« Reply #40 on: June 02, 2019, 12:48:07 AM »

Model Number 304-20
Device Problems Corroded ; High impedance; Mechanical Problem; Low impedance
Event Date 06/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was seen on the patient's device. The physician considered programming the patient's device off but was not sure if she should because the patient still had good seizure control. The device history records of the generator and lead were reviewed, and both devices performed to specification prior to release. The physician decided to only decrease the patient's settings since the patient wasn't having any issues associated with the high impedance and was still seizure free. There was also no known cause of the high impedance, such as trauma. No surgical intervention has occurred to date.
 
Event Description
The patient was seen again, and low impedance was present on the patient's device. The patient's device was programmed off. No surgery has occurred to date.
 
Event Description
Lead revision surgery occurred. The explanted device has not been received by the manufacturer to-date.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided on follow-up report#2 that the device had been received by the manufacturer. Device available for evaluation, corrected data: the date the device was received was inadvertently not provided on follow-up report#2.
 
Event Description
The explanted device was received by the manufacturer. Analysis was completed on the returned lead portions. Visual analysis identified broken coils approximately 1. 5 mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting on one of the broken coil strands. The area on the remaining broken coil strands was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture which most likely completed the fracture. A flat spot was observed on the coil surface. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6685451
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« Reply #41 on: June 05, 2019, 12:20:56 AM »

Model Number 304-20
Device Problem Fracture
Event Date 09/01/2017
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2017 that a vns patient has high lead impedance. System diagnostics taken on (b)(6) 2017 showed impedance greater than 10,000 ohms. The patient did not complain of pain or changes of seizure control in clinic but the patient¿s caregiver noted he complained of neck pain several days ago. The device was not disabled since the patient was still getting benefits from the device. The pain was not stimulation related according to the patient. However, it is likely that the pain is related to the lead fracture and may be due to residual pain from the stimulation. Surgical intervention has not occurred to date.
 
Event Description
Information was received that the explanting did not return the products or provide them to the sales representative for return. The hospital's policy is to dispose of the explanted products at that hospital. No additional or relevant information has been received to date.
 
Event Description
An implant card was received stating that the patient had a full replacement due to high impedance. The explanted devices were discarded and are not available for return. No additional or relevant information has been received to date.
 
Event Description
Information was received that a user facility medwatch report was submitted. The medwatch states that the explanted devices will be returned to the manufacturer although no products have been received to date. (b)(4). No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6900580
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« Reply #42 on: June 08, 2019, 04:53:47 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 04/18/2019
Event Type  Malfunction   
Event Description
It was reported that a patient's device was showing high impedance on multiple tablets. The patient was not experiencing any adverse events and the patient's parents also stated that the patient "has been better than ever before". It was further noted that a pop-up message appeared when the high impedance message was seen. A session report was received along with tablet data. The company representative was unable to recall what the error message specifically noted, but stated it was a warning message that impedance was "greater than 600 ohms". Programming history was reviewed and noted from the last diagnostic that low impedance was seen. It was stated that the patient had not reported any pain or increase in seizures. It was noted that the patient was sleeping better than before. The patient was seen back in the office where the device was reinterrogated. It was stated that no error message was seen upon the first interrogation, but after a system diagnostic and second interrogation, a low impedance error message was seen. Chest and neck x-rays were ordered for the patient. It was stated that no issues or fractures were seen. No additional, relevant information was received to date. No known surgery for the low impedance has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8606541
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« Reply #43 on: June 11, 2019, 12:47:53 AM »

Model Number 302-20
Event Date 03/26/2013
Event Type  Malfunction   
Event Description
A neurologist reported to our consultant that they had vns patient who had high lead impedance and was still seizure free. They made the choice to leave their device on. They were not sure how this happened, but were debating what he was going to do (replace or not). No report of any patient fall or injury prior to their high lead impedance. No surgery is planned at this time. Good faith attempts are underway for further details about the reported event.
 
Event Description
A copy of the physician's programming data was received by the manufacturer, but it did not contain diagnostics for (b)(6) 2013. Additional information received from the nurse at the physician's office revealed that no x-rays were taken and intervention is still not planned. No surgery is planned at this time. The last diagnostics were performed in (b)(6) 2012 at which time they were within normal limits. They were not aware of any patient trauma or injury that may have contributed to the high impedance.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
The initial report inadvertently did not report the patient's age at the time of finding the high impedance. The initial report inadvertently did not report the date that the high impedance was found. The initial report inadvertently reported the incorrect date of the diagnostic data. Review of device history records performed. Review of lead device history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3072717
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« Reply #44 on: June 15, 2019, 10:59:11 PM »

Model Number 304-20
Device Problems High impedance; Appropriate Term/Code Not Available
Event Date 06/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A high impedance event was observed for the patient's device within the programming history. Generator and system diagnostic tests were performed, which indicated high impedance results. The physician noted that the patient had some discomfort with the device and had raspy voice when talking due to vns stimulation. The physician concluded that the vns is still working because each stimulation of the vns made patient's voice raspy. The settings were adjusted from 1. 0 ma to 0. 875 ma with the other setting parameters remaining the same. The patient tolerated well and had no further of raspy voice. Patient isn't experiencing any side effects or seizures specific to the high impedance. No known surgical interventions have occurred to date to address the high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7035996
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« Reply #45 on: June 19, 2019, 03:57:34 AM »

Model Number 300-20
Device Problem Low impedance
Event Date 11/16/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a battery replacement surgery, a patient's replacement device was found to have low impedance. The surgeon tried troubleshooting by reinserting the lead pin into the connector block multiple times and then performing an impedance test using a test resistor. The results of the impedance test with the test resistor displayed normal impedance, indicating no generator malfunction. The surgeon indicated that there was no noticeable lead damage or break, or suspected reason for low impedance. The battery was still implanted, but the lead was not replaced. No surgical intervention has occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information from the nurse indicated that the patient is not pursuing a lead revision because her seizure activity after the generator replacement has improved despite the low impedance report. No other additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7095354
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« Reply #46 on: June 23, 2019, 03:41:31 AM »

Model Number 302-20
Device Problem Fracture
Event Date 12/13/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was observed on this patient's device during a system diagnostic test. The neurologist does not believe there was any trauma or manipulation. The device was left it on, as the patient has been seizure free and there was no discomfort. The patient has been referred for surgery. No known surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
Surgery has taken place for this patient's generator and lead replacement, and the products were discarded after surgery. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7156647
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« Reply #47 on: June 27, 2019, 11:47:38 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/14/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Company representative noted that the patient's device showed high impedance. No known trauma occurred to the vns area. The patient¿s device was also reported to be programmed on. The patient was noted to still feel the firing every 5 minutes. There were no pain or complains and still felt like he was getting good efficacy. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7315476
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« Reply #48 on: July 27, 2019, 12:17:13 PM »

Model Number 302-20
Device Problem Fracture
Event Date 09/10/2013
Event Type  Malfunction   
Event Description
Programming data was reviewed, and low impedance was identified for a patient that had recent generator replacement surgery. The patient was re-implanted on (b)(6) 2015, and, on (b)(6) 2015, system diagnostics resulted in low impedance. System diagnostics were performed again on (b)(6) 2015, which resulted in low impedance. Since the low impedance was identified so close to generator replacement surgery, programming history of the patient's previous generator was reviewed. Low impedance was first identified with the previous generator on (b)(6) 2013. Therefore, the low impedance is most likely related to the lead that was present for both the previous generator and the current generator. The patient had not been seen since the low impedance was identified, and no appointment had been scheduled. There were no complaints from the patient, and their seizure control was fine. No intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5317699
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