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Author Topic: Poor X-Ray Image  (Read 30085 times)
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dennis100
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« Reply #30 on: June 22, 2017, 12:22:11 AM »

Model Number 300-200
Event Date 05/28/2010
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 initially reported that a pt presented high lead impedance readings during a routine office visit. The pt stated that she can no longer feel the stimulation from therapy which started about a month ago. There were no reports of trauma or manipulation that could not have caused or contributed to reported events and there were no causal or contributory medication or programming changes prior to the onset of the events. The pt's device was programmed off and x-rays were taken. A copy of the x-rays was sent to the manufacturer for review and during the review, a suspect area was identified immediately after the electrode bifurcation of the lead body where the lead may not be continuous. Image quality of the x-rays prevented further assessment of this area. A portion of the lead was behind the generator and continuity in that portion of the lead could not be assessed. Revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1740255
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dennis100
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« Reply #31 on: June 25, 2017, 03:13:35 AM »

Model Number 300-20
Event Date 06/28/2010
Event Type Malfunction
Event Description
It was reported that the vns pt was seen for follow up with the treating neurologists two weeks after having the pulse generator replaced, and upon interrogation of the new generator, the physician received a warning message that high lead impedance was detected, lead impedance >10,000 ohms, and that the output current was not being delivered. The neurologist increased the output current from 1 ma to 1. 25 ma and the same warning message appeared after re-programming. The neurologist did not perform a diagnostic test on the device. X-rays were taken and sent to the manufacturer for review. Review of x-rays revealed no obvious anomalies or gross lead discontinuities; however, there was a suspect area in the lead body in the neck region where a gross lead discontinuity was not able to be identified due to poor image quality. The lead pins did appear to be fully inserted inside the generator connector blocks upon review of the x-rays. The pt is scheduled for surgery to explore the cause of the high lead impedance, however, surgery has not taken place to date. Good faith attempts to obtain additional info from the neurologist have been made, but no additional info has been received to date. A manufacturer rep was present at the recent generator replacement surgery where intra-operative diagnostic testing revealed normal device function at that time.

Manufacturer Narrative
Method: manufacturer reviewed x-rays of implanted device. Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions: 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=1783021
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dennis100
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« Reply #32 on: June 26, 2017, 07:55:30 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type Malfunction
Event Description
It was reported that the vns pt was seen for a routine follow up appointment, and an unk diagnostic test revealed high lead impedance, dcdc = 7. The pt also reports an increase in seizure frequency, and magnet mode stimulation is not able to be perceived. X-rays were taken and sent to manufacturer for review. Review of x-rays revealed no obvious gross lead discontinuities, and the lead pin did appear to be fully inserted inside the generator connector block; however, there were two suspect areas in the lead body next to the generator visualized in the pa view of the chest and due to poor image quality, a discontinuity is not able to be confirmed. The pt has been referred to a surgeon for consultation, and revision surgery is likely. Good faith attempts to obtain additional info are underway.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1765160
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dennis100
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« Reply #33 on: June 27, 2017, 04:01:53 AM »

Model Number 302-20
Event Date 08/02/2010
Event Type Malfunction
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device failure suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that high lead impedance (7/limit/high/no) was received on both sys and normal mode diagnostics at a follow-up appointment with the treating neurologist. There was no report of trauma or manipulation to the device that could have contributed to the reported high lead impedance and the last known good diagnostics were from (b)(6)2010. The pt's generator was programmed off and was refered for x-rays. X-ray were sent and reviewed by the mfr. Review of x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thrus appeared to be intact. The connector pin was visualized to be fully inserted and the lead wires appeared to be intact at the connector pin. There was some lead located behind the generator which could not be fully assessed. A suspect area in the lead body was visualized near the anchor tether, but image contrast prevented conclusive determination of a lead fracture. At the moment, revision surgery is likely.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1842506
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dennis100
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« Reply #34 on: June 28, 2017, 06:10:39 AM »

Model Number 302-20
Event Date 09/24/2012
Event Type Malfunction
Manufacturer Narrative
Device manufacturing records were reviewed. Review of the manufacturing records for the lead confirmed the lead met all final testing specifications prior to distribution.

Event Description
Review of the manufacturing records for the lead confirmed the lead met all final testing specifications prior to distribution.

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.

Event Description
A programming history review was performed which found the patient's last settings from (b)(6) 2012 and system diagnostic results from date of implant.

Event Description
Product analysis was performed on the explanted lead and generator. The returned portion of the lead measured approximately 41. 6cm in length. Three sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Also, the connector ring has scratches most likely caused by the canted spring in the pulse generator header during insertion of the lead connector. The exact point in time of when this occurred is unknown. A discolored area was noted at the end tip of the connector pin. No obvious pitting was noted at this region. The small o-ring boot has partial detachment from the connector ring assembly prior to the connector ring exposed area. No adverse effect was identified on the device performance as a result of this condition. The connector ring has what appears to be pitting. Scratches most likely caused during manipulation of the lead by the user were noted on the connector pin and ring. The lead assembly is covered with what appears to be organic matter at approximately 1cm and 31-31. 6cm from boot. The organic matter as removed to perform proper inspection of the lead. The outer silicone tubing has what appear to be internal abrasions at multiple locations. An abrasion was identified on the connector boot. The outer silicone tubing appears to have been compressed at approximately 9, 14. 8, and 17cm from boot. A kink in one of the lead coils was noted at approximately 19. 8cm from boot. The outer silicone tubing has cut openings at approximately 26. 5cm, 32. 6cm, and 33cm from boot. The tubing cut at 32. 6cm from boot reached the inner silicone tubing of the positive lead coil creating an opening. No obvious damage to the coil was noted at this location. Abrasion on the inner silicone tubing of the lead coils was noted at this location. The lead assembly has remnants of what appears to be dry 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 portion. Scanning electron microscopy images of the connector ring verified that pitting or electro-etching conditions have occurred at the connector ring. 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 observation and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Results of diagnostic testing on the generator indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 3. 024 volts, (not at ifi) as measured during completion of test parameter 7. 16. 10. 2 of the final electrical test. The data in the diagaccumconsumed memory locations revealed that 9. 631% 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.

Manufacturer Narrative
Date of event, corrected data: incorrect date entered in this field on the initial mdr. Explant date, corrected data: explant date inadvertently not included in supplemental mdr #1. Device failure occurred, but did not cause or contribute to a death.

Event Description
Additional information was received which confirmed that the surgery took place on (b)(6) 2013. The explanted lead and generator were returned on (b)(6) 2013 and are pending product analysis. No additional information is available.

Event Description
On (b)(6) 2012 the nurse reported that high impedance was found upon interrogation of the patient's device that day. Diagnostics performed on the last visit of (b)(6) 2012 had been within normal limits. There was no report of any trauma or fall that could have caused a fracture in the lead; however, x-rays were taken and sent to the company for review. The patient's output current was not disabled for the high impedance on this visit. A review of x-rays found no breaks of fractures of the lead; however there were potions of the lead that could not be assessed due to the image quality, angle of the generator, and portions of the lead being outside of the image. Follow up with the physician found that in addition to the high impedance, the patient was experiencing an increase in seizures and the patient's magnet was no longer aborting the seizures. It was also noted that the patient is very immobile, so there is no repetitive motion for him. The family noticed the increase in seizures in the last week of september, but it is unknown what the pre-vns baseline is so a comparison of the seizure frequency could not be made. No additional information was provided. The patient is scheduled for surgery on (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2873424
« Last Edit: March 30, 2018, 01:40:54 AM by dennis100 » Logged
dennis100
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« Reply #35 on: June 29, 2017, 01:55:27 AM »

Event Date 07/12/2010
Event Type Malfunction
Event Description
Rptr indicated a recently implanted vns pt had high lead impedance readings with diagnostics testing. X-rays were reviewed by the mfr but the poor image quality prevented assessment. Attempts for additional info and programing history are in progress.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized; image quality was very poor. Devise 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=1800146
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dennis100
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« Reply #36 on: July 01, 2017, 12:33:37 AM »

Model Number 302-20
Event Date 08/02/2010
Event Type Malfunction
Event Description
It was initially reported that during recently performed diagnostics, high lead impedance was observed. The patient was said to historically have diagnostics within normal limits. The patient was said to have had no falls and is at presently seizure-free. X-rays were taken and images were emailed to manufacturer for review. Based on the x-ray image received there was no anomaly visualized that could have been contributing to the high lead impedance reported. Due to the limited images available and poor image quality, the lead body could not be completely assessed. A search performed in the manufacturer's programming history database did not provide any diagnostic history for patient's device. At this time there is no decision known about the referral for revision surgery. X-rays images have been requested for additional review. No further information is available at this time.

Manufacturer Narrative
Method - manufacturer reviewed x-rays of implanted device. Results - x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions - 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=1831834
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dennis100
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« Reply #37 on: July 02, 2017, 08:38:14 AM »

Model Number 302-20
Event Date 10/07/2010
Event Type Malfunction
Event Description
Neurology reported to our country representative that they had a vns patient in clinic with high lead impedance on their system diagnostic testing. The patient's vns was programmed off. X-rays were received for review and based on the poor image quality, no obvious anomalies were identified that could be contributing to the reported high lead impedance. A portion of the electrode area was not in the field of view, therefore a lead discontinuity cannot be ruled out on the portions of the lead unable to be visualized. The pin appeared to be fully inserted based on the view available. The patient's last known good system diagnostic testing was (b)(6) 2009 (output status ok, lead impedance ok, dcdc 3). The patient had become unwell with acute sepsis and subsequent liver and renal failure in (b)(6) 2010 and was admitted to intensive care. The patient's treating physician thinks it could be possible the patient's vns lead was damaged with the various jugular lines that the patient had during his intensive care stay. Currently the patient's antiepileptic drug therapy has been adjusted and the plan is to replace the lead and if necessary device within the next few months. No surgery is scheduled at this time. Good faith attempts will be made once surgery is scheduled for the product to be returned for analysis.

Event Description
Further information was received from the area representative indicating the patient underwent generator replacement surgery. Surgical intervention began with opening up the site of the device, and on closely examining, the pin was fully, correctly and tightly inserted. This was confirmed by the surgeon and his assistant. The exposed part of the lead was also examined, but there was no damage or abnormalities visible. The surgeon then connected a new generator just a final confirmation that the there was still a lead problem, and interrogation and system diagnostic check was carried out on the replacement. The diagnostic check was normal, with a dcdc of 2. This was repeated several times, with the same result. The surgeon manipulated the area of the coils in the neck (externally as no intervention had taken placed here) and the dcdc code remained at 2. Surgery finished with closure of the chest wound and no intervention regarding the lead.

Manufacturer Narrative
Method: manufacturer review of x-rays of implanted device. Results: x-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Conclusions: device malfunction suspected, but did not cause or contribute to a death or serious injury.

Event Description
The explanted generator was returned to the manufacturer and underwent analysis. Analysis of the generator indicated 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1891001
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dennis100
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« Reply #38 on: July 04, 2017, 12:06:09 AM »

Model Number 302
Event Type Malfunction
Event Description
Our country rep for (b)(4) was contacted by a vns physician reporting a vns pt with high lead impedance on their system diagnostic and normal mode diagnostic testing. Prior to the pt's high impedance being attained, they participated in (b)(4) olympics. The pt's vns is not programmed off at this time. The pt is being referred for surgery to access the cause of the high impedance. One x-ray view was received for review. The alignment of the positive and negative electrodes appeared to be normal; however, the anchor tether did not appear to be on the vagus nerve. There appeared to be a suspected area between the positive and negative electrode as no lead could be visualized in this section; however, a lead break cannot be confirmed due to poor image quality. A strain relief bend and loop could not be assessed due to absence of neck x-rays and poor image quality. There appeared to be a sharp angle near the anchor tether; however, quality of image was poor and therefore, it cannot be confirmed. Only one tie-down was visualized. The filter feed-thru wires appeared to be intact. The generator is placed in the left chest in a normal orientation. The connector pin appeared to be fully inserted. The lead appeared to be intact at the connector pin and there was some lead behind the generator. Based on the x-ray received, no obvious fractures could be visualized; however, the sharp angle and a suspected lead break between the electrodes contributing to the high lead impedance cannot be ruled out. Good faith attempts will be made for product return if product is explanted.

Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized; however, the sharp angle and a suspected lead break between the electrodes contributing to the high lead impedance cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1872504
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dennis100
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« Reply #39 on: July 08, 2017, 03:26:29 AM »

Model Number 103
Device Problem Energy output to patient tissue incorrect
Event Date 05/10/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's device was unable to deliver the programmed output current (2. 25ma) and was only able to deliver 1. 5ma of output current. The impedance was higher than normal, which caused the system to be unable to deliver the intended output current. X-rays were performed and reviewed by the manufacturer. The lead pin did not appear to be inserted fully into the generator, which could have been the cause of the increased impedance and low output current. No gross fractures were identified, but a microfracture could not be ruled out due to image quality. The patient was referred for surgery to correct the low output current, but no surgery has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6610158
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« Reply #40 on: July 13, 2017, 03:06:00 AM »

Model Number 302-20
Event Date 10/31/2010
Event Type  Malfunction   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, 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 by a company rep that a vns pt was seen at a physician's office due to the pt experiencing a fall. Ever since the fall, the pt experienced an increase in seizures that were below pre-vns baseline. System diagnostics were performed at the office visit and were indicative of high lead impedance and also were confirmed by a company rep. The pt was recently implanted on (b)(6) 2010. The pt's device was to be programmed off to o ma and referred for x-rays. Moreover, add'l info from a company rep indicated the pt's device was not programmed off because neither the pt nor physician wanted the device programmed off. Furthermore, prior to the high impedance, the pt was seizure free, hence a replacement surgery is likely. Review of the mfr's programming history was unsuccessful as the pt's device had no info registered in the database to confirm last known good diagnostics. X-rays were received and evaluated by the mfr. Review of x-rays indicated the generator was able to be visualized and the connector pin did not appear to be fully inserted in the generator. The placement of the generator in the chest appeared to be normal, and the filter feed wires appeared intact. The electrodes appeared to be in proper alignment. The visualized portion of the lead body appears to be intact at the connector pin and void of any gross discontinuities or acute angles. The portion of the lead behind the generator could not be assessed for lead discontinuities. A portion of the lead above the generator appears to be tangled/coiled, a device condition typically seen with individuals with "twiddler syndrome. " a suspect area was also noted in this region but due to the image quality a definite determination could not be made. Add'l info was received from the surgeon indicating that he recently saw the pt and programmed the stimulator on and the pt was able to perceive stimulation. However, his review of the x-rays indicated the wire to be in good position and was in contact with the connector. Furthermore, he saw no reason to explore the pt's generator and resumed therapy and care to treating physician. At the moment, good faith attempts to obtain add'l info have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1943939
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« Reply #41 on: July 14, 2017, 03:35:12 AM »

Model Number 302-20
Event Date 12/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Mfr review of x-rays. X-rays reviewed by the mfr, no gross lead discontinuities visualized. Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Our (b)(4) distributor was contacted by a vns treating physician and it was reported that there was a pt with high lead impedance. The pt had been dizzy for a month and on (b)(6) had a fall. After the fall, they were transferred to hospital where system diagnostic testing was performed and showed high impedance dcdc7. Previously (b)(6) 2009, their dcdc had been a 2. X-rays were rec'd for review at the mfr. The generator was able to be visualized and the connector pin did appear to be fully inserted in the generator. The placement of the generator in the chest appeared to be normal, and the filter feed wires appeared intact. The electrodes appeared to be in proper alignment. The presence of a strain relief bend was noted but a strain relief loop did not appear to be present. The strain relief bend does appear to have been placed per product labeling. There is a suspected area caudal to the anchor tether, but due to image quality a break cannot be confirmed. There was one tie-down present that was placed lateral to the anchor tether. The visualized portion of the lead body appears to be intact at the connector pin and void of any gross discontinuities or acute angles. The portion of the lead behind the generator could not be assessed for lead discontinuities. Based on the x-rays rec'd, no anomalies or lead discontinuities were identified in the visualized portion of the pt's vns device which could be contributing to the reported event, although the presence of an unpronounced lead discontinuity cannot be ruled out. The pt's vns remains programmed on at 0. 25ma output current and a decision has not been made if the pt is going to have any surgical interventions taken at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1975319
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« Reply #42 on: July 15, 2017, 11:55:17 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
A vns treating physician reported to our technical product specialist in (b)(4) that they had a pt presenting with high lead impedance in (b)(6) 2011. The pt has been known to have a 'hard' fall during seizures. The pt's ap chest x-ray was received for review. Due to the poor film contrast and quality of the x-ray image it was unable to be assessed whether any gross fractures, discontinuities, strain relief, or electrode placement may be contributing to the pt's high impedance. There was a portion of the lead body behind the generator that was unable to be evaluated. Based on the views available, the full insertion of the lead pin could not be assessed; therefore, unable to rule out as potential causes of the pt's high impedance. No further info was received.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized. 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=2023010
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« Reply #43 on: July 18, 2017, 08:45:18 AM »

Model Number 103
Event Date 03/01/2013
Event Type  Injury   
Event Description
It was reported that the vns patient was complaining of pain at the generator site. It was not tied to any cycle, and the mother stated it occurred randomly. It was noted that the patient was intellectually disabled. He had an x-ray that radiology thought looked like a kink in the lead, but the surgeon did not think so. The pain resolved when the device was turned off. The surgeon programmed the device to the lowest settings, and the pain returned. At the (b)(6) 2013 visit, the patient gave the impression that the pain occurred when he was handling other electronic devices (dvd player, handheld electronic devices) and receives a shock in his hand. This then was followed by pain at his device. The mother stated that the pain had lasted as long as 10 minutes or until she put a magnet over the generator. None of his parameters would give him 10 minutes of stimulation. The neurologist speculated if some static shock was leading to some fault in the vns programming. The neurologist increased the output current in the office, and the patient had no complaints for the 20 minutes he was there. The patient was seen again on (b)(6) 2013. The pain was better, but they pinpointed the pain occurring whenever he plugged a device into a power outlet. They no longer permitted him to do this. Otherwise he was tolerating his device settings well. The neurologist interrogated the device and noted that he has had 658 magnet activations since implanted in (b)(6) 2012, but the last activation appeared to have been on (b)(6) 2013. Notably, he has had a few episodes of pain since i last saw him on (b)(6) 2013. The output current was increased because he was still having multiple generalized convulsions weekly, which he tolerated. However, the neurologist was still concerned that the patient would have pain in the context described. The neurologist also noted that the patient tolerated the device fine as long as he was not plugging in some other device. The episodes had decreased in occurrence by avoiding plugging in objects. Additional information was received stating that the patient was seen in the (b)(6) 2015. The patient was experiencing painful stimulation at the generator and electrode sites as well as headaches. The neurologist believed that the patient¿s lead was kinked based on x-ray images. The patient underwent surgery on (b)(6) 2015 to explant his device. The explanted device has not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Information was received from a nurse at the neurologist's office. She indicated that the patient had pain near the vns site and had not complained of headaches. The pain started around (b)(6) 2013. The pain is related to vns and started after blood pressure cuff over chest near vns device. The pain was not associated with the duty cycle. The pain always stopped when magnet was taped over vns. The device was explanted because there is not a recurring benefit from device (initially there was) and due to pain. Explant of the lead was up to the surgeon. It is unknown if the lead was explanted. There is a plan for replacement. X-rays were received from the neurologist's office and reviewed by company representatives. One ap and one lateral view image was taken which included the lead and generator in each. The lateral image was unable to be assessed due to the image quality. The ap image was reviewed. The generator was placed normally in the left chest. The lead pin was fully inserted inside the connector block, and the filter feed-thru wires appeared fully intact. A short portion of lead was located behind the generator. The area of the electrode site could not be assessed as the angle of the image overlaid the wires such that the separate lengths of wire could not be distinguished. In the lead portions that could be visualized, there were no gross fractures or discontinuities observed. Based on the x-rays received, the cause for the reported pain and painful stimulation cannot be determined. There was nothing seen that would indicate there was any damage to the generator or lead, leading to a pain scenario. However, the presence of a micro-fracture in the lead or abraded insulation cannot be ruled out.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event; corrected data: the previously submitted mdr inadvertently provided an incorrect event date. Event description; corrected data: the previously submitted mdr inadvertently did not include the information provided by the nurse. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4859662
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« Reply #44 on: July 19, 2017, 01:59:09 AM »

Model Number 302-20
Event Date 01/01/2010
Event Type  Malfunction   
Manufacturer Narrative
Method: mfr reviewed x-rays of implanted device. Results: x-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions: device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
A vns physician reported that on (b)(6) 2011 he performed a system diagnostic on a pt and the results indicated output = limit, eos = no, and impedance = high. The dcdc results could not be recalled. The last acceptable diagnostic results were obtained on (b)(6) 2010. The pt was set to 1. 5 ma/20 hz/250 microsec/21 sec/5 min and 1. 75 ma/60 sec/500 microsec. The pt reportedly slipped and fell on ice on (b)(6) 2011. The pt was not experiencing any adverse effects. The device was to be disabled and x-rays were taken. The x-rays were reviewed by the mfr and a suspicious area was identified in the cervical region, which was visualized as an interruption in the color continuity of the images. However, due to the quality of the received images, it was unable to be determined if this was a lead discontinuity or artifacts of the picture. No obvious discontinuities or acute angles were noted. The x-ray results were relayed to the treating physician. A revision surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2064052
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« Reply #45 on: July 20, 2017, 03:34:07 AM »


Model Number 302-20
Event Date 02/23/2011
Event Type  Malfunction   
Event Description
It was reported to our country mgr in spain that there was a vns pt with high impedance on their normal mode and systems diagnostic testing. X-rays were received for review at the mfr. No sharp angles or discontinuities were noted although the quality of the x-rays was not clear. There was some lead behind the generator and it was noted that the pin was fully inserted inside the connector block. It was additionally reported that it was possible that their generator had migrated. Surgery will be planned. At this time good faith attempts are underway and thus far no further info has been attained.
 
Manufacturer Narrative
Method: mfr review of x-rays of implanted device. Results: x-rays reviewed by the mfr, no gross lead discontinuities visualized. Conclusions: device malfunction suspected but did not cause or contribute to a pt death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2064050
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« Reply #46 on: July 21, 2017, 02:39:14 AM »

Model Number 102
Event Date 05/25/2011
Event Type  Injury   
Event Description
Additional information received revealed that the patient has not achieved the same efficacy since this current generator was implanted in that since surgery in 2009, the patient has experienced a slow gradual increase in seizure frequency. There were no reports of trauma or manipulation and the patient is tentatively scheduled for revision surgery later this month.
 
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, 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 by a neurologist that vns pt had increase in seizures and could not perceive stimulation. Diagnostics were within normal limits. Pt's seizure activity has not changed since the last office visit on (b)(6) 2011. Pt's mother said that the pt no longer coughed like she used to. Pt stopped feeling stimulation about 2 - 3 months ago, despite the increase in settings on (b)(6) 2011. The settings were further increased to 2ma on (b)(6) 2011 but pt still was not able to perceive stimulation. The treating neurologist stated that he saw a dcdc = 0 when he performed sys diagnostics and was concerned about a short circuit and pt not feeling stimulation. Thus, pt will likely be referred for surgery. X-rays were taken and reviewed by the mfr. Generator placement appeared normal. The lead connector pin appeared to be completely inserted into the generator connector block. The generator feed-through wires appeared to be intact. The electrodes appeared to be in proper alignment. No gross fracture or lead discontinuities could be visualized on the lead portion assessed, however, there was a suspicious area noted in the bend caudal to electrodes, but cannot be confirmed due to a lack of clear lateral view of the chest. There was a portion of the lead body behind the generator that was unable to be assessed. Additionally, the previously placed electrodes and a small portion of the lead body were still present. The location of this portion of the device was cephalad to the most recent lead body.
 
Event Description
Product analysis of the explanted lead and generator has been completed. During analysis of the lead, puncture and slice marks were found on the outer silicone tubing which provided a leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During analysis of the explanted generator, it was noted that the septum was not cored thus eliminating the possibility of a potential unintended electrical current path through the body fluids (addressing the allegations of pain and painful stimulation). The pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2172670
« Last Edit: July 10, 2018, 07:09:48 AM by dennis100 » Logged
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« Reply #47 on: July 22, 2017, 01:44:55 AM »

Model Number 300-20
Event Date 02/07/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient's device showed high lead impedance upon diagnostic testing. Follow-up with patient's treating neurologist revealed that chest and neck x-rays of the patient's device were taken. The neck x-rays did not reveal any obvious anomalies and the lead could not be visualized on the chest x-rays due to poor image quality. The x-rays were not sent to the manufacturer for review. No patient manipulation or trauma occurred, per physician. The patient underwent full revision surgery and the explanted products were returned to manufacturer, but analysis is pending.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2030476
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« Reply #48 on: July 24, 2017, 12:39:10 AM »

Model Number 302-20
Event Date 03/24/2011
Event Type  Malfunction   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, 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 a pt presented high lead impedance (specific results not provided) at a routine office visit. The pt's device was programmed off and the pt was referred for revision surgery which has not taken place to date. Additional info received from the site revealed that there were no reports of any manipulation or trauma that could have caused or contributed to the high lead impedance. X-rays were taken and sent to the mfr for review. There were no obvious anomalies for causes for the high lead impedance identified however due to the quality of the images, completed lead pin insertion could not be assessed. Additionally, a portion of the lead was behind the generator and continuity of the lead body in that portion of the lead could not be assessed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092156
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« Reply #49 on: July 25, 2017, 04:00:06 AM »

Model Number 302-UNK
Event Date 03/17/2011
Event Type  Malfunction   
Event Description
Our local partner in (b)(4) was contacted by a vns treating physician reporting that they had a pt presenting with high lead impedance on their normal mode and system diagnostic testing. The pt did not have any fall or injury preceding their high impedance event. Their vns has not been programmed off as the pt is still using their magnet therapy. The physician was provided our recommendations to do that when a pt has high lead impedance. No surgery is planned at this time. Based on the x-ray review possible gross fractures, discontinuities, or sharp angles could exist since the lead could not be fully assessed due to poor image contrast in the x-ray. The connector pin could not be assessed for whether it was fully inserted into the connector block due to the views available and the poor contrast of the image; therefore, this could be a cause of the pt's high impedance. Also, whether a strain relief loop was present and the portion of the lead coiled behind the generator, could not be assessed; therefore, unable to rule out as potentially contributing to the pt's high impedance. Another report will be sent if surgery is planned at a later date.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device malfunction 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=2095881
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« Reply #50 on: July 27, 2017, 10:58:38 AM »

Model Number 302-20
Event Date 01/01/2011
Event Type  Malfunction   
Event Description
It was reported that the pt's device was showing high impedance on system diagnostics. No trauma or manipulation occurred which could have caused or contributed to the high impedance. It was also reported that the pt is not feeling stimulation, but his seizures are still controlled. The pt's device was programmed off. X-rays were taken and reviewed by the manufacturer. No anomalies were noted, but due to poor image quality, a proper assessment could not be performed. Revision surgery is likely, but has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2058401
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« Reply #51 on: July 29, 2017, 12:41:35 AM »

Model Number 302-20
Event Date 04/26/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities. Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Our distributor in (b)(4) was contacted by a vns treating physician reporting that they had a patient with high lead impedance on their system diagnostic testing. There was no report of any fall or injury preceding their high impedance. X-rays were received for review. The generator placement cannot be assessed because the orientation of the x-ray images received cannot be determined. The filter feedthru wires, lead pin insertion, and the lead wires at the connector pin could not be assessed due to poor image quality. There is also a small portion of the lead behind the generator and continuity in that portion of the lead could not be assessed. The electrodes appeared to be properly aligned and placed on the nerve. There is a strain relief bend which appears to be per labeling as at least 1-cm of the lead is routed parallel to the nerve prior to onset of the bend. There is no strain relief loop present. There are two tie-downs seen in the images provided. There is one tie-down placed lateral to the anchor tether securing the strain relief bend, however, there are no tie-downs securing a strain relief loop in place. There appears to be a sharp angle and lead twisting after the anchor tether, however, because there is only one view available, this cannot be confirmed. There are no lead discontinuities observed in the visible portions of the lead body. However, due to poor image quality, a fracture or micro-fracture cannot be ruled out. Based on the information provided to date, the root cause for the patient's high impedance is unknown. No surgery date has been attained at this time. Investigation is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107786
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« Reply #52 on: July 29, 2017, 05:35:30 AM »

Model Number 102
Event Date 04/26/2011
Event Type  Malfunction   
Manufacturer Narrative
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr and the lead pin may not be fully inserted into the header of the generator only based on one view and further investigation is needed to determine if this is the case or not. Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Our local distributor in (b)(4) was contacted by a vns treating physician reporting that he had a vns pt with high lead impedance on their system diagnostic testing. Additionally reported that they were having recently an increasing number of seizures. It is unk if this is over their prevns rate nor relationship to their high impedance. No medication changes have been made or interventions taken for this. No pt manipulation or trauma was reported prior to their high impedance being attained. X-rays were received for review. The generator placement cannot be assessed because the orientation of the x-ray images received cannot be determined. The filter feedthru wires were intact and the lead wires appear to be intact at the pin. The lead pin did not appear to be fully inserted as a portion of the pin could not be visualized past the second connector block. There is also a small portion of the lead behind the generator and continuity in that portion of the lead could not be assessed. The electrodes appeared to be properly aligned and placed on the nerve. There is a strain relief bend which appears to be per labeling as at least 1-cm of the lead is routed parallel to the nerve prior to onset of the bend. There is no strain relief loop present. There are two-downs seen in the images provided. There is one tie-down placed lateral to the anchor tether securing the strain relief bend, however, there are no tie-downs securing a strain relief loop in place. There are no lead discontinuities observed in the visible portions of the lead body, however a fracture or micro fracture cannot be ruled out. Based on the info provided to date, the root cause for the pt's high impedance may be due to the pin not being fully inserted. However, due to image quality, a definitive conclusion cannot be drawn. Investigation is underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2107764
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« Reply #53 on: July 29, 2017, 09:24:38 AM »

Model Number 302-20
Event Date 04/18/2011
Event Type  Malfunction   
Event Description
It was reported that the patient's vns indicated high impedance at a routine office visit. It was indicated that the patient had a ball fall on her left side about two weeks prior to the office visit however it is unknown if this event could have led to the high impedance. It was recommended to the physician that she disabled the patient's vns stimulation. Ap and lateral chest and neck x-rays were requested and received by the manufacturer. No anomalies were visualized on the x-rays however the images were of poor quality. The lead pin did appear to be fully inserted however, indicating that an unpronounced lead discontinuity is likely the cause of the high impedance. Surgery to replace the patient's vns lead and generator has occurred. Attempts for the return of the explanted product are in progress. No adverse events have been reported.
 
Manufacturer Narrative
Method - manufacturer reviewed x-rays of implanted device. Result: x-rays reviewed by manufacturer, no gross lead discontinuities visualized. Conclusion: 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=2101955
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« Reply #54 on: July 30, 2017, 12:15:23 AM »

Event Date 04/11/2011
Event Type  Malfunction   
Event Description
It was reported by a company representative that high lead impedance (7/limit/high) was received at a follow-up appointment with the treating physician. The patient's generator was programmed off due to the high lead impedance and x-rays were taken. X-rays were received by the manufacturer and reviewed. Review of x-rays indicated that the generator placement appeared to be normal, and the filter feed-through wires appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. The electrodes were placed on the nerve in accordance to the manufacturer labeling. There was some lead behind the generator that could not be further assessed. No obvious lead discontinuities or acute angles were observed in the observed portions of the lead body that could be assessed. A suspect area was visualized to be in the neck area after the placement of the second tie-down. However, due to the resolution of the x-ray films, a discontinuity could not be confirmed.
 
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=2101704
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« Reply #55 on: July 30, 2017, 04:34:00 AM »

Model Number 302-30
Event Date 04/12/2011
Event Type  Malfunction   
Event Description
On (b)(6) 2011, it was reported by a vns treating physician that the vns patient was presenting with high impedance following a diagnostics test. The particular diagnostic test ran was not specified, but the results were output current-low/output delivered- 0. 00ma/lead impedance - high/ impedance value - greater than 10000ohms. X-rays were taken and will be sent to the manufacturer for review. The surgeon reported that prior to surgery they believed the problem to be that the lead connector pin was not fully inserted into the header of the generator. On the day prior to the surgery, the patient presented with high impedance but no eos message and the device was then programmed off. During surgery, after the connector pin had been replaced into the generator header, the device was programmed on and it registered eos as well as high impedance. The lead impedance then normalized with a new generator when the generator was outside the wound. After closing the incision, the high impedance warning returned. No patient trauma or manipulation occurred that is thought to have caused or contributed to the patient's high impedance. One day post -op, the patient was interrogated and the patient still had high impedance. The patient's x-rays were received by the manufacturer on (b)(4) 2011 and reviewed. The x-rays were taken on (b)(6) 2011, two-days prior to the patient's surgery on (b)(6) 2011. It appeared that the connector pin was fully inserted into the connector block. Whether any gross fractures or discontinuities existed could not be assessed due to the poor contrast of the x-ray images. There was a portion of the lead body coiled behind the generator that also could not be assessed. The explanted generator was returned for product analysis on (b)(4) 2011, that has not yet been completed. The patient went for lead replacement surgery on (b)(6) 2011, due to lead discontinuity reasons. The lead impedance after the surgery was reported to read ok. Good faith attempts for product return will be made. When additional information is received, it will be reported.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, whether any gross lead discontinuities existed was unable to be assessed due to poor image contrast of the x-rays. 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=2094678
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« Reply #56 on: July 30, 2017, 09:28:04 AM »

Model Number 302-20
Event Date 03/31/2011
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
On (b)(6) 2011, it was reported by a vns treating physician to the manufacturer's consultant that the vns patient was seen on (b)(6) 2011 and showed high impedance. The week prior, the patient had a fall and it was thought that the fall could have been the cause of the high impedance because the patient has a history of the same issue. The patient's device is not yet disabled but will likely be at a later date if not immediately replaced. The patient was referred for x-rays. The date of the patient's last diagnostics was not known, but it was believed to be within normal limits. The patient's x-rays were received by the manufacturer for review. No lead breaks could be confirmed although the quality of the x-ray was poor. There was a portion of the lead coiled behind the generator that could not be assessed; therefore unable to rule out as potentially containing a lead break contributing to high impedance. The consultant obtained programming/diagnostic history from the physician and has sent to the manufacturer for review; however it has not yet been received. Surgery is likely, but has not been scheduled yet. When additional information is received, it will be reported.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2092416
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« Reply #57 on: July 31, 2017, 07:18:56 AM »

Model Number 102
Event Date 05/30/2011
Event Type  Malfunction   
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities noted or issues seen with the generator.
 
Event Description
A vns programming physician in israel reported that they had a vns pt whose generator they were unable to interrogate. It is possible the child had a fall. The pt is going to be referred for generator replacement surgery. Since the event started, the mother has noted a possible change in their behavior but cannot be more specific. Good faith attempts are underway for further details about the event. X-rays were received for review. The generator is visualized in the left upper chest in a normal orientation. Filter feedthru wires appear to be intact and the lead pin appears to be fully inserted into the header of the generator. The lead body is intact at the lead pin. The lead body and electrode site were able to be visualized. The electrodes appeared to be in alignment and implanted in the correct orientation. Based on the clarity of the pictures provided, the strain relief bend and loop cannot be assessed. There is a possibility that there is one tie down but cannot fully be identified based on the picture clarity. Most of the lead was visible and no obvious lead discontinuity or anomalies were identified. Some lead is behind the generator and this portion cannot be assessed. Based on the x-ray review, no obvious lead discontinuities or anomalies were observed in the x-ray images that may be contributing to the report of the device being unable to be interrogated.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2154187
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« Reply #58 on: August 05, 2017, 12:07:41 AM »

Model Number 302-20
Event Date 05/26/2011
Event Type  Malfunction   
Event Description
It was reported by a company representative that a vns patient was seen at a follow-up appointment with treating neurologist and both system and normal mode diagnostics resulted in high lead impedance (dc dc 7). The patient's generator was programmed off due to the high lead impedance and x-rays were taken. An x-ray view of the patient's chest was received by the manufacturer and review of the view indicated that the generator was placed in normal orientation. The lead pin appeared to be fully inserted inside the connector pin. A clear view of the lead was not available; hence anomalies in the lead body could not be seen based on the quality of the x-ray. Additional information was received through a return product form indicating the patient underwent full revision surgery due to lead discontinuity. An implant card was also received indicating the patient was re-implanted with vns therapy and lead impedance was ok after re-implant. The explanted generator and lead have been returned to the manufacturer and currently undergoing analysis. At the moment good faith attempts to obtain additional 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=2181421
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« Reply #59 on: August 06, 2017, 01:03:41 AM »

Model Number 300-20
Event Date 07/20/2011
Event Type  Malfunction   
Event Description
During the generator replacement surgery for the pt, a high impedance was discovered once the new generator had been connected to the existing leads. The old generator had been "dead", preventing communication with it. The surgeon attempted to re-insert the lead pin, but the high impedance was still present. The new generator was tested with a test resistor, and it was found to be properly functioning. The lead was once again connected, but the high impedance was still present. Last known diagnostics for the pt on (b)(6) 2005 were within normal limits. The pt was referred to another surgeon for a full revision. X-rays of the pt were obtained and there were no anomalies noted that could be contributing to the reported high impedance; however, an unpronounced lead discontinuity could not be ruled out as the images' quality was poor. Also, the pt was noted to have an increase in seizures prior to the replacement; furthermore, the pt was known to injure himself at times during his seizures, which could have contributed to the high impedance, though nothing specific was noted by the doctor. The explanted generator was returned to the manufacturer for analysis. The pt subsequently underwent a full replacement surgery. Attempts for further info have been unsuccessful to date.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2248024
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