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Author Topic: Poor X-Ray Image  (Read 33832 times)
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dennis100
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« on: May 21, 2017, 03:18:08 AM »

Model Number 300.20
Event Date 01/01/2008
Event Type  Malfunction    
Manufacturer Narrative  
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description  
It was reported that high lead impedance readings were obtained when normal mode diagnostics were performed on a vns patient's device. The date the diagnostics were performed was not provided. X-rays were taken and sent to the manufacturer for review. Due to the poor image quality of the x-rays, a complete assessment could not be performed; however, no anomalies were observed in the visible portions of the lead. There were no reports of patient manipulation or trauma that could have caused the reported event and the patient's device has been programmed off.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1345109
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dennis100
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« Reply #1 on: May 21, 2017, 03:19:15 AM »

Model Number 300-20
Event Date 12/23/2008
Event Type  Malfunction   
Manufacturer Narrative 
Manufacturer reviewed x-rays of the implanted device. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Important to note that image quality was poor, so leads could not be thoroughly evaluated. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
Reporter indicated that the patient had generator replacement surgery in (b) (6) 2008, and went to the neurologist for a follow-up appointment. When the physician interrogated the generator, she received a "high impedance" error message. No trauma or manipulation was reported that may have contributed to the high impedance. Per the reporter, it is possibly due to fibrosis of the nerve. X-rays were taken and reviewed by the manufacturer. Upon review, no abnomalities were noted, though the lead could not be thoroughly assessed due to poor image quality. Patient had lead and generator replaced in (b) (6) 2009. Product had been returned to the manufacturer, but analysis is pending.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1353564
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dennis100
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« Reply #2 on: May 21, 2017, 03:20:35 AM »

Model Number 102
Event Date 01/30/2013
Event Type  Injury   
Manufacturer Narrative 

 
Event Description 
On (b)(6) 2014, it was reported that the patient¿s vns was being explanted due to discomfort at the generator site and that the vns has been disabled for 2 years. The patient underwent explant of the device and good faith attempts for the return of the explanted product has not been successful to date. It was previously reported on (b)(6) 2013 that the patient was experiencing pain along the lead site upon stimulation and had been going on at all levels of stimulation (0. 25ma and higher). The patient¿s device was interrogate and turned off. It was then reported on (b)(6) 2013 that the patient complained of pain along the whole lead and generator site, and it came and went with stimulation cycles. The patient has always felt the pain since implantation on (b)(6) 2013. The patient was seen by the physician on (b)(6) 2013 gain and the device was turned back on to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 25ma/magnet pulse width=250usec/magnet on time=60sec. The patient immediately complained of discomfort along the lead path. Normal mode diagnostics were then performed which showed a dcdc of 0. Then system diagnostics were performed which showed a dcdc of 3. The patient stated that he had discomfort along the lead the entire time and that it subsided once the generator was turned off. It was noted that the patient has had his generator up to output=1. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec which is when he was subsequently turned down due to discomfort. The patient was referred for x-rays and noted that if a lead break is observed then he would like the device removed, but if there is no lead break then he wants the device explanted. X-rays were received on (b)(6) 2013. The generator is visible in the left chest and is normally placed. The lead pin appears fully inserted inside the connector block. Feed thru wires appear intact. Lead wires at the connector pin appear intact. Lead is present behind the generator. The lead is visible routing upwards to the left neck. The electrodes appear aligned. A strain relief bend is present and is placed per labeling. One tie-down is present and is securing the bend. The presence of a strain relief loop cannot be assessed due to poor image quality. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. Based on the images available, a cause for the painful stimulation cannot be established. Note that an anomaly in the lead portion not visible cannot be ruled out.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242424
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dennis100
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« Reply #3 on: May 21, 2017, 03:22:00 AM »

Model Number 302-20
Event Date 10/01/2009
Event Type  Malfunction   
Event Description 
It was reported to manufacturer that the vns patient was seen for a follow-up visit and high lead impedance resulted from a system diagnostic test. The physician programmed the output current to 0ma and sent the patient for x-rays. There was no report of patient manipulation or trauma. The x-rays were sent to manufacturer for review where the lead connector pin did not appear to be fully inserted, as it was not visualized to extend past the connector block. In addition, there was a suspect area of the lead near the electrode bifurcation, where a possible discontinuity was observed in one of the quadfilar coils, however, due to poor image quality, this portion of the lead was not able to be adequately assessed. The patient was referred to a surgeon, and revision surgery is likely.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, the lead pin was not able to be visualized past the connector block, and there was a suspect area of the lead near the bifurcation which a possible discontinuity was observed in one of the quadfilar coils, however due to poor image quality, this portion of the lead was not able to be adequately assessed. 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=1553537
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dennis100
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« Reply #4 on: May 21, 2017, 03:23:40 AM »

Model Number 304-20
Event Date 07/21/2016
Event Type  Malfunction   
Event Description 
It was reported that during an office appointment high impedance was observed. X-rays were taken and received by the manufacturer. A review of the x-rays found that due to the poor quality of the images most of the lead could not be assessed. Therefore a potential lead fracture could not be ruled out in this portion of the lead. The lead portion that could be evaluated did not have any obvious lead fractures. Additionally due to the poor image quality and angle of the generator the adequacy of the insertion of the pin could not be determined. It was later reported that the generator was turned off due to the patient experiencing pain in her chest. The patient was then referred for a lead and generator replacement. No surgical interventions are known to have occurred to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5878811
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dennis100
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« Reply #5 on: May 21, 2017, 03:25:09 AM »

Model Number 102
Event Date 01/30/2013
Event Type  Injury   
Manufacturer Narrative 

 
Event Description 
On (b)(6) 2014, it was reported that the patient¿s vns was being explanted due to discomfort at the generator site and that the vns has been disabled for 2 years. The patient underwent explant of the device and good faith attempts for the return of the explanted product has not been successful to date. It was previously reported on (b)(6) 2013 that the patient was experiencing pain along the lead site upon stimulation and had been going on at all levels of stimulation (0. 25ma and higher). The patient¿s device was interrogate and turned off. It was then reported on (b)(6) 2013 that the patient complained of pain along the whole lead and generator site, and it came and went with stimulation cycles. The patient has always felt the pain since implantation on (b)(6) 2013. The patient was seen by the physician on (b)(6) 2013 gain and the device was turned back on to output=0. 25ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=0. 25ma/magnet pulse width=250usec/magnet on time=60sec. The patient immediately complained of discomfort along the lead path. Normal mode diagnostics were then performed which showed a dcdc of 0. Then system diagnostics were performed which showed a dcdc of 3. The patient stated that he had discomfort along the lead the entire time and that it subsided once the generator was turned off. It was noted that the patient has had his generator up to output=1. 25ma/frequency=30hz/pulse width=250usec/on time=30sec/off time=5min/magnet output=1. 5ma/magnet pulse width=250usec/magnet on time=60sec which is when he was subsequently turned down due to discomfort. The patient was referred for x-rays and noted that if a lead break is observed then he would like the device removed, but if there is no lead break then he wants the device explanted. X-rays were received on (b)(6) 2013. The generator is visible in the left chest and is normally placed. The lead pin appears fully inserted inside the connector block. Feed thru wires appear intact. Lead wires at the connector pin appear intact. Lead is present behind the generator. The lead is visible routing upwards to the left neck. The electrodes appear aligned. A strain relief bend is present and is placed per labeling. One tie-down is present and is securing the bend. The presence of a strain relief loop cannot be assessed due to poor image quality. There do not appear to be any gross fractures, discontinuities, or sharp angles in the lead. Based on the images available, a cause for the painful stimulation cannot be established. Note that an anomaly in the lead portion not visible cannot be ruled out.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4242424
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dennis100
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« Reply #6 on: May 21, 2017, 03:26:45 AM »

Model Number 302-20
Event Date 02/04/2010
Event Type  Malfunction   
Event Description 
It was reported that high lead impedance was read in system , normal and magnet mode diagnostics during a follow up visit. Further information received from the nurse indicated the patient was not able to perceive normal stimulation as settings were increased to test the perception and were concluded to be negative perception from patient. Moreover, the patient reported pain from the generator to the left arm while performing movement since the past two months and feels the generator is moving. No patient trauma was reported at the moment and the device was not disabled as the patient did not agree to have it disabled. X-rays were taken and evaluated by the manufacturer. The review of the x-rays revealed the generator was placed in the left chest in normal orientation. The filter feed-thru appeared to be intact. The lead wires appeared to be intact at the connector pin and the lead connector pin appeared to be fully inserted into the generator connector block. The lead body was coiled beside the generator in the chest region, and there was no portion of the lead body located behind the generator that could not be visualized. Even though the lead body in the neck region could be visualized, the image quality in this area was poor. No obvious acute angles were observed in the portion of the lead body that could be assessed. However, a discontinuity in the lead body was observed in the chest region near the generator. At the moment interventions planned are unknown as 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=1634010
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dennis100
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« Reply #7 on: May 21, 2017, 03:28:42 AM »

Model Number 103
Event Date 11/15/2010
Event Type  Malfunction   
Event Description 
It was reported by a neurologist that a vns pt was having an increase in seizures above pre-vns baseline. Pt fell prior to the event and the generator seems to have migrated. The neurologist could not locate the generator easily under the skin and could not interrogate the vns device. The nurse exerted pressure on the wound over the generator and the pt stated that she felt the wand was over the generator. Physician tried to interrogate again but had no success. He troubleshoot the handheld device by unplugging it from the wall and securing all the connections. He also changed the 9v battery and the green power light stayed on for 25 seconds when the reset buttons were pressed. Physician stated he has recently interrogated other vns pts in the last 2 days and had no problems with his programming system. The pt was referred for x-ray where no obvious anomalies were identified in visualized portion of the pt's vns device. The alignment of the positive and negative electrodes appeared to be normal. No strain relief loop is based on the ap view. The generator was placed on the left chest and a small amount of lead was placed behind the generator. The connector pin appeared to be fully inserted. The filter feed-thru wires appeared to be intact. The lead also appeared to be intact at the connector pin. No obvious lead break or acute angles were observed in the lead body that could be visualized. Due to poor image quality, certain section of the lead body could not be assessed properly. No intervention has been planned at this time for the increase in seizures or migration.
 
Manufacturer Narrative 
Method: mfr reviewed x-rays of implanted device. Results: x-rays reviewed by the mfr, no gross lead discontinuities visualized.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1941224
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dennis100
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« Reply #8 on: May 21, 2017, 03:30:15 AM »

Model Number 250
Device Problems No display or display failure; Poor quality image; Defective item 
Event Date 10/19/2009
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that a physician's handheld screen was blank. The screen had a blue line going down the left side and soft/hard resets and taking out of the battery did not resolve the issue. The power light would turn on, however, the screen would remain blank. The physician was sent a replacement handheld device and his old handheld device was returned to the manufacturer for analysis. There were no anomalies found with the software that could have contributed to the reported event. During analysis of the handheld, it was observed that the screen was defective which caused the screen to be blank. Once the screen was replaced with a known good screen, the issue resolved.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1553352
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dennis100
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« Reply #9 on: May 21, 2017, 03:31:47 AM »

Model Number 302-20
Event Date 01/20/2012
Event Type  Malfunction   
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description 
Analysis was completed on the returned portion of the lead. Analysis of the returned lead indicated a break was identified in the positive coil. Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location. However, due to pitting and mechanical distortion (smoothed surfaces) the fracture mechanism cannot be determined. Other than the above mentioned observations, and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative 
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was initially reported by a surgeon that high impedance was found in the or. The surgeon indicated the electrode in the part proximal was partially loose; however repositioning the electrode still showed high lead impedance. Additional information was received from the area representative indicating that on office visit on (b)(6), 2012 system diagnostics showed high impedance; output status = limit. Patient was sent to revision on (b)(6). Anchor tether was partially out of the nerve. After reconnecting, for a short moment, system diagnostic showed ok, but right after again showed high impedance. The generator was programmed to 0 ma. X-rays were received and reviewed by the manufacturer. Review of x-rays indicated the generator was in a normal orientation in the left chest. Based on image quality, the full insertion of the connector pin inside the connector could not be assessed. The generator feed through wires appeared to be intact. The electrodes seemed to be aligned properly. The presence of lead behind the generator could not be assessed due to poor image quality. No gross lead discontinuities or sharp angles could be visualized. Additional information was received from the area representative indicating the patient underwent lead replacement surgery. The explanted lead was returned to the manufacturer and currently undergoing analysis.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2474687
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« Reply #10 on: May 21, 2017, 03:33:00 AM »

Model Number 300-20
Device Problem High impedance 
Event Date 01/01/2008
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 initially reported that the pt had high lead impedances as shown on multiple diagnostics performed since (b) (6) 2008. The pt's diagnostic history has shown that she has had high lead impedances on both normal and system diagnostics. Device has remained on per mother's request. The site has indicated that they suspect that fibrosis may be occurring with the pt, because of the increasing dcdc codes over time, but a lead discontinuity has not been ruled out. The pt is expected to have revision surgery since she has been responding well to vns therapy, but the mother has decided to wait since the pt isn't experiencing any adverse effects and is still doing well clinically. There has been no reported manipulation or trauma according to the mother. X-rays from (b) (6) 2008 and (b) (6) 2009 were sent to the mfr for review. Due to the poor image quality, there were no obvious anomalies identified that could be contributing to the high impedance event. A search was performed in the in-house programming database to calculate battery life of generator. Calculation resulted in approximately 1. 0 years until eri=yes.
 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=1468067
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« Reply #11 on: May 21, 2017, 03:34:18 AM »

Model Number 300-20
Event Date 01/01/2008
Event Type  Malfunction   
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description 
It was reported that pt had an anterior spinal fusion, and the surgeon used electrocautery. The device was turned off prior to surgery. When the device was turned back on and diagnostics were performed, it resulted in high lead impedance on system and normal mode diagnostics. X-rays were received and reviewed by cyberonics. No obvious acute angles or lead discontinuities were observed on the visible lead portions. However, the contrast on the films fade further down towards generator. Due to this poor image contrast near the generator, the lead could not completely be assessed. Based on the x-ray views received, no cause for the high impedance could be determined. Physician is wanting to wait until the pt recovers completely from the back surgery before doing the revision.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1096204
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« Reply #12 on: May 21, 2017, 03:36:11 AM »

Model Number 302-20
Event Date 11/01/2012
Event Type  Malfunction   
Event Description 
It was initially reported that the patient was found to have high impedance on a system diagnostic test performed on (b)(6) 2012. The patient was previously seen on (b)(6) 2012 and diagnostics at that time were said to be ok. After that appointment, the patient's seizures increased from 10/month to 25/month. It was also noted that the patient was experiencing headaches and insomnia. The patient returned to the office on (b)(6) 2012 when the high impedance was noted. The physician believed that the issue may have been related to incomplete pin insertion. X-rays were performed and images were provided to the manufacturer for review. The generator was able to be visualized. Due to the poor quality of the image, verification that the lead pin was inserted past connector block was unable to be assessed. The generator placement appeared to be normal, and the filter feed-throughs appears intact. In the portion of the lead that is visible, no gross fractures or discontinuity were observed. A portion of the lead was located behind the generator and could not be assessed. Based on the x-rays received there were no anomalies or lead discontinuities observed that could have been causing the reported events. However, due to the lack of images available and poor quality of the images, the entire lead body and generator could not be assessed as well as the connector pin being fully inserted into the connector block. Additionally micro-fractures in the lead could not be ruled out. The patient was referred for and underwent a lead revision surgery on (b)(6) 2012. The lead has since been returned however product analysis is not yet complete. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative 
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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 
Additional information was received indicating that there was no suspected trauma which was believed to have contributed to the high impedance. The physician attributed the headaches, insomnia and increased seizures to the high impedance. It was indicated that the insomnia was first noted on (b)(6) 2012 when the headaches were first noted 10 days after that on (b)(6) 2012. Both were said to be related to stimulation and there were no known changes to the patients settings, medications, or external factors which had occurred resulting in the headaches, insomnia or increased seizures. Additionally the patient does not have a history of insomnia pre-vns. No interventions, other than the lead replacement surgery were performed for any event. The physician also noted that all of the patient's seizure types had increased and the increase was said to be above the patient's pre-vns baseline frequency. Product analysis on the lead has since been completed. An analysis was performed on the returned lead portions and during the visual analysis the (-) green electrode quadfilar coil appeared to be broken approximately 23mm from the electrode bifurcation. Scanning electron microscopy was performed and identified evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The puncture, incision and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. No other obvious anomalies were noted. The setscrew marks found on the 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=2882727
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dennis100
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« Reply #13 on: May 21, 2017, 03:37:31 AM »

Model Number 302-20
Device Problem High impedance 
Event Date 12/02/2009
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 
Reporter indicated high lead impedance readings were obtained after a pt's vns was re-enabled following an mri. The pt may have had possible trauma. The vns was disabled. X-rays were reviewed which did not identify any obvious anomalies, but the image quality was poor. It could not be determined if the lead pin was fully inserted into the generator. Vns revision surgery is possible, but has not been scheduled to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1581625
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« Reply #14 on: May 21, 2017, 03:40:19 AM »

Model Number 302-20
Device Problem Fracture 
Event Date 10/01/2012
Event Type  Malfunction   
Manufacturer Narrative 
Corrected data: with the additional information received, the high impedance appears to be related to the lead device. Corrected data: with the additional information received, the device appears to be the lead with the known information. Manufacturer reviewed x-rays of implanted devices. Review of manufacturing records performed. Review of the generator and lead manufacturing records confirmed all quality tests were passed prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description 
The patient had surgery on (b)(6) 2012 for high impedance. Prior to the procedure, system diagnostics were performed, and high impedance <10,000 was shown. After removing the pulse generator from the pocket, the surgeon checked the connection of lead pin. He found that the setscrew was not tightened. He performed a generator diagnostic test with the test resistor which resulted in okay results. After re-connecting the lead pin and tightening the setscrew, system diagnostics tests were performed several times and were within normal limits. A final system diagnostic test performed after closing the chest incision resulted in okay results. Manufacturer labeling recommends to verify that the connector pin is fully inserted into the lead receptacle (in the pulse generator by tightening the setscrew until the hex screwdriver begins to click). The pin should be visible in the area at the back end of the connector block.
 
Event Description 
It was later reported that after the surgery on (b)(6) 2012, high lead impedance (>10,000 ohms) was observed again on (b)(6) 2013 at a follow-up appointment. The surgeon reported that x-rays taken 04/04/2013 did not show the contributory cause of the high impedance. There was reportedly no patient manipulation or trauma that could have contributed to the high impedance. Diagnostics on (b)(6) 2013 were within normal limits. Ap and lateral neck and ap chest x-rays dated (b)(6) 2013 were reviewed by the manufacturer. The filter feed-thru wires appear intact and the lead pin could be seen past the second connector block, indicating that it is fully inserted into the generator. It could not be assessed if the lead wires at the connector pin were intact due to the image quality. The electrodes were observed in the neck and appear to be in proper alignment; however, the conductor portion of the positive and negative electrodes appear to possibly be opposite to one another. No gross discontinuities were identified in the areas of the lead that could be assessed. A sharp angle was noted on lead by the left clavicle bone; however it could not be confirmed if this was truly a sharp bend or only appeared as such due to the angle of the image. Based on the x-ray images provided, the cause of the high impedance is unknown. The presence of additional micro-fractures in the lead and issues with the lead in the areas that could not be assessed cannot be ruled out. After the x-ray review was provided to the surgeon, the surgeon suspects that there is a lead fracture (which is not clear on the x-ray due to the poor quality) which has been causing high lead impedance prior to the surgery on (b)(6) 2012. The patient's device is still turned on, but they plan to turn it off at the patient's next appointment. Although revision surgery is likely, it has not occurred to date.
 
Event Description 
Further follow-up revealed that the physician feels like the lead may have been damaged during the patient's yosakoi dancing. The patient's family wants to wait on vns replacement and see whether the patient's seizures increase over the next few months. The patient will be seen in approximately (b)(6) 2013 and the family will likely have a decision at that time. Surgery is still likely; however, will likely occur at a later date.
 
Event Description 
Additional follow up was performed which revealed that a non-absorbable suture was used during implant surgery to secure the generator to the fascia.
 
Event Description 
No patient adverse events have been reported at this time.
 
Event Description 
A company distributor in (b)(6) reported through a vns therapy system questionnaire reporting high lead impedance event. System diagnostics test was performed by the surgeon, and high lead impedance (<10,000 ohms) was shown. The physician compared x-ray images from the date of implant ((b)(6) 2012) and (b)(6) 2012 (first follow-up appointment), and noted that the generator has "changed location. There was reportedly not any patient manipulation or trauma that could have contributed to the event. Although surgery is likely for the high impedance, it has not occurred to date. No additional information has been received to date. Ap and lateral neck x-ray images and an ap check x-ray images dated (b)(6) 2012. Additionally, ap and lateral neck and chest x-rays images dated (b)(6) 2012. The generator was visible in the lateral portion of the lower chest. The generator appeared to have migrated inferiorly in comparison to the chest x-rays dated (b)(6) 2012. With the angle and quality of the chest x-ray, the connector pin appears to be adequately inserted inside the connector block, but it cannot be assessed whether it is fully inserted. The lead wires appear to be intact at the connector pin, and the feedthru wires appear intact. The lead is routed upwards to the left side of the neck. The electrodes are visualized in the neck and appear to be in alignment. Lead is present behind the generator and cannot be assessed for continuity in the (b)(6) 2012 images. There are no gross lead discontinuities or sharp angles present in either the (b)(6) 2012 images. Based on the x-rays images received, there are no gross lead fractures or sharp angles that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. The cause of the high impedance cannot be determined with the x-ray images provided. The generator appears to have migrated in relation to the images dated (b)(6) 2012. However, the reason cannot be determined from the x-rays.
 
Event Description 
It was reported that generator and lead surgery is scheduled for (b)(6) 2013 because the reason for the high impedance is unclear per review of the x-rays. However, surgery has not occurred to date.
 
Manufacturer Narrative 
Manufacturer reviewed x-rays of implanted devices. Device failure is suspected, but did not cause or contribute to a death or serious injury. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description 
An additional set of x-rays was provided for this patient's high impedance years after the initial report. The x-ray images were reviewed by the manufacturer and showed a gross lead discontinuity was present between the positive and negative electrodes of the implanted lead. No known surgical intervention has occurred to date.
 
Manufacturer Narrative 
Brand name, corrected data: with the additional information received, the high impedance was related to the lead pin not being fully inserted into the generator connector block so the suspect device is the generator. Type of device name, corrected data: with the additional information received, the initial report inadvertently reported the device incorrectly. Suspect medical device model #, serial #, lot #, expiration date, corrected data: with the additional information received, the initial report inadvertently reported the device product information incorrectly. Device manufacturer date, corrected data: with the additional information received, the initial report inadvertently reported the device product information incorrectly.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2811167
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« Reply #15 on: May 25, 2017, 12:30:56 AM »

Event Date 03/09/2009
Event Type  Malfunction   
Event Description 
It was reported the patient had high lead impedance output status ok, dcdc 5 on a systems test and normal mode diagnostic test dcdc 7. The patient's dcdc code on their systems test had gone from a 2 to a 5 from (b) (6) 2008 til (b) (6) 2009 when at a 5. The patient was admitted to hospital for an increase in seizures, unknown if over the patient's pre vns seizure rate. The patient reported that he received several times a ball to his chest prior to the high impedance being attained. X-rays were reviewed at manufacturer and a suspect area was identified on a portion of the lead body near the generator, but a lead break could not be confirmed due to the poor image quality. On the portions of the lead that could be assessed, no obvious lead discontinuities or acute angles were observed. The patient underwent surgery and had their generator and lead replaced. The explanted product will be returned for product analysis.
 
Manufacturer Narrative 
Manufacturer review of x-rays. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device malfunction is suspected but did not cause or contribute to a death.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1426996
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« Reply #16 on: May 27, 2017, 01:15:27 AM »

Model Number 300-20
Event Date 01/01/2009
Event Type  Malfunction   
Event Description 
It was reported that upon a follow up visit, a pt's device was showing high impedance with system and normal mode diagnostics. There was no known trauma or manipulation that could have contributed to the events. The review of the x-rays provided did not show any gross discontinuities or anomalies, but there were portions that could not be assessed properly due to poor image quality, so lead discontinuity could not be ruled out at this time. The cause for the high impedance is unknown at this time, but device failure could not be ruled out. The pt is scheduled for a surgery consult, but there hasn't been a surgery scheduled to date.
 
Manufacturer Narrative 
Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities were visualized. Device failure is suspected, but did not contribute to serous injury or death.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1424610
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« Reply #17 on: May 28, 2017, 12:46:02 AM »

Model Number 302-20
Event Date 06/02/2009
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 
Reporter indicated a pt no longer felt vns stimulation. It was later learned high impedance readings were noted with vns diagnostics testing. No trauma or device manipulation was admitted. The reporter was advised to disable the vns due to the high lead impedance. X-rays were received which did not identify any obvious lead anomalies, but the film quality was poor and prevented adequate assessment. All attempts to the reporter for additional info and the plan of care regarding the pt's vns have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2613211
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« Reply #18 on: May 29, 2017, 01:10:49 AM »

Model Number 302-20
Event Date 05/07/2009
Event Type  Malfunction   
Event Description 
Reporter indicated a vns therapy patient presented at normal office visit with high impedance on a system diagnostic test. No trauma or patient manipulation has been reported. Manufacturer reviewed x-rays and a cause for the high lead impedance could not be determined. The quality of the x-ray prevented the assessment of the lead pin insertion to the generator. Good faith attempts to obtain additional information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1439647
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« Reply #19 on: May 29, 2017, 01:14:23 AM »

Model Number 302-20
Device Problem Battery impedance issue 
Event Date 05/01/2009
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 
Reporter indicated that high lead impedance readings were obtained during a follow up office visit following a generator revision surgery. The physician indicated that the pt did not have issues with high lead impedance prior to the date of the report and the diagnostic testing performed twice resulted in high lead impedance. Add'l info received from a company representative who was present during the generator revision surgery revealed that diagnostics were performed on the newly implanted generator and stated that high lead impedance readings were initially received; however, once the connector pin was reinserted the high lead impedance readings resolved. X-rays were taken and sent to the manufacturer for analysis; however, the quality of the images was not ideal. No anomalies were observed; however, the entire lead could not be viewed. This info was shared with the physician's office. It is likely that the pt will undergo revision or exploratory surgery to further investigate the issue; however, no date has been set.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1471775
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« Reply #20 on: May 30, 2017, 01:47:17 AM »

Model Number 302-20
Event Date 01/01/2009
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 
Reporter indicated that high lead impedance readings were obtained during a routine office visit. There were no reports of patient manipulation or trauma, however, the patient was able to move the generator around in the pocket even though it was secured with a non-absorbable suture during implant. The patient does not have "twiddler's syndrome". X-rays were taken and sent to the manufacturer for review. The lead appeared intact, however, the electrode portion of the lead could not be assessed due to the quality of the x-rays as well as the angle of the pt's neck in the x-rays provided. Revision surgery is likely.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1470312
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« Reply #21 on: May 31, 2017, 12:11:58 AM »

Model Number 302-20
Event Date 08/01/2009
Event Type  Malfunction   
Event Description 
It was initially indicated by the surgeon that the pt's system mode diagnostics results gave high lead impedance. No manipulation or trauma was reported. Pt's device was turned off. X-rays were received and reviewed. Quality of x-rays was poor and no obvious lead discontinuities or acute angles were observed in the portions of the lead body that could be visualized.
 
Event Description 
It was reported that the explanted device was discarded.
 
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 
Further follow-up revealed that the patient underwent device replacement. No additional relevant information has been received to date.
 
Manufacturer Narrative 
Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative 
(b)(4).
 
Event Description 
Clinic notes were later received showing the patient stated his vns was explanted due to keloid scarring and vocal cord paralysis. Attempts for additional relevant information have been unsuccessful to date.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1495345
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« Reply #22 on: June 06, 2017, 03:59:35 AM »

Model Number 302-UNK
Event Date 01/01/2010
Event Type Malfunction
Manufacturer Narrative
Conclusions - device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported by the physician that the patient showed high impedance on system diagnostics. X-rays will be taken. X-ray images were sent to manufacturer for further review. X-ray image was viewed and no device anomalies were identified which could have contributed to the reported event of high lead impedance. Due to image quality and a lack of x-ray views, the presence of a lead discontinuity at the noted area of suspicion, in neck region or proper connector pin insertion can not be ruled out as a possible causative factor. Patient was also having lack of efficacy. It is unknown if the high lead impedance event was resulting in lack of efficacy. Good faith attempts to obtain additional information have been unsuccessful.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1619796
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« Reply #23 on: June 06, 2017, 04:00:35 AM »

Model Number 302-20
Event Date 01/01/2009
Event Type Malfunction
Event Description
Reporter indicated that the pt's device was registering high impedance on both a system diagnostic, and a normal mode diagnostic. However, the dcdc converter codes were fluctuating to some degree. Reporter indicated that the pt was still able to feel stimulation suggesting that some therapy is still being delivered. X-rays were taken and sent to the mfr for analysis. No obvious anomalies were found on the x-rays, but due to image quality, a portion of the lead could not be evaluated, but proper lead pin insertion was confirmed, suggesting that the most likely cause of the high impedance is a lead fracture, either in part or in whole.

Manufacturer Narrative
Device failure 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=1511706
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« Reply #24 on: June 09, 2017, 08:44:12 AM »

Model Number 302-20
Device Problem High impedance
Event Date 04/18/2017
Event Type Malfunction
Event Description
It was reported that the during an office visit high impedance was observed. No recent falls or trauma that may have contributed to the high impedance were reported to have occurred. The patient was referred for surgery to address the high impedance. X-rays were performed and reviewed by the manufacturer. During the review no obvious lead fractures were observed, however due to the image's quality and a portion of the lead being behind the generator, the integrity of the entire lead body could not be fully assessed. Additionally, the presence of a micro fracture cannot be ruled out. The lead pin appeared to be fully inserted into the generator however due to due to the angle of the generator the lead pin's position could not be confirmed. No surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6564828
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« Reply #25 on: June 09, 2017, 01:07:21 PM »

Model Number 304-20
Device Problem Low impedance
Event Date 04/11/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that during an office visit a diagnostic test was performed and resulted in low impedance. It was also reported that the patient had been experiencing an increase in seizures and a change in behavior which both appeared to be related to the low impedance. X-rays were performed and reviewed by the manufacturer. However due to the poor quality of the images provided the integrity of the lead was difficult to assess. Therefore the cause of the low impedance could not be determined. The patient was then referred for surgery where the lead and generator were replaced. The explanted products have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563365
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« Reply #26 on: June 09, 2017, 01:08:32 PM »

Model Number 304-20
Device Problem Low impedance
Event Date 04/12/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a diagnostic test during an office visit resulted in low impedance. It was noted that patient had not seen a recent change in seizure frequency. X-rays were ordered by the physician and the images were reviewed by the manufacturer. No anomalies or fractures were noted in the x-ray images. However, due to the quality of the images provided the lead¿s integrity was difficult to assess in some locations. There was a portion of the lead that appeared to potentially be a sharp angle however this could not be confirmed in the other x-rays images. It was noted that the lead pin appeared to be fully inserted however due to the angle of the generator the lead pin's position could not be fully assessed. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563232
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« Reply #27 on: June 09, 2017, 01:09:17 PM »

Device Problem Fracture
Event Date 04/17/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
A physician called to report that a patient had high impedance during a routine diagnostic test in a follow-up visit. The patient's last known diagnostic test had been performed in (b)(6) 2015 and there was no known trauma between these clinic visits. X-ray images were sent to the manufacturer for review, but due to the quality of the images, they were unable to identify a definitive cause for the high impedance. No known surgical intervention has occurred to date and no additional relevant information has been received to date.

Manufacturer Narrative
The initial report inadvertently reported the incorrect implant date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6558429
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« Reply #28 on: June 10, 2017, 01:02:04 AM »

Model Number 103
Device Problem No Known Device Problem
Event Date 05/27/2016
Event Type Injury
Event Description
Communication with the patient¿s treating physician showed that surgery was not to preclude a serious injury and was simply in relation to discomfort. Surgical intervention has not occurred to date, and no additional pertinent information has been received to date.

Manufacturer Narrative

Event Description
It was reported that the patient was experiencing discomfort with stimulation in her throat. This was not ameliorated with attempts to lower settings. The physician expressed wanting to get the patient¿s vns explanted. Lead impedance was within normal limits, and review of x-rays by the physician did not show any obvious problems that could be causing or contributing to the painful stimulation. X-ray images taken after the onset of the painful stimulation were reviewed by the manufacturer. Ap and lateral x-rays of the neck and an odontoid view were included in the reviewed images. The generator was placed normally per labeling. The connector pin of the lead could not be fully assessed to be inserted inside the connector block due to the viewing angle and quality of the image. The feedthru wires appeared intact. The electrode placement appeared to be per device labeling. A small portion of the lead was behind the generator, making the lead difficult to assess in this area. There were no apparent sharp angles or gross fractures of the lead that could be seen in the images given. The wires at the lead connector pin appeared to be intact. No additional pertinent information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6548498
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« Reply #29 on: June 11, 2017, 02:08:34 AM »

Model Number 302-20
Event Date 03/29/2010
Event Type  Malfunction   
Manufacturer Narrative 
Device failure is suspected.
 
Event Description 
It was initially reported that diagnostics performed indicated that high lead impedance was present, but specifics were not available. It was also mentioned by the parent that the magnet activations were no longer being perceived for approx two months prior. The pt's seizures were also said to be "different", but no further details have been made on the issue. X-rays were taken and sent to the mfr for analysis. No gross lead fractures or discontinuities were visualized on the portions of the lead body that could be assessed. However, the image quality in the neck area was poor, and there was a portion of the lead body located behind the generator that could not be assessed. Based on the x-rays received, there were no gross lead discontinuities or anomalies observed that could be contributing to the high lead impedance event. However, a led discontinuity cannot be ruled out on the portions of the lead that could not be fully assessed. Good faith attempts to obtain additional info have been unsuccessful to date. A review of the mfr's programming history database indicated that the last known diagnostics were within normal limits.
 
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1686255
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