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dennis100
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« on: December 23, 2018, 05:47:45 AM »

Model Number 302-20
Event Date 11/14/2012
Event Type  Malfunction  
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Analysis of programming history. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Device failure is suspected by physician, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the patient had a dcdc code of 0 on both systems and normal mode. The patient also reported that he had not been feeling stimulation. It was suggested that the output current could be increased to see if the patient felt stimulation but the patient was already at 3. 5 ma and increasing the output current would not be an option. The patient was sent for x-rays and the x-rays were provided to the manufacturer for review. Based on the x-rays received, no obvious anomalies were identified that could be contributing to a short circuit. There were no gross fractures or discontinuities that were visualized. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed and the possibility of a micro-fracture cannot be ruled out. Review of the patient diagnostics in the manufacturers programming history showed that the patient has always had dcdc code of 0 on system diagnostics. The physician's office was concerned that there may be a lead break so the patient was referred for a lead and generator replacement. Surgery is likely but has not occurred to date. There was no reported trauma or manipulation. The dcdc code of 0 is the reason that the office felt there may be a lead break. They understand based on the patients history that dcdc code of 0 may not be a lead break but they wanted to replace the patient just to be sure.

Event Description
Additional information was received that product analysis was completed on the generator and lead. The generator output signal was monitored for more than 24 hours while the generator was placed in a simulated body temperature environment, with results showing no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Visual examination noted tool marks on the pulse generator case, most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc. ) the pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. A small portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Additionally one loose tie down was returned. During the visual analysis pitting was observed on the surface of the connector pin. Sem was performed and identified evidence of being melted and pitting on the surface of the connector pin. Energy dispersion spectroscopy (eds) was performed on the connector pin pitted and identified the area as containing chromium, iron, nickel, manganese, silicon, and molybdenum. Eds was performed on the clean surface of the connector pin and identified the area as containing chromium, iron, nickel, and molybdenum. Another eds was performed on the melted surface of the connector pin and identified the area as containing chromium, iron, nickel, manganese, phosphorous, and molybdenum. It is unknown what caused the melted appearance on the connector pin surface. What appeared to be white deposits were observed in various locations. Eds was performed and identified the deposits as containing sodium, silicon, phosphorous, zirconium, and calcium. Upon visual inspection of the generator cavity no anomalies were observed. During the visual analysis the quadfilar coils appeared to be stretched, wavy and spiraled, in some areas. The connector ring quadfilar coil appeared to be burnt in half. Sem was performed and identified the burnt areas as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). It is unknown exactly what caused the quadfilar coils to melt. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the openings on the outer and inner silicone tubes and the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool during the explant of this lead. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, the observed location of the bare touching coils may have been a possible cause. With the exception of the observed melted areas on the connector pin and both of the quadfilar coils the condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings of the pa, there is no evidence to suggest discontinuities in the returned portion of the device. The observed inner tubing openings where bare coils were touching could have potentially contributed to the low impedance and suspected short circuit condition. Note that since a small portion of the lead assembly (body) including the electrode section was not returned for analysis, an evaluation cannot be made on that portion of the lead.

Event Description
Additional information was received that the patient had a generator and lead replacement. Prior to surgery diagnostics run. The generator was replaced first and diagnostics were run with the new generator both outside and inside the pocket. When diagnostics were run inside the pocket low impedance was received. It was decided to replace the lead. When diagnostics were run again they were within normal limits. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planed but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2885140
« Last Edit: December 24, 2018, 06:15:22 AM by dennis100 » Logged
dennis100
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« Reply #1 on: December 24, 2018, 06:20:20 AM »

Model Number 302-20
Event Date 12/08/2011
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
Additional information was received on (b)(4) 2012, when product analysis was completed on the section of the lead assembly that was returned. The lead's electrodes were not returned for evaluation. Scanning electron microscopy images of the pin shows that pitting or electro-etching conditions have occurred on the connector pin at the region where the reddish-brown deposits were noted. An energy dispersive spectrometry analysis performed on a sample of the reddish-brown deposits identified fe, cr, ni, p, mo, na, si, and ca as the composition for the substance. The higher percentage of iron in this sample suggests oxidation may have occurred. Since a portion of the lead, including the electrode array, was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. Product analysis on the generator was completed on (b)(4) 2012. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. Magnet activations performed at the bench (at a distance of one-inch, spacer block, from generator) demonstrate the appropriate magnet output for the programmed settings. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; there were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Additional information was received on (b)(6) 2012 when the physician reported that no x-rays had been taken by the physician. The patient has been scheduled for a full revision surgery in (b)(6) 2012.

Event Description
On (b)(6) 2011 a vns treating physician reported that the vns patient has high impedance. The patient stated that in the past couple of months he has been noticing that when he swipes his magnet he doesn't feel the "tickle" he normally feels. There has been no trauma. The physician has referred the patient for a full revision surgery. The patient's settings were output=2. 5ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 8min/magnet output=2. 75ma/magnet on time=60sec/magnet pulse width=250usec. A battery life calculation was performed which showed 0. 41 years until eri=yes. Although surgery is likely, it has not yet occurred. No further information regarding the high impedance has been received from the physician to date.

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

Event Description
Additional information was received on (b)(6) 2012 when it was discovered that the vns patient had a full revision surgery on (b)(6) 2012. The generator had been replaced for prophylactic reasons and the leads were replaced due to high impedance. The lead impedance after surgery was reported to be within normal limits. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(6) 2012 that has not yet been completed.

Event Description
Additional information was received on (b)(6) 2012 when it was discovered that the vns patient was scheduled for surgery on (b)(6) 2011 but it was cancelled because the patient had something to drink. The surgery will be rescheduled. The patient was last seen by the physician on (b)(6) 2011 and this was when the high impedance was first observed. A system diagnostics test showed results of lead impedance=high/near end of service=no. The patient's device was then disabled that day due to the high impedance. Although surgery is likely it has not yet occurred.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2395574
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dennis100
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« Reply #2 on: December 24, 2018, 06:22:40 AM »

Model Number 103
Event Date 12/12/2012
Event Type  Malfunction   
Manufacturer Narrative
New information received corrects the suspect device.

Event Description
A review of programming and diagnostic data was performed which identified a high impedance event. The high impedance was observed on (b)(6) 2012. Follow up with the nurse found that the high impedance was observed the same day the patient's generator was being replaced due to a depleted battery. The lead was not replaced. The patient was implanted with a new generator and diagnostics were all fine. Additional information from the physician found that the high impedance was initially seen as 10,000 ohms. Diagnostics two weeks after surgery showed an impedance value of 5,000 ohms, and then 10,000 ohms months later. The physician stated that before the high impedance was observed, the patient did fall. It was confirmed that the high impedance was initially observed during surgery. Ap and lateral chest and neck x-rays were taken and sent to the manufacturer for review. The generator was seen in the left chest. The filter feedthru wires were intact. The connector pin inside the connector block does not appear to be completely inserted. The lead wire was intact at the location of the connector pin. There did not appear to be any lead discontinuities or sharp bends, however there was a portion of the lead located behind the generator that could not be assessed. The electrode placement was not done as per labeling as the electrode placement is inverted. There appeared to be no propper strain relief bend or loop per labeling. There were two tie downs present, but they did not appear to be placed per labeling to secure the strain relief bend. No additional information has been provided.

Event Description
The physician reported that he may not refer the patient for replacement and may just leave the device off; however, the plan was unclear. It was later reported that the surgeon reported that he would correct the patient's lead and that the generator would be replaced also if need be. Surgery is planned, but has not occurred to date.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized; however, lead pin not fully inserted past the connector block. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
The patient underwent generator and lead replacement on (b)(6) 2014. It was reported that the generator was replaced prophylactically and that the high impedance was likely attributed to the lead pin not being fully inserted into the generator header. The generator and lead were returned for analysis. Analysis of the lead was completed on 05/06/2014. During the visual analysis a half set of setscrew marks was found at the end of the connector pin, indicating the connector pin had not been fully inserted into the cavity of the pulse generator at one time. The marks are evidence of a potentially insufficient mechanical contact between conductive surfaces of the generator and connector ring, resulting in a suspect electrical connection to the lead. However, based on the location of the setscrew marks on the pin, it is unknown whether a good electrical connection was present for the connector ring. During the visual analysis what appeared to be pitting was observed on the surface of the connector ring. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector ring. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the connector ring pit deposit and identified the area as consisting of silicon, potassium, chromium, iron, nickel, sodium, manganese, fluorine and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. However, a review of the patient x-rays' issue file correspondence suggest the electrodes may not have been attached to the nerve as intended. Other than observed pitting on the connector ring surface, no other obvious anomalies were noted except for the half set of setscrew marks found at the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated allegations of 'hgh impedance'. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Analysis of the generator is underway, but has not been completed to date. N.

Event Description
Analysis of the generator was completed on (b)(6) 2014. Electrical test results showed that the pulse generator performed according to functional specification. Visual inspection results revealed no external device abnormalities. There were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3589007
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dennis100
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« Reply #3 on: December 31, 2018, 09:24:07 AM »

Model Number 302-20
Event Date 12/27/2012
Event Type  Malfunction   
Event Description
Reporter indicated that during a prophylactic vns generator replacement surgery, the lead was noted to be broken when the generator was removed from the patient. It is not known if the lead was accidentally cut in the surgery or broke prior to the surgery. Vns diagnostics testing immediately prior to the surgery revealed normal results. A new lead and generator were implanted. The explanted lead and generator have been returned and are pending analysis. Attempts for additional information are in progress.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury. Additionally, the failure was due to significant patient manipulation of the lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the returned vns generator and lead was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. During the lead visual analysis of the returned 43mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, fluorine, nickel and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. During the visual analysis of the returned 43mm portion the ends of the quadfilar coils appeared to be twisted together inside the connector boot. Scanning electron microscopy was performed and identified the area as being twisted together and mechanically damaged which prevented identification of the coil fracture type with residual material and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). The condition of the remaining portions of the returned lead is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. However, based on the overall condition of the returned lead, there appears to be evidence of significant manipulation, which may have contributed to the observed stress-induced fractures. Note that since a large portion of the lead assembly (body) including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2928444
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dennis100
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« Reply #4 on: January 01, 2019, 04:08:43 AM »

Model Number 103
Event Date 07/02/2014
Event Type  Malfunction   
Event Description
Initially, it was reported that high impedance was observed and the patient was experiencing an increase in seizures. It was reported that the patient had recently suffered a fall during ice skating. The physician assistant believes the device was damaged during the fall. X-rays were taken and sent to manufacturer for review. X-rays identified that the lead pin did not appear to be fully inserted into the generator header. The patient underwent surgery. The surgeon opened the chest pocket to check the connection and when the generator was removed the lead pin fell out of the header confirming a generator/lead connection issue. The surgeon implanted a new generator and lead. The explanted lead and generator were received for analysis. Analysis of the lead was completed on (b)(4) 2015. During the visual analysis of the returned 289mm portion what appeared to be rust-like deposits and pitting were observed on the connector pin surface. Scanning electron microscopy was performed and identified evidence of pitting on the surface of the connector pin. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin rust-like deposit and identified the area as consisting of chromium, iron, nickel, silicone and phosphorus. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, sodium, manganese, silicone and sulphur. A definite cause for the pitting could not be determined based on the lead portion returned. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator was completed on (b)(4) 2015. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no additional performance or any other type of adverse conditions found with the pulse generator. The generator decoder identified that the high impedance occurred prior to (b)(6) 2014.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4576543
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« Reply #5 on: January 07, 2019, 01:28:49 AM »

Model Number 302-20
Event Date 10/26/2013
Event Type  Malfunction   
Event Description
The data dump for the generator identified that the lead impedance changed from 2935 ohms to 13129 ohms on (b)(6) 2013. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis what appeared to be pitting was observed on the connector pin surface. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the connector pin pit deposit and identified the area as consisting of chromium, iron, nickel, silicon, fluorine, sodium, potassium, aluminum and molybdenum. Another eds procedure was performed on the clean surface of the connector pin and identified the area as consisting of chromium, iron, nickel, silicone and molybdenum. A definite cause for the pitting could not be determined based on the lead portion returned. The slice mark and abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The condition of the returned lead portion is consistent with that which typically exists following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. The generator analysis will be reported in mfr. Report #1644487-2014-00731.
 
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that the patient will be referred to surgeon for revision surgery. No known trauma or patient manipulation occurred that is believed to have caused or contributed to the high impedance. It is unknown if x-rays were performed. Surgery is likely, but has not occurred to date. Attempts to obtain additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received stating that the vns patient¿s device was explanted on (b)(6) 2014. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3608939
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dennis100
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« Reply #6 on: June 17, 2019, 04:01:52 AM »

Model Number 302-20
Device Problems High impedance; Appropriate Term/Code Not Available
Event Date 12/08/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Patient was referred for a prophylactic generator replacement. During the replacement surgery, high impedance was observed with dcdc - 7 on system diagnostic test with the existing device. The surgeon inserted the lead pin into the generator a couple of times to rule out incomplete pin insertion but continued to get high impedance. The lead and generator were therefore replaced. The explanted devices have not been received to date.
 
Event Description
The explanted devices were received. Analysis is underway but has not been completed to date.
 
Event Description
The generator was explanted for prophylactic reasons. The device performed according to functional specifications of the current automated final test. Analysis of the generator in the analysis lab concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portions and the reported allegations of fracture of lead were confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned portion what appeared to be pitting and rust-like deposits were observed on the connector pin surface. Energy dispersion spectroscopy (eds), which provides chemical or element identity/composition analysis, was performed on the connector pin rust-like deposits and identified the area as consisting of sodium, silicone, phosphorus, nickel, chromium and iron. Another eds procedure was performed on the clean connector pin surface and identified the area as consisting of chromium, silicone, sulphur, iron and nickel. A definite cause for the pitting could not be determined based on the lead portions returned. Several broken coils were observed. Scanning electron microscopy (sem) was performed and identified the some areas as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type with pitting on the broken coil strands. 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. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.
 
Event Description
It was noted during a review of a programming data card that high impedance was observed during system diagnostics the patient's generator implant surgery on (b(6) 2016. This is the generator that was explanted with the lead. It is unclear if this is related to pin insertion troubleshooting event or related to the lead fracture. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7151020
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