VNS Message Board

VNS DISCUSSIONS => Legislative Activism In Regards to VNS => Topic started by: dennis100 on April 13, 2018, 01:07:38 AM



Title: White Deposits
Post by: dennis100 on April 13, 2018, 01:07:38 AM
Model Number 102
Device Problem No Known Device Problem
Event Date 04/02/2015
Event Type  Death   
Event Description
Analysis of the generator was completed on (b)(6) 2015. The module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on (b)(6) 2015. Note that the majority 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
The autopsy finding were listed as clinical history of rett syndrome with a history of uncontrolled seizures, musculature atrophy of extremities, scoliosis; pulmonary congestion/edema; history that the decedent was found unresponsive in a prone position in bed. The conclusion was noted to be that the decedent died as a result of a seizure disorder associated with rett syndrome. The manner of death was listed as natural.
 
Event Description
It was reported that the vns patient passed away. The funeral home indicated that the device was explanted by the medical examiner and would be returned for analysis. The medical examiner's office indicated that the autopsy is pending, but would be provided when completed. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4772129


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:08:08 AM
Model Number 101
Event Date 12/23/2008
Event Type  Malfunction   
Event Description
Product analysis was performed on a returned generator. External visual examination noted header fracturing around the connector blocks, feed thru wires, and anchor. No evidence of body fluid penetration was observed in the fractures. The cause of the fracturing was not determined. Excluding the header fractures, no additional surface abnormalities were noted on this device. The septa were not cored. Internal visual examination noted a white substance covering several areas (and components) on the pcb. Sem analysis identified elements in the substances as deposits of lead and tin (solder) and chlorine. The source of the chlorine could not be determined. Generator eos was confirmed (as result of battery depletion). The depletion was an expected event based on the results of a battery life analysis, utilizing the pts programmed settings. A post burn-in test could not be performed on the module. The corrosive effects of the chlorine prevented proper electrical functioning of the unit. The extent to which this condition may have impacted battery longevity or device functionality is not known.
 
Manufacturer Narrative
Conclusions: device malfunction occurred, 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=1365495


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:08:57 AM
Model Number 103
Event Date 01/22/2013
Event Type  Malfunction   
Event Description
Additional information was received that the patient had a lead and generator replacement. Attempts for product return are in process. X-rays were received by the manufacturer and were reviewed. Based on the x-ray received the lead not being fully inserted in to the connector block may be a reason for the high impedance. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead however the presence of a microfracture in the lead cannot be ruled out. As the entire lead could not be assessed, continuity in that portion of the lead cannot be confirmed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution. The patient had their generator turned off after the high impedance was seen.
 
Event Description
Further follow-up revealed that the lead was tested prior to surgery, but that the surgeon wanted to replace the entire vns system regardless. It appears that no troubleshooting was performed to resolve the high impedance since the surgeon elected to replace the entire vns system. The cause of the high impedance is believed to be a lead pin insertion issue.
 
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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 found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be specs of white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing calcium. Refer to attached eds sheet for additional information. No obvious anomalies were noted except for the one and a half sets 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. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device. However, the incomplete lead pin insertion condition may have contributed to the high impedance situation. Note that since a portion of lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Indentions were observed on the lower thread of the setscrew, indicating that the setscrew was down during lead insertion. However, indentions were observed on the bottom of the setscrew, which indicates that either the lead pin or test resistor was secured with the setscrew. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No obstructions were observed in the header lead cavity or connector blocks. In addition, the in-line cavity test passed and a bench lead inserted completely passed the negative connector block. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 980 volts as measured shows a non-ifi condition. The data in the diagaccum consumed memory locations revealed that 3. 039% of the battery had been consumed. Other than the noted condition there were no performance or any other type of adverse condition found with the pulse generator.
 
Manufacturer Narrative

Event Description
It was initially reported that the patient had an increase in seizures since a generator replacement surgery. When the patient was seen in the office the warning message 'high lead impedance warning with impedance '10,000 ohms, programmed current possibly not being delivered at the programmed settings' was observed. Diagnostics were run and the results were: output status -low, output current - 0 ma, impedance - high, impedance value - 10,000 ohms, ifi no. It was believed that it was an issue of the lead pin not being fully inserted. There was no reported manipulation or trauma. The patient had their generator disabled when the high impedance was observed. X-rays were taken but have not been sent to the manufacturer for review. An x-ray reported was received but did not comment on the integrity of the vns system. The increase in seizure was due to the high impedance and was below pre-vns baseline. There were no specifics on seizure type. No other issues were reported to the office. Surgery is likely but has not occurred.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Manufacturer Narrative
Date of event; corrected data: supplemental manufacturer report #02 inadvertently did not update the event date. Additional information indicates that the event occurred on (b)(6) 2014. Aware date; corrected data: the initial manufacturer report provided an incorrect aware date. Describe event or problem; corrected data: supplemental manufacturer report #02 inadvertently did not include the review of the internal device data. Relevant tests/laboratory data; corrected data: supplemental manufacturer report #02 inadvertently did not include the internal device data.
 
Event Description
Review of the as-received internal device data showed that the last 25% change in the impedance value on (b)(6) 2013, where the impedance value changed from a normal limits range to high lead impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3015352


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:09:31 AM
Model Number 302-20
Event Date 07/01/2013
Event Type  Malfunction   
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
It was reported that generator replacement surgery the surgeon inspected the lead and found that there was a calcified area on the lead. It was reported that the part of the lead that had the calcified area appeared to be cracked and damage. The surgeon decided to replace the lead also. The explanted devices are expected to be returned for analysis, but have not been received to date.
 
Event Description
The generator and lead were returned for analysis. Analysis of the generator was completed on 11/06/2013. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 11/12/2013. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, aluminum and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3347595


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:10:11 AM
Model Number 103
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
Generator analysis generator pa approved: (b)(4) 2013. In the pa lab, the device output signal was monitored for more than (b)(4), 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. Attempts for additional information have been unsuccessful.
 
Event Description
It was reported that the patient was scheduled for lead replacement surgery. The lead was replaced on (b)(6) 2013. The lead was received for analysis on (b)(4) 2013. Analysis is underway, but has not been completed 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
The lead analysis was completed on (b)(4) 2013. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing calcium, sodium, magnesium, zirconium, silicone and phosphorus. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.
 
Event Description
On (b)(6) 2013, it was reported that diagnostics on this date indicated high impedance. It was reported that the patient fell in february and that was believed to be the cause. It was also stated that beginning in march, the patient began having an increase in seizure frequency and intensity. There have not been any other changes that could have been a cause to the seizure changes. The patient was last seen on (b)(6) 2012 at which time diagnostics were within normal limits. The patient's device was disabled, and the patient was referred for revision and x-rays. X-rays were reviewed: the generator and lead are visible with almost uniform brightness/contrast across the images. Placement of the generator is normal in the left chest pocket, and the feedthru wires appear intact. It cannot be confirmed that the connect pin is fully inserted inside the connector block. A strain relief bend is present and is placed per labeling. A strain relief loop is not present. Two tie-downs are also present, one of which is securing a strain relief bend as specified per labeling. Lead is present behind the generator. There are not any gross fractures or discontinuities in the lead. There appears to be a sharp angle near the header of the generator in a portion of the lead. The lead wires appear intact at the connector pins. On (b)(6) 2013, it was reported that this patient underwent generator revision on (b)(6) 2013. The lead was not replaced. The explanted generator was returned on (b)(6) 2013 and is pending product analysis.
 
Manufacturer Narrative
Review of programming history. Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized, complete pin insertion could not be verified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081227


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:11:30 AM
Model Number 300-20
Event Date 05/25/2012
Event Type  Malfunction   
Event Description
In the pa 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. 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. An analysis was performed on the returned lead portions. Note that 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. What appeared to be white deposits were observed on the marked connector boot. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. Abrasions were also identified in multiple locations, possibly caused by wear. No obvious anomalies were noted except for the set of setscrew marks found near the end of the unmarked connector pin indicating the pin had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the unmarked 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. There is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of a lead fracture.
 
Event Description
On (b)(6) 2013, it was reported that the explanted devices would be returned. The lead and generator were returned on (b)(6) 2013 and are currently undergoing product analysis.
 
Manufacturer Narrative

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
Clinic notes dated (b)(6) 2012, indicated that the patient had not had a seizure in approximately a year. The generator was recently replaced and the patient's mood was reported to be better since the stimulator was placed. The patient reported that she did not feel any stimulation though the setting has been relatively low. The patient was previously at 2. 0 ma and the device was currently at 0. 75 ma. The device was interrogated on this date and found be at the previously prescribed settings. The output current was increased to 1. 0 ma; however, a lead test performed after the increase indicated high impedance. The normal mode and magnet mode output currents were programmed to 0 ma. Radiology notes from the physician (dated (b)(6) 2012) indicated that, upon review of pa and lateral chest x-rays, no obvious change in the electrode lead extending from the battery pack on the left. The top of the wire seemed to be within the supraclavicular region on the left and the anterior paracervical soft tissue area. The indication was possible vns lead displacement. The findings were that the old study of (b)(6) 2011, revealed a battery pack over the left anterior chest wall, with small leads extending to the lower paracervical region on the left. The wire was looped in the supraclavicular area. The exam on (b)(6) 2012, showed the same looped appearance of the electrode overlying the left supraclavicular paravertebral region. The lungs were clear without plural effusion. An implant card, received on (b)(6) 2012, indicated that the patient underwent total revision on (b)(6) 2012. Follow up showed that the generator was replaced to be compatible with the patient's new single-pin lead. Attempts for product return have been unsuccessful as a manufacturer's consultant stated that the explanted devices were believed to have been disposed of. A review of the patient's programming history showed data for three dates: (b)(6) 2012 (date of generator revision), (b)(6) 2012. A system diagnostic on (b)(6) 2012, showed normal results. No diagnostic are were performed at the (b)(6) 2012 appointment. A battery life calculation on (b)(6) 2012, resulted in 17. 95 years to eri=yes. It was also shown that the device was disabled on (b)(6) 2012.
 
Manufacturer Narrative
Description of event, corrected data: previously submitted mdr inadvertently omitted from physician notes. This report is being submitted to correct this information. Analysis of programming history.
 
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
It was reported by a company representative that high impedance was received at a follow-up appointment. The patient had recently undergone battery replacement surgery and diagnostics were not performed post op. The patient also indicated that she was unable to perceive stimulation as she used to. Additional information from the area representative indicated the patient's generator was programmed off due to the reported high lead impedance. No patient manipulation or trauma were reported to have had contributed to the event. X-rays were taken and sent to the manufacturer for review. Review of x-rays indicated the generator placement appeared to be normal. The leads appeared to be fully inserted inside the connector block. The filter feed-thrus appeared to be intact. The placement of the electrodes was not assessed as x-ray images were not made of the neck area. There was some lead behind the generator which could not be assessed. No acute angles or lead discontinuities were observed in the chest area that was visible. However, the neck and upper chest area was not evaluated based on lack of x-ray views. At the moment, attempts for further information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2621930


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:12:09 AM
Model Number 302-30
Event Date 01/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013, the patient underwent full revision. Attempts for product return have been unsuccessful.
 
Event Description
The generator and lead were returned for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. 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. Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 3mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type. The remaining two broken coil strands were identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. During the visual analysis of the returned 40mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 3mm and 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed on the (-) green electrode quadfilar coil breaks (found at 3mm and 1. 5mm) and identified the areas as being mechanically damaged with pitting which prevented identification of the coil fracture type. Determination could not conclusively be made on the fracture mechanism. 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Event Description
On (b)(6) 2013, a physician reported that diagnostics showed high impedance (>10,000 ohms), and low output status. The patient was last seen on (b)(6) 2012 with normal impedance ((b)(6) 2012) (1986 ohms, eos: no). The patient did not report any traumatic events or fall, and there were no programming changes since that time. The patient denied any symptoms. The patient's device was programmed off. Attempts for x-rays have been unsuccessful. Surgery is likely but has not taken place. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967767


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:14:14 AM
Model Number 302-20
Event Date 06/25/2012
Event Type  Malfunction   
Event Description
An analysis was performed on the returned lead portion. Note that the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the connector pin quadfilar coil appeared to be broken approximately 240mm (connector end) and 243mm (electrode mating end) from the end of the connector boot in the area of observed abraded openings. Visual analysis was performed and identified the areas as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. What appeared to be remnants of dried body fluids and white deposits were observed inside the outer and connector pin inner silicone tubing, throughout the majority of the returned portion. The abraded openings found on the outer and connector pin inner silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids / white deposits found inside the outer and inner silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
The patient had surgery (b)(6) 2012. Our consultant attended the surgery reported that when the surgeon exposed the carotid sheath, he stated there was not enough room remaining on the vagus nerve to place another lead. For this reason, the lead was cut and the electrodes remain on the nerve. No new system was implanted. The explanted portions of the lead were not returned for analysis. Their explanted generator was returned for analysis. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Manufacturer Narrative
Device malfunction occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that a vns patient had high lead impedance with a dcdc 7. The patient is having seizures which they think is from their vns not working. No x-rays have been ordered. The patient did not have any fall or injury preceding the event. The patient is referred for surgery (b)(6) 2012.
 
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2664590


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:14:56 AM
Model Number 302-20
Event Date 11/14/2012
Event Type  Malfunction   
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 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.
 
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
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2885140


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:16:11 AM
Model Number 300-20
Event Date 02/22/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 and are pending product analysis.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
Reporter indicated via the manufacturer¿s implant card that the patient had vns generator and lead replacement surgery on (b)(6) 2013 due to ¿increased seizures¿, and that a new model 104 vns generator was ¿wasted, inserted, and removed¿ but not implanted at the surgery. Attempts for additional information and return of the explanted devices are in progress.
 
Event Description
Reporter indicated high lead impedance was observed for a patient at an office visit on (b)(6) 2013. Approximately two to three weeks prior to the office visit, the patient began experiencing dizziness, not feeling vns stimulation, and the patient's seizures were described as "different". The vns was disabled and x-rays were performed but will not be sent to the manufacturer. Vns diagnostics were last within normal limits in (b)(6) 2013. The patient had no known trauma and does not manipulate the vns. The patient is active is sports. The reporter feels the vns lead may be broken and causing the change in seizures, dizziness, and stimulation not perceived. No programming or medication changes preceded these issues. Surgery to replace the vns lead and generator is likely, but has not occurred to date.
 
Event Description
On (b)(4) 2013 product analysis was completed on the lead. During the visual analysis of the returned 47mm portion quadfilar coil 1 appeared to be broken approximately 12mm and 14mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 12mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 14mm) and identified the area as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type with fine pitting. Flat spots and pitting were observed on the coil surface. During the visual analysis of the returned 58mm portion the (+) white electrode quadfilar coil appeared to be broken at the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as having extensive pitting and mechanical damage which prevented identification of the coil fracture type. 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 abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Product analysis on the generator was completed on (b)(4) 2013. Review of the data indicated that the pulsedisabled byte was set to a value that represents a vbat

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3050791


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:17:05 AM
Model Number 300-20
Event Date 10/04/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was performed on the generator and lead. The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the (b)(4) 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. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portions. Note that a 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. During the visual analysis of the returned 149mm and 93mm portions quadfilar coil 2 appeared to be broken. Scanning electron microscopy was performed and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the remaining broken quadfilar coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with 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 abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of lead fracture/high impedance.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2013 were received on (b)(6) 2013. The patient denied any seizures activity since the last clinic visit. The patient's device was programmed off. The notes stated that the patient's device was rechecked several time. There were occasions/positions that the device did not function, lending support to a microfracture. Surgery is likely but has not taken place. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
It was reported that the patient was seen on (b)(6) 2012 and high impedance was observed on a system diagnostic test. The generator was programmed off and x-rays were ordered. There was no reported trauma to the neck and chest and the patient has been seizure free. The patient was last seen in january and at that time, the diagnostics were said to be within normal limits, however specifics were not provided.
 
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) 2013, this patient underwent full revision. Attempts for product return have been unsuccessful.
 
Manufacturer Narrative

Event Description
X-ray images were received for the patient and were reviewed. Both connector pins appeared to be fully inserted inside the connector blocks and the feedthru wires appears to be intact. The placement of the generator appears to be normal. A portion of the lead is behind the generator, and cannot be assessed. There appears to be no gross fractures, discontinuities or sharp angles in the portion of the lead that is visible. Based on the x-ray images provided, an exact cause for the report of high impedance could not be determined. A portion of the lead behind the generator could not be assessed, therefore a lead fracture in that portion of the lead cannot be ruled out. The presence of micro-fractures in the lead can also not be ruled out. It was indicated that the patient had done well with vns. The patient has been referred for revision. Surgery is likely but has not occurred to date.
 
Event Description
The explanted devices were returned on (b)(6) 2013 and are pending product analysis.
 
Event Description
Additional information was received on the date of surgery, (b)(6) 2013, indicating that the surgeon requested for diagnostics to be performed. Multiple diagnostic tests were performed on the device in the or with the surgeon and some of the results were within normal limits. One system diagnostic test was performed at 1. 0ma which resulted in a dc/dc = 5 and high lead impedance. The patient's output current was then increased to 2. 00ma and the diagnostic test was within normal limits with dc/dc = 3. Normal mode had a dc-dc value of 5 and everything else was within normal limits. Due to this, the surgeon did not think that there was an issue with the lead. The surgeon decided to cancel the surgery as everything seemed to be fine with the lead per the testing that was performed in front of him. The patient's generator was then re-enabled. On (b)(6) 2013 additional information was received indicating that the patient had been experiencing shocking in the arm. It was reported that the patient had been experiencing the shocking pain in the arm since leaving the or. The patient had been seen again by is neurologist and diagnostics again revealed high impedance with a dc/dc = 7. The patient was scheduled for another follow up appointment on (b)(6) 2013. High impedance was again replicated, sitting down and standing up. The neurologist discussed the findings with the surgeon, and the patient is again being scheduled for surgery. The generator was again disabled, and it was indicated that the pain that the patient was experiencing was occurring with stimulation and was believed to be related to the high impedance in the system. Surgery is likely but has not occurred to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that all functional tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2815171


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:17:43 AM
Model Number 302-20
Event Date 08/29/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that the vns patient was scheduled for a prophylactic battery replacement on (b)(6) 2012; however, during surgery, the lead was determined to need replacement due to the lead being frayed and the wires exposed. The surgeon later stated that system diagnostics from surgery showed dcdc=0 and lead impedance=ok. No x-rays were taken prior to surgery. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fraying/wires exposed. The explanted lead and generator were returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed. The reason for explant on the form received with the explanted products indicated that the housing on the leads were frayed and the wires were exposed. Clinic notes dated (b)(6) 2012 were received, which indicate that the patient's mother has not noticed the patient's voice changing at all lately with activation of the magnet. Clinic notes dated (b)(6) 2011, stated that the patient's vns was interrogated and settings left unchanged but the physician was unable to perform a lead test due to poor patient cooperation. The patient was referred for prophylactic generator replacement since the patient was reaching end of service. The patient's programming history was reviewed and all the system diagnostics tests showed results within normal limits and all showed a dcdc of 0 except for one date ((b)(6) 2005) that showed a dcdc of 2.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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)(6) 2012 when product analysis was completed on the explanted generator. The generator performed according to functional specifications. Product analysis on the generator was completed on (b)(6) 2012. During the product analysis there were no anomalies found with the pulse generator. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lead products and identified them as containing silicon, calcium, sodium and phosphorus. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other and creating a potential short-circuit condition. The condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies, beyond the abraded openings, 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2755718


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:18:19 AM
Model Number 105
Event Date 04/10/2013
Event Type  Injury   
Event Description
Additional information was received that the patient had elective generator replacement that was complicated by a post-operative wound infection. Another physician attempted in situ treatment of the infection. The infection was at the generator site, but the whole system was removed due to chronic infection. Cultures were taken but returned negative as the patient had been on a long term antibiotic. No patient manipulation or trauma occurred that is believed to have caused/contributed to the infection.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.
 
Event Description
Lead analysis was performed: what appeared to be white deposits were observed on inner silicone tubing. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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, 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.
 
Event Description
On (b)(4) 2013, it was reported that this vns patient had an infection at the surgical site along with generator extrusion. The patient was to be kept on antibiotics for several weeks. Clinic notes from (b)(6) 2013 indicated that the patient was having more brief seizures but the clusters were not lasting as long. The patient had an infection at this time in the pocket that was being treated with antibiotics. No changes were made to settings. The patient also presented with an infected suture line with some purulent drainage that improved on antibiotics with some redness. The site was cleaned on this date. Notes from (b)(6) 2013 indicated that there was progressive opening of the wound such that the generator could be seen. It was believed that the patient's brace may have put pressure on the incision and continued to breakdown of the wound and/or wound infection. Follow-up showed that the patient was previously seen on (b)(6) 2013, and the patient's seizures had not significantly improved because the patient was not up to his previous settings. The increase in seizures from (b)(6) 2013 was believed to be related to the lower settings, but the relation to baseline was unknown. Additional follow-up showed that cultures returned negative because the patient was treated at different facility with antibiotics. There was no known patient manipulation or trauma that is believed to have caused/contributed to the infection. The infection was at the generator site with no visible infection at the lead site. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Lead and generator explant occurred on (b)(6) 2013, and the devices were returned on (b)(6) 2013. Generator product analysis concluded that the device was operating properly. Electrical tests showed that the pulse generator was operating within specification. 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=3112828


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:19:22 AM
Model Number 302-20
Event Date 01/21/2013
Event Type  Malfunction   
Event Description
The pulse generator performed according to functional specifications in the product analysis lab. There were no performance or any other type of adverse conditions found with the pulse generator. The device was not at end of service. Analysis of the lead was also completed. Note that the electrodes were not returned for analysis, but a significant portion of the lead was returned; therefore, a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, zirconium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the allegation of high impedance. Attempts for additional information from the treating physician regarding whether high impedance was observed on normal mode or system diagnostics have been unsuccessful to date. It was previously reported by the physician that high impedance was not observed on system diagnostics, but the question may have been misinterpreted so further follow-up was performed. High impedance on systems diagnostic indicates the vns system would not be functioning properly.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that all quality tests were passed on the generator and lead prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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
It was initially reported that the patient was referred for generator replacement due to generator end of service. However during surgery on (b)(6) 2013, a generator and lead revision was performed due to high lead impedance with dcdc=7, indicating high impedance. The explanted products were returned to the manufacturer; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. Follow-up with the referring physician¿s office revealed that high impedance was observed on (b)(6) 2013 with a message that read "prior current not being delivered". However, it was indicated that dcdc=7 was not observed on systems diagnostics. The device was turned off on (b)(6) 2013. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance, and the patient did not exhibit any clinical symptoms that may have been associated with the high impedance. No additional information was provided. Attempts for additional information from the surgeon's office have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2995296


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:19:59 AM
Model Number 300-20
Event Date 08/03/2010
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was noted that during a review of diagnostic history for an effectiveness check associated with a mfr investigation, the following generators were noted to have received an impedance measurement <600 ohms indicating the potential presence of a short-circuit condition. At the moment good faith attempts to obtain add'l info have been unsuccessful to date.
 
Event Description
Analysis of the returned generator was completed. An end of service (eos) warning message was verified in the product analysis laboratory (pa lab) and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. The reported eos allegation was duplicated in the pa lab. During the bench interrogation (at approximately 0. 5 inches between the pulse generator and the programming wand) the pulsedisabled and eos warnings were set. The pulsedisabled byte would not reset. Therefore, the system diagnostics and final electrical test could not be performed. The data in the diag accum consumed memory locations revealed that 119. 305% of the battery had been consumed. The post burn-in electrical test results show that the pulse generator module performs according to functional specifications, except that the c4 capacitor is out of specification. Based on engineering testing, this decreased capacitance condition is an expected event for an aged capacitor of the type used for c4, as the manufacturing test limits for c4 value do not take aging into account. This condition does not indicate a failure of the device or the component, and is not expected to have an adverse effect on battery longevity. A battery life calculation resulted in 0. 0 years remaining before the near eos flag would be set. An incomplete programming/diagnostic history (2. 5 year gap) indicates the estimation does not use all the data required to make an accurate estimation. Other than the noted events (pulsedisabled and c4), there were no additional performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Further information was received indicating that the patient underwent full replacement surgery on (b)(6) 2016. The generator was replaced due to end of service and the lead was replaced due to low impedance. The patient¿s vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with 1263 ohms. The explanted devices were returned to the manufacturer on 03/25/2016. Analysis of the returned generator is underway but it has not been completed to date. Analysis of the returned lead portions was completed and a condition was observed that could potentially contribute to the reported ¿low impedance¿ allegation. The bare and exposed conductive coils may be a contributing factor. During the visual analysis, abraded openings were observed on both of the inner silicone tubes. The quadfilar coils appeared to be bare and exposed in the areas of the abraded openings. Abraded openings were not observed on the outer silicone tubing. The slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the inner silicone tubes and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the abraded openings observed on the inner silicone tubes, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is evidence to support the ¿low impedance / short circuit condition¿ allegations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2266046


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:20:35 AM
Model Number 102R
Event Date 07/30/2012
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)(6) 2012 indicating that x-rays were not performed and there was no suspected manipulation or trauma which may have caused the high impedance. Programming history was also received and revealed that high impedance was first observed on (b)(6) 2012 during a normal mode diagnostic test. The patient underwent revision surgery on (b)(6) 2012. Prior to surgery, diagnostics were performed and the patient had a dc/dc of 6 no normal mode diagnostics and a dc/dc of 7 on system mode diagnostics. The explanted products were returned, however analysis has not yet been completed.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis on the lead was completed on (b)(6) 2012. The reported high impedance allegations were not verified within the returned lead portion. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. Analysis on the generator was also completed. Visual analysis of the pulse generator identified a delaminated header. Additionally, x-rays of the feed thru wires inside the header confirmed that they were severed. Analysis in the pa lab concluded that the delamination of the header probably occurred before the device was explanted; based on the diagnostic data, the body remnants, dried body fluid and white deposits that were found inside the header. The delamination and feed-thru wire breakage would account for the high impedance and the body remnants, dried body fluid and white deposits that were found inside the header.
 
Event Description
It was reported on (b)(6) 2012 that the patient had been referred to a surgeon as high impedance was observed at a follow up visit. The dc/dc code was provided as 7. Revision is likely but has not occurred to date. No additional information is known at this time.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2721493


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:21:12 AM
Model Number 102
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Product analysis of the returned generator found that the septum was not present in the septum cavity. During visual examination of the device, residue was observed on the pulse generator feed-thru assembly and is known to be related to the manufacturing process of the component. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. In addition, white deposits were observed on the pulse generator case and header. White deposits were also observed in the header septum cavity and the setscrew hex socket. No septum was observed in the header septum cavity. Based on the observed white deposits in the header septum cavity, suggest the septum was not present during all of the device implantation time. The pulse generator module performed according to functional specifications. Other than the white deposits, 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=3537868



Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:22:18 AM
Model Number 302-20
Event Date 01/22/2013
Event Type  Malfunction   
Event Description
Additional information was received on (b)(6) 2013 reporting that the patient's mother indicated that vns therapy was not working properly for the patient which the physician attributed to the loss of vns therapy due to the high impedance. The physician reported that after the patient's generator replacement on (b)(6) 2012, everything was going well. Once the high impedance was observed at a follow-up visit, the mother complained that the vns magnet was not functioning as it was before and the patient]'s seizures were increasing in frequency and severity. The events began (b)(6) 2012. The physician believes the increased seizures frequency and severity, in addition to the magnet no longer appearing to function as before, was likely related to loss of vns therapy. With the therapy, the patient had seizure reduction around 20%. The length of the seizure and the reduction of post-ictal state was noticeable and was the most benefit from vns therapy. At the time of the high impedance, no further reduction in seizures was noted. No medication changes preceded the seizure changes, and the patient is reported to be adherent to the medication schedule. At this time medication doses have been risen, but the seizure frequency and intensity remains nearly the same per the physician.
 
Event Description
Although surgery is likely, it has not occurred to date. The patient's family has elected to move forward with surgery.
 
Event Description
The physician reported that during a follow-up appointment for the vns patient, high lead impedance was found on system and mode normal diagnostics. The reported impedance value was greater than 10,000 ohms. The physician disabled the patient's device and ordered a x-ray of site the device implantation. The patient´s mother told the physician that the patient did not suffer any trauma or manipulation that is believed to have contributed to the high impedance. The patient previously had a generator replacement on (b)(6) 2012. No patient adverse events have been reported. Ap and lateral views of the chest and ap and lateral views of the neck were reviewed by the manufacturer. The x-ray film images were dated (b)(6) 2013. Due to the angle of the x-ray it cannot be confirmed whether the lead pin is fully inserted into the generator header. The feed-thru wires appear to be intact. The lead appears to be routed upwards to the left side of the neck. The electrodes are visualized in the neck and appear to be aligned. There is a portion of the lead behind the generator; therefore, this portion of lead cannot be assessed for continuity. Based on the x-rays images received, there are no gross lead fractures that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. Although surgery is likely, the surgery has not occurred to date.
 
Manufacturer Narrative
Review of device history records performed. Review of the lead device history records confirmed all quality tests were passed prior to distribution.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Manufacturer Narrative
Suspect medical device, corrected data: after review of additional x-rays, the suspect device is the generator. Suspect medical device, corrected data: after review of additional x-rays, the suspect device is the generator, so the initial report inadvertently reported the date incorrectly. Manufacturer reviewed chest x-rays of implant device. X-rays reviewed by the manufacturer, lead pin not fully inserted past the connector block of generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
A mri was performed on (b)(6) 2013 per manufacturing labeling precautions, but the surgeon reported that the mri report was not conclusive for the report of fibrosis in the patient¿s neck. The patient is therefore being referred for surgery. Although surgery is likely, it has not occurred to date.
 
Event Description
Additional information was received that the patient had the vns lead replacement on (b)(6) 2013. The surgery came out ok and the high impedance was resolved. The explanted lead was returned to the manufacturer and product analysis was performed. During the visual analysis the returned 417mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 1mm from the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the (-) green electrode quadfilar coil break (found at 1mm) and identified the area on three of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the fourth broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress indu ced fracture (torsional appearance) which most likely completed the fracture. Pitting and residual material were observed on the coil surface. Scanning electron microscopy was performed on the electrode (mating) end of the (-) green electrode quadfilar coil break (found at 1mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. 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 abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device.
 
Event Description
Additional information was received indicating the patient's family is evaluating the patient's benefit to vns prior to referral for surgery. Normal and system diagnostics on (b)(6) 2013 resulted in high lead impedance (>10,000 ohms). The device was turned off on (b)(6) 2013. Another set of x-rays were performed. Ap and lateral view of the chest x-rays were reviewed by the manufacturer. Based on the x-rays images received, there are no gross lead fractures that can be visualized. However, the presence of an unpronounced lead discontinuity cannot be ruled out. Additionally, the lead pin appears to not be fully inserted in the generator header which is the likely cause of the high impedance. Attempts for additional information have been unsuccessful to date.
 
Event Description
The patient had surgery on (b)(6) 2013. It was reported that during surgery the surgeon found a lot of fibrosis involving the generator and the route of the vagus nerve. Extraction of the generator was very difficult due to the fibrosis. After 30 minutes, the surgeon was able to remove the generator. The surgeon then loosened the screw of the lead pin from the generator. A generator diagnostic test was performed and resulted in results within normal limits. The lead pin was re-inserted, and system diagnostics resulted in high impedance again twice with impedance greater than 10,000 ohms. The surgeon suspects that fibrosis between the vagus nerve and the lead due to intra-operative findings. The surgeon removed a lot of the fibrous tissue but did not touch the nerve because the route of the vagus nerve was fibrosed, and it was difficult to assess. The patient had keloid tissue around the scar areas. The patient was put on corticoids in the area of the generator to prevent serious injury. He ordered a mri of the neck with the surgery findings and report of mri, the surgeon is referring the patient for lead replacement in another procedure. Neither the generator or lead were explanted/replaced. Although surgery may occur, it has not occurred to date. The high impedance was reported to have occurred about one month after generator replacement which occurred on (b)(6) 2012.
 
Manufacturer Narrative
Date of event, corrected data: the supplemental report inadvertently reported the date of the high impedance being first observed incorrectly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2967697


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:23:19 AM
Model Number 104
Event Date 07/09/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient was having her device explanted due to having pseudo-seizures and anxiety. The physician did not think the patient was a good candidate for vns therapy originally. Clinic notes dated (b)(6) 2013 reported that the patient¿s vns generator was checked and it appeared to be ¿malfunctioning. ¿ the physician reported in the notes that excessive stimulation was provided, and he was unable to program the settings down. Therefore, the vns magnet was taped over the device to disable the stimulation. The physician noted that it was desired to have the device explanted anyway, so she was referred for surgery. Previously on (b)(6) 2013, the patient asked to have her vns settings turned down. The physician turned the settings down to 0. 75 ma with the plan to turn it off at the next visit in two months. Patient was admitted to medical center on (b)(6) 2013 and discharged on (b)(6) 2013 due to recurrent seizures. Eeg confirmed that the patient does not have epileptic seizures. Attempts to the physician for additional information on not being able to program the device settings down have been unsuccessful to date. The patient was originally implanted with vns in 2001 but had generator replacement in 2010. The patient had generator and lead explant on 07/26/2013. The explanted products were received by the manufacturer on 08/01/2013. However, analysis has not been completed to date. The return product form indicated reason for explant was "patient desired. ".
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. The pulse generator was interrogated at multiple orientations adjacent to the programming wand, with a one inch spacer between the pulse generator and the programming wand. The pulse generator interrogated at all orientations. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications as defined in ets 28-0000-3300/2. The battery, 2. 952 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 15. 884% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur, sodium, magnesium and calcium. 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 measurements taken during decontamination verified an electrical and mechanical contact between the generator and connector pins 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. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Review of device history records. Review of the generator device history records confirmed all quality tests were passed prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3267316


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:24:24 AM
Model Number 302-20
Event Date 12/26/2012
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2014. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 157mm portion quadfilar coil 1 appeared to be broken approximately 5mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 157mm portion quadfilar coil 2 appeared to be broken approximately 15mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. 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 abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
New information received corrects the date of explant.
 
Event Description
Additional information was received indicating that the physician believed that the generator battery depleted too quickly. A battery life calculation (results previously reported) and review of programming history showed normal battery depletion.
 
Event Description
Additional information was received from the distributor stating that the vns patient was being scheduled for surgery to have the generator and lead explanted, and the generator had reached end of service. Additionally, it was reported that the patient will not be re-implanted with a new device for reasons unknown. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Attempts to obtain the date the devices were explanted are underway.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure is occurred but did not cause or contribute to a death or serious injury.
 
Event Description
A/p and lateral views of the chest and neck, dated (b)(6) 2013, were received and reviewed. The generator was visualized in normal orientation in the patient¿s left chest area. The lead appeared to be intact at the lead pin and the filter feedthru wires appear intact. The lead pin could not be seen past the second connector block in the image, therefore it could not be assessed if the lead pin was fully inserted. A portion of the lead appeared behind the generator and could not be assessed. The lead was seen in the left side of the patient¿s neck. A strain relief loop was observed; however, a strain relief bend did not appear to be present. No sharp angles were observed in the portions of the lead that could be visualized; however, a possible lead discontinuity was seen in the lead body. Based on the x-ray images, it is possible that the high impedance is due to a lead discontinuity. Additionally, micro-fractures in the lead cannot be ruled out. No further interventions have been taken since the last report. No additional information has been provided.
 
Event Description
It was reported that the generator was explanted on (b)(6) 2014.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, it was reported that high impedance was seen in regards to this patient's device. After the first interrogation, the output current was reduced by 0. 25 ma, and the pulsewidth was reduced from 500 usec to 250 usec. Another diagnostic test was performed with high impedance results. The patient was last seen on (b)(6) 2011. Programming history was also provided. Per the patient's mother, the patient manipulated the device often. The generator was described as very superficial and palpable. Follow-up showed that patient manipulation was believed to have caused or contributed to the high impedance events. The device was not disabled. It was unknown when the device protrusion began, but the patient had lost weight within the last year, which may have contributed to the protrusion. The physician did not allege that the body was rejecting the device. No interventions were taken for the protrusion event. The weight loss was the cause of the excess of manipulation of the generator by the patient. A/p and lateral views of the neck and a/p view of the chest were reviewed. The reported events are high lead impedance and generator protrusion. The generator was visualized in the patient's left chest. The lead appeared to be intact at the lead pin and the lead pin was seen past the connector blocks indicating complete lead pin insertion. The integrity of the filter feedthru wires could not be assessed due to the angle of the x-rays provided. For the same reason, it could not be confirmed whether or not there was any lead behind the generator. The lead was seen in the left side of the patient's neck. No sharp angles were seen in the portions of the lead that could be visualized; however, there was a portion of the lead by the generator that could not be seen due to the angle of the x-ray images provided. A lead discontinuity was seen in the lead bifurcation. Follow-up showed that the weight loss was not believed to be related to vns. The patient did not often go to appointments, so the weight loss was only noticed at a recent appointment. The patient's mother indicated that the weight loss began one year ago. No interventions for this were taken. Surgery is likely but has not taken place.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2925866


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:25:11 AM
Model Number 303-20
Device Problems Fluid leak; Mechanical issue; Low impedance
Event Date 06/08/2015
Event Type  Malfunction   
Event Description
The explanted lead and generator were received. Analysis performed on the generator shows that there were no additional performance or any other type of adverse conditions. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 078 volts, shows an ifi=no condition. A portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the bilumen tubing appeared to be twisted, in most areas. During the visual analysis the bilumen tubing appeared to be twisted and the (-) green electrode spot-weld and portion of ribbon appeared to be torn from the ribbon. Abraded openings were observed on the bilumen tubing and the tri-filar coils appeared to be exposed in these areas. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddling of device). The abraded openings found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing. What appeared to be white deposits were observed on the bilumen tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposits as containing silicon. With the exception of the abraded openings and exposed tri-filar coils, the condition of the returned lead portion is consistent with those that typically exist 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 portion were performed, during the visual analysis, and no discontinuities were identified.
 
Manufacturer Narrative

Event Description
Device diagnostics showed a low impedance value in (b)(6) 2016 and the device was turned off. The patient had remained seizure free with the device turned off, and so the decision was made to remove the device. Patient underwent explant of the generator and lead. The explanted devices have not been received to date.
 
Manufacturer Narrative

Event Description
Low impedance was observed in the patient's device programming data on (b)(6) 2015. Additional information was received from a nurse that the patient's device was temporarily disabled on (b)(6) 2015 due to mri and that the patient did not see the physician until (b)(6) 2015. Per the clinic note in (b)(6) 2015, the vns device was interrogated and low impedance was observed. The physician acknowledged that this might be due to a lead fracture and disabled the vns from 1. 5 ma to 0 ma to see if patient needs to continue vns therapy as he has not had any seizures in several years. Patient was again seen in (b)(6) 2016 and possible removal of the device was considered. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5514040


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:25:49 AM
Model Number 302-20
Event Date 05/30/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high impedance. Diagnostics were run and resulted in an impedance value of 5208 ohms which did not trigger the impedance ¿ high. When diagnostics were run again high impedance was seen and the impedance value was 5352 ohms. High impedance triggers at 5300 ohms. There was no reported trauma or manipulation. Diagnostics were within normal limits on (b)(6) 2012 with an impedance value of 2460 ohms. Follow-up indicated that x-rays were taken and per the physician it did not appear that the lead pin was fully inserted as it could not be seen past the connector block. X-rays were not provided to the manufacturer for review. Surgery is likely but has not occurred. No further information was provided. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Manufacturer Narrative
New information changes the suspect device.
 
Event Description
Analysis of the lead was completed on 04/17/2014. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on three of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type and residual material. Pitting was observed on the coil surface. The remaining broken coil strand was identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 63mm) and identified the area on two of the broken coil strands as being mechanically damaged with fine pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. The remaining broken coil strands were identified as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Pitting was observed on one of the coil melt areas. What appeared to be spatter was found on the quadfilar coil strand. 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 abraded openings found on the outer and (+) connector ring inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and (+) inner silicone tubes. For the observed (-) connector pin inner tubing dried remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. The melted appearance on some of the quadfilar coil strands appears to be related to the explant procedure. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent surgery on (b)(6) 2013. It was reported that the lead pin was fully inserted into the generator header and was not the cause of the lead impedance. It was reported that the lead impedance was resolved with lead replacement and the generator was not replaced. The explanted lead was returned to manufacturer for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188480


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:26:33 AM
Model Number 300-20
Event Date 10/20/2011
Event Type  Injury   
Manufacturer Narrative

Event Description
Additional information was received on (b)(6), 2012 when it was discovered that the vns patient was having a full revision surgery that day due to prophylactic reasons. The patient's settings after surgery were going to be output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The explanted lead and generator were returned to the manufacturer for product analysis on (b)(4) 2012 that has not yet been completed.
 
Event Description
On (b)(6) 2011 a vns treating physician reported that he is referring the patient for a prophylactic full revision surgery since he is unable to increase the patient's settings to a 130usec pulse width without her having adverse issues. The patient's device is showing elective replacement indicator=no but the patient is having an increase in seizures. A system diagnostics test performed on (b)(6) 2011 showed output=ok/lead impedance=ok/dcdc=2/eri=no and a normal mode diagnostics test showed output=ok/lead impedance=ok/dcdc=2/eri=no. It was reported that on (b)(6) 2011, when normal mode diagnostics were performed, the patient grabbed her throat, gasped for air, and made an odd coughing noise. A system diagnostics had previously been performed with no adverse events and the results showed an output=ok/lead impedance=ok/dcdc=1/eri=no. The patient's settings were output=1. 75ma/frequency=20hz/pulse width=250usec/on time=30sec/off time=1. 1min/magnet output=2ma/magnet on time=60sec/magnet pulse width=250usec. The patient's mother reported that some weeks the patient will not have a single seizure and then others she will have a couple of seizures. The physician lowered the patient's pulse width but reported that the patient is more than likely faking the events as she has a past history of falsifying events. A battery life calculation was performed with the patient's programming history and it showed negative years until elective replacement indicator (eri)=yes. The manufacturer's consultant later reported that the patient always has a reaction like grabbing her throat when a lead test is performed or a magnet is swiped. She reported that the physician does not know the cause of the patient's events including the increase in seizures. It is unknown if the cause could be stimulation being higher or a potential lead issue so they are going to prophylactically replace the whole system since it is nearing end of service, the lead has been implanted for so long, and they are unsure why the patient is having these events. The physician has since decreased the patient's pulse width to 130usec. The physician also reported that he believes that the patient is exaggerating the events for attention. Although surgery is likely, it has not yet occurred.
 
Event Description
Additional information was received on (b)(4), 2012 when product analysis was completed on the generator. The device performed according to functional specifications. No elective replacement indicator (eri) flags were observed during testing. The device was continuously monitored for 25. 25 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. On (b)(6) 2012 product analysis on the lead was completed. A portion of the lead assembly body, including the unmarked connector pin section, marked connector pin / boot section with model and serial number tag and the electrodes was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity testing could not be performed during the decontamination procedure because the connector pin sections of the returned portion were not returned. Continuity checks of the returned lead portion 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 portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2377262


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:27:17 AM
Model Number 300-20
Event Date 11/12/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012 the physician reported that he ran diagnostics on the patient and there was a suspected lead break. Clinic notes dated (b)(6) 2012 were later received which state that the patient experienced an increase in drop attacks (nine in about five weeks) in october with continued generalized seizures in that same time frame. As of the date of the notes, the patient had only experienced one drop attack in (b)(6). The physician tried to perform normal mode diagnostics; however he was unable to because the lead impedance was too high. He stated that he tried to adjust the patient's settings as recommended; however, this did not solve the problem either. Via the notes, the physician stated that he was concerned the seizures and drop attacks may have increased due to the vns "no longer operating properly". He clarified the issue by reiterating that the lead impedance was too high and that the patient may need a lead replacement, but no surgery is planned at this time. It is unclear if the normal mode diagnostics issue was resolved, as the physician has normal mode diagnostic results listed within the same clinic notes. Follow up with the physician found that the patient's system diagnostic results showed the high impedance and a dcdc code of 7. No additional information has been provided.
 
Event Description
On (b)(6) 2012 it was reported that the patient had his generator and lead replaced due to "battery depletion and high lead impedance". However, clinic notes dated (b)(6) 2012 state that the generator was replaced because the old generator would not be compatible with the new lead. The replacement surgery is detailed in the notes. It was noted that the lead was "well incorporated" on the vagus nerve and that there was a lot of scar tissue on the vagus nerve around that area. The lead was carefully removed and the new device was implanted. After and through the procedure device diagnostics were performed. In each case it was stated that the device was well within the manufacturer's specifications and that lead impedance was noted as "okay" and dc/dc converter was "1". The device was left at 0ma output current after the procedure. The clinic notes also stated that the device was turned off after the high impedance was originally found. Product analysis was performed on the returned generator and found tool marks on the pulse generator. The marks are 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 septum was not cored. No other surface abnormalities (such as sharp edges, header delamination, open pockets, decomposition, corrosion or voids) were noted on this device. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. The lead was returned on (b)(6) 2012 and is pending product analysis.
 
Event Description
Product analysis on the explanted lead found fluid leaks, abrasions, detachment of the connector boots, and white deposits. The reported fracture of the lead was not observed; however, it was noted that the electrodes were not returned, therefore a complete evaluation could not be performed on the entire lead product. 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 found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. 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 pins 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 a discontinuity in the returned portions of the device which may have contributed to the stated allegations of a fractured lead. Additional information was received confirming that the patient had an increase in seizures; however, this increase was the same as pre-vns baseline levels. It was not specified what the relationship of the increase was to vns. Interventions were taken for the increased seizures which resulted in a "good" outcome. The exact interventions were not noted; however, the patient had a generator and lead replacement. The patient has multiple seizure types which all increased. No causal or contributory programming changes, medication changes, or other external factors preceded the onset of the seizures. No patient manipulation or trauma occurred that is believed to have caused or contributed to the potential lead fracture. No x-rays were taken by the physician. No other information was provided.
 
Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2869853


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:27:52 AM
Model Number 300-20
Event Date 06/03/2011
Event Type  Malfunction   
Event Description
Reporter indicated a patient's vns was unable to be interrogated and was believed to be at end of service. The patient's vns generator was later replaced, and the lead was also replaced due to the patient experiencing shock-like sensations in the right side of the neck prior to the generator being completely at end of service. The generator and lead were returned for analysis. Analysis of the generator confirmed normal end of service, and the battery was depleted. During the visual analysis of the lead, the marked connector quadfilar coil appeared to be broken past the electrode bifurcation. Scanning electron microscopy was performed on the marked connector quadfilar coil break and identified the area as having extensive pitting, which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the unmarked connector quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. What appeared to be evidence of electro-etching was observed on the coil surface of the unmarked quadfilar coil. During the visual analysis of the returned 19mm portion the green (-) electrode quadfilar coil appeared to be broken at the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis of the returned 7mm portion the white (+) electrode quadfilar coil appeared to be broken approximately 4mm from the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. 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. During the decontamination process incisions were made to allow for continuity checks. The ends of the inner silicone tubes appeared to be abraded open / torn. 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 found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins 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. Attempts for further information are in progress.
 
Manufacturer Narrative
Device failure occurred.
 
Event Description
Manufacturer follow up with the treating neurologist indicated the patient was seen only once in (b)(6) 2011, prior to the vns replacement surgery on (b)(6) 2011, and the vns was unable to be interrogated at that office visit due to believed end of service. It is unknown if any trauma occurred. No x-rays were performed. The neck pain was not reported to the neurologist at the (b)(6) 2011, office visit.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2249715


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:28:26 AM
Model Number 101
Event Date 04/25/2012
Event Type  Malfunction   
Manufacturer Narrative
Review of programming/device diagnostic history performed.
 
Event Description
Product analysis for the explanted lead was approved on (b)(6) 2012. The electrodes were not returned for analysis, and therefore, a complete evaluation could not be performed on the entire lead product. The incision marks found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing sodium, phosphorus, sulfur, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion 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 portion of the device which may have contributed to the stated complaint. Product analysis for the explanted generator was approved on (b)(6) 2012. The generator was confirmed to be at end of service: an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. On (b)(6) 2012, the patient's physician reported that the patient had not been seen and did not have any information. The physician was unaware that the patient underwent explant. Attempts for additional information have been unsuccessful to date.
 
Event Description
On (b)(6) 2012, a nurse reported that this vns patient was being referred for explant for an unknown reason. Follow up with the physician's office on (b)(6) 2012 showed that the patient recently presented with pain at the generator site and an indication that the patient's stimulator was not working. It was also stated that the patient never really received adequate therapy from vns. The patient underwent explant surgery on (b)(6) 2012. The explanted lead and generator were received on (b)(6) 2012 and are currently undergoing product analysis. A battery life calculation was performed on (b)(6) 2012. The years to eri = yes was negative. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2597198


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:29:12 AM
Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
Event Description
On (b)(6) /2013, it was reported that high impedance was seen during generator revision due to end of service. The surgeon performed a generator diagnostic on the newly implanted generator. The generator was then reconnected to the lead ensuring that the pin was past the connector block and fully inserted. Diagnostics again showed high impedance. The surgeon inspected the portion of the lead that was able to be visualized, and a break was seen with fluid in the tubing. The lead was not replaced at this time. No patient manipulation or trauma was suspected, no x-rays were taken, and the explanted generator was discarded. The new generator was not programmed on. The last known diagnostics indicated a system diagnostic with dcdc=2 approximately two years prior. The patient was lost to follow-up; however, the patient had been experiencing an increase in seizures six months prior (below baseline), and the resident generator could not be interrogated or programmed because it was at end of service. The patient could not feel normal mode or magnet mode stimulation. The patient's physician believed the increase was due to loss of therapy. A blc at this time indicated negative results. Lead revision is likely but has not taken place.
 
Event Description
The patient had their lead replaced on (b)(6) 2013 and their explanted product has been returned for analysis. Analysis completion is pending.
 
Manufacturer Narrative
Analysis of programming history. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional prior to distribution. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Notes from the patient's (b)(6) 2013 surgery were received on (b)(4) 2013. The device was reportedly not functioning for several years. (this was clarified to mean the device was at end of service). In surgery, the generator was disconnected and a new unit was connected to the existing lead. Testing showed impedance: the device was rechecked and retested. Inspection of the lead showed a longitudinal linear separation in the plastic around the metallic wires. While the wires themselves were grossly intact and there was no side of disconnect or fracture, the sheath around the wires appeared to have been worn down and split in a linear distribution. The plastic itself appeared to have eroded away from the wires. The lead was not replaced at this time. The generator was sewn into place. Lead revision is still likely but has not taken place.
 
Event Description
The lead analysis was completed on (b)(4) 2013. Analysis of the lead showed that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis of the returned 309 mm portion showed abraded openings on the outer and inner silicone tubing in some areas. Visual analysis found that the quadfilar coil one appeared to be burnt in half in the body area of the returned lead portion. Scanning electron microscopy was performed and identified the burnt area as having the appearance of being melted, with re-solidified material (evidence of being melted at one time). Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coils were exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 211 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and mechanical damage. During the visual analysis of the returned 309 mm portion quadfilar coil two appeared to be broken approximately 250 mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no 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 abraded openings found on the outer and inner silicone tubing two and the torn ends observed on both of the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2983386


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:29:50 AM
Model Number 102
Event Date 09/12/2014
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient demanded the vns to be explanted. It was reported that the vns did not meet the patient's expectations and that the patient experienced shortness of breath during sports. It was reported that during sports the patient was disturbed when his colleagues saw the implanted device. Since the patient did not experience efficacy he wanted to be explanted. The patient underwent generator and partial lead explant (leaving electrodes). The explanted generator and lead portion were received for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the generator was completed on 10/09/2014. The device performed according to functional specifications. Analysis in the pa lab concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 10/09/2014. Note that the lead assembly (body) including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. White deposits were observed on the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur, zirconium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4164063


Title: Re: White Deposits
Post by: dennis100 on April 13, 2018, 01:30:39 AM
Model Number 101
Device Problem No Information
Event Date 07/02/2015
Event Type  Death   
Event Description
It was reported that a vns patient died. No information is available to date regarding the circumstances around the patient's death. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The vns system was explanted postmortem. The explanted devices were received by the manufacturer; analysis of the devices is underway, but it has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions. Note that 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
An analysis was performed on the explanted generator, 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. Analysis in the pa lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found.
 
Manufacturer Narrative

Event Description
Review of available vns device programming history by the manufacturer indicates that the device was switched off on (b)(6) 2006. The explanted device was received by the manufacturer as programmed off and analysis showed the battery was not depleted. There is no evidence from the available information the device was ever turned on again and the patient was most likely not receiving vns therapy at the time of the death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5406289


Title: Re: White Deposits
Post by: dennis100 on April 14, 2018, 12:16:12 AM
Model Number 105
Device Problem No Known Device Problem
Event Date 04/18/2015
Event Type  Death   
Manufacturer Narrative

Event Description
The explanted products were received on (b)(4) 2015 for analysis. In the pa lab, the generator 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. The battery, 3. 036 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis on the lead is underway but has not been completed to date.
 
Event Description
Analysis was completed on the returned portion of the lead. A majority 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. There appeared to be white deposits observed in various locations, which contained silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings , there is no evidence to suggest an anomaly with the returned portion of the device.
 
Manufacturer Narrative
Suspect device udi: (b)(4). Corrected data: this information was inadvertently left off of initial mfr. Report.
 
Event Description
It was reported that the vns patient passed away on (b)(6) 2015. Follow-up with the physician¿s office revealed that the cause of death was believed to be sudep and not related to vns. The death was not witness and the patient was found cyanotic in the bathroom. The patient had a history of illegal substance abuse and compliant with aeds. No further information relevant to the event has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4872433


Title: Re: White Deposits
Post by: dennis100 on April 16, 2018, 12:41:48 AM
Model Number 302-20
Event Date 03/28/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2103, a surgery referral form was received indicating that this vns patient was referred for surgery due to high impedance. Diagnostics from (b)(6) 2013 were provided. Clinic notes dated (b)(6) 2013 were received. These indicated that the patient continued have to seizure on to three times week that tended to cluster, lasting anywhere from 10-15 minutes. The father did not believed that the vns was working given the continued seizures. An interrogation showed that the settings were stable and that the circuit was intact. The father expressed concerns that there was a break in the leads, but this was not indicated. The device did indicate that the device was near end of battery life. (this was not reflected in programming history. ) follow-up showed that high impedance was first seen on (b)(6) 2013. The device was not programmed off after high impedance was seen, no x-rays were taken, and no patient manipulation or trauma occur that is believed to have caused or contributed to the event. Programming and diagnostic history were provided: diagnostics were within normal limits. The patient underwent full revision on (b)(6) 2013. The explanted products have not been received to date.
 
Manufacturer Narrative
Review of programming history. Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were returned on (b)(4) 2013 for analysis. Product analysis on the generator showed that the device performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. An analysis was performed on the returned lead portion and the reported lead break allegation was confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the positive connector ring quadfilar coil appeared to be broken approximately 11 mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081424


Title: Re: White Deposits
Post by: dennis100 on April 17, 2018, 12:32:52 AM
Model Number 302-20
Event Date 03/17/2013
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
Describe event or problem: corrected data: the initial mdr did not report the change in seizures pattern that was known about and possible related to the high impedance per the physician at the time of the initial report only the increase in seizures were mentioned on the initial mdr.
 
Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the generator and lead. In the pa 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. 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. Sem images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load ¿ cut leads). Abrasions were identified on the outer silicone tubing at multiple locations. The outer tubing had what appeared to be internal abrasions at multiple locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner silicone tubing. No obvious point of ingress was noted other than the end of the returned lead portion, in which incisions were necessary to perform proper inspection of the coil. What appeared to be white deposits were observed in various locations. Eds was performed and identified the deposits as containing sodium, magnesium, silicon, phosphorous, chlorine, and calcium. Upon visual inspection of the generator cavity no anomalies were observed. Two 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. 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 observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Information was received that the patients seizures has also changed in character in that they are more generalized convulsive events lasting 1-2 minutes than the partial events she was had been having previously. The physician also felt this was possibly related to the high impedance. Her medications were unchanged and her blood levels were solid.
 
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. X-rays were taken but have not been provided to the manufacturer for review. It was unknown if there was any manipulation or trauma. The patient has been having an increase in seizure and the magnet was not aborting seizures beginning two days before the high impedance was seen. No further information was provided regarding the high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3069042


Title: Re: White Deposits
Post by: dennis100 on April 19, 2018, 12:11:57 AM
Model Number 302-20
Event Type  Malfunction   
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
The patient had full revision surgery on (b)(6) 2013. Their explanted products have been returned for analysis and are pending completion.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr) corrected data (b)(4) 2012 should have been (b)(4) 2013.
 
Event Description
It was reported that a vns patient had high impedance on a system diagnostic test and their generator was then disabled. Additionally it was reported that the "vns magnet seems less effective in stopping the seizures" at this time. The patient was seen in clinic on (b)(6) 2013. His last clinic visit date was,(b)(6) 2011. The patient's seizures have been under stable control. His seizure frequency is variable; are increased when he doesn't sleep or during intercurrent illnesses, but on average he has 1-5 seizures daily. The patient's mother reported that the vns magnet seems less effective in stopping the seizures; she was unable to give estimate of when she first noted this. Overall the mother is pleased with his current seizure control. He receives vagus nerve stimulation programmed to deliver 1. 5 ma for 30 seconds every 3 minutes with a pulse width 500 usec and frequency 30 hz; tolerating without adverse effects; no snoring. The mother feels the vns has been effective for seizure control particularly use of the magnet to stop seizures prior to their high impedance. Their magnet not being as effective is being attributed to their loss of therapy from their high lead impedance. Their was no report of any trauma or manipulation of their device prior to their high impedance being attained. The last time the patient was seen was (b)(6) 2011 and diagnostic testing on their device was within normal limits at that time. X-rays have not been provided for review. Surgery is likely. There is a tentative date of (b)(6) 2013 for revision.
 
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 not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the returned generator and lead. In the 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. 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. An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. For the observed outer and inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of ¿explanted / due to lead break / high impedance¿. Note that since a portion of the lead assembly (body) including the electrode array section 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=3037670


Title: Re: White Deposits
Post by: dennis100 on April 19, 2018, 12:12:31 AM
Model Number 302-20
Event Date 07/20/2006
Event Type  Malfunction   
Event Description
Additional information was received that physician¿s office did not have information or records from the high impedance in 2006. Product analysis was completed on the generator and lead. The generator 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. 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. Note that the majority 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. 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 portion 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 portion of the device. Note that since the majority of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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
Analysis of programming history.
 
Event Description
It was initially found while reviewing programming history for the patient that the patient had high impedance on (b)(6) 2006. The patient had their generator turned off (b)(6) 2007, unknown if related to the high impedance. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3041379


Title: Re: White Deposits
Post by: dennis100 on April 19, 2018, 12:13:31 AM
Model Number 302-20
Event Date 03/07/2013
Event Type  Malfunction   
Event Description
It was reported that the patient presented for follow up on (b)(6) 2013 at the neurologist's office and high lead impedance was observed. The patient was reporting discomfort in the neck when he turns her head to the left, when lifting things, but not during stimulation on-times. There was no specific cause for the high lead impedance, but the discomfort started about two months prior. Additionally, the patient did start working with his father about two months ago, which does include heavy lifting. There have been no drop seizures for the patient recently. The patient's father thinks that the lifting could be the cause, but the physician is not sure since he is a new patient. The device will be left on at patient's request since there are currently no adverse issues and increase in seizures. The patient is likely going for revision surgery due to the high lead impedance and believed related pain in the neck. The patient was referred for x-rays which were provided to the manufacturer for review. Ap chest and neck and lateral chest and neck x-rays dated (b)(6) 2013 were reviewed by the manufacturer. Based on the x-ray images provided, the cause of the high impedance could not be determined; however, a micro fracture or lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out. Additional information received on (b)(4) 2013 indicates the physician states there is nothing obvious to be causing the pain. There are no interventions planned to date. The patient has not reported any complaints. Although surgery may occur in the future, it has not occurred to date.
 
Event Description
Additional information was received stating that the vns patient was scheduled for surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. During surgery, the surgeon noted a suture above the electrode and dark areas on the nerve at the initial lead implant site. The patient¿s generator was replaced and the replacement generator was tested with the existing lead. Diagnostic results showed high impedance (impedance value >= 10,000 ohms). The patient¿s lead was replaced and diagnostic results showed lead impedance within normal limits for the replacement devices. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Follow up found that the patient went to the physician's office on (b)(6) 2013 and wanted the vns device turned back on. The physician has turned the device on to 0. 25ma and the patient is feeling some pain, especially when he turns his head to the right. The patient wants the device to remain on because he is having more seizures and is unable to get a replacement due to insurance issues. The patient also reports that he feels a pulling sensation to his neck when he turns his head to the right. The patient reports no seizures in august, but seventeen in september. The physician is aware of the manufacturer's recommendations to keep the device off, but has elected to turn it back on to a low setting.
 
Event Description
Additional programming/diagnostic history from the manufacturer's database was reviewed which confirmed the high impedance observed on (b)(6) 2013. It does not appear that the device was programmed off on this date, but there was no history following (b)(6) 2013.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted devices. Review of manufacturer device history records performed. Review of manufacturer device history records confirmed all quality tests were passed for the lead prior to distribution. X-rays reviewed by manufacturer, no gross lead discontinuities visualized. Device failure is suspected, but has not caused or contributed to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on (b)(4) 2014. During the visual analysis of the returned 30mm portion quadfilar coil 1 appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. 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 abraded openings found on the outer silicone tubing and one inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and one inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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. Te that since the (+) white and (-) green electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that the patient was seen by the treating neurologist on (b)(6) 2013. The patient's device was disabled at the visit due to a couple of reasons. The patient was experiencing discomfort in the neck (lead site). Per the patient, he experiences a "weird feeling" when he turns to the left. The patient and caregiver were unsure about if the discomfort was associated with vns stimulation when asked. The patient's device was disabled partly as a result of this. Additionally, the patient has been experiencing an increase in seizures over the past few months that are both above and below pre-vns baseline levels. The physician was still not sure the relationship of the increased seizures to vns because at the same time as the high impedance, the patient also had multiple changes in brand name medications, was switched to generic medications and also switched physicians and had a lack of care at one point. The physician thinks there are too many factors and decided to disable the device to have a better idea of the situation. Over the last few months, the seizures have been more than the patient is used to experience prior to vns. It was planned to switch the patient back to brand name medication, but no other interventions were planned at this time. Vns magnet mode was left on for rescue purposes if necessary; however, the patient stated that it does make his neck discomfort more pronounced when he swipes it. Due to insurance reasons, the patient has not been scheduled for surgery thus far. The physician was to re-evaluate the patient the following month.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3036493


Title: Re: White Deposits
Post by: dennis100 on April 20, 2018, 12:41:06 AM
Model Number 302-20
Event Date 03/13/2013
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. Results of diagnostic testing indicated the generator was operating properly. The battery status indicated ifi=no in the pa lab. The battery voltage was 2. 985 volts, (not at ifi) as measured. The data in the diagaccumconsumed memory locations revealed that 16. 526% 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. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. 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.
 
Event Description
It was initially reported that the patient had high lead impedance (>10,000 ohms) at a recent appointment. Diagnostics were attempted multiple times with the same result. The generator was turned off and the patient was referred for surgery. Surgery is planned but it has not been confirmed that surgery has occurred. Good faith attempts for additional information have been unsuccessful 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.
 
Manufacturer Narrative

Event Description
Additional information was received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Manufacturer Narrative
Age at time of event: corrected data: follow-up report #2 inadvertently did not update the patient age based on the updated event date. Date of event: corrected data: follow-up report #2 inadvertently did not update the event date based on additional information which was received during product analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3132104


Title: Re: White Deposits
Post by: dennis100 on April 20, 2018, 12:41:59 AM
Model Number 300-20
Event Date 06/06/2012
Event Type  Malfunction   
Manufacturer Narrative
The supplemental 2 mdr incorrectly reported that model 102r, serial number (b)(4) generator was returned; however, this was found to be an error. The model 102r, serial number (b)(4) generator was not returned. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The model 102r, serial number (b)(4) generator was not returned to the manufacturer as previously reported. An analysis was performed on the returned lead portions and a lead fracture was confirmed. Note the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 22 mm portion three broken coil strands were observed on quadfilar coil 1 and quadfilar coil 2 appeared to be broken near the electrode bifurcation. Scanning electron microscopy was performed on both of the coils and identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage 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. The abraded open / cut and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. A summary of the results can be found on figure 14. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of ¿explanted / due to lead break / high impedance¿. 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. The model 104, serial number (b)(4) generator was returned and product analysis was performed. Results of diagnostic testing indicated that the battery status indicated ifi=no in the product analysis lab. 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
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted vns lead, model 102r, sn (b)(4) generator, and unused new model 104, sn (b)(4) generator were returned and are pending analysis.
 
Event Description
Reporter indicated that x-rays did not show any lead breaks, and high lead impedance is still occurring. The x-rays will not be sent to the manufacturer for review. The reporter was advised to disable the vns due to the high impedance. The patient later had vns lead and generator replacement surgery performed on (b)(6) 2013. Diagnostics with the new generator and lead were within normal limits. Attempts for return of the explanted devices are in progress.
 
Event Description
Reporter indicated that high lead impedance was obtained for a patient at an office visit with vns diagnostics testing on (b)(6) 2013. The patient had no trauma and did not manipulate the vns. The last acceptable diagnostics were on (b)(6) 2012, but were not specified. The vns was disabled and the patient was referred for surgery. Prior to the surgery on (b)(6) 2013, vns diagnostics indicated normal device function. A new generator was connected to the resident lead and normal impedance was obtained, so the lead was not replaced. When the patient presented at an office visit later on (b)(6) 2013, high lead impedance was obtained. X-rays and possible replacement of the lead and generator is planned. Attempts for additional information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3133821


Title: Re: White Deposits
Post by: dennis100 on April 21, 2018, 12:43:55 AM
Model Number 302-20
Event Date 04/06/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned for analysis on (b)(4) 2013. The abraded openings found on the outer and one inner 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 and inner silicone tubes. What appeared to be specs of white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur and calcium. 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. However, since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In the pa 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. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. 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
Reporter indicated a patient was having increased seizures and was unable to feel vns magnet mode stimulation since (b)(6) 2013. High lead impedance was also noted with vns diagnostics testing in early (b)(6) 2013. The reporter felt the ¿lead was off the nerve¿ or not connected with the generator since (b)(6) 2013. The patient had no known trauma and did not manipulate the vns. The vns was not disabled. The seizures are above pre-vns baseline level, and are partial-complex seizures only. The patient forgot a dose of medication and had a seizure on (b)(6) 2013; this may be cause of the increased seizures per the reporter. The vns generator is believed to be at end of service per the reporter. The patient had been seizure-free since (b)(6) 2012. The patient had vns lead and generator replacement surgery performed on (b)(6) 2013 due to ¿battery/lead impedance¿. Attempts for return of the explanted devices are in progress.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any discontinuities. As the setscrew marks on the lead pin indicate proper insertion, a lead fracture is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3138009


Title: Re: White Deposits
Post by: dennis100 on April 22, 2018, 12:23:09 AM
Model Number 302-20
Event Date 05/08/2013
Event Type  Malfunction   
Event Description
Review of programming history for the patient¿s previous generator was performed on (b)(6) 2013. At the time of generator explant ((b)(6) 2013), impedance was normal at 1618 ohms.
 
Event Description
Lead analysis showed that the connector pin, connector ring, portions of the quadfilar coils and anchor tether and the white electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The abraded openings found on the inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed and identified the deposit as containing silicon, phosphorus and calcium. Except for the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. With the exception of the abraded tubing openings, no obvious anomalies were noted. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Note that a break of a few strands would still allow current flow through that portion of the lead. This observation is supported by results of electrical measurements which verified continuity between the ends of this lead section. Based on the findings in the product analysis lab, there is evidence of an abraded inner tubing opening in the returned portions of the device.
 
Manufacturer Narrative
Device failure occurred but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Analysis of programming history.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125424


Title: Re: White Deposits
Post by: dennis100 on April 22, 2018, 12:24:12 AM
Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
Analysis of a lead that was explanted due to an infection was completed on (b)(6) 2013. The infection and explant were reported in mfr. Report # 1644487-2013-00992. Analysis of the returned lead portion found that 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 found inside the outer silicone tubing. There was fluid observed in the inner tubing which found no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on one of the inner silicone tubes was noted to be due to wear. What appeared to be white deposits were observed in various locations. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. With the exception of the inner tubing abraded opening, no other obvious anomalies were noted. The setscrew marks found on the connector pins 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, with no discontinuities identified. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125282



Title: Re: White Deposits
Post by: dennis100 on April 24, 2018, 12:43:52 AM
Model Number 302-20
Event Date 02/01/2013
Event Type  Malfunction   
Event Description
It was reported that interrogation of the device resulted in high impedance >10,000 ohms. It was reported that the patient underwent generator replacement in (b)(6) 2012. The patient has been experiencing an increase in seizures and behaviors. The patient is being evaluated for replacement surgery. The patient was sent for neck and chest x-rays which were reviewed by the radiologist. The radiologist's review noted that the patient was experiencing neck pain. The review identified that the lead appears to be intact over the left lateral chest. The lead was coiled and was difficult to evaluate. Clinic notes dated (b)(6) 2013 noted that the patient's seizures have increased since the last visit in (b)(6) 2012. It was reported that the did well for several months following the last visit; however, 2 months ago she started experiencing an increase in seizures up to three to four generalized tonic-clonic seizures per week. It was also noted that the patient's mother reported that the patient's speech seems to have deteriorated and that the patient is having severe behavioral problems. The notes indicated that the recent increase in seizure frequency may be secondary to the vns malfunction. The notes indicate that the physician reduced the patient's settings from 1. 5ma/1. 8 min off to 1ma/3 min off. Attempts to obtain additional information have been unsuccessful to date. Surgery is likely; however, has not occurred to date.
 
Event Description
Further follow-up revealed that the patient underwent surgery on (b)(6) 2013. During the surgery after the patient was anesthetized, diagnostic tests resulted in normal impedance readings. The patient's head was turned in different orientations to rule out positional high impedance which were all within normal limits. Different programming systems were also used which also resulted in normal readings. The surgeon decided that he will not replace the lead since diagnostics were within normal limits. The surgery was aborted and the patient taken to recovery.
 
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data: 09/09/2016. Supplemental mdr #7 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 7 is 09/09/2016. Date received by manufacturer (mo/day/yr), corrected data: 10/26/2016. Supplemental mdr #8 inadvertently reported the incorrect aware date of 07/18/2016. The correct aware date of supplemental mdr # 8 is 10/26/2016.
 
Manufacturer Narrative
Device failure is suspected.
 
Event Description
The explanted generator and lead were received on 10/26/2016. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the pa lab. In addition, the septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids, (addressing the allegations of ¿pain¿). In the pa lab, the device output signal was monitored for more than 24-hrs, while the pulse 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 battery, 2. 992 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of; ¿fracture of lead(s) / explanted / due to lead break / high impedance¿ (lead section) and ¿pain¿ (lead section) were confirmed. A condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The ¿increased seizures¿ (patient section) allegation is beyond the scope of activities performed in the pa laboratory environment: however, the observed discontinuities may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. During the visual analysis abraded openings were observed on the outer and inner silicone tubes and the quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the connector pin quadfilar coil break (found at 99mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining broken coil strand was identified as being mechanically damaged with no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Scanning electron microscopy was performed on the connector ring quadfilar coil break and identified the areas on the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 160mm portion quadfilar coils 1 and 2 appeared to be broken. Scanning electron microscopy performed on the quadfilar coil 1 coil break identified the areas on the broken coil strands as being pitted with mechanical damage which prevented identification of the coil fracture type. Scanning electron microscopy performed on the quadfilar coil 2 coil break identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strand. 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 abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. With the exception of the discontinuities and abraded openings, the condition of the returned lead portions is consistent with those that typically exist 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. Based on the findings in the product analysis lab, there is evidence to support the ¿fracture of lead(s) / explanted / due to lead break / high impedance / low impedance / low impedance message, short circuit condition¿ allegations.
 
Event Description
On (b)(6) 2016, it was reported that low impedance with <600 ohms was observed on patient's device. Possible causes were discussed and patient manipulation was ruled out. X-rays were planned to be sent for review. Programming history for the device was reviewed. The device was temporarily disabled sometime after (b)(6) 2012 till (b)(6) 2013 due to high impedance. It is suspected that the current low impedance may be related to the previous high impedance observed in 2012. No known product replacements have occurred 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.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices have not been received to date.
 
Event Description
Clinic notes were received for patient's full revision surgery referral. Notes dated 7/15/2016 indicate that the lead impedance was greater than 10,000 in 2013 and patient was referred to surgeon for a lead revision. On the day of surgery on (b)(6) 2013, intraoperative device showed that the lead impedance was not over 10,000 but rather was okay at 3069ohms. The surgeon tested the device several times with the different programming systems but all of the tests showed the lead impedance was okay and the lead impedance values ranged from 3060 to 3179 ohms. As a result, the surgeon did not revise the lead at that time. More recently, patient was seen by the neurologist and the lead impedance was less than 600 ohms, and so patient was referred back to surgeon for evaluation and management. A chest x-ray was performed, which showed a lead fracture. According to caregiver, patient's seizures have been increasing in frequency. Patient had done quite well over the past couple of years, but more recently, within the past six months, experienced an increase in seizure frequency. Patient has had no real behavioral concerns until just recently likely related to the vns not working because of the lead fracture. Lead revision is planned but has not occurred to date.
 
Manufacturer Narrative
Describe event or problem: supplemental mdr #3 incorrectly reported that the high impedance was observed in 2012, when in fact, it was only observed in 2013.
 
Event Description
Lead product information was received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3115964


Title: Re: White Deposits
Post by: dennis100 on April 26, 2018, 12:31:02 AM
Model Number 300-20
Event Date 04/04/2013
Event Type  Malfunction   
Event Description
Additional information was received that product analysis was completed on the generator and lead. The reported end of service allegation was duplicated in the pa laboratory and determined to be the result of normal expected battery depletion, based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations¿. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was initially reported that the patient had high impedance on system diagnostics (dcdc = 7). However the nurse reported when normal mode diagnostics the dcdc converted was 2. The generator was recently checked (b)(6) 2012 and impedance was fine with a dcdc converter of 3 but it was unknown which diagnostic mode was run. The patient has not had any recent adverse events and there has not been any recent patient manipulation or trauma. The patient does have drop seizures and these may have caused damage to the device as the patient violently falls during those seizures. The nurse brought the patient back for another appointment to have her generator turned off. The patient was sent for x-rays and the x-rays were provided to the manufacturer for review. Based on the x-ray received there was nothing seen that would indicate there was any damage to the generator or lead; however, the presence of a micro-fracture in the lead cannot be ruled out. The patient will likely have surgery but it has not occurred to date. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator and lead prior to distribution.
 
Event Description
Additional information was received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Manufacturer Narrative

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3092908


Title: Re: White Deposits
Post by: dennis100 on April 28, 2018, 12:26:47 AM
Model Number 300-20
Event Date 05/16/2013
Event Type  Malfunction   
Event Description
Lead analysis was approved on (b)(4) 2013. An analysis was performed on the returned lead portions. 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, aluminum, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
Event Description
Product analysis was performed on the explanted generator. ' results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery voltage was 2. 922 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 41. 839% 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
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. Age at time of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update the patient age at the time of the event. Date of event, corrected data: per follow-up with the physician, the high impedance was first observed on (b)(6) 2013. This report is being submitted to update this field.
 
Event Description
It was reported that a vns patient had a lead break and would be having revision surgery. The patient had full revision surgery on (b)(6) 2013. Good faith attempts were made for product return and at this time it has not been received. Good faith attempts are underway for further details about the reported event.
 
Event Description
An implant card was received on (b)(4) 2013 indicating that the vns generator and lead were replaced due to the models being out of date on (b)(6) 2013. The lead impedance measurement on the new implants were not indicated.
 
Manufacturer Narrative
Device available for evaluation, corrected data: the explanted device was returned; however, this was inadvertantly not included on previous mdrs.
 
Manufacturer Narrative
Device malfunction suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Follow up found that on (b)(6) 2013, the patient was seen in the office and the physician had it noted that the lead was to be replaced, but there was no indication of why. The programming history was not provided and no further information was available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3173790


Title: Re: White Deposits
Post by: dennis100 on April 30, 2018, 12:36:15 AM
Model Number 302-20
Event Date 05/02/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records for the lead and generator showed that the devices met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 10/23/2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner silicone tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator was completed on (b)(4) 2013. The decoder showed that the change in the impedance from 4819 to 13168 occurred on (b)(6) 2013. In the pa 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. 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
Clinic notes indicate that the patient has been referred to surgery for generator replacement. It was noted that the patient has showed a good response to vns therapy for 9 years and that the physician believes the patient should continue with vns therapy for optimal seizure control. Surgery is planned, but has not occurred to date.
 
Manufacturer Narrative
Corrected data: new information changes the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2013 it was observed in the vns patient¿s clinic notes that high impedance was found and the patient was being referred for a vns generator revision. The patient¿s device was disabled on (b)(6) 2013, and they were referred for x-rays. On (b)(6) 2013 it was also noted that the patient experienced an increase in seizures. The patient's mother reported that the patient's seizures may have increased to having at least one seizure per week; typically lasting about 30 seconds and the patient's last grand mal seizure was six months prior to the (b)(6) 2013 office visit. The patient's mother further stated she was not sure if the generator was "functioning properly" which appears to be due to the patient experiencing an increase in seizures. During the review of the clinic notes, it was observed that the "mom states that when the magnet is used, the patient "makes a funny face and swallows hard. " the patient's mother did not indicate she believed the patient was experiencing pain or discomfort. The manufacturing records for the lead and generator was reviewed and device met all specifications prior to distribution. Good faith attempts were made to the physician and it was later reported that the no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The increase in seizures was first observed in (b)(6) 2013. The increased seizures were below pre- vns baseline. The relationship of increased seizures and vns therapy was unknown per physician. No known contributory programming changes, medication changes, or other external factors preceded the onset of increased seizures. On (b)(6) 2013 x-rays were taken and the physician stated that the device appeared to be intact. However, x-rays will not be provided for review.
 
Event Description
It was reported that the patient underwent genreator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis on (b)(6) 2013. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3257514


Title: Re: White Deposits
Post by: dennis100 on May 02, 2018, 01:09:06 AM
Model Number 302-20
Event Date 09/16/2012
Event Type  Malfunction   
Event Description
An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing calcium, sodium, magnesium, potassium, zirconium, silicone, phosphorus and sulphur. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device. The pulse generator was explanted/returned due to "prophylactic replacement". In the 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 963 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 067% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
(b)(4).
 
Event Description
An evaluation of data obtained from the generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2012 (3235 ohms to 12832 ohms) signifying the start of the high impedance event. A high impedance warning message was first received during a follow up visit on (b)(6) 2012 during an interrogation of the patient¿s generator.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report indicated the event occured in (b)(6) 2013 however, a review of the generator data suggests that the high impedance was first detected on (b)(6) 2012. The information has been corrected in this report.
 
Event Description
On (b)(6) 2013, it was reported that high impedance was seen regarding this patient¿s device. Follow-up showed that the high impedance was first noted in (b)(6) 2013 at which time the device was disabled. The patient was inconsistent with follow-up. At the last visit, many months prior, diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 were provided. The patient was seen after a long hiatus, and the mother reported that the patient was having more seizures. The patient was seen by a different facility two months prior and was taken off of vimpat. Monitoring of the vns device showed likely dislodgement of the leads. It was recommended that the device was disabled, and appropriate adjustments were made. Clinic notes dated (b)(6) 2013 indicated that patient was having more frequent seizures; however, the physician noted that there was a very unconvincing description of the individual instances: the patient had a right hand tremor, and the mother pointed to it indicating a seizure. It was noted that the patient was treated with a powerful combination of anticonvulsants, including a very high dose of banzel. However, dosing and choice of anticonvulsants remained constricted by the interventions of the patient¿s mother who believed that the medications were causing behavioral issues and overlooked the prominent mental retardation. There was no specific injury or manipulation, but this was possible given the patient¿s mrdd and occasional aggression issues. X-rays had not been taken. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent a full revision. The explanted lead and generator were returned on (b)(6) 2013 and are pending analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3198957


Title: Re: White Deposits
Post by: dennis100 on May 04, 2018, 12:32:27 AM
Model Number 105
Event Date 06/12/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2013 information was received from the reporter that the patient had a measurement of high impedance. The physician observed a high impedance message of 6071 ohms while running system diagnostics for the patient during a (b)(6) 2013 visit. The physician did not disable the patient¿s generator after the impedance warning. X-rays were taken of the patient, but will not be sent to the manufacturer due to the format in which they were recorded does not allow for the physician to send them. The physician stated that the patient is very active and the physician does believe that manipulation or trauma could have possibly contributed to the high impedance. The physician also stated that he would be referring the patient to a neurosurgeon for evaluation. Device manufacturing records were reviewed for the patient¿s generator and lead and the manufacturing records confirmed that they both passed all functional tests prior to distribution. A review of the manufacturer¿s programming history was performed, showing that programming history data is available from (b)(6) 2011 to (b)(6) 2013. High impedance was observed as having occurred on (b)(6) 2012 with a reading of 6,202 ohms during a system diagnostics test. High impedance was observed as having occurred on (b)(6) 2013 with a reading of 6,071 ohms during a system diagnostics test. Based on a rough battery life estimation using calculation tables for the model of generator implanted and the last known settings, the generator is not at end of service. Follow-up determined that the patient was seen for consult by a neurosurgeon on (b)(6) 2013 and that he is tentatively planning a full vns system revision, but that surgery has yet to be scheduled. Attempts for additional information will remain in continuation.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The lead analysis was completed on 09/04/2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The following was found during the visual analysis of the returned 132mm portion: the connector pin appeared to be pitted. Scanning electron microscopy was performed and identified evidence of surface irregularities, pitting and electro-etching on the surface of the connector pin. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 78mm from the end of the connector boot. Discoloration was observed on the (-) connector pin quadfilar coil, in some areas and the coil appeared to be dissolved in other areas, throughout. 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. With the exception of the identified discontinuities and observed surface irregularities, pitting and electro-etching observed on the connector pin surface, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious issues 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. Setscrew marks were observed on the connector pin, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin. The connector pin appeared to be pitted. The (+) connector ring inter-face backfill appeared to be partially detached and the (+) connector ring quadfilar coil appeared to be kinked. White deposits were observed, in several areas. What appeared to be remnants of dried body fluids were observed inside the outer and (-) inner silicone tubing, in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the end of the connector boot with the inner silicone tubes and quadfilar coils pulled and looped thru. The (-) connector pin quadfilar coil appeared to be discolored, in some areas. The end of the (-) connector pin quadfilar coil was observed at approximately 78mm from the end of the connector boot. Incisions were made to expose the end of the coil and the end appeared to be broken. An abraded opening was observed on the outer silicone tubing approximately 82mm-86mm from the end of the connector boot. The end of the outer silicone tubing appeared to be abraded open / cut. The following was found on the returned 47mm portion: the end of the outer silicone tubing appeared to be abraded open / cut. The (-) connector pin quadfilar coil appeared to have dissolved. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. A white deposit was observed on the outer silicone tubing. What appeared to be remnants of dried body fluids were observed inside the outer silicone tubing, throughout. The following was found on the returned 220mm portion: white deposits were observed on the outer silicone tubing. Portions of the (-) connector pin quadfilar coil appeared to have dissolved. The (-) connector pin quadfilar coil appeared to be broken approximately 103mm, 134mm and 185mm (with abraded opening on inner silicone tubing) from the end of the cut / torn outer silicone tubing. Discoloration was observed on the (-) connector pin quadfilar coil. Incisions were made to expose the broken coil ends and to allow for sem photos. During the cleaning process a small portion of the coil break found at 103mm became detached. A slice mark was observed on the outer silicone tubing. The mark penetrated the outer insulation. Unable to determine if the inner silicone tubes were damaged. The end of the (-) connector pin quadfilar coil appeared to be broken approximately 220mm from the end of the cut / torn outer silicone tubing. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. The generator analysis was completed on 09/04/2013. Visual examination performed revealed scratches on the generator can most likely associated with the explant procedure. The septum was not cored, but body fluid remnants were noted on the connector block. Body fluid remnants were also noted on the canted spring. No other surface abnormalities were noted on this device. The generator is operating within specification. Results of diagnostic testing indicated the device was operating properly. Other than the observed condition of body fluids remnants on the connector block and canted spring, there were no adverse functional, mechanical, or visual issues identified with the returned generator.
 
Event Description
It was reported the patient had an additional surgery unrelated to the event discussed within this mfr. Report. During the surgery, the surgeon removed the remaining electrodes which were not previously removed during the explant of the lead. The explanted electrodes have not been received by the manufacturer to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Review of the investigation showed the lead discontinuity was likely caused by a charge imbalance caused by the m105 generator, once a lead becomes compromised, causing corrosion which can result in lead discontinuity. This information was initially reported correctly in mfr. Report # 1644487-2014-00290. The second mfr. Report (1644487-2014-00290) was inadvertently created but did correctly report the incident.
 
Manufacturer Narrative
The information was inadvertently reported on an additional mfr. Report (1644487-2014-00290). Brand name, model #, serial #, lot #, exp. Date, implant date and mfg date: the information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
On (b)(4) 2013 it was reported that the patient underwent a full revision surgery on (b)(6) 2013. Pre-operative interrogation showed the device at settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec/eri=no. Multiple pre-operative system diagnostics were inconsistent and showed impedance values ranging from 5718 ohms to 7549 ohms. The generator was explanted and the surgeon reported he could visualize the lead pin past the connector block and that the set screw was tight. A new generator was then connected to the existing lead. Proper pin insertion was verified and the set screw was tightened. System diagnostics resulted in high lead impedance (>10,000ohms). The surgeon then explanted the lead. He stated that there were no obvious issues with the visible portion of the lead extending from the generator pocket. However, in the process of removing the lead from the neck incision, he reported that one of the lead segments past the bifurcation was milky white colored and was not connected to any helical coil. The other lead segment appeared normal and was cut as close to the helical coil as possible. He was not sure which wire was which due to heavy scarring. All three helical coils from the old lead were left on the nerve and the surgeon reported he implanted the new lead coils distal to the old helical coils. The new generator was then connected to the new lead. Proper pin insertion was verified with the surgeon and a single click was heard when tightening the set screw. Two system diagnostic tests (one out-of-pocket and one in-pocket) indicated output=ok/lead impedance=ok/impedance value=1164ohms/eri=no and output=ok/lead impedance=ok/impedance value=1124ohms/eri=no respectively. The surgeon ordered the new generator to be programmed to the same settings as the old generator. Final interrogation confirmed settings of output=2ma/frequency=30hz/pulse width=500usec/on time=30sec/off time=1. 1min/magnet output=2. 75ma/magnet pulse width=500usec/magnet on time=60sec. The explanted lead and generator were returned for product analysis on (b)(4) 2013. Product analysis is underway and has not yet been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3221371


Title: Re: White Deposits
Post by: dennis100 on May 04, 2018, 11:18:44 PM
Model Number 302-20
Device Problems Fluid leak; Fracture
Event Date 03/19/2018
Event Type  Malfunction   
Event Description
It was reported by a company representative that during a generator replacement surgery for the patient, a lead fracture was found. The company representative interrogated the explanted generator and confirmed the device was near end-of-service. There was no knowledge of the lead fracture prior to the surgery. The lead was replaced. It was reported that the lead was already broken and was verified by the or staff. The explanted devices were received by the manufacturer. Analysis was completed for the returned lead on 04/12/2018. The majority of the lead assembly, including the electrodes was not returned for analysis. Therefore, a complete evaluation could not be performed. The coil appeared to be broken in multiple locations. Scanning electron microscopy was performed and identified the areas as having evidence of being worn to the point of fracture with flat spots and residual material on coil surface and no pitting. The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7430790



Title: Re: White Deposits
Post by: dennis100 on May 06, 2018, 12:45:11 AM
Model Number 302-20
Event Date 06/01/2013
Event Type  Malfunction   
Event Description
The device history record (dhr) for the lead was reviewed and no anomalies or performance issues were found. During the analysis of the explanted lead, abraded openings were also observed on the inner and outer tubing.
 
Event Description
It was reported that the patient underwent surgery for the high impedance on (b)(6) 2013. During the surgery a new generator was placed on the existing lead. Device diagnostic testing again resulted in high impedance. Only the generator was replaced during the surgery and the new generator was left programmed off. The patient's family was informed and plans to replace the lead were made. Surgery has not occurred 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
It was reported that the explanted generator was discarded and would not be returned for analysis.
 
Event Description
It was reported that device diagnostic testing resulted in high impedance (dc dc code 7). The physician did not program the device off after observing the high impedance. X-rays have not been taken. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high lead impedance. The patient was referred to surgery. Surgery is planned, but has not occurred to date.
 
Event Description
It was reported that the patient underwent lead replacement surgery on (b)(6) 2013. The lead was returned to manufacturer for analysis on 09/25/2013. Analysis of the lead was completed on 10/10/2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 329mm portion quadfilar coil 1 appeared to be broken approximately 183mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed and identified the area on one broken coil strand as having extensive pitting which prevented identification of the coil fracture type. Two of the remaining broken coil strands were identified as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. The last remaining broken coil strand was identified as having evidence of electro-etching. Electro- etching and pitting were observed on the coil surface. During the visual analysis of the returned 329mm portion quadfilar coil 1 appeared to be broken approximately 3mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 3mm) and identified the area as having evidence of a stress induced fracture, pitting and evidence of electro-etching on the coil surface. Determination could not conclusively be made on the fracture mechanism. Two of the broken coil strands were identified as having evidence of electro-etching and mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 3mm) and identified the area as having extensive pitting with mechanical damage which prevented identification of the coil fracture type. 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 abraded openings and slice mark found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Manufacturer Narrative
(b)(4).
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that there were no nonconformances of devices issues prior to shipment. Describe event or problem, corrected data: previously submitted reports did not include the abraded opening found in the lead tubing during product analysis. The information is being included in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3306720


Title: Re: White Deposits
Post by: dennis100 on May 06, 2018, 12:45:58 AM
Model Number 300-20
Event Date 07/24/2013
Event Type  Malfunction   
Event Description
The patient's vns device was replaced on (b)(6) 2013 and the explanted device was returned to the manufacturer. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 178mm portion the (-) unmarked connector pin quadfilar coil appeared to be broken approximately 75mm from the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. During the visual analysis of the returned 178mm portion the (+) marked connector pin quadfilar coil appeared to be broken approximately 56mm past the end of the outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and a secondary break line. During the visual analysis of the returned 184mm portion quadfilar coil 1 and quadfilar coil 2 appeared to be broken approximately 3mm from the end of the abraded open / cut outer / inner silicone tubing. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting. During the visual analysis of the returned 184mm portion quadfilar coil 2 appeared to be broken approximately 16mm and 22mm from the end of the abraded open / cut / outer / inner silicone tubing. The coil breaks were observed inside the extending portion of inner silicone tubing 2. After the cleaning process determination could not be made between the two coil break areas. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type. During the visual analysis of the returned 184mm portion the opposite end of quadfilar coil 2 appeared to be broken approximately 16mm from the end of the cut inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (torsional appearance) with mechanical damage, no pitting and a secondary break line. 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 abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur, chlorine and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the marked 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 marked connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks found on the unmarked connector pin provides 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that during generator replacement surgery for ifi = yes a high lead impedance (dc dc code 7) was obtained once the new generator was connected to the existing lead. The lead was removed from the new generator and reinserted to ensure proper connection and device diagnostics again resulted in high lead impedance (dc dc code 7). It was reported that diagnostics prior to the case showed no lead issues. A lead revision was not performed at that time due to consent not being obtained for lead revision prior to the procedure. The surgeon will consult with the patient prior to lead revision. It was reported that the device remained programmed off after the surgery. No patient manipulation occurred that could have caused or contributed to the high impedance reading. No x-rays have been taken as the surgeon was going to consult with the neurologist. Surgery is likely; however, 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 programming history was reviewed. Review of data for the generator that was implanted on (b)(6) 2013 showed high impedance during three system diagnostics on the date of implant. A generator diagnostic with a test resistor was within normal limits indicating that the lead was likely the cause of the high impedance. Review of decoder data from the generator explanted in (b)(6) 2013 shows that based on the last internal automeasure of the device on (b)(6) 2013, the impedance was 3062 ohms; therefore, the high impedance likely occurred on (b)(6) 2013.
 
Manufacturer Narrative
(b)(4) date of event, corrected date: previously submitted mdr indicated that the event date was (b)(6) 2013; however, this should be (b)(6) 2013. This report is being submitted to correct this data. Date of this report, corrected data: previously submitted mdr indicated that the aware date was 07/25/2013; however, this should be 07/24/2013. This report is being submitted to correct this data.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis was completed on the generator. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3295171


Title: Re: White Deposits
Post by: dennis100 on May 07, 2018, 12:26:38 AM
Model Number 300-20
Event Date 08/28/2013
Event Type  Malfunction   
Event Description
On (b)(6) 2013 it was reported that during generator replacement surgery due to end of service, it was found that the lead pin was disconnected and the lead wire further down had exposed wire. The surgeon cut the lead and proceeded with a full revision. The reason for lead replacement was noted as lead discontinuity, with an exposed lead break. Product analysis of the explanted generator confirmed end of service as a result of normal battery depletion. The depletion was an expected event as determined by battery life calculation and battery voltage measurement. The module performed according to functional specifications as defined in post burn-in electrical test. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. An analysis was performed on the returned lead portions which confirmed discontinuity. Note that the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 90 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 46 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. 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. During the visual analysis of the returned 89 mm portion the end of the (-) unmarked connector quadfilar coil appeared to be broken approximately 49 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having the appearance of being melted. What appeared to be spatter was found on the surface of the quadfilar coil strands. Based on the obvious signs of mechanical damage on the coil surfaces, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool (electrosurgical unit) during the explant of this lead. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity on the (+) marked connector quadfilar coil and the melted area on the (-) unmarked quadfilar coil, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3373200


Title: Re: White Deposits
Post by: dennis100 on May 09, 2018, 12:54:51 AM
Model Number 102R
Event Date 02/05/2007
Event Type  Malfunction   
Event Description
Initially, it was reported that the generator was unable to be interrogated and believed to be due to end of service so the patient was referred to surgery. During the surgery, the surgeon opened the generator pocket and noticed that the header of the generator was coming off of the generator and he could see the glue separating. The surgeon indicated that there was moisture in the header as well. A new generator was implanted and device diagnostic testing resulted in high impedance. The high impedance was reported in mfr. Report # 1644487-2013-03232. The generator was returned for analysis on (b)(4) 2013. The generator analysis was completed on (b)(4) 2013. Analysis of the generator identified that the end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The generator was unable to be interrogated in the pa lab which was determined to be the result of normal battery depletion. Analysis in the pa lab determined that the ¿detachment of the header¿, occurred during the patient implant duration. This is based upon the white substance deposits found on top of the can and on the feedthru capacitor area that were under the header. The device performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, 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=3413735


Title: Re: White Deposits
Post by: dennis100 on May 09, 2018, 12:55:50 AM
Model Number 102
Event Date 07/01/2010
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient reported that she had the vns device explanted because it was not working right and had shifted a little. The patient described the device "not working right" as the fact that she was unable to catch her breath while jogging. The patient's mother stated that the vns was not working as well as it used to and stated that the patient had seizures coming from multiple areas of her brain. Per the mother, a right temporal resection was done after the vns was removed. The patient's physician is recommending a new vns implant. The explanted devices were returned and product analysis (pa) was performed. In the pa 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. 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. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lead products and identified them as containing silicon, calcium and phosphorus. The condition of the returned lead portion 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 portion 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 portion of the device. Note that since the majority of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Attempts have been made for additional information; however, they were unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3435067



Title: Re: White Deposits
Post by: dennis100 on May 13, 2018, 12:08:54 AM
Model Number 302-30
Event Date 10/05/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Initial mfr. Report inadvertently listed the incorrected suspect device.
 
Event Description
It was reported that the patient underwent generator and lead replacement. Preoperative diagnostics were within normal limits. The physician's assistant reported that diagnostics in the physician's office were also within normal limits. During the surgery, the lead (including electrodes) and generator were removed. The surgeon indicated that the electrodes were wrapped tight around the vagus nerve and a "branch" and that there was a lot of scar tissue. The surgeon was certain that it was not the cardiac branches or the laryngeal branches. A new lead was placed on the vagus nerve and new generator was attached to the new lead. Diagnostic tests were within normal limits with the new system. The explanted devices were sent to the hospital pathology and the operating room nurse indicated that the hospital does not usually send back explanted devices. A returned product kit was given and a request to have the explanted devices was provided. It was reported that a company representative went to the site to assess diagnostics on the device prior to surgery being scheduled. It was reported that device diagnostics were unable to be performed due to the patient's complaints of pain and swelling in the neck area. It was reported that the patient was told by the physician that he recommended system replacement based on the patient';s pain and swelling and not based on "bad" diagnostics. The physician left the patient to decide on replacement. The patient reportedly decided on having the device replaced because it was felt that the device was of benefit to the patient. The generator and lead were received for analysis. Analysis of the generator was completed on 04/01/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 04/01/2014. The puncture mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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 portion 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 portion of the device which may have contributed to the stated complaints.
 
Event Description
On (b)(4) 2013, it was reported that the patient had the vns device disabled by an unknown doctor in (b)(6) due to chest and neck pain. This was found out by the physician when the patient was hospitalized and admitted to the epilepsy monitoring unit (emu) for an increase in seizures. The physician turned the device back on and performed diagnostics on (b)(6) 2013 (emu admit date) and the results showed low impedance. The patient continued to have chest and neck pain with stimulation. The neurologist turned off the device and it has been off since (b)(6) 2013. Follow up indicates that although the device was implanted since 2004, it was only turned on for the last year or so (per the patient). The patient may be proceeding with device replacement, but no surgery has taken place to date. Attempts for additional information have been unsuccessful. No additional information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3527747


Title: Re: White Deposits
Post by: dennis100 on May 13, 2018, 12:09:29 AM
Model Number 303-20
Event Date 11/27/2013
Event Type  Malfunction   
Event Description
Analysis of the returned lead portions was performed. The lead assembly was returned in three portions with one tie down attached. Due to the condition of the lead as ¿ received, determining the connector pin versus the connector ring tri-filar coils could not be made during the visual analysis of the returned 202mm portion. The lead assembly has dried remnants of what appear to have once been body fluids inside the bilumen tubing, in some areas. An abraded opening was observed on the bilumen tubing approximately 8mm-10mm from the end of the cut bilumen tubing with one tri-filar coil exposed. White deposits were observed on the bilumen tubing. The end of the (+) white electrode tri-filar coil appeared to be melted. Incisions were made to allow for sem photos.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3539397


Title: Re: White Deposits
Post by: dennis100 on May 28, 2018, 01:33:46 AM
Model Number 300-20
Event Date 01/06/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital with a sore neck and vocal chord paralysis. Device diagnostics resulted in high impedance. The device was programmed off and the patient was referred for surgery for generator and lead replacement. No additional relevant information has been received to date. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient underwent generator and lead explant due to the high impedance. It was reported that a new vns system was not implanted at this time. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/16/2015. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 02/18/2015. Note that the electrodes, plus one inner tube and quadfilar coil 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 314mm portion discoloration was observed on a portion of quadfilar coil 1 and the end appeared to be broken approximately 281mm from the end of the cut outer / inner silicone tubes. What appeared to be a greenish substance was observed inside inner silicone tubing 1 and quadfilar coil 1 appeared to be dissolved in this area. Scanning electron microscopy was performed on quadfilar coil 1 coil break found at 281mm and identified the area as being thin which prevented identification of the coil fracture type and evidence of electro-etching on the 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 abraded opening and puncture 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 the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, chlorine, zirconium, aluminum, sulphur and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
Event Description
Additional information was received on the patient's symptoms. The patient was experiencing dysphagia and hoarseness prior to being admitted to the hospital. The patient was then found to have left true vocal cord (tvc) paralysis. Due to a suspected abscess, the patient went into or for an incision and drainage procedure (found to be fluid collection not abscess). A lead fracture was then observed during the procedure with abraded insulation. The patient's neurosurgeon believes the lead fracture caused stimulation to surrounding neck tissue which led to necrosis and the fluid buildup. The neck fluid buildup is slowly resolving following vns removal. The patient is continuing to have hoarseness although dysphagia has improved. However, in his experience, the neurosurgeon believes tvc paralysis will likely be permanent due to nerve damage.
 
Manufacturer Narrative
Device failure occurred, 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=4453271


Title: Re: White Deposits
Post by: dennis100 on June 09, 2018, 01:14:29 AM
Model Number 300-20
Device Problem Fluid leak
Event Date 01/01/2018
Event Type  Malfunction   
Event Description
The patient underwent prophylactic battery replacement for the desire to have an m106. The explanted devices were returned for analysis. Product analysis on the lead was completed and approved. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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, with no discontinuities identified. Product analysis on the generator m104 was completed and approved. 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. Review of the datadumps shows no issues with high impedance. No additional or relevant information has been received to date,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7534449



Title: Re: White Deposits
Post by: dennis100 on July 30, 2018, 03:26:31 AM
Model Number 302-20
Event Date 08/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Patient identifier; corrected data: the previously submitted mdr did not provide the correct patient identifier. Describe event of problem; corrected data: the previously submitted mdr did not include information of the observed pitting.
 
Event Description
A lead explanted due to infection (mfr. Report #1644487-2014-02414) was returned and analyzed. Analysis of the lead was completed on (b)(4) 2014. Multiple breaks were confirmed in the negative coil of the returned lead portions. Abraded openings were found on the outer and inner tubing near the break locations, possibly caused by wear. A green substance was observed inside the outer silicone tubing in some areas. White deposits were observed on the outer and inner silicone tubes. Coding will be added for the lead fractures and fluid leaks. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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, with no other discontinuities identified. Based on the findings in the product analysis lab, there is evidence of multiple discontinuities in the negative coil of the returned portions of the device. Note that since portions of the (+) white and (-) green electrode quadfilar coils and the anchor tether were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
Scanning electron microscopy identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Based on the information available to date, the reported left scapular abscess appears to be the result of lead dissolution: when a lead fracture occurs and a small length of the lead is exposed to extracellular fluid, the broken end of the lead acts as the electrode. The current delivered by the pulse generator is conducted through the very small surface area of the fractured lead. The result of this event is the pitting at the broken end of the coil wire. Adverse events associated with this event can include infection-like symptoms including inflammation, pain, or edema of abscess. The device issue reported here is related to the events reported in mfr report #1644487-2014-02414.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4177309


Title: Re: White Deposits
Post by: dennis100 on August 30, 2018, 11:42:26 AM
Model Number 300-20
Event Date 06/30/2011
Event Type  Malfunction   
Event Description
Additional information was received that indicated that product analysis was completed on the generator and lead. The generator performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Note that the lead assembly (body) including the electrodes was not returned for analysis and therefore, a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lad products and identified them as containing silicon, calcium and phosphorus. 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 measurements taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. There is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
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 that indicated that that patient had a full revision. The generator and lead have been returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
It was initially reported that the patient was being referred for surgery due to high impedance. There was no reported trauma or injuries to the area. A full revision is planned, but has not occurred to date. Good faith attempts for more information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2197094


Title: Re: White Deposits
Post by: dennis100 on September 09, 2018, 12:41:23 AM
Model Number 302
Event Date 06/01/2011
Event Type  Malfunction   
Manufacturer Narrative
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
Additional information was received regarding the patient. There were no x-rays taken. There was not reported manipulation or trauma that would have contributed to the high impedance. The chance in seizure pattern was causative to the high impedance. There were no changes in programming, mediation or external factors that preceded the onset of the change in seizure pattern. The patient had heir generator and lead replaced. Good faith attempts for product return have been unsuccessful to date.
 
Event Description
Additional information was received that indicated that the generator and lead were return to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
Additional information was received that indicated that product analysis on the generator and lead was complete. The device performed according to functional specifications. No eri flags were observed during testing. The device was continuously monitored for 25. 5 hours. The programmed output current measured within limits and showed no signs of variation. Diagnostic values were as expected for the programmed settings. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. An analysis was performed on the returned lead portion and the reported allegations of lead break were confirmed. Note that a 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. During the visual analysis the connector ring quadfilar coil appeared to be broken approximately 117 mm (connector end) and at 123 mm (electrode mating end) from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on another coil strand was identified as having extensive pitting which prevented identification of the coil fracture and another was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing (b)(4). With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Note that since a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was initially reported that the patient had high impedance on a recent diagnostics. The patient had been having a gradual increase in seizures 1-2 months prior to the high impedance being seen. The patient has been having more intense and longer tonic and at times tonic-clonic seizures for about 2-3 weeks prior to the high impedance being seen. Patient had his generator turned off as a result of the high and it is planned for the patient to have a full revision. Surgery has not occurred to date. Good faith attempts for more information have been unsuccessful to date. Patient had a reported change in seizure pattern seen in (b)(6) 2010 which is reported in mdr # 1644487-2011-02251 that appears to be a separate issue. This change in seizure pattern seems to be related to the patient's high impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2261557


Title: Re: White Deposits
Post by: dennis100 on September 15, 2018, 01:23:18 AM
Model Number 302-20
Event Date 12/01/2011
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. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received through an implant card indicating the patient was re-implanted with vns therapy and lead impedance value was marked as ok.
 
Event Description
It was reported by a nurse that high lead impedance was found during a follow-up appointment. The nurse mentioned the patient also had an increase in seizures and the patient is no longer hoarse. An emg was performed of the patient and it revealed a broken lead wire. No patient trauma or manipulation was suspected to have contributed to the event. The patient's device was programmed off and was referred for x-rays and revision surgery.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate type of report. Report should have read 30-day.
 
Event Description
Additional information was received by the area representative indicating the patient underwent generator and lead removal surgery in which part of the lead was removed. The explanted lead was returned to the manufacturer and is currently under analysis. At the moment surgical plans to re-implant the patient remain underway.
 
Manufacturer Narrative
Device failure is suspected, 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 indicated that a lead discontinuity was not confirmed based on the returned portion of the lead. What appeared to be white deposits were observed on the connector boot. An abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, with no discontinuities identified. 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.
 
Event Description
Further information was received from the area representative indicating that the last known impedance was in (b)(6) 2011 and it was 2601 ohms. The high impedance was noted at a follow-up appointment in which the patient did no longer perceive stimulation along with an increase in seizures. X-rays were taken and reviewed by the manufacturer. Review of x-rays indicated the generator was visualized in a normal placement in the left upper chest. The filter feed-through wires appeared to be intact. The lead wires at the connector pin appeared to be intact. The lead connector pin appeared to be fully inserted into the generator connector block. There is a portion of lead behind the generator that could not be assessed. There was a suspected area near the neck area of the lead. No acute angle was observed in the assessed portions of the lead. At the moment revision surgery is likely, but has not been confirmed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2393479


Title: Re: White Deposits
Post by: dennis100 on September 15, 2018, 01:24:25 AM
Model Number ASKU
Event Date 10/12/2011
Event Type  Malfunction   
Event Description
Product analysis of the explanted lead was completed on (b)(6) 2012. During the visual analysis of the returned 151 mm portion the ends of the marked and unmarked quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area on both quadfilar coils as being mechanically damaged which prevented identification of the coil fracture type with pitting on the marked quadfilar coil break area. 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids / tissue and white deposits found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the unmarked 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. Note that since the marked connector boot, and 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.
 
Event Description
Additional information received revealed that the patient underwent full revision surgery in which the lead and generator were explanted and replaced. The explanted lead was discarded and will not be returned for analysis. Good faith attempts to obtain the explanted generator are in process.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator have been returned to the manufacturer and device evaluation of the explanted generator has been completed. The generator performed according to functional specifications and there was no abnormal performance or any other type of adverse conditions found. Product analysis of the explanted lead has not been completed at this time.
 
Event Description
It was reported that during a prophylactic generator revision surgery, a lead break was identified and the surgery was cancelled as the patient would need a full revision. Follow up with the site revealed that x-rays were not taken prior to surgery and at the time of surgery, a dcdc of 7 was obtained (unknown which mode). No device diagnostics were performed prior to surgery per the physician however the patient was not reporting any issues to the physician which would indicate there was an issue with the lead. Revision surgery to address the high lead impedance will likely occur but has not to date.
 
Manufacturer Narrative
Describe event or problem, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report. Conclusions, corrected data - previous report stated that the lead was discarded however it was not. The information has been corrected on this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2323681



Title: Re: White Deposits
Post by: dennis100 on October 08, 2018, 01:25:41 PM
Model Number 102R
Event Date 03/30/2012
Event Type  Malfunction   
Event Description
Initially a battery life calculation was requested on a vns patient's generator. The patient's settings were 2. 5/30/250/30/3. Their system diagnostic testing was dcdc 3, eri no. The battery life calculation was negative. The patient went to surgery for a prophylactic generator replacement. In preop a system diagnostic test was performed that resulted in the following: high lead impedance with an ok output status, dcdc=6 and eri=yes. The patient was programmed at 2. 75ma. It was noted in the or that the patient's generator had a detached header. There was no specific trauma that was reported preceding the event. The header detachment did not occur during the explant. The explanted generator has been returned for analysis. Analysis is pending completion.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report. Type of report corrected data follow-up # 3 on last emdr should have been a #2. (b)(4) , version no: 2 corrected data: the last emdr was sent version 3 when it should have been version 2. Therefore this emdr being sent version 2.
 
Manufacturer Narrative

Manufacturer Narrative
Operator of device corrected data: updated to patient.
 
Manufacturer Narrative
Device malfunction occurred but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis was completed , the elective-replacement-indicator (eri) was set. A window was cut into the pulse generator case to access the feed-thru output connections on the substrate. Bench test connectors were attached to the negative and positive feed-thru wires, at the substrate, to perform a final electrical test. The generator passed all final electrical testing evaluations with the exception of a single test parameter related to the partially depleted condition. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. The reported detachment of the header at explant was confirmed. The location of the white deposits observed on the pulse generator case suggests that header delamination/separation had occurred. The observed header anomalies found in the visual analysis may have been the contributing factor to their high impedance. The failure mechanism could not be determined; however poor adhesion and tool marks in the header area were observed on the returned product.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2546638


Title: Re: White Deposits
Post by: dennis100 on October 09, 2018, 12:24:02 PM
Model Number 300-20
Event Date 04/21/2012
Event Type  Malfunction   
Event Description
Good faith attempts were made and no further information was attained.
 
Manufacturer Narrative
Type of report corrected data; omitted on initial report, 30 day report.
 
Event Description
Neurology reported that they had a vns patient with high lead impedance. A system diagnostic test resulted in 8393 ohms/limit/high. The patient had their generator replaced on (b)(6) 2012 and no diagnostics have been performed since that date. It is unknown if the patient experienced any trauma to the site. The patient did start to experience pain at the generator site a few days prior to this clinic visit when their vns activated. The site is aware to program their vns off. It is unknown if this has been done. The patient at this time has no surgery planned because they are seizure free. X-rays were received for review. Lateral neck and ap chest x-rays via disc and were reviewed. The generator is visualized in the left upper chest in a normal orientation. Filter feedthru wires appear to be intact and the lead pins appear to be fully inserted into the header of the generator. The lead body is intact at the lead pins. The lead body and electrode site were able to be visualized. The electrodes appeared to be possibly not be in alignment. It is possible the anchor tether is displaced, but cannot be visualized. There is lead behind the generator that cannot be assessed. A strain relief bend is present but not per labeling. The strain relief loop does not appear to be adequate. One tie-down is present but is within the loop. Most of the lead was visible and no obvious lead discontinuities 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 allegation of high lead impedance. It is possible there is an issue with the lead behind the generator that cannot be visualized or a lead break that cannot be seen on x-ray. Good faith attempts are underway for further information.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by manufacturer, no gross lead discontinuity visualized. Device malfunction suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient underwent generator and lead replacement surgery on (b)(6) 2013. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked connector quadfilar coil appeared to be broken approximately 246mm and 248mm from the connector boot. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 246mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 248mm) and identified the area as having flat spots on the coil surface with pitting and mechanical damage. Evidence of a stress induced fracture was observed, but determination could not conclusively be made on the fracture mechanism. 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 abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 other discontinuities were identified. The abraded openings observed on the outer and inner silicone tubes have the potential for contributing to the painful stimulation allegation. Analysis of the generator was completed on (b)(4) 2013. Although the septa were cored, but no bodily fluid remnants were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows a non-ifi condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
New information received identified the date of event. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that the patient's device was disabled (b)(6) 2012. The patient after their device was disabled started to have increased seizures with the loss of therapy. The patient now wants to have full revision surgery. No surgery date planned at this time as the patient has broken ribs that need to heal first.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2585284


Title: Re: White Deposits
Post by: dennis100 on October 10, 2018, 02:39:20 AM
Model Number 300-20
Event Date 04/19/2012
Event Type  Malfunction   
Event Description
A fax was received from the physician on (b)(6) 2012. It is unknown if patient manipulation or trauma occurred that caused or contributed to the event. A product malfunction was indicated. The physician also noted that the patient's device was an older model and would be replaced with a newer model when the lead is replaced. It was also indicated that the patient had not yet undergone surgery has the patient had not kept an appointment with the surgeon. Surgery is still likely but has not taken place to date.
 
Manufacturer Narrative
Manufacturer review x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Only a portion of 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
Pa for the generator was approved on (b)(4) 2012. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.
 
Event Description
Ap chest, lateral chest, and ap neck x-ray images were received on (b)(6) 2012. The generator is visible in the upper, left chest. The generator is placed normally. The connector pins appear to be fully inserted inside the connector blocks. The feedthru wires appear intact. Lead is present behind the generator and cannot be assessed for continuity. No sharp angles are present. Lead wires appear intact at the connector pins. There is a suspect area of continuity in the lead body. A gross lead discontinuity is suspected at the bottom of the strain relief bend. Based on the x-rays images received there appears to be a suspected lead discontinuity. As the entire lead could not be assessed, continuity in the obstructed portion of the lead cannot be confirmed. On (b)(6) 2012, the patient underwent lead and generator explant due to high impedance and a dead battery. The explanted devices were received on (b)(6) 2012. Product analysis for the explanted lead showed that a 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. 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 found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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, 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 a portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
On (b)(6) 2012, a physician reported high impedance readings from systems diagnostics performed on (b)(6) 2012 for a vns patient. The patient did have any serious falls and has not experienced any increase in seizures. X-rays were taken; however, the physician could not see a lead break in the area of the chest that was imaged. Additional x-rays were scheduled; however, it is unclear if they were actually taken. No images were provided for manufacturer review. A battery life calculation was performed with results of 1. 28 years until eri to yes. Surgery is likely but has not taken place 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=2581839


Title: Re: White Deposits
Post by: dennis100 on October 11, 2018, 06:29:28 AM
Model Number 302-20
Event Date 01/26/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(6) 2012, the explanted lead was received by the manufacturer for product analysis. Product analysis was completed on (b)(6) 2012. The connector pin / boot section with model and serial number tag and electrodes were not returned; therefore it was not possible to verify the model and serial number during this analysis. During the visual analysis quadfilar coil 1 appeared to be broken approximately 277mm and 285mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 277mm) and identified the area as having evidence of a stress induced fracture with mechanical damage, residual material and no pitting. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed on quadfilar coil 1 coil break (found at 285mm) and identified the area on two of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism of the remaining quadfilar coil strands. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be remnants of dried body fluids were observed inside one of the inner silicone tubes, in some areas. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
Additional information was received on (b)(6) 2012 when it was discovered that the vns patient underwent a full revision surgery on (b)(6) 2012. The lead was replaced due to high impedance noticed on (b)(6) 2012. Prior to surgery, x-rays showed that the lead was fractured. There has not been any accident or trauma which could have caused the breakage. It was also reported that only the lead will be returned for product analysis, as the generator was disposed of by the hospital. The lead impedance after the new vns system was implanted was noted to be "ok". Attempts have been made for the return of the lead however it has not been received for product analysis to date.
 
Event Description
It was reported by a company representative that high impedance was reported at a follow-up appointment. X-rays were performed and the surgeon was able to see a lead discontinuity. The last known good system diagnostics were from (b)(6) 2011. No patient manipulation or trauma was reported to have contributed to the reported high impedance. X-rays were received and evaluated by the manufacturer. Review of x-rays indicated the generator was visualized in the left upper chest. The filter feed-through wires appeared to be intact. The lead connector pin seemed not to be fully inserted into the generator connector block. There is part of the lead placed behind the generator and could therefore not be assessed. Electrodes seemed correctly aligned on the vagus nerve. A lead discontinuity was visible on the lead body in the neck area. At the moment revision surgery is likely.
 
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=2603919


Title: Re: White Deposits
Post by: dennis100 on October 13, 2018, 04:32:00 AM
Model Number 302-20
Event Date 06/22/2012
Event Type  Malfunction   
Event Description
On (b)(6) 2012, it was reported that a patient underwent total revision on this date and that the explanted devices would be returned to the manufacturer. The generator was replaced due to end of service, and the lead was replaced due to high impedance. A manufacturer's consultant also indicated that these physicians may not be willing to provide additional information. On (b)(6) 2012, the explanted generator and lead were returned and are currently undergoing product analysis. A returned product form received on (b)(4) 2012, indicated that the lead came out in pieces and the largest piece was returned. A battery life calculation was performed on (b)(4) 2012. The results indicated negative years to eri = yes. On (b)(6) 2012, it was reported that the physician would not provide any additional information regarding these events.
 
Manufacturer Narrative
Analysis of programming history. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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
Product analysis for the explanted generator and lead was approved on (b)(6) 2012. The near end of service flag was set (n eos = yes) for the generator. The battery was partially depleted and determined to be the result of normal expected battery consumption based on the battery life analysis and electrical test results. The pulse generator module performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Only a section of the lead was returned for product analysis. The lead's electrodes were not returned. Two tie-downs were returned with the lead. Two sets of setscrew marks were seen on the connector pin, providing evidence that contact between the setscrew and the lead pin existed at least once. One of the setscrew marks is located toward the end tip of the connector pin. 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 when this occurred is unknown. Based on the location of the setscrew marks on the connector pin and scratches from the canted spring observed on the connector ring, it is believed that proper contact between the pulse generator "+" and "-" terminals and the lead connector respective contact points (connector ring and connector pin) existed at least once. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. White deposits were identified on the outer silicone tubing at various locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified si, p, ca, na, and mg as the composition for the substance. The exact reason for the presence of the substance is unknown. The lead assembly was returned for analysis due to high impedance. The reported high impedance allegation was not verified within the returned lead portion. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2647472


Title: Re: White Deposits
Post by: dennis100 on October 19, 2018, 11:21:23 AM
Model Number 302-20
Event Date 08/14/2012
Event Type  Malfunction   
Event Description
Additional information was received indicating that x-rays were taken; however, the device was not visible. Attempts to obtain new images were unsuccessful. The patient's increase in seizures was attributed to the high impedance. The patient underwent revision on (b)(6) 2012. The new device was successfully implant and verified to be working properly. The generator was replaced prophylactically. After re-implant, the patient responded to treatment. The lead and generator were received on (b)(6) 2012. Product analysis for the explanted lead showed that the reported "high impedance" allegation was not verified within the returned lead portion. 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 typical wear and explant related observations, no anomalies were identified in the returned lead portion. Four 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. 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. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. White deposits were identified on the connector boot in the vicinity of the ring/backfill interface. Abrasions were identified on the connector boot. The outer silicone tubing has what appear to be abrasions/imprints. The outer silicone tubing appears to have been compressed at three locations. Abrasions most likely caused by the presence of a tie-down were identified; the outer silicone tubing is cut open at approximately 33 cm from boot. No obvious damage to the lead coils or the inner tubing was noted at this location. The outer silicone tubing has what appear to be internal abrasions at multiple locations. Abrasions were identified on the silicone tubing of the lead coils. The lead assembly has remnants of what appears to be body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portion. No discontinuities were identified within the returned lead portion.
 
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.
 
Event Description
On (b)(6) 2012, it was reported that normal mode and system diagnostics for a vns patient indicated high impedance. Diagnostics were repeated with the same results. The device subsequently programmed off. The physician requested a new generator due to the fact that this generator was implanted in 2008. The event was reported to be continuous, of moderate severity, and possibly related to stimulation. Device parameters were changed as intervention. It was also noted that the patient had an increase in seizures over the previous seizure rate. The patient reportedly has generalized tonic-clonic seizures and atonic seizures. The patient's settings and diagnostics from this date were provided. Additional information was received that x-rays were taken and would be provided for manufacturer review; however, they have not been received to date. The patient had not had any fall, injury or manipulation of her vns lead that could be attributed to the high impedance. The increase in seizures was over thee pre-vns seizure rate at baseline rate two months prior. The physician attributed the loss of therapy to the high impedance. Adjustments to mediation were made to treat seizures and to preclude a serious injury. Surgery is likely, but has not occurred.
 
Manufacturer Narrative
Analysis of programming history.
 
Event Description
Product analysis for the explanted generator was completed on (b)(6) 2012. The pulse generator was explanted/returned due to prophylactic replacement. 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. A battery life calculation on (b)(6) 2012 indicated 6. 49 years remaining.
 
Manufacturer Narrative
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=2744314


Title: Re: White Deposits
Post by: dennis100 on October 31, 2018, 01:28:05 AM
Model Number 300-20
Event Date 10/18/2012
Event Type  Malfunction   
Event Description
Additional information was received that on (b)(6) 2012 that the patient had a full revision surgery on (b)(6) 2012. No other information was provided at this time. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received that the lead was also returned to the manufacturer for evaluation. Product analysis is planned but has not been completed 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 that product analysis was completed on the generator and lead. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. Note that a large 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, molybdenum and calcium. The condition of the returned lead portion 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 pins at one point in time. Continuity checks of the returned lead portion 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 portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section.
 
Event Description
It was initially reported that the patient was having a full revision due to the generator being at end of service and the lead due to high impedance. The patient has been having an increase in seizures unknown if above or below pre-vns baseline. The physician felt that the seizures were due to both the high impedance and medication adjustments. There is no known trauma or manipulation that could have caused the issue. Surgery if likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Manufacturer Narrative
 
Event Description
Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2850997


Title: Re: White Deposits
Post by: dennis100 on November 14, 2018, 08:22:32 AM
Model Number 302-20
Event Date 12/21/2012
Event Type  Malfunction   
Event Description
Product analysis of the explanted devices was completed. 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. The device was not turned off as a result of the high impedance. An analysis was performed on the returned lead portions and the reported allegation of high impedance was confirmed. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis, and therefore, a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 207mm portion the end of quadfilar coil 1 appeared to be broken approximately 150mm from the end of the cut outer silicone tubing. Scanning electron microscopy was performed and identified the area on two of the coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on the remaining quadfilar coil strands was identified as being mechanically damaged and pitted which prevented identification of the coil fracture type. 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 abraded opening found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed on the outer silicone tubing. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified.

Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was initially reported that the patient was referred for generator replacement due to an unknown reason. On the date of surgery on (b)(6) 2013, the company representative became aware that high lead impedance was observed on (b)(6) 2012 by the referring vns physician. Per the most recent clinic notes on (b)(6) 2012, the notes stated that high lead impedance and limited output status was observed, "suggesting either weak battery (but still functioning) or lead impedance. X-rays were obtained and showed no disconnect". The patient reported to be seizure free for two years. He was reportedly doing well and having no problems, per the physician's notes. The surgeon was not aware of any trauma that may have contributed to the high impedance. Intra-operatively, the surgeon replaced the generator which still resulted in high lead impedance. Therefore, the lead was replaced and retested. Two system diagnostic tests were performed and were within normal limits. The explanted generator and lead were received by the manufacturer for analysis; however, product analysis has not been completed to date. The return product form indicated the reason for replacement as lead discontinuity. Ap and later views of the neck and the chest were received and reviewed by the manufacturer. The generator was visualized in the left side of the patient's chest and placement appeared to be normal. The connector pin appeared to be seen past the connector block and filter feed thru wires were intact. The lead appeared intact at the connector pin. There was a small portion of the lead behind the generator and continuity in that portion of the lead body could not be assessed. Leads were visualized towards the left side of the neck area. There were no sharp angles or lead discontinues seen in the portions of the lead that were able to be visualized based on the x-ray image provided, a cause for the high lead impedance could not be identified however the presence of a micro fracture in the lead or a lead discontinuity in the portion of the lead that could not be assessed cannot be ruled out.

Manufacturer Narrative
Device failure occurred, 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=2949056


Title: Re: White Deposits
Post by: dennis100 on November 14, 2018, 08:23:39 AM
Model Number 302-20
Event Date 09/23/2012
Event Type  Malfunction   
Event Description
Reporter indicated that during a vns generator replacement surgery, high lead impedance was noted with the resident lead and new generator. The patient received a new lead and generator. As a lead pin issue was ruled out, a lead fracture is the more likely cause of the high impedance. Attempts for additional information are in progress. The explanted vns generator and lead were returned. Analysis of the generator did not reveal any anomalies, and the generator performed per specifications. The generator was at end of service. Review of internal programming data from the generator indicated an impedance change from normal to high impedance occurred on (b)(6) 2012. Analysis of the lead is pending.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
All attempts to the reporter for additional information have been unsuccessful to date. Analysis of the vns lead was completed. During the visual analysis of the returned 39mm portion the (-) green electrode quadfilar coil appeared to be broken approximately 1mm from the proximal end of the anchor tether. Scanning electron microscopy was performed and identified the area on one of the quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. The area on three of the quadfilar coil strands was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

Manufacturer Narrative
Device failure occurred, 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=2955092


Title: Re: White Deposits
Post by: dennis100 on November 14, 2018, 08:25:07 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
The vns treating physician reported that high lead impedance was found during an office visit on (b)(6) 2013. The patient was last seen on (b)(6) 2012 at which time the lead impedance was within normal limits. The physician reported that an x-rays confirmed a distal fracture. The patient was for replacement surgery as soon as possible to prevent more seizures. Clinic notes from the patient's visit on (b)(6) 2013 were received which indicated the patient continued to do well. However, the patient had a breakthrough seizure earlier in (b)(6), followed by brief myoclonic jerks involving his upper limbs. Since then, he has not had any further seizures. He is seizure free on the ketogenic diet. Also on the last office visit, his seizure medications were being weaned off and had been over of seizure medications for about 8 months. The patient had breakthrough seizures that seem to be related to vns lead fracture. Given the good seizure control, the plan was to continue to wean the patient off of seizure medications. Attempts for additional information from the physician's office have been unsuccessful to date, including to obtain a copy of the x-rays. Although generator and lead replacement surgery is likely, it has not occurred to date.

Manufacturer Narrative
Device failure occurred, and it was believed to have contributed to the patient's increased seizures.

Event Description
Additional information was received from the hospital reporting that the patient had generator and lead replacement surgery on (b)(6) 2013 and the explanted products were available for return. The explanted products were received by the manufacturer on (b)(6) 2013 for analysis. The return product form indicated the reason for replacement as prophylactic generator replacement and due to lead discontinuity. The implant card was also received and confirmed the date of surgery and indicated the reason for generator replacement as battery depletion with near end of service marked. Product analysis has not been completed to date.

Event Description
Operative notes from the patient's revision surgery on (b)(6) 2013 were received which indicated the diagnosis as placement of new lead due to fracture and generator secondary to end-of-life due to length of implant. The patient was doing well but began to lose efficacy with vns. Imaging was obtained which showed a fracture of the lead, explaining the device's 'failure to work. ' during the procedure, an incision was made over the old scar in the neck and dissection was carried down to remove the lead and the anchors. There was significant scar tissue surrounding the sternocleidomastoid, which was carefully dissected free by the surgeon. The lead dove directly posterior at this point, and the surgeon worked through the scar tissue to identify the connecting portion of the electrode. However, the nerve was scarred-in quite heavily, and the surgeon was unable to locate and free up all three of the components that held the nerve. The nerve was traced superiorly into the cicatrix and he tried to free up enough to again identify the previous electrodes, but the scar tissue was so heavy so the surgeon did not feel that he could 'safely dissect the nerve free without some type of injury to it. ' at this point, the surgeon felt that 'removal of the old electrode component was probably not worth the risk of injury to the nerve, and again try to free up as much nerve as possible, although the amount of exposure was very limited. ' the new set of electrodes were then successfully wrapped around the nerve. The surgeon felt that he had adequate contact of the two superior components of the lead, and the third electrode was able to be adequately wrapped around the nerve by laying it down inferiorly. Upon disconnecting the previous lead from the generator, a fracture was observed in the lead. The replacement lead was connected to the replacement generator which resulted in normal impedance upon diagnostics. He noted in the notes that the two electrodes appeared to have good relationships with the nerve. Attempts for additional information from the surgeon have been unsuccessful to date.

Event Description
The surgeon's office reported that there was noted to be scarring around the electrode and vagus nerve. However, the believed cause/relationship to vns was not provided. It may be reasonably assumed that it was related to presence of the electrode on the nerve.

Event Description
Product analysis of the generator showed no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was also completed. Note that a 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. During the visual analysis an abraded opening was observed on the outer silicone tubing and both of the inner silicones were found to be abraded open in half; therefore determination could not be made between the (-) connector pin and (+) connector ring quadfilar coils past this point. These coils were identified as quadfilar coil 1 and quadfilar coil 2. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 239mm, 242mm and 245mm from the end of the connector boot. The (+) connector ring quadfilar coil appeared to be broken approximately 240mm from the end of the connector boot. Scanning electron microscopy was performed and identified the coil break areas as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis quadfilar coil 1 appeared to be broken approximately 247mm from the end of the connector boot and quadfilar coil 2 appeared to be broken approximately 253mm from the end of the connector boot. Scanning electron microscopy was performed and identified the areas as being mechanically damaged which prevented identification of the coil fracture type with pitting on the quadfilar coil 1 coil break. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. 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. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Review of the lead manufacturer history records confirmed all quality tests were passed prior to distribution.

Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected and is suspected to have contributed to the patient's increased.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2950000


Title: Re: White Deposits
Post by: dennis100 on November 14, 2018, 08:26:13 AM
Model Number 300-20
Event Date 01/14/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high impedance. The patient was sent for x-rays but they had not been provided to the manufacturer for review. The patient had their output current turned down to 0. 5 ma and the physician does no plan to turn the patient off. The patient also reported that he was experiencing a shocking sensation at the same appointment where the high impedance was discovered. The patient has a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been complete.

Manufacturer Narrative

Event Description
Additional information was received that the product analysis was completed on the lead. 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 the (+) marked quadfilar coil appeared to be broken approximately 69mm and 73mm from the connector bifurcation and at approximately 10mm from the electrode bifurcation with three broken coil strands at approximately 9mm. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil breaks (found at 69mm and 73mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 10mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. The area on the three broken coil strands was identified as being mechanically damaged. 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 abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. 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.

Event Description
Additional information was received that there was no reported manipulation or trauma. X-rays will not be sent to the manufacturer for review. On diagnostics the dcdc code was 7. Product analysis was completed on the generator but has not been completed on the lead. The generator performed according to functional specifications. During product analysis there were no anomalies found with the pulse generator.

Manufacturer Narrative
Device failure occurred, 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=2955719


Title: Re: White Deposits
Post by: dennis100 on November 17, 2018, 04:30:09 AM
Model Number 300-20
Event Date 02/05/2013
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. Device manufacturing records were reviewed. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized. Review of manufacturing records confirmed device met all specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

Event Description
Product analysis on the leads was completed on (b)(4) 2013. 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. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the half set of setscrew marks found near the end of the marked connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the marked 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Product analysis of the generator was completed on (b)(4) 2013. Results of diagnostic testing indicated that the battery status indicated ifi=yes in the pa lab. The battery is partially depleted, 2. 808 volts (near ifi) as measured during completion of the final electrical test. 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. The internal memory of the device stated that the impedance value went from 91 ohms to 22152 ohms on (b)(6) 2013 which is after explant.

Event Description
On (b)(4) 2013 it was reported that the vns patient has high impedance. Diagnostics indicated that the device was only able to deliver 1. 0 ma despite being programmed to 3. 5 ma. It was also reported that the patient is experiencing an increase in seizures. Clinic notes dated (b)(6) 2013 were received. The clinic notes mention that the patient has vns and "sometimes it does work and there are other times where it will not work". The physician later clarified that this means that sometimes the magnet does not work to abort the patient's seizures and sometimes it does. High impedance was noted during this visit and the patient was having an increase in seizures. The clinic notes also mention that the patient's tremor is back, but not as severe as they used to be. The patient's guardian reported that the patient's seizures have changed and the patient has been experiencing more tremors in the last 2 years that the neurologist states are seizures. She states that sometimes the magnet works and sometimes it does not seem to help with breakthrough seizures. She did state that the patient is using different magnets than those provided for the vns. The caregiver mentioned that she believes that his seizures are overall better than baseline. The patient was referred for x-rays and surgery. The manufacturing records were reviewed for the lead and the device met all specifications prior to distribution. The physician later indicated that the increased seizures were first observed a couple of months ago but the high impedance was first observed on (b)(6) 2013. The physician stated that the increased seizures could be related to the vns. The physician has decided to have the device checked. The increase in seizures were noted to be below pre-vns baseline levels. The patient has been experiencing an increase in staring seizures. No causal or contributory programming changes, medication changes, or other external factors precede the onset of the increase in seizures. No patient manipulation or trauma occur that is believed to have caused or contributed to the event. The device was not disabled. Good faith attempts for the patient's lead product information from the implanting hospital were unsuccessful. Additional clinic notes were received dated (b)(6) 2013 that indicate the patient is having multiple seizures daily which include multiple different types of seizures. Vimpat was added along with depakote and keppra but despite these medications, the patient continues to have increased seizures. The patient underwent a full revision surgery on (b)(6) 2013 due to the high impedance and prophylactic generator replacement. The explanted generator and lead were returned for product analysis on (b)(4) 2013. Product analysis is still underway and has not yet been completed. A/p and lateral x-rays of the chest were received. The lead pins appeared to be fully inserted into the header of the generator. There was a portion of the lead located behind the generator that could not be assessed. There did not appear to be any lead discontinuities or sharp angles in the lead portion that was able to be visualized. Based on the x-ray images provided, an exact cause for the report of high impedance could be determined. However, a small portion of the lead could not be visualized in the chest due to it being behind the generator and a portion of the lead in the neck could not be visualized in the views available. Also, the presence of a micro-fracture in the lead cannot be ruled out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2986519


Title: Re: White Deposits
Post by: dennis100 on November 27, 2018, 07:53:20 AM
Model Number 102R
Event Date 05/20/2013
Event Type  Death   
Event Description
It was reported that the cause of death was due to seizure disorder as a result of a blunt force trauma from a motor vehicle accident. It was reported that the patient was still experiencing seizures at the time of death. It was unknown if the death was a result of a terminal seizure. The generator and lead were returned for analysis on (b)(6) 2013. The generator analysis was completed on (b)(4) 2013. In the pa 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. 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. The lead analysis was completed on (b)(6) 2013. Note that 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins 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, with no discontinuities identified.

Manufacturer Narrative

Event Description
A coroners office called to obtain a returned goods number for an explanted generator. It was reported that it can take up to a month to have the product returned. Thus far it has not been returned. At this time it is unknown the cause of the patient's death. Autopsy results are pending completion. The death was non traumatic but no other information known at this time. Good faith attempts will be made for more information as it becomes available for release.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3188401


Title: Re: White Deposits
Post by: dennis100 on December 01, 2018, 01:32:36 AM
Model Number 302-20
Event Date 06/21/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013 it was reported that the vns patient¿s vns lead was referred for replacement due to high lead impedance. Battery life calculations revealed that the vns generator had 0. 0 years left til end of service. Good faith attempts have been performed and it was later reported that the high impedance issue was first observed on (b)(6) 2013. The patient did not experience pain or any other adverse events. The office reported that their patient¿s vns devices are not turned off unless they are in pain. Thus, the patient¿s device was not changed to 0 ma. No x-rays were taken. No patient manipulation or trauma is believed to have caused or contributed to the high impedance. However, the physician was not able to provide a reason as to why the high impedance issue occurred.

Event Description
On (b)(6) 2013, it was reported that the patient had the vns generator and lead replaced on (b)(6) 2013. Diagnostics were performed which were all ok and the patient was interrogated prior to leaving the operating room to ensure the device was programmed off. However, when the patient came back into the office for a follow up visit, it was found that the device was turned on (reported in mfr #: 1644487-2013-02883). No other information was provided. The explanted device has not been returned.

Event Description
The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis the white (+) and green (-) ribbons appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the electrode ribbons from coming in contact with the vagus nerve; therefore contributing to the reported allegations. With the exception of the observed tissue-covered (+) white and (-) green electrode ribbons the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The slice marks found on the outer and inner silicone tubes 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 and inner silicone tubes. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur, chlorine and calcium. 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. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the high impedance. However the "as-received" condition of the helicals suggest they were not mounted on the vagus nerve during some portion of the implant life. The generator analysis was completed on (b)(4) 2013. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3242310


Title: Re: White Deposits
Post by: dennis100 on December 02, 2018, 01:40:17 AM
Model Number 302
Event Date 06/20/2013
Event Type  Malfunction   
Event Description
Generator and lead were received for analysis on (b)(4) 2013. Analysis of the generator was completed on (b)(4) 2013. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. Analysis of the lead is underway, but has not been completed to date.

Manufacturer Narrative
Device failure is suspected, but did not contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portions and the reported high impedance and lead fracture were confirmed. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 335mm portion the (-) connector pin and (+) connector ring quadfilar coils appeared to be broken. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 270mm) and identified the area on one of the broken quadfilar coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting on the coil surface. The area on another broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 284mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 abraded openings and slice marks found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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. 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. Canted spring marks were not observed on the rear end of the small o-ring. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device. 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.

Event Description
On (b)(6) 2013 it was reported that the vns patient¿s device had a lead fracture. A battery life calculation was performed with the available data. The result revealed 0. 0 years remaining until end of service = yes. The manufacturing records for the generator and lead were reviewed and device met all specifications prior to distribution. It was later reported that the lead fracture was identified on (b)(6) 2013 by x-ray. The patient was previously seen in 2012 and no lead impedance issues were noted. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fracture. Lead and generator were replaced on (b)(6) 2013. Attempts for return of the explanted devices are in progress.

Manufacturer Narrative
Device failure occurred, 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=3231930


Title: Re: White Deposits
Post by: dennis100 on December 02, 2018, 01:41:26 AM
Model Number 302-20
Event Date 05/01/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013 it was reported that the patient has high impedance and x-rays were performed that showed a clear lead break. The x-rays were not sent to the manufacturer for review. The patient underwent revision surgery that day. It was later reported that the high impedance was first observed in (b)(6) 2013. The patient¿s device was not programmed off despite the high impedance. No patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. The explanted lead and generator were returned to the manufacturer on (b)(4) 2013 for product analysis. Product analysis is underway and has not yet been completed.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
An analysis was performed on the returned lead portion. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 252 mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. During the visual analysis the end of the (+) connector ring quadfilar coil appeared to be broken approximately 29 mm past the end of the abraded open / cut outer silicone tubing. The (-) connector pin quadfilar coil extended approximately 192 mm past the end of the abraded open / cut outer silicone tubing and determination could not be made as to whether the end of the coil was pulled and cut. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 29 mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil (found at 192 mm) and identified the area on two of the coil strands as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism on these two coil strands. The area on a third coil strand was identified as having evidence of a stress induced fracture (tension overload). The fourth quadfilar coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process and the abraded opening observed on the connector ring inner silicone tubing. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium and sulphur. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portion of the device. The pulse generator was explanted and returned for product analysis due to prophylactic replacement. 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. The battery, 2. 942 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a-non ifi condition. The data in the diagaccumconsumed memory locations revealed that 21. 081% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

Event Description
Review of manufacturing records confirmed sterilization for lead prior to distribution. No nonconformances were observed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3232148


Title: Re: White Deposits
Post by: dennis100 on December 12, 2018, 01:47:08 AM
Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications 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 that the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% 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. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3357554


Title: Re: White Deposits
Post by: dennis100 on December 13, 2018, 04:12:12 AM
Model Number 300-20
Event Date 08/16/2013
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications and sterilization standards prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
It was reported that the patient had a full vns replacement surgery on (b)(6) 2013 due to a lead fracture. Device manufacturing records were reviewed. Review of manufacturing records confirmed both the generator and lead passed all functional tests prior to distribution. The explanted devices were returned for product analysis. Visual examination noted tool marks on the pulse generator case and header, most likely associated with manipulation of the device during the explant procedure. No other surface abnormalities were noted on this device. The septum was not cored. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. The lead was returned for the allegation of fracture of leads/explanted/due to lead break/high impedance. The lead assembly was returned in two portions and the electrodes and tie downs were not returned. Due to the condition of the lead as ¿ received, determining the marked connector verses the unmarked connector quadfilar coils could not be made during the visual analysis of the returned 132mm portion. Setscrew marks were observed on the marked and unmarked connector pins, providing evidence of a proper mechanical contact between conductive surfaces of both the generator and connect pin. White deposits were observed on the marked connector boot and what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas. An abraded opening was observed on the outer silicone tubing approximately 43mm-45mm from the connector bifurcation. A slice mark was observed on the outer tubing and penetrated the outer insulation, but the inner tubing did not appear to be damaged. On the returned 132mm portion what appeared to be remnants of dried body fluids were observed inside the outer silicone tubing in some areas and quadfilar coil 1 appeared to be broken approximately 20mm from the electrode bifurcation. Incisions were made to allow for sem photos. Continuity testing could not be performed during the decontamination procedure because the returned lead was not connected to a generator when received into pa. During the visual analysis of the returned 132mm portion quadfilar coil 1 appeared to be broken. Scanning electron microscopy was performed on the connector end of quadfilar coil 1 coil break (found at 20mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3347245


Title: Re: White Deposits
Post by: dennis100 on December 14, 2018, 06:08:37 AM
Model Number 302-20
Event Date 08/09/2013
Event Type  Malfunction   
Event Description
The generator and lead were returned for product analysis. The lead was returned for the allegation of high impedance and explanted due to lead break/high impedance. A section of the lead assembly was returned for analysis in one piece. The lead¿s electrodes were not returned for evaluation. Two 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. An opaque appearance was noted on the connector pin in the vicinity of the end tip. 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 connector ring has what appears to be flash extending from the small o-ring boot to the connector ring exposed area 0. 029 inches (max: (b)(4)). This was measured using calipers and a reticle. However, no adverse effect was identified on the device performance as a result of this condition. The lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were noted on the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. White deposits were identified on the outer silicone tubing at approximately 5. 6cm and 32. 6-32. 9cm from the end of the connector boot. The cut ends of the lead coils are located approximately 31. 5cm from the end of the connector boot. Abrasions most likely caused by the presence of a tie-down were identified at approximately 32. 6cm from boot. The outer silicone tubing appears to have been cut at approximately 33. 3cm from boot. The lead coils have a wavy appearance along the lead body. The outer silicone tubing appears to have been compressed at approximately 5. 6, 26. 6, and 27. 1cm from boot. The lead coils are kinked at approximately 25. 6cm from boot. The lead assembly has remnants of what appear to be dry body fluids inside the inner silicone tubing of the positive coil. No obvious point of entrance was identified other than the cut end of the returned lead portion. No discontinuities were identified within the returned lead portion. No obvious pitting was noted. No adverse effect was identified on the device performance as a result of this condition. The returned portion of the lead (connector included) measured approximately 37. 7cm in length. An analysis was performed and the allegations were not verified within the returned lead portion. Note that 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 above mentioned observations and typical wear and explant related observation, no anomalies were identified in the returned lead portion. The generator was returned for the allegation of device disabled due to a product issue and due to prophylactic replacement. Visual examination noted tool marks/dents on the pulse generator case most likely associated with manipulation of the device during the explant procedure. No other surface abnormalities were noted on this device. The septum was not cored. The generator performed according to functional specification. During the product analysis there were no anomalies found with the pulse generator.

Event Description
On (b)(6) 2013, it was reported that the patient was seen on (b)(6) 2013 and that high lead impedance was noted. Clinic notes dated (b)(6) 2013 state the patient's vns was turned off and it was recommended to obtain x-ray images. The notes also indicate that the patient's seizures have increased lately. A report for cervical x-rays performed on (b)(6) 2013 indicates the following: a left-sided neurostimulator is noted with the wires projected over the soft tissues of the left aspect of the cervical spine at the line of the c5 vertebral body. The visualized wires appear to be intact without evidence of fracture. Further impression include that there is no acute displaced fracture in the visualized portion of the cervical spine and that a short segment of the wires posterior to the stimulator are not well visualized. A report for chest ap/pa and lateral x-rays performed on (b)(6) 2013 notes that a neurostimulator is over the left chest and that the visualized wires appear to be intact. It is noted; however, that the proximal extent of the stimulator wires are not included on the radiograph. The wires posterior to the stimulator are not well visualized. The nurse practitioner followed-up to state that the x-rays report was normal. These x-ray images were not sent to the manufacturer for review. Replacement surgery was completed successfully on (b)(6) 2013. The device was programmed on to the prescribing physician's specifications. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3335733


Title: Re: White Deposits
Post by: dennis100 on December 15, 2018, 01:52:39 AM
Model Number 302-20
Event Date 07/03/2013
Event Type  Malfunction   
Manufacturer Narrative
Date of event, corrected data: the initial report indicated the high impedance occurred in (b)(6) 2013 however, additional information received revealed that the date of the high impedance is (b)(6) 2013. The information has been corrected in this report.

Event Description
A review of the data contained within the explanted generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2013 (2442 ohms to 10199 ohms) signifying the start of the high impedance event.

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
On (b)(6) 2013, it was reported that the patient was showing high lead impedance on diagnostics performed that day. The patient's settings were disabled during the visit after the high impedance was observed. The patient was referred for x-rays and the surgeon for replacement. Replacement surgery occurred on (b)(6) 2013. Clinic notes dated (b)(6) 2013 confirm that high impedance was seen. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Attempts have been made for additional information; however, they have been unsuccessful. No additional information has been provided.

Manufacturer Narrative
(b)(4).

Event Description
The explanted generator and lead were returned on 09/12/2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator was subjected to and successfully completed a final electrical test. The generator is operating within specification. Results of diagnostic testing indicated that the battery status indicated ifi=no. The data in the diagaccum consumed memory locations revealed that 36. 384% 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. The lead was returned for analysis due to allegation of high impedance/lead break. A section of the lead assembly was returned for analysis in one piece. The lead's electrodes were not returned for evaluation. Four 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 lead connector has partial detachment at the ring/backfill interface. The reason for this condition is unknown. No adverse effect was identified on the device performance as a result of this condition. Abrasions were identified on the connector boot. Abrasions were identified on the outer silicone tubing at multiple locations. The outer silicone tubing has what appear to be internal abrasions at multiple locations. The outer silicone tubing appears to have been compressed at multiple locations. The negative coil is covered with what appears to be organic matter in the vicinity of the anchor tether location. The organic matter was removed to perform proper inspection of the lead. White deposits were noted on the silicone tubing of the negative coil at approximately 0. 6cm past the anchor tether. A break was noted on the negative coil at approximately 0. 2cm past the electrode bifurcation. The negative coil has an opaque appearance at approximately 0. 1cm prior to the broken end. The lead assembly has remnants of what appears to be dry body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the ends of the returned lead portion. The reported high impedance/lead breaking allegations were verified. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil broken ends (including portion with an opaque appearance) and strand segments show that pitting or electro-etching conditions have occurred at the break location. However, due to metal dissolution, mechanical distortion (smoothed surfaces) and/or surface contamination the fracture mechanism cannot be determined. Note that since the closest and furthest electrode to the bifurcation were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3322939


Title: Re: White Deposits
Post by: dennis100 on December 16, 2018, 03:49:43 AM
Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. 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 abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.

Manufacturer Narrative
Device failure occurred, 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=3414511


Title: Re: White Deposits
Post by: dennis100 on December 16, 2018, 03:50:41 AM
Model Number 300-20
Event Date 01/01/2013
Event Type  Malfunction   
Event Description
It was reported that during lead replacement surgery device diagnostic testing resulted in high impedance (>= 10,000 ohms) prior to removing the generator from the lead. The generator was disconnected from the lead and generator diagnostics were within normal limits. The surgeon then replaced the lead and generator. A new system was implanted. The generator and lead were returned to manufacturer for analysis on (b)(4) 2013. The lead analysis was completed on (b)(4) 2013. During the visual analysis of the returned 203 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm from the end of the connector bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. 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 abraded opening, slice mark and cut out hole found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of explanted due to lead break/high impedance. The generator analysis was completed on (b)(4) 2013. Visual examination performed at the bench revealed scratches on the generator can and header most likely associated with manipulation of the device during the explant procedure. Burn marks were also observed on the pulse generator can and header indicating that the pulse generator may have been exposed to an electro-cautery tool. No other surface abnormalities were noted on this device. The generator is operating within specification. The generator was returned due no malfunction suspected/identified. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. 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
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure occurred, 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=3414519


Title: Re: White Deposits
Post by: dennis100 on December 29, 2018, 03:54:40 AM
Model Number 300-20
Event Date 11/06/2013
Event Type  Malfunction   
Event Description
Analysis of the generator was completed on (b)(4) 2013. The device performed according to functional specification. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2013. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 309mm portion the unmarked connector pin quadfilar coil appeared to be broken approximately 87mm and 98mm from the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector pin quadfilar coil break (and identified the areas as having evidence of being worn to the point of fracture with flat spots, pitting and residual material on the coil surface. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, iron, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
Event Description
It was reported that the patient underwent generator and lead replacement due to high impedance. It was reported that the generator was programmed off after observing the high impedance. It is unknown if any trauma or patient manipulation occurred that could have caused or contributed to the high impedance. X-rays were not taken. The generator and lead were received by device manufacturer for analysis on 11/21/2013. Analysis is underway, but has not been completed to date. The implant card was received and indicated that the lead was replaced due to a lead break.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3497158


Title: Re: White Deposits
Post by: dennis100 on December 29, 2018, 03:55:27 AM
Model Number 302-20
Event Date 11/06/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(6), 2013 it was reported that the patient underwent generator replacement that day and during surgery, high impedance was discovered. The patient was scheduled for a lead revision surgery on (b)(6) 2013. It was reported that the patient¿s generator had been prophylactically replaced on (b)(6)2013 and the lead replaced on (b)(6) 2013 due to the high impedance observed during the prophylactic generator replacement surgery. After replacement, system diagnostics showed results within normal limits. The explanted products have not been returned for product analysis to date. Generator replacement captured on mfr. Report # 1644487-2011-01493. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
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 the (-) connector pin quadfilar coil appeared to be broken approximately 172mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface. What appeared to be pitting was observed on one of the broke coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on one of the broken coil strands. 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 abraded opening and slice marks 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 abraded opening found on the (-) connector pin inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the (+) connector ring inner silicone tubing. What appeared to be white deposits were observed on one of the inner silicone tubes. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3494941


Title: Re: White Deposits
Post by: dennis100 on December 30, 2018, 05:24:33 AM
Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and abraded openings 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, 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=3577015


Title: Re: White Deposits
Post by: dennis100 on January 02, 2019, 02:18:11 AM
Model Number 300-20
Event Date 09/01/2013
Event Type  Malfunction   
Event Description
The physician reported that the patient may have an issue with the device, but no additional details were provided. It was later reported that the patient will be referred to surgeon for possible revision because the device showed high impedance and end of service. The patient underwent generator and lead replacement on (b)(6) 2013. The lead and generator were returned to manufacturer for analysis. An implant card was received indicating that the patient underwent lead and generator replacement due to "lead discontinuity". Analysis of the generator was completed on (b)(6) 2013. 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. Analysis of the lead was completed on (b)(6) 2013. Note that a portion of the lead assembly was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 344 mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 2 mm and 3 mm from the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 2 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and no pitting. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 3 mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. 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 abraded openings found on the outer and (-) unmarked inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the remnants of what appeared to have once been body fluids found inside the outer and (-) unmarked inner silicone tubing. For the observed (+) marked connector pin inner tubing remnants of what appeared to have once been body fluids found inside, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, zirconium, sulphur and calcium. Refer to attached eds sheet for additional information. The slice and puncture marks observed on the inner silicone tubes (past the electrode bifurcation) appeared to have been made by a sharp object which could have occurred during the explant procedure, however this cannot be confirmed. With the exception of the observed discontinuities, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
Manufacturer Narrative
Device failure occurre, 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=3551516


Title: Re: White Deposits
Post by: dennis100 on January 08, 2019, 06:16:48 AM
Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. 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. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. The abraded openings 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 the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur and calcium. 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. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3709847


Title: Re: White Deposits
Post by: dennis100 on January 08, 2019, 06:17:51 AM
Model Number 302-20
Event Date 12/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The explanted devices are expected to be returned to manufacturer for analysis, but have not been received to date.
 
Event Description
An implant card was received that corrected the date of explant.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). It was reported that the diagnostics were within normal limits in (b)(6) 2013 and that the patient started to experienced an increase in seizures in (b)(6). The device was programmed off and the patient was sent for x-rays. It was reported that it is unsure if any trauma occurred that could have caused or contributed to the high impedance, but that the patient experiences drop attacks and the high impedance may be trauma related. It was reported that the seizures were back to pre-vns baseline frequency. The patient was referred to surgery. Surgeon noted that x-rays did not identify a clear lead break, but that the images would be sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the lead. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator was completed. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. 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
The generator and lead were received for analysis. Analysis of the lead was completed on 06/12/2014. The lead assembly was returned intact. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 322mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist 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. Analysis of the generator is underway, but has not been completed 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3606987


Title: Re: White Deposits
Post by: dennis100 on January 10, 2019, 01:12:24 AM
Model Number 302-20
Event Date 03/28/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, 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 manufacturer, no gross lead discontinuities visualized. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include that x-rays were received that were pending review.
 
Event Description
Analysis of the generator was completed on 09/23/2014. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. Analysis of the lead was completed on 09/23/2014. 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 portions of the returned lead assembly appeared to be compressed and twisted and numerous abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 216mm portion quadfilar coil 1 appeared to be broken approximately 32mm and 36mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 32mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with pitting. Determination could not conclusively be made on the fracture mechanism. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 1 coil break (found at 36mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that the vns patient visited the hospital due to an increase in seizures above pre-vns baseline levels. The physician reported that the event was related to vns stimulation. The patient¿s device was tested and system diagnostic results revealed high lead impedance (dc dc ¿ 6). The patient¿s device was not programmed off. X-rays and emg were planned but it is unknown it they have been taken to date. Patient manipulation or trauma is not believed to have caused or contributed to the high impedance. The patient had multiple seizure types that all increased. The seizure type, duration of the seizures, post-ictal period, and auras did not change. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013. No known interventions have occurred to date. Attempts for additional relevant information were made but have been unsuccessful to date.
 
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) /2014 due to lead discontinuity which was reportedly visualized near the lead pin. It was noted that the patient¿s generator was not fixed with a non-absorbable suture, so the generator may have turned while implanted. The patient¿s replacement device was programmed on to previous device settings. The explanted generator and lead were returned to the manufacturer where analysis is currently underway.
 
Event Description
X-rays were provided to the manufacturer on (b)(6) 2014. X-rays dated (b)(6) 2014 were provided to the manufacturer for further review. The generator appears in the left chest in a normal placement. The filter feed-through wires appear to be intact. The lead connector pin appears fully inserted into the generator connector block. The electrodes appeared to be placed in normal arrangement. Part of the lead was behind the generator and could not be assessed. No clear lead breaks or sharp angles were found in the parts of the lead that could be assessed. Based on the images provided, the cause high lead impedance remains unknown. No known interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3772194


Title: Re: White Deposits
Post by: dennis100 on January 11, 2019, 01:38:17 AM
Model Number 302-20
Event Date 03/26/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of the available programming and diagnostic history. Describe event or problem, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Relevant tests/laboratory data, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history. Evaluation codes, including dates, corrected data: the initial manufacturer report inadvertently did not include the review of the available programming and diagnostic history.
 
Event Description
Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.
 
Event Description
It was reported that during generator replacement for end of service, high impedance (9225 ohms) was seen when the new generator was attached to the existing lead. It was reported that interrogation of the device prior to surgery was unsuccessful and the high impedance was not observed until the new generator was attached. The surgeon went to explant the lead and observed that the tubing was "stripped back and exposed down to the wire". The surgeon was unclear if any trauma caused the damage. It was reported that the patient was recently mugged which resulted in bruising; however, it is unknown if this may have caused or contributed to the high impedance. The lead was explanted (leaving electrodes) and a new lead was placed. Diagnostics with the new generator attached to the new lead were within normal limits (1556 ohms). The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2014. Note that the (+) white and (-) green electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer silicone tubing. During the visual analysis of the returned 292mm portion the (-) connector pin quadfilar coil appeared to be broken approximately 282mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material. The two remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. One of the broken coil strands was identified as having evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. During the visual analysis of the returned 146mm portion the end of the (-) green electrode quadfilar coil appeared to be broken approximately 31mm from the end of the abraded open / cut outer silicone tubing. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Determination could not conclusively be made on the fracture mechanism. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. The abraded openings 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur and calcium. With the exception of the observed discontinuities and abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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. Analysis of the generator was completed on (b)(4) 2014. The pulse generator module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device.
 
Manufacturer Narrative
Failure occurred, 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=3771292


Title: Re: White Deposits
Post by: dennis100 on January 12, 2019, 01:47:23 AM
Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with 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 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
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
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3751483


Title: Re: White Deposits
Post by: dennis100 on January 23, 2019, 01:20:13 AM
Model Number 300-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis was completed on the generator but has not been completed on the lead. In the pa 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. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 945 volts, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 14. 910% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the lead. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on the (-) unmarked connector inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, sulphur, chlorine and calcium. Refer to eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to high 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.
 
Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that the patient was reporting an increase in seizures. It was noted that the patient suffers from drop attacks which are believed to be due to the high impedance. It was reported that the drop attacks are normally controlled with vns. There was no recent trauma and the patient did not manipulate the device through the skin. The patient underwent generator and lead replacement. The explanted devices are expected to be returned for analysis, but have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3907422


Title: Re: White Deposits
Post by: dennis100 on January 23, 2019, 01:21:03 AM
Model Number 302-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. It was reported that x-rays were taken and did not identify any lead discontinuity; however, a portion of the lead was not visible. The patient was seen again and subsequent device diagnostics resulted in high impedance (dc dc code - 7). The device was programmed off and the patient was referred for surgery. No surgical intervention has been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The explanted lead and generator were received for analysis. Analysis of the generator was completed on 01/07/2015. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on 01/09/2015. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 233mm and 241mm from the end of the connector boot. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 233mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the (+) connector ring quadfilar coil break (found at 241mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on two of the broken coil strands. The remaining broken coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. 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 abraded openings found on the outer and 1 inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium, magnesium, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Follow-up revealed that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014 due to high impedance. The explanted devices have not been returned to date.
 
Event Description
Additional information was received stating that the vns patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 7).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3909752


Title: Re: White Deposits
Post by: dennis100 on January 27, 2019, 05:01:40 AM
Model Number 300-20
Event Date 03/14/2014
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014. Analysis of the returned lead is currently underway.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance event occurred at least on (b)(6) 2014.
 
Event Description
It was reported that pre-operative diagnostics for generator replacement surgery resulted in high impedance. It was reported that the patient's device was interrogated for the first time in several years. It was reported that both the generator and lead were replaced. The patient was in a motor vehicle accident in 2012; however, it was unknown if this contributed to the high impedance. An implant card was received indicating that the generator and lead were replaced due to lead discontinuity (>10,000 ohms) and near end of service. It was reported that the explanted devices were discarded by the explanting facility; therefore, no analysis can be performed.
 
Event Description
Analysis of the lead was completed on 10/09/2014. 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 of the returned 88mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 13mm past the end of the torn connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, pitting on two of the broken coil strands, no pitting on one of the broken coil strands and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (-) unmarked connector quadfilar coil appeared to be broken approximately 2mm and 4mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 2mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on two of the broken coil strands. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 4mm) and identified the area three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 4mm from the end of the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on three of 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. The abraded openings 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 the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on one of the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur, chlorine and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.
 
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=3981871


Title: Re: White Deposits
Post by: dennis100 on January 28, 2019, 05:02:15 AM
Model Number 302-30
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were received for analysis. Generator analysis was completed on 12/08/2014. 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. Analysis of the lead is underway, but has not been completed to date.
 
Event Description
Analysis of the lead was completed on 12/11/2014. 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 the (-) connector pin quadfilar coil appeared to be broken approximately 2. 5mm from the electrode bifurcation (and the coil appeared to be kinked). The (+) connector ring quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 2. 5mm) and identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 3mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. 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 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. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 note that interrogation of the device showed high impedance and was verified with a second interrogation. The patient was referred for surgery. No known surgical intervention has been performed to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4106898


Title: Re: White Deposits
Post by: dennis100 on February 01, 2019, 11:20:11 AM
Model Number 300-20
Event Date 09/01/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient¿s generator was turned off and the patient was referred for surgery. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 986 volts as measured shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 2. 444% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Note that a large portion of the lead assembly (body) including the (+) white electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 91mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 238mm past the end of the cut / torn / connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine 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 abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since a large portion of the lead assembly (body) including the (+) white electrode 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=4198813


Title: Re: White Deposits
Post by: dennis100 on February 04, 2019, 01:11:20 AM
Model Number 302-20
Event Date 10/21/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
On (b)(4) 2014, product analysis was completed on the generator. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the battery was partially depleted. The partially depleted battery condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the lead was completed on 12/3/2014 which confirmed discontinuity of quadfilar coil (unknown polarity) in the electrode region of the returned lead portions; also observed abraded openings of both outer and inner tubing in body region of lead. A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 41mm portion quadfilar coil 1 appeared to be broken approximately 18mm from the end of the electrode bifurcation. Scanning electron microscopy was performed on the connector end of the quadfilar coil 1 coil break (found at 18mm) and identified the area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type and no pitting. The remaining broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type with pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture. Scanning electron microscopy was performed on the electrode (mating) end of the quadfilar coil 1 coil break (found at 18mm) and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. 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 abraded open / cut and slice marks observed on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy -provides chemical or element identity/composition analysis) was performed and identified the deposit as containing phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.
 
Event Description
Clinic notes dated (b)(6) 2014 reported that the patient's device was unable to be interrogated due to "not-functioning. " the physician¿s office attributed the failure to interrogate to normal end of service which was substantiated by battery life calculation results of 0 years remaining until neos condition at that time in (b)(6) 2014. The notes also reported that the patient¿s seizures were ¿recurring. ¿ it was noted that sometimes the patient does not take her anti-seizure medication regularly. The patient was seen for surgical consult for generator replacement on (b)(6) 2014, and the surgeon was able to perform diagnostics at which time high lead impedance was discovered. The patient had surgery on (b)(6) 2014. Pre-operatively, system diagnostic test was performed and results were high lead impedance. After the generator was replaced, high lead impedance still was observed. Therefore, the lead was also replaced. After the lead was replaced, diagnostics were within normal limits. The explanted devices were returned to the manufacturer for analysis, but analysis has not completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4247650


Title: Re: White Deposits
Post by: dennis100 on February 06, 2019, 01:19:38 AM
Model Number 104
Event Date 11/11/2014
Event Type  Death   
Event Description
Analysis of the lead was completed on 12/15/2014. Note that 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Analysis of the generator was completed on 12/16/2014. 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
It was reported that the vns patient passed away. The funeral home indicated that the patient passed away at home and no autopsy would be performed. The cause of death was noted to be intracerebral hemorrhage. The device was explanted and received for analysis. Analysis is underway, but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4320656


Title: Re: White Deposits
Post by: dennis100 on February 13, 2019, 01:13:16 AM
Model Number 302-20
Event Date 01/23/2015
Event Type  Malfunction   
Event Description
The explanted lead was returned for analysis on (b)(4) 2015. Product analysis for the lead was completed and approved on (b)(4) 2015. An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The bare and exposed conductive coils may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes. The quadfilar coils appeared to be stretched, kinked and bare, in some areas. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist 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.
 
Event Description
It was reported that device diagnostics resulted in low impedance (<600 ohms) and that the patient has experienced worsening seizures. The patient was referred for lead replacement. The patient underwent lead replacement on (b)(6) 2015. It was reported that device diagnostics with the new lead and existing generator were within normal limits. The explanted lead has not been received for analysis to date. No additional relevant information has been received 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.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4531971


Title: Re: White Deposits
Post by: dennis100 on February 15, 2019, 02:57:59 AM
Model Number 302-20
Event Date 02/12/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes received (b)(4) 2015 and dated (b)(6) 2015 state that the patient is being seen for vns surgery, possible battery replacement. Notes state that the device worked well for several years then ¿stopped. ¿ battery interrogated and battery is dead. The patient was seen to discuss replacing the vns generator and electrodes. The patient underwent a full replacement on (b)(6) 2015. The generator and lead were received on (b)(4) 2015. Analysis is underway but has not been completed to date.
 
Event Description
Clinic notes dated (b)(6) 2015 were received. The notes state that the patient reports breakthrough spells and seizures.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
Product analysis for the generator was completed and approved on 06/16/2015. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead was completed and approved on 06/25/2015. The lead assembly was returned for analysis and a break was identified in the positive coil. Scanning electron microscopy images of the positive coil ends and strand segments found in the organic matter show that pitting or electro-etching conditions have occurred at the break locations. Also, images of the suspected positive coil mating end and some of the strand segments show what appears to be wear (flat surfaces) on the coil strands. An abrasion was noted on the connector boot. White deposits were noted at the end of the connector boot. Abrasions were noted on the outer silicone tubing at multiple locations. The outer silicone tubing has a compressed appearance at multiple locations. A portion of the lead assembly is covered with what appears to be organic matter. The inner silicone tubing of the negative coil is abraded. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
On (b)(6) 2015 programming history was reviewed, and high impedance was observed. On (b)(6) 2004 (adjusted date (b)(6) 2013) the device was interrogated and a system diagnostic was performed and resulted in high lead impedance. No further programming history is available.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4627813


Title: Re: White Deposits
Post by: dennis100 on February 20, 2019, 11:17:23 AM
Model Number 302-20
Event Date 03/12/2015
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
The suspect lead was received by the manufacturer. Analysis of the device is underway but it has not been completed to date.
 
Event Description
It was reported that the vns patient had undergone a lead replacement due to lead discontinuity. It was reported that the impedance of the new lead was within normal ranges, dcdc code 1. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted device has not been returned to date.
 
Event Description
Analysis of the returned portion of the lead was completed and found that the quadfilar coil 1 appeared to be broken approximately 26mm and quadfilar coil 2 appeared to be broken at approximately 30mm from the end of the cut outer-inner silicone tubes. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the detached portion from quadfilar 1 coil break (found at 26mm) and identified the area on one end as having extensive pitting which prevented identification of the coil fracture type. The areas on two of the broken coil strands, on the opposite side were identified as being mechanically damaged which prevented identification of the coil fracture type with pitting. The areas on the remaining two broken coil strands were not visible due to the positioning on the fixture. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break and identified mechanical damaged which prevented identification of the coil fracture type, no pitting and flat spots on 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 and slice marks and abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4705248


Title: Re: White Deposits
Post by: dennis100 on February 21, 2019, 11:32:26 AM
Model Number 300-20
Event Date 03/02/2015
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient underwent generator and lead replacement surgery on (b)(6) 2015 due to a reported lead fracture and battery depletion. Attempts for additional relevant information have been unsuccessful to date. The explanted devices were returned to the manufacturer. Analysis is underway, but it has not been completed to date.
 
Event Description
It was reported that the patient¿s vns system showed high impedance. It was reported that x-rays would be taken, but they have not been provided to the manufacturer to date. No known surgical interventions have occurred to date.
 
Event Description
Analysis of the lead confirmed a discontinuity of the negative quadfilar coil in the electrode region of the returned lead portions. The unmarked connector pin quadfilar coil appeared to be broken. Four broken coil strands were identified with two showing evidence of a stress induced fracture with mechanical damage and fine pitting. The area on a third was identified as being mechanically damaged. Flat spots and pitting were 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. 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. White deposits were found in various sites which contained silicon, phosphorus, sodium, magnesium, chlorine, aluminum, sulphur and calcium. With the exception of the observed discontinuity, the returned lead portion shows a condition that is consistent with an explant procedure. No other obvious anomalies were noted. Analysis of the generator found that the battery was at end of service due to normal battery depletion. The device exhibited current consumption rates that are within specification. The pulse generator module performed according to functional specifications.
 
Manufacturer Narrative
Describe event or problem ; corrected data: the previously submitted mdr inadvertently provided an incorrect event description.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4686639


Title: Re: White Deposits
Post by: dennis100 on February 25, 2019, 01:21:14 AM
Model Number 302-20
Event Date 04/14/2015
Event Type  Malfunction   
Event Description
It was reported that device diagnostics resulted in high impedance. The patient was referred for surgery. Clinic notes dated (b)(6) 2015 note that the patient has experienced a dramatic increase in seizures since the last office visit. It was noted that there was an increase in device impedance and that may be why the patient is having increased seizures. It was reported that there is no known trauma or patient manipulation that may have caused the high impedance. It was reported that the seizures were above the patient's pre-vns baseline frequency. No known surgical interventions have been performed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
The patient underwent generator and lead replacement due to high impedance. The explanted generator and lead were received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the returned generator was completed on (b)(4) 2015. The generator performed according to functional specifications. Analysis in the product analysis lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2015. 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 the (-) connector pin quadfilar coil appeared to be broken approximately 306mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material. 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. During the visual analysis the (+) connector ring quadfilar coil appeared to be stretched and kinked approximately 273mm past the end of the cut / torn inner silicone tubes with a spot-weld / slug attached to the end. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. The abraded openings and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the (-) connector pin inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. For the observed dried remnants of what appeared to have once been body fluids found inside the (+) connector ring inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist 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 portion were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4757575


Title: Re: White Deposits
Post by: dennis100 on February 26, 2019, 01:21:01 AM
Model Number 300-20
Device Problems Corroded ; Fluid Leak; Connection Problem
Event Date 05/12/2012
Event Type  Malfunction   
Event Description
Product analysis (pa) for the returned generator was completed. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications, with the exception of the test "backup cap neg to can", which has already been captured in mfr. Report 1644487-2017-03534. There were no additional performance or any other type of adverse conditions found with the generator. Pa for the returned lead was completed. Allegations of lead fractures were confirmed. The electrodes were not returned for analysis; therefore, a complete evaluations could not be performed on the entire lead product. During the visual analysis, the outer silicone tubing appeared to be twisted and compressed in several areas. Fractures were identified and scanning electron microscopy found that they were stress induced fractures. Additionally, pitting was observed on the surface of some of the breaks. Abraded openings 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on one of the deposits and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. With the exception of the observed discontinuities and the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. Based on the findings in the pa lab, there is evidence to suggest discontinuities in the returned portion of the device, which may have contributed to the stated allegations of lead fractures. Note that since the electrode array section was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported the patient has been referred for replacement surgery; however, no surgical intervention has taken place to date.
 
Event Description
Clinic notes dated (b)(6) 2015 note that the patient and her mother feel that the vns was injured or disconnected the year prior and that device diagnostics were within normal limits. It was noted that there was a tightness in the lead that the neurologist was concerned about. The surgeon noted that there is no unusual tightness of the lead. An x-rays assessment was received indicating that the lead wire was disconnected from the device in the left neck. It was reported that device diagnostics performed on (b)(6) 2014 were within normal limits (1704 ohms). The neurologist believes that scar tissue is the reason for the lead tightness feeling that the patient experiences. The neurologist indicated that the patient's parents have asked for the generator and lead to be replaced. X-rays were sent to manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes. It was later reported that high impedance was observed and that revision surgery was planned. A fluoroscopy was performed by the surgeon who found that the lead could not be seen clearly and concluded that the lead may have never been connected. Recent diagnostics were found in the physician's programming system that showed that device diagnostics were within normal limits at one time which showed that the device was at one time connected. The patient was seen on (b)(6) 2015 at which time device diagnostics were within normal limits. It was reported that the device was functioning normally and was programmed back on. The cause of the diagnostics being within normal limits is a believed short circuit situation with the patient's tissue. A device decoder was performed which identified that the lead break likely occurred as early as (b)(6) 2012. The patient was referred back to surgeon. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently reported incorrectly on initial mfr. Report.
 
Event Description
The explanted generator and lead were received by the manufacturer on 03/02/2017. While analysis is expected, it has not been completed to date.
 
Event Description
Additional x-rays were sent to the manufacturer for review. X-rays identified that the lead appeared to be fractured near the electrodes confirming a lead break.
 
Event Description
The patient underwent a full vns revision on (b)(6) 2016. It was noted when the lead was removed, it appeared to be fractured and the lead wires were twisted together. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4749594


Title: Re: White Deposits
Post by: dennis100 on March 13, 2019, 12:23:01 AM
Model Number 300-20
Device Problems Break; Calcified
Event Date 08/05/2015
Event Type  Malfunction   
Event Description
Product analysis for the returned lead was completed. It was noted that a portion of the lead assembly, including the electrodes, was not returned for analysis. White deposits were observed in various locations. The deposits were analyzed with energy dispersion spectroscopy which identified silicon, phosphorus, sodium, magnesium, and calcium. During visual analysis, three areas of the coil strands were identified as having the appearance of being melted, with re-solidified material. Based on obvious signs of mechanical damage on the coil surface, it is possible the thermally-damaged coil was exposed to a high temperature device such as a cauterizing tool during the explant of the lead. There were also two stress-related fractures noted on the lead. The stress fractures were due to rotational forces, which most likely completed the fracture with mechanical damage. A third region of the coil appeared to be stretched, kinked, and extended past the end of the cut/torn outer and inner silicon tubes. Determination could not be made if the end was cut. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the marked connector pin, indicating the lead had not been fully inserted into the cavity of the generator at one time. However, additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. The setscrew marks on the unmarked 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 discontinuity was identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the lead.
 
Event Description
Both the lead and the generator were received by the manufacturer. Product analysis for the returned vns generator showed the generator was noted to perform according to functional specifications. Analysis of the vns generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis for the lead is expected but has not been completed to date.
 
Event Description
It was reported the lead was found encapsulated by calcification at the site of the vns generator. When the generator was removed from the pocket, the lead was found to be damaged. Due to the lead damage, the lead was replaced. It was reported the vns device was tested during the pre-operative evaluation and no high impedance was noted. The suspect device is expected to be returned, but has not been received to date.
 
Manufacturer Narrative
Evaluation, results and conclusions; corrected data: this information was inadvertently left off of the supplemental #02 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5051717


Title: Re: White Deposits
Post by: dennis100 on March 14, 2019, 03:55:15 AM
Model Number 302-20
Device Problem Kinked
Event Date 09/28/2015
Event Type  Malfunction   
Event Description
It was reported the lead was replaced due to an observed kink during surgery. The vns generator was replaced due to normal battery depletion. Both the lead and the generator were received for analysis. Analysis is expected, but has not been completed to date. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Product analysis for the generator was completed. It was found that the generator was at the eos (end of service) condition. The depletion was an expected event as determined by the battery life calculation and the battery voltage measurement. There device performed according to specifications.
 
Event Description
Product analysis was completed on the returned portion of the lead. Analysis of the returned portion of the lead determined that the report of a kinked lead was not verified. However, a large 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. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. What appeared to be white deposits were observed in various locations. Chemical analysis was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicone. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins 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 and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5176644


Title: Re: White Deposits
Post by: dennis100 on March 14, 2019, 03:56:14 AM
Model Number 102
Device Problem Entrapment of Device
Event Date 09/21/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that during a near end-of-service battery replacement surgery, a calcified tissue was identified on the upper right portion of the generator can, below the header. The surgeon suspected that the area with calcification was a result of corrosion. The calcified tissue was chipped away from the generator. Systems diagnostics at pre-surgery and during surgery were reported to be within normal limits. There was no tissue located at the header or the welded seam of the generator can. No infection was noted in the area. The product has been received for analysis, which has not been completed to-date.
 
Event Description
Analysis was completed on the returned generator. Other than typical explant procedure related observations, no surface abnormalities, such as sharp edges, header delamination, open pockets, decomposition, corrosion, or voids were noted on this device. There were white deposits on the can. A scanning electron microscopy analysis of the foreign matter indicated that it was calcium and phosphorus. There was no evidence of dried body fluid or corrosion in the connector block. There was no indication from the device that an end of service condition existed. A battery life calculation resulted in 0. 50 years remaining before the elective replacement indicator flag would be set. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5159392


Title: Re: White Deposits
Post by: dennis100 on March 14, 2019, 03:57:03 AM
Model Number 302-20
Device Problem High impedance
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns device diagnostics resulted in high impedance. A dc-dc code 7 was observed during the normal mode and system mode diagnostic tests. No patient adverse events were reported. It was reported that the patient's device was turned off on (b)(6) 2015. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. It was reported that the lead was replaced due to lead break and the generator was prophylactically replaced. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits. Return of the explanted lead to the manufacturer is expected but it has not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
The explanted lead was returned to the manufacturer on (b)(6) 2015. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis was completed on the returned lead portions and the reported allegations was confirmed. Note that the anchor tether, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils 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 417mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 12mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type with residual material. The remaining broken coil strands was identified as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type. 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 abraded openings 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. What appeared to be white deposits were observed on the inner silicone tubing of the returned 14mm portion. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. 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. 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 portions were performed, during the visual analysis, with no discontinuities identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5182911


Title: Re: White Deposits
Post by: dennis100 on March 16, 2019, 12:15:20 AM
Model Number 302-30
Device Problems Break; High impedance
Event Date 05/17/2015
Event Type  Malfunction   
Event Description
It was reported by the neurologist the patient was scheduled for vns surgery as the vns was checked showing high impedance and it is unsure if the lead pin is out or if a new lead needs to be placed. It was also reported the patient's device was turned off on (b)(6) 2015. It was later reported the patient underwent surgery on (b)(6) 2015 and the lead and the generator were both replaced. The lead was replace due to high impedance and the generator was prophylactically replaced. Additionally, it was reported there was a lead break at the strain relief bend, right by the tie down. It was also clarified the generator was replaced prophylactically as the physicians were unclear how long the device had been broken and were not comfortable using the old device due to the broken lead and risk of infection from taking the generator out, then putting it back in after removing and replacing with the new lead. The lead and the generator were received. Analysis is expected but has not been completed to date.
 
Event Description
Product analysis found that the high impedance most likely occurred on (b)(6) 2015 as the impedance value was noted to have changed from 1224 ohms to 11619 ohms on that date. It was found through testing that the generator performed according to functional specifications. The final electrical test shows and ifi = no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions and lead fractures were confirmed. It should be noted that portions of the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Fractures were found on all three coil strands. One of the coils had extensive pitting that prevented identification of the fracture type. It was noted that all three broken coil strands were mechanically damaged which prevent identification of the fracture type, with evidence of a stress induced fracture, which most likely completed the fracture on all three broken coil strands. One of the coil strands was identified as having evidence of a stress induced fracture with mechanical damage and pitting. Determination could not conclusively be made on the fracture mechanism. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the outer silicone most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. White deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, and calcium. It was found that the returned white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the white electrode ribbon from coming in contact with the vagus nerve. With exception of the observed discontinuities and the tissue covered white electrode ribbon, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Based on the findings in the product analysis lab, there is evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the stated allegations.
 
Manufacturer Narrative
This information was inadvertently left off of supplemental #01 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5126663


Title: Re: White Deposits
Post by: dennis100 on March 19, 2019, 12:23:52 AM
Model Number 300-20
Device Problem High impedance
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures. A system diagnostic test was later performed for patient and high impedance with dcdc 7 was observed. Additional information was obtained that the patient was discharged then re-admitted due to a generalized seizure. Patient was referred for replacement surgery and underwent full revision surgery on (b)(6) 2015. The explanted products are expected to be returned but have not been received to date.
 
Event Description
Generator and lead were returned due to lead discontinuity and were received on 11/30/2015. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Analysis of the lead is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of ¿fracture of leads and high impedance¿ were confirmed. A portion of inner silicone tubing and quadfilar coil between the electrode bifurcation and anchor tether was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. Scanning electron microscopy was performed on the area of the break on quadfilar coil 1; the remaining coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Flat spots and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break area and the area was identified as having extensive pitting which prevented identification of the coil fracture type. Flat spots and 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 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5246076


Title: Re: White Deposits
Post by: dennis100 on March 23, 2019, 12:15:08 AM
Model Number 302-20
Device Problem High impedance
Event Date 11/23/2015
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system on (b)(6) 2015. It was reported that the patient underwent generator replacement surgery on (b)(6) 2015 for prophylactic reasons. The diagnostic results in or and since have been good (dcdc 2), until on (b)(6) 2015 where the normal and system diagnostic testing showed high impedance (dcdc 7). X-rays were taken and sent to the manufacturer for review. The generator appears to be placed in the upper chest in normal arrangement. The pin connector is fully inserted. The electrodes appeared to be placed in normal arrangement. Strain-relief bend and loop seemed to have been used. One tie-down was found (visible) holding the lead but not as specified in labeling. A portion of lead behind the generator could not be assessed. No suspected lead break was found on the visible part of the lead. It was reported that the device was turned off on (b)(6) 2015. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. The patient's vns system was tested upon connection of the new lead to the new generator and system diagnostics returned impedance results within normal limits with was 1345 ohms. It was reported that the generator was replaced due a generator issue. This event is reported in the medwatch number 1644487-2016-00042. Return of the explanted devices to the manufacturer is expected but they have not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer on 01/08/2016. Analysis of the returned lead portions was completed and the reported allegations were confirmed. During the visual analysis of the returned 218mm portion quadfilar coil 2 appeared to be broken approximately 194mm from the end of the cut outer / inner silicone tubes. Scanning electron microscopy (sem) was performed on the connector end of the quadfilar coil 2 coil break (found at 194mm) and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on one of the broken coil strands. The area on the remaining broken coil strands was identified as having evidence of a stress induced fracture with mechanical damage and no pitting. Determination could not conclusively be made on the fracture mechanism. Flat spots were observed on the coil surface. Sem was performed on the electrode (mating) end of the quadfilar coil 2 coil break (found at 194mm) and identified the area as being mechanically damaged (smooth surfaces) which prevented identification of the coil fracture type. Flat spots and pitting were 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy provides chemical or element identity/composition analysis) was performed on the deposit observed on the connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5297221


Title: Re: White Deposits
Post by: dennis100 on March 24, 2019, 01:18:06 AM
Model Number 302-20
Device Problems Corroded ; Fluid Leak; High impedance
Event Date 11/11/2015
Event Type  Malfunction   
Event Description
It was reported on 11/11/2015 that the patient had an end of service replacement that day. The physician was unable to interrogate the generator. When the new generator was connected to the existing lead, high impedance was observed around 8000 ohms. The lead was disconnected and reinserted. The physician verified that the lead pin was advanced beyond the connector block and the set screw was tightened down. Impedance was measured again and the value was over 8000 ohms. The surgeon was not able to replace the lead that day. The old lead remained connected to the new generator and the generator was left at 0. 0 ma. The explanted generator was discarded after surgery. Replacement of the lead is expected but has not been completed to date.
 
Event Description
It was reported on (b)(6) 2015 that the patient had a follow-up appointment on (b)(6) 2015 and the patient no longer has high impedance. Since intermittent impedance or a microfracture cannot be ruled out, the patient's device may still be malfunctioning. No additional relevant information has been received to date.
 
Event Description
Programming history database was reviewed on (b)(6) 2016 for the recently received model 106 generator data. History was available from date of implant, (b)(6) 2015. The system diagnostics were performed 5 times and each time resulted in high impedance. (b)(6) 2015: 8:41:57 am - ok/ok/8894/ok; (b)(6) 2015: 8:43:15 am - ok/ok/8523/ok; (b)(6) 2015: 8:47:17 am - ok/ok/9039/ok; (b)(6) 2015: 8:55:56 am - ok/ok/9026/ok; (b)(6) 2015: 8:56:38 am - ok/ok/5980/ok.
 
Event Description
Information was received 08/08/2017 that the patient¿s device was found to have high impedance in the 6,000 ohms range. X-rays were received and reviewed but could not conclusively identify a cause of the high impedance.
 
Event Description
X-rays were received and review showed there is a sharp angle in the lead body observed just proximal from the generator implant site. Full revision surgery occurred. Impedance was high in pre-op. The surgeon removed the battery and re-inserted the pin but the impedance was still high. The battery was tested alone with the test resistor, and the impedance was within normal limits. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
Further information was received that both the generator and lead were returned to the manufacturer. Product analysis was completed on both products. Analysis on the generator did not find any anomalies. The generator performed according to all specifications, and besides markings associated with explant, no visual abnormalities were noted. Data from the generator was also reviewed. High impedance was seen on the day of explant. Product analysis on the lead identified multiple coil breaks along the returned lead body. Scanning electron microscopy was performed and identified some areas as being mechanically damaged which prevented identification of the coil fracture type. Scanning electron microscopy also identified some of the fractures of being stress induced by fatigue or rotational stress. Pitting was also observed on some of the various broken coils indicating stimulation was likely present at one point. Residual material was observed on one of these broken coils. Multiple abraded openings were also noted on the outer tubing. There were also areas of abraded openings in the inner tubing near some of the fractures. This allowed fluid to breach the inner and outer tubing. White deposits were also noted along the lead body. With the exception of the observed abraded openings and discontinuities the condition of the returned lead portions was consistent with conditions that typically exist 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. The electrodes were not returned and analysis could not be completed on that portion of the lead. No further relevant information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5260887


Title: Re: White Deposits
Post by: dennis100 on March 24, 2019, 01:19:05 AM
Model Number 302-20
Device Problem High impedance
Event Date 10/23/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the patient had an appointment that day and system diagnostics were run with results of high impedance. The device was programmed off the day the high impedance was observed. No x-rays are scheduled at this time. They do not suspect that there was any trauma or manipulation. The patient had a full replacement on (b)(6) 2015. It was reported that the negative electrode was detached from the lead. Attempts for product return have been made, but the explanted device has not been received to date.
 
Event Description
Information received on 12/01/2015 indicated that the explanted device was discarded after surgery and is therefore unavailable for analysis.
 
Event Description
Generator and lead were received for analysis on 02/10/2016. Product analysis for the generator was completed and approved on 02/29/2016. From the generator decoder received from the device, the change in impedance from 5058 ohms to 6448 ohms occurred on (b)(6) 2015. In the 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. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead has not been completed to date.
 
Event Description
Product analysis for the lead was completed and approved on 03/07/2016. Note that portions of the (+) white and (-) green electrode quadfilar coils, the anchor tether and (-) green electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on one of the inner silicone tubes. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device.
 
Manufacturer Narrative

Event Description
Based on findings from product analysis, no evidence of corrosion was found on the patient's lead. The figures provided show a heavily manipulated lead (suggestive that the patient was a twiddler).
 
Manufacturer Narrative
Describe event, corrected data. Supplemental mdr #5 incorrectly reported information that was inaccurate.
 
Event Description
Re-evaluation of the product analysis results revealed that the manipulation of the lead was attributed to the explant-related events and is not believed to have contributed to the high impedance during implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5263683


Title: Re: White Deposits
Post by: dennis100 on March 25, 2019, 12:17:50 AM
Model Number 304-20
Device Problems Disconnection; Low impedance; Lead
Event Date 12/21/2015
Event Type  Malfunction   
Event Description
Low impedance was reported to be observed on the patient's vns device. The patient was referred for revision surgery due to the observed decrease in impedance. There was no trauma reported that could have caused or contributed to the low impedance and there were no reported adverse events. The patient underwent revision surgery on (b)(6) 2016. During the surgery, the surgeon observed a lead discontinuity near the generator site. Attempts for additional relevant information were unsuccessful to date.
 
Event Description
Product analysis for the returned generator demonstrated that accurate resistance measurements were obtained in all instance using various electrical loads. A comprehensive automated electrical evaluation showed that the vns generator performed according to functional specifications. The final electrical test showed an ifi = no condition. There were no performance or any other type of adverse conditions found with the vns generator. Product analysis for the returned lead found abraded an opening on the inner silicone tube, in one locations, and abraded openings on the outer silicone tube. The abraded opening on the outer tubing and the cut ends made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have been body fluids found inside the outer tubing. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposits observed on the connector boot and identified the deposit as containing silicon and sodium. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide the 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 visual analysis and no discontinuities were identified. Based on these findings in the product analysis lab, there was no evidence to support the low impedance, short circuit, or fractured lead allegations. It should be noted that a portion of the lead assembly, including the electrodes, was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product.
 
Event Description
It was also reported the patient had an increase in seizures, above pre-vns baseline levels, which began after the lead fracture occurred. The increased seizures continued once the new devices were implanted and was reported, and will continue to be investigated, in mfr. Report 1644487-2016-01782.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5371786


Title: Re: White Deposits
Post by: dennis100 on March 25, 2019, 12:18:45 AM
Model Number 302-20
Device Problem High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's vns device was showing high lead impedance upon interrogation. It was reported that the patient experienced a breakthrough seizure in (b)(6) 2015, after previously having been seizure free. The physician assessed this increase in seizures to a loss of therapy from the high impedance. No known surgical interventions have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient's vns impedance was reportedly normal during initial implant in 2011. No additional relevant information has been obtained to date.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices were received on (b)(6) 2016. Analysis is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of fracture of leads was confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis and scanning electron microscopy confirmed two broken coil strands as having extensive pitting. The area on a third broken coil strand was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture with flat spots on the coil surface. Pitting and flat spots were observed on the coil surface. Multiple areas on the broken coil strands had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. 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. An abraded inner tubing opening near the break location was also observed. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half 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. 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 portions were performed, during the visual analysis, and no other discontinuities were identified. In the (b)(4) 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. In addition, 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=5375035


Title: Re: White Deposits
Post by: dennis100 on March 26, 2019, 02:05:31 AM
Model Number 300-20
Event Date 12/16/2015
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery on (b)(6) 2015, the surgeon noted that the lead wire was exposed through the tubing. Pre-operative and intra-operative diagnostic results showed lead impedance within normal limits. The surgeon elected to replace the lead during the procedure. The explanted devices have not been returned to date.
 
Event Description
The lead was received for analysis on 04/11/2016. Product analysis for the lead was completed and approved on 04/18/2016. 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 abraded openings were observed on the outer silicone tubing. The abraded openings and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies, beyond the outer tubing openings, 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, with no discontinuities identified. The outer silicone tubing contained abraded openings, but there were no abraded openings noted on the inner tubing which could have caused device malfunctions.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5358882


Title: Re: White Deposits
Post by: dennis100 on March 28, 2019, 07:14:04 AM
Model Number 302-20
Event Date 01/13/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported during prophylactic generator replacement, the surgeon found the lead wiring out of the tubing. When the surgeon went to remove the generator from the pocket the lead broke in half. It was reported that device diagnostics prior to generator replacement were within normal limits. The explanted generator and lead were received for analysis. Analysis of the generator was completed on 02/08/2016. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead was completed on 02/02/2016. 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 of the returned lead portions the quadfilar coils did not appeared to be broken and abraded openings were not observed on the outer or inner silicone tubes. Slice marks were observed in various areas on the outer silicone tubing. The 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 the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the analysis results of the lead, it is likely that the damage to the lead occurred as a result of the surgery; however, attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5432331


Title: Re: White Deposits
Post by: dennis100 on March 29, 2019, 07:28:06 AM
Model Number 300-20
Event Date 03/01/2016
Event Type  Malfunction   
Manufacturer Narrative
Device evaluated by mfr: corrected data: yes. Initial mdr inadvertently marked that the product was not returned to manufacturer. However, the product was received and an evaluation of the product was provided in the initial mdr.
 
Event Description
An implant card was received indicating that the patient underwent full revision surgery due to battery depletion of the generator and lead pin being stuck in the generator that was to be explanted. During a generator replacement surgery on (b)(6) 2016, the surgeon had difficulties removing the second lead pin from the dual pin generator. The screwdriver was used to try to relieve the pressure and the pin was eventually removed, but the lead pin was "stripped" during the removal process. It was also noted that the first lead pin was difficult to remove as well. The surgeon pilled the pin out so hard that the lead separated and a back string was visible within the lead. A full revision of the lead and generator was performed and the explanted generator and a portion of the lead were received on (b)(4) 2016. The reported ¿end of service and low battery¿ allegations were confirmed in the pa lab; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Although the device communicated at decontamination at zero inch distance (it did not communicate in the pa lab at zero inch distance), the reported ¿failure to program¿ allegation was duplicated in the pa lab and determined to be the result of normal battery depletion. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found. Visual analysis confirmed that there were white deposits on the can, in the header and in the negative connector block/set screw area. A sem analysis of the foreign matter indicated that it was calcium and phosphorus. The reported ¿difficulty removing the lead during revision surgery¿ most likely was caused by the white deposits on the negative septum and in the negative connector block/set screw area. An analysis was performed on the returned lead portions and the reported ¿fracture of leads' allegation was not confirmed. A majority of the lead assembly (body) including the connector pin / boot sections with model and serial number tag was not returned; therefore it was not possible to verify the model and serial number during this analysis and a complete evaluation could not be performed on the entire lead product. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. 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 discontinuities in the returned portions of the device which may have contributed to the stated allegation of ¿fracture of leads. '.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5540011


Title: Re: White Deposits
Post by: dennis100 on March 30, 2019, 01:05:23 AM
Model Number 304-20
Event Date 02/17/2016
Event Type  Malfunction   
Event Description
It was reported that during a generator replacement surgery due to a low battery, a break was found in the lead and it was replaced by the surgeon. The lead and generator have been received for analysis which is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Event Description
Analysis was completed for the returned generator 03/31/2016. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. During the bench interrogation with a one and one-quarter inch spacer block between the generator and the programming wand the "pulsedisabled" and end-of-service warnings were set. With the pulse generator case removed and the battery still attached to the printed circuit board, the battery measured 1. 817 volts, verifying an end-of-service condition. The pulse generator performed according to functional specifications. Other than the noted event of end-of-service-pulsedisabled, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies. The last >25% change in impedance recorded was on (b)(6) 2010 with an initial value of 1366 ohms and a final value of 2797 ohms and was within normal limits. Analysis was completed on the returned lead portions on 03/31/2016 and the report of lead fracture was not confirmed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure and no 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. There is no evidence to suggest discontinuities in the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5505545


Title: Re: White Deposits
Post by: dennis100 on March 31, 2019, 06:35:55 AM
Model Number 302-20
Event Date 04/08/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on vns patient's system. The patient was due to undergo generator replacement surgery, when high impedance was identified; the vns patient's device was tested and system mode diagnostic results revealed high impedance (dc dc code 7) and near end of service = no. It was reported that the device replacement surgery was performed. The patient's vns system was tested upon connection of the new generator to the existing lead and high impedance persisted. It was reported that the newly implanted device was disabled. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Additional information was received indicating that the generator was replaced due to battery depletion. The return of that explanted device to the manufacturer is expected but it has not been received to date. It was reported that a lead revision due to lead discontinuity is planned. No known surgical interventions have occurred to date.
 
Event Description
The explanted generator was received to the manufacturer on 04/28/2016. Analysis of the returned generator was completed. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator.
 
Event Description
Further information was received indicating that the patient underwent lead replacement surgery on (b)(6) 2016. The lead was replaced due to lead discontinuity. The patient's vns system was tested upon connection of the new lead to the generator and system diagnostics returned impedance results within normal limits with 1568 ohms. The explanted lead was returned to the manufacturer on 06/09/2016. Analysis is underway but it has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of "fracture of leads" were confirmed. Note that the (-) green electrode was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 40mm portion the (+) white electrode quadfilar coil appeared to be broken approximately 19mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. During the visual analysis of the returned 9mm portion the end of the (+) white electrode quadfilar coil appeared to be broken approximately 18mm past the end of the cut inner silicone tubing. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture with pitting. Flat spots and pitting were 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. During the visual analysis the (+) white electrode ribbon appeared to be embedded in what appeared to be remnants of dried body tissue. This condition may have prevented the (+) white electrode ribbon from coming in contact with the vagus nerve. With the exception of the observed discontinuity and the tissue-covered (+) white electrode ribbon the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins 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. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portions of the device which may have contributed to the stated allegations of high impedance. Note that since the (-) green electrode was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. However, the positive electrode condition may have contributed to the reported ¿high impedance¿.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5614469


Title: Re: White Deposits
Post by: dennis100 on April 05, 2019, 01:17:55 AM
Model Number 302-20
Event Date 07/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On 5/16/2016 the patient¿s mother reported that her daughter¿s generator was unable to be interrogated by the new physician and that her previous physician noted an ¿impedance issue¿ at the last appointment on (b)(6) 2015. The mother noted that it was very difficult to get her daughter's device managed because she was never able to consistently see a physician or at the same facility. The patient¿s mother then stated that over the last several months ((b)(6) 2015), her daughter has been having an increase in grand mal seizures and the mother was concerned that it would get worse. The mother confirmed that the patient is not as bad as she used to be prior to the vns therapy. The patient¿s mother later reported that high impedance had been seen during the clinic visit on (b)(6) 2015. At that time, no therapy level adjustment was made to discontinue therapy. The doctors had told the patient the high impedance was possibly due to scar tissue but therapy was allowed to continue. The patient¿s new doctor is unable to communicate with the patient's vns therapy system and the patient reports an increase in seizures as well as a failure of the magnet to abort the seizures. The patient¿s settings were noted to be output=2ma/frequency=20hz/pulse width=250usec/on time=14sec/off time=1. 1min. A review of the patient¿s programming history revealed that system diagnostics performed on (b)(6) 2015 showed results within normal limits and no high impedance.
 
Event Description
Generator and lead replacement surgery occurred on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date.
 
Manufacturer Narrative
Relevant test data, corrected data: the date of systems diagnostics was inadvertently reported as (b)(6) 2015, when the date was intended to be reported as (b)(6) 2013.
 
Event Description
Additional information was received that the patient was referred for revision surgery. It was reported that the device had been turned off for a while. The generator and lead were explanted on (b)(6) 2016. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted lead and generator were received. Analysis was completed for the returned lead portions. The lead coil appeared to be broken approximately 1mm and 2mm from the end of the electrode bifurcation. A short section of coil was observed between the two coil breaks. Scanning electron microscopy was performed on the coil break found at 1mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Scanning electron microscopy was performed on the short section of the coil break found between 1mm and 2mm and identified the area as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the coil break found at 2mm and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Pitting and flat spots were observed on the coil surface. Abraded openings were found on the outer silicone tubing, and most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the connector boot. During the visual analysis electrode ribbons appeared to be partially embedded in what appeared to be remnants of dried body tissue. With the exception of the observed discontinuities, abraded openings and tissue covered electrode ribbons the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. No other anomalies were noted. Analysis was completed for the returned generator. Review of the downloaded data from the pulse generator shows high impedance on the date of explant, (b)(6) 2016. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The pulse generator was interrogated at multiple orientations adjacent to the programming wand. The pulse generator interrogated at all orientations. The device output signal was monitored while the pulse generator was placed in a simulated body temperature environment. Results showed that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring, demonstrate the appropriate magnet output for the programmed settings. 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. The battery, voltage measured 2. 938 volts and shows the intensified follow-up indicator was not set. The downloaded data revealed that 26. 496% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5707811


Title: Re: White Deposits
Post by: dennis100 on April 10, 2019, 12:47:50 AM
Model Number 103
Event Date 06/14/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an post-operative infection at the surgical site following a recent generator replacement surgery on (b)(6) 2016. A surgery was planned initially for the device removal. The surgeon later elected to hold off on the explant surgery that was scheduled as the patient's blood work was much better and so was the would at incision site. Additional relevant information has not been received to date. A review of device history records showed that the generator was sterilized prior to distribution.
 
Event Description
Additional information was received on (b)(6) 2016 that the patient still has infection. Patient underwent explant of the vns generator and lead on (b)(6) 2016 due to infection. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received for analysis on 09/29/2016. Verification of the alleged ¿infection¿ is beyond the scope of activities performed in the pa laboratory environment. However, potential contributing factors to this condition have been considered / evaluated and none were found to exist in this situation. The dhr shows that the pulse generator passed all specifications prior to its release. 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. The battery, 2. 973 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions for the reported allegation of; ¿explanted / due to infection¿ (lead and patient sections). The allegation is not an actionable issue. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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, 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 complaint.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5808204


Title: Re: White Deposits
Post by: dennis100 on April 11, 2019, 01:39:46 AM
Model Number 302-20
Event Date 06/14/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported the patient was found to have high lead impedance on (b)(6) 2016. The patient denied any trauma which may have caused the device failure. Chest x-rays were ordered and a battery life calculation was performed to see if the patient would need a full vns revision. A battery life calculation was performed which showed the device had approximately 1. 4 years remaining until neos = yes (near end of service). The programming history database was reviewed; however, only information from 10/27/2010 through 12/15/2015 was available. No anomalies were noted within the available information. Information was later received confirming that the patient did have high impedance on (b)(6) 2016.
 
Event Description
An implant card was received showing the patient was re-implanted with a new generator and lead on (b)(6) 2016. The generator and lead were later received by the manufacturer for product analysis. During lead product analysis, a lead break was not confirmed. However, it should be noted that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be specs of white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur, and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No 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 visual analysis, and no discontinuities were identified. Based on the findings in the pa lab, there was no evidence to suggest discontinuities in the returned portions of the lead which may have contributed to the reported high impedance. Product analysis for the returned generator was also completed and found that the generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5793446


Title: Re: White Deposits
Post by: dennis100 on April 12, 2019, 12:17:00 AM
Model Number 304-20
Event Date 05/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that a vns patient's device showed low impedance at 600 ohms. No injuries, falls, or trauma were reported. It was stated by the patient's mother that they get efficacy from the magnet. The patient has been referred for full revision. Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective. An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation. " the device had been programmed off on (b)(6) 2016. Lead and generator revision surgery occurred on (b)(6) 2016. A lead break was visualized approximately one-third of the distance from the generator. The explanted devices have not been received to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.
 
Event Description
The explanted devices were received for analysis on 10/05/2016. Analysis was performed on the returned lead portion 10/24/2016. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes. The coils were bare and exposed in the areas of the abraded openings. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium. With the exception of the twisted appearance and abraded openings, the condition of the returned lead portions is consistent with those that typically exist 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 portion were performed, during the visual analysis, and no discontinuities were identified. Analysis was completed for the returned generator 10/27/2016. The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016. The device was explanted later on (b)(6) 2016. Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. 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. The battery measured 3. 055 volts and shows an intensified follow-up indicator was not set. 18. 519% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5916022


Title: Re: White Deposits
Post by: dennis100 on April 12, 2019, 12:17:49 AM
Model Number 300-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Patient underwent explant due to pain as reported in mfr. Report # 1644487-2016-01153. An analysis was performed on the returned lead portions. The electrodes portion of the leads was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings were found on the outer and inner silicone tubing. These abraded openings and the cut ends that were made during the explanted process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the marked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the inner tubing abraded opening, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the connector pins 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, with no discontinuities identified. Based on the findings, there is evidence of an inner tubing abraded opening.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5778892


Title: Re: White Deposits
Post by: dennis100 on April 17, 2019, 06:29:44 AM
Model Number 302-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
Clinic notes were received for patient's referral for surgery due to high impedance. Clinic notes state that the vns is currently turned off secondary to high impendence and lead fracture. Notes also describe receiving a warning message about the device being able to deliver a maximum of 2 ma output current previously. Device diagnostics showed high lead impedance. No known surgical interventions have occurred to date.
 
Event Description
The patient underwent a full revision surgery on (b)(6) 2016. The explanted lead and generator were received on 10/04/2016. Analysis is underway but has not been completed to date.
 
Event Description
Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 3. 006 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegations of lead fracture and high impedance, which were confirmed. A large portion of the lead assembly (body) including the electrode section was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break areas were also observed. Flat spots and pitting were observed on the coil surface. Determination could not conclusively be made on the fracture mechanism. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, which most likely completed the fracture on one of the broken coil strands. 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 abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5954926


Title: Re: White Deposits
Post by: dennis100 on April 19, 2019, 12:45:36 AM
Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The device was programmed off and patient was referred for lead revision and prophylactic generator replacement. Patient's mother reported that the patient's seizure activity has increased every day since device has not been working. No additional relevant information has been received to date. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Event Description
A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130470


Title: Re: White Deposits
Post by: dennis100 on April 21, 2019, 03:25:01 AM
Device Problem Fracture
Event Date 11/03/2016
Event Type  Malfunction   
Event Description
It was reported that the patient's device showed high impedance. The device was programmed off and patient was referred for lead revision and prophylactic generator replacement. Patient's mother reported that the patient's seizure activity has increased every day since device has not been working. No additional relevant information has been received to date. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent full revision surgery. The surgeon believes the single incision technique used during the initial implant surgery may have contributed to the lead break. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Event Description
A portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No 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 portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130470


Title: Re: White Deposits
Post by: dennis100 on April 24, 2019, 12:33:35 AM
Model Number 302-20
Device Problems Mechanical Problem; Appropriate Term/Code Not Available
Event Date 12/08/2016
Event Type  Malfunction   
Event Description
During a generator replacement surgery, the old generator was unable to be interrogated. When the lead was connected to the new generator, high impedance was observed. The company representative performed 3 system diagnostics in a row. Each time, the output current was low, current delivered was 0. 25ma, and lead impedance was high >=10000 ohms. The old lead pin was fully inserted into the m 103 prior to system diagnostics. The surgeon looked under magnification to confirm, then disconnected lead, inspected lead and insertion point and confirmed again. High impedance was still present after confirming complete insertion. A full revision surgery was performed as a result. With the new lead connected to the new generator, impedance was within normal limits. The explanted lead has not been received to date.
 
Event Description
The generator and lead were received. Analysis is underway but has not been completed yet.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The reported ¿end of service and low battery¿ allegations on the generator were confirmed in the lab; an open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. Analysis of the generator in the 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 lead fracture and high impedance were confirmed. A portion of the outer silicone tubing and a portion of the connector ring quadfilar coil 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 lead, the lead coils appeared to be broken in several areas. Scanning electron microscopy performed on the several coil breaks identified the areas as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, some with pitting and some without pitting, evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands. The area on one of the two remaining broken coil strands was identified as having extensive pitting which prevented identification of the coil fracture type. The area on the last broken coil strand was identified as having evidence of being worn to the point of fracture which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. During the visual analysis of the returned 15mm portion the (-) green quadfilar coil appeared to be broken approximately 3mm past the end of the cut / torn inner silicone tubing. 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 slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the inner silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6179592


Title: Re: White Deposits
Post by: dennis100 on April 24, 2019, 12:34:24 AM
Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 12/07/2016
Event Type  Malfunction   
Event Description
Patient was scheduled for a prophylactic generator replacement on (b)(6) 2016 due to ifi - yes. Prior to the surgery, high impedance noted in three times and twice again in the or. The generator was replaced first and the lead was connected to the new m 106 generator. High impedance persisted and so the lead was revised. Impedance was within normal limits after the lead revision. The explanted devices have not been received to date.
 
Event Description
The explanted lead and generator is believed to be discarded.
 
Event Description
The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions and the reported allegation of fracture of lead(s) was not confirmed. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found in the outer and inner silicone tubing, 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 the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. White deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except the half set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional 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. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6198234


Title: Re: White Deposits
Post by: dennis100 on April 26, 2019, 05:59:52 AM
Model Number 302-20
Device Problems High impedance; Mechanical Problem
Event Date 01/06/2017
Event Type  Malfunction   
Event Description
During an generator replacement surgery, high impedance warning message was seen upon interrogating the generator that was to be implanted; no system diagnostic was performed. The high impedance seen upon interrogation is expected since no system diagnostic cleared the stored value. System diagnostic test must be performed in order for the generator to test the impedance when connected to the lead, which was not performed during this surgery. During troubleshooting, the surgeon examined the lead and noticed that there was a small tear in the sheath of the lead near the lead tip that he believed could be causing the impedance issue. The surgeon also commented that the lead felt brittle and calcified and elected to replace the lead. The explanted lead has been received and is undergoing product analysis. No other relevant information has been received to date. Manufacturing report number 1644487-2017-03055 will discuss the detached septum plug that was observed for the generator during the same surgery.
 
Event Description
Product analysis was completed on the returned portion of the explanted lead. The electrode array was not returned along with a segment of the lead near the electrodes. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. White deposits were found along the body of the lead. Energy dispersive spectroscopy showed that the deposits consisted of phosphorous, calcium, and silicon. No discontinuities were identified on the portion of the lead that was returned. No anomalies were noted that impacted the functionality of the device. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6291475


Title: Re: White Deposits
Post by: dennis100 on May 01, 2019, 12:40:27 AM
Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
High impedance was observed with the patient's vns. Follow up with the nurse found that the patient came in on (b)(6) 2015 with their device disabled due to high impedance. The nurse turned that patient's device on and performed a lead impedance test. She then programmed the patient's device back off. The patient was recently referred for surgery. No surgical intervention has occurred to date. No other relevant information has been received to date.
 
Event Description
The patient underwent surgery in (b)(6) 2017 where the patient's lead was explanted. The explanted lead has been received and is undergoing product analysis.
 
Manufacturer Narrative
Event description, corrected data: it was inadvertently not provided in follow-up report#1 that the explanted generator was received by the manufacturer also.
 
Event Description
The explanted generator was received by the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. Electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 2. 968 volts and was not at an end-of-service condition. The downloaded data revealed that 15. 012% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis was completed on the returned lead portions. The lead coil wires were found to be broken. Scanning electron microscopy was performed and identified extensive pitting. There was evidence of a rotational stress induced fracture. The area on the remaining broken coil strand was identified as having evidence of a fatigue stress induced fracture with mechanical damage, no pitting and evidence of a rotational stress induced fracture. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings, incision marks and slice mark found on the outer and inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of body fluids inside the outer and inner silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6309412


Title: Re: White Deposits
Post by: dennis100 on May 09, 2019, 06:55:30 AM
Model Number 302-20
Device Problems Fracture; Adverse Event Without Identified Device or Use Problem
Event Date 03/11/2017
Event Type  Malfunction   
Event Description
Patient reported that he is getting painful, jolting stimulation when he turns his head. The patient was seen by the neurologist, who stated that the patient was being referred for vns battery replacement due to battery near end of life. This was reported to be an intervention for the painful stimulation as the physician believes the vns nearing end of life is the cause of the pain. Information was later received that the device is at end of service and patient was referred for replacement. Patient visited the er for pain in the vns area. Clinic notes were received for the replacement referral, indicating that the magnet did not abort an seizure. The physician attributed this to the low battery of the generator. In clinic notes, neos - yes was marked. Patient underwent generator replacement surgery but the explanted generator will not be returned per the explant facility.
 
Event Description
After generator replacement, the patient reported that he was unable to feel both normal and magnet stimulation. Upon interrogation of the device a high impedance warning message was observed. Diagnostic testing was performed. Impedance was found to be ok, but on the higher end (5221 ohms) with low output status. The generator was only supplying 1. 625 ma when normal mode was programmed to 1. 75 ma. There appears to be an intermittent impedance issues. X-rays were performed and a very obvious lead fracture was observed. The patient did not remember any falls or trauma that could have caused it however he knew something was wrong because he could not longer feel magnet stimulation and he had an increase in seizures. Patient underwent lead revision and the surgery reportedly went well but took a lot of time to complete. The explanted lead has not been received to date.
 
Event Description
The explanted lead was returned to the manufacturer. Analysis is underway but has not been completed.
 
Event Description
Analysis of the lead confirmed discontinuities of both positive and negative quadfilar coils in the body region of the returned lead portions. Abraded openings of both outer and inner tubing near the break locations were also observed. Scanning electron microscopy was performed on quadfilar coil break and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, residual material and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. The area on the remaining broken coil strands was identified as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. Pitting was observed on the coil surface in some areas. During the visual analysis, the negative electrode quadfilar coil appeared to be broken approximately 1 mm from the end of the abraded open / cut / outer / inner silicone tubes and the positive white electrode quadfilar coil appeared to be broken at approximately 2 mm. 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 abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium sulphur and calcium. With the exception of the abraded openings observed on the outer and inner silicone tubes and the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The set screw marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6509179


Title: Re: White Deposits
Post by: dennis100 on May 14, 2019, 12:17:53 AM
Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2016
Event Type  Injury   
Event Description
The nurse practioner is referring patient for full revision due to migration. Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult. No known surgical interventions have occurred to date. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017. There are no known causes for the migration such as trauma or manipulation. Surgical intervention is planned to preclude a serious injury. The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant. No known surgery has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were received. 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. There are no performances or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date.
 
Event Description
Analysis of the received lead was completed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings 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. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins 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, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6455535


Title: Re: White Deposits
Post by: dennis100 on May 18, 2019, 12:34:40 AM
Model Number 300-30
Device Problem Fluid Leak
Event Date 01/26/2017
Event Type  Malfunction   
Event Description
A patient¿s lead and generator were explanted in order to participate in a clinical trial of another device. The explanted devices were received for analysis by the manufacturer. Analysis was completed for the returned generator. The device output signal was monitored for more than 24 hours, 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. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. Analysis was completed on the returned lead portions. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer and inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The 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, with no discontinuities identified. With the exception of the abraded openings, no other obvious anomalies were noted. Additional relevant information has not been received to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6593215


Title: Re: White Deposits
Post by: dennis100 on May 30, 2019, 05:53:41 AM
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/23/2017
Event Type  Injury   
Event Description
A physician stated that during a generator replacement surgery, he identified that a patient had some foreign white substance identified in the generator pocket. Follow-up was performed and the physician's op notes stated that the physician saw something resembling a plastic coating on the fascia under the generator incision site, but that all the scar tissue was normal. The patient was seen post-op and reportedly not experiencing any adverse events related to the surgery and was healing normally. The explanted generator was returned to the manufacturer for analysis which has not been completed to date. No further relevant information has been received to date.
 
Event Description
The explanted generator had analysis completed where the generator diagnostics were as expected for the programmed parameters. The device passed a comprehensive automated electrical evaluation. The stored data showed normal battery consumption and normal impedance values pre-operatively. There were no performance or any other type of adverse condition identified with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6647872


Title: Re: White Deposits
Post by: dennis100 on May 30, 2019, 05:54:23 AM
Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 04/12/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for a full revision. Clinic notes were received from visits on (b)(6) 2017 regarding a full revision for high impedance. On (b)(6) 2017 it was provided that the patient's seizure control is worse since the last visit. The physician stated that the vns had high lead impedance. On the visit on (b)(6) 2017 x-rays were reviewed and it was provided that the lead has fractured upon review of the x-rays. Surgery occurred and the explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date. Additional relevant information has not been received to-date.
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The battery measured 2. 947 volts during the electrical test, and shows the battery was not at an end-of-service condition. The data showed that 80. 131% of the battery had been consumed. An 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 attributed to clinical use of the device. Analysis was completed for the returned lead portions. The coil appeared to have dissolved in some areas with a greenish tint observed inside the inner silicone tubing. The connector pin coil appeared to be broken scanning electron microscopy was performed coil break and identified the area as being thin, having extensive pitting which prevented identification of the coil fracture type. The remaining broken coil strand appeared to be mechanically damaged. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. No other 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6614319


Title: Re: White Deposits
Post by: dennis100 on May 30, 2019, 05:55:07 AM
Model Number 300-20
Device Problems High impedance; Mechanical Problem
Event Date 05/19/2017
Event Type  Malfunction   
Event Description
A prophylactic generator and lead replacement was planned due to desire for the latest model generator that has the autostim feature as the patient has approximately 30 grand mals a month 38; nocturnal seizures. During the surgery, high impedance was observed with the existing devices. Both lead and generator were replaced and the high impedance resolved. Company representative reported observing the lead wire without the insulation. The explanted generator and lead were received. Analysis is underway but has not been completed to date.
 
Event Description
An end-of-service warning message was verified in the lab for the explanted generator and found to be associated with the output being disabled by the pulse generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. A large portion of the lead assembly including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins 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. Based on the findings in the lab, there is no evidence to suggest discontinuities in the returned portions of the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6639086


Title: Re: White Deposits
Post by: dennis100 on June 06, 2019, 01:41:51 AM
Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
Patient underwent explant of vns generator and lead as patient felt that it never helped. The device was reported to have been disabled for years prior to explant. Analysis was performed on the returned lead portions. During the visual analysis, the lead coil appeared to be broken. Scanning electron microscopy was performed on the coil break and identified the area as being mechanically damaged with pitting which prevented identification of the coil fracture type. Two of the broken coil strands appeared to have evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Residual material was observed on the coil surface. The remaining broken coil strands were identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. 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 abraded openings 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 the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon and phosphorus. With the exception of the observed abraded openings and discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Since a portion of the lead assembly including the electrode array section was not returned, 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=6866725


Title: Re: White Deposits
Post by: dennis100 on June 10, 2019, 12:12:28 AM
Model Number 302-20
Device Problem Fracture
Event Date 08/16/2017
Event Type  Malfunction   
Event Description
Report received that high impedance was found after performing system diagnostics on new generator in the operation room. The patient was scheduled for a generator replacement due to battery depletion, and the generator was unable to be interrogated. When the new generator was implanted and connected to the lead, a system diagnostic was run and showed high impedance. The lead was explanted. Further information was received that during the surgery, the lead pin was confirmed to be inserted into the generator properly. Generator diagnostics were also performed on the new generator and the results showed normal impedance. A review of the programming history did not indicate whether or not high impedance was seen prior to the replacement. Recent system diagnostics prior to surgery could not be provided by the patient's physician. The lead and generator were explanted and received by the manufacturer, but analysis has not been approved to date. No other relevant information has been provided to date.
 
Event Description
Product analysis was completed on the generator. The generator could not be interrogated due it reaching normal battery depletion. A review of the generator data showed a 26. 3% change in impedance. The pre and post change impedance values were both normal. The data did not show the onset of high impedance as the battery became too depleted to perform automeasures for impedance. The measured battery voltage was consistent with the estimated charge consumed. No further relevant information has been received to date.
 
Event Description
Further information was received that product analysis was completed on the lead. The lead was returned in two portions. Visual examination showed one portion had stretched and kinked quadfilar coils. On this portion, set screw marks were present and white deposits were observed in various locations. Abrasions were also noted on the connector boot. Dried remnants of what appeared to be bodily fluids were inside the outer silicone tubing. Other abraded openings were seen along the outer tubing of this portion. On the second portion, white deposit was also seen. Besides typical markings and damage associated with explant, no visual anomalies were noted. No discontinuities were found during the continuity checks for the returned portions. However, there was a portion of the lead which included the electrodes which was not returned for analysis and an assessment on that portion could not be made. No further relevant information has been received to date,.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6849884


Title: Re: White Deposits
Post by: dennis100 on June 12, 2019, 02:28:15 AM
Model Number 300-20
Device Problems Corroded ; Mechanical Problem
Event Date 09/08/2017
Event Type  Malfunction   
Event Description
Report received that a patient's lead was found to be corroded after explant. The reason for the lead explant was initially unknown. The patient was originally scheduled for a generator replacement due to end of service. However, both the lead and generator were replaced. Lead information was illegible due to corrosion covering the labeling. Further information was received that the lead was explanted because it was not compatible with the new generator. System diagnostics had been performed about 4 months prior to explant and results were normal. A review of the device history record indicated all quality inspections were performed and passed prior to release for distribution. The lead was returned and received by the manufacturer. Product analysis has not been completed on the lead to date. No further relevant information has been provided.
 
Event Description
Product analysis was completed on the lead. Product analysis was completed on the lead. A section of the lead assembly was returned for analysis in two pieces with the lead connector still attached to the pulse generator header. The electrodes were not returned for analysis and an assessment could not be made. Photograph and x-ray images showed that both the marked and unmarked portions were not fully inserted. However, a continuity check was performed and indicated proper contact was still made. It was also found that the lead connectors were incorrectly inserted with the marked (positive) connector in the negative cavity of the pulse generator header. The first portion of the retuned lead was inspected. Three set screw marks were seen providing evidence that proper contact had been made at one time. A single set screw indentation was noted at the end tip of the marked connector pin. Abrasions were noted on the connector boot. White deposits were also noted on the connector boot. Abrasions were noted on the silicone tubing of the marked connector. The positive coil had a spiral/wavy appearance. The second portion of the lead was also visually inspected. Three set screw marks were seen providing evidence that proper contact had been made at one time. The marked connector pin had an opaque appearance in the vicinity of the set screw marks. Abrasions were also noted on the unmarked connector boot. White deposits were noted on the unmarked connector boot. Abrasions were noted on the silicone tubing of the unmarked connector. The unmarked connector appeared to have been torn at the connector bifurcation. No discontinuities were identified within the returned lead portions. Scanning electron microscopy images of the unmarked connector pin at the opaque appearance region shot that pitting or electro-etching conditions have occurred on the surface of the pin. An energy dispersive spectrometry analysis performed on a sample of the white deposits identified the composition of the substance. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6925690


Title: Re: White Deposits
Post by: dennis100 on June 15, 2019, 10:49:55 PM
Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a consult for generator replacement due to battery depletion, a lead fracture was observed in x-rays. The generator battery was reported to be dead. Both the generator and lead were replaced. The explanted lead was received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative

Event Description
During the visual analysis, multiple quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. Pitting and residual material were observed on the coil surface. Scanning electron microscopy identified an area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on one and residual material on the other two 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. The abraded opening / torn areas 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. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042802


Title: Re: White Deposits
Post by: dennis100 on June 23, 2019, 03:34:20 AM
Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem; Appropriate Term/Code Not Available
Event Date 12/12/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that prior to a generator replacement case, high impedance was detected on the patient's generator. The device was programmed at 2. 75ma and the current delivered was 0. 75ma. There were no visible fractures, but at the end of the lead that inserts into the generator there was a white material on the outside of the lead. The surgeon did try to remove it, but nothing would come off. The lead and generator were replaced. The explanted products were received but product analysis has not been completed on the suspect device has not been received to date. No further relevant information has been received to date.
 
Manufacturer Narrative

Event Description
Product analysis was completed on the returned lead. The lead was returned in 5 portions with the anchor tether and second electrode not returned. A coiled portion of the lead was encased in a large piece of body tissue. There were white deposits along the lead bod, which; energy dispersion spectroscopy found to contain silicon, phosphorus, sodium, magnesium and calcium. Product analysis identified two lead fractures in the lead body. With regards to the first fracture, scanning electron microscopy found that one strand break had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The other three strand breaks' fracture mechanism could not be identified due to mechanical damage. Pitting/corrosion was observed in the area of the fracture. With regards to the second fracture, scanning electron microscopy found that three of the coil strands at the fracture had evidence of a stress induced fracture (fatigue appearance. The final strand's fracture mechanism could not be identified due to mechanical damage. Corrosion was observed in the area of the second fracture. The corrosion at the lead fracture sites provides evidence that stimulation was present for some time after the fractures occurred. Finally, an abraded opening in the inner and outer tubing at the location of one of the lead fractures. Two other abraded opening were identified in the outer tubing. These openings provided a leakage path for body fluids into the inner and outer tubing. No further anomalies were identified. Product analysis was completed on the returned generator. As received, the generator was in near end of service condition (neos-yes). A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications and was in ifi-yes condition. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7173394