Pages: [1] 2 3 4  All   Go Down
Print
Author Topic: White Deposits  (Read 4285 times)
0 Members and 2 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #1 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #2 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #3 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #4 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #5 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #6 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #7 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #8 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #9 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #10 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #11 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #12 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #13 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #14 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #15 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #16 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

Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #17 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #18 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #19 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #20 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #21 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #22 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #23 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #24 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #25 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #26 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #27 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #28 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 55552


« Reply #29 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
Logged
Pages: [1] 2 3 4  All   Go Up
Print
Jump to: