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dennis100
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« on: December 23, 2018, 10:01:08 AM »

Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/02/2015
Event Type  Death   
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
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
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
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dennis100
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« Reply #1 on: December 23, 2018, 10:02:10 AM »

Model Number 302-20
Event Date 08/29/2012
Event Type  Malfunction   
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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2755718
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dennis100
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« Reply #2 on: December 23, 2018, 10:04:25 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
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.

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.

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
The explanted devices were returned on (b)(6) 2013 and are pending product analysis.

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that all functional tests were passed prior to distribution.

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
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
On (b)(6) 2013, this patient underwent full revision. Attempts for product return have been unsuccessful.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2815171
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dennis100
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« Reply #3 on: December 23, 2018, 10:06:43 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
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
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
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
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dennis100
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« Reply #4 on: December 23, 2018, 10:07:59 AM »

Model Number 302-30
Event Date 01/22/2013
Event Type  Malfunction   
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
On (b)(6) 2013, the patient underwent full revision. Attempts for product return have been unsuccessful.

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

Event Description
Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2014. 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
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dennis100
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« Reply #5 on: December 23, 2018, 10:09:54 AM »

Model Number 300-20
Event Date 05/25/2012
Event Type  Malfunction   
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
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
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.

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.

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
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« Reply #6 on: December 23, 2018, 10:11:18 AM »

Model Number 103
Event Date 02/01/2013
Event Type  Malfunction   
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.

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.

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.

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
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.

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3081227
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« Reply #7 on: December 23, 2018, 10:12:13 AM »

Model Number 302-20
Event Date 07/01/2013
Event Type  Malfunction   
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.

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.

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« Reply #8 on: December 23, 2018, 10:14:11 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
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
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.

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
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.

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.

Manufacturer Narrative

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.

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« Reply #9 on: December 23, 2018, 10:15:49 AM »

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

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

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

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

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

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« Reply #10 on: December 23, 2018, 10:17:04 AM »

Model Number 105
Event Date 04/10/2013
Event Type  Injury   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

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.

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.

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.

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« Reply #11 on: December 24, 2018, 07:40:12 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.

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« Reply #12 on: December 24, 2018, 07:41:32 AM »

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

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

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

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

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

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

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

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« Reply #13 on: December 24, 2018, 07:42:34 AM »

Model Number 104
Event Date 07/09/2013
Event Type  Malfunction   
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.

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. ".

Manufacturer Narrative
Review of device history records. Review of the generator device history records confirmed all quality tests were passed prior to distribution.

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« Reply #14 on: December 24, 2018, 07:45:05 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
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.

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
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.

Event Description
Although surgery is likely, it has not occurred to date. The patient's family has elected to move forward with surgery.

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
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.

Manufacturer Narrative
Date of event, corrected data: the supplemental report inadvertently reported the date of the high impedance being first observed incorrectly.

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
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.

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« Reply #15 on: December 24, 2018, 07:46:35 AM »

Model Number 300-20
Event Date 08/03/2010
Event Type  Malfunction   
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.

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

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.

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« Reply #16 on: December 29, 2018, 03:31:15 AM »

Model Number 302-20
Event Date 02/27/2013
Event Type  Malfunction   
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.
 
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.

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« Reply #17 on: December 29, 2018, 03:32:06 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3125424
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« Reply #18 on: December 29, 2018, 03:33:13 AM »

Model Number 302-20
Event Date 03/13/2013
Event Type  Malfunction   
Event Description
Additional information was received that the patient had a generator and lead replacement. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed.
 
Event Description
It was initially reported that the patient had high lead impedance (>10,000 ohms) at a recent appointment. Diagnostics were attempted multiple times with the same result. The generator was turned off and the patient was referred for surgery. Surgery is planned but it has not been confirmed that surgery has occurred. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative

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
Age at time of event: corrected data: follow-up report #2 inadvertently did not update the patient age based on the updated event date. Date of event: corrected data: follow-up report #2 inadvertently did not update the event date based on additional information which was received during product analysis.
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. Results of diagnostic testing indicated the generator was operating properly. The battery status indicated ifi=no in the pa lab. The battery voltage was 2. 985 volts, (not at ifi) as measured. The data in the diagaccumconsumed memory locations revealed that 16. 526% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, chlorine and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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« Reply #19 on: December 29, 2018, 03:34:13 AM »

Model Number 302-20
Event Date 03/17/2013
Event Type  Malfunction   
Event Description
It was initially reported that the patient had high impedance at a recent appointment. The patient had a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. X-rays were taken but have not been provided to the manufacturer for review. It was unknown if there was any manipulation or trauma. The patient has been having an increase in seizure and the magnet was not aborting seizures beginning two days before the high impedance was seen. No further information was provided regarding the high impedance.
 
Event Description
Information was received that the patients seizures has also changed in character in that they are more generalized convulsive events lasting 1-2 minutes than the partial events she was had been having previously. The physician also felt this was possibly related to the high impedance. Her medications were unchanged and her blood levels were solid.
 
Manufacturer Narrative

Event Description
Additional information was received that product analysis was completed on the generator and lead. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Sem images of the positive coil show that pitting or electro-etching conditions have occurred at the cut end. The most likely cause for the observed pitting condition is that the generator was not programmed off at the time of explant (generator was still programmed to deliver an output, attempting to deliver therapy through an open electrical load ¿ cut leads). Abrasions were identified on the outer silicone tubing at multiple locations. The outer tubing had what appeared to be internal abrasions at multiple locations. The lead assembly has remnants of what appears to be dry body fluid inside the inner silicone tubing. No obvious point of ingress was noted other than the end of the returned lead portion, in which incisions were necessary to perform proper inspection of the coil. What appeared to be white deposits were observed in various locations. Eds was performed and identified the deposits as containing sodium, magnesium, silicon, phosphorous, chlorine, and calcium. Upon visual inspection of the generator cavity no anomalies were observed. Two sets of setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the lead pin existed at least once. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem: corrected data: the initial mdr did not report the change in seizures pattern that was known about and possible related to the high impedance per the physician at the time of the initial report only the increase in seizures were mentioned on the initial mdr.

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« Reply #20 on: December 29, 2018, 03:35:07 AM »

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

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« Reply #21 on: December 29, 2018, 03:35:55 AM »

Model Number 302-20
Event Date 07/20/2006
Event Type  Malfunction   
Event Description
It was initially found while reviewing programming history for the patient that the patient had high impedance on (b)(6) 2006. The patient had their generator turned off (b)(6) 2007, unknown if related to the high impedance. The generator and lead were returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.
 
Event Description
Additional information was received that physician¿s office did not have information or records from the high impedance in 2006. Product analysis was completed on the generator and lead. The generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Note that the majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. Note that since the majority of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Analysis of programming history.

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« Reply #22 on: December 29, 2018, 03:36:50 AM »

Model Number 102
Event Date 09/12/2014
Event Type  Injury   
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.
 
Manufacturer Narrative

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.

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« Reply #23 on: December 29, 2018, 03:37:38 AM »

Model Number 101
Event Date 04/25/2012
Event Type  Malfunction   
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.
 
Manufacturer Narrative
Review of programming/device diagnostic history performed.
 
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.

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« Reply #24 on: December 29, 2018, 03:38:35 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.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2012 it was reported that 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.

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« Reply #25 on: December 29, 2018, 03:39:29 AM »

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

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« Reply #26 on: December 29, 2018, 03:40:41 AM »

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

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« Reply #27 on: December 29, 2018, 03:41:33 AM »

Model Number 302-20
Event Date 04/06/2013
Event Type  Malfunction   
Event Description
Reporter indicated a patient was having increased seizures and was unable to feel vns magnet mode stimulation since (b)(6) 2013. High lead impedance was also noted with vns diagnostics testing in early (b)(6) 2013. The reporter felt the ¿lead was off the nerve¿ or not connected with the generator since (b)(6) 2013. The patient had no known trauma and did not manipulate the vns. The vns was not disabled. The seizures are above pre-vns baseline level, and are partial-complex seizures only. The patient forgot a dose of medication and had a seizure on (b)(6) 2013; this may be cause of the increased seizures per the reporter. The vns generator is believed to be at end of service per the reporter. The patient had been seizure-free since (b)(6) 2012. The patient had vns lead and generator replacement surgery performed on (b)(6) 2013 due to ¿battery/lead impedance¿. Attempts for return of the explanted devices are in progress.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any discontinuities. As the setscrew marks on the lead pin indicate proper insertion, a lead fracture is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
The generator and lead were returned for analysis on (b)(4) 2013. The abraded openings found on the outer and one inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be specs of white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur and calcium. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a discontinuity in the returned portions of the device. However, since a large portion of the lead assembly (body) including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was verified. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected.

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« Reply #28 on: December 29, 2018, 03:42:46 AM »

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

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« Reply #29 on: December 29, 2018, 03:43:58 AM »

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

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« Reply #30 on: December 29, 2018, 03:45:02 AM »

Model Number 101
Device Problem Insufficient Information
Event Date 07/02/2015
Event Type  Death   
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.
 
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.
 
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.

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« Reply #31 on: December 29, 2018, 03:46:05 AM »

Model Number 105
Device Problem Adverse Event Without Identified Device or Use 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.
 
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.
 
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.

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« Reply #32 on: December 29, 2018, 03:47:15 AM »

Model Number 302-20
Event Date 11/06/2013
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
On (b)(6), 2013 it was reported that the patient underwent generator replacement that day and during surgery, high impedance was discovered. The patient was scheduled for a lead revision surgery on (b)(6) 2013. It was reported that the patient¿s generator had been prophylactically replaced on (b)(6)2013 and the lead replaced on (b)(6) 2013 due to the high impedance observed during the prophylactic generator replacement surgery. After replacement, system diagnostics showed results within normal limits. The explanted products have not been returned for product analysis to date. Generator replacement captured on mfr. Report # 1644487-2011-01493. Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 172mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of being worn to the point of fracture with flat spots on the coil surface. What appeared to be pitting was observed on one of the broke coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting on one of the broken coil strands. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening and slice marks found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded opening found on the (-) connector pin inner silicone tubing most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the inner silicone tubing. There was no obvious path found for the fluid ingress observed inside the (+) connector ring inner silicone tubing. What appeared to be white deposits were observed on one of the inner silicone tubes. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, potassium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #33 on: December 29, 2018, 03:48:52 AM »

Model Number 302-20
Event Date 05/30/2013
Event Type  Malfunction   
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.

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
New information changes the suspect device.

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
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.

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« Reply #34 on: December 30, 2018, 05:22:36 AM »

Model Number 302-20
Event Date 10/18/2013
Event Type  Malfunction   
Event Description
Initially, it was reported that the patient was underwent generator and lead explant due to being seizure free with medication. It was reported that the patient's generator had been programmed off for about 18 months for that reason. The patient requested that the device be explanted. The generator and lead were returned for analysis. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The incision mark and abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, zirconium, sulphur and calcium. Abraded inner tubing openings were observed. With the exception of the abraded openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Analysis of the generator was completed on (b)(4) 2013. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #35 on: December 31, 2018, 09:39:22 AM »

Model Number 300-20
Event Date 10/18/2012
Event Type  Malfunction   
Event Description
Additional information was received that the lead was also returned to the manufacturer for evaluation. Product analysis is planned but has not been completed to date.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the generator and lead. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found with the generator. Note that a large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pins at one point in time. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. Note that since a large portion of the lead assembly (body) including the electrode array section.
 
Event Description
It was initially reported that the patient was having a full revision due to the generator being at end of service and the lead due to high impedance. The patient has been having an increase in seizures unknown if above or below pre-vns baseline. The physician felt that the seizures were due to both the high impedance and medication adjustments. There is no known trauma or manipulation that could have caused the issue. Surgery if likely but has not occurred to date. Good faith attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution.
 
Manufacturer Narrative

Event Description
Review of manufacturing records confirmed there were no unresolved non conformances found with the generator or lead prior to distribution.
 
Event Description
Additional information was received that on (b)(6) 2012 that the patient had a full revision surgery on (b)(6) 2012. No other information was provided at this time. The generator was returned to the manufacturer for evaluation. Product analysis is planned but has not been completed. Good faith attempts for additional information have been unsuccessful to date.

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« Reply #36 on: December 31, 2018, 09:40:20 AM »

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

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« Reply #37 on: January 01, 2019, 04:23:40 AM »

Model Number 102R
Event Date 05/20/2013
Event Type  Death   
Event Description
A coroners office called to obtain a returned goods number for an explanted generator. It was reported that it can take up to a month to have the product returned. Thus far it has not been returned. At this time it is unknown the cause of the patient's death. Autopsy results are pending completion. The death was non traumatic but no other information known at this time. Good faith attempts will be made for more information as it becomes available for release.
 
Event Description
It was reported that the cause of death was due to seizure disorder as a result of a blunt force trauma from a motor vehicle accident. It was reported that the patient was still experiencing seizures at the time of death. It was unknown if the death was a result of a terminal seizure. The generator and lead were returned for analysis on (b)(6) 2013. The generator analysis was completed on (b)(4) 2013. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The lead analysis was completed on (b)(6) 2013. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, zirconium and calcium. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

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« Reply #38 on: January 02, 2019, 01:54:16 AM »

Model Number 300-20
Event Date 09/17/2013
Event Type  Malfunction   
Event Description
During generator replacement surgery for end of service it was noted that high impedance was found after attaching a new generator to the existing lead. The lead was then also explanted and a new vns system was implanted. The lead was returned for analysis on (b)(4) 2013. Analysis of the lead was completed on (b)(4) 2013. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 44 mm portion quadfilar coil 1 appeared to be broken approximately 23 mm from the electrode bifurcation. Scanning electron microscopy was performed on the quadfilar coil break and identified the area on two of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting. The remaining broken coil strands were identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. The generator decoder found that the high impedance was first observed on (b)(6) 2013 which is the date of explant. Analysis of the generator was reported in mfr. Report # 1644487-2013-03234.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.

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« Reply #39 on: January 02, 2019, 01:55:05 AM »

Model Number 302-20
Event Date 01/01/2013
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
Additional information was received that the high impedance was seen (b)(6) 2013 and the patient was turned off that day. The last good diagnostics was (b)(6) 2013 however results were not provided. X-ray were taken but will not be sent in to manufacturer for review. During surgery there was a lot of scar tissue that was seen and there were no lead breaks or other issue visualized. It was unknown if this was the cause of the high impedance but it was felt that it may have contributed. The cause of the fibrosis/scar tissue was unknown. Product analysis was completed on the generator and lead. Results of diagnostic testing indicated that the battery status indicated ifi=no in the pa lab. The battery is 2. 889 volts (not at ifi). The data in the diagaccumconsumed memory locations revealed that 65. 153% of the battery had been consumed. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Review of internal memory shows that the high impedance occurred (b)(6) 2013. During the visual analysis of the returned 390mm portion the (+) connector ring quadfilar coil appeared to be broken approximately 331mm from the end of the connector boot. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, zirconium, sulphur and calcium. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
It was reported that the patient would have a full vns revision surgery due to high lead impedance. The device was replaced due to "malfunction of vns device and high lead impedance" on (b)(6) 2013, per the hospital. Device manufacturing records were reviewed and no unresolved non conformances were found. Attempts have been made for additional information; however, they have been unsuccessful.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #40 on: January 02, 2019, 01:57:31 AM »

Model Number 300-20
Event Date 01/14/2013
Event Type  Malfunction   
Event Description
Additional information was received that the product analysis was completed on the lead. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (+) marked quadfilar coil appeared to be broken approximately 69mm and 73mm from the connector bifurcation and at approximately 10mm from the electrode bifurcation with three broken coil strands at approximately 9mm. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil breaks (found at 69mm and 73mm) and identified the areas as having extensive pitting which prevented identification of the coil fracture type. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 10mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting. The area on the three broken coil strands was identified as being mechanically damaged. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the product analysis lab, there is evidence to suggest a discontinuity in the returned portion of the device. Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
It was initially reported that the patient had high impedance. The patient was sent for x-rays but they had not been provided to the manufacturer for review. The patient had their output current turned down to 0. 5 ma and the physician does no plan to turn the patient off. The patient also reported that he was experiencing a shocking sensation at the same appointment where the high impedance was discovered. The patient has a generator and lead replacement and the explanted products were returned to the manufacturer for evaluation. Product analysis is planned but has not been complete.
 
Manufacturer Narrative

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

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« Reply #41 on: January 08, 2019, 06:14:01 AM »

Model Number 300-20
Event Date 03/03/2014
Event Type  Malfunction   
Manufacturer Narrative
Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the generator was completed on (b)(4) 2014. Electrical test results showed that the pulse generator performed according to functional specifications. There were no adverse functional, mechanical, or visual issues identified with the returned generator. Analysis of the lead was completed on (b)(4) 2014. Note that the electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 197mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 25mm and 29mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 25mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type and residual material. Scanning electron microscopy was performed on the (+) marked connector quadfilar coil break (found at 29mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type with fine pitting on two of the broken coil strands. Pitting was observed on the coil surface. The abraded openings and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The abraded openings found on the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sulphur and calcium. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results revealed high lead impedance (impedance value ¿ 8620 ohms) during an office visit on (b)(6) 2014. The patient recently had some slips and falls. The patient underwent generator and lead replacement surgery due to high impedance on (b)(6) 2014. The generator was also replaced as diagnostic results revealed near end of service. The surgeon noted that there was a lot of scar tissue present. The explanted generator and lead have been returned to the manufacturer where analysis is currently underway. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2013.

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« Reply #42 on: January 08, 2019, 06:14:55 AM »

Model Number 302-20
Event Date 12/01/2013
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The explanted devices are expected to be returned to manufacturer for analysis, but have not been received to date.
 
Event Description
An implant card was received that corrected the date of explant.
 
Manufacturer Narrative

Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death.
 
Event Description
It was reported that device diagnostics resulted in high impedance (>10,000 ohms). It was reported that the diagnostics were within normal limits in (b)(6) 2013 and that the patient started to experienced an increase in seizures in (b)(6). The device was programmed off and the patient was sent for x-rays. It was reported that it is unsure if any trauma occurred that could have caused or contributed to the high impedance, but that the patient experiences drop attacks and the high impedance may be trauma related. It was reported that the seizures were back to pre-vns baseline frequency. The patient was referred to surgery. Surgeon noted that x-rays did not identify a clear lead break, but that the images would be sent to manufacturer for review. Review of x-rays did not identify any obvious discontinuities with the lead. Surgery is likely, but has not occurred to date.
 
Event Description
Analysis of the returned generator was completed. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
The generator and lead were received for analysis. Analysis of the lead was completed on 06/12/2014. The lead assembly was returned intact. During the visual analysis the (+) connector ring quadfilar coil appeared to be broken approximately 322mm from the end of the connector boot. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as having extensive pitting which prevented identification of the coil fracture type with mechanical damage. Scanning electron microscopy was performed on the electrode (mating) end of the (+) connector ring quadfilar coil break (found at 322mm) and identified the area as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus and calcium. With the exception of the observed discontinuity, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. Analysis of the generator is underway, but has not been completed to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #43 on: January 10, 2019, 01:10:49 AM »

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

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« Reply #44 on: January 11, 2019, 01:36:02 AM »

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

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« Reply #45 on: January 12, 2019, 01:44:15 AM »

Model Number 302-30
Event Date 03/17/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Analysis of the lead was completed on 04/22/2014. During the visual analysis the (+) white electrode quadfilar coil appeared to be broken approximately 1. 5mm from the proximal end of the anchor tether. Scanning electron microscopy was performed identified the area as being mechanically damaged with pitting. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy, provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that device diagnostics resulted in high impedance and the patient was referred for surgery. The patient underwent generator and lead replacement on (b)(6) 2014. Pre-operative device diagnostics resulted in high impedance. The explanted generator and lead were returned for analysis on (b)(6) 2014. Analysis of the generator was completed on (b)(6) 2014. The device performed according to functional specifications. Analysis of the generator in the pa lab concluded that no abnormal performance or any other type of adverse condition was found; however, during decontamination an elective replacement indicator was observed. Analysis of the lead is underway, but has not been completed to date. Further follow-up revealed that no patient manipulation or trauma occurred that is believed to have caused or contributed to the high impedance. Attempts to obtain additional information have been unsuccessful to date.

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« Reply #46 on: January 23, 2019, 01:17:42 AM »

Model Number 300-20
Event Date 06/02/2014
Event Type  Malfunction   
Event Description
Additional information was received that the generator and lead were returned to the manufacturer for evaluation. Product analysis was completed on the generator but has not been completed on the lead. In the pa lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 945 volts, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 14. 910% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received that product analysis was completed on the lead. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on the (-) unmarked connector inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, sulphur, chlorine and calcium. Refer to eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portion of the device which may have contributed to high impedance. Note that since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Event Description
It was reported that device diagnostics resulted in high impedance (> 10,000 ohms). It was reported that the patient was reporting an increase in seizures. It was noted that the patient suffers from drop attacks which are believed to be due to the high impedance. It was reported that the drop attacks are normally controlled with vns. There was no recent trauma and the patient did not manipulate the device through the skin. The patient underwent generator and lead replacement. The explanted devices are expected to be returned for analysis, but have not been received to date.

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« Reply #47 on: January 23, 2019, 01:18:36 AM »

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

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« Reply #48 on: January 27, 2019, 04:57:10 AM »

Model Number 302-20
Event Date 09/16/2012
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
An evaluation of data obtained from the generators memory revealed that a >25% change in system impedance was estimated to have occurred on (b)(6) 2012 (3235 ohms to 12832 ohms) signifying the start of the high impedance event. A high impedance warning message was first received during a follow up visit on (b)(6) 2012 during an interrogation of the patient¿s generator.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report indicated the event occured in (b)(6) 2013 however, a review of the generator data suggests that the high impedance was first detected on (b)(6) 2012. The information has been corrected in this report.
 
Event Description
On (b)(6) 2013, it was reported that high impedance was seen regarding this patient¿s device. Follow-up showed that the high impedance was first noted in (b)(6) 2013 at which time the device was disabled. The patient was inconsistent with follow-up. At the last visit, many months prior, diagnostics were within normal limits. Clinic notes dated (b)(6) 2013 were provided. The patient was seen after a long hiatus, and the mother reported that the patient was having more seizures. The patient was seen by a different facility two months prior and was taken off of vimpat. Monitoring of the vns device showed likely dislodgement of the leads. It was recommended that the device was disabled, and appropriate adjustments were made. Clinic notes dated (b)(6) 2013 indicated that patient was having more frequent seizures; however, the physician noted that there was a very unconvincing description of the individual instances: the patient had a right hand tremor, and the mother pointed to it indicating a seizure. It was noted that the patient was treated with a powerful combination of anticonvulsants, including a very high dose of banzel. However, dosing and choice of anticonvulsants remained constricted by the interventions of the patient¿s mother who believed that the medications were causing behavioral issues and overlooked the prominent mental retardation. There was no specific injury or manipulation, but this was possible given the patient¿s mrdd and occasional aggression issues. X-rays had not been taken. Surgery is likely but has not taken place.
 
Event Description
On (b)(6) 2013, this vns patient underwent a full revision. The explanted lead and generator were returned on (b)(6) 2013 and are pending analysis.
 
Event Description
An analysis was performed on the returned lead portions. Note that a portion of the lead assembly (body) including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing calcium, sodium, magnesium, potassium, zirconium, silicone, phosphorus and sulphur. Refer to attached eds sheet for additional information. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device. The pulse generator was explanted/returned due to "prophylactic replacement". In the lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 963 volts as measured during completion of test parameter 7. 16. 10. 2 (measured diagvbat) of the final electrical test, shows a non-ifi condition. The data in the diagaccumconsumed memory locations revealed that 11. 067% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #49 on: January 27, 2019, 04:58:02 AM »

Model Number 300-20
Event Date 03/14/2014
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were returned to the manufacturer for analysis. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the as-received internal device data showed that the last 25% change in the impedance value was on (b)(6) 2014. Analysis of the returned lead is currently underway.
 
Manufacturer Narrative
Date of event; corrected data: additional information indicates that high impedance event occurred at least on (b)(6) 2014.
 
Event Description
It was reported that pre-operative diagnostics for generator replacement surgery resulted in high impedance. It was reported that the patient's device was interrogated for the first time in several years. It was reported that both the generator and lead were replaced. The patient was in a motor vehicle accident in 2012; however, it was unknown if this contributed to the high impedance. An implant card was received indicating that the generator and lead were replaced due to lead discontinuity (>10,000 ohms) and near end of service. It was reported that the explanted devices were discarded by the explanting facility; therefore, no analysis can be performed.
 
Event Description
Analysis of the lead was completed on 10/09/2014. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 88mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 13mm past the end of the torn connector silicone / inner silicone tubes. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, pitting on two of the broken coil strands, no pitting on one of the broken coil strands and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture was observed on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (-) unmarked connector quadfilar coil appeared to be broken approximately 2mm and 4mm from the end of the connector bifurcation. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 2mm) and identified the area on three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on two of the broken coil strands. Scanning electron microscopy was performed on the (-) unmarked connector quadfilar coil break (found at 4mm) and identified the area three of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on one of the broken coil strands. The area on the fourth broken coil strand was identified as being mechanically damaged which prevented identification of the coil fracture type and no pitting. Pitting was observed on the coil surface. During the visual analysis of the returned 170mm portion the (+) marked connector quadfilar coil appeared to be broken approximately 4mm from the end of the connector bifurcation. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (torsional appearance) which most likely completed the fracture on three of the broken coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings and slice marks found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The slice mark found on one of the inner silicone tubes and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, potassium, aluminum, sulphur, chlorine and calcium. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.

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« Reply #50 on: January 28, 2019, 05:00:04 AM »

Model Number 302-30
Event Date 08/14/2014
Event Type  Malfunction   
Event Description
It was reported that the patient underwent generator and lead replacement. The generator and lead were received for analysis. Generator analysis was completed on 12/08/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway, but has not been completed to date.
 
Event Description
Analysis of the lead was completed on 12/11/2014. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 2. 5mm from the electrode bifurcation (and the coil appeared to be kinked). The (+) connector ring quadfilar coil appeared to be broken approximately 3mm from the electrode bifurcation. Scanning electron microscopy was performed on the (-) connector pin quadfilar coil break (found at 2. 5mm) and identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. Pitting was observed on the coil surface. Scanning electron microscopy was performed on the connector end of the (+) connector ring quadfilar coil break (found at 3mm) and identified the area as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuities the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes dated (b)(6) 2014 note that interrogation of the device showed high impedance and was verified with a second interrogation. The patient was referred for surgery. No known surgical intervention has been performed to date. No additional relevant information has been received to date.

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« Reply #51 on: February 01, 2019, 11:18:05 AM »

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

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« Reply #52 on: February 04, 2019, 01:08:49 AM »

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

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« Reply #53 on: February 06, 2019, 01:18:33 AM »

Model Number 104
Event Date 11/11/2014
Event Type  Death   
Event Description
Analysis of the lead was completed on 12/15/2014. Note that the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, sulphur and calcium. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Analysis of the generator was completed on 12/16/2014. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
It was reported that the vns patient passed away. The funeral home indicated that the patient passed away at home and no autopsy would be performed. The cause of death was noted to be intracerebral hemorrhage. The device was explanted and received for analysis. Analysis is underway, but has not been completed to date.

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« Reply #54 on: February 21, 2019, 11:30:06 AM »

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

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« Reply #55 on: February 25, 2019, 01:17:22 AM »

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

Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
Product analysis of the returned generator was completed on (b)(4) 2015. The generator performed according to functional specifications. Analysis in the product analysis lab concluded proper functionality of the generator and that no abnormal performance or any other type of adverse condition was found. Analysis of the lead was completed on (b)(4) 2015. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the (-) connector pin quadfilar coil appeared to be broken approximately 306mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type with residual material. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. During the visual analysis the (+) connector ring quadfilar coil appeared to be stretched and kinked approximately 273mm past the end of the cut / torn inner silicone tubes with a spot-weld / slug attached to the end. Scanning electron microscopy was performed and revealed a spot-weld / slug at the end of the coil attached to a portion of the ribbon. The abraded openings and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. The abraded openings found on the (-) connector pin inner silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the inner silicone tubing. For the observed dried remnants of what appeared to have once been body fluids found inside the (+) connector ring inner silicone tubing, there was no obvious path for fluid ingress other than the cut ends that were made during the explanted process. What appeared to be white deposits were observed on the outer silicone tubing. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium, aluminum, sulphur and calcium. With the exception of the observed discontinuity the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #56 on: February 26, 2019, 01:19:40 AM »

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

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« Reply #57 on: March 13, 2019, 12:21:36 AM »

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

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« Reply #58 on: March 14, 2019, 03:52:31 AM »

Model Number 102
Device Problem Entrapment of Device
Event Date 09/21/2015
Event Type  Malfunction   
Manufacturer Narrative

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

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« Reply #59 on: March 14, 2019, 03:53:25 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/06/2015
Event Type  Malfunction   
Event Description
It was reported that vns device diagnostics resulted in high impedance. A dc-dc code 7 was observed during the normal mode and system mode diagnostic tests. No patient adverse events were reported. It was reported that the patient's device was turned off on (b)(6) 2015. No known surgical interventions have been performed to date. No additional relevant information has been received to date.
 
Event Description
Further information was received indicating that the patient underwent full revision surgery on (b)(6) 2015. It was reported that the lead was replaced due to lead break and the generator was prophylactically replaced. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits. Return of the explanted lead to the manufacturer is expected but it has not been received to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Event Description
The explanted lead was returned to the manufacturer on (b)(6) 2015. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis was completed on the returned lead portions and the reported allegations was confirmed. Note that the anchor tether, portions of the (+) white and (-) green electrode inner silicone tubes and quadfilar coils were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 417mm portion the end of the connector ring quadfilar coil appeared to be broken approximately 12mm from the electrode bifurcation. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as having extensive pitting which prevented identification of the coil fracture type with residual material. The remaining broken coil strands was identified as being mechanically damaged (smooth surfaces) with pitting which prevented identification of the coil fracture type. Pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed on the inner silicone tubing of the returned 14mm portion. Energy dispersion spectroscopy was performed on the deposit and identified the deposit as containing silicon, phosphorus, sodium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified.

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« Reply #60 on: March 16, 2019, 12:13:36 AM »

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

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« Reply #61 on: March 19, 2019, 12:22:13 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/01/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was admitted to the hospital due to an increase in seizures. A system diagnostic test was later performed for patient and high impedance with dcdc 7 was observed. Additional information was obtained that the patient was discharged then re-admitted due to a generalized seizure. Patient was referred for replacement surgery and underwent full revision surgery on (b)(6) 2015. The explanted products are expected to be returned but have not been received to date.
 
Event Description
Generator and lead were returned due to lead discontinuity and were received on 11/30/2015. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator. Analysis of the lead is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of ¿fracture of leads and high impedance¿ were confirmed. A portion of inner silicone tubing and quadfilar coil between the electrode bifurcation and anchor tether was not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Analysis confirmed discontinuity of both positive and negative quadfilar coils in the electrode region of the returned lead portions. Scanning electron microscopy was performed on the area of the break on quadfilar coil 1; the remaining coil strand was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, no pitting and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture. Flat spots and pitting was observed on the coil surface. Scanning electron microscopy was performed on the quadfilar coil 2 coil break area and the area was identified as having extensive pitting which prevented identification of the coil fracture type. Flat spots and pitting was observed on the coil surface. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, sulphur and calcium. Refer to attached eds sheet for additional information. With the exception of the observed discontinuities the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

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« Reply #62 on: March 23, 2019, 12:13:29 AM »

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

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« Reply #63 on: March 25, 2019, 12:16:13 AM »

Model Number 302-20
Device Problem High impedance
Event Date 07/01/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the patient's vns device was showing high lead impedance upon interrogation. It was reported that the patient experienced a breakthrough seizure in (b)(6) 2015, after previously having been seizure free. The physician assessed this increase in seizures to a loss of therapy from the high impedance. No known surgical interventions have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received via clinic notes that this patient's vns impedance was reportedly normal during initial implant in 2011. No additional relevant information has been obtained to date.
 
Event Description
Patient underwent full revision surgery on (b)(6) 2016. The explanted devices were received on (b)(6) 2016. Analysis is underway but has not been completed.
 
Event Description
An analysis was performed on the returned lead portions and the reported allegations of fracture of leads was confirmed. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Visual analysis and scanning electron microscopy confirmed two broken coil strands as having extensive pitting. The area on a third broken coil strand was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. The area on the fourth broken coil strand was identified as having evidence of being worn to the point of fracture with flat spots on the coil surface. Pitting and flat spots were observed on the coil surface. Multiple areas on the broken coil strands had evidence of a stress induced fracture (fatigue appearance) with mechanical damage and pitting. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. An abraded inner tubing opening near the break location was also observed. What appeared to be white deposits were observed on the connector boot. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted except for the half set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. In the (b)(4) lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

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« Reply #64 on: March 29, 2019, 07:26:53 AM »

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

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« Reply #65 on: March 30, 2019, 01:03:57 AM »

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

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« Reply #66 on: March 31, 2019, 06:34:44 AM »

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

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« Reply #67 on: April 10, 2019, 12:46:52 AM »

Model Number 103
Event Date 06/14/2016
Event Type  Injury   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient developed an post-operative infection at the surgical site following a recent generator replacement surgery on (b)(6) 2016. A surgery was planned initially for the device removal. The surgeon later elected to hold off on the explant surgery that was scheduled as the patient's blood work was much better and so was the would at incision site. Additional relevant information has not been received to date. A review of device history records showed that the generator was sterilized prior to distribution.
 
Event Description
Additional information was received on (b)(6) 2016 that the patient still has infection. Patient underwent explant of the vns generator and lead on (b)(6) 2016 due to infection. The explanted devices have not been received to date.
 
Event Description
The explanted generator and lead were received for analysis on 09/29/2016. Verification of the alleged ¿infection¿ is beyond the scope of activities performed in the pa laboratory environment. However, potential contributing factors to this condition have been considered / evaluated and none were found to exist in this situation. The dhr shows that the pulse generator passed all specifications prior to its release. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 973 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator. An analysis was performed on the returned lead portions for the reported allegation of; ¿explanted / due to infection¿ (lead and patient sections). The allegation is not an actionable issue. The electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium, molybdenum and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except for the set of setscrew marks found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator at one time. Additional setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaint.
\
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« Reply #68 on: April 11, 2019, 01:38:42 AM »

Model Number 302-20
Event Date 06/14/2016
Event Type  Malfunction   
Manufacturer Narrative

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

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« Reply #69 on: April 12, 2019, 12:14:26 AM »

Model Number 304-20
Event Date 05/01/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a vns patient's device showed low impedance at 600 ohms. No injuries, falls, or trauma were reported. It was stated by the patient's mother that they get efficacy from the magnet. The patient has been referred for full revision. Clinic notes were received indicating that the vns magnet was initially effective, but is now no longer effective. An increase in seizures since may 2016 was documented and was attributed to "vns dysfunction resulting in low impedance value on interrogation. " the device had been programmed off on (b)(6) 2016. Lead and generator revision surgery occurred on (b)(6) 2016. A lead break was visualized approximately one-third of the distance from the generator. The explanted devices have not been received to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the relevant test data was inadvertently not included in the initial report.
 
Event Description
The explanted devices were received for analysis on 10/05/2016. Analysis was performed on the returned lead portion 10/24/2016. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The outer silicone tubing appeared to be twisted and abraded openings were observed on the outer and inner silicone tubes. The coils were bare and exposed in the areas of the abraded openings. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, sulphur and calcium. With the exception of the twisted appearance and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis was completed for the returned generator 10/27/2016. The downloaded from the generator shows an indication of decreased impedance, as the last >25% change in impedance value showed the pre-change impedance value was 63 ohms and the post-change value was 257 ohms, with a time of change detection on (b)(6) 2016. The device was explanted later on (b)(6) 2016. Review of the manufacturer's programming history database shows the last known diagnostic test was performed on (b)(6) 2016 with an impedance value of 1812 ohms. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery measured 3. 055 volts and shows an intensified follow-up indicator was not set. 18. 519% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator. Review of the downloaded generator data revealed no anomalies.

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« Reply #70 on: April 12, 2019, 12:15:10 AM »

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

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« Reply #71 on: April 17, 2019, 06:28:36 AM »

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

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« Reply #72 on: April 19, 2019, 12:44:13 AM »

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

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« Reply #73 on: April 24, 2019, 12:31:00 AM »

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

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« Reply #74 on: April 24, 2019, 12:31:49 AM »

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

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« Reply #75 on: April 26, 2019, 05:58:44 AM »

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

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« Reply #76 on: May 09, 2019, 06:54:01 AM »

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

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« Reply #77 on: May 14, 2019, 12:16:48 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/08/2016
Event Type  Injury   
Event Description
The nurse practioner is referring patient for full revision due to migration. Replacement was stated to be necessary because patient's current vns has migrated to the edge of the chest wall, rendering access very difficult. No known surgical interventions have occurred to date. Additional relevant information has not been received to date.
 
Event Description
Additional information was received that the device migration occurred between visits in (b)(6) 2016 and (b)(6) 2017. There are no known causes for the migration such as trauma or manipulation. Surgical intervention is planned to preclude a serious injury. The previous implant surgeon confirmed that a non absorbable suture was used to secure the generator to fascia during the implant. No known surgery has occurred to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead were received. The pulse generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There are no performances or any other type of adverse conditions found with the pulse generator. Analysis of the lead is underway but has not been completed to date.
 
Event Description
Analysis of the received lead was completed. The electrodes were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. The abraded openings found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Energy dispersion spectroscopy (provides chemical or element identity/composition analysis) was performed on the deposit observed on the unmarked connector boot and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The set screw marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device.

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« Reply #78 on: June 15, 2019, 10:48:33 PM »

Model Number 302-20
Device Problems Fracture; Appropriate Term/Code Not Available
Event Date 01/01/2017
Event Type  Malfunction   
Manufacturer Narrative

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

Event Description
During the visual analysis, multiple quadfilar coils appeared to be broken. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture. Determination could not conclusively be made on the fracture mechanism. Pitting and residual material were observed on the coil surface. Scanning electron microscopy identified an area on three of the broken coil strands as being mechanically damaged which prevented identification of the coil fracture type with pitting on one and residual material on the other two broken coil strands. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. The abraded opening / torn areas found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed on the deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. Since a portion of the lead assembly including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

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