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Author Topic: Fluids Within Lead  (Read 42127 times)
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dennis100
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« Reply #660 on: April 16, 2019, 12:33:48 AM »

Model Number 304-20
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Initial reporter phone#: (b)(6).
 
Event Description
High impedance was identified on a system diagnostic test on (b)(6) 2016. The generator was programmed off after the high impedance was identified. The patient underwent full replacement on (b)(6) 2016. X-rays were provided to the manufacturer and reviewed. The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact. The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling. No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin. Sharp angles were observed in the portion of the lead near the generator. A gross fracture was identified in the lead. The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.
 
Event Description
The explanted lead and generator were both returned to have product analysis performed. The lead was returned in two portions. During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed. The connector boot also appeared detached from the connector ring surface. Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil's surface. Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type. During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture. Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting. Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing. Dried remnants of what appeared to be body fluids was found within the inner tubing. The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016. Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms. The battery voltage was found at 2. 956v and approximately 45% of the charge had been consumed. The generator was found as conforming to all functional specifications.
 
Manufacturer Narrative
Supplemental report #1 inadvertently did not update the event date per the new information identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5974973
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dennis100
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« Reply #661 on: April 16, 2019, 12:34:45 AM »

Model Number 302-20
Event Date 08/25/2016
Event Type  Malfunction   
Event Description
During a prophylactic generator replacement surgery, the surgeon saw the lead was tied in a knot. When he straightened the lead out, he noticed the insulation of the lead was degraded. Impedance on the previous device was less than 600ohms. Therefore the surgeon performed a full revision surgery. The explanted devices were received on 09/20/2016. Analysis is underway but has not been completed to date.
 
Event Description
An analysis was performed on the returned lead portions and the reported "mechanical problem / abraded insulation" (lead section) allegation was verified. 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 outer silicone tubing appeared to be compressed, twisted with abraded openings, in several areas. During the visual analysis, multiple lead portions appeared to be melted. What appeared to be spatter and pitting was found on the surface of the quadfilar coil strands. Based on the obvious signs of melting 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. The abraded openings and melted appearance 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. For the observed inner tubing fluid remnants, there was no obvious path for fluid ingress other than the melted / torn ends that were made during the explanted process. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. 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, 2. 813 volts, shows an ifi=no condition. There were no performance or any other type of adverse conditions found with the pulse generator.

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dennis100
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« Reply #662 on: April 17, 2019, 06:53:43 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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dennis100
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« Reply #663 on: April 21, 2019, 03:22:01 AM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 04/01/2016
Event Type  Malfunction   
Event Description
The mdr with the manufacturing number 1644487-2016-02697 houses the report of the header becoming detached from the patient's generator. Information was received which indicated that high impedance was seen on the patient's generator during a system diagnostic on (b)(6) 2016. The patient had been experiencing a change in seizure pattern and increase in the frequency of seizures since (b)(6) 2016. The patient had begun experiencing more convulsive seizures and status epilepticus. The physician elected to adjust the patient's medications. The patient's device was also found to be at end of service. The patient was referred to obtain a replacement. Surgery occurred on (b)(6) 2016 where the patient had their generator removed. A new generator was introduced and the patient's lead was contended. The high impedance persisted so the lead was replaced. No other relevant information has been received to date. The explanted product has not been received to date.
 
Manufacturer Narrative
Human error allowed the inappropriate term of contended to be used rather than connected.
 
Event Description
The patient's explanted lead has been received and is undergoing product analysis which has not been completed to date. Product analysis was completed on the generator used during surgery to test the lead and no anomalies were found. No additional relevant information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the patient's explanted generator. During analysis, the elective replacement indicator (eri) flag was set. An open can measurement of the battery voltage confirmed that the eri flag had been properly set; the device was operating at low battery voltage. Based on the bench analysis and the electrical test results, the device exhibited current consumption rates that were within specification; thereby, demonstrating normal battery depletion to a ¿depleted¿ condition. " product analysis was completed on the patient¿s lead. Lead continuity was tested and it was found that there was a discontinuity with the lead. Scanning electron microscopy images of the negative coil shows pitting and corrosion at the break location. The break appears to be stress induced in at least two strands of the coil. The lead insulation tubing was punctured by the negative electrode past the electrode bifurcation. Lead assembly has dried remnants of body fluid inside the inner silicone tubing at the connector region no obvious point of entrance was noted. No other anomalies were found that impacted the functionality of the device. The electrodes were not returned. No other relevant information has been received to date.

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dennis100
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« Reply #664 on: April 22, 2019, 12:34:07 AM »

Model Number 302-20
Device Problems Fluid Leak; High impedance
Event Date 08/16/2016
Event Type  Malfunction   
Event Description
It was reported that the patient had a lead replacement surgery for high impedance. Additional information from a company representative was received. A lead fracture was not visualized during the surgery and incomplete pin insertion was ruled out as the cause of the high impedance. Attempts to retrieve the lead have been made, but the lead has not been received to date. Additional relevant information has not been received to date.
 
Event Description
The physician stated the date the high impedance was first discovered through interrogation of the device on (b)(4) 2016. The physician stated that falls due to seizures could have possibly contributed to the high impedance. The physician stated the impedance was ok when the current generator was placed. The physician did an assessment on patient x-rays. The assessment indicated a new configuration of the device in the upper left chest since prior radiographs. Ap lateral, repeat lateral, and oblique view of the vagus nerve stimulator device was performed showing nothing definitive for a lead disruption. There was a questionable gap upper limb vagus nerve stimulator lead on the oblique view, but when viewed in multiple other projections, no lead disruption can be confirmed, particularly the lateral view. The leads that extend downward in the chest to the generator appear intact. There appears to be a portion of the lead behind the generator that could not be assessed. The chest radiograph is normal otherwise. No definite lead disruption was indicated to have been seen when considering findings on four radiographs the explanted generator was received on 11/21/2016. Analysis is underway, but hasn't been completed to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: the generator replacement and return is reported in mfr. Report # 1644487-2016-02567. Previous supplemental mdr #1 inadvertently did not add this information. Previous supplemental mdr #1 inadvertently stated that the lead was returned, however the generator was returned, not the lead. The generator return is captured in mfr. Report # 1644487-2016-02567. Previous supplemental mdr #1 inadvertently stated that the lead was returned to the mfr, however the generator was returned, not the lead. The generator return is captured in mfr. Report # 1644487-2016-02567. Previous supplemental mdr #1 inadvertently stated that the lead was returned to the mfr and was awaiting analysis, however the generator was returned, not the lead. The generator return is captured in mfr. Report # 1644487-2016-02567.
 
Event Description
A return product form was received for the lead. The lead was not returned, however in the form it listed the reason for the lead return as "leads had fluid in them". Additional information from a nurse practitioner with the physician's operative notes was received. She stated that the surgeon did see fluid in the old lead from the lead replacement. Information from a livanova therapeutic consultant indicated that the reason for the fluid leak was that during the explant procedure, the surgeon cut the lead. He stated this was a normal part of the procedure and the cut was not pre-existing. He said this was the reason for the earlier report from the nurse practitioner. While the company representative believed that the fluid in the lead came from the surgeon cutting the lead as part of the explant process, this could not be confirmed to be the only source of fluid entering the lead. A device history review was performed and no unresolved non conformances were found. Analysis was performed on the returned generator. Review of the data downloaded shows an indication of increased impedance. On the implant date, the impedance was within normal limits at 2275 ohms. In (b)(6) 2016, the impedance was noted to be high at 11,405 ohms. On the date of explant, the impedance was noted twice; once at 4000 ohms, and another time at 17,985 ohms. The 4000 ohms was likely from a test with a test resistor, which indicates the generator was functioning properly. The 17,985 ohms was likely after the lead pin was re-inserted, which provides evidence that the lead is the cause of the high impedance. During analysis, interrogations and system diagnostics were performed and the device performed according to specification during testing with multiple resistances. The lead has not been received to date. The generator replacement, return, and analysis is captured in mfr. Report # 1644487-2016-02567 no additional relevant information has been received to date.
 
Event Description
Additional information indicates the hospital does not know what happened to the lead as they could not find it. It is possible that the lead was returned but it has not been received to date. No additional relevant information has been received to date.

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dennis100
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« Reply #665 on: April 22, 2019, 12:35:02 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 10/14/2016
Event Type  Malfunction   
Event Description
An implant card was received showing a full replacement for the patient during a prophylactic ifi replacement. Additional information was received from a company representative stating the reason the lead was replaced is the physician found the lead to have a cut in it during the replacement. The physician said that he did not cut the lead, therefore it seems to have been a pre-existing condition. He also said that the only pre-op diagnostic he saw was an ifi indicator. Per programming history date on (b)(6) 2016, diagnostics for the device were okay. Therefore the lead was likely functioning as intended up to the date of surgery and the patient was receiving intended therapy. The lead has not been received to date.
 
Event Description
The explanted lead was received on (b)(6) 2016. Analysis is underway, but hasn't been completed to date.
 
Event Description
Analysis was performed on the generator. The pulse generator performed according to functional specification. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was performed on the lead assembly. An abraded opening was identified in the outer silicone tubing. 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 portions. No obvious point of entrance was noted other than the identified outer tubing openings (for outer tubing fluid ingress) and the cut end of the returned lead portions (for inner tubing fluid ingress).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6082516
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dennis100
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« Reply #666 on: April 22, 2019, 12:36:07 AM »

Model Number 300-20
Event Date 07/12/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The patient underwent a generator replacement due to neos=yes on (b)(6) 2016. The patient's lead was replaced the same day for compatibility reasons. Prior to replacement surgery, system diagnostics confirmed system function. After surgery, two lead portions were received by the manufacturer for product analysis, however the electrode array was not included. The patient's lead was found to be fractured within the tubing and in the same area an abrasion in the outer and inner tubing was found. The abrasion was believed to be due to wear. Fluid was found within the lead inner tubing and this was attributed to the brasion. Regarding the lead fracture, two strands of the lead were fractured due to wear, the final strand of the lead was fractured due to rotational stress that likely occurred during product analysis continuity checks. Trauma or manipulation to the site of the abrasion and fracture was denied. No additional relevant information has been received to date.

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« Reply #667 on: April 22, 2019, 12:37:00 AM »

Model Number 302-30
Device Problems Corroded ; Fluid Leak
Event Date 09/13/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a lead and generator replacement and the reason for the replacement was initially unknown. Further follow-up found that high impedance was observed during a routine office visit. The generator was then disabled. The patient underwent lead and generator replacement surgery. The explanted products were received and are currently pending product analysis.
 
Event Description
Product analysis was completed on the explanted generator. The generator was successfully interrogated and the battery indicator was ifi = no. Analysis found that the generator performed according to functional specification. The internal data on the generator was reviewed and it indicated that the last >25% change in impedance occurred on (b)(6) 2016. The prechange value was 6,673 ohms and the post change value was 8,660 ohms. Both values are outside of the acceptable range for impedance value.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the received lead. Upon receipt it was noted that the lead was received in five portions. Visual analysis found that in two of the lead portions the quadfilar coils were fractured. Scanning electron microscopy was performed on the received lead portions. It was noted that there was evidence of pitting which indicated that stimulation was being provided to the lead after the fracture had occurred. The mechanism of the fractures appeared to be stress induced. Additionally, bodily fluids were found inside the inner tubing and it appeared that abraded openings in the inner and outer tubing had created a path of entry for the fluid. The cause of the abraded openings appeared to be normal wear. Analysis confirmed the presence of the lead fracture and additionally found evidence of pitting and abraded openings in the lead's inner and outer tubing.
 
Manufacturer Narrative
Methods: this information was inadvertently left off on mfg. Report #0. Results: this information was inadvertently left off on mfg. Report #2.

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« Reply #668 on: April 22, 2019, 12:38:00 AM »

Model Number 302-20
Device Problem Fluid Leak
Event Date 08/01/2016
Event Type  Malfunction   
Event Description
The surgeon reported finding high impedance on the patient's generator during a visit on (b)(6) 2016. There was no known trauma, but it was stated that trauma was "certainly possible given his condition". No revision surgery for the high impedance has occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported that the patient's underwent full revision of generator and lead due to high impedance. The suspect product was received for analysis. No further relevant information has been received to date.
 
Event Description
Analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. No anomalies were found, the internal data of the generator was reviewed and found that the last 25% change in impedance occurred on (b)(6) 2017 from impedance within normal limits (4281 ohms) to high impedance (5633 ohms). This suggests an intermittent lead fracture with fluctuating high impedance as high impedance was detected prior to (b)(6) 2017. Product analysis was completed on the lead. The lead assembly was returned in two portions. The electrode array was not returned, so a complete analysis could not be performed on the product. Set-screw marks were observed on the lead pin, which indicates that at one point in time there was a good electrical and mechanical connection between the lead and generator. There were multiple instances of abraded openings of the inner tubing and of the inner and outer tubing. Portions of the quadfilar coil were exposed. There were bodily fluids found in both the inner and outer tubing that were attributed to these openings. The cause of these abraded opening was determined to be wear. A lead fracture was nit found on the returned portions. Beyond the abraded openings, the condition of the lead was typical of that of leads after explant. No further anomalies found. No further relevant information has been received to date.

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« Reply #669 on: April 22, 2019, 12:42:00 AM »

Model Number 304-20
Device Problems Fluid Leak; Fracture
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
It was reported that the patient was having generator replacement due to neos, which became a full revision when a lead fracture was found. The surgeon said he did not cut the lead. It was reported that the patient had fallen some time ago (specific date unknown). The surgeon reported the patient was also experiencing an increase in seizures recently, which he believed may be due to the lead break. The device was interrogated during surgery, but no diagnostics could be run. A company representative stated this was because the device was actually eos pulse disabled, not neos. The programming tablet and wand were confirmed to be functioning. The explanted lead and generator was received on 11/08/2016. Analysis is underway, but hasn't been completed to date. Per a return product form, the adverse event listed stated "lead was off generator in the pocket. " no additional relevant information has been received to date.
 
Event Description
Per company representative, the statement the lead was not attached to its end in the generator header during the surgery. The lead being off the generator likely refers to the discontinuity in the lead. Analysis was performed on the returned generator. An end-of-service warning message was verified during analysis 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 generator was most likely at a near end of service state and the high energy exposure resulted in further energy depletion from the battery. This resulted in the observed ¿pulse-disable¿ condition. During analysis, the pulse generator would not interrogate (with a space of 0. 0 inches between the pulse generator and the programming wand). With the pulse generator case removed and the battery still attached to the printed circuit board assembly (pcba), the battery measured 1. 640 volts, confirming an eos condition. The data revealed that 113. 225% of the battery had been consumed. The electrical test results show that the pcba performs according to functional specifications, except that the c4 capacitor is out of specification. 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. There were no additional performance or any other type of adverse conditions found with the pulse generator. Analysis performed on the returned lead identified a break in the positive and the negative lead coils. The appearance of the lead suggests patient manipulation of the implanted device. Scanning electron microscopy images of the lead coils show that a stress-induced fracture (due to rotational forces) has occurred on the lead coils. The exact point in time of when it occurred is unknown. Also, secondary stress-fissures were noted in the vicinity of the broken strands. A cut in the outer silicone tubing was noted. Abrasions were noted on the outer silicone tubing at multiple locations. Organic matter covered the inside and outside of the coil ends at the lead break site. The lead assembly has dried remnants of what appear to have once been body fluids inside the inner silicone tubing. No obvious point of entrance was noted other than the identified tubing opening and the end of the returned lead portions. Note that since a portion of the lead (including the electrode array) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

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« Reply #670 on: April 24, 2019, 01:24:06 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 08/02/2016
Event Type  Malfunction   
Event Description
It was reported that the patient¿s generator registered high lead impedance shortly after generator replacement surgery on (b)(6) 2016. The generator was reported to have been pulse enabled leading up to the high impedance reading. During the appointment, the patient looked to the left, and the impedance moved from approximately 10,000 ohms to the 6000s ohms range. Lead impedance was reportedly within normal limits at the conclusion of the replacement surgery. X-ray images were received and reviewed by the manufacturer. The generator was placed normally per labeling. Due to the angle of the generator and quality of the image, the insertion of the lead pin could not be fully assessed. The feedthru wires appeared to be intact. The lead electrodes appeared to be appropriately placed per labeling. There were no apparent sharp angles or gross fractures of the lead that could be seen in the portions of the lead that could be visualized. The lead appeared obscured by the generator based on the lead tract. However, it is uncertain if the lead is actually behind the generator. Based on the x-rays received, the cause for the high impedance could not be determined. There was no visual indication of damage to the generator or lead. Nonetheless, the presence of a micro-fracture in the lead could not be ruled out. Surgery to address the high impedance has not occurred to date. No additional pertinent information has been received to date.
 
Event Description
It was reported that a high impedance flag continued to be observed on the patient¿s vns system. Multiple body positions were attempted with the same result. The patient¿s caregivers reportedly noted that they believed "something was wrong with [their] child's battery" in the summer of 2016 due to increased behaviors at school and home. The generator that was explanted in the previous generator replacement case underwent product analysis. When received, the internal data was downloaded from the pulse generator. Review of the data indicated that the generator had reached an end of service condition. Additionally, there was evidence of increased impedance during the use life of the generator. The suspect lead and paired generator were explanted. The explanted lead and generator were received by the manufacturer and are undergoing product analysis.
 
Event Description
Product analysis was completed on the other returned generator. Visual examination showed only observations consistent with the explant process; no surface abnormalities were noted on this device. The device output signal was monitored for more than 24-hrs in a simulated body temperature environment. The pulse generator showed expected level of output currents and no signs of variation. Both interrogation and system diagnostic tests were performed. 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 measured 2. 984 volts during functional testing and showed an ifi=no condition. The internal device data showed that 3. 159% of the battery had been consumed. The internal device data contained evidence of increased impedance during the implant life of the device. One day following the implant of the device, the generator registered a change of impedance from 5659 ohms to 13572. The extended impedance history also contained evidence of high impedance as early as the date of implant. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis was completed on the returned lead portions. Note that since a portion of the lead was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Setscrew marks were seen on the connector pin, providing evidence that proper contact between the setscrew and the connector pin existed at least once. Inspection of the first portion of the returned lead showed the outer silicone tubing has an abraded opening approximately 9. 4-10cm from the boot. Inspection of the second portion of the returned lead showed the outer silicone tubing is abraded open at approximately 21-21. 3cm from the boot. The lead assembly has dried remnants of what appear to have once been body fluids inside the outer silicone tubing due to the abraded outer tube openings. Impedance measurements to identify potential discontinuities were performed, and showed no discontinuities within the returned lead portions. Other than the above mentioned observations and typical wear and explant related observations, no anomalies were identified in the returned lead portions.

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« Reply #671 on: April 24, 2019, 01:25:02 AM »

Model Number 303-20
Device Problem Fluid Leak
Event Date 10/03/2016
Event Type  Malfunction   
Event Description
It was reported that a vns patient was referred for full revision as the last device interrogation resulted in high lead impedance. Clinic notes were received form a visit dated (b)(6) 2016 which provided that the patient's generator was interrogated and showed high impedance of greater than 10,000 ohms. The physician reduced the settings from 3. 0 ma to 2. 5 ma and pulse width increased from 250 to 500 and did not disable the device. Battery life was reported to be at 50%. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred on (b)(6) 2017. The explanted devices have not been received by the manufacturer to-date.
 
Manufacturer Narrative
Date received by manufacturer, corrected data: the date received by manufacturer was inadvertently provided as 02/15/2017, when it was intended to be 03/09/2017 for follow-up report #2 as this was a correction report only.
 
Manufacturer Narrative
Date returned to manufacturer, corrected data: the date the device was returned was inadvertently not provided in follow-up report #1. Device evaluated by manufacturer, corrected data: the field for device evaluation was inadvertently not marked in follow-up report #1.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. An electrical evaluation showed that the generator performed according to functional specifications. The battery measured 2. 989 volts and did not show an end-of-service condition. The downloaded data revealed that 59. 694% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the generator. Analysis was completed on the returned lead portion. A portion of the lead assembly including the electrodes was not returned for analysis and a complete evaluation could not be performed on the entire lead product. The connector pin tri-filar coil appeared to be broken approximately 249mm from the end of the connector boot. Scanning electron microscopy was performed and identified the area as having evidence of a stress induced fracture with fatigue appearance and mechanical damage, pitting on one of the broken coil strands and evidence of a stress induced fracture due to rotational forces on two of the broken coil strands. Pitting and residual material were observed on the coil surface. The abraded openings found on the bilumen tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the bilumen tubing. 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 #672 on: April 24, 2019, 01:25:59 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 #673 on: April 26, 2019, 06:17:54 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 #674 on: April 29, 2019, 05:32:57 AM »

Model Number 304-20
Device Problem Fracture
Event Date 01/20/2017
Event Type  Malfunction   
Event Description
High impedance of 9000 ohms was observed for patient's device. Patient underwent lead revision surgery as a result. The explanted lead has not been received to date.
 
Event Description
The suspect lead was received. Analysis is underway but has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
A portion of the lead assembly was 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 185 mm and 192 mm from the end of the connector boot. Scanning electron microscopy was performed on the connector pin quadfilar coil break and the area was identified as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage, fine pitting on one of the broken coil strands and evidence of a stress induced fracture (rotational forces) which most likely completed the fracture on two of the broken coil strands. Scanning electron microscopy was performed on the connector pin quadfilar coil break 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 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. 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 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 portion were performed, during the visual analysis, and no other discontinuities were identified. Based on the findings in the lab, there is evidence to suggest a discontinuity in the returned portion of the device which may have contributed to the stated high impedance. The pulse generator was explanted/returned due to ¿prophylactic replacement¿. 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. There were no performance or any other type of adverse conditions found with the pulse generator.

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« Reply #675 on: April 29, 2019, 05:33:57 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture; High impedance
Event Date 01/25/2017
Event Type  Malfunction   
Event Description
It was reported that the patient¿s vns system registered high lead impedance. There was no suspected trauma to the area of the vns. Follow up with the neurology office showed that the patient was being referred for surgery, but surgery had not occurred to date. The device was confirmed to have been disabled after the high impedance was encountered. The generator and lead device history records were reviewed, and it was found that all specifications were met prior to distribution. No additional pertinent information has been received to date.
 
Event Description
The patient¿s implant card from the preceding implant surgery was reviewed. It was found that impedance was within normal limits at the time of completion of surgery. No additional pertinent information has been received to date.
 
Event Description
It was reported that the patient¿s lead was replaced in surgery. When the surgeon opened up the patient¿s generator pocket, the lead was observed to have an obvious lead break about 6 inches from the connector pin. Based on the appearance of the lead, the surgeon expressed the patient likely excessively manipulated the lead. The suspect lead was received by the manufacturer and is undergoing product analysis. No additional pertinent information has been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that the electrodes were not returned for analysis. Therefore, a complete evaluation could not be performed on the entire lead. During the visual analysis, the ends of both the connector pin and connector ring quadfilar coils appeared to be broken approximately 8mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the connector pin coil break and identified the area as having evidence of electro-etching and residual material. Sem was performed on the connector ring coil break 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. An abraded opening found on the outer silicone tubing likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. With the exception of the above observations, 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 a good mechanical and electrical connection was present at one point in time. Continuity checks of the returned lead portion were performed and no other discontinuities were identified.

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« Reply #676 on: April 29, 2019, 05:34:58 AM »

Model Number 304-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/08/2017
Event Type  Malfunction   
Event Description
A call was received from a physician indicating that high impedance was seen with the patient's device. The patient's device was then programmed off. There was no reported trauma or manipulation that is believed to have caused the high impedance. No x-rays were taken at this time and no surgical intervention has occurred to date. A decoder revealed that no high impedance had been seen as of (b)(6) 2016. No other relevant information has been received to date.
 
Event Description
It was reported that the patient was underwent lead and generator replacement surgery. The surgeon found that the lead appeared intact and the old electrodes appeared to be in full contact with the nerve however it was the surgeon's opinion that the strain relief of the previous lead was not adequate. However the placement of the previous lead has not been evaluated by the manufacturer therefore its unclear if the strain relief was placed per labeling. The surgeon also noted that there was fibrosis adhering the lead electrodes to the vagus nerve and the jugular vein. The surgeon did not want to disturb the scar tissue so the lead was clipped at the electrodes and the new electrodes were implanted above the old electrodes. The explanted lead and generator have not been received to date.
 
Manufacturer Narrative
"the explanted lead and generator were received. " this information was inadvertently left off on mfg. Report #1. Corrected data: device available for evaluation; this information was inadvertently left off on mfg. Report #2. Corrected data. Device evaluated by mfr; this information was inadvertently left off on mfg. Report #1. Corrected data: (b)(4).
 
Event Description
The explanted lead and generator were received. Analysis was completed for the generator and found that the device met functional specification. During test various electrical loads were attached to the generator and the results of subsequent diagnostic tests were as expected.
 
Event Description
Analysis was completed on the lead. It was noted that the lead was received in one portion however the segment containing the electrodes and tie downs was not returned. Setscrew marks were observed on the lead¿s connector pin; indicating that there was proper contact between the lead and generator at one point in time. Fractures were identified in the quadfilar coil in two parts of the lead. Scanning electron microscopy was used to evaluate the lead fracture and observed signs of pitting which indicates that stimulation was being provided after the fracture occurred. Abrading openings were also identified in the outer tubing and bodily fluid was found inside the outer tubing in various locations.

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« Reply #677 on: April 29, 2019, 05:35:54 AM »

Model Number 302-20
Device Problem High impedance
Event Date 12/09/2016
Event Type  Malfunction   
Event Description
It was reported that a patient underwent a replacement surgery and after replacing the generator, high impedance was identified consistently. Intra-operative impedance values were normal, but post-op impedance values were high. Further follow-up found that the explanted generator had trouble establishing communication. This event was reported under mfr report # 1644487-2017-02969. The lead was reportedly visually inspected by the explanting surgeon and no breaks were found, but there were fluid breaches in the tubing. The patient's new generator was then removed because the high impedance could not be resolved.
 
Event Description
The explanted generator was reportedly discarded after surgery.

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« Reply #678 on: May 01, 2019, 12:29:02 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
A patient underwent a full revision surgery due to a reported high impedance event. The post-op impedance values were reportedly within normal limits. The explanted lead was sent to the manufacturer for product analysis. Analysis has not been completed to date. No further relevant information has been receive to date.
 
Manufacturer Narrative
The initial report inadvertently stated that the device had not been returned for evaluation when it had actually been returned the day prior (b)(6) 2017).
 
Manufacturer Narrative
(b)(4).
 
Event Description
An analysis was performed on the returned lead portion. Gross lead fractures were observed during the gross visual analysis of the returned lead. Scanning electron microscopy was performed on the broken coil strands. One of the broken coil strands was identified as having evidence of a stress induced fracture and the fracture type on the other broken coil strand was unable to be identified due to metal pitting. Abraded openings were found on the outer silicone tubing. These abraded openings and the cut ends made during the explant procedure provided the leakage path for what appeared to be dried remnants of body fluid. Set screw marks were identified and showed evidence that at one point in time a good mechanical and electrical connection was present between the pulse generator and the connector pin. Other than the above, no anomalies were identified on the returned lead portions.

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« Reply #679 on: May 01, 2019, 12:29:45 AM »

Model Number 304-20
Device Problem Fluid Leak
Event Date 01/19/2017
Event Type  Malfunction   
Event Description
The patient was undergoing surgery due to high impedance that was reported in mfg. Report #1644487-2017-03158. The high impedance resolved after the lead's pin was reinserted into the generator. However during the surgery it was observed that there was fluid inside the lead's tubing. The physicians who performed the surgery stated that there appeared to be a needle puncture in the outer tubing of the lead near the area where a suture had been placed for strain relief. The lead and generator were then replaced. The explanted lead was received and is currently pending product analysis.
 
Event Description
Product analysis was completed on the received lead. It was noted that the lead was received in two portions containing the electrodes and connector pin. It was noted that the outer tubing had abrasions and a compressed appearance in multiple locations. There also appeared to be internal abrasions of the outer tubing at multiple locations. There were no other obvious points of entry for fluid other than the observed abrasions and it appeared that the abrasions were most likely caused by manipulation that occurs during the implant and explant procedures.

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« Reply #680 on: May 01, 2019, 12:30:39 AM »

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

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« Reply #681 on: May 01, 2019, 12:31:26 AM »

Model Number 104
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/31/2017
Event Type  Injury   
Manufacturer Narrative
Additional information: product return and product analysis of the generator is not require because it will not provide any supplemental information to the reported infection.
 
Event Description
During a full revision surgery, an infection was identified at the patient's generator site. The surgery was being performed due to a high impedance as reported in mfr. Report# 1644487-2017-03186. The patient did not have a new device implanted due to the infection. A review of the manufacturing records for the implanted generator showed that the device had passed been sterilized per specifications prior to release for distribution.
 
Event Description
Additional information was received indicating that the patient's generator was removed due to the infection.

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« Reply #682 on: May 01, 2019, 12:32:40 AM »

Model Number 302-20
Device Problems Fluid Leak; Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient's generator incision had approximately a 1 cm opening. The patient was taken to surgery to where the incision cleaned and closed. The generator was left implanted. Review of the manufacturing records confirmed that the generator was sterilized and passed quality control inspection prior to distribution. It was noted that a few months prior to this report the generator had been repositioned due to infection. This event was reported in mfg report #1644487-2016-02673 however with the information available it does not appear that the current dehiscence wound is related to the previous infection. No additional relevant information has been received to date.
 
Event Description
It was reported that the generator pocket began filling up with fluid shortly after surgery that addressed the dehiscence wound. The fluid appeared to be building up behind the generator and the generator appeared to be "floating" in the pocket due the fluid. The patient was referred for surgery to drain the pocket and explant the generator. During the operation the surgeon observed that there was fluid inside the lead. Diagnostic testing was performed prior to surgery and there were no issues observed with the lead impedance. The surgeon was concerned that the fluid leaks in the lead could have been a contributing factor for the infection issues that were previously reported in this report and in mfg report #1644487-2016-02673. Manufacturing records were reviewed for the lead it was confirmed that the lead was sterilized prior to distribution. The lead and generator were both explanted at that time. Historically, the explanting facility does not return explanted products to manufacturers. Therefore product return is not expected. This report will continue to capture the fluid leaks in the lead and dehiscence wound events while g report #1644487-2016-02673 will capture the initial infection that occurred after the generator replacement surgery.

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« Reply #683 on: May 01, 2019, 12:33:31 AM »

Model Number 304-20
Device Problems Fluid Leak; Low impedance
Event Date 01/27/2017
Event Type  Malfunction   
Event Description
A physician reported that a patient had low impedance identified on a system diagnostic test. The patient had not been seen for 6 months when the low impedance message was observed. There were no patient symptoms reportedly occurring after the low impedance message was identified. The patient's physician opted not to program the device off because the patient was not having any pain. The child was reportedly very active and fell quite a bit, but there was no specific trauma thought to be related to the low impedance. No known surgical intervention has occurred to date.
 
Event Description
Additional information was received via clinic notes stating that the patient had been reportedly pulling at her lead and the physician believed she had pulled the lead from the generator, causing the low impedance.
 
Event Description
The patient underwent a full replacement due to the low impedance and the post-op impedance values were within normal limits. The explanted lead and generator were both returned to the manufacturer for product analysis. Analysis has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator and lead both had product analysis completed. The analysis of the generator verified its ability to accurately measure impedance values in all instances. A comprehensive electrical evaluation showed that the device performed according to all functional specifications. A review of the generator data showed evidence that low impedance was present prior to explant. The returned lead portions had a visual analysis performed which identified abraded openings in the outer and inner silicone tubing, which provided leakage paths for what appeared to have once been body fluids inside the silicone tubes. A condition was created by this abraded insulation where the exposed coils could have come into contact with each other. The set screw marks on the lead pin provided evidence that at one point in time a good mechanical connection existed between the lead and the generator. Other than the abraded openings and the resulting exposed quadfilar coils, no anomalies were identified with the returned lead portions.

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« Reply #684 on: May 03, 2019, 01:22:42 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 12/28/2016
Event Type  Malfunction   
Event Description
A patient reportedly had low impedance identified on a system diagnostic test. A diagnostic test was performed immediately afterwards and high impedance was found. There was no report of trauma, but the patient was reportedly extremely active. The patient's device was reportedly working as intended during the previous office visit.
 
Event Description
The patient underwent a full replacement surgery due to the high impedance. The post-op impedance values were within normal limits. The explanted lead and generator were both sent to the manufacturer for analysis, which has not been completed to date.
 
Event Description
The returned generator and lead had analyses completed one each respective device. The analysis of the generator confirmed in its ability to accurately measure impedance values and showed that the device performed according to all functional specifications. The generator was monitored for a greater than 24 hour period while placed in a simulated body temperature environment and the results confirmed in the generator's ability to accurately provide the intended output. The review of the generator data confirmed that the high impedance first occurred in (b)(6) 2016. A portion of the lead, including the electrodes, were not returned for analysis so a complete evaluation could not be performed. During the visual analysis, the connector ring quadfilar coil was broken approximately 355mm from the end of the connector boot and scanning electron microscopy was performed and showed evidence of extensive pitting which prevented identification of the coil fracture type. Pitting and residual matter were observed on the coil surface. An abraded opening was also identified on the outer silicone tubing and likely provided a leakage path for what appeared to be dried remnants of body fluid inside the outer silicone tubing. The setscrew marks identified on the lead connector pin provided evidence that a good mechanical and electrical connection was present and one point in time between the generator and the lead.

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« Reply #685 on: May 05, 2019, 12:33:51 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 02/15/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance warning message was observed during an office visit. The physician did not suspect any recent trauma contributing to the high impedance. It was also reported that the patient was experiencing an increase in seizures and the vns magnet was no longer effective in aborting the patient's seizures. This appeared to be occurring at the same time as the high impedance. X-rays were performed and the radiologist did not observe anything unusual however these x-rays have not been reviewed by the manufacturer to date. The patient returned to the office a week later where a diagnostic test was performed and confirmed the high impedance. The vns was then disabled and the patient was referred for a lead replacement. At surgery the surgeon attempted to reinsert the lead pin into the generator however the high impedance did not resolve. Therefore it appeared that the likely cause of the high impedance was a lead fracture and not a connection issue between the lead and generator. The lead was then replaced and the high impedance resolved. The explanted lead has not been received to date.
 
Event Description
The explanted lead was received by the manufacturer and is currently pending product analysis. X-rays of the patient prior to the replacement was received and reviewed by the manufacturer. The placement of the generator was observed to be normal and per labeling. However it was observed that the lead had not been placed with strain relief methods recommended in labeling. Additionally, a sharp angle was observed in the portion of the lead in the neck. A second location appeared to potentially have a sharp angle as well however this could not be confirmed with the images provided. Based on the x-rays received the cause of the high impedance could not be confirmed however it appeared that the observed sharp angle may be contributing. It was noted that a portion of the lead was behind the generator and therefore could not be fully assessed. Therefore the presence of a fracture in this portion of the lead or a micro-fracture in any part of the lead cannot be ruled out.
 
Event Description
Analysis was completed on the lead. The lead was received in 3 portions that included the connector pin and electrodes. Set screw marks were confirmed on the connector pin, indicating good contact between lead and generator at one time. The lead tubing appeared compressed in several locations. At one portion of the lead there was dried bodily fluid inside the outer tubing and along with an abraded opening in the outer tubing. Both quadfilar coils appeared to be kinked and one coil appeared to be fractured. Scanning electron microscopy was used to evaluate the coil and pitting was observed at the point of the fracture. The pitting indicates that stimulation was being provided after the coil fractured. The analysis was able to confirm the presence of the lead fracture.

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dennis100
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« Reply #686 on: May 05, 2019, 12:34:52 AM »

Model Number 304-20
Device Problems Fluid Leak; Low impedance
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
The manufacturer received the patient¿s explanted generator and lead for product analysis. Product analysis was completed on the explanted generator. Review of the internal device data showed record of an impedance change from 182 to 280 ohms, both meeting the criteria of low lead impedance, experienced prior to device explant. Low impedance was also registered on the last recorded automatic impedance measurement. Visual examination of the generator showed only observations consistent with the explant process; no surface abnormalities were noted on this device. 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 at 2. 935 volts during the functional testing. The internal device data revealed that 16. 474% of the battery had been consumed. Besides the identified low impedance condition believed to relate to the explanted lead, there were no performance or any other type of adverse conditions found in the analysis of the pulse generator. Product analysis results for the returned lead were reviewed. A large portion of the lead assembly - including the electrodes - was not returned for analysis, and therefore could not be evaluated. Visual and functional tests were performed on the portion of the lead that was returned. Abraded openings were found in the outer silicone tubing that were determined to be due to wear. Dried remnants of what appeared to have once been body fluids were found inside the outer silicone tubing. No discontinuities in the returned lead portion were identified. The condition of the returned lead portion is otherwise consistent with conditions that typically exist following an explant procedure. No other obvious anomalies or evidence to suggest an anomaly were noted. The lead's device history record was reviewed, and it was found all specifications were met prior to distribution. No additional pertinent information has been received to date.

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dennis100
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« Reply #687 on: May 05, 2019, 12:35:31 AM »

Model Number 304-20
Device Problem Fluid Leak
Event Date 02/24/2017
Event Type  Malfunction   
Event Description
It was reported that a patient was undergoing generator replacement surgery when the surgeon identified a hole and fluid inside the lead tubing. It was not communicated whether the fluid was in the outer or inner tubing of the lead. The surgeon did not replace the lead as diagnostics showed that impedance was within normal limits. No further relevant information has been received to date.
 
Event Description
The physician reported that the hole and fluid inside the tubing was in the outer tubing only.

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dennis100
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« Reply #688 on: May 05, 2019, 12:36:10 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture; Mechanical Problem
Event Date 03/26/2012
Event Type  Malfunction   
Event Description
A nurse reported that a patient had a potential lead break. Follow-up was received indicating that the patient had experienced a fall, which caused the high impedance. X-rays were provided and reviewed but were not able to identify a definitive cause for the high impedance. The patient later underwent a full device explant due to lack of efficacy and the explanted devices were sent to the manufacturer for analysis. The returned generator confirmed proper functionality and the ability to accurately measure impedance values. No anomalies were identified on the returned generator. The returned lead had product analysis performed which verified there was a lead fracture, but due metal dissolution and the mechanical distortion at the fracture location, the mechanism for the fracture could not be clearly identified. Abraded openings were also noted on the outer and the inner silicone tubing. The abraded opening on the inner silicone tubing was present at approximately the same location as the fractured coil. The returned lead also had dried remnants of what appeared to have once been body fluids inside the inner tubing of the lead.

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dennis100
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« Reply #689 on: May 09, 2019, 07:09:08 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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