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Author Topic: Silicone Tubing  (Read 93696 times)
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dennis100
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« Reply #1020 on: June 25, 2019, 12:43:08 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 06/17/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the company representative was asked to attend a surgery she thought was only a generator replacement. However upon checking the device prior to surgery high impedance was observed. The lead and generator were then replaced. The explanted products have not been received to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received and are pending analysis. The lead's product information was identified following the explant. It indicated that the lead had been implanted for several years. A review of the diagnostic history from the internal database showed that impedance was within acceptable limits in the most recent history.
 
Event Description
Analysis was completed on the returned lead and generator. The generator case had scratches, tool marks and burn marks which are consistent with manipulation and exposure to electrocautery during the explant procedure. Upon interrogation the battery indicator was found to be ifi = yes. A series of interrogations and diagnostics were performed on the generator and the results were normal. During testing the generator performed to functional specification and passed electrical testing. The lead assembly was received in two pieces with the lead¿s pin still connected to the generator. The furthest electrode to the bifurcation was not returned for evaluation. Prior to decontamination a continuity check was performed while the lead pin was still inserted into the lead and the continuity check verified there was proper contact between the set screw and the lead pin was present. Visual analysis of the lead completed for both lead segments. It was found that the lead was tangled and the outer tubing was abraded in the segment which included the lead pin. In both segments the lead coils were kinked and the electrode was noted to be damaged and partially detached, this was potentially related to the explant procedure. A fracture was identified in the lead coil in the lead assembly that was not attached to the lead pin and therefore not part of the continuity check. Pitting was observed at the point of fracture which indicates that the stimulation was being provided while the fracture was present.

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« Reply #1021 on: June 25, 2019, 12:44:12 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture; Mechanical Problem; Low impedance
Event Date 10/23/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient was referred for vns generator replacement surgery due to the desire for a newer model vns generator and additional efficacy. However, prior to surgery, low impedance was observed on the patient's device. It was reported that, upon inspection of the lead by the surgeon, the wires of the lead were exposed through the insulation. The patient underwent full vns replacement surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The explanted vns generator and lead were received by the manufacturer. Generator product analysis was completed. The generator performed according to functional specifications. The battery measured 2. 732 v at the completion of the fet, indicating an intensified follow-up indicator, or ifi, condition. There were no performance or other adverse conditions found with the generator. The explanted vns lead is still pending product analysis.
 
Event Description
Lead product analysis was completed. The allegations of the abraded insulation and lead fracture were verified in the product analysis, or pa, lab. Abraded openings were identified on the outer and inner tubing of the lead coils. A coil break was identified in the lead positive coil and scanning electron microscopy, or sem, images of the negative coil revealed what appeared to be wear resulting in reduction of coil diameter to the point of break. The identified openings in the inner tubing may be a contributing factor to the reported low impedance message. The outer tubing was abraded open at approximately 6. 3-7. 9 cm, 16. 3-17. 5 cm, 58. 7-59. 9 cm, 61-63. 1 cm, 64. 7-65. 2 cm, and 69. 6 cm from the connector boot. The inner tubing of the negative coil was abraded open at approximately 19. 7-20. 5 cm from the connector boot. The inner tubing of the positive coil was abraded open at approximately 58. 4-60 cm from the connector boot. A single strand of the negative coil was broken approximately 30. 5 cm and approximately 36. 3 cm from the connector boot. Remnants of dried body fluids were observed inside the outer and inner tubing. No obvious points of entry were noted other than the identified openings and cut ends of the lead portions. Based on the appearance of the returned portions, it was believed that the identified damage to the electrodes was most likely caused during explant. The overall appearance of the lead suggests manipulation of the lead by the patient. Other than the mentioned observations and typical wear/explant related observations, no additional anomalies were identified in the return lead portions.

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« Reply #1022 on: June 26, 2019, 05:52:27 AM »

Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 12/18/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was observed on the patient's device. The patient was referred for a full revision surgery because the generator was at 25% battery and the lead replacement is due to the high impedance. No surgical intervention is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
Additional information was received that the patient's lead and generator were replaced due to the high impedance. The explanted generator and lead were planned to be sent back to the manufacturer so product return is expected. The lead and generator have not been received by the manufacturer to date.
 
Manufacturer Narrative
 
Event Description
The explanted lead and generator were returned for analysis. Analysis was completed on the lead. The lead was returned in one piece for analysis however the electrodes were not included. There were set screw marks on the connector pin indicating that at one point in time proper contact existed with the device. There were multiple locations of abrasions noted on the exterior of the lead. There were also internal abrasions noted most likely because of the presence of tie downs. A coil break was identified in the positive coil past the electrode bifurcation. A segment of the positive coil was subjected to sem inspection. The sem showed pitting at the lead break location however due to dissolution of the metal the fracture mechanism could not be obtained. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
Generator analysis was completed on the explanted generator. There were no performance or any other type of adverse conditions found with the generator other than a low battery condition that was contributed to by the high impedance noted on the device.

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« Reply #1023 on: June 27, 2019, 11:49:34 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 01/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
High impedance was observed on a patient's device during generator replacement surgery due to low battery. System diagnostics indicated high impedance was present with the existing system. The existing generator was replaced, and high impedance was still present when an additional system diagnostic test was performed, indicating a problem with the existing lead. Using a test resistor, a generator diagnostic test was performed for the explanted generator and returned results within the normal limits, confirming proper function of the generator. The lead was then explanted and replaced with a new lead. The explanted lead and generator have not been received by the manufacturer for analysis to date.
 
Manufacturer Narrative
Describe event or problem, corrected data: initial report inadvertently did not include updated device disposition. Device available for evaluation?, corrected data: initial report inadvertently did not include updated device disposition. Device evaluated by mfr?, corrected data: initial report inadvertently did not include updated device disposition.
 
Event Description
The explanted lead and generator were received for analysis. Analysis was approved for the generator. The low battery flag was properly set according to the as-received voltage of the generator. The device performed according to functional specifications. No abnormal performance or any other type of adverse condition was found with the performance of the generator. Analysis has not been approved for the lead to date.
 
Manufacturer Narrative

Event Description
Analysis was approved for the lead. Note that since a portion electrode array of the lead was not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead. Three sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. Abraded openings were noted on the outer and inner tubing. A tear was identified in the connector boot, partially exposing the manufacturing id tag. A lead break was identified in the positive coil. Microscopy images of the positive coil show pitting and flat surfaces at the break location. No other anomalies were identified in the returned lead portions. No additional relevant information has been received to date.

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« Reply #1024 on: June 28, 2019, 10:14:27 PM »

Model Number 302-30
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/20/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was seen at a routine post-op appointment. The patient had a recent generator replacement on (b)(6) 2018. The pa stated x-rays were taken to check the leads and they appear fine. The patient had surgery on (b)(6) 2018. Pin insertion was attempted but unsuccessful as high impedance still showed. The test resistor connected with the generator showed normal impedance therefore the lead was replaced which resolved the issue. The explanted lead has not been received for analysis to date. No additional or relevant information has been received to date.
 
Manufacturer Narrative

Event Description
The explanted lead was received for analysis. Product analysis on the lead was completed and approved. An analysis was performed on the returned lead portion and the reported allegations of lead fracture were confirmed. 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. During the visual analysis the end of the connector pin quadfilar coil appeared to be broken approximately 122 mm 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 and pitting on the coil surface. It is unknown if the break 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, 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. With the exception of the discontinuity and abraded openings, the condition of the returned lead portion is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. No additional or relevant information has been received to date.

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« Reply #1025 on: June 28, 2019, 10:15:31 PM »

Model Number 300-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/21/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
High impedance was observed on a patient's device during a generator replacement surgery due to low battery. A system diagnostic test was performed with the existing lead and generator indicating high impedance. The device was interrogated three weeks prior with no impedance issues at that time. The existing generator was then explanted and replaced with a new generator. Testing was performed on the explanted generator which returned normal results with a good impedance value, confirming proper function of the generator. The lead was then explanted and replaced with a new lead. The explanted lead and generator have not been received by the manufacturer for analysis to date. No other relevant information has been received to date.
 
Manufacturer Narrative
Event description, corrected data: the initial report inadvertently did not indicate the products have been received by the manufacturer. Device available for evaluation, corrected data: the initial report inadvertently did not indicate that the device was available for evaluation. Device evaluated by mfr, corrected data: the initial report inadvertently did not indicate that the device is pending evaluation. Evaluation codes, corrected data: the initial report inadvertently did not indicate codes to represent that the device is pending evaluation.
 
Event Description
The generator and lead were received by the manufacturer for product analysis. Analysis is underway but has not been completed to date. No other relevant information has been received to date.
 
Event Description
Product analysis was performed on the lead and the generator. An end-of-service warning message was verified and found to be associated with the output being disabled by the pulse generator. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. Other than the noted event of the generator reaching end of service, there were no additional performance or any other type of adverse conditions found with the pulse generator. The lead underwent product analysis and abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions and a break was identified in the positive coil. Scanning electron microscopy images of the positive coil show corrosion at the break location, and that a stress-induced fracture most likely occurred. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions. No other relevant information has been received to date.

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« Reply #1026 on: June 28, 2019, 10:16:37 PM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 04/02/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported by a medical professional that a patient's device was found to have high lead impedance at a surgical consult to replace the patient's generator that was at end-of-service. X-ray images were received by the manufacturer and were reviewed. Based on the images provided, the pin appeared to be fully inserted past the connector block. The feed-through wires appeared intact, and the generator was placed in the upper left chest, as expected. There was a suspect region in the strain relief bend of the wiring where no obvious fractures or sharp angles were identified, however, due to the angle and quality of the images provided, this portion of the lead was difficult to fully assess. A strain relief bend was present and placed per labeling. A strain relief loop was present, but was not placed per labeling. Based on the images provided, there was no obvious cause for the high impedance; however the presence of micro-fractures cannot be ruled out. A full revision surgery was performed. Prior to the surgery, diagnostics on the device were run again and resulted in high impedance. During the surgery, the old generator was removed and the replacement generator was attached to the old leads. Diagnostics were performed again, still showing high impedance. The old leads were explanted, including all three helices from the nerve, and were replaced. The new leads were attached to a new generator and diagnostics showed impedance was fine. Tablet data was also received confirming the high impedance observed on these occasions. Product analysis is underway but has not been completed to date. No other additional or relevant information has been received to date.
 
Event Description
Product analysis was completed and approved for the returned leads and generator. Lead product analysis: the leads were returned in two parts, and a break was found through a continuity check in one of the electrode coils where the inner silicone tubing appeared to be abraded open and torn in half. Set screw marks were observed on the connector pin, indicating proper connection between the generator and leads. Abraded openings were observed on the outer and inner silicone tubings. Extensive pitting was identified through scanning electron microscopy of the coil strands. With the exception of the abraded openings and 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. Generator product analysis: end-of-service condition was confirmed in the generator and was found to be associated with the output being disabled by the pulse generator, due to an indication of increased impedance prior to explant. Review of the last noted impedance change in the device indicated an impedance change of 9035 ohms to 11957 ohms detected on (b)(6) 2016. Subsequent testing could not be performed as the pulse disabled bit of the generator could not be reset.

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« Reply #1027 on: June 28, 2019, 10:17:37 PM »

Model Number 302-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 02/16/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was identified after diagnostics were performed during a generator replacement surgery due to battery depletion. The generator was replaced, but the high impedance was still present. The lead was then replaced, and the surgeon reported seeing a lead fracture. No further relevant information has been received to date.
 
Event Description
The generator and lead were received into analysis. The data from the generator was reviewed, which showed that high impedance had been present for over a year and a half prior to the surgery. It could not be determined when the high impedance was first present. No further relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
Analysis on the lead was approved. Abraded openings were noted on the outer and the inner silicone tubing (past the electrode bifurcation) of the lead coils. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil break; showed that pitting or electro etching conditions have occurred at the break location. Due to metal dissolution the fracture mechanism could not be ascertained. Note that since portion of the electrode array was not returned for analysis, an evaluation and resulting commentary could not 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. Analysis on the generator was also approved. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. 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 were no performance or any other type of adverse conditions found with the pulse generator. The data from the generator showed that the last 62;25% change in impedance was over a year and a half prior to explant, but it went from high impedance to higher impedance. Therefore, it cannot be determined when the high impedance was first present.

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« Reply #1028 on: July 01, 2019, 12:54:14 AM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 10/24/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A report was received indicating a patient was hospitalized for an unknown reason. A representative of the hospital requested a vns replacement as soon as possible. It was later reported via clinic notes that the patient was hospitalized due to increased nocturnal seizure activity and insomnia that had been occurring for 1 month prior to the hospitalization. Per the notes, the patient's mother reported that the seizures were representative of the patient's normal activity, but she believed the nocturnal seizures were more frequent. During the hospital stay, the vns was interrogated and was found to have low battery and high lead impedance. The patient's medications were increased due to vns not working. The patient underwent lead and generator replacement surgery due to the high impedance and low battery. The explanted lead and generator were received by the manufacturer for analysis, but analysis has not been approved for the explanted devices to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
 
Event Description
Analysis approved for the generator. When received, the data was downloaded from the generator and reviewed. Both the pre- and post-change values of the most recent significant change in impedance value indicated high impedance. No surface abnormalities were noted on this device. The pulse generator diagnostics were as expected for the programmed parameters. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. The pulse generator performed according to functional specifications. Analysis was also approved for the returned lead. The lead was returned in two pieces. Two sets of set screw marks were seen on the connector pin providing evidence that proper contact between the set screw and the connector pin existed at least once. Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings were noted in the outer and the inner silicone tubing. A lead break was identified in the positive coil. Microscopy images of the positive coil break show that pitting or occurred at the break location. Also, the positive coil shows what appears to be wear at the break. One strand of the positive coil mate end shows appearance suggesting that a stress-induced fracture occurred due to rotational forces. The overall appearance of the lead is consistent with patient manipulation of the implanted device.

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« Reply #1029 on: July 02, 2019, 12:44:15 AM »

Model Number 303-20
Device Problems Fracture; Therapy Delivered to Incorrect Body Area ; Adverse Event Without Identified Device or Use Problem
Event Date 05/01/2018
Event Type  Injury   
Manufacturer Narrative

Event Description
It was reported that the patient was feeling "electrical jolts" and recurrent pain at the vns site. Clinic notes received for the referral indicate that patient has recurrent left chest pain most likely related to vns placement as well as on occasion "feeling electrical jolts" suggestive of vns dysfunction/malfunction. It was reported that the electrical jolt occurs with stimulation on occasion but not every single time of stimulation. There is no pattern on when it occurs or with certain specific body movements. Surgical exploratory surgery was planned in regard to probable replacement of vagal nerve stimulator in view of chest pain as well as "electrical jolts" to preclude a serious injury but has not occurred to date.
 
Event Description
An implant card was received for the patient's full revision surgery. The implant card indicated that the generator was at intensified follow-up (ifi) = no pre-operation, and that the replacement was for discomfort in the neck. As no malfunctions were noted, and it is known that impedance issues would trigger an error message warning upon interrogation, it is reasonable to assume there was no impedance issue noted. It was stated that at the surgery, the patient was feeling a sharp pain at his electrode site about 4 months prior to the surgery. The pain was associated with stimulation as it seemed to be occurring every 5 minutes, however the neurologist stated that the device was turned off for the past 6-8 weeks. The device diagnostics were checked. Upon running diagnostics, the patient grabbed his neck and began coughing. The neurologist ordered and x-ray of the lead site and had not seen anything abnormal. When settings were increased to 0. 25 ma output current, the patient stated not feeling any stimulation. Output currents were increased to normal mode 0. 5 ma and magnet mode 0. 75 ma; the patient grimaced slightly and said the pain was ok. When the magnet was swiped, the patient began coughing and stated the pain was too much. The device was disabled again, and it was decided the patient would undergo a full revision. The explanted devices were returned for analysis. No abnormalities were noted from the generator. Diagnostics and interrogations were performed with various loads. Communication, impedance, and current delivered were as expected for all tests performed. The output signal was monitored for over 24 hours and placed in a simulated body temperature environment. The generator performed as expected and according to functional specifications. The lead assembly was returned in four portions with one loose tie down. Slice marks were observed in the tubing and the tri-filar coil appeared to be cut in half. The slice mark appeared to have been made by a sharp object which may have occurred during the implant procedure, however this could not be confirmed. The lead assembly had dried remnants of likely body fluids inside the tubing. The slice mark found most likely provided the leakage path to the dried remnants of likely body fluids. With the exception of this slice mark, the conditions of the returned lead portions were consistent with those typically seen from explant procedures. No other obvious anomalies were noted other than a bend connector pin. The set screw marks found on the lead connector pin provided evidence that at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, and except for the cut negative coil, no discontinuities were identified. No additional relevant information has been received to date.

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« Reply #1030 on: July 02, 2019, 12:45:17 AM »

Model Number 304-30
Device Problems Fracture; Mechanical Problem
Event Date 02/08/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
High impedance was observed for patient's vns device. X-ray images of ap chest and lateral chest were provided. The lead pin¿s insertion could not be fully assessed due to the angle and quality of the image. The pulse generator feedthru wires appear to be intact. The electrode position appears to be normal. No gross lead fracture was observed; however, due to image quality the entire lead body could not be accurately assessed. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
 
Event Description
Patient under lead and generator replacement surgery. The surgeon checked pin insertion and the impedance remained high. So a full revision was completed to replace the lead and generator. The explanted devices have not been received to date.
 
Event Description
The explanted lead was received. The lead was replaced due to lead discontinuity. Analysis is underway but has not been completed.
 
Manufacturer Narrative
 
Event Description
An abraded opening was noted on the outer silicone tubing. Scanning electron microscopy images of the lead coils show that pitting or electro¿etching conditions have occurred in at least one strand of the quadfilar coils at the cut ends of the lead during explant surgery. 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 at time of explant surgery). 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. 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 performance or any other type of adverse conditions found with the pulse generator.

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« Reply #1031 on: July 04, 2019, 12:12:35 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/09/2018
Event Type  Death   
Manufacturer Narrative

Event Description
A medical examiner reported that the patient had passed away and indicated that they would like to return the device. Medical examiner was also interested to know if the patient was receiving stimulation at the time of death as possible seizure related death is suspected. However, the cause of death and relation to vns therapy are unknown. No additional relevant information has been received to date.
 
Event Description
The explanted generator and lead were received. Analysis is pending and has not been completed to date.
 
Event Description
A large portion of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. The abraded opening and slice mark found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portion of the device. 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 pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications (final configuration r-wave test). The pulse generator did show signs of premature battery depletion. This is reported in mfr. Report # 1644487-2018-01493.

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« Reply #1032 on: July 04, 2019, 12:13:57 AM »

Model Number 304-20
Device Problems Corroded ; Fracture
Event Date 05/30/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was observed on the patient's vns. X-rays were ordered, but not reviewed by the manufacturer to date. A review of device history records revealed that the vns lead passed quality control inspection prior to distribution. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported by clinic notes received by the manufacturer that the patient had not been feeling well for the last two to three weeks prior to the clinic visit and that the seizures had been more intense and lasted longer. It was also reported that the patient's appetite had increase along with her fatigue. The vns was programmed off as a result of the observed high impedance. The notes for the following clinic visit indicated that the patient's seizure frequency had increased. The patient underwent vns lead replacement surgery. The explanted lead has not been received by the manufacturer to date. Follow up with the physician's office revealed that the patient's breast size had increased 3 cup sizes in a few months and that the patient underwent breast reduction surgery. The surgeon performing the reduction surgery found that the breast tissue itself had damaged the lead and the vns surgeon agreed with this assessment.
 
Event Description
Lead product analysis was completed. The reported fractured lead was confirmed in the product analysis, or pa, lab. During visual analysis, a quadfilar coil appeared to be broken approximately 5 mm from the cut inner tubing. Scanning electron microscopy, or sem, was performed and identified the area on two of the broken strands as having evidence of a stress induced fracture (fatigue) with mechanical damage, fine pitting on one, residual material and evidence of a stress induced fracture (rotational). Pitting observed on the coil surface indicated that stimulation was present for a certain period of time. Abraded openings were identified in the outer tubing. Other than the lead fracture and abraded openings, the condition of the returned lead portions was consistent with those following explant.

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« Reply #1033 on: July 05, 2019, 09:56:48 PM »

Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 05/09/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
High impedance was detected on the patient's replacement generator during replacement surgery. Their previous generator was at end-of-service. It was reported that the surgeon "messed with the lead" when high impedance was observed and that a sheath was placed with wiring around the lead, which resolved the high impedance. The lead was reportedly cut by the resident during surgery and the surgeon attempted to fix the lead. The surgeon found fluid inside of the "plastic part" of the lead, a hole was identified and the surgeon attempted to remove fluid in the lead from the hole and then wrap the lead. The patient's new generator was left in the pocket, not connected to the lead, and the generator output currents were disabled. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8665094
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« Reply #1034 on: July 14, 2019, 04:07:12 AM »

Model Number 304-20
Device Problem Device Contamination with Body Fluid
Event Date 07/18/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that during a patient¿s prophylactic generator replacement, the lead wires were found to be exposed after the chest site was opened. All pre-surgical diagnostics and diagnostics at the neurologist follow up two weeks prior showed normal impedance readings. The lead and generator were replaced. Additional relevant information has not been received to-date. The explanted devices have not been received by the manufacturer to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7773202
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« Reply #1035 on: July 16, 2019, 11:01:19 PM »

Model Number 302-20
Device Problem Fracture
Event Date 07/26/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During a generator replacement surgery, the generator was replaced and diagnostics on the new generator attached to the lead showed high impedance. The impedance was measured 5 times, lead pin insertion was check, the header was rinsed with solution, and lead pin was cleaned. However the device still showed high impedance. Visually the surgeon examined an insulation defect right where the stiff pin part of the lead ends but felt sure the wire itself still intact. No trauma has been reported by the caregiver but there are injuries reported in the past, caused by accident. X-rays were taken. No known surgical interventions have occurred to date to replace the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7798706
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« Reply #1036 on: July 16, 2019, 11:01:59 PM »

Model Number 304-30
Device Problem Fracture
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient had an emergency surgery to explant a lead that was stated per the stepdad to be internally burning him. It was unknown if there was trauma to the site, if devices were explanted, diagnostics, or who the surgeon was. A call was received confirming that both the generator and lead were explanted due to painful stimulation, exposed lead wires and "drainage" from the exposed wires. The devices were to be shipped back for analysis. Surgical operation notes were received indicating pus, an infection at the electrode site and "exposed, infected" devices, however it was stated per the patient's physician that nothing had happened to the lead or generator and that the patient had also been sent to "infectious disease" who had clarified that there was no infection seen. Impedance measurements from march 2018 showed ok impedance, within normal limits. The physician stated the patient had been doing well with vns and was looking to have the patient re-implanted with vns. The devices were returned for analysis, however analysis has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7883963
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« Reply #1037 on: July 16, 2019, 11:02:45 PM »

Model Number 300-20
Device Problem Mechanical Problem
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A patient underwent a full revision surgery for patient comfort due to a chronic neck pain. The neurologist was unsure if the pain was related to the device or not. The explanted devices were shipped back for analysis. Analysis was completed for the generator, indicating no apparent device malfunctions. The lead assembly was returned in four portions; the portion of the lead assembly including the electrodes and tie downs was not returned. Setscrew marks were observed on both connector pins, indicating good electrical connection existed at one point. Abraded openings were found on both the outer and inner silicone tubing in one of the return portions of the lead. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Other than the abraded tubing openings, no additional obvious anomalies were noted. It was concluded that the abraded openings were likely due to normal wear. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7912423
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« Reply #1038 on: July 27, 2019, 12:18:46 PM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 01/18/2019
Event Type  Malfunction   
Event Description
It was reported that a generator could not be implanted during a generator replacement surgery since the setscrew felt loose and would not tighten. It was stated that lead pin was removed and reinserted before attempting to tighten the setscrew again. The silicone cover reportedly came off and the screw was seen to be loose in the socket area. Another generator was implanted with no issues. It was reported that no excessive force was used during the surgery and that the plug fell out while trying to tighten the screw. The surgeon ensured to turn the screwdriver the correct direction (clockwise) when tightening the screw. A review of device history records for the generator was performed and shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. The suspect generator has not been received to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8371550
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« Reply #1039 on: August 09, 2019, 09:53:07 PM »

Model Number 103
Device Problem Premature End-of-Life Indicator
Event Date 06/14/2019
Event Type  Malfunction   
Event Description
A report was received that during a prophylactic generator replacement for a patient, the surgeon found a small slit in the tubing and could visibly see fluid in the lead. However, the physician questioned whether the fluid in the lead could have been the reason for the shorter life span of the generator at the patient's pre-op settings. A full revision was performed at this time. A manual manufacturer's battery life calculation was performed with additional data provided by the sales representative and operating room specialist. The result revealed expected time to neos = 4. 8 years. Device history records were reviewed and the device passed all functional specifications and quality tests and were sterilized prior to distribution. The suspect device has been explanted but has not been received for analysis to date. No additional relevant information has been received to date. The fluid leak is reported in mfg report 1644487-2019-01323 as there is no confirmed relationship between the generator's premature battery depletion and the fluid leaks, as impedance was within normal limits prior to surgery.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8773208
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« Reply #1040 on: August 09, 2019, 09:53:49 PM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 04/12/2019
Event Type  Malfunction   
Event Description
While investigating high impedance for mfr report# 1644487-2019-00844, the lead was received and underwent analysis. Product analysis of the lead was completed. Multiple abraded openings were identified in the outer tubing and appeared to be the path for bodily fluids found in the outer tubing. An abraded opening in the outer and inner tubing was identified near the electrodes- the lead coil was exposed, stretched and kinked. Continuity checks of the returned lead portions were performed and no discontinuities were identified. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good electromechanical connection was present between the lead and generator. 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. No other obvious anomalies were noted. It was originally believed that high impedance was due to the lead but upon completion of the generator analysis, it was determined that the generator was the suspect product. This manufacturing report was created to house the malfunction of the abraded inner tubing of the lead. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8751573
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« Reply #1041 on: September 06, 2019, 09:52:25 PM »

Model Number 304-30
Device Problems Corroded ; Mechanical Problem; Therapy Delivered to Incorrect Body Area
Event Date 07/12/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was feeling painful stimulation. Pre-operatively to a prophylactic replacement surgery. Although impedance was within normal limits at 1483 ohms, the surgeon was concerned about the lead, so he examined it while replacing the generator. Upon doing so, he observed a tear in outer casing of lead and corrosion about 5 cm to 6 cm up from the generator. As a result, he also replaced the lead. The explanted product was discarded. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8866683
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« Reply #1042 on: September 06, 2019, 09:53:04 PM »

Model Number 304-20
Device Problems Fracture; Mechanical Problem
Event Date 08/01/2019
Event Type  Malfunction   
Event Description
It was reported that high impedance was detected on the patient's device. The patient underwent a full revision due to high impedance. The surgeon opened the chest pocket first and found complete disintegration of lead insulation about 3 inches from the pin for about 2-3 inches. There was no indication of manipulation and no twisting of lead. The patient was in a car accident approximately a year prior and the surgeon speculated that this could be the cause. No further relevant information has been received to date. The suspect product has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8933214
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« Reply #1043 on: October 11, 2019, 11:10:12 PM »

Model Number 304-20
Device Problems High impedance; Device Contamination with Body Fluid
Event Date 08/27/2019
Event Type  Malfunction   
Event Description
It was reported that a patient was found with high impedance despite the physician performing diagnostics several times. The patient was planned for revision. The lead was revised due to a lead issue being confirmed during surgery. Per a livanova representative, during the surgery the physician could see little moisture bubbles in the lead confirming a breach. The surgeon did not think there was any trauma or patient manipulation of the vns recently and there were no adverse events for the patient related to the high impedance the explanted lead has not been received by the manufacturer to date and no additional relevant information has ben received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9084578
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« Reply #1044 on: October 11, 2019, 11:11:00 PM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 08/05/2019
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary because the reported events have been determined as not related to vns therapy.
 
Event Description
It was reported that the patient underwent vns replacement surgery and that one week post-op, the patient's incision sites looked good. However, a few days later, the patient reported a sudden swelling at the generator site and presented to urgent care, where bactrim was prescribed. The patient then followed up with the implanting surgeon. An incision was made to release drainage and the patient was prescribed cefzil. It was determined that the hematoma needed further treatment and needed to be cleaned out in surgery. The patient underwent surgery to address the hematoma. Upon opening the chest, the surgeon noted pus inside of the lead. It was stated that the surgeon saw "yellow and green" on the lead. It was reported that the impedance values were ok. The surgeon was not comfortable with opening the neck due to the infection. The surgeon planned on removing the generator and a portion of the lead, then tying it down, and waiting for the infection to clear. When attempting to remove a portion of the lead, it was found that a section of the lead further up from the generator appeared to have an opening and they were able to "push stuff out of it". The abraded opening and fluid inside the tubing was reported in mfr. Report #1644487-2019-01885. A review of device history records revealed that the generator was sterilized and passed quality control inspection prior to distribution. The lead was implanted approximately six years prior and, therefore, the sterility of the device post-manufacturing is not relevant. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=9129087
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« Reply #1045 on: October 11, 2019, 11:11:54 PM »

Model Number 302-30
Device Problems Fracture; Mechanical Problem
Event Date 08/12/2019
Event Type  Malfunction   
Event Description
Clinic notes were received for the patient indicating that the patient's device could not be interrogated due to battery depletion. Notes indicated that there was no discontinuities observed in the patient's lead on x-rays. The patient's generator was replaced due to the low battery. Upon replacement with the new generator, high impedance was observed. It was not seen on the previous generator as the previous generator could not be interrogated due to battery depletion the surgeon then found a kink in lead and sheathing gone. Due to lack of time, the surgeon could not replace the lead at that time. The explanted generator was discarded and the case ended without lead replacement. No further relevant information has been received to date. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8971360
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