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Author Topic: Corrosion/Disintegration  (Read 59203 times)
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dennis100
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« Reply #780 on: June 26, 2019, 06:01:26 AM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 02/07/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
The patient was referred for a generator replacement, and prior to surgery, high impedance was found on the patient's device after performing a system diagnostic test on the existing device. The surgeon therefore proceeded in performing a full revision surgery where both the lead and generator were replaced. The explanted devices have not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead and generator were received by the manufacturer for product analysis. The generator underwent product analysis and the device performed according to functional specifications. Product analysis on the lead is underway but has not been completed to date. No other relevant information has been received to date.
 
Event Description
The lead underwent product analysis and the report of a lead fracture was verified. A break was identified at the end of the negative coil. The silicone tubing of the negative coil has an abraded opening at the break location, as well as several other abraded openings in various locations. Scanning electron microscopy images of the negative coil break show that pitting or electro etching conditions have occurred at the break location. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7299498
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dennis100
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« Reply #781 on: June 27, 2019, 11:52:54 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7315501
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dennis100
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« Reply #782 on: June 28, 2019, 10:21:11 PM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture; Mechanical Problem
Event Date 10/01/2017
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during the patient¿s generator replacement surgery, their explanted generator could not be interrogated. When their generator was replaced, a system diagnostic test was performed and high impedance observed. The lead pin was removed and reinserted with a second result of high impedance. Therefore the lead was inspected, and the surgeon noticed a small tear in the lead. The lead was therefore explanted and a new lead was implanted. Additional information was received from the surgeon¿s office stating that the tear in the lead was present in the outer and inner tubing. The surgeon¿s believed cause of the reported tear in the lead was stated to be due to the patient falling 6 months prior when they sustained a left clavicle fracture. Lastly it was stated that the vns has been working poorly for those 6 months. The explanted products have not been received by the manufacturer to date. No other relevant information has been received to date.
 
Event Description
The lead and generator were received by the manufacturer for product analysis. The lead underwent product analysis and abraded openings were observed on the outer silicone tubing with a small abraded opening on one of the inner silicone tubes. Several fractures were observed in the returned portion of the lead. Scanning electron microscopy was performed which identified pitting and residual material on the fractured pieces. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. The abraded openings found on the inner and 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 and inner silicone tubing. 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. With the exception of the observed discontinuity and abraded tubing openings, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The generator underwent product analysis and the battery status was confirmed to be set at eos (end of service) = yes. With the exception of the end of service battery status setting, the device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7321919
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dennis100
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« Reply #783 on: June 28, 2019, 10:22:00 PM »

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7335824
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dennis100
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« Reply #784 on: June 28, 2019, 10:22:51 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7337306
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dennis100
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« Reply #785 on: June 28, 2019, 10:23:38 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7336664
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dennis100
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« Reply #786 on: June 28, 2019, 10:24:37 PM »

Model Number 302-20
Device Problems Corroded ; Fluid Leak; Fracture
Event Date 09/01/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a company representative that during a replacement surgery high impedance warnings were seen with the new generator. The lead was disconnected and impedance was tested with the test resistor in place, which resulted in about 3,400 ohms. The lead was then reinserted back into the generator and the lead was visualized past the connector block. The diagnostics then resulted in high impedance again. The patient was then closed, and diagnostics results afterward showed high impedance. After the patient went to post-op, the settings were increased to 2. 0ma and then to 2. 25ma, which she commented that she was not able to feel the stimulation, and was present prior to the surgery. The diagnostics were again performed, which resulted in high impedance. The patient and her husband said there was a bike accident two weeks prior, but did not believe that the lead or the generator was affected. They said that the patient had been doing really well, but about six months ago the depression had come back aggressively. Lead replacement surgery occurred (b)(6) 2018. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Manufacturer Narrative
Relevant tests/laboratory data, corrected data: the diagnostics data were inadvertently not provided on the initial report.
 
Event Description
Analysis was completed for the returned generator. The device passed all communication testing on the bench. The device output signal was monitored for more than 24 hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. The device performed according to functional specifications. Analysis concluded proper functionality of the pulse generator and that no abnormal performance or any other type of adverse condition was found.
 
Event Description
Analysis was completed for the returned lead. Abraded openings were noted on the outer and the inner silicone tubing. A break was identified in the negative coil. Scanning electron microscopy images of the negative coil break show that pitting or electro-etching conditions have occurred at the break location. A portion of the lead, including the electrode array was not returned for analysis, and an evaluation and 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 portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7349672
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« Reply #787 on: July 01, 2019, 12:58:08 AM »

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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7237426
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« Reply #788 on: July 02, 2019, 12:51:27 AM »

Model Number 302-20
Device Problems Corroded ; Fracture; High impedance
Event Date 02/13/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient's device was found to show high lead impedance. It was noted that if the leads were revised, the generator would also be prophylactically replaced to minimize number of surgeries for the patient. No surgery has occurred to date. No additional relevant information has been received to date.
 
Event Description
A full revision surgery occurred. It was noted that the patient's replacement lead was implanted on the right vagus nerve due to fibrosis on the left vagus nerve. It is indicated per labeling that fibrosis between the nerve and electrode is a possible cause of high lead impedance. Follow up with the physician's office provided the settings and diagnostics of the patient's device prior to replacement. The system diagnostics indicated high impedance, end of service (eos) = no. No devices were received to date. No additional relevant information was received to date.
 
Manufacturer Narrative

Event Description
The patient's explanted devices were returned for analysis. Product analysis was completed for the generator and lead. The generator performed according to functional specifications and analysis of the device found no abnormalities or malfunctions. The explanted lead was returned in five portions. Visual examination of the portions found that the setscrew marks were observed on the connector pin, indicating a proper mechanical contact between the conductive surfaces of both the generator and connector pin, ensuring a good electrical connection with the lead. The quadfilar coil 1 appeared to be broken near the anchor tether. Scanning electron microscopy was performed and identified the area on three of the broken coil strands as being mechanically damaged, with pitting and residual material. Pitting was observed on the coil surface, and was likely related to stimulation present for a certain period of time. No other anomalies were noted. Based on the findings from product analysis, there was evidence to suggest a discontinuity in the returned portions of the device. Note that since the positive and negative electrodes were not returned, no analysis could be performed on those portions of the lead. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7326901
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dennis100
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« Reply #789 on: July 04, 2019, 12:17:29 AM »

Model Number 300-20
Device Problem Fracture
Event Date 04/12/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The neurologist had noted high impedance for patient's device. Patient underwent generator and lead revision due to high impedance. The explanted lead has not been received to date.
 
Event Description
The explanted lead and generator were received. 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. During the visual analysis of the lead, electrode quadfilar coil appeared to be broken. Scanning electron microscopy was performed and identified the area as being mechanically damaged which prevented identification of the coil fracture type, no pitting and residual material on two of the broken coil strands. Residual material was observed on the coil surface. Scanning electron microscopy was performed on the other end and identified the area as being mechanically damaged which prevented identification of the coil fracture type, fine pitting and residual material on three of the broken coil strands. Pitting and residual material 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. With the exception of the observed discontinuity the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7574371
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dennis100
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« Reply #790 on: July 04, 2019, 12:18:19 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7629171
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« Reply #791 on: August 09, 2019, 09:58:21 PM »

Model Number 101 NCP
Event Date 04/02/2018
Event Type  Injury   
Event Description
My disabled son had his vagus nerve stimulator queried at a routine neurology visit in (b)(6) 2018. This showed a lead malfunction. A chest x-ray showed a partial lead detachment. On (b)(6) 2018 surgery was done to replace the vns at (b)(6) in (b)(6). Surgery showed the leads had corroded and one was not attached. The neurosurgeon had to leave part of the leads in that are wrapped around the vagus nerve due to scar tissue. He was not able to remove the scar tissue to fully remove the old leads. Original leads were placed (b)(6) 2000 with the first surgery at (b)(6) in (b)(6) (dr (b)(6)). Cyberonics rep for (b)(6) is aware and was present for the surgery. We do not know why the leads corroded and the long term risks for them being left in wrapped around his vagus nerve. Dr (b)(6), np neuro surgeon: dr (b)(6). Vns generator has been replaced several times as expected for the battery. Fda safety report id# (b)(4).

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« Reply #792 on: August 09, 2019, 09:58:56 PM »

Model Number 300-20
Device Problem Fracture
Event Date 06/06/2017
Event Type  Malfunction   
Event Description
An implant card was received that the patient had a generator and lead replacement due to high impedance. The generator was replaced due to compatibility with new lead. The notes from the replacement indicated that the patient's explanted lead was "disintegrating", likely referring to lead fracture(s) and was removed completely. It was reported that the explanted products were not available for return to the manufacturer for product analysis; therefore return of the suspect product is not expected to date. No further relevant information was received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8780552
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