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dennis100
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« Reply #270 on: April 19, 2019, 01:14:17 AM »

Model Number 304-20
Device Problem Mechanical Problem
Event Date 11/07/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
During implant surgery for the patient¿s lead, it was noticed that after the lead had been tunneled a deformity on the electrode was observed. The surgeon was able to connect the anchor and positive electrode with no issues, but when connecting the negative electrode he stated it appeared bent, and he didn¿t think it would attach to the nerve properly. There was no abnormality observed with the lead prior to the lead being removed from the packaging. It is unclear how the deformity occurred. The deformed lead was returned for product analysis which has not been completed to date. The design history record for the lead was reviewed and showed that the lead passed all quality control checks prior to being released for distribution.
 
Event Description
Product analysis for the lead was completed and found that the negative electrode ribbon did appear to be detached from the silicone helix, which has lost its helical shape. There were also creases present on the positive and negative electrodes along with remnants of dried body fluid. These finding are consistent with damage incurred during implant/explant surgeries.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6138374
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dennis100
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« Reply #271 on: April 24, 2019, 12:47:29 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 11/23/2016
Event Type  Malfunction   
Event Description
It was reported by a medical professional that a vns patient presented in clinic with hoarseness which has come on with stimulation recently. He also has high impedance upon system diagnostics. The patient reports he has had no falls and no impacts. The only physical activity he has performed lately has been lifting boxes at work. He does not attribute the current lead issues to any particular event. It was provided that when the patient moves his head to the left the lead impedance value was normal and the lead impedance value is high when his head is turned to the right. 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. Follow-up to the company representative who attended the surgery provided that pre-operative diagnostics were within normal limits when the patient¿s head was facing forward, however when diagnostics were performed with the patient¿s head turned to the right, the impedance was high at 7,500 ohms. She stated that after the lead had been removed upon visual examination, it was apparent that the lead coil was broken and ¿bent¿ and the outer tubing was split open. The explanted generator was received by the manufacturer and analysis is underway, but has not been completed to-date. The explanted lead was not returned to the manufacturer.
 
Event Description
Analysis was completed for the returned generator. Various electrical loads were tested and results demonstrated accurate resistance measurements were obtained in all instances. Proper functionality of to provide appropriate output currents was successfully verified and the septum was not cored eliminating the possibility of an unintended electrical current path through body fluids. The device output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment. Results showed no signs of variation in the generator¿s output signal and the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. An electrical evaluation showed the generator performed according to functional specifications. The battery measured 3. 075 volts and did not show an end-of-service indicator. The downloaded data revealed that 22. 513% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6188111
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dennis100
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« Reply #272 on: April 24, 2019, 12:48:10 AM »

Model Number 304-20
Device Problems Fracture; Mechanical Problem
Event Date 12/02/2016
Event Type  Malfunction   
Event Description
It was reported that the surgeon found a lead fracture during a generator replacement surgery. High impedance was not detected on the previous generator or on the replacement generator. The surgeon's operating notes clarified that there was an obvious split of the sheathing over the wires but that impedance was appropriate at 2500 ohms. He indicated that he believed that the lead will have a limited lifespan. He also noted that in a different location, there was a kink in the wire, and when it was straightened out, there was an obvious tear. The lead was not replaced during this surgery. No additional relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
The patient's following physician indicated that there was no reported trauma or manipulation to the lead. Further information from the operative notes were received. The surgeon indicated that the lead looked "old," but he also reported that he believed the lead was functioning properly. He planned to implant the generator submuscularly but because of the condition of the lead, decided to implant the generator superficially. No additional 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=6199979
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« Reply #273 on: April 26, 2019, 06:07:06 AM »

Model Number 303-20
Device Problem Low impedance
Event Date 09/20/2017
Event Type  Malfunction   
Event Description
It was reported that a patient¿s generator showed a low impedance message, upon interrogation. Clinic notes from a visit on (b)(6) 2017 were received for a referral that indicate the device has an issue and has since been turned off. The notes detail that the patient has been having an increase in ¿spells¿, clarified by the physician as partial seizures. Follow-up from the surgeon provided the low impedance was still present on the device. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Revision surgery occurred on (b)(6) 2017. During the surgery the physician found the lead to be severely twisted into a coiled knot. The generator pocket was then dissected and it was discovered that the generator¿s stitch was broken and the twisting of the lead had continued all the way down to the generator. The physician stated the patient had manually rolled the generator from the exterior, breaking the stitch and continued to manipulate and roll the generator within the pocket until the lead became severely twisted. The severe twisting caused the impedance issue, and when the surgeon removed and untwisted the lead, the impedance issue was corrected. The surgeon installed the same generator, repositioned the same lead, stitched two tie downs of the lead in the neck, re-stitched the generator, and stitched a tie down of the lead in the pocket. Three diagnostic tests returned with impedance within normal limits.
 
Manufacturer Narrative
Unique identifier (udi) #, corrected data: the unique identifier was inadvertently provided incorrectly on the initial report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6950569
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dennis100
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« Reply #274 on: April 29, 2019, 05:12:12 AM »

Model Number 300-20
Device Problem High impedance
Event Date 01/26/2017
Event Type  Malfunction   
Event Description
It was reported that a patient's device had high impedance. The patient recently began experiencing painful stimulation and an increase in seizures. The patient was scheduled to undergo a full revision surgery due to high impedance. It was also reported that the patient experienced coughing with increases in stimulation, but it is unclear whether the coughing had always occurred with stimulation or began with high impedance. The patient's increased seizures were occurring approximately once a month. X-rays were reviewed for the patient. It was difficult to assess whether the lead pins were both fully inserted inside the connector blocks due to the angle of the images provided; however, it appeared that neither of the two lead pins were fully inserted inside the connector blocks. Additionally, it could not be determined whether the feedthrough wires appeared intact. No gross fractures were observed, and no sharp angles in the lead were identified. The presence of a microfracture and/or lead discontinuity could not be ruled out. The patient¿s high impedance was likely due to incomplete pin insertion of both of the lead pins. Programming history was also reviewed, but there were no diagnostic results available. No additional information has been provided to date. No known surgical intervention has taken place to date.
 
Event Description
It was reported that high impedance was observed on the patient's device during surgery. A kink in the patient's lead was believed to be the cause of the high impedance, but the high impedance did not resolve when the lead was straightened out. The surgeon decided to proceed with a full revision. It was reported that the patient's increase in seizures was above his pre-vns baseline. The patient was reportedly experiencing painful stimulation in his left neck and shoulder, and the coughing that occurred with settings increases was not seen prior to the high impedance. The lead was discarded by the hospital, and the generator has been received; however, analysis on the generator has not been approved to date. No further information has been provided to date.
 
Event Description
Analysis was approved for the generator. Visual examination did not identify any anomalies with the generator. In its as received condition, the generator communicated normally. During the analysis, there was no indication from the device that an end of service condition existed. The device performed according to functional specifications. Product analysis did not confirm the end of service allegation and concluded that there was no abnormal performance or other adverse condition with the generator. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6347523
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dennis100
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« Reply #275 on: May 03, 2019, 01:17:03 AM »

Model Number 302-20
Device Problem High impedance
Event Date 02/01/2017
Event Type  Malfunction   
Event Description
Information was received indicating that high impedance was observed with the patient's generator. It was noted that x-rays were taken by the physician and reviewed. No visible fracture in the lead was observed. The x-rays have not been received or reviewed to date by the manufacturer. The surgeon reported that the lead wire is twisted and resulting in high impedance. No additional relevant information has been received to date. No known surgical intervention has occurred to date to revise the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6440714
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dennis100
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« Reply #276 on: May 05, 2019, 12:16:04 AM »

Model Number 304-20
Device Problem Fracture
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
Clinic notes were received for a replacement referral from a visit dated (b)(6) 2017. Within the notes it was provided that after interrogation the device was non-functional. The patient was reported to have done very well with vns. It was stated she developed seizures over the past weeks. Follow-up from the company representative provided that the patient had seen the neurologist and a message indicating high lead impedance displayed. The neurologist had lowered the patient¿s output current. At surgical consult, the surgeon interrogated the device and the same message appeared. Systems diagnostics were then performed and were within normal limits. Four days later at surgery on (b)(6) 2017, the previous generator was removed and the new generator was placed. Systems diagnostics performed while the lead was connected to the new generator were within normal limits. The surgeon asked the company representative to interrogate the previous generator after it was removed (no lead attached). The high lead impedance message again appeared after doing so. The company representative asked the surgeon about the lead pin insertion with the previous generator, and he stated he had visually inspected the lead pin and found it to have been fully inserted. The lead in the generator pocket area was heavily coiled and appeared to have a kink in a portion with evidence of scar tissue. He stated he did not visually observe a fracture or breaks in the lead. Additional relevant information has not been received to-date. No known surgery has occurred to-date to replace the lead.
 
Manufacturer Narrative
Event description, corrected data, it was inadvertently not provided on the initial report that the explanted generator was discarded by the explant facility.
 
Event Description
The explanted generator was reported to have been discarded.
 
Event Description
The explanted generator was first reported to have been discarded, however was later available for return. The explanted device has not been received by the manufacturer to-date.
 
Event Description
The explanted generator was received and analysis was completed. The pulse generator was interrogated successfully at multiple orientations adjacent to the programming wand. Various electrical loads were attached to the generator diagnostic tests demonstrated that accurate resistance measurements were obtained in all instances. The device output signal was monitored for more than 24 hours, in a simulated body temperature environment. Results showed no signs of variation in the output signal and the device provided the expected level of output current for the entire monitoring period. Diagnostics were as expected for the programmed parameters. Electrical evaluation showed the generator performed according to specifications. The battery, was not at an end-of-service condition. The downloaded data revealed that (b)(4)% of the battery had been consumed. There were no performance or any other type of adverse conditions found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6412271
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« Reply #277 on: May 05, 2019, 12:16:57 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.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6411939
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« Reply #278 on: May 06, 2019, 03:19:49 AM »

Model Number 304-20
Device Problem Fracture
Event Date 12/15/2016
Event Type  Malfunction   
Event Description
It was reported that a patient needed a full revision. Further information was received indicating that the patient's device had high impedance. The patient had full revision surgery due to the high impedance. The explanted products have not been received to date.
 
Event Description
The explanted lead and generator were received, but analysis has not been approved to date.
 
Event Description
Analysis on the generator was 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. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. Analysis of the lead has not been approved to date.
 
Event Description
Analysis on the lead was approved. Note that a portions of the electrode inner silicone tubes and quadfilar coils and anchor tether were not returned for analysis, and 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 and twisted. The twisted condition of the lead suggested some level of patient manipulation occurred during the implant life of the device. There were two lead breaks identified in the returned lead portion. Scanning electrode microscopy identified that both fractures were due to mechanical damage and had pitting present. One of the fractures was due to rotational forces, which caused a stress induced fracture. With the exception of the observed discontinuities, the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. Continuity checks of the returned lead portions were performed, and no other discontinuities were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404916
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« Reply #279 on: May 06, 2019, 03:20:35 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/01/2016
Event Type  Injury   
Event Description
It was reported that the patient was experiencing constant erratic vns stimulation which was painful. The patient was evaluated by the physician who performed diagnostic testing and nothing abnormal was found. The vns settings were not changed during this appointment. The patient then presented to the physician's office several months later with the same complaint of painful constant and erratic vns stimulation. During this visit the vns settings were reduced for the patient's comfort. X-rays were performed and no issues were observed by the physician. However these x-rays have not been reviewed by the manufacturer to date. The patient also reported that she attempted to disable the device with the vns magnet however she was unsuccessful. Upon interrogation and diagnostic testing it was shown that magnet stimulation had been activated several times in the previous week. It appeared that the patient misunderstood how the vns magnet worked and believed that if she placed the magnet over the generator it would permanently disable the device. However the vns it will only inhibit stimulation while the magnet is placed over the generator and once the magnet is removed the device will begin stimulating again. The patient was then referred for generator replacement. At surgery the surgeon observed that the vns lead was twisted. The surgeon untwisted the lead and did not observe any obvious breaches in the lead insulation. After the new generator was attached the existing lead diagnostic testing was within the acceptable limits. The explanted generator was received and is currently pending product analysis.
 
Event Description
Analysis was completed on the received generator. Upon receipt it was noted that the battery indicator was at not at near end of service. During functional testing the output of the generator was monitored for 24 hours and no variations in the output or magnet signals were noted. The generator performed to functional speciation.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6404696
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« Reply #280 on: May 06, 2019, 03:24:13 AM »

Model Number 103
Event Date 10/01/2010
Event Type  Injury   
Event Description
It was reported by a patient through a company representative that the patient's generator suture in the chest pocket had broken loose. The event happened when the patient was laying down on the ground and had a dog jump on her chest. The patient's treating neurologist performed diagnostics on the patient's device and were within normal limits (no specifics). Moreover with movement, the patient has vocal cord paralysis and possibly due to the strain of the lead pulling on the nerve. Per the patient, she has to manually hold the generator in the pocket by herself. Also, if the patient looks upward she coughs because of the weight of the device pulling on the nerve. Patient is scheduled to see the surgeon for evaluation. Additional information was received from a company representative indicating the patient underwent revision surgery. Upon surgery, the lead was twisted and pulled tension on neck; the strain relief was broken as well. The surgeon placed new pocket in chest above old pocket and sutured to fascia. He then recreated strain loop in neck. Currently, the patient called and said she is no longer feeling need to vomit or cough with neck movement. No new lead or generator was needed. Stimulation was not turned on. Patient still has vocal cord paralysis from this event so her treating physician will determine when vns will be programmed on. Mfr. Report #1644487-2010-02742 was submitted to report on the event of vocal cord paralysis. Moreover, good faith attempts to obtain additional information from the treating neurologist have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1919363
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« Reply #281 on: May 08, 2019, 10:15:55 AM »

Model Number 303-20
Device Problem Mechanical Problem
Event Date 04/07/2017
Event Type  Malfunction   
Event Description
It was reported that a lead was identified with a misshaped helix out of the box. The helix was reportedly not lined up. The lead was not implanted in the patient and a replacement lead was used in its place. A review of the manufacturing record of the lead confirmed it had passed all quality inspections prior to release for distribution. The lead has been returned to the manufacturer, but analysis has not been completed to date.
 
Event Description
The returned lead assembly was analyzed in the product analysis lab where it was confirmed that the helices were misshapen. Visual analysis identified bends and creases on the positive and negative electrode ribbons. The positive ribbon was partially detached from the helical. No discontinuities were identified with the returned lead, no abrasions were noted, and no setscrew marks were observed, confirming that the lead had never been implanted. The misalignment of the helices as observed in the lab had no adverse effect on the lead's ability to perform as intended.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6529452
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« Reply #282 on: May 11, 2019, 12:41:02 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/14/2016
Event Type  Injury   
Event Description
The patient underwent battery replacement on (b)(6) 2016 due to reported battery depletion. Explant notes for the patient's generator explant in 2016 were received and indicated that the generator was flipped and turned and the wires were coiled in a twisted manner into a knot. This was able to be un-round and untied. After explant, it was stated the 106 was then secured more efficiently with silk sutures. A lead test was performed and showed good impedance 2309 ohms. While the notes don¿t indicate that the reason for surgery was due to the device migration (patient was referred due to low battery), the notes do state that this was a more difficult than usual procedure due to findings of the wires and generator twisting resulting in extra time to unwind and inspect the wires and electrode connector. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8562074
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« Reply #283 on: May 14, 2019, 12:48:56 AM »

Model Number 304
Event Date 03/27/2017
Event Type  Malfunction   
Event Description
The surgeon was about to place the lead and noticed it was mis-shaped and defective. The surgeon chose to not place the lead into patient due to these concerns.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6489672
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« Reply #284 on: May 14, 2019, 12:49:54 AM »

Model Number 302-20
Device Problems Fluid Leak; Fracture
Event Date 03/08/2017
Event Type  Malfunction   
Event Description
It was initially reported the patient was referred for vns generator replacement surgery due to normal battery depletion. During the generator replacement surgery, the lead was found to have a broken sheath, leaving the wire open and high impedance was observed. Due to the broken sheath and high impedance, the lead was replaced, and the generator was replaced due to the normal end of battery life. It was noted that full lead extraction was unsuccessful; therefore, the new lead was placed beside the old lead. There were no consequences post-surgery. The lead and the generator are expected to be returned to the manufacturer for analysis; however, they have not been received to date.
 
Event Description
Product analysis was completed on the returned lead portion. Note that the electrodes were not returned for analysis, and therefore a complete evaluation could not be performed on the entire lead product. An abraded opening on the outer silicone tubing and abraded openings in the same location on both of the inner silicone tubes most likely provided the leakage path for what appeared to have once been body fluids in the outer and both outer silicone tubes. Due to the appearance of these findings, the cause may be related to patient manipulation, as the lead was also twisted in several areas. Although set screw marks were observed near the end of the connector pin and indentations were observed on the rear end of the small front o-ring ¿ which indicate the lead had not been fully inserted into the generator at one point in time ¿ there are additional set screw marks found on the lead connector pin in a typical location. Furthermore, programming data showed that lead impedance was within normal limits for at least three years after the previous implant surgery. Besides these observations, the condition of the returned lead portion was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. Continuity checks of the returned lead portion were performed, and no discontinuities were identified. There is no evidence to suggest the presence of discontinuities in the returned portion of the device which may have contributed to the high impedance, although the entire lead was not returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6471823
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« Reply #285 on: May 20, 2019, 09:13:24 PM »

Model Number 303-20
Device Problems Corroded ; Fracture
Event Date 07/01/2016
Event Type  Malfunction   
Event Description
X-rays performed of the patient's device at the surgeon's office revealed a lead break. The x-rays were not reviewed by the manufacturer. The patient underwent full revision surgery due to high lead impedance. The explanted lead and generator were received by the manufacturer, but analysis on the devices has not been approved to date. No additional relevant information has been provided to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The patient's device showed high impedance at the time that the lead break was identified via x-rays. The surgeon later reviewed the patient's previous x-rays and saw that the lead actually broke 9 months prior. High impedance was not observed during that 9-month period. The lead break observed in the previous x-rays was not as large as the lead break observed when the high impedance value was observed. The x-rays were not reviewed by the manufacturer. The patient's parents had previously reported to the surgeon that the patient had experienced an increase in seizures during the 9-month period. The surgeon believed that the patient's influenza contributed to the high impedance. Analysis was approved for the generator. When received, the data was downloaded from the generator and reviewed. The data revealed a large increase in impedance that occurred on the same date that the surgeon observed high impedance on the patient's device. Electrical testing showed that the generator performed according to functional specifications, and no anomalies were identified during analysis. Analysis was also approved for the lead. The lead was returned in two portions. 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. Visual examination of the lead identified that the coil of the connector ring had been broken, stretched, or kinked in multiple positions. Extensive pitting was also observed on the surface of the coil in several positions, indicating that stimulation was being delivered after the coil had broken. Stress-induced fractures were identified in several locations; the fracture mechanisms could not be identified in other locations due to mechanical damage. Microscopic analysis of the coil shows characteristics typical of a lead discontinuity, including material fracture, rough or pitted surface, thinned material thickness, electro-etching, or material dissolution in several locations. The lead tubing appeared to be twisted in multiple areas. Continuity checks of the returned lead portions were performed, and no other discontinuities aside from those described were identified. The twisted condition of the lead suggested some level of patient manipulation occurred during the implant life of the device. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563374
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« Reply #286 on: May 23, 2019, 10:58:14 PM »

Model Number 304-20
Device Problems Fluid Leak; Fracture; Mechanical Problem
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A system diagnostic test was performed and showed high impedance. It was also reported that patient had been manipulating the device by rotating the generator in the surgical pocket. X-ray images were reviewed by the physician and reportedly confirmed a lead fracture had occurred. The patient had a full revision surgery to replace the fractured lead and generator, and the post-op impedance values were within normal limits. While in surgery, it was reported that the lead was extremely twisted and coiled up. The explanted lead and generator have not been received by the manufacturer to date.
 
Event Description
The explanted generator and lead were both returned for product analysis. Analysis was completed on the returned generator which confirmed that the generator had performed according to all functional specifications. All diagnostic tests resulted in impedance values within expected limits for the applied loads. Data from the generator revealed that high impedance was present prior to the generator being replaced. The analysis on the lead has not been completed to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was completed on the returned lead portions, which did not include the electrodes. During the visual analysis, the outer silicone tubing had a twist and compressed appearance. Additionally, several abraded openings were identified on the lead tubing and the quadfilar coil was found to be broken approximately 3 mm from the electrode bifurcation. Scanning electron microscopy (sem) was performed on the broken coil and was unable to identify the coil fracture type. The abraded openings on the outer silicone tubing provided a leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. The set screw marks found on the lead connector pin provided evidence that at one point in time, there was a good mechanical and electrical connection between the lead and generator. Other than the abraded insulation and the lead fractures identified in the lab, the condition of the returned lead was consistent with those typically seen following explant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6547477
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dennis100
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« Reply #287 on: May 23, 2019, 10:59:18 PM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported to a company representative that a patient experienced an increase in seizures and had gone to the emergency department. At the emergency department the vns was interrogated and the physician notes indicated no issues with system diagnostics. Additional relevant information has not been received to-date.
 
Event Description
Full revision occurred. Normal impedance was reported at surgery. The battery was not at end-of-service. It was provided the generator will not be returned. It was noted in surgery the lead was twisted however, high impedance was not found. The explanted lead was received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Manufacturer Narrative
Date of event, corrected data: it was inadvertently not provided in follow-up report #1 that the date of the event was clarified to be (b)(6) 2017.
 
Event Description
Follow-up from the physician¿s office provided the vns was causing shocks and the shocking was then causing seizures to occur. The mother then wanted the whole device replaced. She stated that after the replacement, all has been well. It was stated that the vns had reduced seizures since being implanted and although more seizures were occurring they were not worse than before. Analysis was completed for the returned lead. The coil appeared to be stretched, kinked, wavy and spiraled, in some areas. The returned connector pin coil appeared to be broken and during the incision process several broken coil strands were observed. Scanning electron microscopy was performed and identified the area as having evidence of a rotational stress induced fracture with secondary break lines and no pitting. Residual material was observed on the coil surface. The analysis supports that the breaks occurred as a result of the explant process due to the rotational type of fracture on the broken coil wire surfaces and secondary break lines. 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 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=6546464
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dennis100
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« Reply #288 on: May 23, 2019, 11:00:28 PM »

Model Number 302-20
Device Problem High impedance
Event Date 05/31/2017
Event Type  Malfunction   
Event Description
Clinic notes were received for patient's vns surgery referral. Per vns interrogation, the battery is approaching end of service and high impedance was observed. No known surgical interventions have occurred to date.
 
Event Description
Patient underwent generator and lead replacement surgery. Prior to surgery, the operating room specialist interrogated the generator, which showed high impedance. He then performed a system diagnostic test which showed both high impedance and neos - yes. The surgeon performed generator and lead replacement and mentioned that the lead looked like it was in a knot and that he had never seen anything like it. The impedance after replacement was 2000 ohms. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6680827
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