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dennis100
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« Reply #780 on: April 29, 2019, 05:16:54 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
The patient was seen at an office visit where it was noted that the lead impedance was high. There was no known trauma that may have contributed to the high impedance. X-rays were taken and evaluated by the physician. It was noted that no lead discontinuity was visualized. To date no surgical intervention has occurred. No other relevant information has been received to date.
 
Event Description
X-rays were received from the physician's office and were reviewed. It was noted that the lead pin may not have been fully inserted into the connector block from the images provided. A review of past diagnostics for the patient's device shows that the impedance was within a normal range as of (b)(6) 2015.
 
Event Description
The patient underwent lead revision. The explanted lead is suspected to be discarded as the explant facility does not have it.

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dennis100
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« Reply #781 on: April 29, 2019, 05:18:42 AM »

Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/28/2013
Event Type  Death   
Event Description
Patient's explanted devices were returned by a funeral home. It was found via online obituary search that the patient passed away. Analysis is underway but has not been completed to date. No additional relevant information has been received to date. An internal sudep evaluation was performed by the manufacturer which determined the death to be possible sudep.
 
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 condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted except the set of setscrew marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. The additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device. During the bench interrogation (with a distance of one and a quarter inches (spacer block) between the pulse generator and the programming wand) the pulsedisabled and eos warnings were set. With the pulse generator case removed and the battery still attached to the pcba, the battery voltage indicated an eos condition. The postburn electrical test results show that the pcba performs according to functional specifications. The electrical performance of the generator, as measured in the pa lab, will be used to conclude that no anomalies exist and the end-of-service (eos) condition is an expected event. The were no performance or any other type of adverse conditions found with the pulse generator.

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dennis100
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« Reply #782 on: April 29, 2019, 05:19:53 AM »

Model Number 105
Device Problem High impedance
Event Date 01/31/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit a system diagnostic test was completed which found that the vns system could not deliver the programmed output current. A second diagnostic test was later performed during the same visit where high impedance was observed. Based on the two system diagnostic tests, there appeared to be an intermittent impedance issue. The physician did not know of any of trauma to the patient that could have contributed to the high impedance event. It was also reported that the patient had been experiencing an increase in seizure frequency and the physician believed this was related to the high impedance event. The patient was referred for a lead and generator replacement. However, no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
It was reported by the physician that the patient's increase in seizures was below the pre-vns frequency baseline. Generator replacement for the patient took place on (b)(6) 2017 due to prophylactic reasons. Systems diagnostics were performed post-operatively and the impedance was within normal limits.
 
Event Description
It was reported that during the surgery the surgeon did not attempt pin reinsertion before replacing the generator. The explanted generator has not been received to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Brand name, corrected data: follow-up report #2 inadvertently listed wrong device brand name. Changed lead model 304 to pulse gen model 105. Type of device, name, corrected data: follow-up report #2 inadvertently listed wrong device name. Changed lead to generator. Model #, corrected data: follow-up report #2 inadvertently listed wrong model number. Changed 304-20 to 105. Serial #, corrected data: follow-up report #2 inadvertently listed wrong serial number. Changed (b)(4). Lot #, corrected data: follow-up report #2 inadvertently listed wrong lot number. Changed 3815 to 3786. Expiration date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong expiration date. Changed 12/31/2017 to 09/23/2015. If explanted, give date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong explant date. Changed na to (b)(6) 2017. Device manufacture date (mo/day/yr), corrected data: follow-up report #2 inadvertently listed wrong manufacture date. Changed 12/06/2013 to 11/06/2013.
 
Event Description
The generator was received by the manufacturer. Product analysis was completed on the generator. The reports of high impedance and lead pin not fully inserted were not duplicated in the product analysis lab. No obstructions were observed in the header cavity or the connector blocks. A test lead fully inserted past the connector block. Proper lead cavity dimensions were verified. Various loads were applied and all diagnostic tests reported accurate impedance measurements. Functionality of the generator was verified in the pa lab by monitoring the generator for more than 24 hours in a simulated body temperature environment. No variations in output signal were observed and the diagnostics were as expected. There were no performance or adverse conditions found with the pulse generator.
 
Event Description
The patient's lead was explanted due to a second high impedance reported in mfg. Report 1644487-2017-03782, which was kept separate from this report, mfg. Report 1644487-2017-03264, as the initial reported high impedance resolved with generator replacement. Product analysis was completed on the returned lead. The allegation of high impedance was not confirmed in the product analysis lab. A set of set-screw marks were observed near the end of the lead pin indicating that the lead pin was not fully inserted at one point. Additional set-screw marks revealed that a good connection was present at one point. A more detailed account of the product analysis is summarized in mfg. Report 1644487-2017-03782.

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dennis100
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« Reply #783 on: May 05, 2019, 12:18:40 AM »

Model Number 105
Device Problem High impedance
Event Date 02/20/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed during an office visit. Impedance was noted to have been within acceptable limits at the previous visit. The physician did not know why the high impedance was occurring since the patient had not reported any recent falls. X-rays had not been ordered. The manufacturing records of the generator were reviewed and confirmed that the generator passed qc inspection prior to distribution. The product information of the lead was unknown therefore the manufacturing records could not be reviewed. No surgical interventions are known to have been taken to date. No additional relevant information has been received to date.
 
Event Description
It was reported that surgery occurred and the patient's generator was replaced. It was reported by the surgeon that the lead pin appeared to be fully inserted prior to removing it from the generator. However, diagnostic testing was not performed on the generator prior to explantation. The high impedance resolved after the existing lead pin was inserted into the new generator. Therefore only the generator was replaced during the surgery. The cause of the high impedance appears to be related to poor connection between the lead and previous generator. The explanted generator was received by the manufacturer and is currently pending analysis.
 
Event Description
Product analysis was completed on the generator. The generator was shown to accurately measure impedance values and when a test lead was used. The dimensions of the generator's cavity were assessed and it was found to meet specification and a test lead could be fully inserted into the cavity past the negative connector block. The generator was shown to function according to specifications. The analysis was unable to confirm the cause of the high impedance.
 
Event Description
It was later reported that high impedance had been observed with the patient's new generator and the existing lead. Since the high impedance captured in this report had resolved during the previous surgery the recent high impedance was considered a separate and new event which was captured in mfg. Report # 1644487-2017-04329. The explanted lead was received and underwent analysis. During the analysis it was observed that 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. The two sets were at different locations of the pin indicating that the set closer to the tip of the pin may have been related to the pin insertion issues reported in this report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6413558
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dennis100
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« Reply #784 on: May 06, 2019, 03:02:51 AM »

Model Number 302-20
Device Problem Fracture
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for a lead revision due to a suspected lead break. It was also reported that the patient experienced minimal discomfort and intermittent vocal hoarseness. Further follow-up found that the patient had been doing yard work and felt discomfort in his upper left chest. The normal mode of the device was programmed off and the magnet mode left programmed on. The physician later performed diagnostic testing which indicated that there was high impedance in the system. The patient was referred to surgery where the generator was first replaced and the existing lead was inserted into the new generator. However high impedance did not resolve which indicated an issue with the lead. The lead was then replaced and the new lead and new generator functioned within acceptable limits. The explanted lead and generator have not been received to date.
 
Event Description
The generator and lead were received by the manufacturer. Product analysis on the generator was completed. Analysis of the generator in the product analysis lab concluded that no abnormal performance or any other type of adverse condition was found. Product analysis on the lead has not been completed to date.
 
Event Description
Product analysis was completed on the lead. Set-screw marks were identified at the end of the connector pin, indicating that the lead pin had not been fully inserted at one time. However, additional set-screw marks were found that indicated at one time, a good mechanical an electrical connection was present. It is unclear if the set-screw markings near the end of the pin contributed to the recent high impedance event. An abraded opening was found. However, only the outer tubing was abraded. No discontinuities were identified during the continuity tests and analysis was unable to confirm the presence of a lead fracture. However, it was noted that the portion of the lead with the electrodes were not received.
 
Event Description
The surgeon reported that the lead replacement was to preclude serious injury.
 
Event Description
Follow up with the surgeon revealed that the high impedance value previously reported was observed after the new vns generator was implanted. The lead was replaced after the high impedance was observed on the new generator.

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dennis100
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« Reply #785 on: May 09, 2019, 07:01:08 AM »

Model Number 302-20
Device Problem Fracture
Event Date 04/06/2017
Event Type  Malfunction   
Event Description
It was reported that the a company representative was in the operating room and there was a lead break. The patient was referred for a lead and generator replacement which occurred a few days later. The explanted products have not been received by the manufacturer to date. X-rays were later received and reviewed by the manufacturer. It was noted that the x-rays were not dated therefore it is unknown when the images were taken. The portions of the lead that could be visualized did not contain any obvious fractures. However it was noted that a portion of the lead was behind the generator and therefore could not be evaluated. Additionally, the presence of a micro-fracture in the lead cannot be ruled out. No additional relevant information has been received to date.
 
Event Description
The explanted lead was received by the manufacturer for analysis. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion. Of note, there were seven (7) set screw marks on the lead connector pin which suggests that incomplete pin insertion may have been an issue at one point. No additional relevant information has been received to date.

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dennis100
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« Reply #786 on: May 11, 2019, 12:47:42 AM »

Model Number 106
Device Problem High impedance
Event Date 03/19/2019
Event Type  Injury   
Event Description
It was reported that the patient was referred for surgery due to the surgeon¿s concern that the lead pin may have slipped out and the physician has reportedly obtained x-rays. Clinical notes were later received which reported that high impedance of >10,000 ohms was seen on the patient¿s vns and that the patient was experiencing an increase in seizures. The patient's generator was later replaced and lead impedance was within normal limits. The explanted generator was discarded. Information was later received that the surgeon had visually confirmed that the lead pin was not inserted past the second connector block both intra-operatively and upon review of the x-rays. The surgeon chose to replace the generator instead of re-inserting the pin into the generator. Additionally, there were no abnormalities were seen both visually (in the or) and on the x-rays. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8511132
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dennis100
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« Reply #787 on: May 14, 2019, 12:27:11 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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dennis100
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« Reply #788 on: May 14, 2019, 12:28:23 AM »

Model Number 302-20
Device Problem Fracture
Event Date 03/29/2017
Event Type  Malfunction   
Event Description
Clinic notes were received from a visit on (b)(6) 2017. The notes provide that the patient¿s vns showed high lead impedance. It was reported the patient¿s seizures were doing fairly well. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explanted devices have not been received by the manufacturer to-date.
 
Event Description
The explanted devices were received 06/21/2017. Analysis is underway, but has not been completed to-date for the lead. Analysis was completed for the returned generator 07/06/2017. The generator diagnostics were as expected for the programmed parameters. A comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The measured battery voltage did not show a low battery condition. There were no performance or any other type of adverse conditions found with the pulse generator.
 
Event Description
Analysis was completed on the returned lead portion. A large portion of the lead assembly was not returned and therefore a complete evaluation could not be performed. The lead coils were broken in several locations. Scanning electron microscopy was performed, and the area had evidence of a fatigue stress fracture, fine pitting and rotational stress fracture which likely completed the fracture. Pitting and residual material were observed on the coil surface. The abraded opening found on the outer silicone tubing and the cut ends that were made during the explanted process, likely provided the path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the inner tubing fluid, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process. No other anomalies were noted except the set of set screw marks observed near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator, at one point in time. An additional pair of set screw marks provide evidence that, at one point in time, a good mechanical and electrical connection was present.

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dennis100
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« Reply #789 on: May 14, 2019, 12:32:25 AM »

Model Number 106
Device Problem High impedance
Event Date 03/15/2017
Event Type  Malfunction   
Event Description
A physician reported that a patient had high impedance identified after interrogating the patient's device. The physician was told he could program the patient's device off. Clinic notes were received from the patient during a clinic visit stating that the patient had begun having an increase in seizure frequency (5-6 seizures per day). The patient's vns settings were adjusted as a result but the patient's seizure frequency did not decrease. The patient's mother tried swiping the magnet, which did not help. A review of the manufacturing record for the implanted lead confirmed it had passed all quality inspections prior to release for distribution.
 
Manufacturer Narrative
Follow-up report type, corrected data: supplemental mdr #1 inadvertently did not have correction report selected. The initial mdr should have selected "adverse event. ".
 
Event Description
Positional system diagnostics were performed on a patient with high impedance. Because the patient was not ambulatory, only two different positions could be tested, but both showed high impedance. The patient's physician scheduled the patient for full revision surgery. While in surgery, the surgeon removed, cleaned, and re-inserted the lead pin into the generator. After the lead pin was re-inserted, the system diagnostics were all within normal limits.

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« Reply #790 on: May 18, 2019, 12:21:06 AM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
It was reported that a lead could not be fully inserted into a generator, causing high impedance to occur during implant surgery. The surgeon tried removing and reinserting the lead multiple times, but the high impedance continued to occur. The lead could not be implanted due to the high impedance/insertion difficulties. The generator was tested with a test resistor and confirmed that it was accurately measuring impedance values. A different lead was implanted and post-op impedance values were all within normal limits. The lead that was not implanted has not been received by the manufacturer to date.
 
Event Description
The lead that was unable to be inserted was returned to the manufacturer for analysis. The visual analysis of the lead found the small o-ring appeared partially detached from the connector pin. Dimensional analysis was performed on the small o-ring, the large o-ring, the connector pin, and the connector boot and provided results all within normal limits. A half set of screw marks was identified on the lead pin confirming that the lead had not been fully inserted during implant. Continuity checks of the returned lead assembly verified that there were no discontinuities present. The remainder of the lead was within specifications and no other abnormal performance or other adverse conditions were identified.
 
Event Description
An internal investigation of pin insertion difficulties identified two possible cause of pin insertion difficulties. First, it was determined that if any lead's large o-ring boot diameter was closer to the assembly specification of 0. 135 in max, it may cause insertion difficulty. Second, model 303 lead assembly document allows for di water to be used for lubrication of the pin for insertion, if required, although it is not prescribed in labeling. It is suspected that the costa rica manufacturing facility potentially used di water to lubricate the pin when excessive force was needed. This lead had both characteristics. The lead's large o-ring boot diameter was 0. 134 in, which is close to the 0. 135 inches specification max and therefore, may cause pin insertion difficulties. In addition, review of the device history records found that the lead was manufactured in costa rica and therefore may have been subject to di water lubrication.

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« Reply #791 on: May 18, 2019, 12:22:07 AM »

Model Number 106
Device Problem High impedance
Event Date 12/01/2016
Event Type  Malfunction   
Event Description
It was reported via clinic notes that an impedance value of >10000 ohms was observed on a patient's device. The patient's settings were decreased due to the high impedance, causing the patient to experience an increase in seizures. The patient was not known to have experienced any trauma. X-rays of the device were not ordered at either the patient's clinic visit or the surgical consult. No additional relevant information has been provided to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent full revision surgery. The explanted lead and generator have been returned to the manufacturer, but analysis for the explanted devices has not been approved to date. No additional relevant information has been received to date.
 
Event Description
Analysis was approved for the returned generator. When received, the programming data was downloaded from the generator and reviewed. High impedance was first observed 4 months after implant and occurred intermittently through the remainder of the implant time of the device. Visual examination of the generator did not identify any abnormalities with the external part of the generator. The generator was interrogated, and system diagnostic tests were performed and returned results within the normal limits. Electrical evaluation showed that the device performed according to functional specifications. There were no performance or any other type of adverse condition found with the pulse generator. Analysis was approved for the returned lead. The lead body was returned in one portion. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. Set screw marks were observed towards the end of the connector pin, indicating the connector pin had not been fully inserted into the generator. No other sets of set screw marks were observed. Canted spring indentations were also observed on the rear end of the small front o-ring, indicating insufficient mechanical contact between the generator and connector ring. The position of the set screw marks and canted spring indentations indicate that there may have been a suspect electrical connection to the lead. No discontinuities were identified during the continuity check of the lead. There was no evidence to suggest an anomaly with the returned portion of the lead. Incomplete insertion of the connector pin may have been a potential cause for the observed high impedance condition. No additional relevant information has been provided to date.

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« Reply #792 on: May 18, 2019, 12:22:57 AM »

Model Number 302-30
Device Problems Fracture; High impedance
Event Date 02/09/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device when interrogated. The patient had an x-ray performed where it was stated no break could be seen. The x-rays have not been reviewed by the manufacturer to date. The patient was referred for a lead replacement 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
It was reported that the patient underwent surgery where the vns generator was replaced and the high impedance resolved. No fractures were observed at the time of the surgery so the lead was not initially replaced. The explanted generator was tested on its own and found to be functioning properly. After the surgery the device was programmed on and intermittent high impedance was observed. This indicated that there might be an intermittent microfracture. The patient was returned to the operating room and the lead was replaced. Impedance was then within normal limits with the new lead and generator. The explanted lead and generator was discarded following the surgery.
 
Event Description
The manufacturer received two user facility medwatch reports related to the events previously captured in this report, (b)(4).
 
Event Description
It was reported that the explanted products were actually not discarded and were available for return. The products have not been received to date.
 
Manufacturer Narrative
Corrected data: describe event or problem; "the explanted lead and generator were received" this information was inadvertently left off on mfg. Report #3. Corrected data: device available for evaluation?; this information was inadvertently left off on mfg. Report #3.
 
Event Description
The explanted lead and generator were received and underwent product analysis. The generator performed to functional specification during analysis. No anomalies were observed during a series of diagnostic tests and interrogations. It was noted only a portion of the lead was received and the segment did not contain the electrodes. Upon visual analysis it was found that the lead¿s pin had two full sets of set screw marks, indicating proper contact between the generator and lead had existed at one point in time. However there was a single set screw mark near the end of the lead pin which indicated that proper contact was not occurring at one point in time. It was unclear when this partial connection occurred. The lead's connector boot was partially detached and there were abrasions near the connector boot. The reason for the partial detachment and abrasions was unknown. Abrasions were noted in the outer tubing in multiple locations and there was fluid inside the inner and outer tubing. The only obvious point of entry was the end of the lead that had been cut during the explant and the abrasions in the outer tubing. Continuity testing was performed on the lead and no discontinuities were identified within the returned lead portion. Other than the abraded outer insulation, no other anomalies were identified in the lead.

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« Reply #793 on: May 20, 2019, 08:56:20 PM »

Model Number 303-20
Device Problems High impedance; Difficult to Insert
Event Date 04/18/2017
Event Type  Malfunction   
Event Description
A report was received stating there was a high impedance problem for a lead during an implant. The lead was unable to be implanted due to it causing high impedance. The high impedance was reportedly not related to lead insertion difficulties. The lead was replaced with a second lead and system diagnostics returned impedance values within normal limits. The lead with high impedance during attempted implant has not been received by the manufacturer to date. No further relevant information has been received at this time.
 
Event Description
The lead that was not implanted due to the high impedance was returned to the manufacturer for analysis. The return product form received with the lead stated that part of the reason for the return was difficulty inserting the lead. Analysis has not been completed to date.
 
Event Description
The returned lead assembly had analysis completed where the gross visual analysis found the small o-ring detached from the connector pin. The average dimensional measurements of each individual lead portion showed that the device was within dimensional specifications. A half set of screw marks was identified on the end of the connector pin, showing that the lead had not been fully inserted into the generator cavity. The was also inserted into a test generator and was fully inserted without any noted issues.
 
Event Description
An internal investigation on insertion difficulty determined the root cause as ¿process/procedure¿ due to the following: lead model 303 assembly document in one manufacturing facility allows to wet connector in water for lubrication, if required. This is not a common practice during assembly process at the other manufacturing facility. The large o-ring boot diameter is critical and has direct impact on the maximum insertion force. The tolerance on specification of large o-ring boot diameter is not appropriate considering this dimension being critical and related to the insertion difficulties experienced in field.

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« Reply #794 on: May 23, 2019, 10:45:26 PM »

Model Number 106
Device Problem High impedance
Event Date 05/31/2017
Event Type  Malfunction   
Event Description
It was reported by a physician that a vns patient had high lead impedance after their initial implant. The patient was at their first dosing appointment. A review of the manufacturing records confirmed the generator met all specifications prior to distribution. An x-ray image was received of the device. The placement of the generator is implanted in the left chest below the clavicle. The pin cannot be visualized past the connector block. Strain relief was not adequate. Two tie-downs appear to be present. No obvious gross lead discontinuities or sharp angles were observed in the visible portion of the lead. The cause of the high impedance was not conclusive based upon the image received. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
The patient had generator replacement surgery. The impedance after the generator was replaced was normal, indicating that the most likely cause of the high impedance was incomplete pin insertion. The explanting facility discards product and was unable to return the device for analysis. No further relevant information has been received to date.
 
Event Description
The physician reported that the lead pin was not re-inserted into the generator prior to replacing the generator. However, based on the fact that the impedance resolved with generator replacement, the most likely cause of the high impedance was incomplete pin insertion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6675327
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« Reply #795 on: May 23, 2019, 10:46:09 PM »

Model Number 103
Device Problem High impedance
Event Date 06/01/2017
Event Type  Malfunction   
Event Description
It was reported that high impedance was found on the patient's device. The patient's vns system had been implanted for about five months. The device history records of the generator and lead were reviewed, and the devices conformed to all specifications prior to release. No further relevant information has been received to date.
 
Event Description
The patient had exploratory surgery, and the lead pin was identified to not be inserted fully. Once the lead pin was re-inserted, the high impedance resolved.

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« Reply #796 on: May 30, 2019, 05:28:31 AM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem
Event Date 11/13/2016
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on a patient's device. Clinic notes from that office visit also indicated that the patient was experiencing an increase in seizures that began three weeks prior to the clinic visit. The patient had fallen while in her wheelchair. The neurologist believed that the fall had caused a lead fracture which ultimately resulted in the high impedance and seizure increase. Upon observing the high impedance and noting that the device was delivering an output current that was lower than programmed, the neurologist programmed the patient's output currents off. The patient underwent full revision surgery. The explanted products have not been returned to the manufacturer to date. No additional relevant information has been provided to date.
 
Event Description
The explanted lead and generator were received by the manufacturer. Analysis was approved on the returned generator. When received, the data was downloaded from the generator and reviewed. No visual anomalies were identified with the generator. The generator was interrogated and system diagnostic tests were performed and returned results within the normal limits. The generator performed according to functional specifications. Analysis has not been approved on the lead to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Date of event, corrected data: follow-up report #01 inadvertently did not update date per results of analysis describe event or problem, corrected data: follow-up report #01 inadvertently did not contain full results of analysis relevant tests/laboratory data, including dates, corrected data: follow-up report #01 did not contain data relevant to analysis.
 
Event Description
Analysis on the generator indicated that the last larger than 25% change in impedance value occurred five months prior to the high impedance being observed during the clinic visit. Both the impedance values prior to and after the change signified high impedance. Analysis was approved for the lead. The lead was returned in five portions, and the tie downs were not returned. Set screw marks were observed near the end of the connector pin. During the visual analysis, portions of the outer and inner tubing appeared to be twisted and abraded open with the coil of the connector pin exposed. The connector ring coil appeared to be broken in multiple positions. Extensive pitting was identified at the coil breaks, which prevented identification of the coil fracture type. No other obvious anomalies were noted. No additional relevant information has been provided to date.

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« Reply #797 on: May 30, 2019, 05:29:20 AM »

Model Number 106
Device Problem High impedance
Event Date 05/17/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was seen by their physician and high impedance was noted. The patient was referred for revision surgery. Clinic notes were received from a visit on 05/17/2017 indicating the patient is having less frequent episodes. Interrogation of the vns showed high lead impedance. Clinically, the patient is not feeling all firing and especially when he is using the magnet.
 
Event Description
The patient underwent surgery, and during pre-operative system diagnostics, high impedance was confirmed. X-rays displayed in the or indicated the lead pin may have not been fully inserted. The surgeon then examined the lead in the generator and stated he thought he could see the lead pin fully inserted. The lead pin was removed and no anomalies were noted. The generator socket also appeared clear. The lead pin was re-inserted fully and the set screw tightened to multiple clicks. Two system diagnostics, one out-of-pocket and one in-pocket indicated normal impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6633170
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« Reply #798 on: June 03, 2019, 04:24:22 AM »

Model Number 302-30
Device Problem Fracture
Event Date 02/27/2017
Event Type  Malfunction   
Event Description
Clinic notes reported that a patient was referred for full revision surgery due to high impedance. The high impedance was identified via diagnostic test, which indicated that the device was providing a lower output current than was programmed. The physician requested x-rays of the patient's device. The x-rays were sent to the manufacturer; however, since x-ray viewer software did not accompany the images, the x-rays could not be reviewed by the manufacturer. The patient underwent full revision surgery due to battery depletion and high impedance. The explanted devices were planned for return to the manufacturer, but have not been received by the manufacturer to date. No additional relevant information has been received to date.
 
Event Description
The explanted lead and generator were received by the manufacturer; however, analysis has not been approved to date. No additional relevant information has been received to date.
 
Event Description
Analysis was approved on the generator. When received, the data was downloaded from the generator and reviewed. A >25% increase in impedance was observed 6 months prior to explant. Since the impedance values before and after the observed increase indicated high impedance, it is likely the high impedance existed prior to the date that the change was observed. No visual anomalies were identified with the generator. Testing was performed on the internal circuitry of the generator, and the device performed according to functional specifications. Analysis was also approved for the lead. A portion of the lead assembly was returned in one piece, but the electrodes were not returned and thus an assessment cannot be made on that portion of the lead. Five sets of set screw marks were seen on the connector pin providing evidence that proper contact between the lead and generator existed 4 times; one set of the set screw marks was located at the end tip suggesting that the lead connector pin was not completely inserted at one point in time. A lead fracture was not observed in the returned portion 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=6821687
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« Reply #799 on: June 05, 2019, 12:10:16 AM »

Model Number 302-20
Device Problems Fracture; Mechanical Problem
Event Date 08/28/2017
Event Type  Malfunction   
Event Description
A system diagnostic test revealed high impedance on a patient's device. The following day, the patient underwent lead and generator replacement surgery, and preoperative diagnostic testing also showed high impedance. During the surgery, the physician confirmed that the lead pin had been fully inserted into the generator, leading him to believe that a lead fracture was the cause of the high impedance. The explanted lead was returned to the manufacturer for analysis, but analysis has not been approved to date. No additional relevant information has been received to date.
 
Event Description
Analysis was approved for the lead. The lead was returned in two portions; however, the lead electrodes were not returned for evaluation so an assessment could not be made on that portion of the lead. Two pairs of set screw marks were observed on the connector pin, providing evidence that proper contact between the set screws twice. A single set screw indentation was observed at the end tip of the connector pin suggesting that the lead connector pin was not inserted completely at one point. An abrasion was also observed on the connector boot, and several abraded openings were observed on the outer and inner tubing in multiple locations. A coil break was also identified, and microscopy suggested that a stress-induced fracture occurred in the negative coil. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6888355
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« Reply #800 on: June 05, 2019, 12:11:03 AM »

Model Number 304-20
Device Problems Corroded ; Fracture; High impedance; Mechanical Problem
Event Date 07/26/2017
Event Type  Malfunction   
Event Description
It had been previously captured in mfg. Report # 1644487-2017-03411 that high impedance was caused by inadequate pin insertion. In that report the generator was replaced at the same surgery where the high impedance resolved. During the surgery the surgeon confirmed that the lead pin was adequately inserted into the generator. The patient later presented for a follow-up appointment due to an increase in seizures and high impedance was observed again. However since the high impedance had resolved during the previous surgery it appears that the recent high impedance is a separate and new event. The patient was referred for a lead replacement however no surgical interventions are known to have occurred to date. No additional relevant information has been received to date.
 
Event Description
The patient underwent lead replacement surgery and the explanted lead was received. Product analysis is currently underway.
 
Event Description
Analysis was completed on the returned lead portion. The lead was received in two pieces that did not include the electrodes. 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. The two sets were at different locations of the pin indicating that the set closer to the tip of the pin may have been related to the pin insertion issues reported in mfg. Report 1644487-2017-03411. A suspected coil break was identified in one of the lead coils at approximately 0. 4 cm past the end of the electrode bifurcation along with pitting at the fracture. Pitting indicated that the fracture was present while stimulation was being provided. Abrasion in the outer tubing were noted in multiple locations. No other discontinuities were identified within the returned lead portion. Analysis confirmed the present of a lead fracture and abraded openings in the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6805383
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« Reply #801 on: June 05, 2019, 12:11:55 AM »

Model Number 105
Device Problem High impedance
Event Date 07/19/2017
Event Type  Malfunction   
Event Description
Patient underwent prophylactic generator replacement. During the replacement, high impedance was observed on both the old and new generator. A microfracture is suspected since or specialist verified proper lead insertion and the high impedance was still occurring on both generators. System diagnostics were verified to be run multiple times and eventually the high impedance was resolved. The first couple tests showed impedance >10,000 ohms initially, and then the tests showed the following impedances: 8560, 7173, 5933, 2413, 2186, 2093, and 1640 ohms. As the final two tests showed normal impedance, the surgeon decided to close up the patient's incision without replacing the lead. The device was left programmed off. The explanted generator was received and analysis is underway but has not been completed. Per clinic notes received for patient's replacement referral, the parents reported that they swipe the magnet with each seizure cluster up to five times, but feel it has not been helpful. No additional relevant information has been received.
 
Event Description
Proper functionality of the pulse generator in its ability to provide appropriate programmed output currents was successfully verified in the product analysis lab. The device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. Magnet activations performed during output monitoring (at a distance of one-inch, spacer block, from the generator), demonstrate the appropriate magnet output for the programmed settings. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications, with the exception of the expected low battery. The electrical performance of the generator, as measured in the lab, was used to conclude that no anomalies exist and the near-end-of-service (neos) condition is an expected event. No additional performance or any other type of adverse conditions found with the pulse generator. Additional programming data was received. Based on the decoder data, the high impedance observed on the day of replacement is believed to be incomplete pin insertion. Per the decoder, the explanted generator's last known 25% change in impedance prior to troubleshooting done during the surgery was from 6/7/2017 (993 ohms to 2780 ohms). This indicates that there was no high impedance present before the day of surgery. On the day of surgery, the explanted generator showed high impedance on only instance and a subsequent system diagnostic test following the high impedance observation showed normal impedance. Therefore it is likely that the one instance of high impedance is due to incomplete pin insertion, which resolved after proper pin insertion for the next system diagnostic test.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental mdr #1 inadvertently left out some information that was intended to be reported.
 
Event Description
For the newly implanted generator at the time of surgery, there were several system diagnostic tests that showed high impedance initially. However the last few (5) system diagnostics showed normal impedance with values 2413, 2186, 2093, 1960, and 1640 ohms. As impedance slowly decreased and returned to normal impedance for the new generator, there is no generator issue suspected. It is likely that the lead pin was not inserted the first few tries of the diagnostics that resulted in high impedance. After lead pin manipulation and troubleshooting during the surgery, the impedance likely returned to normal limits when proper connection between the lead pin and the generator was established.

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« Reply #802 on: June 05, 2019, 12:12:40 AM »

Model Number 304-20
Device Problem High impedance
Event Date 09/01/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was in clinic for the first appointment around 2 months after vns implantation and high impedance was observed on the patient's device. The patient was scheduled for a surgery to address the issue. 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 a revision surgery took place due to the high impedance and it was found that the lead was not fully inserted into the generator which was causing the high impedance. The pin was re-inserted into the generator and the impedance value was found to be ok.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6896389
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« Reply #803 on: June 06, 2019, 01:48:17 AM »

Model Number 105
Device Problem High impedance
Event Date 04/25/2017
Event Type  Malfunction   
Event Description
It was reported that a vns patient was scheduled for revision surgery. It was later provided the reason was due to high impedance discovered at an office visit 3 weeks prior. X-rays were ordered and showed no obvious lead break. The patient has had 2 seizures recently. Review of the manufacturing records revealed no unresolved discrepancies prior to distribution. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Surgery occurred and it was discovered that the lead pin was not fully inserted. The lead pin was reinserted and the impedance value was normal.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6873668
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« Reply #804 on: June 07, 2019, 04:44:47 AM »

Model Number 304-20
Device Problem Fracture
Event Date 04/02/2019
Event Type  Malfunction   
Event Description
An implant card was received indicating that a patient received a full revision (both generator and lead replacement). It was reported that the lead was replaced due to high lead impedance, and that the generator was replaced prophylactically. The explanted lead underwent product analysis. Note that the (-) green electrode was not returned for analysis, therefore an evaluation and resulting commentary could not be made on that portion of the lead. Setscrew marks were found near the end of the connector pin indicating that the lead had not been fully inserted into the cavity of the generator at some point in time. However, additional setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. During the visual analysis of the quadfilar coil it appeared to be broken approximately 2mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage and fine pitting. The area on the remaining broken coil strands was identified as being mechanically damaged with pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified. With the exception of the observed discontinuity, no further anomalies were observed and the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No other relevant information has been received to date.

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« Reply #805 on: June 08, 2019, 12:40:37 AM »

Model Number 304-20
Device Problem High impedance
Event Date 04/27/2019
Event Type  Malfunction   
Event Description
It was reported that the patient had a seizure related fall and since has not perceived stimulation. Per the patient. Diagnostics was performed by the physician and found battery was ok and impedance was high. Per the physician, the patient has received good efficacy from the device and patient reports the magnet had helped. The neurologist turned off all modes and has referred the patient for x-rays. Anterior/posterior and lateral neck and chest x-rays were reviewed. The generator placement was determined to be normal the left chest. Based on the scope of the image, the feed through wires were intact, however the pin could not be visualized passed the second connector pin per the scope of the image. There was a portion of the lead routed behind the generator. The lead wires did appear to be intact at the connector pins. The lead was assessed for fractures and no gross fractures or discontinuities. Based on the information gathered in the file regarding the patient¿s high impedance, a possible device malfunction cannot be ruled out. While the x-rays suggest that the pin is not fully inserted, additional information was provided that the patient recently fell and cannot perceive stimulation and the patient¿s impedance was over 10,000 ohms. The generator was implanted a little over a year before the high impedance was seen and based on the reported events, trauma over user error appears to be the cause of the high impedance. Therefore, with the available information the high impedance may likely be caused by a microfracture / device malfunction and not just incomplete pin insertion. Surgery has not occurred to date.

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« Reply #806 on: June 10, 2019, 12:15:50 AM »

Model Number 106
Device Problem High impedance
Event Date 08/09/2017
Event Type  Malfunction   
Event Description
Report was received that high impedance was found in the operating room. The patient was receiving a full revision surgery. After the old generator and lead were removed, a new generator and lead were implanted. Prior to the conclusion of surgery, system diagnostics were run on this system and resulted in high impedance. Proper pin insertion was reportedly verified and the nerve was irrigated. Generator diagnostics were performed using a test pin and the results returned were normal. The surgeon decided to try another lead, but the surgeon reportedly had difficulty placing the electrodes on the lead. Prior to completing the surgery, the patient began to show signs of arrhythmia (captured in mfr. Report #1644487-2017-04402) the anesthesiologist reportedly recommended that the surgery be terminated because the arrhythmia was likely related to vagus nerve manipulation in conjunction with duration under anesthesia. The patient returned for surgery at a later date to complete the lead revision, but it was found that vagus nerve was attached to the jugular vein by scarring. The scarring could not be dissected and the lead revision could not be completed. The device history record was reviewed and showed the lead passed all quality specifications prior to release for distribution. No known surgical intervention has been completed to date. No further relevant information has been received to date.
 
Event Description
Product analysis was completed and approved on the lead. The condition of the electrodes and helices were consistent with conditions that typically exist after manipulation during an attempted implant. Three half sets of set screw marks were found near the end of the connector pin indicating the lead had not been fully inserted into the cavity of the generator. There was no dimensional issue found in the connector portion of the lead which would have prevented it from being inserted into the generator. Continuity checks were performed and no discontinuities or fractures were identified. Overall length and resistance measurements of the complete returned lead were determined to be in compliance with those defined in the manufacturing specifications. No further information has been received to date.
 
Event Description
Further information was received that the patient had an implant surgery where a new lead was successfully implanted. Additionally, the implanted generator was replaced with a new generator as the surgeon did not want to use the generator that had been implanted without connection to any lead. The generator has not been received to date. No further relevant information has been received to date.

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« Reply #807 on: June 11, 2019, 12:17:15 AM »

Model Number 106
Device Problem High impedance
Event Date 09/26/2017
Event Type  Injury   
Event Description
It was reported that a patient was hospitalized due to a rash of seizures. Upon doing system diagnostics, the physician reported he saw high lead impedance. He would like this patient to be expedited for a lead revision due to the increase in seizure activity. Revision surgery occurred. The explanted devices have not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
Follow-up to the company representative who attended the surgery provided that during the surgery the lead pin was re-inserted. The impedance was shown to be normal after the lead pin re-insertion, however the surgeon elected to replace the lead anyway. There was no fracture or break identified in the surgery.
 
Event Description
It was reported that the explanted lead was discarded.

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« Reply #808 on: June 12, 2019, 02:18:52 AM »

Model Number 302-20
Device Problems Corroded ; Fracture
Event Date 09/08/2017
Event Type  Malfunction   
Event Description
A patient underwent lead and generator replacement surgery due to a high impedance message observed during diagnostic testing of the device. The explanted lead and generator were returned to the manufacturer, but product analysis has not been completed to date.
 
Event Description
Analysis was approved for the generator. The generator communicated normally upon interrogation, and the device had not yet reached end of service. The generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. Analysis was approved for the lead. A section of the lead assembly was returned for analysis in two pieces. The electrodes were not returned for evaluation so an assessment on that portion of the lead cannot be made. 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 twice. A single set screw indentation was noted at the end tip of the connector pin suggesting that the lead connector was not inserted completely at one point in time. A lead break was observed in the positive coil of the lead past the electrode bifurcation. The tubing was also torn at this location. Microscopy was performed and identified pitting at the break location; however the fracture mechanism could not be identified. No additional relevant information has been received to date.

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« Reply #809 on: June 13, 2019, 02:53:41 AM »

Model Number 106
Device Problem High impedance
Event Date 09/06/2017
Event Type  Malfunction   
Event Description
High impedance was observed on a patient's device during a clinic visit. Diagnostics performed during the first follow up visit after initial implant surgery were within the normal limits; however, when the high impedance was identified, only 0ma output current was being delivered. Per the company representative, the patient was not known to have experienced any trauma or manipulated the device prior to the observed high impedance. X-rays were reviewed by the neurologist, and no abnormalities were identified with the lead. The x-rays were not reviewed by the manufacturer. The patient was referred to the implanting neurosurgeon. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The patient underwent surgery to remedy the high impedance. It was confirmed that the lead pin was not fully inserted into the generator header. During surgery, impedance testing was performed on the generator and confirmed that the device was functioning properly. The lead was then reinserted into the generator, and system diagnostics were within the normal limits. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6909672
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