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dennis100
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« Reply #60 on: November 10, 2018, 01:13:04 AM »

Model Number 1000
Device Problem High impedance
Event Date 07/31/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A nurse practitioner reported that she received a high impedance reading when running system diagnostics. High impedance was present during patient's previous appointment as well. Patient was referred to neurosurgery but the patient was sent back to for evaluation. X-rays were ordered. Patient underwent surgery for high impedance. The lead pin was re-inserted but the high impedance was still present. Surgeon noted fluid in the generator header. During the process of cleaning the fluid from the header and re-inserting the lead pin, the diagnostic test was re-run and the high impedance was still present. The lead pin was removed again to attach a new generator, at which time the septum plug came out of the generator header. When the surgeon went to unscrew the lead from the generator, the silicon septum plug came out of the screw head. It was stated that the area was cleaned out and rechecked and there was still high impedance. The generator was replaced and the high impedance was resolved upon diagnostic testing. The lead was not replaced. The suspect generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7987521
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dennis100
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« Reply #61 on: November 10, 2018, 01:13:48 AM »

Model Number 106
Device Problems Difficult to Insert; Mechanical Problem
Event Date 09/12/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported a company representative, that a generator immediately did not look right to the surgeon after being taken out of the packaging for an implant surgery. The septum plug looked frayed and did not look right initially the surgeon could not get the lead to go past the first connector block, but eventually he was able to use the hex screw driver to get the lead in. Then the lead pin tip would not go past the second connector block. The surgeon indicated that the generator and lead connection didn't look right. Impedance was ok at 2030 ohms but they had hesitations about using the generator. The surgeon had reportedly done many surgeries in the past. It was noted that he had tried irrigating the lead cavity. The attending company representative indicated that the surgeon probably tried to use the hexscrew 20 times. The surgeon decided to use a new generator. The manufacturer's device history records of the suspect generator were reviewed. The generator passed final quality and functional specification prior to release. The suspect product was received but product analysis on it has not been completed to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7939457
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dennis100
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« Reply #62 on: December 19, 2018, 12:16:49 PM »

Model Number 104
Event Date 10/26/2013
Event Type  Injury   
Manufacturer Narrative

Event Description
The patient was hospitalized on (b)(6) 2013 for complaints of pain in the chest at the generator site along with diagnosed left vocal cord paralysis. The chest pain was not occurring with vns stimulation. The patient was seen by the ear nose throat (ent) doctor and the vns was disabled for the day, which resulted in the chest pain resolving. The ent felt that the vns could be turned back on after one day and the patient's settings were reduced from the previous ones (1. 0ma instead of 2. 75 ma). Diagnostics were all ok.

Event Description
Additional information was received that the vocal cord paralysis was believed to be due to rapid cycling and once they change the cycle, the patient has had no further issue. The patient is doing well now with no vns issues. The generator replacement is not related to the reported events of pain and vocal cord paralysis.

Event Description
On 12/10/2014 product analysis was completed on the explanted generator. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Burn marks were observed on the pulse generator case, which indicated that the pulse generator may have been exposed to an electro-cautery tool during device explant. A reset of the pulse disable bit in the generator memory was performed to allow for an output to once again be provided by the generator for subsequent testing. The septum was cored, but no evidence of body fluids were observed in the header septa cavities, thus eliminating the possibility of a potential unintended electrical current path through body fluids. 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. 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.

Event Description
On (b)(6) 2014 it was reported that the patient underwent generator replacement on (b)(6) 2014 due to battery depletion. The explanted generator was returned for product analysis on 11/18/2014. Product analysis is still underway and has not yet been completed.

Event Description
Additional information has been received that the patient will be having a generator replacement. Surgery is likely but has not been completed to date. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3485389
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dennis100
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« Reply #63 on: January 04, 2019, 08:31:14 AM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 11/21/2018
Event Type  Malfunction   
Event Description
It was reported that high impedance was observed on the patient's newly implanted vns generator, which is captured in mfg. Report #1644487-2018-02331. The patient had underwent vns generator replacement surgery approximately a week prior due to prophylactic reasons. The diagnostics post-operatively were within normal limits. It was later reported that the septum plug fell out of the patient's replacement generator during surgery. While the detachment of the septum plug could have been a contributing factor to the observed high impedance, there has been no indication to date that high impedance was the result of incomplete lead pin insertion and, therefore, the detachment of the component will be housed in this report. It is unclear if the septum plug was reinserted or left off of the implanted generator. A review of device history records revealed that the generator passed quality control inspection prior to distribution. The x-ray image was reviewed by the manufacturer. The placement of the m1000 generator per labeling could not be assessed due to the limited view of the x-ray image provided. Due to the angle of the image, it was unable to be assessed whether the lead pin is fully inserted. The feedthru wires appear to be intact. Only the portion of the lead immediately adjacent to the generator was visible in the x-ray image provided. The review was unable to assess if strain relief and tie-downs were present and placed according to labeling due to the limited view of the x-ray image provided. No apparent sharp angles or gross fractures were identified in the visible portions of the lead. However, a segment of the lead is behind the generator and the lead portions not visible in the image provided could not be assessed. The patient underwent vns generator replacement surgery. The explanted product has not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8175054
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dennis100
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« Reply #64 on: February 03, 2019, 03:35:06 PM »

Model Number 102
Event Date 09/15/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the vns patient underwent generator replacement surgery on (b)(6) 2014 due to end of service. Prior to replacement, the surgeon stated that some sort of silicone based substance was leaking from the generator. The substance was described as white in color, and the surgeon believed that it was an inorganic-based substance. A sample of this was sent to the pathology lab at the hospital for analysis. No results of the pathology lab¿s analysis have been received to date. The generator was explanted and returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the generator was completed on 10/31/2014. Residue was observed on the pulse generator feed-thru assembly and is known to be related to the manufacturing process of the component. There was evidence of body fluid remnants on the case exterior. The septum was cored, but no evidence of dried fluids was found in the septum cavity. No leaking white substance was observed on the pulse generator. The module performed according to functional specifications. There was no condition noted during the product analysis evaluation that would suggest any anomaly with the device. The final pathology results indicate soft tissues, left side of chest, organized fat necrosis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4157456
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dennis100
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« Reply #65 on: February 04, 2019, 02:39:28 AM »

Model Number 103
Event Date 10/09/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
On (b)(6) 2014 it was reported that the device was explanted on (b)(6) 2014 due to a malfunction. No further information was received. The explanted generator and lead were returned for product analysis on (b)(4) 2014. Product analysis is still underway and has not yet been completed.
 
Event Description
Analysis of the generator and lead were completed. The reported malfunction allegation not duplicated in the laboratory. The device output signal was monitored for more than 24-hours, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The pulse generator diagnostics were as expected for the programmed parameters. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. The septum was cored, but not in the slit of the septum. Bodily fluid remnants were observed in the header septum cavity, on/in the negative connector block, and on the setscrew. However, no pitting or corrosion was observed. In addition, the setscrew socket shows mechanical wear (more than typically observed), indicating multiple insertions and/or insertion attempts into the setscrew socket, which may have been a contributing factor for the cored septum. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product. Other than the septum anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator. Note that the electrodes were not returned for analysis and 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. Based on the findings in the lab, there is no evidence to suggest an anomaly with the returned portion of the device which may have contributed to the stated complaints. It was reported in 2013 that the patient went to the surgeon initially and decided to move forward with repositioning her generator due to patient comfort which the surgeon agreed. However, the patient was later unwilling and wanted the device explanted. The patient had previously expressed desire to have vns explanted as also previously reported in manufacturer report #: 1644487-2013-03087.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4245161
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dennis100
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« Reply #66 on: February 07, 2019, 02:15:36 AM »

Model Number 103
Event Date 12/24/2014
Event Type  Malfunction   
Event Description
The patient reported on (b)(6) 2016 that he believed that the generator was turned on (magnet mode only) because the generator was activated by the detectors at the doors of a large retail store, which caused the patient to have painful stimulation from his left neck to his ear, which made him drop to the floor. His stitches also came out because of the fall to the floor. The patient and his mother believed that the device was defective due to the electro-magnetic interference with the device. The patient had the generator explanted due to the painful stimulation, and the patient reported that the generator was analyzed by a vns technician that was certified by the state and had documentation that the device was defective. The patient did not know where the analysis was done. However, the device was returned to the manufacturer and analysis was performed. There were no anomalies identified with the generator other than the septum being cored. There was no bodily fluids inside the septum, though, so there would not have been a path for stimulation to reach the patient body. The patient also reported feeling the painful stimulation in the neck and ear, which is not near the patient generator. Therefore, the painful stimulation can reasonably assumed to not be related to the cored septum. The device performed according to specifications. No further relevant information has been received to date.
 
Event Description
Analysis of the returned generator was completed. There were no performance or any other type of adverse conditions found with the pulse generator. The septum was cored but no bodily fluid remnants were observed in the header septum cavity. Monitoring of the device output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. Various electrical loads were attached to the generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4430571
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dennis100
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« Reply #67 on: February 09, 2019, 01:35:28 AM »

Model Number 106
Device Problems High impedance; Detachment of Device or device Component
Event Date 08/14/2018
Event Type  Malfunction   
Event Description
It was reported that the diagnostics at the time of implant were normal. The patient's device was interrogated a month after implant and impedance came back has high. X-rays were conducted an no fractures were visible. The pin was possibly not fully in place however it was difficult to visualize through the x-ray. The patient underwent surgery for a possible revision due to the high impedance upon opening the chest incision it was seen that the lead pin had come out slightly as a consequence of the screw coming undone and the silicone cover was detached. It was reported that the lead pin was inserted properly and secured by tightening the setscrew at the time of initial implant. The surgeon removed the generator and replaced the silicone cover and placed the generator back in. The device was tested and normal impedances were seen. After the surgery, while the patient was recovering, 3 diagnostics tests showed high impedance. And low output current delivered. The patient was taken back in to surgery and it was seen that the lead was again not fully inserted. A new generator was implanted and high impedance was still seen, therefore the lead was revised. The set screw being undone and the detachment of the septum plug is reported. The high impedance suspected to be due to the lead is reported in mfr. Report # 1644487-2018-02262. The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8242712
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dennis100
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« Reply #68 on: March 09, 2019, 01:40:58 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 01/20/2019
Event Type  Malfunction   
Event Description
It was reported that the patient underwent a lead replacement surgery, and during the surgery the septum plug came out. Per the report the generator involved was not implanted. The device has not been received by the manufacturer to date. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8341172
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dennis100
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« Reply #69 on: April 13, 2019, 03:33:51 AM »

Model Number 303-20
Device Problem Difficult to Insert
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that during a first implant surgery, the surgeon had difficulties to insert the lead into the generator block. It was reported that during the surgery on (b)(6) 2016, the lead got stuck and it wouldn't completely go into the receptor head of the generator. The grub screw was lost out of the head and both lead and generator had to be replaced. It was reported that both products (generator and lead) are still at the hospital for examination to see if there is any defect. No further information was provided to date.
 
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
Further information was received from a nurse, indicating that the suspected device will be returned to the manufacturer for analysis. It was reported that when the reported issue was found, another device was implanted instead. Review of manufacturing records confirmed that both, the generator and the lead passed all functional tests prior to distribution.
 
Event Description
The suspected generator and lead were returned to the manufacturer on 09/26/2016. An analysis was completed on the returned lead portions and the reported "insertion difficulties" (lead section) allegation was not confirmed. The connector pin section including the small front o-ring and large o-rings was not returned. A portion of the connector boot was returned. The condition of the returned lead portions is consistent with conditions that typically exist following an attempted implant procedure. No obvious anomalies were noted. Continuity checks of the returned portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest a product anomaly with the returned portions of the lead which may have contributed to the stated complaint. An analysis was completed on the returned generator and the reported allegation of "insertion difficulties" was not duplicated in the laboratory. No obstructions were observed in the pulse generator header lead cavity or the connector blocks. The in-line cavity go gauge test passed and a bench in-line lead fully inserted into the pulse generator header, past the negative connector block (lab conditions). The pulse generator header lead cavity (critical dimension 1) accepts a pin gauge of 0. 136 inches minus (limits 0. 137 +/- 0. 002). The pulse generator header lead cavity, critical dimension 1, meets specification. In addition, review of the ram/flash data downloaded from the pulse generator shows an impedance test was performed on the date of the attempted implant ((b)(6) 2016). The "time stamp impedance diagleadzhistory" results show: impedance value (ohms): 14240 - time stamp: (b)(6) 2016. This would suggest the lead pin was inserted into the pulse generator header. The reported allegation of "detachment of component(s) set screw" was not duplicated in the laboratory. The septum was cored and damaged on the underneath side. This suggests that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) set screw". The pulse generator performed according to functional specifications. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery shows an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 0. 767% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
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. 135 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. 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. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5893260
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dennis100
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« Reply #70 on: April 22, 2019, 01:25:03 AM »

Model Number 106
Event Date 10/11/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
During a lead replacement surgery on (b)(6) 2016 for the patient, the surgeon was unscrewing the septum plug with a screw driver to perform a generator test, but in doing so, the rubber seal on the implanted generator came off. The generator then had to be replaced. Attempts to retrieve the generator have been made, but the generator has not been received to date.
 
Manufacturer Narrative
The initial report inadvertently did not report: "the lead replacement is captured in mfg report # 1644487-2016-02568. ".
 
Event Description
The generator was received by the manufacturer for analysis. However, analysis has not been completed to date. The lead replacement is captured in mfg report # 1644487-2016-02568.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Analysis was performed on the returned generator. The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment. The pulse generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery voltage was measured at 3. 047 volts and shows an ifi=no condition. The data revealed that 18. 459% of the battery had been consumed. The septum was not returned, therefore no measurements could be taken. However, the header septum cavity does not met specification requirements; the header septum cavity measured 0. 127+ (plus pin gauge set) inches (limits 0. 125 inches +/-0. 002). Although the header septum cavity is slightly out of specification, a septum from inventory stock inserted and secured appropriately into the pulse generator header septum cavity. The explant process may have been the contributing factor for the detachment of the septum plug. There were no additional performance or any other type of adverse conditions found with the pulse generator. Review of device history records showed no unresolved non conformances on the generator prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6080091
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dennis100
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« Reply #71 on: May 11, 2019, 01:10:06 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 03/20/2019
Event Type  Malfunction   
Event Description
Initial report was that the generator's septum plug came out of the generator during lead pin insertion during surgery. The surgeon attempted to replace the septum plug and it was noted that the septum plug would not seat properly in the generator. The lead insertion was noted to be without difficulties. A backup generator was used in place. The device history records for the generator were reviewed and show that no unresolved non-conformance's were found. The device met all specifications for release prior to distribution. The product was received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8506083
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« Reply #72 on: June 02, 2019, 12:41:08 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 06/13/2017
Event Type  Malfunction   
Event Description
During a new patient implant, the surgeon backed the setscrew all the way out and it could not be put back in. The surgeon used a new generator for the surgery. The suspect generator was received and analysis is underway.
 
Event Description
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. The ¿detachment of component(s) septum plug¿, was observed ¿as received¿ prior to decontamination, the septum was inserted up-side down in the header septum cavity, which may possibly be implant-related. In addition, the returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. Furthermore, the returned septum shows what appear to be tears in the body of the septum, suggesting that the torque wrench was pushed into the septum, which may have been the contributing factor for the detachment of septum plug. 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=6695459
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« Reply #73 on: June 08, 2019, 12:36:49 AM »

Model Number 106
Device Problem Detachment of Device or device Component
Event Date 05/01/2019
Event Type  Malfunction   
Event Description
It was reported that the patient was receiving a replacement due to battery depletion. During the replacement surgery, the initial generator used had the septum plug come out after using the torque wrench therefore it was not used. A backup generator was used for the replacement. The generator has not been received for analysis to date. No additional relevant information had been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8631636
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« Reply #74 on: June 09, 2019, 12:32:58 AM »

Model Number 106
Device Problem Detachment Of Device Component
Event Date 08/29/2017
Event Type  Malfunction   
Event Description
During a lead revision surgery, the setscrew came out of the generator, and therefore the generator was replaced as well. A review of device history records for the generator shows that no unresolved non-conformances were found. Additional information was received reporting that the doctor barely unscrewed the set screw and the screw backed out. No other relevant information has been received to date.
 
Event Description
The product has been received by the manufacturer and analysis is underway but has not been completed to date. No additional relevant information has been provided to date.
 
Event Description
The generator underwent product analysis. The device was monitored and showed no signs of variation in the output signal. The pulse generator diagnostics were as expected for the programmed parameters. The detachment of the set screw, was observed when the product was received. The returned set screw shows mechanical wear on the socket, suggesting numerous insertion attempts. In addition, the underneath side of the returned set screw shows indention marks, suggesting a lead pin or an in-line test resistor was once secured by the set screw. The returned septum shows damage on the underneath side, which suggest the returned set screw was extracted up into the returned septum, which may have been the contributing factor for the detachment of components. 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=6857562
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