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dennis100
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« Reply #90 on: March 19, 2019, 12:43:02 AM »

Model Number 103
Device Problems Screw; Loose or Intermittent Connection
Event Date 09/09/2015
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported on (b)(6) 2015 that a m103 generator was opened but not used due to a loose setscrew and septum plug. It was stated on the questionnaire form that the screw and silicone protection for the screw of the generator disconnected very easily. The physician decided to use another generator to implant because she did not feel safe to implant the generator with the screw loose. Review of the design history record showed that no unresolved defects or non conformances were associated with this device. The device also passed all specifications/inspections prior to distribution. The device is expected to be returned but has not been received to date.
 
Event Description
The generator was received for analysis on (b)(6) 2015 with the reason state as "there was loosening the screw and silicone protection that keeps the fixed electrode in the generator. " product analysis for the generator was completed and approved on (b)(6) 2015. The generator was returned due to detachment of components, septum plug and set screw. Visual examination revealed damage to the bottom of the septum by the setscrew, setscrew marks were observed on the inside of the septum which would indicate that the setscrew was backed out too far. The septum was also cored. The results of the visual examination would indicate that the detachment of the septum was due to user error. Review of the data in the decoder sheet revealed that the impedance value was 4000 ohms and the estimated occurrence was (b)(6) 2015. Which would indicate that the test resistor was inserted into the header and a diagnostic test was performed. Setscrew marks were also noted on the tip of the test resistor. Electrical test results showed that the pulse generator performed according to functional specifications. Other than the septum damaged condition there were no adverse functional, mechanical, or visual issues identified with the returned generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5154341
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dennis100
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« Reply #91 on: March 24, 2019, 02:44:29 AM »

Model Number 302-20
Device Problem High impedance
Event Date 10/23/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that the patient had an appointment that day and system diagnostics were run with results of high impedance. The device was programmed off the day the high impedance was observed. No x-rays are scheduled at this time. They do not suspect that there was any trauma or manipulation. The patient had a full replacement on (b)(6) 2015. It was reported that the negative electrode was detached from the lead. Attempts for product return have been made, but the explanted device has not been received to date.
 
Event Description
Information received on 12/01/2015 indicated that the explanted device was discarded after surgery and is therefore unavailable for analysis.
 
Event Description
Generator and lead were received for analysis on 02/10/2016. Product analysis for the generator was completed and approved on 02/29/2016. From the generator decoder received from the device, the change in impedance from 5058 ohms to 6448 ohms occurred on (b)(6) 2015. In the 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. There were no performance or any other type of adverse conditions found with the pulse generator. Product analysis for the lead has not been completed to date.
 
Event Description
Product analysis for the lead was completed and approved on 03/07/2016. Note that portions of the (+) white and (-) green electrode quadfilar coils, the anchor tether and (-) green electrode were not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. What appeared to be white deposits were observed on one of the inner silicone tubes. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, and no discontinuities were identified. Based on the findings in the product analysis lab, there is no evidence to suggest discontinuities in the returned portions of the device.
 
Manufacturer Narrative
 
Event Description
Based on findings from product analysis, no evidence of corrosion was found on the patient's lead. The figures provided show a heavily manipulated lead (suggestive that the patient was a twiddler).
 
Manufacturer Narrative
Describe event, corrected data. Supplemental mdr #5 incorrectly reported information that was inaccurate.
 
Event Description
Re-evaluation of the product analysis results revealed that the manipulation of the lead was attributed to the explant-related events and is not believed to have contributed to the high impedance during implant.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5263683
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dennis100
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« Reply #92 on: March 26, 2019, 02:13:08 AM »

Model Number 303-20
Device Problem Appropriate Term/Code Not Available
Event Date 12/01/2015
Event Type  Injury   
Event Description
It was reported on (b)(6) 2015 that the patient was experiencing a painful, jolting sensation in her neck. The pain was constant. The device was turned down from 1. 75ma to 1. 25ma, but the patient reported that it was still painful. The date of onset of the pain was unknown. No known trauma had occurred. The physician performed diagnostics, and the impedance was within normal limits at 2800 ohms. It was reported on (b)(6) 2015 that the patient was referred for generator and lead replacement surgery with the device likely programmed to not delivery therapy until surgery. An implant card was later received reporting that the patient had lead replacement on (b)(6) 2015 due to pain at the lead site. The generator was not replaced. No additional relevant information has been received to date. The explanted lead has not been received by the manufacturer for analysis to date.
 
Event Description
Additional information was received from the surgeon reporting that he was observed during lead replacement surgery that one of the helicals was off of the vagus nerve, so he believes this was causing the painful stimulation to the patient's muscles. There was no particular event that was known or believed to have contributed to the helical coming off the nerve, but he notes that she does have tonic-clonic seizures so it may have occurred from a seizure. The helical appeared to be pulled medially and pulled quite a bit. The device was turned off prior to surgery for the pain. He has not heard from the patient since surgery, so takes that as a good sign that her pain has improved/resolved. No further information was provided. The explanted lead was received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
Analysis of the lead was also completed. No obvious anomalies were noted. The 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 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 discontinuity in the returned portions of the device. Note that since the (-) green electrode was not returned, an evaluation and resulting commentary cannot be made on that portion of the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5359167
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dennis100
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« Reply #93 on: March 27, 2019, 01:24:25 AM »

Model Number 102
Device Problems Plug; Device Dislodged or Dislocated
Event Date 12/15/2015
Event Type  Malfunction   
Event Description
It was reported that a vns patient underwent lead replacement surgery on (b)(6) 2015. During the connection of the new lead to the existing generator, when the hex wrench was removed after tightening the setscrew, the septum plug pulled out, and remained on the shaft of the hex wrench. The surgeon tried to put the plug back in place into the generator's header. As there is no way to guarantee that the septum plug will remain in place after it has come out, it was decided to replace the generator too. No patient adverse events were reported. The lead was replaced due to high impedance. This event was reported in the medwatch report number 1644487-2015-06742. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The return of the explanted generator is expected but it has not been received to date.
 
Event Description
The explanted generator was returned to the manufacturer on (b)(6) 2016. Analysis is underway but it has not been completed to date.
 
Event Description
Analysis of the returned generator and septum was completed. Product analysis (pa) indicates that the reported allegation of ¿detachment of component(s)/septum plug¿ cannot be evaluated in the pa laboratory setting. However, measurements obtained in the pa lab of the original generator header septum cavity and septum dimensions meet specification. Septum was returned after the pulse generator had already been received and an analysis completed on it. The septum and setscrew were placed in the header septum cavity of the original generator and the setscrew was successfully secured by a bench torque wrench. In addition, the septum sealed properly in the header septum cavity. The septum was measured and meets specification for the septum measurements. Observed condition of the septum suggests manipulation during the attempted implant procedure contributed to the detachment event. Other than the damage to the septum, there were no other anomalies found. In the pa 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. The generator performed according to functional. 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=5346606
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dennis100
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« Reply #94 on: March 29, 2019, 07:43:05 AM »

Model Number MODEL 250
Device Problems Battery; Cover; Break; Failure to Charge; Detachment Of Device Component; Handpiece
Event Date 01/08/2016
Event Type  Malfunction   
Event Description
It was reported that the handheld device would not charge as the handheld battery cover had broken off the device. The handheld device and software flashcard have been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis found that the handheld device was returned without a battery cover. As a result, the handheld would not power on. No other anomalies were identified. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5405028
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dennis100
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« Reply #95 on: March 31, 2019, 07:13:03 AM »

Model Number MODEL 250
Device Problem Detachment Of Device Component
Event Date 02/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the site's tablet was missing its power button, presumed lost after several months in use. The power button has been replaced and the device is able to power on as expected. Review of the tablet computer's device history records confirmed all quality tests were passed prior to distribution. No additional pertinent information has been received to date.
 
Event Description
It was reported that the tablet¿s power button was found to be missing again. The tablet has not been received by the manufacturer to date. No additional pertinent information has been received to date.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The suspect tablet was received by the manufacturer, and product analysis was subsequently completed. The failure for the tablet to power on was confirmed, which was determined to be due to the missing power button. When the push button switch located where the power button was previously attached was pressed, the tablet turned on and completed all functional testing with no observed anomalies. Product analysis concluded that the missing power button appears to be related to retention tabs and/or user error, which allowed accidental removal of the component.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5502341
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dennis100
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« Reply #96 on: April 02, 2019, 12:14:40 AM »

Model Number MODEL 250
Event Date 04/19/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that the power button on a physician's tablet had come off and was lost. The device turned on when the metal connector in the hole where the power button used to be were pushed with a pen. The programming system has not been received for analysis to date. Additional relevant information has not been received to date.
 
Manufacturer Narrative
Event description, corrected data: the event description inadvertently stated that the device had not been received for analysis. Device evaluation, corrected data: the field was inadvertently provided as not having been received by the manufacturer in the initial report.
 
Event Description
The tablet was received for analysis on 04/29/2016, which is underway but has not been completed to-date.
 
Event Description
Analysis was completed on the returned tablet 06/07/2016. Visual analysis of the tablet was able to verify that the power button was missing. Further analysis also identified that the low profile tactile switch on the power board was damaged. When the power button is pressed, it applies pressure to the tactile switch and powers on the tablet. No further anomalies were identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5646383
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dennis100
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« Reply #97 on: April 04, 2019, 12:47:56 AM »

Model Number 302-20
Event Date 05/31/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance (>=10000 ohms. ) was observed on vns patient's system. It was reported that the patient had been feeling pain at neck for two weeks. On (b)(6) 2016, the patient's device was programmed at output current 1. 5ma, pulse width 500¿sec, frequency 30hz, on time 30sec and off time 5min. It was reported that the generator was turned off that day. It was reported that x-rays will be performed to see a possible lead discontinuity which could probably be due to a fall. A complete surgical revision will be scheduled but no known surgical interventions have been performed to date. Additional information was received indicating that x-rays have not yet been done, because the parents are quite reluctant about that. It was reported by the physician that in theirs records, there is a notification of the electrode wire-protuberance under the patient¿s skin on the neck; this was on (b)(6) 2014. No coincidental trauma and pain were observed; the device was working normally. It was reported that ultrasound investigation was performed that time, and no structural changes were described: the lead did not look interrupted.
 
Event Description
Further information was received indicating that the patient underwent lead revision surgery on (b)(6) 2016. The lead was replaced due to high impedance. The patient's vns system was tested upon connection of the new lead to the existing generator and system diagnostics returned impedance results within normal limits with 1480 ohms. Review of manufacturing records confirmed all tests passed for the concerned lead prior to distribution. It was reported that the explanted lead will not be returned to the manufacturer for analysis as it was disposed. Additional information from the physician indicated that the patient is now ok with a new e lead in place. It was reported that the patient never had any fall, blow or any other trauma in the neck region or area of vns generator. The lead protuberance appeared suddenly on (b)(6) 2010, under the skin on the lower part of her neck. When this happened, an ultrasound investigation was performed and no other intervention was taken; the patient was doing well, had no pain and very rare seizures and her mother reported that vns works well (hoarseness of patient voice). Later in (b)(6) 2016, the protuberance disappeared; the physician thinks that it was the moment when the electrode finally slipped completely from the vagal nerve. As it turned out during the revision, this protuberance was a part of electrode (a non-active one, the ground) that slipped from the vagal nerve. X-ray performed before the surgical procedure, indicated that one electrode was not in the correct place. It was reported by the physician that the reason must be an inappropriate position-fixation of electrodes when implanted.
 
Event Description
Additional information was received from the physician indicating that the day of the implant, on (b)(6) 2014, the device was tested and system diagnostics returned impedance results within normal limits with 1480 ohms. It was reported that on (b)(6) 2014 (after the lead protuberance appeared on (b)(6) 2014), the vns system was still ok and system diagnostics returned impedance results within normal limits with 2194 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5731782
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« Reply #98 on: April 04, 2019, 12:48:43 AM »

Model Number 102R
Event Date 04/01/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient had generator and replacement surgery due to high impedance, as captured in mfr report # 1644487-2016-00649. During surgery, it was identified that the generator header was completely separated from the can. Product analysis of the generator identified that the battery depletion was an expected event as determined by the battery life calculator and battery voltage measurement. Review of the device history record showed no unresolved non-conformances existed prior to device distribution. During the analysis, it was found that there was sufficient adhesive on the header and can indicating that the separation of the header from the can was not due to any sort of manufacturing error. The presence of foreign matter in the feed-thru area and along the header attach area indicates that this condition was present prior to explant however, the exact time at which the separation occurred is unknown. The cause of the detached header could not be ascertained. However, an area of separation between the generator case and header was noted as evident by the foreign matter in the feed-thru area and along the header attach area.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5727989
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« Reply #99 on: April 05, 2019, 01:22:30 AM »

Model Number 304-20
Event Date 05/10/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported by a company representative that during an initial implant the lead was not used by the surgeon as the metal became detached from the helix on the positive coil. When the surgeon used a new lead, there were no further issues. Review of the device manufacturing records revealed that the device met specifications prior to distribution. The product has been received for analysis which is underway, but has not been completed to-date.
 
Event Description
Analysis was completed on the returned lead portion 06/17/2016. During visual analysis the white electrode ribbon appeared to be stretched and mangled. The helical was misshaped and the suture partially detached. Imprints found on the inside groove of the helical were most likely made by the suture as a result of the manufacturing process. It appeared the ribbon and suture had been pulled out of the helical. The condition of the returned lead assembly is consistent with conditions that typically exist following an attempted implant procedure; however the absence of setscrew marks on the connector pin is evidence that the lead assembly was not fully implanted. The stretched ribbons and misshaped helices were most likely caused while attempting to place the electrodes on the vagus nerve. The sutures on the electrode helices appear to be intact. No obvious anomalies were noted. The lead was returned intact. Results of the overall dimensional and resistance measurements show that those parameters are within specification per the manufacturing assembly documentation. The condition of helical electrodes suggest extensive manipulation, leading to a misshaped helical section, and appears to be a user-related issue.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5702908
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« Reply #100 on: April 06, 2019, 12:19:42 AM »

Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/12/2018
Event Type  Injury   
Event Description
Article titled "improved quality of life and cognition after early vagal nerve stimulator implantation in children" was reviewed and three adverse events were identified for the patients studied within the cohort. 3 of the patients developed infections post implant and 1 of those patients required revision surgery due to the infection. 1 patient passed away prior to the study (captured in mfr. Report # 1644487-2019-00452) 1 patient had disconnection of their electrodes from the vagus nerve that required revision surgery(captured in mfr. Report # 1644487-2019-00454). It was reported that there was no permanent morbidity due to these events. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8404598
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« Reply #101 on: April 10, 2019, 01:20:35 AM »

Model Number 302-20
Event Date 06/30/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had full revision surgery due to battery depletion. It was later reported that the lead was replaced due to the electrode being detached from the nerve. The explanted generator and lead were received on 07/05/2016. Analysis of the generator identified that the device exhibited current consumption rates that are within specification, thereby demonstrating normal battery depletion to an end-of-service condition. The electrical performance of the generator were used to conclude that no anomalies exist and the eos condition is an expected event. 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 explanting surgeon confirmed that the lead was not detached from the nerve. High impedance was identified, and there was fluid inside the outer tubing that brought the surgeon to believe that the lead wires had been compromised. Analysis of the lead identified two lead breaks and corrosion at the break locations. Due to wear at one of the break locations, the fracture mechanism could not be determined. The other break appeared to be due to stress/mechanical damage. The electrodes were not returned for analysis, so a complete evaluation could not be performed on the entire product. With the exception of the observed discontinuity the condition of the returned lead portions was consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5821251
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« Reply #102 on: April 11, 2019, 02:03:14 AM »

Model Number 102R
Event Date 06/17/2016
Event Type  Malfunction   
Event Description
The patient had generator replacement surgery on (b)(6) 2016 due to battery depletion. It was identified as the generator was going to be explanted that the header was completely detached from the generator can. The physician stated that the patient is violent and causes harm to himself. The patient's father also reported that the patient often pounds on his chest, which may have caused the header to be broken. There was not excessive manipulation of the generator during the explant surgery. The device history record of the generator was reviewed, and the device passed all functional specifications prior to release. The explanted generator was received on 07/06/2016. Analysis has not been approved to date.
 
Event Description
Analysis was approved on 07/20/2016. An open can measurement of the battery voltage determined that the battery was depleted. The end of service condition was the result of normal, expected battery depletion based on the battery life calculation, the electrical test results and the bench evaluation. There were no tool marks on the can or header, which normally rules out an explant related detachment. There were no dried bodily fluids identified on the can (header area) or header, which normally rules out an implant period related detachment. Therefore, the cause of the header detachment is unknown. The device performed according to functional specifications. Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5796144
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« Reply #103 on: April 11, 2019, 02:04:03 AM »

Model Number 104
Event Date 06/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that during generator replacement surgery the septum plug on the generator became detached and the surgeon was unable to put it back in place. At that time the generator and septum plug were removed from the field and a different generator was implanted. A review of manufacturing records showed that the generator was sterilized and passed qc inspection prior to distribution. The new generator that the plug came out of was received and is currently pending product analysis.
 
Event Description
Product analysis was completed on the returned generator. It was noted that the positive septum plug was not received. Therefore it could not be analyzed. The negative septum plug was received and it was noted that it was not cored and meet dimensional specifications. The header septa was also evaluated and found to meet dimensional specification. Visual analysis noted tool marks on the generator case and header which appeared to be associated with the manipulation of the device during the attempted implant procedure. Functional analysis found that the generator performed to all functional specifications. The cause of the detachment could not be determined due to the positive septum plug not being received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5791153
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« Reply #104 on: April 13, 2019, 03:32:05 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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« Reply #105 on: April 14, 2019, 01:08:04 AM »

Model Number 106
Event Date 07/22/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the physician was in the process of implanting the patient with a new generator when the septum plug became detached from the generator and was lost. The physician also reported that the set-screw wasn't tightening prior to the septum plug becoming detached. It was confirmed that the septum plug was lost outside of the patient. The generator was received on 07/29/2016. Analysis has not been approved to date.
 
Event Description
Analysis was approved on 08/25/2016. The returned setscrew showed mechanical wear at the socket (suggesting numerous insertion attempts), but the socket was not stripped. The underneath side of the returned setscrew showed indention marks: suggesting a lead pin or test resistor was once secured by the setscrew and; the indention mark on the slanted edge of the setscrew suggests the setscrew caught the edge of the lead pin or test resistor. In addition, the returned setscrew showed mechanical wear on the threads. The mechanical wear on the returned setscrew threads (and based on the scratches / tool marks observed on the negative connector block) suggests re-insertion attempts of the returned setscrew. The negative connector block showed mechanical wear on the flat surface, at the edge before the threads. In addition, scratches and or tool marks (from an unknown source) were observed on the lead pin channel of the negative connector block, which is atypical to what is normally observed in the analysis lab. The septum was not returned for evaluation. The header septum cavity met specification requirements. Therefore, a root cause for the conditions could not be determined. A bench setscrew was inserted into the negative connector block and secured a bench in-line lead, which fully inserted into the generator header past the negative connector block (lab conditions). The pulse generator diagnostics were as expected for the programmed parameters. The pulse generator performed according to functional specifications. The battery showed an ifi=no condition. Other than the mechanical wear and scratches/tool marks on the negative connector block, there were no performance or any other type of adverse condition found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5878478
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« Reply #106 on: April 16, 2019, 12:26:01 AM »

Model Number 304-20
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Initial reporter phone#: (b)(6).
 
Event Description
High impedance was identified on a system diagnostic test on (b)(6) 2016. The generator was programmed off after the high impedance was identified. The patient underwent full replacement on (b)(6) 2016. X-rays were provided to the manufacturer and reviewed. The generator was shown to be properly placed in the left chest as instructed per labeling, the connector pin appeared fully inserted to the connector block, and the feedthru wires appeared intact. The lead appeared to have adequate strain relief as well as tie-downs present to hold the strain relief as instructed in labeling. No portion of the lead was identified behind the generator, and the lead wires appeared intact at the connector pin. Sharp angles were observed in the portion of the lead near the generator. A gross fracture was identified in the lead. The explanted lead and generator have been returned to the manufacturer, but no analysis has been performed to date.
 
Event Description
The explanted lead and generator were both returned to have product analysis performed. The lead was returned in two portions. During the visual analysis, the outer silicone tubing of both portions appeared twisted and compressed. The connector boot also appeared detached from the connector ring surface. Scanning electron microscopy (sem) was performed on the connector pin quadfilar coil break and identified the area on two of the broken coil strands as having evidence of a stress induced fracture (fatigue appearance) with mechanical damage. The remaining broken coil strands were identified as having extensive pitting which prevented identification of the coil fracture type. Pitting was observed on the coil's surface. Scanning electron microscopy was also performed on the connector ring quadfilar coil break, but extensive pitting prevented identification of the coil fracture type. During the analysis of the second returned portion, a coil break was identified and the sem identified the area as having evidence of a stress induced fracture. Identification of the fracture mechanism could not be made on the remaining broken coil strand due to extensive pitting. Abraded openings were identified on multiple portions of the returned lead through both the outer and inner tubing. Dried remnants of what appeared to be body fluids was found within the inner tubing. The setscrew marks found evidence that at one point in time, a good mechanical and electrical connection was present the explanted generator was returned and product analysis was completed on 10/11/2016. Review of the ram/flash data from the generator showed increased impedance occurred on (b)(6) 2016 and resulted in an increase from 9,541 ohms to 12,377 ohms. The battery voltage was found at 2. 956v and approximately 45% of the charge had been consumed. The generator was found as conforming to all functional specifications.
 
Manufacturer Narrative
Supplemental report #1 inadvertently did not update the event date per the new information identified.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5974973
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« Reply #107 on: April 16, 2019, 12:26:56 AM »

Model Number 102R
Event Date 07/15/2016
Event Type  Malfunction   
Event Description
Information was received that indicated the header of a patient's generator had become detached. This was discovered during the revision surgery on (b)(6) 2016. The device has not been received to date and no other relevant information has been received to date.
 
Manufacturer Narrative
Correction data: initial mdr inadvertently omitted information known prior to submission of the mdr.
 
Event Description
A device history record review showed that the header was cleaned on 10/02/2012 and secured to the generator can on 10/03/2016. The generator then passed all subsequent quality control tests and was released for shipment. There is no report that the patient experienced any trauma that may have cause the dislodgement of the header from the body of the generator. Diagnostics performed on (b)(6) 2013 show lead impedance within normal limits and battery status not at end of service. The facility where the explant occurred disposed of the device after surgery, thus no product return is expected. The surgeon indicated that the header was partially attached to the generator can when the patient was opened for surgery. Thus the explant surgery did not cause the header to become dislodged.

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« Reply #108 on: April 17, 2019, 06:44:59 AM »

Model Number 106
Device Problem Difficult to Insert
Event Date 09/02/2016
Event Type  Malfunction   
Manufacturer Narrative
Udi number: (b)(4).
 
Event Description
It was reported that during an implant surgery on (b)(6) 2016, the surgeon found a suspected device malfunction. It was reported that when inserting the screw driver into the silicon housing, the silicon became detached from the generator. The surgeon then discarded this generator and used a new device instead. No patient adverse event was reported. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. The return of the suspected device is expected but it has not been received to date.
 
Event Description
The suspected generator was returned to the manufacturer on 09/26/2016. An analysis was completed on the returned generator and the reported allegation of "detachment of component(s) septum plug" was not observed in the product analysis lab. The header septum cavity meets specification. The returned septum meets specification. However, the septum was damaged on the underneath side, suggesting that the setscrew was extracted up into the septum. This may be the contributing factor for allegation of "detachment of component(s) septum plug". 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 showed an ifi=no condition. The data in the diagaccumconsumed memory locations revealed that 1. 828% of the battery had been consumed. There were no performance or any other type of adverse condition found with the pulse generator.
 
Event Description
Additional information was provided indicating that the reason the physician had unscrewed the septum to the point of it popping out was due to difficulties he was having inserting the lead pin into the generator header block. The surgeon was reportedly having issues fully inserting the lead, so he kept unscrewing the septum plug until it came out.
 
Event Description
During a preliminary investigation initiated to study field complaints related to insertion difficulties reported during vns implant surgery, it was determined that the dimensions of the lead connector are critical to ease of insertion into the generator header during implant. Any measurement closer to the maximum assembly specification may cause insertion difficulty. It was also determined that the lead assembly document used at a secondary facility allowed for the lubrication of the lead connector with di water or the manufacturer's treated water in cases of excessive insertion force during functional tests, a practice not common to assembly at the main manufacturing facility. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5959327
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« Reply #109 on: April 21, 2019, 03:32:07 AM »

Model Number 102
Device Problem Detachment Of Device Component
Event Date 10/20/2016
Event Type  Malfunction   
Event Description
It was reported by a company representative that a patient¿s vns device had high impedance and was referred for revision surgery. Revision surgery occurred (b)(6) 2016. Follow-up from the company representative who attended the case provided that the patient had high impedance after he had a fall during a seizure. Prior to surgery diagnostics were performed and showed high impedance, and a second set of diagnostics which also showed high impedance. In surgery, the chest pocket was opened and it was discovered that the old generator was implanted under the muscle. When the surgeon was taking the generator out, he said the header was broken and the filter feed-thru wires were already pulled out. After he took the generator out, the header fell completely off. Since the generator was under the muscle, the surgeon thinks the fall may have caused the generator to be pushed up against the bone and broke the header. The new generator was put on the old leads, above the muscle and the diagnostics were within normal limits. The lead was not revised. The explanted device has not been received by the manufacturer to-date. Additional relevant information has not been received to-date.
 
Event Description
The explanted devices were received by the manufacturer. Analysis is underway, but has not been completed to-date.
 
Event Description
Analysis was completed for the returned generator. The reported detachment of header was confirmed. The reported high impedance was confirmed as well, as the output wires from the header were completely broken. After test wires were connected to the device¿s output, the device met functional specifications. With the exception of the header detachment, analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6105078
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« Reply #110 on: April 22, 2019, 12:53:58 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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« Reply #111 on: April 22, 2019, 12:54:57 AM »

Model Number 106
Event Date 11/03/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
On (b)(6) 2016, patient underwent generator replacement. When the new generator was connected to existing lead, high impedance was observed. The surgeon attempted to reinsert the pin, but the high impedance did not resolve. The surgeon backed the set screw all the way out and was unable to put it back in. The surgeon then used a new generator. Diagnostics with the new generator still observed high impedance. As a result, the lead was replaced. Further clarification was received from the operating room specialist. The generator was replaced and the lead pin was inserted into the lead pin and the set screw was tightened. During system diagnostics, high impedance was observed. The operating room specialist instructed the surgeon to remove the lead pin and reinsert it. The surgeon unscrewed the setscrew too far and the septum plug came out while trying to remove the lead pin to re-insert it. The septum plug came out during the unscrewing process. The surgeon wanted to implant a new generator as a result. The high impedance persisted with the new generator and so the lead was revised. After lead and generator revision, the high impedance resolved. Per the hospital policy, the products may not be returned. The suspect generator has not been received to date. The high impedance issue is reported in mfr. Report# 1644487-2007-01886.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6130288
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« Reply #112 on: April 22, 2019, 12:55:52 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6138374
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« Reply #113 on: April 26, 2019, 06:10:36 AM »

Model Number 103
Device Problem Detachment Of Device Component
Event Date 12/28/2016
Event Type  Malfunction   
Event Description
A generator was being ready to be implanted when the septum plug was found detached from the generator header block. The physician stated that before tightening the set screw, the septum plug came out. A photo of the generator with the septum plug removed was provided and reviewed. The generator was not implanted in a patient and another generator had to be used. The device history record for the generator was reviewed and verified that the generator had passed all quality inspections prior to release for distribution. The generator has not been received to the manufacturer to date.
 
Event Description
The generator that was not implanted was received by the manufacturer for product analysis. The product analysis has not been completed to date.
 
Event Description
Analysis was completed on the returned generator due to the reported septum plug being detached. The returned septum and the septum cavity were both verified to meet all specifications required for their respective components. 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 returned setscrew showed mechanical wear at the socket, indicating multiple insertion attempts were made, but the socket was not stripped and the returned torque wrench fully inserted with no issues. Additionally, the underneath side of the returned setscrew showed indentions, suggesting a lead pin or test resistor was once secured by the setscrew.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6272529
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« Reply #114 on: April 26, 2019, 06:11:23 AM »

Model Number 103
Device Problem Detachment Of Device Component
Event Date 01/06/2017
Event Type  Malfunction   
Event Description
During a revision surgery a septum plug of the m103 generator became dislodged during the troubleshooting. The generator was not implanted in the patient. Another generator was implanted successfully. The generator was received for product analysis on 01/24/2017. A review of the design history record found no anomalies. No other relevant information has been received to date. Manufacturing number 1644487-2017-03104 will discuss the issue identified with the lead during troubleshooting.
 
Manufacturer Narrative
(b)(4).
 
Event Description
Product analysis was completed on the returned generator. Tool marks were present on the can of the generator and header. The set screw plug was not cored. Microscopic assessment of the returned set screw showed mechanical wear suggesting that numerous insertion attempts may have occurred. The set screw appears to have been extracted up into the set screw plug. The first thread on the set screw was bare suggesting that the set screw was bottomed out on the negative connector. The set screw socket was not stripped as a bench torque wrench could fit within the socket. No other anomalies were observed that affected functionality.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6291469
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« Reply #115 on: May 06, 2019, 03:26:47 AM »

Model Number 104
Device Problem Detachment Of Device Component
Event Date 02/16/2017
Event Type  Malfunction   
Event Description
It was reported that the septum plug for the negative lead pin fell out of a generator during replacement surgery. The physician was screwing in the positive lead pin when the negative pin's septum plug fell out. Reportedly, the septum plug fell out without having been touched. The surgeon was able to pop the septum plug back into place, and a backup generator was not available. The surgeon then decided to use the generator with the septum plug popped back into place and implanted it in the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6401681
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« Reply #116 on: May 07, 2019, 07:11:13 AM »

Model Number 303-20
Device Problem Detachment Of Device Component
Event Date 02/01/2017
Event Type  Malfunction   
Event Description
It was reported via clinic notes that a patient was experiencing an increase in seizure frequency and duration. The patient had recently begun experiencing daily seizures for several weeks. One of the patient's medications was increased at a clinic visit two months prior. The physician noted that the patient's battery was at one-quarter remaining as of the current clinic visit and believed that the patient's vns was not as helpful as it used to be. The patient was referred for generator replacement surgery. It was later reported that during generator replacement surgery, the lead was found detached from the nerve and was coiled up in the generator pocket. The surgeon planned to proceed with a full revision. A photograph of the lead was provided, which showed that the patient¿s lead was wrapped around itself inside the generator pocket. When the patient¿s generator pocket was opened during the surgery, the surgeon found the electrodes detached from the vagus nerve and the lead wrapped around itself several times in a large knot. The electrodes were also detached from the lead. The patient¿s generator suture was still intact, and there was scar tissue in the generator pocket that most likely provided contact between the lead and the tissue. It was reported that there was very little scarring on the patient¿s vagus nerve. The patient¿s neurologist did not notify the surgeon or company representatives of any diagnostic issues, consistent with the diagnostic test results reported via clinic notes. Diagnostics performed in the operating room prior to surgery were also within normal limits. The surgeon believed that the patient manipulated the lead and caused it to coil up inside the generator pocket. The patient¿s parents denied any occurrences of their daughter manipulating the lead, adding that the patient¿s disability caused low finger dexterity. The existing lead and generator were discarded after explant and thus were not returned for analysis.
 
Event Description
It was reported that the patient's nurse did not believe that the patient's seizure increase was related to changes in the patient's medication. The nurse believed that a low battery was the cause of the increased seizures, and she stated that the patient's seizure increase was above the patient's pre-vns baseline. As the patient's lead and electrodes were found detached from the vagus nerve during replacement surgery, the report that the patient's seizures were due to low battery is incorrect. No additional relevant information has been provided to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6382903
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« Reply #117 on: May 08, 2019, 10:17:48 AM »

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6529452
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« Reply #118 on: May 09, 2019, 07:13:18 AM »

Model Number 300-20
Device Problem Fracture
Event Date 03/22/2017
Event Type  Malfunction   
Event Description
During a patient's generator replacement surgery, the surgeon unscrewed the two lead pins and attempted to remove them from the patient's device; however, the positive lead pin would not come out of the generator. When the surgeon pulled on the positive lead pin to remove it, the lead wire detached from its silicone casing, breaking the lead. It was later reported that the patient underwent full revision surgery. The patient's explanted devices were discarded and are unavailable for analysis. The device history record of the lead was reviewed, and the lead met all specifications for release. No additional relevant information has been provided.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6503930
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« Reply #119 on: May 11, 2019, 12:44:29 AM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 03/07/2019
Event Type  Malfunction 

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8472063
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