Pages: 1 2 [3] 4 5 6  All   Go Down
Print
Author Topic: Detachment  (Read 6132 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #60 on: January 22, 2019, 04:45:45 AM »

Model Number 304-20
Event Date 12/18/2014
Event Type  Injury   
Event Description
Additional information was received from the neurologist that the patient required a revision of her vns in (b)(6) 2015 secondary to a possible allergic reaction to silicone sheathing. She subsequently had slow wound healing. Patient was seen on (b)(6) 2015 after apparently expressing a ruptured suture. It was not felt by the neurosurgeons to be infected at that time. Patient likely developed a uri in (b)(6) 2016 and then developed a left breast cellulitis necessitating removal of the device.
 
Event Description
Additional information was received that the patient completed her iv antibiotics on (b)(6) 2016 & her picc line was removed. Patient was told that vns could not be re-implanted as she has too much scar tissues. Due to patient's severe allergic reaction to the device & her body rejecting it, the surgeon will not be implant vns again for patient.
 
Event Description
On (b)(6) 2016 an email was received that the patient developed a cellulitis that needs to be removed. Additional information was received that the patient had her battery and lead wires removed on (b)(6) 2016 due to an infection. Patient is not sure if the coils are still intact on the vagus nerve as one of the coils came through the small open wound on patient's neck incision that never healed after she was implanted on (b)(6) 2014. Patient could not remember the month or year this happened. The opening was big enough to insert tip of qtip. Patient stated that the open wound happened approximately about a month after sutures were removed by the surgeon. Patient was instructed to use neosporin on the open wound, keep it dry and let air get to it. No oral antibiotics were given. Patient did not go to primary care provider at this time either. When one of the tie-downs was pushed through the wound opening in patient's neck, patient consulted the surgeon, who discussed that it was patient's body rejecting the device and that patient should be ok since there were two other tie downs in place. In 2015, patient had a mammogram. Patient thinks that the compression from the mammogram machine pulled the wires and made the generator move. Patient had to have surgery on the leads after that because the leads were displaced. Patient underwent repositioning surgery on (b)(6) 2015 for patient comfort. After the leads were repositioned and tied down, patient stated she was ok but still had the small wound on her neck and that it would open and close up on its own and at times leak some fluid. Patient was referred to wound care center for treatment for a couple of months. Patient later got a very bad sore throat, ear ache and was coughing up mucus in (b)(6) 2016. A throat culture was performed but no antibiotics were given. A review of device history records showed that both the lead and generator were sterilized prior to distribution. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5867152
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #61 on: January 24, 2019, 03:48:46 AM »

Model Number 105
Event Date 07/30/2014
Event Type  Malfunction   
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the generator confirmed all quality tests were passed prior to distribution.
 
Event Description
It was reported that during generator implant, the rubber septum plug over the set screw popped out when the surgeon was tightening the set screw. It was reported that the plug fell out of the sterile field. The plug was unable to be located within the or and a new generator was implanted. It was reported that the physician did not use any excessive force that may have caused the plug to come off. It was reported that the plug popped out easily as if it was not attached. The generator was returned for analysis. Analysis is underway, but has not been completed to date.
 
Event Description
Analysis of the returned generator was completed. There were no adverse functional, mechanical, or visual issues identified with the returned generator. No signs of manipulation of the returned setscrew were present and the septum was not returned for evaluation. The header septum cavity meets specification. Therefore, a root cause for the condition could not be determined. Results of diagnostic testing indicated the device was operating properly. Electrical test showed that the pulse generator was operating within specification.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4042354
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #62 on: January 24, 2019, 03:49:41 AM »

Model Number 103
Event Date 06/05/2014
Event Type  Malfunction   
Event Description
It was reported that during prophylactic generator replacement surgery, the septum of the vns patient¿s replacement generator had detached from the generator. The surgeon reinserted the septum and implanted the generator.
 
Manufacturer Narrative

Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3906744
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #63 on: January 24, 2019, 03:50:22 AM »

Model Number MODEL 250
Event Date 07/31/2014
Event Type  Malfunction   
Event Description
It was reported that the neurosurgeon¿s tablet device was not responding to the tablet stylus but responded to touch from his finger. The stylus battery was replaced; however, the issue did not resolve. The tablet and stylus have not been returned to date.
 
Event Description
Analysis of the returned tablet device was completed. A visual analysis of the digitizer pen identified that the button cover was detached. The button is the equivalent of a right-click. Although the button cover was detached, the pen was able to be used to navigate through the vns software with no anomalies. During the analysis, no anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge. The tablet performed according to functional specifications.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the tablet device passed all functional tests prior to distribution.
 
Event Description
The tablet was received for analysis. Analysis is underway, but has not been completed to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4037136
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #64 on: January 25, 2019, 09:15:39 AM »

Model Number 300-20
Event Date 07/24/2014
Event Type  Injury   
Manufacturer Narrative

Manufacturer Narrative
Corrected data: the initial mfr. Report inadvertently reported the event as both serious injury and malfunction; however, this should only have been reported as a serious injury.
 
Event Description
Additional information was received which stated the patient experienced neck pain prior to the revision surgery, even though the diagnostics were within limits. It was noted that when the lead was explanted fluid was found inside. After the revision surgery, the patient's neck pain didn't go away for the first few days after the surgery, but then it did resolve.
 
Event Description
It was reported that the vns patient was experiencing intense pain in her neck. The patient¿s device was subsequently disabled; however, the patient continued to experience stabbing pains but less frequently than before disablement. X-rays were taken and the lead reportedly appeared to be ¿unwrapped from the nerve. ¿ the patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanting facility discarded the explanted lead; therefore, no analysis can be performed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4027949&pc=LYJ
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #65 on: January 27, 2019, 09:38:14 AM »

Model Number 300-20
Event Date 06/10/2014
Event Type  Malfunction   
Manufacturer Narrative
Device failure suspected, but did not cause or contribute to a death.
 
Event Description
It was reported that the patient would be referred for generator replacement. Clinic notes dated (b)(6) 2014 note that the patient has not reported any adverse effects with continuing device stimulation and that the patient's seizures remain in good control. It was noted that continuing device stimulation is important as long as the patient does not experience any adverse effects and that generator replacement will be expedited. No known surgical intervention has been performed to date.
 
Event Description
It was reported by the physician that the vns electrodes appeared to have been attached to the sympathetic nerve instead of the vagus nerve. He believes that the electrode had been on the nerve at some point in time and that it may have become detached. The patient has developed horner¿s syndrome, which was due to the surgery. The syndrome was reported to be permanent, but mild, no additional interventions were taken.
 
Event Description
It was reported that the patient underwent generator and lead replacement. The surgeon indicated that the lead appeared to be on a similar nerve close by the vagus nerve. It was later reported that the surgeon believes he may have damaged a nerve during electrode removal that may be causing the patient's eye to droop. It was reported that the explanting facility does not return explanted devices without patient consent. Attempts to obtain additional relevant information have been unsuccessful to date.
 
Event Description
Clinic notes dated (b)(6) 2014 note that the patient has noticed an increase in micro-seizures since using a bone stimulator to help with bone fusion following neck surgery. The neurologist advised the patient to discontinue use of the bone stimulator to see if the seizures decrease. Clinic notes dated (b)(6) 2014 note that when the patient discontinued use of the bone stimulator, the patient's seizures abruptly stopped about 7-10 days later. It was noted that device diagnostics resulted in low impedance (<600 ohms). No surgical intervention has been performed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3985372
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #66 on: January 28, 2019, 05:37:28 AM »

Model Number 300-20
Event Date 08/28/2014
Event Type  Malfunction   
Event Description
Product analysis for the generator that was completed on 04/16/2015 concluded that the generator detachment of components was most likely attributed to explant related events. Therefore the possibility of a lead break cannot be ruled out. The patient's lead has not been explanted to date.
 
Event Description
It was reported that the patient underwent generator replacement on (b)(6) 2015. It was stated that the generator was in two pieces as the header was detached from the generator. The lead was not replaced. When the new generator was attached to the old lead impedance values were good at 2825 ohms. The generator was returned for analysis on 03/19/2015. Analysis is currently underway but has not been completed to date.
 
Event Description
Product analysis for the generator was completed and approved on (b)(4) 2015. 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. The output exhibited output variations on chart. This condition was due to an intermittent connection on the alligator clip, used to establish an electrical connection to the generator. The pulse generator was monitored again for more than 24-hrs and 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 reported ¿detachment of components(s)/header¿ allegation, most likely occurred during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. In addition, the generator as received photo shows no evidence of bodily fluid remnants in the case/header area. Therefore, this observation/finding is not considered a device failure, but instead the result of extensive manipulation of the product during or after the explant process. The generator performed according to functional specifications. Other than the intermittent connection issue that is not related to the generator and the header anomaly (visual analysis), there were no performance or any other type of adverse conditions found with the pulse generator.
 
Manufacturer Narrative
Corrected data: changed suspect device to lead.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the vns patient was experiencing painful stimulation. The patient¿s device was tested and system diagnostic results revealed high impedance (dc dc ¿ 6). X-rays were taken and were reported by the physician to be unremarkable. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4115750
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #67 on: January 29, 2019, 07:20:46 AM »

Model Number 302-20
Event Date 08/08/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient was having issues with pain and with device migration. Clinic notes were received indicating that the patient had severe fatigue and tremors over the last two months. She later reported having a strange tremor in her head that occurred several times per day. It was noted that patient¿s device had migrated from its original position and was located at the wall of the axilla. Chest and neck x-rays were ordered because the patient reported occasional shocking sensations to the left side of the neck. The patient was instructed to temporarily disable her device with the magnet to determine whether her symptoms would subside. An implant card was received indicating that the patient underwent generator and lead replacement surgery due painful stimulation, shocking sensations and lead discontinuity. The patient¿s lead reportedly fell off the patient¿s vagus nerve and caused high impedance. The explanted generator and lead have not been returned to date. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4103125
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #68 on: January 29, 2019, 07:21:24 AM »

Event Date 08/19/2014
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the patient¿s lead electrodes were observed to be not in contact with the patient¿s vagus nerve. As result, diagnostic results showed high impedance. It was noted that the patient¿s vagus nerve was very thin. No known surgical interventions for the reported high impedance and electrode placement have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4096581
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #69 on: February 04, 2019, 02:52:49 AM »

Model Number 102
Event Date 10/16/2014
Event Type  Malfunction   
Event Description
It was reported that during vns implant surgery, the septum plug of the generator popped out when the surgeon was withdrawing the hex screwdriver after tightening the setscrew. The septum plug could not be reinserted, so a new generator was used to complete the procedure. The unused generator has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Analysis of the returned generator was completed. There were no anomalies found with the pulse generator. The septum cavity and septum met the specification measurements. The septum and setscrew was placed in the header septum cavity and was successfully secured by a bench torque wrench. The generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4249336
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #70 on: February 07, 2019, 01:23:04 AM »

Model Number 105
Event Date 01/05/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The generator with the detached septum plug was returned to the manufacturer for analysis. No signs of manipulation of the returned setscrew were present. The septa meet specification requirements. The header septum cavity meets specification requirements. Therefore, a root cause for the event could not be determined.
 
Manufacturer Narrative
(b)(4). Additional manufacturer narrative and/or corrected data; corrected data: the initial mdr inadvertently did not include the suspect device udi. This report is being submitted to correct this data.
 
Event Description
It was reported that during generator and lead replacement surgery on (b)(6) 2015 due to high impedance, the septum plug from the vns patient¿s replacement device popped out while removing the hex screw driver after tightening the setscrew. It was noted that the surgeon is very experienced and careful. Another generator was used to complete the procedure. The explanting facility will not return the device to the manufacturer for analysis; therefore, no analysis can be performed. The high impedance event was reported in manufacturer report # 1644487-2014-03035.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4460754
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #71 on: February 07, 2019, 01:24:10 AM »

Model Number 103
Event Date 11/05/2014
Event Type  Malfunction   
Event Description
Review of device manufacturing records confirmed that the suspect device passed all functional tests prior to distribution. The screwdriver used during the surgery was discarded.
 
Manufacturer Narrative

Event Description
It was reported that during initial vns implant surgery on (b)(6) 2014, the surgeon tightened the setscrew and stated that the septum plug ¿popped out¿ while removing the hex screwdriver. No anomalies were observed with the hex screwdriver. The surgeon elected to reinsert the septum plug back into place and closed the patient. System diagnostic results showed normal device function. Attempts for additional relevant information will be made.
 
Manufacturer Narrative
Corrected data: previously submitted mdrs inadvertently omitted the unique device identifier (udi) for the suspect medical device. (b)(4). This report is being submitted to correct this information.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4300066
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #72 on: February 07, 2019, 01:24:53 AM »

Model Number 302-20
Event Date 05/10/2012
Event Type  Malfunction   
Event Description
It was reported by a physician that high impedance was read at a follow-up appointment upon performing system diagnostics. The patient was referred for x-rays and the generator was programmed off. The last known good system diagnostics were noted to be from (b)(6) 2011. X-rays were received and evaluated by the manufacturer. The generator was placed in the lower left chest, in the left side of it, a few centimeters below the axilla. The filter feed-through wires appeared to be intact. The lead connector pins appeared to be fully inserted into the generator connector block. The lead wires at the connector pin appeared to be intact. The negative and positive electrode appeared not be aligned, and the negative electrode seems to be detached from the vagal nerve. Portions of the lead appeared to be behind the generator and could not be fully assessed. An acute angle appears to be present right below the positive electrode. At the moment, good faith attempts to obtain further information have been unsuccessful to date.
 
Manufacturer Narrative
Type of report, corrected data: initial report inadvertently did not indicate type of report. Report should have read 30-day.
 
Event Description
Additional information was received that the patient did not have any trauma or manipulation of their device reported prior to the event. At this time no surgery is scheduled. The patient may in the future have either replacement or explant of their lead. The patient is reported to be doing well and a decision will be made in (b)(6) when they see a surgeon.
 
Event Description
Additional information was received from the area representative indicating there was no manipulation or trauma involved that could have had contributed to the report of high lead impedance. At the moment no interventions have been planned for the patient.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. Review of x-rays by the manufacturer revealed a gross lead discontinuity. Device failure occurred, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2592703
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #73 on: February 09, 2019, 01:22:31 AM »

Model Number 304-20
Device Problem Detachment of Device or device Component
Event Date 12/10/2018
Event Type  Malfunction   
Event Description
It was reported that during replacement surgery, new devices were tested outside of the pocket, impedance was normal and then the surgeon was unable to get the set screw driver to disengage the lead terminal pin from the generator. Ultimately a new lead and generator had to be implanted. The new lead's electrodes were successfully implanted onto the vagus nerve and the terminal pin was connected to new device 106 (while still out of the pocket). After successful system diagnostic testing, the neurosurgeon tried to remove the lead from the header of the device and could not do so. The neurosurgeon said the he ¿could not back out the setscrew. ¿ a new system was successfully implanted in the patient. The lead tubing was seen disconnected near the area where the led pins are inserted into the generator. The device have not received 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=8218897
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #74 on: February 09, 2019, 01:23:10 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #75 on: February 11, 2019, 01:15:55 AM »

Model Number 300-20
Event Date 01/15/2015
Event Type  Malfunction   
Event Description
Analysis of the explanted generator was completed. Visual examination confirmed that the header was detached from the pulse generator case, which is not typical in a surgical procedure. It is very likely that the header was detached from the pulse generator case during or after the explant process. This is based on the location of the tool marks observed on the pulse generator case and header. Other than the observed generator header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.
 
Event Description
Additional information was received that the patient underwent a generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and high impedance. The explanted generator and lead were received for analysis. When received, the generator's header was detached, but this was stated to have occurred during explant. Analysis of the explanted lead was completed. Note that the majority of the lead assembly (body) including the electrodes was 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 was consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pins provided evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified. Analysis of the explanted generator has not been completed to date.
 
Event Description
It was reported that the vns patient¿s device was tested and diagnostic results reveal high lead impedance (dcdc ¿ 7). The patient¿s device was subsequently disabled. It was noted that the patient is cognitively impaired and requires ambulatory assistance mainly on the left side which the physician believed, along with the age of the device, was the cause of the high impedance condition. The patient was referred for surgery but no known surgical interventions have occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Only a portion of the lead was returned for analysis which did not reveal any anomalies. Device failure is suspected in the lead portion not returned, but did not cause or contribute to a death or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=4494144
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #76 on: February 14, 2019, 01:15:19 AM »

Model Number 102R
Device Problem Detachment Of Device Component
Event Date 10/23/2017
Event Type  Malfunction   
Event Description
It was reported that the patient was having difficulty with his vns causing pain and some erratic readings. The neurologist notified the surgeon and they wanted him to be seen urgently and possibly have surgery. The patient¿s generator was explanted. Further information was provided that the explanted generator appeared to be ¿split in two. ¿ from images provided it appears that the header on the generator was detached. It was also stated that the patient had felt infrequent stimulation. Impedance prior to surgery was stated to be within normal limits. Regarding the initial report of pain, it was stated that the pain was infrequent, and felt as if he could hardly feel stimulation and all of sudden felt higher stimulation. The pain was felt at the left chest just under the clavicle. The ¿erratic readings¿ report was referring to the patient¿s infrequent stimulation. The 4000-5000 ohms impedance was verified to be from system diagnostics. The physician believes that the detachment of the header occurred prior to surgery, most likely believed to be due to day to day activity as the patient has lived a ¿hard¿ life. The explant generator has not been received for analysis to date. No additional relevant information has been received.
 
Event Description
Product analysis for the generator was completed and approved. The reported ¿detachment of header¿ allegation, was confirmed in the lab. A window was cut into the can and test leads were attached to the output connections for monitoring of the device and for testing purposes. 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 device performed according to functional specifications of the current automated final test. Other than the header anomaly, there was no abnormal performance or any other type of adverse condition found with the generator. The cause of the header detachment could not be determined in analysis. Examination did not reveal body fluid remnants on the can, which would indicate partial separation during the implant period.
 
Event Description
The generator was received for analysis. Product analysis is currently underway but has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7039508
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #77 on: February 16, 2019, 01:43:39 AM »

Model Number 105
Event Date 02/16/2015
Event Type  Malfunction   
Event Description
Analysis of the returned generator was completed. Review of the data indicated that the generator reached end of service condition. Burn marks were observed on the pulse generator case, indicating that the pulse generator may have been exposed to an electro-cautery tool during device implant, which may have been a contributing factor for the end of service condition. The pulse generator diagnostics were as expected for the programmed parameters. The battery, 3. 234 volts, shows an ifi=no condition. No signs of manipulation of the returned setscrew were present (socket not stripped) and the septum was not returned for evaluation. The header septum cavity meets the specified requirements. Therefore, a root cause for the condition could not be determined. Additionally, the lead replacement surgery that occurred on (b)(6) 2015 was also reported in manufacturer report # 1644487-2014-01974.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Describe event or problem. Corrected data: the manufacturer report number for the lead replacement surgery was inadvertently left out of the initial report.
 
Event Description
During a lead replacement surgery, the septum plug from the generator came out. The septum plug was reinserted into the generator with no issues. However, after connecting the lead to the generator, diagnostics indicated that the newly implanted generator was near end of service. The use of the hex screwdriver during the placement of the septum plug is suspected to be cause of the premature battery depletion of the generator. The generator was replaced and returned to manufacturer on (b)(6) 2015. Analysis is underway but has not been completed.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4595931
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #78 on: February 19, 2019, 03:08:21 AM »

Model Number 102R
Device Problems Generator; Detachment Of Device Component; Failure to Interrogate
Event Date 09/01/2015
Event Type  Malfunction   
Event Description
It was reported that during removal of the patient's generator the header was observed to be detached from the can of the generator upon opening the pocket. The surgeon used the torque wrench to unscrew the lead from the header. When the lead was connected to the new pulse generator normal diagnostic values were observed. Information received from the provider indicated normal lead impedance was seen on multiple device checks between (b)(6) 2015. The device exhibited it's elective replacement indicator (eri) and on (b)(6) 2015 the device could not be interrogated. There was no reported patient manipulation or trauma noted before the replacement surgery. Review of manufacturing records confirmed there were no unresolved non conformances found with the generator prior to distribution. The explanted generator has not been returned to the manufacturer for evaluation.
 
Event Description
The pulse generator was received for product analysis. Visual examination noted tool marks/dents on the pulse generator case and the header had scratches on it. The marks are most likely associated with manipulation of the device during the explant procedure as the markings are consistent with devices typically used in a surgical procedure (forceps, etc. ). The septum was not cored. Visible adhesive at the generator top matches up with the adhesive on the bottom of the header supporting a secure bond. The anchor tab furthest from the feed-thru capacitors is slightly bent. The anchor tab closest to the feed-thru capacitors is bent on the side furthest from the feed-thru capacitors. Visual assessment of the final manufacturing x-ray showed no abnormalities at the time of manufacture. A scanning electron microscopy (sem) was performed on the anchor welds. The sem images show appearance suggesting that a stress-induced fracture has occurred at one side of one of the anchor welds. However due to mechanical distortion (smoothed surfaces) the fracture mechanism cannot be verified. The device battery was confirmed to be depleted past end of service. The depletion was an expected event as determined battery voltage measurement and battery life calculation. The battery life calculation, based on known programmed settings, indicated 0. 0 years remaining until neos = yes. The module performed according to functional specifications. Other than the header detachment, there were no performance or any other type of adverse conditions found with the pulse generator. Review of the programming history database showed no evidence of high impedance. There is no evidence of device performance being impacted while implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5105421
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #79 on: February 19, 2019, 03:09:33 AM »

Model Number 302-20
Event Date 02/01/2012
Event Type  Malfunction   
Event Description
Product analysis was completed on the generator and lead. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Note that the electrodes were not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis of the returned 96mm portion the quadfilar coils appeared to be stretched and kinked approximately 72mm and 92mm past the end of the electrode bifurcation. The end of quadfilar coil 1 appeared to be broken approximately 72mm from the end of the electrode bifurcation. Scanning electron microscopy was performed and identified the area as having extensive pitting which prevented identification of the coil fracture type. It is believed that stimulation was present for a certain period of time as evidenced by the presence of metal pitting. Low magnification sem analysis of the quadfilar coil shows characteristics typical of a lead discontinuity which may include: material fracture, rough or pitted surface, thinned material thickness, electro-etching or material dissolution. With the exception of the observed discontinuity, the condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. No other obvious anomalies were noted. The resistance measurement taken during decontamination verified an electrical and mechanical contact between the generator and connector pin at one point in time. Continuity checks of the returned lead portions were performed, during the visual analysis, and no other discontinuities were identified.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative

Manufacturer Narrative
Date of event, corrected data: the initial report inadvertently reported the incorrect date. The clinic notes received on (b)(4) 2012, indicated that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time which likely contributed to the high impedance.
 
Manufacturer Narrative
Manufacturer reviewed x-rays of implanted device. X-rays reviewed by the manufacturer, no gross lead discontinuities visualized.
 
Event Description
The implant card was received and confirmed the generator and lead replacement surgery on (b)(6) 2012. The generator was replaced prophylactically, and the lead was replaced due to the electrode being off the nerve and therefore causing the high impedance. Lead impedance following replacement was okay. Product analysis for the explanted products has not been completed to date.
 
Event Description
The patient had generator and lead replacement surgery on (b)(6) 2012 due to the high impedance. The explanted products were received by the manufacturer for analysis, however it has not occurred to date. The return product form reported that the generator was replaced prophylactically and the lead was replaced due to the electrode being off of the nerve.
 
Event Description
It was reported normal mode and systems diagnostic tests revealed high impedance. The physician's office planned on disabling the device on this day and was referring the patient for x-rays. The patient had a blackout in (b)(6) and feel on his left shoulder. He has had shoulder pain ever since, but has not felt a difference in vns stimulation. This fall may have contributed to the high impedance, per the physician. The last time diagnostics were performed on the patient's device was reportedly a year ago. The patient is likely being referred for generator and lead replacement surgery, but it has not occurred to date. Attempts for additional information have been unsuccessful to date. Film and computer a/p and lateral x-rays images of the neck and chest were reviewed by the manufacturer. It appears that one (or both) electrodes is detached from the nerve, as the positive electrode is angled at approximately a 120 degree angle from the negative electrode. It is unlikely that the patient's nerve curves in such a fashion. It appears that the positive electrode may be detached from the nerve. There were no acute angles or lead discontinuities seen in the visible portion of the lead body. Based on the x-ray images provided, the cause for the reported high impedance is most likely related to the electrode being detached from the nerve. The presence of a microfracture in the lead or a lead discontinuity in the portion of the lead that was behind the generator cannot be ruled out.
 
Event Description
Clinic notes were received dated (b)(6) 2012, which again reported that the patient blacked out in (b)(6) 2012, fell, and landed on his left shoulder. The patient feels like he pulled the lead at that time. It was also noted that the battery is low. The patient felt that the vns was helping him prior to the device being disabled when the high impedance was first observed at (b)(6). The notes also reported that the x-rays revealed that the lead appears to be off the vagal nerve, which was reported by the manufacturer. The physician is referring the patient for generator and lead replacement surgery. Although surgery is likely, it has not occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2543658
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #80 on: February 23, 2019, 02:07:41 AM »

Model Number 302-20
Event Date 12/01/2014
Event Type  Malfunction   
Event Description
It was reported that the vns patient had been seizure-free following initial implant of the device on (b)(6) 2014 when she experienced two seizures in one day. The patient¿s device settings were subsequently adjusted and the patient was doing well until having a severe seizure on (b)(6) 2015. Prior to implant, the patient had a couple seizure clusters each month. When the patient was seen in (b)(6) 2014, it was noted that there was a slight bulge in the patient¿s skin at the lead incision site. Approximately two months ago, the patient¿s parents noticed that the bulge was more noticeable. The patient¿s device was tested during an office visit on (b)(6) 2015 and system diagnostic results revealed high impedance (dcdc ¿ 7). X-rays were taken and were reported by the physician to be unremarkable. The patient underwent lead replacement surgery on (b)(6) 2015. The bulge was found to be the result of protrusion of the lead anchor tether and a tie-down. When opening the lead incision, the surgeon found that the lead anchor tether had detached from the patient¿s nerve and was surrounded by scar tissue. The lead was replaced and system diagnostic results with the replacement lead and generator showed lead impedance within normal limits (dcdc ¿ 2). Patient manipulation is not believed to have caused or contributed to the events; however, it was reported that the patient experienced falls when she had the previously mentioned seizures. The explanted lead has not been returned to date. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4804056
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #81 on: February 25, 2019, 02:12:49 AM »

Model Number MODEL 250
Event Date 04/17/2015
Event Type  Malfunction   
Event Description
The tablet was returned to the manufacturer. An analysis was performed on the returned tablet and it was noted that the device did not have the power button. No further anomalies associated with the tablet performance were noted during testing using the ac adapter or the main battery with a full charge.
 
Manufacturer Narrative
(b)(4). Device manufacturing records were reviewed. Review of manufacturing records confirmed that the tablet passed all functional tests prior to distribution.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to death or serious injury.
 
Event Description
It was reported that the power button of a medical professional¿s tablet had detached from the device and it was lost. The tablet could not be switched on afterwards. Device manufacturing records confirmed that the tablet passed all functional tests prior to distribution. The tablet has not been received by the manufacturer to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4764437
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #82 on: March 03, 2019, 04:45:19 AM »

Model Number 302-20
Device Problem High impedance
Event Date 06/25/2015
Event Type  Malfunction   
Event Description
Further information was received indicating that the patient's epilepsy is well controlled without vns and that a surgical revision is not planned. X-rays of the patient dated on were reviewed by the manufacturer. The generator is placed in a normal position in the upper left chest. The filter feed-through wires appeared to be intact. The lead connector pin is fully inserted. The lead wires at the connector pin appeared to be intact. The electrodes at the vagus nerve implant site are not aligned, and the negative one appeared to be detached from the nerve. A strain relief loop was present, but not a bend. One tie-down was visible, securing the loop. Portions of the lead appeared to be behind the generator and could not be fully assessed. No acute angles, no breaks were found in the parts of the lead that could be assessed.
 
Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that both the lead and the generator passed all functional tests prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
Event Description
It was reported that the patient铠vns system was tested on (b)(6) 2015 and system diagnostics returned a high impedance result with >=10000 ohms, current delivered=0. 5ma, ifi=no. The programmed output current was reduced to 1ma and the pulse width was reduced to 250usec. It was reported that the patient was implanted with vns in (b)(6) 2011 and became seizure-free in (b)(6) 2011. It was reported that the cessation of seizures was thought to be a result of natural progression of the disease as opposed to the effect of vns. X-rays were taken and they were reported to be unremarkable by the healthcare professional. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2012. Review of manufacturing records confirmed that the lead and the generator passed all functional tests prior to distribution. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4924659
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #83 on: March 06, 2019, 01:33:19 AM »

Model Number 302-20
Device Problems Detachment Of Device Component; High impedance
Event Date 07/17/2015
Event Type  Malfunction   
Event Description
Additional information was received that the patient's pain had been occurring in the patient's neck prior to the generator and lead replacement surgery. The pain began occurring following a settings increase. Thus, the settings were decreased which helped the pain. The pain was thought to perhaps have been caused by the detached electrode. No additional relevant information has been obtained to date.
 
Event Description
Analysis was completed on the patient's explanted generator. Analysis showed that the generator performed according to functional specifications. Analysis of the generator concluded that no abnormal performance or any other type of adverse condition was found. An analysis was performed on the returned lead portion. Note that a portion of the lead assembly including the electrodes was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. 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 portion were performed, during the visual analysis, and no discontinuities were identified.
 
Manufacturer Narrative
Describe event or problem; corrected data: the previously submitted mdr inadvertently failed to report the device evaluation.
 
Manufacturer Narrative

Event Description
Clinic notes were received and indicated that the patient had experienced pain associated with stimulation. There was also a report of a settings adjustment which helped with the pain. The patient then underwent a prophylactic generator replacement surgery on (b)(6) 2015. However, pre-operative system diagnostics resulted in high impedance detected on the patient's vns system. Thus, the lead was replaced as well. It was reported that during the lead replacement, it was seen that the positive electrode and anchor tether of the lead had become detached from the patient's vagus nerve, leaving only the negative helical electrode still attached. No lead fractures were noted. It was unknown how the lead had become partially detached form the nerve. The diagnostics were normal following the generator and lead replacement. The explanted generator and lead were received by the manufacturer for analysis. However, analysis has not been completed to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5002392
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #84 on: March 07, 2019, 01:40:08 AM »

Model Number 304-20
Device Problem High impedance
Event Date 07/31/2015
Event Type  Malfunction   
Event Description
It was reported the patient's surgery was scheduled for (b)(6) 2015. The replacement surgery was completed on (b)(6) 2015. It was reported the physician believed the anchor tether came off the nerve and he elected to replace the lead. The vns generator was replaced prophylactically. Both the vns generator and the lead received by the manufacturer. Product analysis is expected but has not been completed to date. No additional relevant information has been received to date.
 
Event Description
Product analysis for the returned generator was completed. The end of service warning message was verified and found to be associated with the output being disabled by the vns generator, burn marks were observed on the vns generator which indicated the generator may have been exposed to electro-cautery during explant. The vns generator was reset in order to allow for subsequent testing. It was found using the downloaded data from the generator that the date of the impedance increase was 05/04/2015. Electrical tests were performed on the vns generator and the results demonstrate that accurate resistance measurements were obtained in all instances. 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 vns generator current for the entire monitoring period. The electrical evaluation showed that the vns generator performed according to functional specifications. Product analysis for the returned lead was completed. It should be noted the electrodes were not returned for analysis; therefore, a complete evaluation could not be performed on the entire lead product. Visual analysis showed a portion of the lead assembly appeared to be twisted and knotted together. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddler). The abraded opening found on the outer silicone tubing and the cut ends that were made during the explant process most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. For the observed inner remnants, there was no obvious path for fluid ingress other than the cut ends that were made during the explant process.
 
Event Description
It was reported by the physician that high impedance was observed on the patient's vns device during an office visit on (b)(6) 2015. It was also reported the patient began experiencing an increase in seizures at the end of (b)(6). It was stated the physician believes the recent increase in seizures is due to the high impedance observed. It was noted the physician will keep the device programmed on for now. No known surgical interventions have occurred to date.
 
Manufacturer Narrative
If explanted, give date; corrected data: this information was inadvertently left off of supplemental #01 mfr. Report. Device available for evaluation; corrected data: this information was inadvertently left off of supplemental #01 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5113453
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #85 on: March 09, 2019, 01:59:36 AM »

Model Number 1000
Device Problem Detachment of Device or device Component
Event Date 01/18/2019
Event Type  Malfunction   
Event Description
It was reported that a generator could not be implanted during a generator replacement surgery since the setscrew felt loose and would not tighten. It was stated that lead pin was removed and reinserted before attempting to tighten the setscrew again. The silicone cover reportedly came off and the screw was seen to be loose in the socket area. Another generator was implanted with no issues. It was reported that no excessive force was used during the surgery and that the plug fell out while trying to tighten the screw. The surgeon ensured to turn the screwdriver the correct direction (clockwise) when tightening the screw. A review of device history records for the generator was performed and shows that no unresolved non-conformances were found. The device met all specifications for release prior to distribution. The suspect generator has not been received 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=8371550
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #86 on: March 10, 2019, 02:06:03 AM »

Model Number 300-20
Device Problems High impedance; Material Separation
Event Date 08/25/2015
Event Type  Malfunction   
Event Description
A device check on a patient's device revealed high impedance and a dc dc value of 4. The patient was reported to have an increase in seizures but it could not be determined if they were due to the high impedance, the age of the implanted generator or other factors. The patient was sent for x-rays which were not provided to the manufacturer for review. The physician elected to leave vns stimulation turned on since the patient was not experiencing any pain with stimulation and the patient was scheduled for revision surgery. During the revision surgery it was observed that the generator header had detached from the generator casing. The lead was disconnected from the header and the generator and lead were each explanted and replaced. Lead impedance with the new generator and lead was normal, 1402 ohms. No impedance testing of the explanted lead was performed. It is unknown if patient manipulation or trauma contributed to the header separation from the casing. It was reported that the patient is in a wheelchair and is lifted in and out of it frequently, however, the patient has not been involved in any accident or falls. It is unknown if the pre-surgical x-rays indicated evidence of the header separation. The physician was unable to determine the exact date of the increased seizures or if the seizure frequency was above or below the patient's pre-vns seizure rate. The patient's family stated, "it could have been more. " the explanted generator and lead have not been received by the manufacturer for product analysis to date.
 
Event Description
Based on the observed tool marks on the generator case and the condition of the header and casing in the detachment area, it is very likely that the reported header detachment occurred during the explant procedure. There was no evidence of dried body fluid or corrosion on the header or can in the detachment area. In order to test electrical function of the device a window was cut in the casing to facilitate output connections, however, an internal component was inadvertently damaged during the cutting of the window. After the component was replaced with a known good component, device testing was completed and the device was found to be operating properly according to all functional specifications. The lead assembly was returned in multiple portions, however, the electrodes and tie downs were not returned and therefore a complete evaluation could not be performed on the entire lead product. Abraded openings due to wear and incision marks were identified in multiple locations of the returned lead segments. Dried remnants of what appeared to have once been body fluids were observed inside the outer silicone tubing and likely entered via the cut ends of the lead segments. The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure. The setscrew marks found on the lead connector pins provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed during the visual analysis and no discontinuities were identified. Except for abraded openings in the outer tubing, there were no observed product related issues with the returned lead portions. Based on product analysis of the returned pulse generator and lead it is likely that the reported high lead impedance was due to a lead fracture in a segment of the lead which was not returned to the manufacturer for product analysis.
 
Event Description
The physician stated there were no obvious pulse generator header issues observed on pre-surgical x-rays. The explanted pulse generator and lead have been received by the manufacturer and are currently undergoing product analysis.
 
Manufacturer Narrative
The initial mdr report should have indicated "not returned to mfr. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5097678
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #87 on: March 10, 2019, 02:06:47 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #88 on: March 13, 2019, 01:28:10 AM »

Model Number 106
Event Date 10/07/2015
Event Type  Malfunction   
Event Description
During a surgery on (b)(6) 2015, the septum plug and screw detached from the generator during the implant process. While attempting to remove the lead from the generator, the surgeon popped out the septum plug and set screw. Therefore the device was replaced. A review of device history records for the generator and lead shows that no unresolved non-conformances were found. The explanted products are expected to be returned but has not been received to date.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5193801
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 63498


« Reply #89 on: March 18, 2019, 01:38:36 AM »

Model Number 302-30
Device Problems Low impedance; Device Displays Incorrect Message
Event Date 11/06/2015
Event Type  Malfunction   
Event Description
It was reported by the physician that the patient no longer feels stimulation. It was also reported the physician received the low impedance <600 ohms warning when interrogating the device. The patient was referred to a consultation for a full revision and replacement of the vns system. It was also reported the patient is severely mentally retarded and developmentally delayed. The patient is also prone to violent outbursts.
 
Event Description
It was reported the patient is a poor historian and the date of initial onset for the inability of the patient to perceive stimulation is not known. Additionally, it was reported there was no known trauma or incident suspected that could have caused or contributed to the reported event. No additional relevant information has been received to date.
 
Event Description
It was reported the patient underwent lead and generator revision surgery on (b)(6) 2016. Pre-operative testing of the vns verified the low impedance previously observed. The physician put a new generator on the existing lead and found 615 ohms. The decision was made to removed and replace the lead. It was found during surgery the electrodes were not on the nerve and there was no strain relief loop or anchor tethers present. The new lead was placed on the nerve, tethered and connected to the new generator. Diagnostics were performed and showed 2155 ohms. There was no known trauma or manipulation that could have caused the lead to come off of the nerve; however, the patient is autistic and combative. No additional relevant information has been received to date.
 
Event Description
Product analysis for the returned generator was completed. The generator output signal was monitored for more than 24 hours while in a simulated body temperature environment. Results showed no signs of variation in the generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed the generator performed according to functional specifications. The battery voltage measured during analysis showed an ifi = yes (intensified follow-up indicator) condition. There were no performance or any other type of adverse conditions found with the generator.
 
Event Description
Pa for the returned lead portion was approved on (b)(6) 2016. The lead was found to have abraded openings on the outer and inner silicone tubing of the lead coils. Also, the positive and negative lead coils have what appear to be wear (flat surfaces) at the exposed portions located past the electrode bifurcation. The reported ¿low impedance¿ allegation was not verified. Though it was difficult to state conclusively, the identified exposed coil portions at the silicone tubing abraded openings may confirm this to be a contributing factor for the reported low impedance/short circuit condition. However, the exact point in time when the short occurred is unknown. Note that since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portion.
 
Event Description
It was also observed, during lead product analysis, that the lead connector boot had partial detachment at the ring/backfill interface. The reason for this condition was unknown.
 
Manufacturer Narrative
Describe event or problem; corrected data: this information was inadvertently left off of the supplemental #04 mfr. Report.
 
Event Description
The lead assembly had dried remnant of what appeared to have once been body fluids inside the inner and the outer silicone tubing. No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5257603
Logged
Pages: 1 2 [3] 4 5 6  All   Go Up
Print
Jump to: