Pages: 1 ... 7 8 [9] 10   Go Down
Print
Author Topic: Short Circuit  (Read 78833 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #240 on: October 05, 2018, 12:09:27 PM »

Model Number 106
Device Problem Premature End-of-Life Indicator
Event Date 03/21/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that patient's device was showing eos yes after only being implanted for two years. The patient¿s settings were still at 0ma due to the eos pulse disablement. A review of device history records for the generator shows that no unresolved non-conformances were found. Internal investigation determined that this behavior was likely related to an increased duration of the high battery impedance experienced by batteries during the beginning of life (bol) or an internal short that managed to ¿burn¿ itself out.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7920766
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #241 on: October 06, 2018, 04:37:47 AM »

Model Number 304-20
Event Date 08/09/2016
Event Type  Malfunction   
Event Description
It was reported that a patient had low impedance results on his first follow-up visit following initial implant. Two system diagnostics were performed and showed low impedance. There was reportedly no trauma that had occurred since implant, but the patient reportedly felt a "heat sensation all day" at one point. The patient reported that they had still experienced coughing when the settings were increased. It was noted that impedance values were intermittently within normal limits pre-operatively. When the patient's position changed, he sometimes got impedance values in normal limits and other times got low impedance. The physician reported that he saw a "bubble" in the connector cavity that he believed was causing the low impedance. The surgeon opted to perform generator replacement and leave the lead intact. The explanted generator has not been received to date. No further relevant information has been received to date.
 
Event Description
After the patient's generator replacement surgery on (b)(6) 2016, the impedance values were within normal limits. It was reported that the explanted generator would not be returned for analysis per the explant facility's policy. X-rays were provided to the manufacturer for review. The a/p chest x-ray showed that the lead pin was fully inserted into the connector block, the feedthru wires appeared intact at the connector block, and the generator was placed normally in the left chest just below the clavicle. A portion of the lead was found routed behind the generator. No gross lead discontinuities were identified, no sharp angles were identified, and the lead appeared intact at the connector pin. An assessment could not be made on the portion of the lead routed behind the generator. Therefore, the presence of a microfracture and any additional information regarding the lead portion behind the generator cannot be assessed. No additional relevant information has been received to date.
 
Event Description
Full analysis was completed on the generator and confirmed its ability to accurately measure impedance values. The device was placed in a simulated body environment and the generator showed no signs of variation in the output signal and demonstrated the expected level of output current. The generator was subjected to multiple electrical loads and verified the ability to accurately measure impedance values within an appropriate range. The generator septum was visually analyzed and verified that it was not cored. No other surface anomalies were identified on the generator. The generator performed according to all functional specifications with respect to accurately measuring impedance values.
 
Manufacturer Narrative
(b)(4).
 
Event Description
The explanted generator was returned and had product analysis completed, verifying that the generator was able to accurately measure impedance values. This verified that there was an intermittent short circuit in the lead. Negative impedance values were measured when there was a 0 ohm load applied to the generator.
 
Event Description
The explanted generator was returned for analysis. Historical diagnostic data was also provided and reviewed. Historical found the date that the low impedance message was first identified and verified that the impedance had bounced back up as previously reported to about 2,000 ohms at one time. The explanted generator is currently undergoing analysis.
 
Manufacturer Narrative
Describe event or problem, corrected data: the initial report inadvertently did not include information regarding post generator replacement. Relevant tests/laboratory data, including dates: the initial report inadvertently did not include the post generator replacement impedance value.
 
Manufacturer Narrative
Describe event or problem, corrected data: supplemental report #1 inadvertently did not include notice that the generator had been returned.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5950353
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #242 on: October 18, 2018, 01:20:02 AM »

Model Number 302-20
Event Date 08/29/2012
Event Type  Malfunction   
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Manufacturer Narrative
Device failure is suspected but did not cause or contribute to a death or serious injury.
 
Event Description
Additional information was received on (b)(6) 2012 when product analysis was completed on the explanted generator. The generator performed according to functional specifications. Product analysis on the generator was completed on (b)(6) 2012. During the product analysis there were no anomalies found with the pulse generator. The abraded openings found on the outer and inner silicone tubes, most likely provided the leakage path for what appeared to be remnants of dried body fluids found inside the outer and inner silicone tubes. What appeared to be white deposits were observed in various locations. Eds (energy dispersion spectroscopy - provides chemical or element identity/composition analysis) was performed on the same type of white deposits found during the visual analysis of similar lead products and identified them as containing silicon, calcium, sodium and phosphorus. The abraded openings on two adjacent sections of inner tubing created a condition whereby the exposed conductive coils could come in contact with each other and creating a potential short-circuit condition. The condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies, beyond the abraded openings, 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.
 
Event Description
On (b)(6) 2012, it was reported that the vns patient was scheduled for a prophylactic battery replacement on (b)(6) 2012; however, during surgery, the lead was determined to need replacement due to the lead being frayed and the wires exposed. The surgeon later stated that system diagnostics from surgery showed dcdc=0 and lead impedance=ok. No x-rays were taken prior to surgery. No patient manipulation or trauma occurred that is believed to have caused or contributed to the lead fraying/wires exposed. The explanted lead and generator were returned for product analysis on (b)(6) 2012. Product analysis is still underway and has not yet been completed. The reason for explant on the form received with the explanted products indicated that the housing on the leads were frayed and the wires were exposed. Clinic notes dated (b)(6) 2012 were received, which indicate that the patient's mother has not noticed the patient's voice changing at all lately with activation of the magnet. Clinic notes dated (b)(6) 2011, stated that the patient's vns was interrogated and settings left unchanged but the physician was unable to perform a lead test due to poor patient cooperation. The patient was referred for prophylactic generator replacement since the patient was reaching end of service. The patient's programming history was reviewed and all the system diagnostics tests showed results within normal limits and all showed a dcdc of 0 except for one date ((b)(6) 2005) that showed a dcdc of 2.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2755718
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #243 on: November 08, 2018, 01:18:31 AM »

Model Number MODEL 250
Event Date 12/20/2012
Event Type  Malfunction   
Event Description
Reporter indicated that the pins located on the handheld computer were bent and that the flashcard was unable to be inserted. The physician indicated that there was nothing that could have occurred that would have caused the pins to become bent nor were there any accidental attempts to place the flashcard in the handheld backwards. The handheld was returned to device manufacturer for analysis on (b)(6) 2013; however, analysis has not yet been completed to date.
 
Event Description
Two flashcards were returned on (b)(6) 2013 and analyzed with the handheld. Visual analysis of the handheld verified that five of the flashcard slot pins were bent. The cause of the bent pins is associated with mishandling of the device. Once the pins were straightened, no anomalies associated with the handheld performance were noted. Analysis of the flashcards revealed that the 8. 1 version flashcard had 3 bent pins and as a result of the bent pins, the returned handheld would freeze when the flashcard was inserted. Once the electrical shorts were removed and the pins were repaired, not further anomalies were identified. The 8. 0 version flashcard had no anomalies associated and performed according to functional specifications.
 
Manufacturer Narrative
 
Manufacturer Narrative
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=2902159
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #244 on: December 03, 2018, 04:00:39 AM »

Model Number 103
Event Date 03/31/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).

Event Description
It was reported that this patient's generator was replaced, and the explanted generator was discarded after surgery. No other relevant information has been received to date.

Event Description
It was reported that diagnostic tests were taken on the generator prior to implanting of device outside of the pocket and after device was in the pocket. The test before implant showed the battery was not at near end of service condition, but the test after the generator was in the pocket showed that the device was at end of service condition. It was reported that the generator was not cold prior to implant. The physician decided to continue implanting the generator. The manufacturer's or specialist that attended the surgery did not see cautery come in contact with the generator, but the cautery device was lying on the patient when the generator was introduced. The surgeon also submerged the generator in a tray with antibiotic solution prior to implant. The manufacturer investigated the programming data available from surgery. The voltage dropped from 3. 287v to 1. 884v during the surgery. The initial interrogation (before implant) and system diagnostics were at ifi = no, and the subsequent diagnostics (after implant) measured between 1. 884v and 1. 988v. The drop in voltage is an indicator that the device likely came in contact with an electro-cautery device or an electrostatic discharge, causing the asic latch-up condition. Electro-cautery is known to potentially cause battery depletion and its usage is warned against in labeling. No known surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5594516
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #245 on: December 03, 2018, 04:02:00 AM »

Model Number 103
Device Problems Premature End-of-Life Indicator; Defective Device; Device Displays Incorrect Message
Event Date 06/10/2015
Event Type  Malfunction   
Event Description
An user facility medwatch was received on 10/05/2015 reporting an unspecified error during device replacement requiring a second procedure. The medwatch report date was 07/07/2015 via the fda's medwatch program and report # was mw5044181.

Event Description
It was reported that the company representative observed end of service vbat < eos message on two different programmers. The hospital registered nurse reported that it is possible that the resident used bovie electrocautery. If electrocautery comes in contact around the generator, this is a known cause for premature end of service of the battery.

Event Description
A copy of the programmer data from the surgery was reviewed. The device was interrogated on date of implant and was set to 1. 5ma. The battery status indicator was already revealing near end of service (neos) = yes. It was reported that the device was off at time of implant. Review of the generator device history record was performed and confirmed that all quality specifications were passed prior to distribution. No anomalies were observed during the manufacturer process, and the device was confirmed to be set to 0ma at time of manufacturer release.

Manufacturer Narrative

Event Description
It was reported that the patient had generator replacement on (b)(6) 2015, and was seen post-operatively to turn on the replacement device, but a near end of service (neos) message was observed upon interrogation. The surgeon reported that electro-cautery was not used in proximity to the generator during surgery. He felt that the generator was defective. The generator was subsequently replaced the same day. The explanted generator has not been received to date by the manufacturer for analysis. The hospital¿s policy is to keep explanted devices. Good faith attempts for additional, relevant information have been unsuccessful to date.

Manufacturer Narrative
The user facility medwatch report received was identified to be related to the event previously reported within this manufacturer report which reported the events and device information previously. (b)(4). Based on the investigation, the premature end of life of the generator is suspected asic latch-up as a result of electrocautery during implant surgery. However, a definitive conclusion cannot be made, as the explanted generator was not received by the manufacturer for analysis. Good faith attempts for product return have been unsuccessful. This event is addressed in labeling and is due to asic latch-up. Per section 1. 6. 4. 1 of the vns therapy system physician's manual (u. S. ), "use of electrosurgery (electrocautery or radio frequency [rf] ablation devices) may damage the pulse generator. During the vns implantation procedure, do not use electrosurgical equipment after the pulse generator has been introduced to the sterile field. [. ] electrostatic discharge (esd) may damage the pulse generator. Care should be taken when using the hex screwdriver to avoid touching the metal shaft when the screwdriver is engaged with the setscrew of the pulse generator. This shaft can serve as a path to conduct electrostatic discharges into the device circuitry. ".

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4874583
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #246 on: December 03, 2018, 04:02:44 AM »

Model Number 103
Event Date 02/01/2010
Event Type  Malfunction   
Event Description
It was reported that a vns patient's generator was explanted due to high lead impedance. The explanted generator was returned to the manufacturer and underwent product analysis. Product analysis performed on the returned generator revealed an end of service warning message which was associated with the output being disabled by the pulse generator. Once the output was re-enabled the following was observed: electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The reported eos condition was not duplicated during the pa analysis. Capa (b) (4) further investigated the eos condition of the generator and revealed the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1702210
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #247 on: December 03, 2018, 04:03:45 AM »

Model Number 103
Event Date 08/22/2016
Event Type  Malfunction   
Event Description
Analysis of the returned generator was completed. It indicated that the reported allegation of ¿asic latch-up condition¿, could be verified in the pa laboratory. Review of the data downloaded from the pulse generator indicated that the pulsedisabled byte was set to a value that represents a vbat

Event Description
Further information from the surgeon was received indicating that during the surgery, an equipment could have touched the device, which could have caused the premature end of service. The explanted generator was returned to the manufacturer on 10/31/2016. Analysis is underway but it has not been completed to date.

Manufacturer Narrative
(b)(4).

Event Description
It was reported that a physician could not interrogate a vns patient's device on (b)(6) 2016. It was reported that the day before, on (b)(6) 2016, the patient underwent surgery due to infection where the wound was cleaned without explanting the device (event reported in the medwatch report 1644487-2016-02050). Before the surgery, the device was switched off without any issues. The physician did not perform a diagnostics test, but there was no issue with the patient's generator. After the surgery, when the physician tried to switch the device back on (on (b)(6) 2016), communication issues occurred. The physician tried many times before she could finally interrogate the generator. It then stated that the generator was at end of service. The device was implanted in (b)(6) 2016 (2 months ago). Diagnostics test showed: low output current, impedance ok, 2806 ohm, eos yes. It was reported that another physician came to help using her programming system, but she could never communicate with the device. Review of manufacturing records confirmed that the generator passed all functional tests prior to distribution. Further information from the physician indicated that, 10 days after the surgery they still could not interrogate the patient's generator. As the infection was still there, it was decided to explant the device. It was reported that the patient underwent explant surgery on (b)(6) 2016. The return of the explanted device is expected but it has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5948700
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #248 on: December 03, 2018, 04:04:25 AM »

Model Number 103
Event Date 11/09/2009
Event Type  Malfunction   
Event Description
It was reported that a vns pt's generator was explanted due to pain at the generator site. The explanted generator was returned to the mfr and underwent product analysis. Product analysis performed on the returned generator revealed an end of service warning message which was associated with the output being disabled by the pulse generator. Once the output was re-enabled, the following was observed: electrical test showed that the pulse generator was operating within specification. There were no adverse functional, mechanical, or visual issues identified with the returned generator. The reported eos condition was not duplicated during the pa analysis. Capa (b)(4) further investigated the eos condition of the generator and revealed the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge. The pain event is further reported in mfr report # 1644487-2009-02675 along with the product analysis of the generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1614971
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #249 on: December 03, 2018, 04:05:05 AM »

Model Number 103
Event Date 03/01/2010
Event Type  Malfunction   
Event Description
It was initially reported by the surgeon that the patient is having his battery replaced due to eos. Patient's eri status showed that only one month is remaining. Explanted generator was returned to manufacturer for analysis. Analysis was completed by the manufacturer. Product analysis of the returned generator revealed that an end of service warning message was received and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, the reported demipulse eos condition was duplicated during diagnostic testing, using parameters from the programming history, which indicated that the generator was approaching eos, (1 month at the returned parameters). There were no adverse functional, mechanical, or visual issues identified with the returned generator. Additional information received from the surgeon's nurse revealed that electrocautery was used during explant of the generator. She did not know the specifics of the electrocautery. Further investigation determined that the root cause of the eos warning messages as being an asic latch-up condition resulting from the pulse generator receiving an electrical transient during implant surgery. The electrical transient is the result of electromagnetic induction (emi) or electrostatic discharge (esd). This emi and/or esd causing the asic latch-up can be attributed to: the use of monopolar electrosurgery in direct contact with the pulse generator; monopolar electrosurgery in close vicinity to the pulse generator; or a major electrostatic discharge.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1711607
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #250 on: December 03, 2018, 04:06:07 AM »

Model Number 104
Event Date 07/02/2013
Event Type  Malfunction   
Manufacturer Narrative
End of service message seen upon interrogation of the pulse generator.

Event Description
It was reported that the patient was in the operating room under anesthesia for prophylactic generator replacement, it was observed that the replacement model 104 device was at ifi (intensified-follow-up condition) with ifi=yes observed during when pre-operatively, the device was at 100% battery capacity. Therefore, the model 104 replacement device was also explanted, and not used. Troubleshooting was performed during surgery. The company representative observed the surgeon use electrocautery during the original explant, but was unable to verify if it was used with the replacement model 104 device was placed. The surgeon reported that he was not sure if he used electrocautery in the vicinity of the replacement device, as surgery is a complicated process. No other issues were reported from the surgery. The patient was implanted with another generator successfully. The unused generator was returned to the manufacturer for analysis. However, product analysis has not been completed to date. Additionally, a copy of the programming/diagnostic data from the surgery was copied by the company representative, but the data has not been uploaded/reviewed to date. If electrocautery was used in the vicinity of the replacement generator, the asic latch-up condition may have occurred where the errrant end of service conditions may be due to the asic remaining in a trickle charge state when an undeliverable output current is programmed.

Event Description
Analysis of the generator was completed on (b)(6) 2013. An end-of-service warning message was verified in the pa lab and found to be associated with the output being disabled by the pulse generator. Once the output was re-enabled, results of electrical test results demonstrated that the pulse generator was operating within specification. Burn marks on the generator case suggest it was exposed to high energy such as an electro-cautery system during the attempted implant. Results of diagnostic testing indicated the device was operating properly. Following a re-enable of the generator output, electrical test results showed that the pulse generator performed according to functional specifications.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3248849
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #251 on: December 04, 2018, 01:58:55 AM »

Model Number 103
Event Date 04/10/2009
Event Type  Malfunction   
Manufacturer Narrative
Date received by manufacturer (mo/day/yr), corrected data. Follow-up report #1 inadvertently listed the aware date as (b)(6) 2011, which was the aware date for the initial report. The correct aware date for the follow-up #1 report should have been (b)(6) 2011.

Event Description
A review of pt programming data revealed that during the pt's initial follow up visit ((b)(6) 2009) after implant surgery ((b)(6) 2009) a "vbat < eos threshold" warning message was received indicating that the pt's demipulse generator was likely in the presence of electrocautery causing an asic latch-up condition during the implant procedure. As a result of this exposure the capacity of the generators battery was altered leading to an atypical depletion state. The generator was returned and reported in mdr # 1644487-2011-01531 due to a premature eos allegation. An end-of-service warning message was verified in the product analysis lab and found to be associated with the output being disabled by the pulse generator. Post burn-in electrical test results showed that the pulse generator performed according to functional specifications. There was a capacitor that was measured to be out-specification but had no adverse effect on device functionality. The battery is depleted, 1. 56 volts as measured with the can removed and battery still attached to the pcb. The data in the memory locations revealed that 34. 928% of the battery had been consumed.

Event Description
Attempts were made for operative notes for the implant and explant of the generator however they will not be provided as it is against their policy.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=2211867
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #252 on: January 16, 2019, 01:36:46 AM »

Model Number MODEL 250
Event Date 04/08/2014
Event Type  Malfunction   
Event Description
It was reported that the physician's handheld will not power on and the charge light does not illuminate when the unit is plugged into the ac power cord. A known working power cord was used and the charge light would still not illuminate and the handheld would not power on. The lock button was not engaged. The physician was provided a new programming tablet and the handheld and flashcard were returned for analysis. Analysis of the handheld was completed on (b)(4) 2014. No anomalies associated with the main battery were identified during the analysis. During the analysis it was identified that the handheld would not power on. The cause for the identified anomaly is associated with an open fuse in the handheld. Once the fuse was replaced no anomalies associated with the handheld were noted during testing using the ac adapter or the main battery with a full charge. The cause for the open fuse is most likely related with an electrical short caused by the damaged record button on the side of the handheld. No other anomalies were identified. Analysis of the flashcard was completed on (b)(4)2014. No anomalies associated with flashcard software or databases were identified during the flashcard analysis. The flashcard and software performed according to functional specifications.
 
Manufacturer Narrative
Device failure occurred, but did not cause or contribute to a death or serious injury.
 
Event Description
Clinic notes were received dated (b)(6) 2014 for the patient. Per the notes, the patient was in to see the physician for a follow up evaluation for seizures. During the visit, the clinic notes stated that the patient's generator was not able to be interrogated due to "technical issues". Through additional investigation, the physician confirmed that these "technical issues" were referring to the reported event of the hand held programming device not being able to power on, which was reported in mfr report # 1644487-2014-01221.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3800223
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #253 on: January 17, 2019, 02:12:41 AM »

Model Number 102R
Event Date 04/13/2016
Event Type  Malfunction   
Manufacturer Narrative
Brand name; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Type of device; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Model #, serial #, lot#, exp. Date, and other; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. Operator of device; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report. If implanted, give date; corrected data: this information was inadvertently reported incorrectly on the initial mfr. Report.
 
Event Description
It was reported the patient underwent generator replacement surgery on (b)(6) 2016. It was noted the company representative tested the new m104 generator and diagnostics showed a dcdc value of 2, which is within normal limits. The surgeon asked the company representative why they were doing a lead revision and the company representative explained that is what the physician requested. The patients neck was somewhat contracted and the surgeon was concerned that he wouldn't be able to get adequate exposure to complete the revision. The surgeon spoke with the physician and the decided to only do a generator replacement and they did not replace the lead. Additional diagnostics were run with the patient's head in 3 different positions to rule out lead discontinuity. The surgeon was satisfied. The m104 generator was then attached to the existing lead, diagnostics were checked and found to be normal, and the generator was left off per the surgeon's request. The explanted generator was received by the manufacturer for analysis; however, analysis has not been completed to date. The returned product form (rpf) stated the generator was replaced prophylactically. The implant card was received by the manufacturer and showed that after the new m104 generator was placed, diagnostics showed 2380 ohms, which was within normal limits. Attempts for additional information have been unsuccessful to date.
 
Manufacturer Narrative
Brand name; type of device; model#, serial#, lot#, other; operator of device; if implanted, give date; corrected data: this information was incorrectly reported on the initial mfr. Report.
 
Event Description
It was reported by the physician that the patient's device was found to be programmed to 0ma output current on (b)(6) 2016. It was noted the patient was previously seen on (b)(6) 2016 and the device had been programmed to 2. 75ma, diagnostic results were ok, and the device was interrogated prior to the patient leaving the appointment. The physician tried to re-program the patient to 1. 25ma, but the patient gagged, and when he re-interrogated the device, it was set to 0ma again. The physician stated he was going to leave the patient off after learning that low impedance could be a short circuit, and leave the device programmed off because the patient gagged. It is unknown if low impedance was actually observed. The programming history database was reviewed and a battery life calculation was performed; however, the information available only went to 10/08/2014 and was not relevant to the issues which were observed in april and may of 2016. Attempts for additional relevant information have been unsuccessful to date.
 
Event Description
Product analysis was performed on the returned generator. The device output current 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 generator's output signal and demonstrated the device provided the expected level of output current for the entire monitoring period. The generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the generator. Additionally programming history was received into the in-house programming history database and was reviewed. It was found that generator diagnostics were run, which programmed the device off. This is an expected event after running generator diagnostics. It was noted that the physician changed the patient's setting back, but then ran generator diagnostics again, causing the device to be programmed off once again. Generator diagnostics should only be run in the or while using a test resistor, prior to implanted the device into the patient. All other diagnostic results showed the generator was working properly.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5743402
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #254 on: February 13, 2019, 01:27:02 AM »

Model Number 302-20
Event Date 01/23/2015
Event Type  Malfunction   
Event Description
The explanted lead was returned for analysis on (b)(4) 2015. Product analysis for the lead was completed and approved on (b)(4) 2015. An analysis was performed on the returned lead portions and a condition was observed that could potentially contribute to the reported ¿low impedance / low impedance message, short circuit condition¿ (lead section) allegations. The bare and exposed conductive coils may be a contributing factor. Note that since a portion of the lead assembly including the electrodes was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. Abraded openings were observed on the outer silicone tubing and both of the inner silicone tubes. The quadfilar coils appeared to be stretched, kinked and bare, in some areas. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted process, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer silicone tubing. What appeared to be white deposits were observed in various locations. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other 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.
 
Event Description
It was reported that device diagnostics resulted in low impedance (<600 ohms) and that the patient has experienced worsening seizures. The patient was referred for lead replacement. The patient underwent lead replacement on (b)(6) 2015. It was reported that device diagnostics with the new lead and existing generator were within normal limits. The explanted lead has not been received for analysis to date. No additional relevant information has been received to date.
 
Manufacturer Narrative
Device manufacturing records were reviewed. Review of manufacturing records of the lead confirmed all quality tests were passed prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.
 
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=4531971
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #255 on: February 21, 2019, 11:42:38 AM »

Model Number MODEL 250
Event Date 03/20/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that the usb port of the tablet device was damaged and was missing a component. Attempts to perform interrogations resulted in error message stating ¿unable to open port. ¿ the tablet device has been returned to the manufacturer where analysis is currently underway.
 
Event Description
Product analysis was completed for the tablet device on 04/23/2015. The tablet was received without a serial cable. An analysis of the tablet was performed and a visual analysis identified damage to the tablet back cover and usb port. The cause of the damage is unknown, but can be attributed to mishandling of the device. Additionally, functional testing of the tablet identified that it would not power on. The cause for the anomaly is associated with incorrect power and ground wire connections to the wi-fi card. The condition created an electrical short and prevented the tablet from powering on. No further anomalies were identified. Analysis determined that this was definitely not an out of box failure. There was obvious physical damage to the tablet as evidenced by a separated cover and damaged port. This was likely due to the device being dropped. The port was damaged, but still functional, and was used during testing. Even though the port was functional, the damage could definitely have contributed to the ¿unable to open port ¿error which was observed. With the wires reversed, the tablet could not power on. The tablet was also visibly used. There were archived databases present. The tablet would not have functioned at all with the wires connected as it was received. It is likely that after the tablet was dropped, the user incorrectly connected the wires. The company field representative stated that he went to the office to troubleshoot, was able to turn on the tablet and received the ¿unable to open port¿ error. He took the tablet with him that day and it was not dropped. Based on this, it is unclear how the wires became reversed leading to a failure to power on the tablet.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4685212
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #256 on: February 23, 2019, 02:33:04 AM »

Model Number 302-20
Event Date 03/03/2015
Event Type  Malfunction   
Event Description
It was reported that the patient was referred for an end of service replacement that took place that day. The patient¿s generator prior to surgery was interrogated and showed ifi-yes. Diagnostics were also taken and resulted in a low impedance of <600 ohms. The patient was doing doing fine and has no increased seizures, so since the ifi=yes flag was seen they decided to replace before it actually gets to eos in case the seizures come back. Patient¿s programming history shows that the impedance has been dropping slowly since implantation suspecting a possible short circuit. The surgeon checked the lead and reported that he did not see anything obvious in terms of abrasions or fluid in lead at the area near the generator. He took out the old generator and replaced with a new generator. He performed the system diagnostics again and got high impedance at 9236 ohms. The surgeon re-inserted the pin and performed diagnostics which again showed a low impedance of <600 ohms. The surgeon performed two more diagnostic results which both showed low impedance but the surgeon decided to not revise the lead since he did not feel comfortable replacing it with just the diagnostic results. Patient was doing well prior to surgery so if there is an issue later on, he will bring them back into surgery. He informed the patient¿s family about his decision also. The explanted generator will not be returned for analysis.
 
Manufacturer Narrative
Device failure is suspected, 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=4649309
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #257 on: March 02, 2019, 04:09:08 AM »

Model Number 302-30
Device Problem Low impedance
Event Date 07/09/2015
Event Type  Malfunction   
Event Description
On (b)(6) 2015 a physician asked whether low impedance in diagnostic testing (60;600) is suggestive of a short circuit. The physician later reported that he does have a patient with low impedance. This low impedance was first observed on (b)(6) 2015 on a system diagnostics test. The physician did not make any changes to the patient's settings at that time. The physician indicated that the patient has an intellectual disability and therefore is unable to express any change in stimulation perception, but that the patient's seizures have been increasing since her last visit in (b)(6). Although surgery is likely, it has not occurred to date.
 
Manufacturer Narrative
Device failure is suspected, but did not cause or contribute to a death.
 
Event Description
On (b)(6) 2015 the patient's generator product information was provided by the implanting facility.
 
Event Description
On (b)(6) 2015 the explanted generator and lead were received for product analysis. Product analysis has been completed on the generator. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. In the product analysis lab, the device output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications; there were no performance or any other type of adverse conditions found with the pulse generator. Product analysis is still underway on the leads and has not yet been completed.
 
Event Description
On (b)(4) 2015 it was reported that the patient underwent a full revision surgery that day. Attempts were made for the return of the explanted products but they have not been received to date.
 
Event Description
Product analysis was completed on the leads on 1/25/2016. The majority of the lead assembly (body) including the electrodes was not returned for analysis; therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis abraded openings were observed on the outer and in one area of the connector ring inner silicone tubing. The quadfilar coil appeared to be stretched and exposed. The abraded openings found on the outer silicone tubing and the cut ends that were made during the explanted 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. With the exception of the abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other 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.
 
Event Description
It was reported that the patient is having an evoked potential test.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4932439
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #258 on: March 04, 2019, 08:00:15 AM »

Model Number 303-30
Event Date 07/29/2015
Event Type  Malfunction   
Event Description
It was reported on (b)(6) 2015 that a low impedance warning message was seen on a patient's device upon interrogation. This was the patient's first appointment after battery replacement on (b)(6) 2015. It was noted that after the replacement, diagnostics were taken and came back in range. It was then noted that following a running of the system diagnostics the impedance resulted in range, 1692 ohms. The decoder information from generator was received and indicated that the impedance values were fluctuating from normal impedance values back to low impedance values and then back to normal impedance. Based on these impedance values it is clear that there is a short in the circuit causing the impedance to fluctuate between normal and low readings. This is likely due to wear on the lead based on the age of the device. While surgical intervention is likely, no surgery has been planned or scheduled to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5048038
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #259 on: March 05, 2019, 07:33:02 AM »

Model Number 304-20
Device Problems Fracture; Device Displays Incorrect Message ; Lead
Event Date 07/23/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
Analysis of the explanted generator and lead was completed. Analysis of the lead confirmed openings of both the outer and inner silicon tubing in adjacent areas, exposing conductive quadfilar coils and creating a potential short-circuit condition. Analysis of the generator revealed no anomalies. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. There were no performance or any other type of adverse conditions found with the pulse generator. The downloaded data from the generator revealed that low impedance was observed (change from 207 ohms to 379 ohms on (b)(6) 2015).
 
Event Description
The explanted generator and lead have been received by the manufacturer for analysis. However, analysis has not been completed to date.
 
Event Description
It was reported that the patient presented to the er with increased seizures below pre-vns baseline. Upon diagnostics while in the er, low impedance was noted. It was stated that the low impedance message appeared indicating the impedance value was less than 600 ohms. The device was thus disabled. Review of the manufacturer's available programming history for this patient revealed that diagnostics on date of implant, (b)(6) 2011, revealed normal impedance values. It was reported that the patient had a status epilepticus event one night while the device was disabled, prior to the date of surgery. The patient underwent generator and lead replacement surgery on (b)(6) 2015 due to prophylactic generator replacement and low impedance. Diagnostics prior to surgery again revealed low impedance. It was also reported that a lead fracture was visually observed during the surgery. The explanted generator and lead have not be received by the manufacturer for analysis to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5009042
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #260 on: March 17, 2019, 02:40:40 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
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #261 on: March 24, 2019, 01:16:02 AM »

Model Number 302-20
Device Problems Insulation; Hole In Material; Low impedance; Scratched Material
Event Date 12/10/2006
Event Type  Malfunction   
Event Description
Information was received indicating that low lead impedance was repeatedly observed via system diagnostics with a new pulse generator and a prior implanted lead during a generator replacement surgery. The surgeon verbally reported that the lead looked odd. It is unknown if generator diagnostics were performed with a test resister to test the generator's ability to accurately measure impedance. The physician did not replace the lead and the patient is being referred for a revision surgery. Subsequently received operative notes indicate that the physician observed a significant gap (opening) in the silicone insulation of the lead and attributed the low impedance to this condition. Pictures were taken of the lead and submitted and show possible, but inconclusive, insulation abrasion. A review of programming history with the prior device indicates system diagnostics lead impedances ranging from 0 to 2 with a decrease from 2 to 0 for the last several years of the available date. System diagnostic data from the date of replacement surgery with the prior pulse generator indicates dcdc 0, a warning of low lead impedance and impedance value <600 ohms. Attempts for additional relevant information have been unsuccessful to date and no known surgical interventions have occurred to date.
 
Event Description
The patient underwent lead explant and replacement on (b)(6) 2015. The surgeon left the electrode portion of the lead implanted and the new lead electrodes were placed above the former electrodes. It was observed that the lead insulation was broken down. No pre-operative device check was performed. The explanted lead has not been received by the manufacturer to date.
 
Event Description
The explanted lead was returned to the manufacturer. Product analysis confirmed abraded openings of the outer and inner silicone tubes in adjacent areas, exposing the conductive quadfilar coils and creating a potential short-circuit condition. A break of the positive coil in the electrode region of the returned lead was also observed. It is unknown if the break occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. With the exception of the discontinuity and abraded openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. No other obvious anomalies were noted. Note that since a portion of the lead assembly (body), including the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.
 
Manufacturer Narrative
(b)(4).

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5275057
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #262 on: March 29, 2019, 07:50:40 AM »

Model Number 304-20
Event Date 01/01/2016
Event Type  Malfunction   
Event Description
During a prophylactic generator replacement (ifi = yes) on (b)(6) 2016, the surgeon accidentally cut the lead and had to perform lead revision. The explanted generator and lead were received. An analysis was performed on the returned lead portions. The reported allegations of lead fracture due to surgeon accidentally cutting the lead was confirmed based on the condition of the returned lead portions. During the visual analysis of the returned lead, abraded openings were observed on the connector pin and connector ring inner silicone tubes. Pitting was observed on the connector ring quadfilar coil surface, in this area. Analysis confirmed opening of both inner tubing sections in adjacent areas, exposing conductive quadfilar coils and resulting in coil pitting and a potential short-circuit condition. With the exception of the slice marks, puncture marks and abraded inner tubing openings, the condition of the returned lead portions is consistent with those that typically exist following an explant procedure. The abraded openings of both inner tubes is suspected to have occurred during the implant life and prior to explant surgery. 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, there is no evidence to suggest discontinuities in the returned portions of the device which may have contributed to the stated allegations of high impedance/lead fractures. A comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications. The battery, 2. 914 volts, shows an ifi=no condition. Various electrical loads were attached to the pulse generator and results of diagnostic tests demonstrate that accurate resistance measurements were obtained in all instances. 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=5542841
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #263 on: April 02, 2019, 12:21:51 AM »

Model Number 304-20
Device Problems Fracture; High impedance; Low impedance
Event Date 04/17/2016
Event Type  Malfunction   
Manufacturer Narrative
(b)(4).
 
Event Description
A physician reported to an international distributor that low lead impedance had been observed in a patient's vns system at a device follow-up. X-rays were taken and provided to the manufacturer for review. The x-rays showed no obvious anomalies but did reveal a possible sharp bend in the lead just above the generator and a possible pin insertion issue. The entire lead body could not be evaluated based on the x-ray images submitted. Submitted diagnostic data shows three low impedance (<600 ohms) measurements on (b)(6) 2016 along with 7 normal impedance measurements on that same date. A decrease in impedance is observed in the data over the last seven months. No patient adverse events have been reported. The physician intends to monitor the patient's condition and continue normal patient following. No specific intervention is planned and no surgical interventions have occurred to date.
 
Event Description
Follow-up on this event was provided indicating that the patient's impedance values were fluctuating. The patient had low impedance values that fluctuated to high impedance on (b)(6) 2016. Then, on (b)(6) 2016 the impedance values were all within normal limits. Then, the patient was visited on (b)(6) 2016 and the impedance values were high on multiple system diagnostic tests. The system diagnostic test on (b)(6) 2016 was also high. Then, the patient was seen on (b)(6) 2017 and the impedance was within normal limits. A new set of x-rays was provided for review and there was no indication of a sharp angle on this x-ray and the lead pin did not appear fully inserted into the connector block. No know surgical intervention has occurred to date.
 
Event Description
The patient was seen for a clinic visit on (b)(6) 2018, and high lead impedance was observed on her device. The distributor noted that the patient's device had previously shown both high and low lead impedance, but the impedance values had recently been within the normal range. Diagnostics performed at the clinic visit indicated an output current of only 0. 50 ma was being delivered, although the generator was programmed to 1. 5 ma. The distributor planned to send x-rays to the manufacturer for review. The x-rays were received by the manufacturer but have not been reviewed to date. The full programming history was reviewed for the patient's generator. Fluctuating impedance values were observed throughout a significant portion of the programming history, including the aforementioned low and high impedance, along with several internal impedance changes not observed in previous diagnostic tests. Low impedance was internally detected between multiple interrogations when impedance appeared to be normal in system diagnostic testing, indicating several quick fluctuations in impedance value. On (b)(6) 2017 impedance values were within the normal limits and remained so through multiple clinic visits until (b)(6) 2018; however, the high impedance was internally detected three days prior. No additional relevant information has been received to date. No surgical intervention has occurred to date.
 
Event Description
The x-ray images were reviewed by the manufacturer. Due to the angle of the generator in the image, lead pin insertion into the generator could not be assessed. The filter feedthrough wires appeared intact, and the lead wire appeared intact at the lead pins. The lead was observed in the neck and chest. Due to the exclusion of the patient¿s upper neck from the provided images, the presence of strain relief could not be assessed in its entirety; however, a strain relief bend did appear to be present, and a strain relief loop appeared to be complete. Two tie-downs secured the lead at the strain relief bend, and one tie-down secured the lead at the strain relief loop. A portion of the lead appeared to be routed behind the generator. No gross fractures or lead discontinuities were observed in the provided images as visibility of the lead was lost near the collarbone. 3d-ct images were also included with the provided x-ray images. The presence and completeness of the lead strain relief was confirmed in the 3d-ct images. The portion of the lead routed behind the generator was also visible in the images, and a gross fracture was visualized in the portion of the lead that was not visible in the x-ray image. The thickness of the lead was minimal at the fracture location compared to the remainder of the lead body, signaling the potential for a short circuit condition to have existed. No additional relevant information has been received to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5672042
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #264 on: April 08, 2019, 02:18:31 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 08/30/2017
Event Type  Malfunction   
Event Description
It was found in programming history that there was evidence of fluctuating lead impedance levels, indicating a short circuit or low impedance condition. No additional information has been received.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8392232
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #265 on: April 13, 2019, 03:59:48 AM »

Model Number 304-20
Event Date 06/30/2015
Event Type  Malfunction   
Manufacturer Narrative

Event Description
During review of the in-house programming/diagnostic history database, it was observed that low impedance was observed at office visit on (b)(6) 2015. A subsequent diagnostic test was performed during the same visit and resulted with normal impedance levels. It is unknown if any patient manipulation or trauma occurred that could have caused or contributed to the low impedance reading. Review of the programming data that captured the low impedance found that when the low impedance message presented the actual impedance value was measured as 384 ohms. Further follow-up found that the generator was still presenting with a low impedance message during a visit on (b)(6) 2016. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient was experiencing a funny sensation in the neck and throat; which was attributed to vns stimulation. This change in perception was noted at the same time that the low impedance was observed and therefore appears to be related. The patient was referred for a lead and generator replacement however no surgical interventions are known to have occurred to date.
 
Event Description
The patient underwent vns lead and generator replacement surgery. In pre-op, diagnostic testing resulted within normal limits. During surgery the surgeon observed approximately 1 inch of the lead insulation was stripped off of the lead. The missing piece of the lead insulation could not be located. The lead and generator were then explanted and later received by the manufacturer. Both products are currently pending product analysis.
 
Event Description
Product analysis on the generator was completed. During analysis the output signal of the generator was monitored for more than 24-hrs and no variations in the output signal or expected level of output current were observed. The generator performed to functional specification.
 
Event Description
Product analysis was completed on the received lead portions. It was noted that the portion of the lead with the electrodes was not received therefore a complete evaluation could not be performed on the entire lead. The lead was received in 4 portions with the segment containing the lead connector pin still inserted into the generator. A continuity measurement verified electrical and mechanical contact between the generator and the lead pin. X-rays were taken and revealed that the canted spring of the generator was making contact with the connector ring of the lead. The continuity of the lead portions were evaluated and no discontinuities were identified within each portion. During analysis it was observed that the outer and inner silicone tubing had abrasions which would have made it possible for the quadfilar coils to come in contact with each other which would have caused a short circuit condition that would result in low impedance. Bodily fluids were observed inside the inner and outer tubing and coil fractures were observed in multiple areas however pitting was not observed. Analysis determined that the mechanism for some of the fractures appeared to be stress induced. However the mechanism for all of the fractures could not be determined. Based on the results of analysis it appears that the cause of the low impedance is related to a short circuit condition in the lead.
 
Event Description
It was reported that the patient experienced discomfort when the lead and generator were implanted.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5896715
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #266 on: May 11, 2019, 01:08:27 AM »

Model Number 304-20
Device Problem Fracture
Event Date 03/12/2019
Event Type  Malfunction   
Event Description
The patient's neurologist had reported that they believed that the there was a lead issue as the impedance was around 800 ohms. It was explained to the neurologist that while the impedance is within normal limits, a representative would attend the surgery. While in surgery, the surgeon was able to see that the lead was exposed and the silicone cover was damaged, and the procedure was updated from a prophylactic generator replacement to a full revision. It was stated that there was a short circuit condition. The patient's lead and generator were replaced. The devices were not returned to livanova 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=8470989
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #267 on: May 14, 2019, 12:23:17 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 03/17/2010
Event Type  Malfunction   
Event Description
It was initially reported from social media post that a patient¿s son did not see any benefit from the vns device. At this point patient information was unknown. Additional information was received from the patient¿s mother which identified the patient whose vns was said to be ineffective. She said that the generator was dead and that vns had "failed" and did not help her son enough to agree to have the generator replaced. She said that the patient's physician had told her that explant would run the risk of infection and that it would be safer to keep the system implanted. The programming history database was reviewed and showed a possible short circuit condition. It appears that there was a dramatic drop in impedance from (b)(6) 2009 dcdc 2 to (b)(6) 2010 showing dcdc 0. Along with the allegation that the device was ineffective, this shows there may have been a short circuit condition present. No additional information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8491506
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #268 on: May 20, 2019, 09:02:43 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Mechanical Problem; Low impedance
Event Date 04/11/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit a diagnostic test was performed and resulted in low impedance. It was also reported that the patient had been experiencing an increase in seizures and a change in behavior which both appeared to be related to the low impedance. X-rays were performed and reviewed by the manufacturer. However due to the poor quality of the images provided the integrity of the lead was difficult to assess. Therefore the cause of the low impedance could not be determined. The patient was then referred for surgery where the lead and generator were replaced. The explanted products have not been received to date.
 
Event Description
The generator and lead were received by the manufacturer. The generator product analysis was completed. Visual analysis noted signs consistent with generator manipulation during explantation. The device was noted to be at ifi = no. The results were expected for all diagnostic tests in which various impedance loads were applied to the generator. The output signal of the generator was monitored for a 24 hour period and there were no variations in the output. The device performed to specification. The lead is pending product analysis.
 
Event Description
Analysis was completed on the lead. The lead was received in two portions of tubing with 3 loose quadfilar coils. Set screw marks confirmed that at one time there was adequate connection between the lead pin and generator. Visual analysis observed several abraded openings in the inner & outer tubing that appeared to be caused by wear. These confirmed openings were in adjacent areas and the exposed conductive quadfilar coils created a potential short-circuit condition thus confirming the report of low impedance. Additionally, lead fractures were observed in various locations. Some fractures appeared to be caused by the explant procedure while others appeared to have been caused by mechanical fatigue. Pitting was observed at some fracture sites, indicating that the stimulation was still be provided after the fracture occurred. It was noted that the three loose strands of coil each had melted ends indicating they were exposed to electrocautery during the explant procedure.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6563365
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 62836


« Reply #269 on: June 09, 2019, 12:51:43 AM »

Model Number 302
Device Problems Corroded ; Fluid Leak; Fracture; Low impedance
Event Date 01/31/2016
Event Type  Malfunction   
Event Description
It was reported that the physician performed a diagnostic test during a visit and observed a low impedance warning. Chest x-rays were reviewed by the physician and a lead fracture was observed. These images have not been reviewed by the manufacturer to date. It is unknown if the patient sustained an injury which could have caused the lead fracture. The device was programmed off and the patient was referred for surgery. No surgical interventions are known to have occurred to date.
 
Event Description
It was reported that the patient underwent lead and generator replacement surgery. The explanted products have not been received to date.
 
Event Description
The explanted lead and generator were received. Both are currently pending analysis.
 
Event Description
Analysis was completed on the returned generator and lead. During testing the generator performed to functional specification and no anomalies were observed. The internal data of the generator was reviewed and confirmed that a low impedance had occurred while implanted. The lead was received in 5 segments which included the lead pin and electrodes. There were set screw marks on the pin which indicated that there was good contact between the lead and generator at one time. Abrading openings were found in the inner and outer tubing in various locations in the lead. Scanning electron microscopy was used to evaluate the lead and found broken coil strands with evidence that the fracture was stress induced from fatigue and rotational forces. There was evidence of pitting on one coil strand which indicates that the fracture was present while stimulation was occurring. Additionally with the abraded insulation, it was found that a short condition was occurring between the coils. Analysis of the lead confirmed the short circuit condition which caused the low impedance.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6852981
Logged
Pages: 1 ... 7 8 [9] 10   Go Up
Print
Jump to: