Pages: 1 [2] 3 4 ... 10   Go Down
Print
Author Topic: Low Impedance  (Read 24161 times)
0 Members and 1 Guest are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #30 on: October 26, 2017, 12:11:00 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 01/08/2014
Event Type Malfunction
Manufacturer Narrative
Analysis of converted programming history.

Event Description
The patient received a lead revision. A company representative reported that the lead was broken. The explanting facility will not return explanted devices to the manufacturer for analysis; therefore, no analysis can be performed.

Event Description
On (b)(6) 2015, the patient went for a routine device check. Low impedance and a possible lead discontinuity were indicated. Company representative reported on (b)(4) 2015 that x-rays were taken and there was no visible lead break.

Manufacturer Narrative
Device manufacturing records and programming history were reviewed. Review of manufacturing records confirmed the device met all final testing specifications prior to distribution. Device failure is suspected, but did not cause or contribute to a death or serious injury.

Event Description
During the patient's vns generator replacement, it was found that system diagnostic tests showed low impedance. The test was repeated with the same results. The surgeon reseated the lead pin and a third test was run, but the same results were obtained. Follow up found that there were no x-rays planned or taken. The patient's family did not report any trauma or manipulation that would have contributed to the impedance. No interventions have been planned, as the physician plans to observe the patient clinically. No other information was provided.

Event Description
On (b)(6) 2014, it was reported that the patient was doing well and diagnostics continued to show low impedance. Review of converted programming and diagnostic data from the date of surgery showed that with the newly implanted generator, four system diagnostic tests were with repeated low impedance results (35 ohms, 21 ohms, 21 ohms, 21 ohms). The explanted generator was also interrogated: data shows that a normal impedance value was stored from the internal check on (b)(6) 2014 (2313 ohms). A subsequent system diagnostic on (b)(6) 2014 continued to show low impedance: 21 ohms. The device remained programmed on. No interventions have been taken to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3602012
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #31 on: October 28, 2017, 02:19:44 AM »

Model Number 300-20
Event Date 02/06/2014
Event Type Malfunction
Event Description
Additional information was received stating that the vns patient underwent generator and lead replacement surgery on (b)(6) 2014. The explanted devices have not been returned to date.

Event Description
It was initially reported that the physician was unable to interrogate the vns patient¿s device, and the physician was receiving a ¿retry¿ message on her handheld whenever she attempted to interrogate the device. Additional information was later received stating that there was not a communication issue, rather the issue was that a diagnostic test preformed on the device revealed low lead impedance (impedance value < 600 ohms) on (b)(6) 2014. Patient manipulation or trauma is not believed to have occurred. No known interventions have occurred to date.

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=3685605
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #32 on: November 01, 2017, 12:34:02 AM »

Model Number 102
Event Date 05/07/2014
Event Type Malfunction
Event Description
It was reported that device diagnostics resulted in low impedance (dc dc code - 0). It was reported that device diagnostics have decreased over a period of time. The patient's parents reported an increase in seizures; however, it was reported that this is hard to quantify as the baseline was high to start off with. The parents also mentioned that the patient was "bashed" in the chest 3 weeks prior. The patient was scheduled for surgery and the plan was to replace the generator first to see if the impedance increased and if not a lead replacement would also be performed. The patient underwent generator replacement surgery. Pre-operative diagnostics confirmed low impedance (dc dc code - 0). The generator was replaced and device diagnostics were within normal limits (impedance value - 2,029 ohms). The lead was not replaced.

Event Description
The explanted generator was returned to the manufacturer for analysis. Monitoring of the generator output signal showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis, there were no anomalies found with the pulse generator.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=3854073
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #33 on: November 02, 2017, 12:54:24 AM »

Model Number 105
Event Date 05/09/2014
Event Type Malfunction
Manufacturer Narrative
Brand name, corrected data: previously submitted mdr indicated that the suspect medical device was the lead; however, this is actually the generator. Type of device, corrected data: previously submitted mdr indicated that the suspect medical device was the lead; however, this is actually the generator. Model #, serial #, lot #, expiration date, corrected data: previously submitted mdr indicated that the suspect medical device was the lead; however, this is actually the generator. Operator of device, corrected data: previously submitted mdr indicated that the patient was the user; however, this should be the medical professional. If implanted, give date (mo/day/yr), corrected data: previously submitted mdr provided the implant date for the lead; however, this should be for the generator. Device manufacture date, corrected data: previously submitted mdr indicated that the suspect medical device was the lead; however, this is actually the generator.

Event Description
Additional information was received that the lead pin was reinserted into the generator during surgery and there has been no recurrence of high impedance since.

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.

Event Description
It was reported that device diagnostics resulted in high and low impedance (5534 ohms, 4298 ohms). A second diagnostic was performed which again resulted in high impedance (5587 ohms). It was reported that the patient had undergone generator replacement the day prior and that device diagnostics at the completion of surgery were within normal limits. It was later reported that the patient was sent for surgery. Pre-operative diagnostics resulted in ok impedance (1985 ohms, 2020 ohms, 2268 ohms). It was reported that the surgeon plans to go forward with the surgery to check lead pin/generator connection. Attempts to obtain additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=3854518
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #34 on: November 11, 2017, 01:22:50 AM »

Model Number 303-20
Device Problem Low impedance
Event Date 09/20/2017
Event Type Malfunction
Event Description
It was reported that a patient¿s generator showed a low impedance message, upon interrogation. Clinic notes from a visit on (b)(6) 2017 were received for a referral that indicate the device has an issue and has since been turned off. The notes detail that the patient has been having an increase in ¿spells¿, clarified by the physician as partial seizures. Follow-up from the surgeon provided the low impedance was still present on the device. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6950569
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #35 on: November 11, 2017, 01:23:40 AM »

Device Problem Low impedance
Event Date 02/24/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was found through a periodic review of the programming history review that low impedance was detected on the patient's device. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6953457
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #36 on: November 11, 2017, 01:24:33 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 03/13/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was found during a review of the programming history that low impedance was observed on the patient's device. An additional diagnostic was run after the first test revealed low impedance for the system which had ok results however the impedance value was close to the defined low impedance value. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6960077
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #37 on: November 12, 2017, 02:49:01 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 09/25/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that a patient¿s device showed low lead impedance on diagnostics. The patient was referred for x-rays. The x-rays have not been received by the manufacturer to-date. The patient was referred for full revision surgery to replace the damaged lead and to replace the generator prophylactically. Additional relevant information has not been received to-date. No known surgery has occurred to-date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6967346
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #38 on: November 18, 2017, 01:16:24 AM »

Device Problems High impedance; Low impedance
Event Date 10/15/2014
Event Type Malfunction
Event Description
It was reported that the vns patient¿s device showed low impedance and later showed high impedance. X-rays were taken and were reported to be unremarkable. No known surgical interventions have occurred 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 or serious injury.

Event Description
Review of device programming history identified that high impedance was indeed observed for this patient's vns system on (b)(6) 2014. The device was disabled at a follow up appointment on (b)(6) 2015. Diagnostics on (b)(6) 2015 confirmed the high impedance. There was no evidence of low impedance in the observed programming history. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4648122
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #39 on: November 24, 2017, 03:13:14 AM »

Model Number 302-20
Device Problem Low impedance
Event Date 01/01/2015
Event Type Malfunction
Event Description
System diagnostics shows that the patient¿s device showed low impedance. It was also mentioned that the patient was in a car accident which might have contributed to the low impedance. Patient was referred for a full revision but surgery has not occurred to date.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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 or serious injury.

Event Description
Patient underwent full revision on (b)(6) 2015. The surgeon mentioned that the patient was a twiddler and that the low impedance was due to patient manipulation of the leads. An image was provided of the lead and generator which show that the lead was twisted and that the insulation was missing for a portion of the leads. The explanted devices were discarded.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4903758
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #40 on: November 24, 2017, 03:13:57 AM »

Model Number 302-20
Event Date 08/02/2012
Event Type Malfunction
Event Description
During review of the patient¿s programming history available in the manufacturer¿s database, it was identified that low impedance was observed for patient's device. Attempts for additional relevant information were unsuccessful.

Manufacturer Narrative
Device manufacturing records and available programming and diagnostic history 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 or serious injury.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=4906861
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #41 on: December 05, 2017, 01:16:01 AM »

Model Number 102
Device Problem Low impedance
Event Date 12/07/2012
Event Type Death
Manufacturer Narrative

Manufacturer Narrative
Evaluation codes; corrected data: the previously submitted mdr inadvertently omitted the new conclusion code per receipt of information relating to cause of death.

Event Description
Cause of death information obtained from the national death index (ndi) was reviewed by the manufacturer which indicated that the patient passed away on (b)(6) 2012 and the patient's cause of death was unspecified infantile cerebral palsy, which was contributed by unspecified septicemia, congestive heart failure, unspecified pneumonia, unspecified coma, other and unspecified convulsions, foreign body in respiratory tract (part unspecified), and inhalation and ingestion of other objects causing obstruction of respiratory tract. There is no allegation or other information indicating that the death is related to vns.

Event Description
The patient died from pneumonia. There was no indication that the pneumonia was related to vns in any way. The device was buried with the patient, so no analysis could be performed.

Event Description
The article "long-term seizure and psychosocial outcomes of vagus nerve stimulation for intractable epilepsy" mentioned that 15 of the vns patients implanted at a certain hospital between 1997 and 2013 that the researchers attempted to contact were found to be deceased. This report will house one of 5 deaths of the known deceased patients that fit the criteria. The patient died on (b)(6) 2012 due to unknown reasons. Programming history suggested low impedance, but there were no patient adverse events to suggest that the death was related to the low impedance in any way. The relationship of the death to vns is unknown. Attempts for further information have been unsuccessful to date. The mfr. Report numbers of the five deaths of known deceased patients are: 1644487-2015-06606, 1644487-2015-06607, 1644487-2015-06608, 1644487-2015-06609, 1644487-2015-06610.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5256308
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #42 on: December 07, 2017, 01:16:39 AM »

Model Number 101
Event Date 03/14/2002
Event Type Malfunction
Event Description
It was reported that the patient's caregiver wanted to have the patient's vns removed due to lack of efficacy. Later, the caregiver reported that the patient's seizures were worse when his vns was on. It is unknown if/when the patient's device was disabled or if the patient had efficacy, because the patient's physician that managed his vns had since retired. Programming history also indicated that there may have been low impedance, as of (b)(6) 2007. The impedance had been within normal limits from 2003 - 2007, so there was no indication that low impedance had been present the entire time the device was implanted. However, the caregiver's reports of lack of efficacy and increased seizures may have been related to low impedance. Attempts for further information were unsuccessful to date. No surgical intervention has occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5399400
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #43 on: December 08, 2017, 01:49:33 AM »

Model Number 304-20
Device Problem Low impedance
Event Date 08/25/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported via clinic notes received that the patient was referred for vns replacement surgery. It was noted that the patient mother was told that the vns was not working, which lead to the referral. Follow up with one of the patient physicians revealed that low impedance was observed on the patient vns. No relevant surgical intervention is known to have occurred to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7072334
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #44 on: December 08, 2017, 11:14:11 PM »

Model Number 304-20
Device Problems Undersensing; Low impedance
Event Date 06/05/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the generator was not detecting heart rate. The internal data of the generator was reviewed and it was determined that low impedance had been detected on the device in the past as well as a large drop in impedance. Low impedance may interfere with heartbeat detection. The generator was later able to detect heart rate when the sensitivity was set to its least sensitive detection setting (sda sensitivity - 1). However, approximately four months later, the generator continued to have difficulty detecting heart rate. Low impedance was detected intermittently through system diagnostics. The patient reported that approximately a year ago she had felt a 'movement' in her neck, where the lead connected to the nerve and when she moved her head back, the movement reversed and 'went back. ' the patient said that she still felt normal and magnet mode stimulation. No known relevant surgical intervention has occurred to date. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7011776
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #45 on: December 08, 2017, 11:15:01 PM »

Model Number 302-20
Device Problem No code available
Event Date 05/17/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
Clinic notes were received stating that the patient's "behavior became much more of a problem since the device was changed. It was also stated the impedance is low (<600 ohms). X-rays were taken but no evidence of lead interruption or vns malfunction was noted. No additional relevant information has been received. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7043494
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #46 on: December 09, 2017, 01:15:06 AM »

Model Number 302-20
Device Problems Mechanical issue; Low impedance
Event Date 10/23/2017
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported that the patient was referred for vns generator replacement surgery due to the desire for a newer model vns generator and additional efficacy. However, prior to surgery, low impedance was observed on the patient's device. It was reported that, upon inspection of the lead by the surgeon, the wires of the lead were exposed through the insulation. The patient underwent full vns replacement surgery. The explanted products have not been received by the manufacturer to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7042648
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #47 on: December 11, 2017, 01:33:18 AM »

Model Number 302-20
Event Date 11/11/2008
Event Type Malfunction
Event Description
It was reported that a patient was having generator replacement surgery, and low impedance was noted at the time of replacement on both the old and new generators. The pin was re-inserted, and diagnostics were performed with the same results. Heart rate detection was verified to have a good detection at sensitivity 1. The surgeon decided not to replace the lead since the previous impedance was dcdc = 0. The patient's device was programmed per the physician's orders. The patient did feel stimulation prior to surgery. The device history record of the lead was reviewed, and the lead passed all functional specifications prior to release. Revision surgery has not occurred to date.

Event Description
The explanted generator was received on 04/19/2016 and analyzed on 05/02/2016 and was found to be conforming to all manufacturer specifications. There were no malfunctions found with the explanted generator.

Manufacturer Narrative

Event Description
The explanted generator has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5436424
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #48 on: December 11, 2017, 01:34:00 AM »

Model Number 302-20
Event Date 01/25/2016
Event Type Malfunction
Event Description
Follow up with the provider indicates that it is unknown if the low lead impedance condition was verified with system diagnostics. Surgery remains likely but has no known surgical interventions have occurred to date.

Manufacturer Narrative

Event Description
A provider indicated that a patient's vns system was exhibiting low lead impedance upon interrogation. Chest x-rays were performed but were reported to be negative for any lead problems. The patient was referred for a surgical consult. Surgery is likely but no known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5449796
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #49 on: December 12, 2017, 01:33:12 AM »

Model Number 302-30
Event Date 03/09/2016
Event Type Malfunction
Event Description
On (b)(6) 2016, low impedance warning message with impedance of < 600 ohms was observed for the patient' s device upon interrogation. Patient previously underwent a generator replacement surgery on (b)(6) 2015. The impedance was also reported to be within normal limits. After the generator was replaced, a break in the silicon tubing near the connector pin was observed and the surgeon mentioned that he might have nicked it. As the surgeon did not have approval for replacing the lead, the lead was not replaced. The impedance with the old lead and new generator was 1710 ohms.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5542886
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #50 on: December 12, 2017, 01:33:53 AM »

Event Date 01/11/2016
Event Type Malfunction
Event Description
It was reported that low impedance message showed during a system test while interrogating a patient vns system. Attempts for additional relevant information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5415777
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #51 on: December 13, 2017, 01:22:49 AM »

Model Number 304-20
Event Date 03/01/2016
Event Type Malfunction
Manufacturer Narrative

Event Description
It was reported on (b)(6) 2016 from the physician that the patient was in the office and has low impedance. The patient is implanted with a m105 device. The physician interrogated and device and received a low impedance message. Then she ran system diagnostics and the result was low impedance/<600 ohms. The physician knew that the last time diagnostics were performed was in (b)(6) and no low impedance was seen. She stated that patient has had seizures and falls during this time so may very well have caused this. The device was disabled at this time per recommendation. The patient's device was disabled upon seeing the low impedance. The patient was sent for an x-ray of the chest and neck to look for a lead fracture. Surgery is likely but has not occurred to date.

Event Description
Patient had a full replacement on (b)(6) 2016. The implant card states the reason for explant was prophylactic for the generator and a possible lead issue for the lead product. The generator and test resistor were received for analysis on 03/31/2016. Lead was not returned. Product analysis for the generator was completed and approved on 04/19/2016. The downloaded decoder data from the generator shows an indication of low impedance as the "diagvinitialprechange" has a value of 226 ohms, and the "diagvinitialpostchange" value of 4066 ohms was seen on date of explant. 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=5526178
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #52 on: December 14, 2017, 03:05:42 AM »

Model Number 303-20
Device Problems Fluid leak; Mechanical issue; Low impedance
Event Date 06/08/2015
Event Type Malfunction
Manufacturer Narrative

Event Description
The explanted lead and generator were received. Analysis performed on the generator shows that there were no additional performance or any other type of adverse conditions. 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. The battery, 3. 078 volts, shows an ifi=no condition. A portion of the lead assembly including the electrode section was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the bilumen tubing appeared to be twisted, in most areas. During the visual analysis the bilumen tubing appeared to be twisted and the (-) green electrode spot-weld and portion of ribbon appeared to be torn from the ribbon. Abraded openings were observed on the bilumen tubing and the tri-filar coils appeared to be exposed in these areas. These findings are consistent with patient manipulation/rotation of the device while it was implanted (twiddling of device). The abraded openings found on the bilumen 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 bilumen tubing. What appeared to be white deposits were observed on the bilumen tubing. Eds (energy dispersion spectroscopy ¿ provides chemical or element identity/composition analysis) was performed and identified the deposits as containing silicon. With the exception of the abraded openings and exposed tri-filar coils, the condition of the returned lead portion 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 portion were performed, during the visual analysis, and no discontinuities were identified.

Event Description
Device diagnostics showed a low impedance value in (b)(6) 2016 and the device was turned off. The patient had remained seizure free with the device turned off, and so the decision was made to remove the device. Patient underwent explant of the generator and lead. The explanted devices have not been received to date.

Manufacturer Narrative

Event Description
Low impedance was observed in the patient's device programming data on (b)(6) 2015. Additional information was received from a nurse that the patient's device was temporarily disabled on (b)(6) 2015 due to mri and that the patient did not see the physician until (b)(6) 2015. Per the clinic note in (b)(6) 2015, the vns device was interrogated and low impedance was observed. The physician acknowledged that this might be due to a lead fracture and disabled the vns from 1. 5 ma to 0 ma to see if patient needs to continue vns therapy as he has not had any seizures in several years. Patient was again seen in (b)(6) 2016 and possible removal of the device was considered. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5514040
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #53 on: December 15, 2017, 01:24:23 AM »

Model Number 103
Device Problem Fracture
Event Date 03/23/2016
Event Type Malfunction
Manufacturer Narrative
Corrected data.

Manufacturer Narrative

Manufacturer Narrative

Event Description
It was reported by the physician's office that a low impedance warning was observed during system diagnostics on (b)(6) 2016. It was noted the patient was not complaining about any painful or erratic stimulation. Attempts for additional relevant information have been unsuccessful to date.

Event Description
No surgical interventions has occurred to date.

Event Description
It was later reported the patient underwent a successful full revision. The pre-op interrogation of the patient's device showed low impedance. When explanting the m103 generator, the surgeon stated there was an obvious lead fracture near the generator, but he was not able to determine the cause of the fracture. The m103 generator and the old lead, up to the point of the anchor tether, were explanted and the electrodes were left in place. A new lead and generator were implanted with the new electrodes placed superior to the old electrodes. System diagnostics were checked for the newly implanted vns and noted to be within normal limits. The explanted product was sent to pathology per hospital protocol. The explanting facility does not return devices back to the manufacturer; therefore, the devices are not expected to be returned for analysis.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5590484
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #54 on: December 20, 2017, 08:07:22 AM »

Model Number 102R
Event Date 04/13/2016
Event Type Malfunction
Manufacturer Narrative

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: 61989


« Reply #55 on: December 27, 2017, 01:27:21 AM »

Model Number 106
Event Date 06/29/2016
Event Type Malfunction
Manufacturer Narrative
(b)(4).

Event Description
An implant card was received for a replacement that occurred on (b)(6) 2016. A lead impedance of 128 ohms was recorded on the implant card indicating low impedance. However, there was no other indication on the implant card that an error message was seen or that there were any abnormal events during the replacement. Attempts for further information were unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=5851200
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #56 on: December 30, 2017, 01:14:32 AM »

Model Number 302-20
Device Problems Fluid leak; Fracture; Mechanical issue
Event Date 08/12/2016
Event Type Malfunction
Event Description
Abraded openings were noted on the outer and the inner silicone tubing of the lead coils resulting in portions of the lead coils being exposed. A break was identified in the positive coil. Scanning electron microscopy images of the positive coil broken ends show what appears to be wear (flat surfaces) on the coils strands resulting in reduction of the diameter of the quadfilar coil strands up to the point of break. Also, scanning electron microscopy images of the lead coils at the suspected torn ends of the first portion of the returned lead show appearance suggesting that the coils were exposed to some type of electro-cautery tool (most likely at explant). One strand shows appearance suggesting that the coils were torn. 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 portions.

Event Description
Additional programming data was received.

Event Description
Patient underwent generator replacement on (b)(6) 2016 and the lead impedance at the time of implant was 687 ohms. The patient had a follow up visit on (b)(6) 2016 and after interrogation, the impedance shown was below 600 ohms, indicating low impedance (< 600 ohms). No known interventions were taken since the patient is receiving efficacy. The impedance will be monitored during each clinic visit.

Manufacturer Narrative

Event Description
Patient underwent lead revision surgery on (b)(6) 2016. The generator was tested with the resistor pin and the impedance was 3246 ohms. The lead wire was noticeably frayed and thus a new lead was implanted. Impedance on new lead when connected to the existing generator was 1029 ohms. The explanted lead was received on 11/28/2016. Analysis is underway but has not been completed to date.

Event Description
Additional programming data was received.

Manufacturer Narrative
Relevant tests/laboratory data, including dates; corrected data: (b)(6) 2016 09:19:46 am: diagvinitialprechange ¿ 483 ohms / diagvinitialpostchange ¿ 650 ohms / time of change detection ¿ (b)(6) 2016 16:17 estimated occurrence (implant (b)(6) 2016). Initial mdr inadvertently indicated the implant date to be (b)(6) 2016 instead of (b)(6) 2016.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=5934938
« Last Edit: December 30, 2017, 01:17:55 AM by dennis100 » Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #57 on: December 31, 2017, 01:41:12 AM »

Event Type Malfunction
Manufacturer Narrative

Manufacturer Narrative

Event Description
The patient represented within this mfr. Report is consistent with the patient represented by case # 1 within the article. The patient represented within mfr. Report 1644487-2012-00043 is consistent with the patient represented in the article by case #2. The patient represented within mfr. Report 1644487-2012-00030 is consistent with the patient represented in the article by case #4. The patient represented within mfr. Report 1644487-2016-02431 is consistent with the patient represented in the article by case #3. The patient represented within mfr. Report 1644487-2016-02432 is consistent with the patient represented in the article by case #5. The patient represented within mfr. Report 1644487-2016-02430 is consistent with the patient represented in the article by case #6.

Event Description
This patient's reason for revision was noted to be due to increased seizures and presumed battery death. The patient's lead was found to have a frayed outer sheath during the replacement surgery. The frayed outer sheath is what appears to have initiated the surgeon's repair of the lead.

Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.

Event Description
An article was found which contained information regarding the in situ repair of the vns lead product for 6 patients. It was noted that 5 of the 6 patients had low impedance values pre-operatively, and the 6th patient had normal impedance, but was found during the course of an elective generator replacement to have fractured electrode insulation. It was noted that where the lead insulation was noted to be compromised, it was irrigated with antibiotic-containing solution and dried with a gauze sponge. An appropriate length of silastic tubing that was sufficient to cover the damaged outer sheath with an additional 1-2 cm of tubing extending beyond the damage on either side was then cut. A fresh no. 11 surgical scalpel was used to make a lengthwise cut down one side of the catheter tubing, opening the catheter so it could be slipped over the damaged area. The cut catheter was then delicately placed around the damaged sheath and secured at multiple points with circumferential 2-0 silk ties until there was no longer a bend in the lead or exposed inner electrode wires. Cyanoacrylate glue was then introduced into the open side of the cut catheter as a sealant in and around the damaged external insulation, up to either end of the repair. The glue was then allowed to fully dry. At this point, the repaired segment was handled in a similar fashion to the undamaged wiring and reimplanted. It was noted that one patient had some internal wiring exposed. For this patient, the physician performed the same steps for the internal wiring and then performed the steps again for the external wiring. Follow up for the patients ranged from 12 to 87 months. All 6 patients have maintained unchanged seizures control. Two of the patients have since undergone generator replacement surgery due to end of vns generator battery life. Both of the patients remain with the original repaired leads and unchanged appropriate lead impedance. A search of the manufacturer's internal databases was able to confirm that 2 of the patients within the article have already been reported under mfr. Report # 1644487-2012-00030 and mfr. Report # 1644487-2012-00043. Since only initials, sex, and age of the patient at the time of surgery were provided in the article, it was unable to be determined whether the remainder of the patients' low impedance and subsequent surgeries had previously been reported to the manufacturer by the physicians. Attempts for additional information have been unsuccessful to date.

Event Description
Only one patient involved in the article was reported in this mfr. Report. The 5 remaining patients have been reported in the following mfr. Report #s: 1644487-2012-00030, 1644487-2012-00043, 1644487-2016-02430, 1644487-2016-02432, 1644487-2016-02431.

Manufacturer Narrative
Describe event or problem; corrected data: the information was inadvertently left off of the supplemental #03 mfr. Report.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6046497
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #58 on: January 01, 2018, 01:20:21 AM »

Model Number 302-20
Event Date 01/01/2012
Event Type Malfunction
Event Description
Analysis of the returned lead showed that both the inner and outer tubing were twisted/torn. No additional relevant information has been received to date.

Manufacturer Narrative
Analysis results. Previous supplemental mdr #1 inadvertently did not include the full analysis results, which were completed on 10/26/2016.

Event Description
The lead was received on 10/26/2016 and product analysis was performed. The electrodes were not returned, therefore a complete evaluation could not be performed on the entire lead product. During the visual analysis the quadfilar coils appeared to be stretched, wavy and spiraled, in some areas and a portion of the returned lead assembly appeared to be twisted and spiraled. During the visual analysis the connector pin and connector ring quadfilar coils appeared to be twisted together. Scanning electron microscopy was performed and the area was identified as having evidence of a stress induced fracture (rotational forces) which most likely completed the fracture with mechanical damage and no pitting. It is unknown if the breaks occurred while stimulation was present due to the absence of metal pitting on the broken coil wire surfaces. The abraded opening and slice mark found on the outer silicone tubing, most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids inside the outer silicone tubing. 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 deposit observed on the outer silicone tubing and identified the deposit as containing silicon, phosphorus, sodium, magnesium and calcium. Refer to attached eds sheet for additional information. With the exception of the twisted condition of the returned lead portion the condition of the returned lead portion is consistent with conditions 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 portion were performed, during the visual analysis, and no discontinuities were identified.

Manufacturer Narrative

Event Description
From clinic notes, it was reported the patient's battery was at near end of service and the patient was being referred for replacement. The physician also noted an increase in seizures and attributed the recent increase in patient seizures to the battery being at near end of service. Prior to the surgery, the patient's father stated he did not think the generator had been working, as he had also noted an increase in seizures for his son in the last 3-4 years. Additional information from the livanova case manager indicated the patient went in for generator replacement on (b)(6) 2016, but the surgery turned into a full replacement of the generator and the lead when low impedance and a compromised lead were discovered. During the revision, low impedance was discovered through indication from the new device being implanted. The physician visualized the lead and noticed it was all very twisted as though someone had been twisting it around for years. A review of the programming history data revealed dcdc code of 0 on (b)(6) 2007. A dcdc code of 0 can be observed for both normal impedance and for low impedance. Therefore it is possible that the low impedance may have present for some time prior to the surgery. The implant facility discarded the generator, and the lead has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6024741
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61989


« Reply #59 on: January 01, 2018, 01:21:32 AM »

Event Type Malfunction
Manufacturer Narrative
Age at time of event; corrected data: this information was inadvertently left off of the initial mfr. Report. Sex; corrected data: this information was inadvertently left off of the initial mfr. Report. Adverse event and/or product problem; corrected data: this information was inadvertently left off of the initial mfr. Report. Outcomes attributed to adverse event; corrected data: this information was inadvertently left off of the initial mfr. Report. Describe event or problem; corrected data: this information was inadvertently left off of the initial mfr. Report. Relevant tests/laboratory data; corrected data: this information was inadvertently left off of the initial mfr. Report.

Manufacturer Narrative
This information was inadvertently left off of the initial mfr. Report.

Event Description
The patient represented within mfr. Report 1644487-2016-02421 is consistent with the patient represented by case # 1 within the article. The patient represented within mfr. Report 1644487-2012-00043 is consistent with the patient represented in the article by case #2. The patient represented within mfr. Report 1644487-2012-00030 is consistent with the patient represented in the article by case #4. The patient represented within mfr. Report 1644487-2016-02431 is consistent with the patient represented in the article by case #3. The patient represented within this mfr. Report is consistent with the patient represented in the article by case #5. The patient represented within mfr. Report 1644487-2016-02430 is consistent with the patient represented in the article by case #6.

Event Description
The article reported the reason for revision for the patient related to case #5 was due to increased seizures and battery depletion. It was noted prior to surgery, the patient had normal impedance testing, but was found during the course of the surgery to have fractured insulation and underwent the lead repair prophylactically.

Manufacturer Narrative

Event Description
An article was found which contained information regarding the in situ repair of the vns lead product for 6 patients. It was noted that 5 of the 6 patients had low impedance values pre-operatively, and the 6th patient had normal impedance, but was found during the course of an elective generator replacement to have fractured electrode insulation. It was noted that where the lead insulation was noted to be compromised, it was irrigated with antibiotic-containing solution and dried with a gauze sponge. An appropriate length of silastic tubing that was sufficient to cover the damaged outer sheath with an additional 1-2 cm of tubing extending beyond the damage on either side was then cut. A fresh no. 11 surgical scalpel was used to make a lengthwise cut down one side of the catheter tubing, opening the catheter so it could be slipped over the damaged area. The cut catheter was then delicately placed around the damaged sheath and secured at multiple points with circumferential 2-0 silk ties until there was no longer a bend in the lead or exposed inner electrode wires. Cyanoacrylate glue was then introduced into the open side of the cut catheter as a sealant in and around the damaged external insulation, up to either end of the repair. The glue was then allowed to fully dry. At this point, the repaired segment was handled in a similar fashion to the undamaged wiring and reimplanted. It was noted that one patient had some internal wiring exposed. For this patient, the physician performed the same steps for the internal wiring and then performed the steps again for the external wiring. Follow up for the patients ranged from 12 to 87 months. All 6 patients have maintained unchanged seizures control. Two of the patients have since undergone generator replacement surgery due to end of vns generator battery life. Both of the patients remain with the original repaired leads and unchanged appropriate lead impedance. One of the patients will be reported within this mfr. Report. The remaining 5 patients within the article were reported in the following mfr. Reports: 1644487-2012-00030; 1644487-2012-00043; 1644487-2016-02421; 1644487-2016-02430; 1644487-2016-02431. Attempts for additional information have been unsuccessful to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6048638
Logged
Pages: 1 [2] 3 4 ... 10   Go Up
Print
Jump to: