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Author Topic: High Impedance  (Read 649679 times)
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dennis100
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« Reply #7440 on: July 05, 2019, 07:19:06 PM »

Model Number 302-20
Device Problem High impedance
Event Date 05/30/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Patient was referred for generator replacement due to low battery. Prior to surgery impedance was noted to be high and the output current was low. The surgeon then proceeded to explant both the generator and lead. The surgeon noted that he could not find the vagus nerve during the surgery therefore the products were not replaced. It was noted that the patient had a small vagus nerve that was hard to identify and that the lead was not attached to the vagus nerve when the surgeon went to explant the device. The explanted lead and generator were received by product analysis. Product analysis has not been completed to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8728663
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dennis100
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« Reply #7441 on: July 05, 2019, 07:21:49 PM »

Model Number 302-20
Device Problem Fracture
Event Date 05/15/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was detected on the patient's generator. 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=8679622
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dennis100
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« Reply #7442 on: July 05, 2019, 07:23:44 PM »

Model Number 304-20
Device Problem High impedance
Event Date 05/13/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Patient presented with high lead impedance. Patient underwent generator replacement in (b)(6) 2019 and impedance was noted to be ok after replacement. The patient was referred for lead revision surgery. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8678531
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dennis100
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« Reply #7443 on: July 05, 2019, 07:24:36 PM »

Model Number 302-20
Device Problem Fracture
Event Date 04/12/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was detected on the patient's generator during a system diagnostic test. No known 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=8665115
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dennis100
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« Reply #7444 on: July 05, 2019, 07:25:40 PM »

Model Number 304-20
Device Problem High impedance
Event Date 05/22/2019
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
The physician reported that a patient is registering high impedance with system diagnostic testing. It was mentioned that both the output status and battery status were both registering as ok. In addition to the high impedance, the patient informed that they are not feeling the stimulation as much as they used to. The patient had ap and lateral chest and neck x-rays taken, which were reviewed by the surgeon. It was mentioned that the surgeon saw nothing on the patient's x-ray, and the ap and lateral chest and neck x-rays were sent to the manufacturer for review. No known surgical intervention has occurred to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8692299
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dennis100
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« Reply #7445 on: July 05, 2019, 09:55:06 PM »

Model Number 302-20
Device Problem Fracture
Event Date 06/05/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that during office visit, system diagnostics was performed and high impedance was found. The patient was referred for a lead revision. No surgical intervention has been reported to date. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8734598
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dennis100
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« Reply #7446 on: July 11, 2019, 12:30:20 AM »

Model Number 304-20
Device Problems Fracture; High impedance
Event Date 07/31/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a company representative that a vns patient's device has high impedance and needs a total revision. Clinic notes from a visit on (b)(6) 2018 provided that the device has very high impedance and is not delivering current. Additional relevant information has not been received to-date. No known surgery has occurred to-date.
 
Event Description
Full revision surgery occurred. The explant facility does not return devices to the manufacturer. Follow-up to the provider indicated the device was replaced due to a lead fracture.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7814541
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dennis100
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« Reply #7447 on: July 11, 2019, 12:31:29 AM »

Model Number 104
Device Problem High impedance
Event Date 01/09/2019
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A patient's explanted devices was returned to the manufacturer and it was later reported that the patient passed away, and is likely the reason the patient's generator was explanted and returned to the manufacturer. Product analysis (pa) was completed and reviewed for the patient's devices. Per the device history data, the patient's device experienced a change from normal to high impedance on (b)(6) 2019. There were no other anomalies found with the generator. The patient was reported to have passed away in (b)(6), however the patient's exact date of death and explant date are both unknown, and therefore it cannot be confirmed that the patient's device did not have high impedance prior to death/explant. Lead pa revealed no anomalies with the returned portion. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8684700
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dennis100
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« Reply #7448 on: July 14, 2019, 03:54:37 AM »

Device Problem Fracture
Event Date 08/15/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A periodic history review was performed and noted a high impedance event on (b)(6) 2016. The device was interrogated and a system diagnostic was performed indicating a limit/high/7/no. A final interrogation was performed. The patient was unknown. Another periodic history review was performed and noted a high impedance event on (b)(6) 2017 on a separate device. Multiple diagnostics were performed indicating high impedance. One system diagnostics showed ok impedance, and then one final system diagnostics was performed indicating high impedance. The patient was unknown. Follow up was performed with the nurse who was indicated to be the user of the programming system interrogating the devices. It was noted that both devices were for the same patient and that the patient was implanted with the first generator in (b)(6) 2008, and the device was replaced on (b)(6) 2017. No lead revision had been performed for the high impedance, and the system remained implanted, turned off. Lead information was unknown. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7811308
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dennis100
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« Reply #7449 on: July 14, 2019, 03:55:23 AM »

Model Number 302-20
Device Problem Fracture
Event Date 07/10/2017
Event Type  Malfunction   
Manufacturer Narrative

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

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7812887
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dennis100
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« Reply #7450 on: July 14, 2019, 03:56:16 AM »

Model Number 302-20
Device Problem Fracture
Event Date 01/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Patient's mood has declined per the physician and patient could not feel stimulation when output current was increased from 2 ma to 3 ma. Upon performing system and normal diagnostics, high impedance was observed. These high lead impedance readings on both diagnostics are indicative of a lead fracture. No known surgical interventions have occurred to date to replace the lead.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7810279
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dennis100
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« Reply #7451 on: July 14, 2019, 03:56:59 AM »

Device Problem High impedance
Event Date 08/22/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was found via a programming history database periodic review that high impedance was present on this patient's device. Additional information was received from the patient¿s neurologist stating that they were aware of the high impedance for this patient, and believed that the reason for the high impedance was due to scarring tissue around the lead electrodes. Intervention was taken which included replacing both the lead and generator. The products have not been received by the manufacturer to date. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7806841
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dennis100
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« Reply #7452 on: July 14, 2019, 03:58:29 AM »

Model Number 304-20
Device Problems Fracture; Mechanical Problem; Device Contamination with Body Fluid
Event Date 02/18/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
High impedance on the patient's device was detected through a periodic review of the manufacturer's programming history database. 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=7814165
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dennis100
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« Reply #7453 on: July 14, 2019, 03:59:12 AM »

Model Number 302-20
Device Problem Fracture
Event Date 02/13/2015
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Review of available programming history showed that high impedance was observed for the device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7815003
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dennis100
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« Reply #7454 on: July 14, 2019, 04:00:16 AM »

Model Number 304-20
Device Problem High impedance
Event Date 12/06/2016
Event Type  Malfunction   
Manufacturer Narrative

Event Description
A periodic review of the manufacturer's programming history database noted a system diagnostic test performed showing high impedance and low output current status. All subsequent diagnostics seen and performed on the same day showed faulted diagnostics. No other programming anomalies were noted. Device history records were reviewed indicating that both the generator and lead passed all quality inspections prior to distribution. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7814058
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dennis100
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« Reply #7455 on: July 14, 2019, 04:01:17 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/03/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Per a periodic review of the manufacturer's programming history database, system diagnostics detected a high impedance event on the patient's device. No further relevant information has been received to date. No known relevant surgical intervention has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7813670
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dennis100
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« Reply #7456 on: July 14, 2019, 04:02:04 AM »

Model Number 302-UNK
Device Problem Fracture
Event Date 01/16/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
An instance of high impedance was detected through a periodic review of the manufacturer's programming history database. No further relevant information has been received to date. No known relevant surgical intervention.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7813441
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dennis100
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« Reply #7457 on: July 14, 2019, 04:02:58 AM »

Model Number 302-UNK
Device Problem High impedance
Event Date 10/24/2016
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Per a periodic review of the manufacturer's programming history database, system diagnostics detected a high impedance event on the patient's device on (b)(6) 2016. The next available diagnostics from (b)(6) 2017 showed that the patient's high impedance had resolved. No further relevant information has been received to date. No known relevant surgical intervention has occurred to date.
 
Event Description
It was reported that the patient had several instances of chinese traditional massage for seizures in the weeks prior to high impedance being detected. No known 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=7813952
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dennis100
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« Reply #7458 on: July 14, 2019, 04:04:04 AM »

Model Number 300-20
Device Problem Fracture
Event Date 07/30/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
High impedance was observed during patient's clinic visit. The generator and lead were implanted for more than 2 years. The physician referred for generator and lead replacement. No known surgical interventions have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7815260
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dennis100
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« Reply #7459 on: July 14, 2019, 04:04:49 AM »

Model Number 300-20
Device Problem Fracture
Event Date 05/19/2017
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
Review of available programming history indicates that high impedance was observed for patient's device. A system diagnostic was then performed that showed in high impedance. Further follow up indicates that the patient passed away. The death is reported in mfr. Report #1644487-2018-01511.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7824212
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dennis100
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« Reply #7460 on: July 16, 2019, 10:57:37 PM »

Model Number 304-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 08/07/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance was found on the patient's device. The patient's generator was disabled due to the high impedance and the patient was referred for surgery. No relevant surgical intervention is known to have occurred 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=7912479
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dennis100
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« Reply #7461 on: July 16, 2019, 10:58:51 PM »

Model Number 304-20
Device Problem Fracture
Event Date 08/23/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that a patient¿s vns device was found to have high impedance. X-rays were ordered, but have not been reviewed by the manufacturer. No known surgery has occurred to-date. Additional relevant information has not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7910748
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dennis100
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« Reply #7462 on: July 16, 2019, 10:59:37 PM »

Model Number 302-20
Device Problem Fracture
Event Date 04/01/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
An implant card was received noting that the patient's lead was replaced due to high impedance. It was reported that the high impedance was first seen in april, and that the explanted lead was discarded after replacement. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7912498
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