Pages: 1 ... 247 248 [249] 250 251 ... 256   Go Down
Print
Author Topic: High Impedance  (Read 731560 times)
0 Members and 18 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« 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
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7463 on: July 20, 2019, 10:05:15 PM »

Model Number MODEL 3000
Device Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 10/18/2018
Event Type  Malfunction   
Manufacturer Narrative
D. Suspect device software version: version 1. 5. 2. 1.
 
Event Description
It was reported that high impedance was detected on a patient's model 102 generator with the m3000 version 1. 5. 2. 1 programming system. It was previously determined through in-house testing that, for model 102/102r generators programmed to output currents > 1ma, system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5. 2. 1 software would display a false high impedance. The cause of these false high impedance messages was a software error on m3000 v1. 5. 2. 1 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. It was determined that m102/102r system diagnostics functioned as expected when the generator was programmed to 0 ma and provided a true impedance value. When the patient¿s generator was programmed to 0 ma, system diagnostics were ok; therefore, the high impedance originally observed was determined to be a false result. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8062747
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7464 on: July 20, 2019, 10:05:58 PM »

Model Number 300-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 10/09/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that high impedance and low output current was detected on the patient's vns. The patient had been having an increase in seizures due to this device issue. 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=8030900
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7465 on: July 20, 2019, 10:06:41 PM »

Model Number MODEL 3000
Device Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 09/26/2018
Event Type  Malfunction   
Manufacturer Narrative
Suspect device software version: version 1. 5. 2. 1.
 
Event Description
It was reported that high impedance was observed on the patient's m102 vns using a vns programming tablet with m3000 v1. 5. 2. 1 software. However, upon running diagnostics after changing the vns output current to 0. 00 ma, there was no high impedance present. There was no resulting treatment decision affected by this event. This issue was duplicated with in-house testing. For model 102/102r generators programmed to output currents greater than 1. 00 ma , it was observed that system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5 software would display a false high impedance. It was communicated to the patient¿s physician that the high impedance observed on the m3000 v1. 5. 1. 2 software was false. It was determined that the cause of this false high impedance message was a software error on m3000 v1. 5. 1. 2 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. It was determined that m102/102r system diagnostics functioned as expected when the generator was programmed to 0 ma and provided a true impedance value. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=7980531
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7466 on: July 20, 2019, 10:07:22 PM »

Model Number 304-20
Device Problem High impedance
Event Date 10/26/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported by a company representative that an implanting physician had seen high impedance while performing a system diagnostic test. As a result, the patient was referred for lead revision. 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=8087460
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7467 on: July 20, 2019, 10:08:08 PM »

Model Number 106
Device Problem High impedance
Event Date 10/05/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
A representative interrogated a patient's device and found it to have high impedance. It was reported that the x-rays indicated potential pin insertion issues, however pin insertion was not confirmed as the cause of high impedance. The patient's generator was replaced and after surgery, impedance was within normal limits. No additional or relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8023931
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7468 on: July 23, 2019, 12:25:36 AM »

Model Number 302-20
Device Problem Fracture
Event Date 09/28/2018
Event Type  Malfunction   
Manufacturer Narrative
 
Event Description
It was reported that the patient had high impedance, low output current, and pain with stimulation. The patient's device was disabled. The patient's generator was also reported to be prematurely depleting, which is reported in mfr report #1644487-2018-02345. The patient's lead and generator were replaced. The devices have not been received into 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=8180482
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 64492


« Reply #7469 on: July 23, 2019, 12:26:30 AM »

Model Number MODEL 3000
Device Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 11/08/2018
Event Type  Malfunction   
Manufacturer Narrative

Event Description
It was reported that high impedance was detected on this patient's model 102 generator using the m3000 version 1. 5. 2. 1 programming system. It was previously determined through in-house testing that, for model 102/102r generators programmed to output currents > 1ma, system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5. 2. 1 software would display a false high impedance. The cause of these false high impedance messages was a software error on m3000 v1. 5. 1. 2 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current >0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. The patient received a generator replacement due to battery depletion, and after the generator replacement to a m106 device, lead impedance was stated to be ok. The explant facility historically is a no return site and discards explanted products in surgery. No other relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=8124101
Logged
Pages: 1 ... 247 248 [249] 250 251 ... 256   Go Up
Print
Jump to: