Pages: 1 ... 8 9 [10]
 91 
 on: May 18, 2019, 01:17:37 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/01/2015
Event Type  Death   
Event Description
It was found through obituary search that this patient passed away. Review of the manufacturer's programming history found that the patient's generator had detected high impedance, as is captured in mfr. Report # 1644487-2017-03833. However, no adverse events were known associated with this high impedance event. No further relevant information has been received to date. The suspect product has not been received to date.
 
Event Description
It was reported by the patient's funeral home that the patient passed away due to sepsis from an enterococcus urinary tract infection. The patient's device was buried with the patient. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6577280

 92 
 on: May 18, 2019, 01:15:43 AM 
Started by dennis100 - Last post by dennis100
Model Number 102
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/09/2017
Event Type  Death   
Event Description
It was found during an obituary search that the patient had passed away. After follow up with the funeral home, it was stated that the cause of death was natural causes however the relation of the vns device was unknown. The funeral home also stated that the device was left implanted and buried with the patient. No additional relevant information has been received to date.
 
Event Description
It was reported by the physician that the cause of death for the patient was status (b)(6)likely provoked by an infection. This was stated not to be related to the vns device.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6577847

 93 
 on: May 18, 2019, 01:11:05 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/27/2017
Event Type  Injury   
Manufacturer Narrative
Device evaluation is not necessary as the event was not related to the performance of the device.
 
Event Description
It was reported by the surgeon's office the patient's vns generator pocket site had split open. The patient underwent explant surgery of both the lead and the generator due to the dehiscence and infection. Review of the device history records for the generator and the lead confirmed both devices had been sterilized prior to distribution.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6572351

 94 
 on: May 18, 2019, 01:09:31 AM 
Started by dennis100 - Last post by dennis100
Model Number 102R
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/09/2015
Event Type  Injury   
Event Description
It was reported by the patient that her generator was visible beneath her skin and that she was experiencing pain at her generator site because the skin over the generator was so thin. The patient mentioned that her device had been like this for two years. The patient's generator later migrated to her armpit and was causing her pain. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Initial report inadvertently listed aware date as 03/09/2017 instead of 03/10/2017.
 
Event Description
The nurse reported that the physician did not have an opinion about the protrusion or migration given the anatomical location the device had migrated to. The patient did not experience any trauma to the site that could have contributed to the generator protrusion and migration. The nurse mentioned that the protrusion was noticeable to the patient, but the patient never manipulated the generator. As such, the physician believed that the generator must have fallen down on its own. The physician planned to resolve the protrusion and migration during replacement surgery. The nurse indicated that the surgery was not required to preclude a serious injury and was for patient comfort. No further relevant information has occurred to date. No surgical intervention has occurred to date.
 
Manufacturer Narrative
Device evaluated by mfr? - device evaluation is not necessary as the reported events are not related to the functionality or delivery of therapy of the device.
 
Event Description
The patient underwent full revision surgery. The new generator was implanted in a different position to resolve the migration and protrusion that occurred with the now-explanted generator. No additional relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6452971

 95 
 on: May 18, 2019, 01:07:45 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2017
Event Type  Injury   
Event Description
It was reported the patient felt a lead pulling sensation in the neck and a sense of choking during stimulation when the vns was programmed to 0. 75ma. The physician explained that the patient did was able to tolerate 075ma for about a week back in (b)(6), but then he started feeling like he was choking consistently, and ended up going to the er. The er called the physician's office who instructed them they could tap the vns magnet over the patient's generator. The physician also noted she had tried every different combination of pulse width setting and frequency setting to attempt to get the patient's output current programmed about 0. 50ma. She attempted this during 3 different office visits. Attempts for additional relevant information have been unsuccessful to date.
 
Manufacturer Narrative
Serial #, lot #, exp. Date, and udi #, device manufacture date: this information was inadvertently left off of the initial mfr. Report.
 
Event Description
It was reported that the normal mode stimulation was programmed back on due to the patient experiencing an increase in seizures due to the loss of therapy from the disablement of the normal mode output current. The output currents were programmed to 0. 25ma for normal mode, 0. 375 for autostim and 0. 5 for magnet mode. Diagnostics were checked during the same visit and the impedance was within normal limits.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6451909

 96 
 on: May 18, 2019, 01:05:29 AM 
Started by dennis100 - Last post by dennis100
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/06/2016
Event Type  Injury   
Event Description
It was reported that the patient has been experiencing discomfort in throat with stimulation, dysphagia (not necessarily associated with stimulation), and pain on the roof of the mouth (not with stimulation) since the patient had the generator replaced. Patient's device was disabled due to these events a few months ago. Most events went away but the patient still experienced pain on the roof of the mouth. Patient did not experience these events prior to generator replacement. Patient had done well previously but is not seeing as much benefit with the auto stimulation as they would have liked. Patient would like to have the device explanted because of these events. No known explant surgery has not occurred to date.
 
Event Description
Patient's entire vns system was removed. The hospital was reported to discard all explants. The explanted devices have not been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6568156

 97 
 on: May 18, 2019, 01:04:47 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem High impedance
Event Date 05/09/2017
Event Type  Malfunction   
Event Description
Follow-up from the provider indicated the cause of the pain in the tooth could not be determined at the time, but was seen by the neurosurgeon. Review of the manufacturing records identified the generator met specifications prior to release.
 
Event Description
Lead revision surgery occurred. The explanted device was discarded by the explant facility.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6604673

 98 
 on: May 18, 2019, 01:04:08 AM 
Started by dennis100 - Last post by dennis100
Model Number 302-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 04/27/2017
Event Type  Injury   
Event Description
It was reported that the patient's device was really bothering her now, by causing neck pain, and that she wanted to have the device removed. She indicated that her physician also wanted her to get her device removed. No further relevant information has been received to date. No known surgical intervention has occurred to date.
 
Event Description
Follow up with the physician's office found that the patient hadn't had her device checked in awhile but the patient thought it was completely dead. Therefore, the physician's office indicated that the pain was due to presence of the device. They indicated that they did not refer the patient for surgery. The manufacturer's battery life calculator was unable to verify battery depletion. No known surgical intervention has 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=6586095

 99 
 on: May 18, 2019, 01:03:30 AM 
Started by dennis100 - Last post by dennis100
Model Number 103
Device Problem Insufficient Information
Event Date 01/01/2017
Event Type  Malfunction   
Event Description
A physician reported that a patient underwent a full replacement surgery due to pain in the chest and neck. The physician indicated that the device had not been working for a few months prior to the replacement. The system diagnostic test showed normal values and patient had an emg-based test that showed good values. No further relevant information has been received to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6600631

 100 
 on: May 18, 2019, 01:02:50 AM 
Started by dennis100 - Last post by dennis100
Model Number 300-20
Device Problem Fracture
Event Date 04/14/2017
Event Type  Malfunction   
Event Description
It was reported that during an office visit on high impedance was observed as a result of a diagnostic test. The settings were not changed at that time. The patient reported that for the past 1-2 weeks she had been experiencing an increase in seizures and left jaw discomfort. She also had been stuttering for the previous 2 days and the vns magnet was not working the same as before. The patient was referred for surgery to address the high impedance but no surgical interventions are known to have occurred to date.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6584365

Pages: 1 ... 8 9 [10]