Pages: 1 ... 24 25 [26]   Go Down
Print
Author Topic: Chest Pain  (Read 229575 times)
0 Members and 4 Guests are viewing this topic.
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61935


« Reply #750 on: May 11, 2019, 03:50:44 AM »

Model Number 1000
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2018
Event Type  Injury   
Event Description
It was reported that the patient experienced pain at generator site following their generator replacement surgery. The patient was referred for generator re-positioning surgery due to their discomfort. It was also reported that the patient's discomfort was preventing them from having a mammogram due to possible breast cancer and that the vns generator had migrated to the areola, causing the discomfort. 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=8527920
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61935


« Reply #751 on: May 11, 2019, 03:51:18 AM »

Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 03/18/2019
Event Type  Injury   
Event Description
It was reported that a patient was set to have a generator replacement for an unknown reason. One good faith attempt has been made to gather the reason for replacement and the surgeon reported that the replacement was due to chest pain at the generator site. 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=8529751
Logged
dennis100
Moderators
Hero Member
*****

Karma: +24/-0
Offline Offline

Posts: 61935


« Reply #752 on: May 18, 2019, 01:29:39 AM »

Model Number 102
Event Date 09/08/2010
Event Type  Injury   
Event Description
Reporter indicated a vns pt was hospitalized for evaluation of vns generator migration and painful stimulation that was occurring in the pt's left arm and chest at the generator site. The vns was to be disabled. The pt has had no trauma and does not manipulate the vns. Attempts for further information are in progress.

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=1869526
Logged
Pages: 1 ... 24 25 [26]   Go Up
Print
Jump to: