Model Number LNQ11 |
Device Problem
Over-Sensing (1438)
|
Patient Problem
Chest Pain (1776)
|
Event Date 04/17/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
This device was reported as included in the field action.Based on the information received and without the return of the product, it cannot be confirmed that this device performed as described in the field action.It is included in the field action in the abundance of caution.
|
|
Event Description
|
It was reported that the patient had chest pain and the implantable cardiac monitor (icm) exhibited oversensing.The device remains in use.No patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|