Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Pain (1994); Discomfort (2330)
|
Event Date 07/11/2016 |
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' implantable cardiac monitor (icm) shifted downward and they had discomfort and pain in the left arm.The device was removed.No further 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
|