Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Skin Discoloration (2074); Swelling (2091); Discomfort (2330)
|
Event Date 04/19/2016 |
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 by the patient that the implantable cardiac monitor (icm) was inserted beneath the breast and now the icm has moved to the side and sits in a vertical position.The patient further reported the insertion site has a red mark and there is some feeling of discomfort.Additionally, there was swelling but that went away after implant.The icm remains in use.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
|