Model Number LNQ11 |
Device Problem
Appropriate Term/Code Not Available (3191)
|
Patient Problem
Hematoma (1884)
|
Event Date 11/27/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the implantable cardiac monitor (icm) patient experienced a haematoma of the right and left breast after implantation of the device.The patient was treated with an infusion.The icm remains in use.The patient is a participant in the symplicity af study.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.
|
|
Event Description
|
It was further reported that the hematoma is most probably due to anti-coagulation subscribed for icm implant procedure.
|
|
Search Alerts/Recalls
|