Model Number LNQ11 |
Device Problem
Migration or Expulsion of Device (1395)
|
Patient Problems
Erosion (1750); Purulent Discharge (1812); Erythema (1840)
|
Event Date 01/11/2022 |
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) site was red and oozing.It was further reported that the icm had poked out of the skin and later fell out completely.The patient is participating in a clinical trial. 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 reported that the implantable cardiac monitor (icm) site was red and oozing.It was further reported that the icm had poked out of the skin and later fell out completely.The patient is participating in a clinical trial. no further patient complications have been reported as a result of this event.
|
|
Search Alerts/Recalls
|