Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Purulent Discharge (1812); Unspecified Infection (1930)
|
Event Date 08/05/2018 |
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 infection and "pus" at the implant site.The icm was "sticking out" from the skin and the patient removed the device.The icm is no longer in use.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|