Model Number LNQ11 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Erosion (1750); Cellulitis (1768)
|
Event Date 12/08/2016 |
Event Type
Injury
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient had pseudomonas cellulitis.It was also noted that there was partial expulsion and erosion through the pocket.The implantable cardiac monitor (icm) was explanted and not replaced.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
Product event summary: the device was returned and analyzed.Analysis was performed and no anomalies were found.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
It was reported that the patient had pseudomonas cellulitis.It was also noted that there was partial expulsion and erosion through the pocket.The implantable cardiac monitor (icm) was explanted and not replaced.No further patient complications have been reported as a result of this event.
|
|
Manufacturer Narrative
|
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|