Model Number MI2355A |
Device Problem
Device Operates Differently Than Expected (2913)
|
Patient Problems
Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)
|
Event Date 02/10/2017 |
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 during the leadless implantable pulse generator (ipg) system implant procedure the patient experienced pericardial effusion, and tamponade from perforation.Pigtail catheter implanted and effusion was drained.The leadless ipg system was removed.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 during leadless ipg implant attempt, tines were not deployed during attempt.Contrast dye was used during and before the deployment of the leadless ipg with three deployments in total.
|
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Search Alerts/Recalls
|