Micra VR2 Adverse Events: FDA MAUDE Data

High Threshold and No Capture During Implant

implantable pulse, pulse generator, replaced implant, attempted used, ipg

High Thresholds and Pacing Loss

implantable pulse, patient complications, generator ipg, result event, ipg

Intraoperative Non-Capture and Recapture Failure

delivery, implantable pulse, intraoperative, leadless implantable, ipg

Cardiac Perforation and Effusion

cardiac, patient complications, tamponade, generator ipg, ipg

High Thresholds and Loss of Capture

implantable pulse, pulse generator, leadless implantable, generator ipg, ipg

Incorrect RTC Value at Manufacturing

daily measurements, clock, incorrect, leadless ipg, ipg