Micra VR2 Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Leadless Pacemaker · First cleared Apr 2016
Total Reports
749
Reports (30d)
38
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Loss of Capture and High Thresholds
implantable pulse, use leadless, pulse generator, leadless implantable, generator ipg
15
reports
Pacing Loss and High Thresholds
pulse, event patient, patient complications, leadless implantable, result event
12
reports
Placement Difficulty with Delivery System
pulse, deflection, delivery, pulse generator, attempted used
9
reports
Incorrect RTC Programming at Manufacturing
clock, incorrect, testing, data, internal
8
reports
Intraoperative Non-Capture and Deflection Issue
delivery, pulse, implantable pulse, pulse generator, leadless implantable
7
reports
Cardiac Perforation and Tamponade
pulse, implantable pulse, pulse generator, leadless implantable, generator ipg
6
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
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