Percepta Quad CRT-P MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
1,392
Reports (30d)
24
Active Signals
2
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Failure with Device Explanted
explanted, pacing, right, ventricular, lead
44
reports
Battery High Impedance with Device Replaced
device explanted, replaced, additional adverse, explanted replaced, explanted
1
reports
Battery High Impedance with Service Recommendations
battery condition, recommended adverse, service time, service cardiac, capacity data
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Regulatory
FDA recalls for this device
Apr 6, 2021 · Open, Classified
There is a SmartSync software issue that results in an overestimation in the displayed longevity of these devices during an approximate 6-month window of time before the device triggers its Recommended Replacement Time (RRT).
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