Serena Quad CRT-P MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
201
Reports (30d)
2
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Infection Leading to Device Explantation
infection, patient complications, complications, result event, explanted
2
reports
Technical Issues with Lead Placement
technical, atrial, right, ventricular, lead
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
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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