Percepta Quad CRT-P MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Pacemaker (CRT-P) · First cleared Mar 2011
Total Reports
1,438
Reports (30d)
30
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
Technical Issues with Lead Placement
technical, atrial, right, ventricular, lead
25
reports
Infection Leading to Device Explantation
infection, patient complications, complications, result event, explanted
23
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).
Evidence
Related research
Citations indexed from PubMed.
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