Quadra Allure MP Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Pacemaker (CRT-P) · First cleared May 2004
Total Reports
1,229
Reports (30d)
21
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Technical Issues with Lead Placement
technical, atrial, right, ventricular, lead
28
reports
Infection Leading to Device Explantation
infection, patient complications, complications, result event, explanted
11
reports
High Impedance Capacity Data Observed
observed, reported pacemaker, device replacement, pacemaker recorded, capacity data
4
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Detection
Active safety signals
Evidence
Related research
Citations indexed from PubMed.
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