Quadra Allure MP Adverse Events: FDA MAUDE Data
ABBOTT (ST. JUDE MEDICAL) · CRT-Pacemaker (CRT-P) · First cleared Feb 2016 · 3 device variants grouped
Total Reports
1,695
Reports (30d)
14
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
High Impedance Leading to Device Explant
explanted, atrial, right, ventricular, lead
45
reports
Dislodged Left Ventricular Lead
left, lead, replaced, left ventricular, ventricular lead
1
reports
High Impedance with Device Still in Service
resulted, remain, monitored, implanted patient, time adverse
1
reports
High Impedance with No Adverse Effects
observed, reported pacemaker, atrial, recommended time, pacemaker recorded
1
reports
Under-Sensing on Implantable Cardioverter
patient consequences, consequences reported, implantable cardioverter, sensing, cardioverter defibrillator
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
Evidence
Related research
Citations indexed from PubMed.
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