EXCELLENCE+ Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead)
Total Reports
143
Reports (30d)
0
Active Signals
1
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
IPG Premature Battery Depletion
pulse, implantable pulse, pulse generator, generator ipg, ipg
2
reports
RA and RV Leads Exhibited Oversensing
exhibited oversensing, remain use, right ventricular, ventricular lead, oversensing
1
reports
RV Lead Undersensing Resulting in Syncope
event patient, patient complications, complications, experienced, result event
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
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,343 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,061 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,591 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,411 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,669 reports
Want automated safety signal detection?
Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.
Get Early AccessUnderstanding this data