CAPSUREFIX Novus Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead) · First cleared Aug 1996 · 8 device variants grouped
Total Reports
44,929
Reports (30d)
662
Active Signals
7
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Undersensing Leading to Patient Complications
event patient, patient complications, patient experienced, result event, ventricular lead
92
reports
Far Field R-Wave Oversensing
exhibited far, ffrw, wave ffrw, field wave, ffrw oversensing
60
reports
Undersensing Leading to Unnecessary Pacing
termination, pacing times, resulting unnecessary, tachycardia atrial, undersensing resulting
55
reports
Undersensing During AF Events
termination, exhibited sensing, tachycardia atrial, atrial fibrillation, fibrillation stored
49
reports
Atrial Lead Undersensing During AF
tachycardia atrial, resulting termination, detected events, progress lead, atrial fibrillation
45
reports
High Thresholds During Implant Attempt
pacing lead, attempted, lead attempted, used replaced, replaced implant
37
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
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 37,761 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,430 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,090 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 19,969 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,531 reports
LINQ II
MEDTRONIC, INC. · 9,526 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. 7 active signals detected right now.
Get Early AccessUnderstanding this data