LEAD Adverse Events: FDA MAUDE Data
BIOTRONIK SE & Co. KG · Permanent Defibrillator Electrode (Lead)
Total Reports
101
Reports (30d)
0
Active Signals
0
Open Recalls
0
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Capped for Performance Issue
lead capped, effects, service, additional adverse, performance
2
reports
Gradual Rise in Shock Impedance
remains service, technical services, services, service adverse, gradual
1
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 45,538 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 38,198 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 37,963 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 28,620 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,141 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,574 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.
Get Early AccessUnderstanding this data