RELIANCE 4-FRONT Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared Aug 1993
Total Reports
3,585
Reports (30d)
101
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Lead Revision Due to Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
20
reports
Gradual Rise in Shock Impedance
impedance measurements, measurements, remains service, shock impedance, ohms
19
reports
Lead Replaced for Performance Anomaly
reported right, product performance, successfully, additional adverse, new lead
16
reports
CRT Lead High Shock Impedance Alert
resynchronization, cardiac resynchronization, crt, therapy, service
10
reports
ICD High Shock Impedance Measurements
measurements, icd, shock, shock impedance, range shock
10
reports
Right Lead Revision for Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
9
reports
Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.
Regulatory
FDA recalls for this device
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Jul 24, 2025 · Open, Classified
Affected lead models may experience gradually rising LVSI measurements in association with calcification of the defibrillation lead coils. The issue may lead to early lead replacement. Most serious harm is death or need for cardiac resuscitation.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Sep 30, 2022 · Open, Classified
There is an incorrect manufacturing date/timestamp within the software which causes an inaccurate display of battery capacity.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,089 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 38,723 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 38,006 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,057 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,299 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,625 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