RELIANCE 4-FRONT Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · Permanent Defibrillator Electrode (Lead) · First cleared May 2018 · 12 device variants grouped
Total Reports
7,970
Reports (30d)
143
Active Signals
0
Open Recalls
4
What the reports describe · Claripulse analysis
Most commonly reported problems
Gradual Rise in Shock Impedance Measurements
technical services, shock impedance, ohms, range, impedance measurements
45
reports
Lead Revision Due to Infection
explanted right, infection additional, effects, revision infection, lead revision
39
reports
Lead Replacement Due to Performance Anomaly
effects, dislodgement, reported right, additional adverse, new lead
33
reports
High Shock Impedance in CRT-D System
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, therapy defibrillator
26
reports
Implantable Lead Revision for Infection
implantable lead, effects, revision infection, reported implantable, lead revision
23
reports
Right Ventricular Lead Revision Due to Infection
explanted right, infection additional, revision infection, additional adverse, lead revision
23
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.
Evidence
Related research
Biventricular pacing and coronary sinus ICD lead implantation in a patient with a mechanical tricuspid valve replacement.
Srinivasan NT, et al. · Journal of cardiology cases · 2015
Precision in Action: Using Intracardiac Echocardiography for Targeted Removal of a Large Lead-Related Vegetation in a Patient With Infective Endocarditis.
Memon M, et al. · Journal of arrhythmia · 2025
A method for successfully implanting an implantable cardioverter-defibrillator wrapped with an expanded polytetrafluoroethylene sheet in a patient with metal allergy.
Morishita K, et al. · Journal of cardiology cases · 2023
Clinical performance of different DF-4 implantable cardioverter defibrillator leads.
Sarrazin JF, et al. · Pacing and clinical electrophysiology : PACE · 2018
Citations indexed from PubMed.
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