RESONATE HF CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2017
Total Reports
595
Reports (30d)
25
Active Signals
1
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
System Revision Due to Infection
crt, explanted cardiac, crt revision, reported crt, revision infection
12
reports
Inappropriate Anti-Tachycardia Pacing Delivery
crt, tachycardia, anti, delivered, atp
10
reports
High Out of Range Shock Impedance Alert
measurements, crt, lead, impedance, range
7
reports
Oversensing of Atrial Signals
crt, remains service, effects, technical services, services
6
reports
Device Explanted for Unspecified Reason
defibrillator crt, cardiac resynchronization, crt, therapy defibrillator, resynchronization therapy
3
reports
Explanted Due to ERI with Battery Issues
battery, additional information, resolve event, patient stable, explanted
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
Regulatory
FDA recalls for this device
Jul 7, 2022 · Open, Classified
There is potential for unanticipated software anomalies to occur when using the Model 2868 Application loaded on the 3120 ZOOM LATITUTDE programmer when communicating with certain Boston Scientific transvenous defibrillators.
Evidence
Related research
Reduction in Heart Failure Hospitalizations Through Real-World HeartLogicTM Alert Response ― A Multicenter Study in Japan ―
Takafumi Oka, et al. · Circulation Journal · 2026
Decongestive treatment adjustments in heart failure patients remotely monitored with a multiparametric implantable defibrillators algorithm
Federico Guerra, et al. · Clinical Cardiology · 2022
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 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