RESONATE HF CRT-D Adverse Events: FDA MAUDE Data
BOSTON SCIENTIFIC CORPORATION · CRT-Defibrillator (CRT-D) · First cleared May 2002
Total Reports
570
Reports (30d)
37
Active Signals
0
Open Recalls
1
What the reports describe · Claripulse analysis
Most commonly reported problems
CRT Revision Due to Infection
crt, explanted cardiac, crt revision, revision infection, crt explanted
12
reports
High Out of Range Impedance Measurements
crt, lead, impedance, range, impedance measurements
7
reports
Inappropriate ATP and Shock Delivered
crt, therapy, tachycardia, delivered, atp
5
reports
Loss of Capture on Left Ventricular Lead
crt, effects, loss capture, service, capture
4
reports
Unable to Interrogate Device
resynchronization, crt, remains service, resynchronization therapy, therapy defibrillator
3
reports
CRT Explanted for Unspecified Reason
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, crt explanted
3
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 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
Prediction of Heart Failure Events With the HeartLogic Algorithm: Real-World Validation
Jagmeet Singh, et al. · Journal of Cardiac Failure · 2023
Usefulness of Multisite Ventricular Pacing in Nonresponders to Cardiac Resynchronization Therapy
Samir Saba, et al. · The American Journal of Cardiology · 2021
Decongestive treatment adjustments in heart failure patients remotely monitored with a multiparametric implantable defibrillators algorithm
Federico Guerra, et al. · Clinical Cardiology · 2022
Clinical Pathways Guided by Remotely Monitoring Cardiac Device Data: The Future of Device Heart Failure Management?
Joanne Taylor, et al. · Arrhythmia & Electrophysiology Review · 2023
Reduction in Heart Failure Hospitalizations Through Real-World HeartLogic<sup>TM</sup> Alert Response ― A Multicenter Study in Japan ―
Takafumi Oka, et al. · Circulation Journal · 2026
Citations indexed from PubMed.
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