Viva XT CRT-D Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared May 2014
Total Reports
944
Reports (30d)
1
Active Signals
0
Open Recalls
78
What the reports describe · Claripulse analysis
Most commonly reported problems
Premature Battery Depletion Observed
defibrillator crt, cardiac resynchronization, battery, crt, resynchronization therapy
2
reports
Inappropriate Therapy for Atrial Events
crt, therapy, complications, tachycardia, ventricular tachycardia
1
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
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Apr 16, 2024 · Open, Classified
Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.
Evidence
Related research
First Demonstration of Cardiac Resynchronization Therapy Defibrillator Service Life Exceeding Patient Survival in a Heart Failure with Reduced Ejection Fraction Cohort
Jeffrey L. Williams, et al. · Journal of Innovations in Cardiac Rhythm Management · 2020
Protecting the most vulnerable during COVID-19 and beyond: a case report on the remote management of heart failure patients with cardiac implantable electronic devices
Fozia Ahmed, et al. · European Heart Journal - Case Reports · 2020
Citations indexed from PubMed.
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