Cobalt HF Quad CRT-D MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2020
Total Reports
952
Reports (30d)
14
Active Signals
1
Open Recalls
78
What the reports describe · Claripulse analysis
Most commonly reported problems
CRT Explanted Due to Infection
resynchronization, crt, infection, patient complications, result event
5
reports
Premature Battery Depletion Observed
defibrillator crt, cardiac resynchronization, battery, crt, resynchronization therapy
5
reports
Inappropriate Therapy for Atrial Events
crt, therapy, complications, tachycardia, ventricular tachycardia
5
reports
Undersensing During Atrial Events
fibrillation, crt, atrial, lead, tachycardia
2
reports
CRT Explanted for Unspecified Reason
defibrillator crt, cardiac resynchronization, crt, resynchronization therapy, crt explanted
2
reports
Oversensed Signals Inhibiting Pacing
defibrillator crt, cardiac resynchronization, crt, therapy defibrillator, resynchronization therapy
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
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
Cost‐effectiveness analyses to assess the value of reactive atrial‐based anti‐tachycardia pacing for patients with pacemakers and defibrillators: An Australian private healthcare system perspective
Adam Gordois, et al. · Journal of Arrhythmia · 2025
Crossley GH, et al. · Pacing and clinical electrophysiology : PACE · 2019
Gould J, et al. · Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal of the working groups on cardiac pacing, arrhythmias, and cardiac cellular electrophysiology of the European Society of Cardiology · 2022
Brown JR, et al. · ESC heart failure · 2020
Citations indexed from PubMed.
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