Cobalt XT HF Quad CRT-D MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2020
Total Reports
2,255
Reports (30d)
60
Active Signals
0
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
50
reports
Inappropriate Therapy for Atrial Events
crt, therapy, complications, tachycardia, ventricular tachycardia
15
reports
Undersensing During Atrial Events
fibrillation, crt, atrial, lead, tachycardia
11
reports
Lead Integrity Alert for Oversensing
non sustained, crt, sustained, lead, use
8
reports
Premature Battery Depletion Observed
defibrillator crt, cardiac resynchronization, battery, crt, resynchronization therapy
8
reports
Lead Insertion Difficulty at Implant
defibrillator crt, cardiac resynchronization, crt, lead, therapy defibrillator
5
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.
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