Cobalt DR MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020 · 2 device variants grouped
Total Reports
919
Reports (30d)
38
Active Signals
4
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate ATP and Shock Delivered
svt, tachycardia svt, tachycardia, ventricular tachycardia, detected
15
reports
ICD Explanted Due to Infection
infection, event patient, patient complications, event implantable, patient experienced
4
reports
Oversensing / Icd Remains / Noise
noise, icd remains, alert lia, icd exhibited, oversensing
4
reports
ICD Explanted for Pocket Infection
infection, patient complications, pocket, event implantable, icd explanted
4
reports
Integrity / Lia / Alert Lia
integrity alert, lead integrity, alert lia, lia, integrity
3
reports
Impedance / Ventricular Lead / Pacing Impedance
lead remains, pacing impedance, impedance, high, ventricular lead
3
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
Oct 29, 2025 · Open, Classified
There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.
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
The development of the extravascular defibrillator with substernal lead placement: A new Frontier for device‐based treatment of sudden cardiac arrest
Amy E. Thompson, et al. · Journal of Cardiovascular Electrophysiology · 2022
An intuitive method to reduce the defibrillation threshold: a case report
Hayyan Asim Chaudry, et al. · European Heart Journal - Case Reports · 2023
Citations indexed from PubMed.
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