Cobalt DR MRI SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020
Total Reports
729
Reports (30d)
20
Active Signals
1
Open Recalls
82
What the reports describe · Claripulse analysis
Most commonly reported problems
Inappropriate ATP and Shock Delivery
svt, fibrillation, tachycardia, ventricular tachycardia, detected
8
reports
Potential EMI Affecting ICD Function
noise, implantable cardioverter, episode, cardioverter defibrillator, defibrillator icd
3
reports
ICD Explanted Due to Infection
infection, event patient, patient complications, defibrillator icd, result event
3
reports
RA Lead Undersensing During Atrial Events
fibrillation, atrial, atrial fibrillation, tachycardia, detected
3
reports
RV Lead Integrity Alert Triggered
integrity alert, lead integrity, alert lia, lia, integrity
2
reports
Pocket Infection Leading to Explant
implantable cardioverter, infection, pocket, cardioverter defibrillator, defibrillator icd
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
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
Patel AS, et al. · HeartRhythm case reports · 2021
Sumitomo N, et al. · Heart and vessels · 2010
Chinnadurai T, et al. · Transplantation direct · 2022
Brodine WN, et al. · The American journal of cardiology · 2005
Rosman L, et al. · Journal of the American Heart Association · 2021
Citations indexed from PubMed.
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