Primo MRI DR SureScan Adverse Events: FDA MAUDE Data
MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Jun 2018 · 2 device variants grouped
Total Reports
166
Reports (30d)
1
Active Signals
0
Open Recalls
82
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
Citations indexed from PubMed.
Keep exploring
Related devices in CRM
CAPSUREFIX Novus
MEDTRONIC, INC. · 46,344 reports
Sprint Quattro Secure S MRI SureScan
MEDTRONIC, INC. · 39,133 reports
EMBLEM S-ICD
BOSTON SCIENTIFIC CORPORATION · 39,062 reports
CapSureFix Novus MRI SureScan
MEDTRONIC, INC. · 29,710 reports
Durata
ABBOTT (ST. JUDE MEDICAL) · 20,458 reports
Quadra Assura MP
ABBOTT (ST. JUDE MEDICAL) · 10,671 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