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Cobalt DR MRI SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Cardioverter Defibrillator (ICD) · First cleared Apr 2020

Total Reports

671

Reports (30d)

7

Active Signals

1

Open Recalls

82

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Patient Reported Unwarranted Shock

icd remains, event patient, patient complications, use, result event

3

reports

2

RA Lead Exhibited Undersensing During AT/AF

atrial, undersensing, tachycardia, ventricular tachycardia, detected

2

reports

3

ICD Explanted Due to Pocket Infection

infection, patient complications, pocket, icd explanted, result event

2

reports

4

ICD Delivered Inappropriate ATP for SVT

tachycardia, ventricular tachycardia, pacing atp, anti tachycardia, atp

2

reports

5

ICD Explanted Due to Patient Infection

infection, event patient, patient complications, icd explanted, result event

2

reports

6

ICD Delivered Inappropriate ATP for AF

anti tachycardia, atp, tachycardia pacing, fibrillation, tachycardia

2

reports

Problem groupings are generated by Claripulse from report narrative text. They summarize what reporters wrote, not adjudicated root cause.

Detection

Active safety signals

Disproportionate reportinghigh

Regulatory

FDA recalls for this device

Class II

Oct 29, 2025 · Open, Classified

There is a potential for delayed time to high-voltage (HV) therapy should a rare sequence of events occur.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

Class II

Apr 16, 2024 · Open, Classified

Potential for manufacturing defect. Weld crack led to devices failing at the leak check step in manufacturing.

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Understanding this data

What FDA MAUDE data does and does not tell you

How these reports are filed, why raw counts mislead, and the limits to know before drawing conclusions.

How a safety signal is detected

What the "Active Signals" count above means and the methods that separate a real signal from noise.

Disclaimer: This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified. Do not attempt re-identification. Report counts may differ from the FDA's MAUDE search due to processing cadence and deduplication. Data is updated weekly.