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Claria MRI CRT-D SureScan Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · CRT-Defibrillator (CRT-D) · First cleared Apr 2017 · 2 device variants grouped

Total Reports

1,553

Reports (30d)

10

Active Signals

1

Open Recalls

78

Monthly Report Volume

Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Premature Battery Depletion

resynchronization, defibrillator crt, battery, crt, therapy defibrillator

3

reports

2

System Explanted Due to Infection

defibrillator crt, crt, infection, patient complications, result event

3

reports

3

RA Lead Undersensing During Atrial Events

fibrillation, atrial, lead, atrial fibrillation, tachycardia

2

reports

4

Inappropriate Therapy for Atrial Tachycardia

crt, patient complications, tachycardia, ventricular tachycardia, result event

2

reports

5

RV Lead Oversensing and Pacing Inhibition

defibrillator crt, crt, lead, use, high

1

reports

6

Patient Reports Issues Post-Implant

result event, defibrillator crt, cardiac, crt, patient complications

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

Changepointcritical

Regulatory

FDA recalls for this device

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.

Class II

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

Althouse AD, et al. · Circulation. Arrhythmia and electrophysiology · 2022

Park KH, et al. · Korean circulation journal · 2016

Matteucci A, et al. · Journal of clinical medicine · 2021

Cunha PS, et al. · International journal of cardiology. Heart & vasculature · 2021

Citations indexed from PubMed.

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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.