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ACHIEVE Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Catheter, Electrode Recording (EP Diagnostic) · First cleared Mar 2011 · 2 device variants grouped

Total Reports

1,337

Reports (30d)

8

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Packaging Defect Causing Catheter Breakage

achieve, replacement, material, replaced procedure, packaging

10

reports

2

Cardiac Tamponade from Catheter Kinking

pericardial effusion, tamponade, effusion, pericardial, pericardiocentesis

4

reports

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

Evidence

Related research

Transvenous Lead Extraction in a Real-World Cohort: Clinical Characteristics, Outcomes, and Performance of the SAFeTY Score.

Racman M, et al. · Journal of clinical medicine · 2026

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.

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How a safety signal is detected

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

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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.