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This system analyzes publicly available FDA MAUDE data. It does NOT provide medical advice. MAUDE data is de-identified — do not attempt re-identification. © 2026 Claripulse.

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MAUDE LookupCardiac Rhythm ManagementUnidentified MEDTRONIC, INC.

Unidentified MEDTRONIC, INC. Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator

Total Reports

1,339

Reports (30d)

37

Active Signals

1

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Lead Undersensing and Loss of Capture

lead remains, impedance, lead exhibited, possible, details

46

reports

2

Post-Implant Infection with Absorbable Envelope

absorbable envelope, absorbable, infection approximately, antibacterial, envelope

13

reports

3

Literature Batch: ICD Outcomes and Interventions

icd, crt, cardiac, intervention, patients

6

reports

4

Premature Battery Depletion in Pulse Generator

implantable pulse, pulse generator, explanted replaced, generator ipg, ipg

4

reports

5

Literature Batch: Leadless Device Complications

events, devices, leadless, patients, ipg

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

Evidence

Related research

Multimodal explainable artificial intelligence identifies patients with non-ischaemic cardiomyopathy at risk of lethal ventricular arrhythmias

Maarten Z H Kolk, et al. · Scientific Reports · 2024

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.