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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 ManagementCapsureSP Novus

CapsureSP Novus Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Permanent Pacemaker Electrode (Lead), Permanent Defibrillator Electrode (Lead) · First cleared Sep 1986 · 2 device variants grouped

Total Reports

369

Reports (30d)

0

Active Signals

2

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

Rising Impedance in Ventricular Lead

impedance, high impedance, impedance lead, rising, ventricular lead

2

reports

2

Abrupt Impedance Changes in RV Lead

event patient, patient complications, reported right, patient experienced, result event

1

reports

3

Patient Death Post IPG Implant

icd, days, patient experienced, implantable, ipg

1

reports

4

Under Sensing in Ventricular Lead

episodes, wave, ventricular lead, oversensing lead, exhibited sensing

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

Disproportionate reportinghighDisproportionate reportingmedium

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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.

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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.