ClaripulseClaripulse
MAUDE LookupResourcesBlog
LoginGet Early Access
ClaripulseClaripulse

Product

MAUDE LookupDashboard

Guides

FDA MAUDE DatabasePost-Market SurveillanceSignal Detection

Learn

BlogResourcesWhy Claripulse?

Legal

Privacy PolicyTerms of Service

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.

Back to Cardiac Rhythm Management
MAUDE LookupCardiac Rhythm ManagementMEDTRONIC LEAD

MEDTRONIC LEAD Adverse Events: FDA MAUDE Data

MEDTRONIC, INC. · Implantable Pacemaker Pulse Generator

Total Reports

502

Reports (30d)

18

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

40

reports

2

Literature Batch: Leadless Device Complications

events, devices, leadless, patients, ipg

14

reports

3

Literature Batch: ICD Outcomes and Interventions

icd, crt, cardiac, intervention, patients

7

reports

4

Premature Battery Depletion in Pulse Generator

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

3

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

Lead integrity alert algorithm decreases inappropriate shocks in patients who have Sprint Fidelis pace-sense conductor fractures.

Kallinen LM, et al. · 2010

Towards eradication of inappropriate therapies for ICD lead failure by combining comprehensive remote monitoring and lead noise alerts.

Ploux S, et al. · 2018

A Novel Quadripolar Active Fixation Left-Ventricular Pacing Lead for Cardiac Resynchronization Therapy: Initial United Kingdom Experience.

Chapman M, et al. · 2019

Implant experience with unipolar polyurethane pacing leads.

Byrd CL, et al. · 1983

Citations indexed from PubMed.

Keep exploring

Related devices in CRM

CAPSUREFIX Novus

MEDTRONIC, INC. · 43,528 reports

→

EMBLEM S-ICD

BOSTON SCIENTIFIC CORPORATION · 36,855 reports

→

Sprint Quattro Secure S MRI SureScan

MEDTRONIC, INC. · 36,335 reports

→

CapSureFix Novus MRI SureScan

MEDTRONIC, INC. · 27,017 reports

→

Durata

ABBOTT (ST. JUDE MEDICAL) · 19,619 reports

→

Quadra Assura MP

ABBOTT (ST. JUDE MEDICAL) · 10,450 reports

→

Want automated safety signal detection?

Claripulse monitors these devices weekly and detects anomalies using 6 statistical methods — spike, trend, changepoint, peer-outlier, and more. 1 active signal detected right now.

Get Early Access

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.