ClaripulseClaripulse
MAUDE Lookup

Guides

FDA MAUDE DatabasePost-Market SurveillanceSafety Signal DetectionISO 14971 Risk ManagementAll guides →

More

BlogReports & ResearchWhy Claripulse?
LoginGet Early Access
ClaripulseClaripulse

Product

MAUDE LookupDashboard

Guides

FDA MAUDE DatabasePost-Market SurveillanceSafety Signal DetectionISO 14971 Risk ManagementAll guides

Learn

BlogReports & ResearchWhy 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 ManagementEMBLEM S ICD

EMBLEM S ICD Adverse Events: FDA MAUDE Data

Oscor Inc. · Implantable Cardioverter Defibrillator (ICD)

Total Reports

455

Reports (30d)

13

Active Signals

0

Open Recalls

0

Monthly Report Volume
Event Type Breakdown

What the reports describe · Claripulse analysis

Most commonly reported problems

1

S-ICD High Shock Impedance Measurements

subcutaneous implantable, impedance, shock impedance, ohms, electrode

4

reports

2

S-ICD Inappropriate Shock from Noisy Signals

subcutaneous, subcutaneous implantable, sensing vector, inappropriate, vector

3

reports

3

Inappropriate Shock from T-Wave Oversensing

shock, inappropriate shock, sensing vector, vector, oversensing

2

reports

4

S-ICD Inappropriate Shock Due to Oversensing

icd delivered, subcutaneous implantable, remains service, delivered inappropriate, inappropriate

2

reports

5

S-ICD Noise Oversensing Causing Shock

noise, subcutaneous implantable, inappropriate shock, data, inappropriate

1

reports

6

Inappropriate Shock from Noise Oversensing

noise, shock, sensing vector, inappropriate, vector

1

reports

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

Keep exploring

Related devices in CRM

CAPSUREFIX Novus

MEDTRONIC, INC. · 44,267 reports

→

EMBLEM S-ICD

BOSTON SCIENTIFIC CORPORATION · 37,350 reports

→

Sprint Quattro Secure S MRI SureScan

MEDTRONIC, INC. · 36,364 reports

→

CapSureFix Novus MRI SureScan

MEDTRONIC, INC. · 27,559 reports

→

Durata

ABBOTT (ST. JUDE MEDICAL) · 19,798 reports

→

Quadra Assura MP

ABBOTT (ST. JUDE MEDICAL) · 10,487 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.

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.