CAPSURE® SENSE 407445Recalls & reported problems

Medtronic, Inc. · LEAD 407445 CAPSURE SENSE PACING US · Class 3 · Implant

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports: 1
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885074200637), received between Apr 1, 2026 and Apr 1, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “High Capture Threshold” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

High Capture Threshold1
Unstable Capture Threshold1

Patient problems

Palpitations1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

InjuryApr 1, 2026High Capture Threshold; Unstable Capture Threshold
IT WAS REPORTED THAT THE PATIENT EXPERIENCED PALPITATIONS. IT WAS NOTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING DURING ATRIAL TACHYCARDIA/ ATRIAL FIBRILLATION (AT/AF) EVENTS RESULTING IN UNNECESSARY PACING AT TIMES AND FALSE TERMINATION OF EPISODES SAVED. IT WAS FURTHER NOTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH AND FLUCTUATING THRESHOLDS. THE RA AND RV LEADS WERE REPROGRAMMED AND REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Palpitations
MAUDE report 24752087 ↗

Device details

UDI-DI	`00885074200637`
Brand	CAPSURE® SENSE
Model	407445
Company	Medtronic, Inc.
Product code	NVN · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
Class	Class 3
FDA submission	P830061
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	Not in Commercial Distribution
Record updated	Mar 20, 2024

Device type (GMDN): Endocardial/interventricular septal pacing lead

An implantable wire with an electrode, insulated with non-conductive material except at its ends, which serves as an electrical conductor to transmit pacing impulses from an implanted pulse generator to the heart; it is not intended to conduct defibrillation impulses. It may transmit intrinsic electrical activity from the heart back to the pulse generator. The electrode end is normally placed through a vein to contact the endocardium where it is fixed, or to penetrate the myocardium of the interventricular septum adjacent to the HIS-Purkinje system; the other end is connected to the pulse generator. It may be impregnated with a steroid intended to reduce inflammation.

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All Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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