CAPSURE® SENSE 407352Recalls & reported problems

Medtronic, Inc. · LEAD 407352 CAPSURE SENSE PACING US · Class 3 · Implant

Adverse event reports: 4
Deaths reported: 0
Injuries reported: 2
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885074200613), received between Dec 7, 2017 and May 1, 2024 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Over-Sensing” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Reports received per month

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

Most reported problems

Device problems

Over-Sensing2
Appropriate Device Problem Term/Code Not Available1
Break1
Pacing Problem1

Patient problems

No Clinical Signs, Symptoms or Conditions2
Device Overstimulation of Tissue1
No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

MalfunctionMay 1, 2024Over-Sensing; Pacing Problem; Over-Sensing; Pacing Problem
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING, INAPPROPRIATE PACING AND SHORT VENTRICULAR INTERVAL COUNTS. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19220847 ↗
InjuryDec 11, 2023Break; Break
IT WAS REPORTED DURING A ROUTINE GENERATOR CHANGE, THAT THE PHYSICIAN DAMAGED THE LEAD INSULATION. THE LEAD WAS CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18300668 ↗
InjuryMay 13, 2021Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available
IT WAS FURTHER REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD WAS REPROGRAMMED. IT WAS NOTED THAT THE STIM WAS ONLY PRESENT VERY OCCASIONALLY FROM CERTAIN MOVEMENTS AND LED TO MINIMAL DISCOMFORT.
Patient problems: Device Overstimulation of Tissue
MAUDE report 11819037 ↗
MalfunctionDec 7, 2017Over-Sensing; Over-Sensing
IT WAS REPORTED THAT A REMOTE TRANSMISSION SHOWED SUSPECTED RIGHT VENTRICULAR (RV) LEAD OVERSENSING ON RECORDED VENTRICULAR HIGH RATE EPISODES. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7091239 ↗

Device details

UDI-DI	`00885074200613`
Brand	CAPSURE® SENSE
Model	407352
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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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.