CAPSURE®SP NOVUS 5592-45 (UDI 00643169590724)Recalls & reported problems

Medtronic, Inc. · LEAD 5592-45 CAPSURE SP US BI SIL ATRL · Class 3 · Implant

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 3
Deaths reported: 0
Injuries reported: 1
Recalls naming it: 0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169590724), received between Dec 9, 2016 and Apr 18, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Under-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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Reports received per month

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

Most reported problems

Device problems

Under-Sensing2
Device Dislodged or Dislocated1
Failure to Capture1

Patient problems

Atrial Tachycardia1
Muscle Stimulation1
No Clinical Signs, Symptoms or Conditions1
Undesired Nerve Stimulation1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

MalfunctionApr 18, 2025Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED UNDERSENSING NOTED ON STORED ELECTROGRAMS (EGM). THE 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 21864497 ↗
MalfunctionFeb 8, 2018Under-Sensing; Under-Sensing
IT WAS REPORTED THAT THE PATIENT EXPERIENCED ATRIAL TACHYCARDIA. UPON DEVICE INTERROGATION, IT WAS REVEALED THAT THERE WAS ATRIAL UN DER-SENSING AND MODE SWITCHING ON THE RIGHT ATRIAL (RA) LEAD. IT WAS ALSO NOTED THAT THERE WAS ONE UNDER-SENSED R-WAVE ON THE RIGHT VENTRICULAR (RV) LEAD. THE RA AND RV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Atrial Tachycardia
MAUDE report 7254284 ↗
InjuryDec 9, 2016Failure to Capture; Device Dislodged or Dislocated; Failure to Capture; Device Dislodged or Dislocated
IT WAS REPORTED THAT WITHIN ONE WEEK POST-IMPLANT, THE PATIENT WENT TO THE EMERGENCY ROOM DUE TO DIAPHRAGMATIC AND NERVE STIMULATION. DEVICE INTERROGATION REVEALED NO ATRIAL CAPTURE ALONG WITH INCREASED OUTPUT. X-RAY SHOWED THAT THE LEAD WAS PULLED BACK AND DISLODGED. THE ATRIAL LEAD WAS PROGRAMMED OFF UNTIL BEING REPOSITIONED THE NEXT DAY. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Patient problems: Muscle Stimulation; Undesired Nerve Stimulation
MAUDE report 6157939 ↗

Device details

UDI-DI	`00643169590724`
Brand	CAPSURE®SP NOVUS
Model	5592-45
Company	Medtronic, Inc.
Product code	DTB · permanent pacemaker Electrode
Class	Class 3
FDA submission	P850089
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 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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