FDA Adverse Event Malfunction Summary report: N

CAPSURE EPICARDIAL LEAD

MDR report key: 22143407 · Received June 4, 2025

Report

Report Number: 2182208-2025-02726
Event Type: Malfunction
Date Received: June 4, 2025
Date of Event: May 6, 2025
Report Date: June 4, 2025
Manufacturer: MEDTRONIC, INC.
Product Code: NVN
UDI-DI: 00681490116503
PMA / PMN Number: P950024
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: 0184 LEAD IMPLANTED: (B)(6) 2008; 1688T LEAD IMPLANTED: (B)(6) 2007. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE LEFT VENTRICULAR (LV) LEAD TRIGGERED A WARNING FOR A LOW PACING IMPEDANCE MEASUREMENT. IT WAS ALSO REPORTED THAT THE PATIENT WAS EXPERIENCING SHORTNESS OF BREATH. THE LV LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
588794	CAPSURE EPICARDIAL LEAD	DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV)	NVN	MEDTRONIC, INC.	4965-35		00681490116503

Patients

Seq	Age	Sex	Outcome	Treatment
1	34 YR	Male		DTPC2D1 CRTD