FDA Adverse Event Injury Summary report: N

MOSAIC

MDR report key: 23775999 · Received December 11, 2025

Report

Report Number: 2025587-2025-06019
Event Type: Injury
Date Received: December 11, 2025
Date of Event: July 22, 2025
Report Date: December 11, 2025
Manufacturer: MEDTRONIC HEART VALVES DIVISION
Product Code: DYE
PMA / PMN Number: P990064
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: PRODUCT ID 900SFC234 (K032755); PRODUCT TYPE: 0195-HEART VALVES; IMPLANT DATE (B)(6) 2025. 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 21 YEARS AND 10 MONTHS POST IMPLANT OF THIS 29MM MITRAL BIOPROSTHETIC VALVE, A PERMANENT PACEMAKER WAS IMPLANTED. THE REASON FOR THE PERMANENT PACEMAKER WAS REPORTED AS LOW EJECTION FRACTION (EF). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2796298	MOSAIC	REPLACEMENT HEART-VALVE	DYE	MEDTRONIC HEART VALVES DIVISION	310F29

Patients

Seq	Age	Sex	Outcome	Treatment
1	65 YR	Female	Required Intervention\| H