FDA Adverse Event Malfunction Summary report: N

MICRA

MDR report key: 21718367 · Received March 28, 2025

Report

Report Number: 9612164-2025-01578
Event Type: Malfunction
Date Received: March 28, 2025
Date of Event: October 14, 2024
Report Date: March 28, 2025
Manufacturer: MEDTRONIC IRELAND
Product Code: PNJ
PMA / PMN Number: P150033
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TH
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THIS IS A SYSTEM REPORT. THE SECTION D INFORMATION IS FOR THE PRIMARY DEVICE, WHICH WAS IN USE WITH THE FOLLOWING: BRAND NAME [MICRA] PRODUCT ID [MC1VR01-DELSYS] (SERIAL: [(B)(6)]). D9: NO 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 WHEN IMPLANTING THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) MULTIPLE POSITIONS WERE ATTEMPTED WITH UNACCEPTABLE PARAMETERS. UPON INSPECTING THE LEADLESS IMPLANTABLE IPG DELIVERY SYSTEM (DS) THE TETHER WAS MOSTLY TEARED UP. THE LEADLESS IPG REMAINS IN-SITU AND THE DS WAS REMOVED. A NEW LEADLESS IPG DS WAS SUCCESSFULLY USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED ASA RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
713294	MICRA	LEADLESS PACEMAKER	PNJ	MEDTRONIC IRELAND	MC1VR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	80 YR	Male