FDA Adverse Event Malfunction Summary report: N

MICRA

MDR report key: 24311737 · Received February 11, 2026

Report

Report Number: 9612164-2026-00727
Event Type: Malfunction
Date Received: February 11, 2026
Date of Event: February 9, 2026
Report Date: February 11, 2026
Manufacturer: MEDTRONIC IRELAND
Product Code: PNJ
UDI-DI: 00763000078690
PMA / PMN Number: P150033
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PL
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

CONTINUATION OF D10: PRODUCT ID: MC2VR01 (SERIAL: (B)(6); PRODUCT TYPE: 0240-IPG; IMPLANT DATE: ON (B)(6) 2026; EXPLANT DATE: (B)(6) 2026. 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 DURING THE IMPLANT PROCEDURE THAT THE LEADLESS IMPLANTABLE PULSE GENERATOR (IPG) DELIVERY SYSTEM (DS) EXHIBITED A BLOCKED TETHER IN THE DS AFTER CUTTING THE TETHER. THE LEADLESS IPG AND DS WAS ATTEMPTED NOT USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
379979	MICRA	LEADLESS PACEMAKER	PNJ	MEDTRONIC IRELAND	MC1VR01-DELSYS		00763000078690

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Male		SEE H11.