MAUDE Adverse Event Report: Medtronic Ireland Micra¿ AV2; LEADLESS PACEMAKER

Model Number	MC2AVR1
Medical Device Problem Codes	Intermittent Capture (1080); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	09/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported during implant that physician deployed the leadless implantable pulse generator (ipg) and delivery system (ds) three times where it exhibited high thresholds and intermittent capture.About one hour post implant the patient experienced pericardial effusion and underwent a procedure for drainage.The leadless ipg remains in use. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Section d references the main component of the system.Other medical products in use during the event include: brand name "[micra]" product id "[mc2avr1-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.

• Brand Name: Micra¿ AV2
• Common Device Name: LEADLESS PACEMAKER
• Manufacturer (Section D): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer (Section G): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer Contact: gerard torenvliet ; 8200 coral sea st ne; mounds view, MN 55112--439 ; +1(763)526-9277
• MDR Report Key: 50867393
• Report Number: 9612164-2026-04779
• Device Sequence Number: 10743095
• Product Code: PNJ
• UDI-Device Identifier: 00763000078645
• UDI-Public: (01)00763000078645(17)270814
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MC2AVR1
• Device Catalogue Number: MC2AVR1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 09/23/2026
• Date Device Manufactured: 02/19/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female