MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number	MC1VR01US
Medical Device Problem Code	Pacing Problem (1439)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Tachycardia (2095)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
It was reported that a patient with a leadless implantable pulse generator (ipg) experienced a series of cardiac events including atrial fibrillation, tachycardia, bradycardia with heart rates detected below 60 beats per minute (bpm) (including readings in the 40s and 50s, a pulse oximeter result of 38, and a manual pulse check of 48).The patient noted that the device was not maintaining the programmed lower rate of 60 bpm, with evidence from device readings and personal monitoring indicating heart rates below the intended threshold on several occasions, particularly at night.The patient suggested that possible inadequate nutrition due to dieting may have contributed to the arrhythmias.The leadless ipg remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: MICRA
• 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 55112-4391 ; 7635269277
• MDR Report Key: 24493906
• Report Number: 9612164-2026-01098
• Device Sequence Number: 4953911
• Product Code: PNJ
• UDI-Device Identifier: 00643169711761
• UDI-Public: (01)00643169711761(17)220328
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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 Expiration Date: 03/28/2022
• Device Model Number: MC1VR01US
• Device Catalogue Number: MC1VR01US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 10/15/2020
• 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
• Patient Age: 71 YR
• Patient Sex: Male