MAUDE Adverse Event Report: Medtronic Ireland Micra¿ VR2; LEADLESS PACEMAKER

Model Number	MC2VR01
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Fall (1848); Fatigue (1849)
Date of Event	07/23/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a "bad fall" and was "tired all the time".The patient was hospitalized. no further patient complications have been reported as a result of this event.
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.

• Brand Name: Micra¿ VR2
• 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: 50404779
• Report Number: 9612164-2026-04237
• Device Sequence Number: 18750058
• Product Code: PNJ
• UDI-Device Identifier: 00763000078683
• UDI-Public: (01)00763000078683(17)250328
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/28/2025
• Device Model Number: MC2VR01
• Device Catalogue Number: MC2VR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Date Device Manufactured: 10/20/2023
• 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
• Patient Age: 78 YR
• Patient Sex: Male