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

Model Number	MC2AVR1
Medical Device Problem Codes	Intermittent Capture (1080); Failure to Capture (1081); Capturing Problem (2891); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)
Health Effect - Clinical Codes	Bradycardia (1751); Hematoma (1884); Pain (1994); Syncope/Fainting (4411)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had a syncopal episode.It was noted that patient experienced bradycardia, pain and hematoma.Patient was externally paced.It was noted that there was rising thresholds, intermittent capture and high thresholds.It was noted the device was losing contact with the myocardial tissue resulting in failure to capture.The leadless implantable pulse generator (ipg) replaced with a new system.
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¿ 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: 50886479
• Report Number: 9612164-2026-04814
• Device Sequence Number: 13450613
• Product Code: PNJ
• UDI-Device Identifier: 00763000078645
• UDI-Public: (01)00763000078645(17)271014
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted 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): 09/24/2026

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?: 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: 09/10/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 04/15/2026
• 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 Age: 89 YR
• Patient Sex: Female
• Patient Weight: 82 LB