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

Model Number	MC2AVR1-DELSYS
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the implant procedure of a leadless implantable pulse generator (ipg) the delivery system exhibited a de ployment issue.The deployment button was broken and the leadless ipg was unable to be deployed.It was noted that when the physician attempted to deploy the device the deployment button moved but the device remained completely seated inside the cup.The delivery system was removed and it was noted that the leadless ipg was stuck inside the catheter at the valve.The leadless ipg was removed from the catheter by pulling on the tether.The leadless ipg was attempted/ not used and replaced.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the delivery system was returned without the device intact in the device cup, and analyzed.Analysis indicated the lumen of the delivery system was torn.The delivery system tether was frayed.The delivery system tether was knotted.The analyst noted the deployment test cannot be performed due to the device was not returned, and the tether and pin were not intact in the delivery system.Visual inspection showed the lumen torn, the tether was knotted and frayed.These finding positively contributed to the deployment of the device during implant.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: 50880679
• Report Number: 9612164-2026-04800
• Device Sequence Number: 18582493
• Product Code: PNJ
• UDI-Device Identifier: 00763000078645
• UDI-Public: (01)00763000078645(17)270814
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MC2AVR1-DELSYS
• Device Catalogue Number: MC2AVR1-DELSYS
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/16/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2026
• 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
• Patient Age: 58 YR
• Patient Sex: Female