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

Model Number	MC2AVR1
Medical Device Problem Codes	Failure to Capture (1081); Under-Sensing (1661); Capturing Problem (2891); Positioning Problem (3009); Unstable Capture Threshold (3269)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2026
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 leadless ipg exhibited non-cap ture, undersensing and out of range (oor) thresholds.Recapturing difficulty was also noted.The leadless ipg was successfully recaptured and attempted/ not used.No patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that the leadless ipg exhibited unstable thresholds.Once the tether was cut for the first deployment the th resholds were fine, but subsequently rose and kept rising.The ipg was removed with a snare.
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.
Additional Manufacturer Narrative
Continuation of d10:this is a system report.The section d information is for the primary device, which was in use with the following: brand name "[micra]" product id "[mc2avr1-delsys]" (serial: (b)(6).D9: yes, return date: 29 sep 2026 h3: <(><<)>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: 50913678
• Report Number: 9612164-2026-04858
• Device Sequence Number: 17491232
• Product Code: PNJ
• UDI-Device Identifier: 00763000078645
• UDI-Public: (01)00763000078645(17)271028
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2026

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
• Device Catalogue Number: MC2AVR1
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/29/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/16/2026
• Supplement Date Received by Manufacturer: 09/28/2026
• Initial Report FDA Received Date: 09/28/2026
• Supplement Report FDA Received Date: 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/08/2026
• 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: 62 YR
• Patient Sex: Female