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

Model Number	MC2VR01
Medical Device Problem Codes	Failure to Capture (1081); Migration or Expulsion of Device (1395); Pacing Problem (1439); Under-Sensing (1661); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993); High Capture Threshold (3266)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Encephalopathy (1833); Renal Failure (2041); Cardiogenic Shock (2262); Respiratory Failure (2484); Cardiac Perforation (2513); Multiple Organ Dysfunction Syndrome (3261); Valvular Insufficiency/ Regurgitation (4449)
Type of Reportable Event	Death
Event or Problem Description
It was reported that the leadless implantable pulse generator (ipg) dislodged and migrated at some point after the hospital discharge.The patient sent a transmission when setting up the home monitor and threshold was high.The physician brought the patient back into the clinic to interrogate the device where it was noted to be non-capture at max output and also non-sensing even at most sensitive setting.The patient was sent for a chest x-ray where it was found that the device had dislodged and migrated deep into the pulmonary artery.The patient was admitted and taken to the cath lab to attempt retrieval but, as it was being pulled back toward the pulmonic valve, the patient became unstable with a pericardial bleed, cardiac pause, and a code blue was called.An emergency sternotomy was performed. the device was not able to be removed and the patient was placed on ecmo and sent to the cardiac intensive care unit (icu).The patient was taken back to the operating room due to excessive blood output in their chest tubes and was found to have a tear in the atrium which was repaired and was sent back to the icu.The patient was weaned off of ecmo but due to multi-system organ dysfunction including encephalopathy, pulmonary valve insufficiency, cardiogenic shock, acute on chronic kidney disease and ventilator dependent respiratory failure, the family decided to transition the patient to comfort care and they expired later that day.
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: 50714579
• Report Number: 9612164-2026-04525
• Device Sequence Number: 16112255
• Product Code: PNJ
• UDI-Device Identifier: 00763000078683
• UDI-Public: (01)00763000078683(17)270928
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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
• Report Date (Section B): 09/10/2026

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: MC2VR01
• Device Catalogue Number: MC2VR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 08/19/2026
• Initial Report FDA Received Date: 09/10/2026
• Date Device Manufactured: 04/13/2026
• 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: Death
• Patient Sex: Female