MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA¿ AV2; LEADLESS PACEMAKER

Model Number MC2AVR1

Device Problems Under-Sensing (1661); Impedance Problem (2950); Positioning Problem (3009); High Capture Threshold (3266)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported that whilst attempting to insert the leadless implantable pulse generator (ipg), the device exhibited no sensing.Upon second deployment, the device exhibited high thresholds and varying impedance.While trying to remove the device, there was recapturing difficulty but was successfully removed with traction. the device was attempted, not used and replaced. no patient complications have been reported as a result of this event.

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.

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Returned product analysis was performed and no anomalies were found.Product event summary pli 20: the full delivery system was returned and analyzed.The lumen of the delivery system was torn.The articulation of the delivery system was out of plane.The articulation curve of the delivery system did not meet specification.The delivery system tether was frayed.There was a deployment issue with the delivery system.The delivery system outer shaft was bent.The analyst noted the full delivery system was returned with the device intact in the device cup.The outer shaft was bent at 5 cm from the distal end of the delivery system.The device was able to be deployed with resistance, the device was able to be pulled by the tether to the recapture cone with resistance, the device was able to be fully recaptured in the device cup.There were no anomalies found with the distal edge of the device cup.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
• Type of Device: 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19003468
• MDR Text Key: 338902773
• Report Number: 9612164-2024-01526
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 00763000078645
• UDI-Public: 00763000078645
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC2AVR1
• Device Catalogue Number: MC2AVR1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Male