MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number MC1VR01US

Device Problem Unable to Obtain Readings (1516)

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

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the device was returned and analyzed.There was an issue observed with the firmware.Hybrid analysis the reported error code correction (ecc) power on reset (por) was confirmed.However, there was no information in the ecc fault buffers, indicating that no ecc event was recorded.No new pors occurred after the ecc por at pre-implant, and no abnormal functionality was observed during analysis.No hybrid anomalies were identified.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• Brand Name: MICRA
• 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: 13437922
• MDR Text Key: 289216907
• Report Number: 9612164-2022-00453
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 00643169711761
• UDI-Public: 00643169711761
• 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: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/28/2022
• Device Model Number: MC1VR01US
• Device Catalogue Number: MC1VR01US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Date Manufacturer Received: 02/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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