MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number MC1VR01

Device Problem Unable to Obtain Readings (1516)

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

Event Date 12/06/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a leadless implantable pulse generator (ipg) implant procedure, electrode impedance was not able to be measured until the mode was programmed to voo.The leadless ipg remains in use.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: 13079084
• MDR Text Key: 287351146
• Report Number: 9612164-2021-04970
• Device Sequence Number: 1
• Product Code: PNJ
• 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: 12/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC1VR01
• Device Catalogue Number: MC1VR01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2021
• 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