MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA AV; LEADLESS PACEMAKER

Model Number MC1AVR1

Device Problems Incorrect Measurement (1383); Over-Sensing (1438); Unable to Obtain Readings (1516); Under-Sensing (1661)

Patient Problem Fatigue (1849)

Event Date 01/06/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that approximately six weeks post implant of the leadless implantable pulse generator (ipg) the patient experienced fatigue.Possible atrial oversensing and undersensing were noted.No a4 wave form and no av synchrony were noted.The ipg was reprogrammed and remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: MICRA AV
• 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: 11215194
• MDR Text Key: 228211496
• Report Number: 9612164-2021-00278
• Device Sequence Number: 1
• Product Code: PNJ
• UDI-Device Identifier: 00763000078621
• UDI-Public: 00763000078621
• 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: 01/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/28/2022
• Device Model Number: MC1AVR1
• Device Catalogue Number: MC1AVR1
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/06/2021
• Date Device Manufactured: 10/16/2020
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Weight: 56