MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number MC1VR01

Device Problems Battery Problem (2885); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/29/2016

Event Type  malfunction  

Event Description

It was reported that in the leadless implantable pulse generator (ipg) had reduced longevity.It was noted this might have been due to elevated thresholds.The device remains implanted.The patient is a participant in the (b)(6).No patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

It was further reported that the leadless implantable pulse generator (ipg) was turned off and replaced with a single chamber transvenous device.

• Brand Name: MICRA
• Type of Device: LEADLESS PACEMAKER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 6921280
• MDR Text Key: 89520240
• Report Number: 9612164-2017-01386
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P150033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2016
• Device Model Number: MC1VR01
• Device Catalogue Number: MC1VR01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2019
• Date Device Manufactured: 05/13/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Weight: 90