MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; LEADLESS PACEMAKER

Model Number MC1VR01

Device Problems Failure to Capture (1081); Device Expiration Issue (1216); Battery Problem (2885); High Capture Threshold (3266)

Patient Problems Syncope (1610); Confusion/ Disorientation (2553)

Event Date 08/09/2017

Event Type  Injury  

Event Description

It was reported that the patient experienced syncope with confusion and loss of awareness.The leadless implantable pulse generator (ipg) was observed with intermittent loss of capture and high thresholds, resulting in battery depletion.The device was subsequently programmed off and remains implanted.A new device will be implanted in the future.The patient is a participant in the post approval clinical surveillance (pacs) product surveillance registry (psr).No patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: this event is a duplicate mfr report number #9612164-2017-01753.Please reference this report for incident details.If information is provided in the future, a supplemental report will be issued.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6938491
• MDR Text Key: 89021760
• Report Number: 9612164-2017-01444
• Device Sequence Number: 1
• Product Code: PNJ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P150033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2017
• 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?: Yes
• Date Manufacturer Received: 03/16/2018
• Date Device Manufactured: 04/29/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 77 YR
• Patient Weight: 65