MAUDE Adverse Event Report: MEDTRONIC IRELAND MICRA; INTRODUCER, CATHETER

Model Number MI2355A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 12/28/2016

Event Type  Injury  

Event Description

It was reported that approximately two weeks after the implant of a leadless implantable pulse generator (ipg), the patient complained of a lump and tenderness at the groin site.A "slight ooze" was noted and the dressing appeared "murky." a superficial incisional surgical site infection was noted.The patient was treated with oral antibiotics and the issue resolved.The leadless implantable pulse generator (ipg) remains implanted.The patient is a participant in the post approval clinical surveillance product surveillance registry study.No further 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.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6469115
• MDR Text Key: 72082194
• Report Number: 9612164-2017-00401
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2018
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00109705
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 04/06/2017
• Supplement Dates Manufacturer Received: 02/02/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 01/20/2016
• 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
• Treatment: MC1VR01 IPG
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 65