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

Model Number MI2355A

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

Patient Problems Death (1802); Sepsis (2067)

Event Date 04/14/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that two days post implant procedure of the leadless implantable pulse generator (ipg), the patient died.The cause of death was sepsis.

Manufacturer Narrative

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

Event Description

It was further reported that the infection was already present at the moment of leadless pacemaker implant.The infection involved the temporary lead and no additional vein access was available for a new temporary lead, therefore physician decided to implant the llipg.The physician is certain that there is no relationship between the device implant and patient death.

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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8607520
• MDR Text Key: 144957859
• Report Number: 9612164-2019-01721
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/15/2020
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00135000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2020
• Date Device Manufactured: 10/16/2018
• 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): Death
• Patient Age: 70 YR
• Patient Weight: 65