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

Model Number MI2355A

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Fistula (1862); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Cardiac Tamponade (2226); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Cardiovascular Insufficiency (4445); Pericarditis (4448); Insufficient Information (4580)

Event Date 01/01/2022

Event Type  Death  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Data was reviewed regarding implants and outcomes of leadless implantable pulse generators (ipgs).They described patient deaths; however, the causes of death were unknown and defined as all-cause, thirty-day mortality.There were patients who experienced acute, thirty-day complications which included puncture site events such as arteriovenous fistula and vascular aneurysms.There were patients who experienced deep vein thrombosis, pulmonary embolisms, pericardial effusion, cardiac tamponade, pain, post implant hematomas or hemorrhages, intraoperative cardiac arrest, pericarditis, and unknown vascular complications.There were dislodgments of leadless ipgs and other unknown malfunctions in which there were revisions, replacements, and other interventions.The status of the devices, delivery systems, and introducers is unknown.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; EI
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 19082779
• MDR Text Key: 339860557
• Report Number: 9612164-2024-01716
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/03/2024
• 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: 79 YR
• Patient Sex: Male