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

Model Number MI2355A

Device Problem Insufficient Information (3190)

Patient Problems Pulmonary Embolism (1498); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Ischemia (1942); Thrombosis (2100)

Event Date 05/03/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that infection occurred and the ipg system was explanted.During the same procedure, leadless implantable pulse generator (ipg) was implanted but few minutes after the extraction of the introducer, the patient blood pressure dropped and the pulmonary embolism was observed.Patient was in cardiac arrest and cardiopulmonary resuscitation was performed for forty five minutes.Thrombolytic drug was given.The patient's blood pressure and the function of the left ventricle was improved.Physician feels that due to the assumed large size of the pulmonary embolism that the clot may have been from an existing deep vein thrombosis that was embolized during the procedure.It was further reported that the patient died on the same evening, few hours post procedure.Bowel ischemia from cardiac arrest due to pulmonary embolism was determined as a cause of death.

• 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: 8657966
• MDR Text Key: 146633942
• Report Number: 9612164-2019-02124
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00643169359888
• UDI-Public: 00643169359888
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: MI2355A
• Device Catalogue Number: MI2355A
• Device Lot Number: 00136384
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2019
• Initial Date FDA Received: 05/31/2019
• Date Device Manufactured: 11/13/2018
• 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: 61 YR