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 Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Pericardial Effusion (3271)

Event Date 06/04/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that during the implant of a leadless implantable pulse generator (ipg) the patient expired due to cardiac arrest and cardiac effusion during the third deployment.It was noted during the implant an ideal location was hard to find, the ipg was deployed twice in the septal position and bad electrical measurements were recorded.During the third deployment the patient began to feel ill and the patient's rhythm dropped from 90 beats per minute to 35 beats per minute.A temporary pacing lead was used and the patient's heart was massaged.An effusion was found and drainage was performed.Treatment was stopped following drainage.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway,ie ; IE
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10137599
• MDR Text Key: 194617110
• Report Number: 9612164-2020-02168
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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
• Type of Report: Initial
• Report Date: 06/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• 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
• Device Lot Number: 00141440
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2020
• 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: 87 YR