MAUDE Adverse Event Report: MEDTRONIC, INC. MICRA; INTRODUCER, CATHETER

Model Number MI2355A

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

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Vomiting (2144)

Event Date 03/25/2020

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.The event only occurred with one patient but specific details on the patient were not provided.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: micra leadless pacemaker retrieval in a pediatric patient.Indian pacing and electrophysiology journal.2020.20;132-134.Doi.Org/10.1016/j.Ipej.2020.03.006.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding a leadless implantable pulse generator (ipg) retrieval in a pediatric patient.The article reports a patient who presented with vomiting and nausea with subsequent bleeding from their left femoral vein site, requiring stitches two days post implant of the leadless ipg.Approximately eight days later, the device exhibited an increase in threshold with a shortened battery longevity.The device also had intermittent loss of capture when the patient turned to their left side and while taking a big breath.The leadless ipg was explanted and replaced.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• Brand Name: MICRA
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11282439
• MDR Text Key: 230434975
• Report Number: 2182208-2021-00516
• 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: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/21/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 13 YR
• Patient Weight: 50