MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC ILR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number MDT-ILR

Device Problems Over-Sensing (1438); Device Sensing Problem (2917)

Patient Problem Bradycardia (1751)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is unknown; the age of the patients was approximately (b)(6) years old.Of note, multiple patients and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.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: remote monitoring alert burden an analysis of transmission in >26,000 patients.Journal of the american college of cardiology, clinical electrophysiology.2021.Vol.7, no.2.Doi.Org/10.1016/j.Jacep.2020.08.029 if information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding remote monitoring alert burden concerning red or yellow alerts on implantable cardioverter defibrillators (icd), cardiac resynchronization therapy (crt) devices, implantable pulse generators (ipg), and implantable cardiac monitors (icm).The article reports patients who received red alerts for right ventricular (rv) lead queries, charge time, pauses, and bradycardia.There were patients who received yellow alerts for right atrial (ra) and left ventricular (lv) lead queries and noise.The status/disposition of the devices and leads appear to be still in use.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: MEDTRONIC ILR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• 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: 11702285
• MDR Text Key: 246668897
• Report Number: 2182208-2021-01588
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-ILR
• Device Catalogue Number: MDT-ILR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/30/2021
• 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 Age: 72 YR