MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SYLMAR) CONFIRM¿ MOBILE TRANSMITTER/ACTIVATOR PATIENT SMARTPHONE

Model Number MTX1000

Device Problems Smoking (1585); Excessive Heating (4030)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

It was reported that the patient's smartphone (mtx) overheated.While the phone was charging, it turned red and caught fire.The smartphone was replaced.No adverse consequences were reported.

• Brand Name: CONFIRM¿ MOBILE TRANSMITTER/ACTIVATOR PATIENT SMARTPHONE
• Type of Device: MOBILE TRANSMITTER/ACTIVATOR PATIENT SMARTPHONE
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 13586798
• MDR Text Key: 289008924
• Report Number: 2017865-2022-03622
• Device Sequence Number: 1
• Product Code: DXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MTX1000
• Device Catalogue Number: MTX1000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: DM4500_IMPLANTABLE CARDIAC MONITOR
• Patient Age: 61 YR
• Patient Sex: Male