REVEAL DX

IMPLANTABLE LOOP RECORDER

This device is manufactured by CARDINAL HEALTH, COVIDIEN, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO and others.

The following problems were reported about this device:

Year Description Events/year Type
2023 Insufficient Information 3 Patient
2023 Protective Measures Problem 2 Device
2023 Display or Visual Feedback Problem 1 Device
2023 Device Markings/Labelling Problem 1 Device
2023 Device Displays Incorrect Message 2 Device
2018 Operating System Becomes Nonfunctional 1 Device
2018 Failure to Interrogate 1 Device
2018 Appropriate Term/Code Not Available 1 Device
2018 Adverse Event Without Identified Device or Use Problem 1 Device
2017 Under-Sensing 1 Device
2017 Premature Discharge of Battery 1 Device
2017 Over-Sensing 1 Device
2017 Migration or Expulsion of Device 1 Device
2017 Failure to Interrogate 2 Device
2017 Battery Problem 2 Device
2017 Adverse Event Without Identified Device or Use Problem 1 Device
2016 Under-Sensing 1 Device
2016 Over-Sensing 2 Device
2016 Failure to Interrogate 2 Device
2016 Electrical /Electronic Property Problem 1 Device
2016 Battery Problem 2 Device
2014 Under-Sensing 10 Device
2014 Unable to Obtain Readings 3 Device
2014 Signal Artifact/Noise 1 Device
2014 Reset Problem 1 Device
2014 Over-Sensing 4 Device
2014 Migration or Expulsion of Device 2 Device
2014 Mechanical Problem 1 Device
2014 Failure to Interrogate 3 Device
2014 Device Sensing Problem 2 Device
2014 Battery Problem 2 Device
2014 Adverse Event Without Identified Device or Use Problem 1 Device
2013 Under-Sensing 9 Device
2013 Unable to Obtain Readings 1 Device
2013 Protective Measures Problem 1 Device
2013 Over-Sensing 4 Device
2013 Failure to Interrogate 1 Device
2013 Device Sensing Problem 2 Device
2013 Communication or Transmission Problem 1 Device
2013 Appropriate Term/Code Not Available 3 Device
2013 Adverse Event Without Identified Device or Use Problem 2 Device
2010 Failure to Interrogate 1 Device