SPRINT FIDELIS

IMPLANTABLE TACHY LEAD

This device is manufactured by MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT, MEDTRONIC CARDIAC RHYTHM MANAGEMENT, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Shock from Patient Lead(s) 1 Patient
2024 Emotional Changes 1 Patient
2024 Signal Artifact/Noise 1 Device
2024 Over-Sensing 1 Device
2024 Insufficient Information 1 Device
2024 Inappropriate/Inadequate Shock/Stimulation 1 Device
2024 High impedance 5 Device
2024 Fracture 2 Device
2024 Failure to Capture 1 Device
2024 Break 1 Device
2023 Wound Dehiscence 1 Patient
2023 Shock from Patient Lead(s) 1 Patient
2023 Obstruction/Occlusion 1 Patient
2023 Limb Pain 1 Patient
2023 Unstable Capture Threshold 2 Device
2023 Signal Artifact/Noise 7 Device
2023 Pacing Problem 1 Device
2023 Over-Sensing 5 Device
2023 Inappropriate/Inadequate Shock/Stimulation 1 Device
2023 Impedance Problem 7 Device
2023 High impedance 8 Device
2023 High Capture Threshold 5 Device
2023 Fracture 8 Device
2023 Device Sensing Problem 1 Device
2023 Decreased Sensitivity 1 Device
2023 Capturing Problem 1 Device
2023 Break 3 Device
2023 Appropriate Term/Code Not Available 1 Device
2023 Adverse Event Without Identified Device or Use Problem 1 Device
2022 Unstable Capture Threshold 2 Device
2022 Signal Artifact/Noise 6 Device
2022 Over-Sensing 7 Device
2022 Inappropriate/Inadequate Shock/Stimulation 1 Device
2022 Impedance Problem 3 Device
2022 High impedance 7 Device
2022 High Capture Threshold 2 Device
2022 Fracture 9 Device
2022 Difficult to Remove 1 Device
2022 Defective Device 1 Device
2020 Fracture 1 Device