DEXTRUS 4135

PACER LEAD

This device is manufactured by BIOTRONIK SE & CO KG, BIOTRONIK SE & KG, BIOTRONIK SE AND CO KG.

The following problems were reported about this device:

Year Description Events/year Type
2024 Unspecified Infection 7 Patient
2024 Pocket Erosion 2 Patient
2024 Under-Sensing 1 Device
2024 Pacing Intermittently 1 Device
2024 Over-Sensing 4 Device
2024 Low impedance 1 Device
2024 Insufficient Information 4 Device
2024 Impedance Problem 3 Device
2024 High impedance 2 Device
2024 Fracture 2 Device
2024 Break 2 Device
2024 Ambient Noise Problem 10 Device
2024 Adverse Event Without Identified Device or Use Problem 6 Device
2023 Unspecified Infection 12 Patient
2023 Over-Sensing 2 Device
2023 Low impedance 1 Device
2023 Insufficient Information 4 Device
2023 Impedance Problem 2 Device
2023 High impedance 2 Device
2023 Fracture 1 Device
2023 Failure to Capture 1 Device
2023 Device Dislodged or Dislocated 1 Device
2023 Break 2 Device
2023 Ambient Noise Problem 6 Device
2023 Adverse Event Without Identified Device or Use Problem 11 Device
2022 Pocket Erosion 1 Patient
2022 Over-Sensing 1 Device
2022 Insufficient Information 6 Device
2022 High impedance 1 Device
2022 Ambient Noise Problem 5 Device
2022 Adverse Event Without Identified Device or Use Problem 14 Device
2020 Unspecified Infection 4 Patient
2020 Pocket Erosion 1 Patient
2020 Bacteremia 1 Patient
2020 Adverse Event Without Identified Device or Use Problem 4 Device