CAPSURE SENSE

IMPLANTABLE PACING LEAD

This device is manufactured by MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO, MEDTRONIC SINGAPORE OPERATIONS, RICE CREEK MFG.

The following problems were reported about this device:

Year Description Events/year Type
2024 Syncope/Fainting 1 Patient
2024 Heart Block 1 Patient
2024 Bradycardia 1 Patient
2024 Unstable Capture Threshold 1 Device
2024 High Capture Threshold 3 Device
2024 Failure to Capture 1 Device
2024 Device Sensing Problem 1 Device
2024 Capturing Problem 1 Device
2023 Unspecified Infection 1 Patient
2023 Signal Artifact/Noise 1 Device
2023 Over-Sensing 1 Device
2023 Impedance Problem 1 Device
2023 High Capture Threshold 1 Device
2023 Device Dislodged or Dislocated 1 Device
2023 Capturing Problem 1 Device
2023 Adverse Event Without Identified Device or Use Problem 2 Device
2022 High Capture Threshold 1 Device
2021 High Capture Threshold 1 Device
2021 Device Dislodged or Dislocated 1 Device
2021 Decreased Sensitivity 1 Device