DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
This device is manufactured by MEDTRONIC SINGAPORE OPERATIONS, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 8 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Erythema | 1 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Positioning Problem | 2 | Device |
| 2024 | Pacing Problem | 1 | Device |
| 2024 | High Capture Threshold | 6 | Device |
| 2024 | Failure to Capture | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2023 | Unspecified Infection | 4 | Patient |
| 2023 | Undesired Nerve Stimulation | 3 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Erosion | 2 | Patient |
| 2023 | Endocarditis | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 3 | Patient |
| 2023 | Unstable Capture Threshold | 2 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Material Integrity Problem | 2 | Device |
| 2023 | Intermittent Capture | 1 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | High Capture Threshold | 8 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Capture | 4 | Device |
| 2023 | Device Dislodged or Dislocated | 4 | Device |
| 2023 | Capturing Problem | 3 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Unspecified Infection | 3 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Device Overstimulation of Tissue | 1 | Patient |
| 2022 | Signal Artifact/Noise | 2 | Device |
| 2022 | Positioning Problem | 3 | Device |
| 2022 | Over-Sensing | 1 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | High Capture Threshold | 5 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Capture | 4 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 7 | Device |
| 2022 | Capturing Problem | 1 | Device |
| 2022 | Break | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Break | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |