DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO, MEDTRONIC SINGAPORE OPERATIONS and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 8 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Stenosis | 1 | Patient |
| 2024 | Skin Discoloration | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Obstruction/Occlusion | 2 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Erythema | 3 | Patient |
| 2024 | Erosion | 2 | Patient |
| 2024 | Dizziness | 4 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Unstable Capture Threshold | 2 | Device |
| 2024 | Under-Sensing | 4 | Device |
| 2024 | Signal Artifact/Noise | 5 | Device |
| 2024 | Pacing Problem | 5 | Device |
| 2024 | Over-Sensing | 6 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | Impedance Problem | 4 | Device |
| 2024 | High impedance | 5 | Device |
| 2024 | High Capture Threshold | 10 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Failure to Capture | 2 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2023 | Unspecified Infection | 4 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Purulent Discharge | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Necrosis | 1 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Unstable Capture Threshold | 3 | Device |
| 2023 | Under-Sensing | 6 | Device |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Over-Sensing | 8 | Device |
| 2023 | Low impedance | 6 | Device |
| 2023 | Impedance Problem | 4 | Device |
| 2023 | High impedance | 8 | Device |
| 2023 | High Capture Threshold | 11 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Failure to Capture | 4 | Device |
| 2023 | Electrical /Electronic Property Problem | 5 | Device |
| 2023 | Decreased Sensitivity | 3 | Device |
| 2023 | Capturing Problem | 4 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Unstable Capture Threshold | 2 | Device |
| 2022 | Under-Sensing | 6 | Device |
| 2022 | Signal Artifact/Noise | 2 | Device |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Over-Sensing | 6 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Low impedance | 4 | Device |
| 2022 | Intermittent Capture | 1 | Device |
| 2022 | Impedance Problem | 5 | Device |
| 2022 | High impedance | 9 | Device |
| 2022 | High Capture Threshold | 11 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Capture | 5 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Decreased Sensitivity | 2 | Device |
| 2022 | Capturing Problem | 3 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2021 | Under-Sensing | 1 | Device |
| 2021 | Signal Artifact/Noise | 3 | Device |
| 2021 | Pacing Problem | 1 | Device |
| 2021 | Over-Sensing | 4 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High Capture Threshold | 1 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Device-Device Incompatibility | 2 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | High impedance | 1 | Device |
| 2020 | High Capture Threshold | 1 | Device |