DRUG ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
This device is manufactured by MEDTRONIC, MEDTRONIC IRELAND, 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 | Wound Dehiscence | 1 | Patient |
| 2024 | Unspecified Infection | 11 | Patient |
| 2024 | Undesired Nerve Stimulation | 2 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Purulent Discharge | 2 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Pain | 3 | Patient |
| 2024 | Obstruction/Occlusion | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Impaired Healing | 2 | Patient |
| 2024 | Fever | 3 | Patient |
| 2024 | Failure of Implant | 2 | Patient |
| 2024 | Erythema | 6 | Patient |
| 2024 | Dizziness | 4 | Patient |
| 2024 | Discomfort | 5 | Patient |
| 2024 | Device Overstimulation of Tissue | 5 | Patient |
| 2024 | Cardiomyopathy | 2 | Patient |
| 2024 | Bradycardia | 3 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Bacteremia | 2 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Abdominal Pain | 2 | Patient |
| 2024 | Unstable Capture Threshold | 2 | Device |
| 2024 | Under-Sensing | 9 | Device |
| 2024 | Signal Artifact/Noise | 5 | Device |
| 2024 | Positioning Problem | 3 | Device |
| 2024 | Pacing Problem | 8 | Device |
| 2024 | Over-Sensing | 15 | Device |
| 2024 | Low impedance | 2 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | Impedance Problem | 5 | Device |
| 2024 | High impedance | 14 | Device |
| 2024 | High Capture Threshold | 23 | Device |
| 2024 | Fracture | 12 | Device |
| 2024 | Failure to Capture | 10 | Device |
| 2024 | Electrical /Electronic Property Problem | 5 | Device |
| 2024 | Device-Device Incompatibility | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 2 | Device |
| 2024 | Decreased Sensitivity | 2 | Device |
| 2024 | Capturing Problem | 9 | Device |
| 2024 | Break | 4 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Unspecified Infection | 7 | Patient |
| 2023 | Tachycardia | 2 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Purulent Discharge | 2 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Heart Block | 2 | Patient |
| 2023 | Fatigue | 3 | Patient |
| 2023 | Erythema | 4 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Discomfort | 5 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Bradycardia | 5 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Arrhythmia | 3 | Patient |
| 2023 | Appropriate Term / Code Not Available | 3 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Unstable Capture Threshold | 2 | Device |
| 2023 | Under-Sensing | 13 | Device |
| 2023 | Signal Artifact/Noise | 6 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 7 | Device |
| 2023 | Over-Sensing | 27 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Low impedance | 7 | Device |
| 2023 | Intermittent Capture | 1 | Device |
| 2023 | Impedance Problem | 15 | Device |
| 2023 | High impedance | 22 | Device |
| 2023 | High Capture Threshold | 24 | Device |
| 2023 | Fracture | 29 | Device |
| 2023 | Failure to Capture | 18 | Device |
| 2023 | Electrical /Electronic Property Problem | 5 | Device |
| 2023 | Device Sensing Problem | 3 | Device |
| 2023 | Device Contamination with Body Fluid | 2 | Device |
| 2023 | Decreased Sensitivity | 3 | Device |
| 2023 | Capturing Problem | 4 | Device |
| 2023 | Break | 5 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Loss of consciousness | 2 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 2 | Patient |
| 2022 | Discomfort | 2 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Unstable Capture Threshold | 3 | Device |
| 2022 | Under-Sensing | 8 | Device |
| 2022 | Signal Artifact/Noise | 8 | Device |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Pacing Problem | 7 | Device |
| 2022 | Over-Sensing | 15 | Device |
| 2022 | Material Split, Cut or Torn | 1 | Device |
| 2022 | Low impedance | 11 | Device |
| 2022 | Intermittent Capture | 5 | Device |
| 2022 | Impedance Problem | 6 | Device |
| 2022 | High impedance | 13 | Device |
| 2022 | High Capture Threshold | 27 | Device |
| 2022 | Fracture | 7 | Device |
| 2022 | Failure to Capture | 5 | Device |
| 2022 | Electrical /Electronic Property Problem | 6 | Device |
| 2022 | Device Sensing Problem | 2 | Device |
| 2022 | Decreased Sensitivity | 3 | Device |
| 2022 | Capturing Problem | 7 | Device |
| 2022 | Break | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Under-Sensing | 2 | Device |
| 2021 | Signal Artifact/Noise | 6 | Device |
| 2021 | Over-Sensing | 8 | Device |
| 2021 | Low impedance | 1 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | High Capture Threshold | 6 | Device |
| 2021 | Electrical /Electronic Property Problem | 2 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Capturing Problem | 3 | Device |
| 2021 | Break | 2 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Over-Sensing | 1 | Device |
| 2020 | Noise, Audible | 1 | Device |
| 2020 | Low impedance | 5 | Device |
| 2020 | High impedance | 1 | Device |
| 2020 | High Capture Threshold | 3 | Device |
| 2020 | Fracture | 1 | Device |
| 2020 | Electrical /Electronic Property Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 2 | Device |