PERMANENT PACEMAKER ELECTRODE
This device is manufactured by MEDTRONIC, MEDTRONIC SINGAPORE OPERATIONS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Infection | 22 | Patient |
| 2024 | Tachycardia | 3 | Patient |
| 2024 | Syncope/Fainting | 3 | Patient |
| 2024 | Swelling/ Edema | 6 | Patient |
| 2024 | Shaking/Tremors | 1 | Patient |
| 2024 | Sepsis | 2 | Patient |
| 2024 | Purulent Discharge | 6 | Patient |
| 2024 | Pocket Erosion | 2 | Patient |
| 2024 | Pain | 5 | Patient |
| 2024 | Obstruction/Occlusion | 4 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Fluid Discharge | 1 | Patient |
| 2024 | Fever | 2 | Patient |
| 2024 | Erythema | 5 | Patient |
| 2024 | Erosion | 2 | Patient |
| 2024 | Dyspnea | 4 | Patient |
| 2024 | Dizziness | 5 | Patient |
| 2024 | Discomfort | 6 | Patient |
| 2024 | Device Overstimulation of Tissue | 2 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Tamponade | 1 | Patient |
| 2024 | Cardiac Perforation | 3 | Patient |
| 2024 | Bradycardia | 2 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Bacteremia | 2 | Patient |
| 2024 | Atrial Fibrillation | 3 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Unstable Capture Threshold | 5 | Device |
| 2024 | Under-Sensing | 50 | Device |
| 2024 | Signal Artifact/Noise | 3 | Device |
| 2024 | Positioning Problem | 2 | Device |
| 2024 | Pacing Problem | 12 | Device |
| 2024 | Over-Sensing | 21 | Device |
| 2024 | Material Integrity Problem | 2 | Device |
| 2024 | Low impedance | 2 | Device |
| 2024 | Intermittent Capture | 7 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Impedance Problem | 6 | Device |
| 2024 | High impedance | 10 | Device |
| 2024 | High Capture Threshold | 23 | Device |
| 2024 | Fracture | 8 | Device |
| 2024 | Failure to Capture | 14 | Device |
| 2024 | Electrical /Electronic Property Problem | 3 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 11 | Device |
| 2024 | Decreased Sensitivity | 4 | Device |
| 2024 | Capturing Problem | 12 | Device |
| 2024 | Break | 3 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2024 | Accessory Incompatible | 1 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Unspecified Infection | 29 | Patient |
| 2023 | Tricuspid Valve Insufficiency/ Regurgitation | 1 | Patient |
| 2023 | Tachycardia | 5 | Patient |
| 2023 | Syncope/Fainting | 3 | Patient |
| 2023 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2023 | Swelling/ Edema | 4 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Shock from Patient Lead(s) | 1 | Patient |
| 2023 | Purulent Discharge | 3 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Perforation | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Obstruction/Occlusion | 1 | Patient |
| 2023 | Necrosis | 2 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hypervolemia | 1 | Patient |
| 2023 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 2 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Fluid Discharge | 2 | Patient |
| 2023 | Fever | 2 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Erythema | 5 | Patient |
| 2023 | Erosion | 3 | Patient |
| 2023 | Endocarditis | 3 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Distress | 1 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Chest Pain | 8 | Patient |
| 2023 | Cellulitis | 2 | Patient |
| 2023 | Cardiomyopathy | 1 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Bradycardia | 5 | Patient |
| 2023 | Bacterial Infection | 7 | Patient |
| 2023 | Bacteremia | 1 | Patient |
| 2023 | Atrial Flutter | 1 | Patient |
| 2023 | Atrial Fibrillation | 3 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Anxiety | 1 | Patient |
| 2023 | Unstable Capture Threshold | 6 | Device |
| 2023 | Under-Sensing | 120 | Device |
| 2023 | Signal Artifact/Noise | 2 | Device |
| 2023 | Positioning Problem | 9 | Device |
| 2023 | Pacing Problem | 11 | Device |
| 2023 | Over-Sensing | 24 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Separation | 1 | Device |
| 2023 | Material Integrity Problem | 2 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Low impedance | 3 | Device |
| 2023 | Intermittent Capture | 4 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Impedance Problem | 17 | Device |
| 2023 | High impedance | 23 | Device |
| 2023 | High Capture Threshold | 58 | Device |
| 2023 | Fracture | 6 | Device |
| 2023 | Failure to Capture | 15 | Device |
| 2023 | Electrical /Electronic Property Problem | 8 | Device |
| 2023 | Device Sensing Problem | 7 | Device |
| 2023 | Device Dislodged or Dislocated | 17 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2023 | Degraded | 1 | Device |
| 2023 | Defibrillation/Stimulation Problem | 1 | Device |
| 2023 | Decreased Sensitivity | 17 | Device |
| 2023 | Capturing Problem | 17 | Device |
| 2023 | Break | 4 | Device |
| 2023 | Appropriate Term/Code Not Available | 5 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 40 | Device |
| 2023 | Activation, Positioning or Separation Problem | 2 | Device |
| 2022 | Wound Dehiscence | 1 | Patient |
| 2022 | Unspecified Infection | 4 | Patient |
| 2022 | Tachycardia | 1 | Patient |
| 2022 | Syncope/Fainting | 3 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Loss of consciousness | 2 | Patient |
| 2022 | Hematoma | 1 | Patient |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Fatigue | 1 | Patient |
| 2022 | Fall | 2 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Cardiac Arrest | 2 | Patient |
| 2022 | Bradycardia | 3 | Patient |
| 2022 | Atrial Fibrillation | 1 | Patient |
| 2022 | Arrhythmia | 2 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Under-Sensing | 53 | Device |
| 2022 | Stretched | 1 | Device |
| 2022 | Signal Artifact/Noise | 7 | Device |
| 2022 | Positioning Problem | 7 | Device |
| 2022 | Pacing Problem | 14 | Device |
| 2022 | Over-Sensing | 17 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Intermittent Capture | 2 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Impedance Problem | 9 | Device |
| 2022 | High impedance | 22 | Device |
| 2022 | High Capture Threshold | 64 | Device |
| 2022 | Fracture | 2 | Device |
| 2022 | Failure to Capture | 20 | Device |
| 2022 | Electrical /Electronic Property Problem | 6 | Device |
| 2022 | Device Sensing Problem | 5 | Device |
| 2022 | Device Dislodged or Dislocated | 22 | Device |
| 2022 | Decreased Sensitivity | 6 | Device |
| 2022 | Collapse | 1 | Device |
| 2022 | Capturing Problem | 21 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 6 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 35 | Device |
| 2022 | Activation, Positioning or Separation Problem | 4 | Device |
| 2021 | Syncope/Fainting | 1 | Patient |
| 2021 | Dizziness | 1 | Patient |
| 2021 | Bradycardia | 1 | Patient |
| 2021 | Arrhythmia | 1 | Patient |
| 2021 | Under-Sensing | 3 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Pacing Problem | 1 | Device |
| 2021 | Over-Sensing | 3 | Device |
| 2021 | Impedance Problem | 3 | Device |
| 2021 | High impedance | 4 | Device |
| 2021 | High Capture Threshold | 2 | Device |
| 2021 | Expiration Date Error | 1 | Device |
| 2021 | Electromagnetic Interference | 1 | Device |
| 2021 | Electrical /Electronic Property Problem | 6 | Device |
| 2021 | Device Dislodged or Dislocated | 2 | Device |
| 2021 | Capturing Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Unspecified Infection | 1 | Patient |
| 2020 | Syncope/Fainting | 1 | Patient |
| 2020 | Muscle Weakness/Atrophy | 1 | Patient |
| 2020 | Unstable Capture Threshold | 1 | Device |
| 2020 | Under-Sensing | 2 | Device |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | Pocket Stimulation | 1 | Device |
| 2020 | Intermittent Capture | 1 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Decreased Sensitivity | 1 | Device |
| 2020 | Capturing Problem | 1 | Device |
| 2020 | Break | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |