DRUG-ELUTING PERMANENT DEFIBRILLATOR ELECTRODES
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC PUERTO RICO, MEDTRONIC SINGAPORE OPERATIONS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 2 | Patient |
| 2024 | Vomiting | 1 | Patient |
| 2024 | Ventricular Fibrillation | 2 | Patient |
| 2024 | Unspecified Infection | 19 | Patient |
| 2024 | Tachycardia | 1 | Patient |
| 2024 | Syncope/Fainting | 3 | Patient |
| 2024 | Swelling/ Edema | 6 | Patient |
| 2024 | Shock from Patient Lead(s) | 3 | Patient |
| 2024 | Sepsis | 3 | Patient |
| 2024 | Purulent Discharge | 4 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Pericardial Effusion | 1 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Muscle Weakness/Atrophy | 2 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Fungal Infection | 1 | Patient |
| 2024 | Fluid Discharge | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Erythema | 5 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Endocarditis | 2 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Cardiac Arrest | 2 | Patient |
| 2024 | Bacterial Infection | 3 | Patient |
| 2024 | Bacteremia | 3 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Under-Sensing | 28 | Device |
| 2024 | Signal Artifact/Noise | 9 | Device |
| 2024 | Pacing Problem | 3 | Device |
| 2024 | Over-Sensing | 32 | Device |
| 2024 | Low impedance | 8 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2024 | Impedance Problem | 12 | Device |
| 2024 | High impedance | 16 | Device |
| 2024 | High Capture Threshold | 18 | Device |
| 2024 | Fracture | 8 | Device |
| 2024 | Failure to Capture | 5 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 4 | Device |
| 2024 | Decreased Sensitivity | 10 | Device |
| 2024 | Collapse | 1 | Device |
| 2024 | Capturing Problem | 5 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Ventricular Fibrillation | 1 | Patient |
| 2023 | Unspecified Infection | 20 | Patient |
| 2023 | Syncope/Fainting | 4 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Shock from Patient Lead(s) | 17 | Patient |
| 2023 | Sepsis | 3 | Patient |
| 2023 | Purulent Discharge | 2 | Patient |
| 2023 | Pulmonary Edema | 1 | Patient |
| 2023 | Presyncope | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Obstruction/Occlusion | 2 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2023 | Hematoma | 1 | Patient |
| 2023 | Heart Block | 1 | Patient |
| 2023 | Fungal Infection | 1 | Patient |
| 2023 | Fluid Discharge | 2 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Erythema | 5 | Patient |
| 2023 | Erosion | 5 | Patient |
| 2023 | Endocarditis | 4 | Patient |
| 2023 | Electrolyte Imbalance | 1 | Patient |
| 2023 | Dyspnea | 5 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Device Overstimulation of Tissue | 2 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cardiac Perforation | 1 | Patient |
| 2023 | Cardiac Arrest | 2 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Bacteremia | 3 | Patient |
| 2023 | Arrhythmia | 2 | Patient |
| 2023 | Appropriate Term / Code Not Available | 4 | Patient |
| 2023 | Unstable Capture Threshold | 2 | Device |
| 2023 | Under-Sensing | 24 | Device |
| 2023 | Stretched | 1 | Device |
| 2023 | Signal Artifact/Noise | 29 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Pacing Problem | 5 | Device |
| 2023 | Over-Sensing | 87 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low impedance | 19 | Device |
| 2023 | Intermittent Capture | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 15 | Device |
| 2023 | Impedance Problem | 36 | Device |
| 2023 | High impedance | 37 | Device |
| 2023 | High Capture Threshold | 21 | Device |
| 2023 | Fracture | 32 | Device |
| 2023 | Failure to Capture | 11 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Device Sensing Problem | 4 | Device |
| 2023 | Device Dislodged or Dislocated | 4 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Decreased Sensitivity | 20 | Device |
| 2023 | Connection Problem | 3 | Device |
| 2023 | Collapse | 1 | Device |
| 2023 | Capturing Problem | 7 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Appropriate Term/Code Not Available | 9 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2023 | Activation, Positioning or Separation Problem | 1 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Obstruction/Occlusion | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Fall | 1 | Patient |
| 2022 | Chest Pain | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Unstable Capture Threshold | 4 | Device |
| 2022 | Under-Sensing | 12 | Device |
| 2022 | Stretched | 1 | Device |
| 2022 | Signal Artifact/Noise | 19 | Device |
| 2022 | Positioning Failure | 1 | Device |
| 2022 | Pacing Problem | 7 | Device |
| 2022 | Over-Sensing | 66 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | Material Twisted/Bent | 1 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Low impedance | 11 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 9 | Device |
| 2022 | Impedance Problem | 26 | Device |
| 2022 | High impedance | 39 | Device |
| 2022 | High Capture Threshold | 13 | Device |
| 2022 | Fracture | 24 | Device |
| 2022 | Failure to Capture | 4 | Device |
| 2022 | Device Sensing Problem | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 2 | Device |
| 2022 | Device Contamination with Body Fluid | 1 | Device |
| 2022 | Defibrillation/Stimulation Problem | 1 | Device |
| 2022 | Decreased Sensitivity | 12 | Device |
| 2022 | Capturing Problem | 5 | Device |
| 2022 | Break | 4 | Device |
| 2022 | Appropriate Term/Code Not Available | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 26 | Device |
| 2022 | Activation, Positioning or Separation Problem | 2 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Thrombosis/Thrombus | 1 | Patient |
| 2021 | Pericardial Effusion | 1 | Patient |
| 2021 | Non specific EKG/ECG Changes | 1 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2021 | Bacterial Infection | 1 | Patient |
| 2021 | Under-Sensing | 2 | Device |
| 2021 | Over-Sensing | 5 | Device |
| 2021 | Low impedance | 3 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 2 | Device |
| 2021 | High Capture Threshold | 1 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Decreased Sensitivity | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
| 2020 | Perforation | 1 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Dyspnea | 1 | Patient |
| 2020 | Cardiac Perforation | 1 | Patient |
| 2020 | Signal Artifact/Noise | 1 | Device |
| 2020 | Over-Sensing | 4 | Device |
| 2020 | Low impedance | 1 | Device |
| 2020 | Impedance Problem | 2 | Device |
| 2020 | High impedance | 2 | Device |
| 2020 | High Capture Threshold | 1 | Device |
| 2020 | Fracture | 1 | Device |
| 2020 | Failure to Capture | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 1 | Device |
| 2020 | Defibrillation/Stimulation Problem | 1 | Device |
| 2020 | Collapse | 1 | Device |
| 2020 | Capturing Problem | 1 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |