DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC PUERTO RICO OPERATIONS CO, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 2 | Patient |
| 2024 | Vascular Dissection | 1 | Patient |
| 2024 | Unspecified Infection | 32 | Patient |
| 2024 | Undesired Nerve Stimulation | 11 | Patient |
| 2024 | Twitching | 1 | Patient |
| 2024 | Twiddlers Syndrome | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Swelling/ Edema | 5 | Patient |
| 2024 | Septic Shock | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Purulent Discharge | 5 | Patient |
| 2024 | Presyncope | 1 | Patient |
| 2024 | Pocket Erosion | 2 | Patient |
| 2024 | Pericardial Effusion | 3 | Patient |
| 2024 | Pain | 7 | Patient |
| 2024 | Obstruction/Occlusion | 2 | Patient |
| 2024 | Nausea | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 1 | Patient |
| 2024 | Hematoma | 2 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Fever | 3 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Erythema | 5 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Dyspnea | 4 | Patient |
| 2024 | Drug Resistant Bacterial Infection | 2 | Patient |
| 2024 | Discomfort | 5 | Patient |
| 2024 | Device Overstimulation of Tissue | 10 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Bacteremia | 4 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Unstable Capture Threshold | 4 | Device |
| 2024 | Positioning Problem | 3 | Device |
| 2024 | Low impedance | 6 | Device |
| 2024 | Intermittent Capture | 2 | Device |
| 2024 | Insufficient Information | 2 | Device |
| 2024 | Impedance Problem | 6 | Device |
| 2024 | High impedance | 12 | Device |
| 2024 | High Capture Threshold | 32 | Device |
| 2024 | Fracture | 4 | Device |
| 2024 | Failure to Capture | 11 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 20 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Capturing Problem | 13 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Appropriate Term/Code Not Available | 3 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 48 | Device |
| 2024 | Activation, Positioning or Separation Problem | 1 | Device |
| 2024 | Accessory Incompatible | 1 | Device |
| 2023 | Wound Dehiscence | 2 | Patient |
| 2023 | Unspecified Infection | 30 | Patient |
| 2023 | Undesired Nerve Stimulation | 9 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Syncope/Fainting | 4 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Skin Erosion | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Purulent Discharge | 5 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 2 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 4 | Patient |
| 2023 | Fatigue | 5 | Patient |
| 2023 | Erythema | 5 | Patient |
| 2023 | Erosion | 2 | Patient |
| 2023 | Endocarditis | 3 | Patient |
| 2023 | Dyspnea | 4 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 3 | Patient |
| 2023 | Dizziness | 3 | Patient |
| 2023 | Discomfort | 5 | Patient |
| 2023 | Device Overstimulation of Tissue | 9 | Patient |
| 2023 | Chills | 1 | Patient |
| 2023 | Chest Pain | 4 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Bacterial Infection | 3 | Patient |
| 2023 | Bacteremia | 6 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Unstable Capture Threshold | 6 | Device |
| 2023 | Positioning Problem | 8 | Device |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low impedance | 5 | Device |
| 2023 | Intermittent Capture | 6 | Device |
| 2023 | Impedance Problem | 10 | Device |
| 2023 | High impedance | 15 | Device |
| 2023 | High Capture Threshold | 31 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Failure to Capture | 32 | Device |
| 2023 | Electrical /Electronic Property Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 15 | Device |
| 2023 | Capturing Problem | 11 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 50 | Device |
| 2023 | Activation, Positioning or Separation Problem | 7 | Device |
| 2022 | Vascular Dissection | 1 | Patient |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Dyspnea | 2 | Patient |
| 2022 | Device Overstimulation of Tissue | 1 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Signal Artifact/Noise | 1 | Device |
| 2022 | Positioning Problem | 3 | Device |
| 2022 | Low impedance | 1 | Device |
| 2022 | Intermittent Capture | 2 | Device |
| 2022 | Impedance Problem | 9 | Device |
| 2022 | High impedance | 8 | Device |
| 2022 | High Capture Threshold | 28 | Device |
| 2022 | Failure to Capture | 11 | Device |
| 2022 | Device Dislodged or Dislocated | 10 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Capturing Problem | 15 | Device |
| 2022 | Appropriate Term/Code Not Available | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 41 | Device |
| 2022 | Activation, Positioning or Separation Problem | 4 | Device |
| 2022 | Accessory Incompatible | 1 | Device |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Pericarditis | 1 | Patient |
| 2021 | Dyspnea | 1 | Patient |
| 2021 | Device Overstimulation of Tissue | 2 | Patient |
| 2021 | Chest Pain | 1 | Patient |
| 2021 | Positioning Problem | 1 | Device |
| 2021 | Intermittent Capture | 1 | Device |
| 2021 | High impedance | 4 | Device |
| 2021 | High Capture Threshold | 6 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Device Dislodged or Dislocated | 1 | Device |
| 2021 | Capturing Problem | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2020 | Paresthesia | 1 | Patient |
| 2020 | Chest Pain | 1 | Patient |
| 2020 | High Capture Threshold | 3 | Device |
| 2020 | Failure to Capture | 1 | Device |