DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 2 | Patient |
| 2024 | Unspecified Infection | 27 | Patient |
| 2024 | Undesired Nerve Stimulation | 7 | Patient |
| 2024 | Twiddlers Syndrome | 1 | Patient |
| 2024 | Syncope/Fainting | 2 | Patient |
| 2024 | Swelling/ Edema | 3 | Patient |
| 2024 | Septic Shock | 1 | Patient |
| 2024 | Sepsis | 4 | Patient |
| 2024 | Renal Failure | 1 | Patient |
| 2024 | Purulent Discharge | 7 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Lethargy | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Hypovolemia | 1 | Patient |
| 2024 | Hyperkalemia | 1 | Patient |
| 2024 | Heart Block | 2 | Patient |
| 2024 | Fever | 3 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Erythema | 3 | Patient |
| 2024 | Erosion | 4 | Patient |
| 2024 | Endocarditis | 4 | Patient |
| 2024 | Dyspnea | 8 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 7 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiogenic Shock | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Bacterial Infection | 2 | Patient |
| 2024 | Bacteremia | 3 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 2 | Patient |
| 2024 | Unstable Capture Threshold | 1 | Device |
| 2024 | Positioning Problem | 1 | Device |
| 2024 | Pocket Stimulation | 1 | Device |
| 2024 | Low impedance | 4 | Device |
| 2024 | Intermittent Capture | 5 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 26 | Device |
| 2024 | Failure to Capture | 19 | Device |
| 2024 | Device Dislodged or Dislocated | 7 | Device |
| 2024 | Capturing Problem | 9 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 7 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 36 | Device |
| 2024 | Activation, Positioning or Separation Problem | 5 | Device |
| 2023 | Unspecified Infection | 20 | Patient |
| 2023 | Undesired Nerve Stimulation | 6 | Patient |
| 2023 | Twiddlers Syndrome | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Swelling/ Edema | 6 | Patient |
| 2023 | Sepsis | 4 | Patient |
| 2023 | Purulent Discharge | 5 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Insufficient Information | 4 | Patient |
| 2023 | Fluid Discharge | 1 | Patient |
| 2023 | Fever | 3 | Patient |
| 2023 | Fall | 3 | Patient |
| 2023 | Erythema | 8 | Patient |
| 2023 | Erosion | 2 | Patient |
| 2023 | Dyspnea | 1 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Device Overstimulation of Tissue | 4 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Bacterial Infection | 2 | Patient |
| 2023 | Bacteremia | 3 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Abscess | 1 | Patient |
| 2023 | Unstable Capture Threshold | 2 | Device |
| 2023 | Positioning Problem | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low impedance | 4 | Device |
| 2023 | Intermittent Capture | 4 | Device |
| 2023 | Impedance Problem | 5 | Device |
| 2023 | High impedance | 6 | Device |
| 2023 | High Capture Threshold | 26 | Device |
| 2023 | Failure to Capture | 21 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 12 | Device |
| 2023 | Deformation Due to Compressive Stress | 1 | Device |
| 2023 | Capturing Problem | 12 | Device |
| 2023 | Break | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 36 | Device |
| 2023 | Activation, Positioning or Separation Problem | 4 | Device |
| 2022 | Undesired Nerve Stimulation | 1 | Patient |
| 2022 | Twiddlers Syndrome | 1 | Patient |
| 2022 | Muscle Weakness/Atrophy | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2022 | Diaphoresis | 1 | Patient |
| 2022 | Chest Pain | 2 | Patient |
| 2022 | Unstable Capture Threshold | 5 | Device |
| 2022 | Positioning Problem | 2 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Low impedance | 4 | Device |
| 2022 | Intermittent Capture | 5 | Device |
| 2022 | Impedance Problem | 5 | Device |
| 2022 | High impedance | 5 | Device |
| 2022 | High Capture Threshold | 27 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Capture | 9 | Device |
| 2022 | Electrical /Electronic Property Problem | 2 | Device |
| 2022 | Device Dislodged or Dislocated | 15 | Device |
| 2022 | Capturing Problem | 11 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2022 | Activation, Positioning or Separation Problem | 4 | Device |
| 2021 | Swollen Lymph Nodes/Glands | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Obstruction/Occlusion | 1 | Patient |
| 2021 | Device Overstimulation of Tissue | 1 | Patient |
| 2021 | Bacteremia | 2 | Patient |
| 2021 | Low impedance | 1 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | High Capture Threshold | 5 | Device |
| 2021 | Failure to Capture | 1 | Device |
| 2021 | Capturing Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |