IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC PUERTO RICO OPERATIONS CO.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Ventricular Fibrillation | 1 | Patient |
| 2024 | Unspecified Infection | 8 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Rash | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Obstruction/Occlusion | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Fungal Infection | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Cardiovascular Insufficiency | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Over-Sensing | 1 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Intermittent Capture | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 7 | Device |
| 2024 | Failure to Capture | 5 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Break | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Infection | 7 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Thrombosis/Thrombus | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Unstable Capture Threshold | 1 | Device |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Over-Sensing | 1 | Device |
| 2023 | Material Integrity Problem | 1 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | High Capture Threshold | 9 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Capture | 3 | Device |
| 2023 | Device Sensing Problem | 1 | Device |
| 2023 | Device Dislodged or Dislocated | 1 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Nerve Damage | 1 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Unstable Capture Threshold | 1 | Device |
| 2022 | Signal Artifact/Noise | 1 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Over-Sensing | 1 | Device |
| 2022 | Output below Specifications | 1 | Device |
| 2022 | Low impedance | 3 | Device |
| 2022 | Impedance Problem | 4 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | High Capture Threshold | 5 | Device |
| 2022 | Failure to Capture | 3 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Device Contamination with Body Fluid | 1 | Device |
| 2022 | Defective Component | 1 | Device |
| 2022 | Capturing Problem | 3 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Ambient Noise Problem | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2021 | Unspecified Infection | 1 | Patient |
| 2021 | Sepsis | 1 | Patient |
| 2021 | Insufficient Information | 4 | Patient |
| 2021 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | High Capture Threshold | 3 | Device |
| 2021 | Failure to Capture | 3 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Insufficient Information | 5 | Patient |
| 2020 | Under-Sensing | 1 | Device |
| 2020 | Product Quality Problem | 2 | Device |
| 2020 | Over-Sensing | 1 | Device |
| 2020 | Low impedance | 1 | Device |
| 2020 | Intermittent Capture | 1 | Device |
| 2020 | Impedance Problem | 1 | Device |
| 2020 | Failure to Capture | 2 | Device |
| 2020 | Device Sensing Problem | 1 | Device |
| 2020 | Device Dislodged or Dislocated | 1 | Device |
| 2020 | Decreased Sensitivity | 1 | Device |
| 2020 | Capturing Problem | 2 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |