IMPLANTABLE PACING LEAD
This device is manufactured by MEDTRONIC, MEDTRONIC PUERTO RICO, MEDTRONIC SA, Q-MED, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 11 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Sepsis | 1 | Patient |
| 2024 | Post Traumatic Wound Infection | 2 | Patient |
| 2024 | Multiple Organ Dysfunction Syndrome | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2024 | Failure of Implant | 3 | Patient |
| 2024 | Electric Shock | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cardiomyopathy | 1 | Patient |
| 2024 | Bradycardia | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Unstable Capture Threshold | 2 | Device |
| 2024 | Under-Sensing | 1 | Device |
| 2024 | Signal Artifact/Noise | 3 | Device |
| 2024 | Over-Sensing | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 2 | Device |
| 2024 | High Capture Threshold | 2 | Device |
| 2024 | Fracture | 3 | Device |
| 2024 | Failure to Capture | 1 | Device |
| 2024 | Electrical /Electronic Property Problem | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 2 | Patient |
| 2023 | Pacing Problem | 1 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | Failure to Capture | 2 | Device |
| 2023 | Capturing Problem | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Unspecified Infection | 3 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Fall | 1 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Signal Artifact/Noise | 2 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Over-Sensing | 3 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Impedance Problem | 3 | Device |
| 2022 | High impedance | 2 | Device |
| 2022 | High Capture Threshold | 6 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Failure to Capture | 1 | Device |
| 2022 | Device Dislodged or Dislocated | 2 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Ambient Noise Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2021 | Unspecified Infection | 2 | Patient |
| 2021 | Tachycardia | 1 | Patient |
| 2021 | Insufficient Information | 19 | Patient |
| 2021 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Pacemaker Found in Back-Up Mode | 4 | Device |
| 2021 | Over-Sensing | 3 | Device |
| 2021 | Noise, Audible | 1 | Device |
| 2021 | Material Integrity Problem | 1 | Device |
| 2021 | Material Erosion | 3 | Device |
| 2021 | Insufficient Information | 6 | Device |
| 2021 | Impedance Problem | 2 | Device |
| 2021 | High impedance | 5 | Device |
| 2021 | Fracture | 1 | Device |
| 2021 | Failure to Capture | 3 | Device |
| 2021 | Capturing Problem | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Insufficient Information | 2 | Patient |
| 2020 | Output Problem | 1 | Device |
| 2020 | Insufficient Information | 2 | Device |
| 2020 | Impedance Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |