PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MDT PUERTO RICO OPERATIONS CO MED REL, MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Fatigue | 1 | Patient |
| 2024 | Fall | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Bradycardia | 3 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Premature Discharge of Battery | 2 | Device |
| 2024 | Pacing Problem | 2 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Drug Resistant Bacterial Infection | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Device Overstimulation of Tissue | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Bradycardia | 2 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Reset Problem | 2 | Device |
| 2023 | Premature Discharge of Battery | 2 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Pacing Problem | 2 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Failure to Interrogate | 3 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Heart Block | 1 | Patient |
| 2022 | Bradycardia | 1 | Patient |
| 2022 | Reset Problem | 1 | Device |
| 2022 | Premature Discharge of Battery | 2 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Mechanical Problem | 1 | Device |
| 2022 | High Capture Threshold | 1 | Device |
| 2022 | Failure to Interrogate | 5 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |