PULSE GENERATOR, PERMANENT, IMPLANTABLE
This device is manufactured by MDT SOFAMOR DANEK PUERTO RICO MFG, 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 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Erosion | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Cardiac Arrest | 1 | Patient |
| 2024 | Asystole | 1 | Patient |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Pacing Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Syncope/Fainting | 2 | Patient |
| 2023 | Muscle Weakness/Atrophy | 2 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Heart Failure/Congestive Heart Failure | 1 | Patient |
| 2023 | Heart Block | 2 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Bradycardia | 3 | Patient |
| 2023 | Aspiration/Inhalation | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Unable to Obtain Readings | 1 | Device |
| 2023 | Reset Problem | 1 | Device |
| 2023 | Premature Discharge of Battery | 6 | Device |
| 2023 | Pacing Problem | 4 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Mechanical Problem | 1 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | High Capture Threshold | 1 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Electromagnetic Interference | 1 | Device |
| 2023 | Communication or Transmission Problem | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Appropriate Term/Code Not Available | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Syncope/Fainting | 1 | Patient |
| 2022 | Loss of consciousness | 1 | Patient |
| 2022 | Failure of Implant | 1 | Patient |
| 2022 | Dyspnea | 1 | Patient |
| 2022 | Dizziness | 1 | Patient |
| 2022 | Premature Discharge of Battery | 4 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | High Capture Threshold | 2 | Device |
| 2022 | Failure to Interrogate | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 7 | Device |