GENERATOR
This device is manufactured by CYBERONICS / LIVANOVA USA, LIVANOVA USA.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Respiratory Problem | 1 | Patient |
| 2024 | Syncope/Fainting | 1 | Patient |
| 2024 | Post Operative Wound Infection | 1 | Patient |
| 2024 | Neck Pain | 1 | Patient |
| 2024 | Implant Pain | 2 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Convulsion, Clonic | 7 | Patient |
| 2024 | Coma | 1 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | Incomplete or Inadequate Connection | 1 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 11 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Mental, Emotional or Behavioural Problem | 2 | Patient |
| 2023 | Unspecified Heart Problem | 1 | Patient |
| 2023 | Tachycardia | 1 | Patient |
| 2023 | Status Epilepticus | 2 | Patient |
| 2023 | Skin Infection | 2 | Patient |
| 2023 | Post Operative Wound Infection | 3 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Neck Pain | 1 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Implant Pain | 5 | Patient |
| 2023 | Hypoxia | 1 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Diarrhea | 2 | Patient |
| 2023 | Cyanosis | 1 | Patient |
| 2023 | Cough | 1 | Patient |
| 2023 | Convulsion, Clonic | 27 | Patient |
| 2023 | Atrial Fibrillation | 1 | Patient |
| 2023 | Asystole | 1 | Patient |
| 2023 | Aspiration/Inhalation | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 6 | Patient |
| 2023 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2023 | Premature Elective Replacement Indicator | 1 | Device |
| 2023 | Premature Discharge of Battery | 5 | Device |
| 2023 | Output below Specifications | 3 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Incomplete or Inadequate Connection | 1 | Device |
| 2023 | Inappropriate or Unexpected Reset | 2 | Device |
| 2023 | High impedance | 2 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Battery Problem: High Impedance | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 44 | Device |
| 2022 | Status Epilepticus | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Discomfort | 2 | Patient |
| 2022 | Convulsion, Clonic | 7 | Patient |
| 2022 | Asystole | 2 | Patient |
| 2022 | Appropriate Term / Code Not Available | 1 | Patient |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | No Apparent Adverse Event | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Incomplete or Inadequate Connection | 4 | Device |
| 2022 | High impedance | 4 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 39 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Depression | 1 | Patient |
| 2021 | Convulsion, Clonic | 1 | Patient |
| 2021 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 2 | Device |