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This device is manufactured by MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC NEUROMODULATION, MEDTRONIC NEUROMODULATION SULLIVAN LAKE, MEDTRONIC PUERTO RICO OPERATIONS CO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Stroke/CVA | 1 | Patient |
| 2024 | Loss of Vision | 1 | Patient |
| 2024 | Dizziness | 1 | Patient |
| 2024 | Cerebrospinal Fluid Leakage | 1 | Patient |
| 2024 | Unstable | 1 | Device |
| 2024 | Unintended Movement | 2 | Device |
| 2024 | Material Twisted/Bent | 2 | Device |
| 2024 | Material Deformation | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Insufficient Information | 3 | Device |
| 2024 | Impedance Problem | 4 | Device |
| 2024 | High impedance | 8 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Difficult to Open or Close | 1 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Break | 5 | Device |
| 2024 | Appropriate Term/Code Not Available | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2024 | Activation, Positioning or Separation Problem | 1 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Undesired Nerve Stimulation | 2 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Pain | 2 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Intracranial Hemorrhage | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Electric Shock | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Unstable | 1 | Device |
| 2023 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2023 | Pocket Stimulation | 1 | Device |
| 2023 | Migration or Expulsion of Device | 1 | Device |
| 2023 | Material Twisted/Bent | 3 | Device |
| 2023 | Malposition of Device | 1 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Insufficient Information | 6 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Impedance Problem | 2 | Device |
| 2023 | High impedance | 10 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Difficult to Open or Close | 2 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Break | 8 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Erythema | 1 | Patient |
| 2022 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2022 | Migration or Expulsion of Device | 3 | Device |
| 2022 | Material Twisted/Bent | 2 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Impedance Problem | 3 | Device |
| 2022 | High impedance | 12 | Device |
| 2022 | Difficult to Open or Close | 1 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Break | 5 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Migration or Expulsion of Device | 1 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |