SPINAL CORD STIMULATOR
This device is manufactured by BOSTON SCIENTIFIC, BOSTON SCIENTIFIC - CORK, BOSTON SCIENTIFIC CORPORATION, BOSTON SCIENTIFIC NEUROMODULATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 3 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Pain | 16 | Patient |
| 2024 | Muscle Weakness/Atrophy | 1 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Implant Pain | 2 | Patient |
| 2024 | Discomfort | 2 | Patient |
| 2024 | Burn(s) | 1 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Wireless Communication Problem | 1 | Device |
| 2024 | Unexpected Therapeutic Results | 11 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Migration | 1 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2024 | Impedance Problem | 1 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | Delayed Charge Time | 2 | Device |
| 2024 | Defective Device | 10 | Device |
| 2024 | Charging Problem | 40 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Undesired Nerve Stimulation | 8 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Stroke/CVA | 1 | Patient |
| 2023 | Pocket Erosion | 2 | Patient |
| 2023 | Pain | 38 | Patient |
| 2023 | Muscle Weakness/Atrophy | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Inadequate Pain Relief | 4 | Patient |
| 2023 | Implant Pain | 5 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Discomfort | 6 | Patient |
| 2023 | Convulsion/Seizure | 1 | Patient |
| 2023 | Burning Sensation | 1 | Patient |
| 2023 | Bradycardia | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Wireless Communication Problem | 2 | Device |
| 2023 | Unexpected Therapeutic Results | 35 | Device |
| 2023 | Positioning Problem | 2 | Device |
| 2023 | Overheating of Device | 1 | Device |
| 2023 | Migration | 6 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 6 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Failure to Disconnect | 1 | Device |
| 2023 | Delayed Charge Time | 14 | Device |
| 2023 | Defective Device | 23 | Device |
| 2023 | Charging Problem | 131 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 34 | Device |
| 2022 | Pain | 14 | Patient |
| 2022 | Insufficient Information | 2 | Patient |
| 2022 | Inadequate Pain Relief | 8 | Patient |
| 2022 | Implant Pain | 6 | Patient |
| 2022 | Discomfort | 2 | Patient |
| 2022 | Burning Sensation | 1 | Patient |
| 2022 | Wireless Communication Problem | 5 | Device |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unexpected Therapeutic Results | 51 | Device |
| 2022 | Premature Discharge of Battery | 5 | Device |
| 2022 | Overheating of Device | 2 | Device |
| 2022 | Migration | 6 | Device |
| 2022 | Intermittent Energy Output | 2 | Device |
| 2022 | High impedance | 8 | Device |
| 2022 | Delayed Charge Time | 7 | Device |
| 2022 | Defective Device | 17 | Device |
| 2022 | Charging Problem | 134 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 39 | Device |
| 2021 | Undesired Nerve Stimulation | 3 | Patient |
| 2021 | Pain | 7 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Inadequate Pain Relief | 2 | Patient |
| 2021 | Implant Pain | 1 | Patient |
| 2021 | Discomfort | 1 | Patient |
| 2021 | Burning Sensation | 2 | Patient |
| 2021 | Wireless Communication Problem | 2 | Device |
| 2021 | Use of Device Problem | 1 | Device |
| 2021 | Unexpected Therapeutic Results | 24 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |
| 2021 | Power Problem | 1 | Device |
| 2021 | No Apparent Adverse Event | 1 | Device |
| 2021 | Migration | 4 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Delayed Charge Time | 4 | Device |
| 2021 | Defective Device | 4 | Device |
| 2021 | Charging Problem | 42 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 14 | Device |
| 2020 | Pain | 3 | Patient |
| 2020 | Inadequate Pain Relief | 1 | Patient |
| 2020 | Discomfort | 2 | Patient |
| 2020 | Burning Sensation | 1 | Patient |
| 2020 | Unexpected Therapeutic Results | 8 | Device |
| 2020 | Migration | 2 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2020 | Delayed Charge Time | 2 | Device |
| 2020 | Defective Device | 3 | Device |
| 2020 | Charging Problem | 10 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 6 | Device |