SPINAL CORD STIMULATOR
This device is manufactured by BOSTON SCIENTIFIC CORPORATE HEADQUARTERS, BOSTON SCIENTIFIC CORPORATION, BOSTON SCIENTIFIC NEUROMODULATION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 1 | Patient |
| 2024 | Urinary Frequency | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Thrombosis/Thrombus | 1 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Shaking/Tremors | 1 | Patient |
| 2024 | Pulmonary Embolism | 1 | Patient |
| 2024 | Paralysis | 1 | Patient |
| 2024 | Pain | 8 | Patient |
| 2024 | Nausea | 2 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Inadequate Pain Relief | 1 | Patient |
| 2024 | High Blood Pressure/ Hypertension | 1 | Patient |
| 2024 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2024 | Hematoma | 3 | Patient |
| 2024 | Headache | 2 | Patient |
| 2024 | Foreign Body In Patient | 1 | Patient |
| 2024 | Failure of Implant | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Convulsion/Seizure | 1 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Atrial Fibrillation | 1 | Patient |
| 2024 | Arrhythmia | 1 | Patient |
| 2024 | Use of Device Problem | 2 | Device |
| 2024 | Unexpected Therapeutic Results | 3 | Device |
| 2024 | High impedance | 3 | Device |
| 2024 | Fracture | 1 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Urinary Incontinence | 1 | Patient |
| 2023 | Unspecified Mental, Emotional or Behavioural Problem | 1 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Sepsis | 1 | Patient |
| 2023 | Respiratory Failure | 1 | Patient |
| 2023 | Rash | 1 | Patient |
| 2023 | Pneumonia | 1 | Patient |
| 2023 | Paresthesia | 1 | Patient |
| 2023 | Pain | 14 | Patient |
| 2023 | Numbness | 1 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Myocardial Infarction | 1 | Patient |
| 2023 | Muscle Weakness/Atrophy | 3 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Ischemia | 1 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Inadequate Pain Relief | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 2 | Patient |
| 2023 | Hemorrhage/Blood Loss/Bleeding | 2 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Headache | 2 | Patient |
| 2023 | Fever | 3 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Emotional Changes | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Cramp(s) /Muscle Spasm(s) | 1 | Patient |
| 2023 | Chest Pain | 1 | Patient |
| 2023 | Cerebrospinal Fluid Leakage | 2 | Patient |
| 2023 | Cardiac Arrest | 1 | Patient |
| 2023 | Burning Sensation | 1 | Patient |
| 2023 | Bacterial Infection | 1 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Apnea | 1 | Patient |
| 2023 | Unexpected Therapeutic Results | 4 | Device |
| 2023 | Migration | 3 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | Fracture | 2 | Device |
| 2023 | Device Dislodged or Dislocated | 4 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 21 | Device |
| 2022 | Sepsis | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Structural Problem | 1 | Device |
| 2022 | Positioning Problem | 5 | Device |
| 2022 | Migration | 1 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2022 | High impedance | 1 | Device |
| 2022 | Fracture | 4 | Device |
| 2022 | Device Dislodged or Dislocated | 5 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 19 | Device |
| 2021 | Pain | 1 | Patient |
| 2021 | Unexpected Therapeutic Results | 2 | Device |
| 2021 | High impedance | 3 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2019 | Insufficient Information | 1 | Patient |
| 2019 | Fever | 1 | Patient |
| 2019 | Erythema | 1 | Patient |
| 2019 | Unexpected Therapeutic Results | 4 | Device |
| 2019 | Positioning Problem | 3 | Device |
| 2019 | Migration | 4 | Device |
| 2019 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2019 | High impedance | 5 | Device |
| 2019 | Fracture | 9 | Device |
| 2019 | Difficult to Remove | 3 | Device |
| 2019 | Device Dislodged or Dislocated | 6 | Device |
| 2019 | Defective Device | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 52 | Device |
| 2018 | Unintended Movement | 4 | Device |
| 2018 | Unexpected Therapeutic Results | 5 | Device |
| 2018 | Positioning Problem | 1 | Device |
| 2018 | Migration | 7 | Device |
| 2018 | Material Separation | 2 | Device |
| 2018 | Material Puncture/Hole | 1 | Device |
| 2018 | Low impedance | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | High impedance | 12 | Device |
| 2018 | Fracture | 13 | Device |
| 2018 | Failure to Fire | 1 | Device |
| 2018 | Failure to Disconnect | 1 | Device |
| 2018 | Difficult to Remove | 2 | Device |
| 2018 | Device Dislodged or Dislocated | 11 | Device |
| 2018 | Detachment of Device or Device Component | 1 | Device |
| 2018 | Defective Device | 2 | Device |
| 2018 | Component Missing | 1 | Device |
| 2018 | Break | 2 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 74 | Device |
| 2017 | Migration or Expulsion of Device | 8 | Device |
| 2017 | Material Separation | 10 | Device |
| 2017 | Material Frayed | 2 | Device |
| 2017 | Material Fragmentation | 2 | Device |
| 2017 | Material Discolored | 1 | Device |
| 2017 | Malposition of Device | 1 | Device |
| 2017 | Kinked | 3 | Device |
| 2017 | Invalid Sensing | 1 | Device |
| 2017 | High impedance | 18 | Device |
| 2017 | Fracture | 17 | Device |
| 2017 | Difficult To Position | 1 | Device |
| 2017 | Device Or Device Fragments Location Unknown | 2 | Device |
| 2017 | Device Inoperable | 1 | Device |
| 2017 | Device Expiration Issue | 1 | Device |
| 2017 | Device Dislodged or Dislocated | 1 | Device |
| 2017 | Component Missing | 2 | Device |
| 2017 | Charging Problem | 1 | Device |
| 2017 | Break | 14 | Device |
| 2017 | Bent | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 62 | Device |
| 2016 | Telemetry Discrepancy | 1 | Device |
| 2016 | Split | 1 | Device |
| 2016 | No Apparent Adverse Event | 4 | Device |
| 2016 | Migration or Expulsion of Device | 1 | Device |
| 2016 | Kinked | 2 | Device |
| 2016 | High impedance | 15 | Device |
| 2016 | Fracture | 5 | Device |
| 2016 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2016 | Device Inoperable | 1 | Device |
| 2016 | Detachment of Device or Device Component | 2 | Device |
| 2016 | Component Missing | 2 | Device |
| 2016 | Charging Problem | 1 | Device |
| 2016 | Break | 3 | Device |
| 2016 | Bent | 3 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 22 | Device |
| 2015 | No Apparent Adverse Event | 2 | Device |
| 2015 | Device, or device fragments remain in patient | 1 | Device |
| 2015 | Break | 1 | Device |
| 2014 | No Apparent Adverse Event | 12 | Device |
| 2014 | Migration or Expulsion of Device | 1 | Device |
| 2014 | Material Separation | 2 | Device |
| 2014 | Kinked | 2 | Device |
| 2014 | High impedance | 10 | Device |
| 2014 | Fracture | 4 | Device |
| 2014 | Device, or device fragments remain in patient | 2 | Device |
| 2014 | Device Dislodged or Dislocated | 5 | Device |
| 2014 | Cut In Material | 1 | Device |
| 2014 | Break | 7 | Device |
| 2014 | Bent | 3 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2013 | No Apparent Adverse Event | 2 | Device |
| 2013 | Migration or Expulsion of Device | 1 | Device |
| 2013 | High impedance | 6 | Device |
| 2013 | Fracture | 6 | Device |
| 2013 | Device, or device fragments remain in patient | 1 | Device |
| 2013 | Device Dislodged or Dislocated | 1 | Device |
| 2013 | Break | 2 | Device |
| 2012 | No Apparent Adverse Event | 1 | Device |