SCS LEAD
This device is manufactured by ABBOTT MEDICAL, ADVANCED NEUROMODULATION SYSTEMS, ST JUDE - NEUROMODULATION, ST JUDE MED - NEUROMODULATION, ST JUDE MEDICAL - NEUROMODULATION and others.
The following problems were reported about this device:
Year | Description | Events/year | Type |
---|---|---|---|
2024 | Inadequate Pain Relief | 1 | Patient |
2024 | Implant Pain | 2 | Patient |
2024 | Impaired Healing | 1 | Patient |
2024 | Failure of Implant | 1 | Patient |
2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
2023 | Inadequate Pain Relief | 1 | Patient |
2023 | Therapeutic or Diagnostic Output Failure | 1 | Device |
2022 | Use of Device Problem | 1 | Device |
2022 | Therapeutic or Diagnostic Output Failure | 4 | Device |
2022 | Material Fragmentation | 1 | Device |
2021 | Inadequate Pain Relief | 1 | Patient |
2021 | Migration | 1 | Device |
2019 | Therapeutic or Diagnostic Output Failure | 1 | Device |
2019 | Migration or Expulsion of Device | 1 | Device |
2019 | Migration | 1 | Device |
2019 | Impedance Problem | 1 | Device |
2019 | High impedance | 5 | Device |
2019 | Fracture | 2 | Device |
2019 | Disconnection | 2 | Device |
2019 | Adverse Event Without Identified Device or Use Problem | 23 | Device |
2018 | Migration | 1 | Device |
2018 | Impedance Problem | 3 | Device |
2018 | High impedance | 9 | Device |
2018 | Fracture | 5 | Device |
2018 | Adverse Event Without Identified Device or Use Problem | 37 | Device |
2017 | Low impedance | 1 | Device |
2017 | Impedance Problem | 2 | Device |
2017 | High impedance | 4 | Device |
2017 | Fracture | 3 | Device |
2017 | Adverse Event Without Identified Device or Use Problem | 57 | Device |
2016 | Impedance Problem | 4 | Device |
2016 | High impedance | 1 | Device |
2016 | Fracture | 5 | Device |
2016 | Device Operates Differently Than Expected | 1 | Device |
2016 | Adverse Event Without Identified Device or Use Problem | 30 | Device |
2015 | Therapy Delivered to Incorrect Body Area | 1 | Device |
2015 | Migration or Expulsion of Device | 1 | Device |
2015 | High impedance | 2 | Device |
2015 | Device Operates Differently Than Expected | 1 | Device |
2015 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
2014 | Therapy Delivered to Incorrect Body Area | 4 | Device |
2014 | Temperature Problem | 1 | Device |
2014 | Self-Activation or Keying | 1 | Device |
2014 | Pocket Stimulation | 1 | Device |
2014 | Migration or Expulsion of Device | 9 | Device |
2014 | Impedance Problem | 11 | Device |
2014 | High impedance | 2 | Device |
2014 | Fracture | 1 | Device |
2014 | Device Operates Differently Than Expected | 44 | Device |
2014 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
2013 | Inappropriate/Inadequate Shock/Stimulation | 2 | Device |
2013 | Impedance Problem | 3 | Device |
2013 | Device Operates Differently Than Expected | 9 | Device |
2013 | Adverse Event Without Identified Device or Use Problem | 6 | Device |
2012 | Device Operates Differently Than Expected | 1 | Device |
2012 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
2011 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
2011 | Device Operates Differently Than Expected | 4 | Device |
2010 | Therapeutic or Diagnostic Output Failure | 2 | Device |
2010 | Device Operates Differently Than Expected | 1 | Device |
2009 | Device Operates Differently Than Expected | 2 | Device |