QUATTRODE LEAD WIDE SPACED, 30 CM

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