OCTRODE LEAD KIT, 90CM LENGTH

SCS LEAD

This device is manufactured by ABBOTT MEDICAL, ADVANCED NEUROMODULATION SYSTEMS, ST JUDE - NEUROMODULATION, ST JUDE MED - NEUROMODULATION, ST JUDE MEDICAL and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Undesired Nerve Stimulation 5 Patient
2024 Twiddlers Syndrome 2 Patient
2024 Post Operative Wound Infection 2 Patient
2024 Inadequate Pain Relief 41 Patient
2024 Headache 1 Patient
2024 Foreign Body In Patient 1 Patient
2024 Failure of Implant 7 Patient
2024 Cerebrospinal Fluid Leakage 1 Patient
2024 Therapeutic or Diagnostic Output Failure 8 Device
2024 Patient-Device Incompatibility 1 Device
2024 Migration 23 Device
2024 Material Twisted/Bent 2 Device
2024 Low impedance 2 Device
2024 Inappropriate/Inadequate Shock/Stimulation 1 Device
2024 Impedance Problem 1 Device
2024 High impedance 9 Device
2024 Adverse Event Without Identified Device or Use Problem 3 Device
2023 Undesired Nerve Stimulation 1 Patient
2023 Skin Erosion 1 Patient
2023 Inadequate Pain Relief 50 Patient
2023 Headache 1 Patient
2023 Failure of Implant 5 Patient
2023 Cerebrospinal Fluid Leakage 1 Patient
2023 Therapeutic or Diagnostic Output Failure 11 Device
2023 Migration 22 Device
2023 Material Fragmentation 1 Device
2023 Low impedance 2 Device
2023 Inappropriate/Inadequate Shock/Stimulation 1 Device
2023 High impedance 10 Device
2023 Fracture 3 Device
2023 Disconnection 1 Device
2023 Adverse Event Without Identified Device or Use Problem 2 Device
2022 Unspecified Infection 1 Patient
2022 Inadequate Pain Relief 4 Patient
2022 Use of Device Problem 1 Device
2022 Therapeutic or Diagnostic Output Failure 10 Device
2022 Migration 18 Device
2022 Low impedance 1 Device
2022 Insufficient Information 1 Device
2022 Inappropriate/Inadequate Shock/Stimulation 1 Device
2022 High impedance 10 Device
2022 Fracture 6 Device
2022 Adverse Event Without Identified Device or Use Problem 5 Device
2021 Therapeutic or Diagnostic Output Failure 4 Device
2021 Adverse Event Without Identified Device or Use Problem 4 Device
2020 Inadequate Pain Relief 1 Patient
2020 Migration 1 Device
2020 Adverse Event Without Identified Device or Use Problem 2 Device