DRG LEAD
This device is manufactured by ABBOTT MEDICAL, ST JUDE MEDICAL - NEUROMODULATION, ST JUDE MEDICAL - NEUROMODULATION (PUERTO RICO ).
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Scar Tissue | 2 | Patient |
| 2024 | Inadequate Pain Relief | 23 | Patient |
| 2024 | Foreign Body In Patient | 3 | Patient |
| 2024 | Failure of Implant | 8 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 2 | Patient |
| 2024 | Use of Device Problem | 2 | Device |
| 2024 | Therapeutic or Diagnostic Output Failure | 4 | Device |
| 2024 | Migration | 7 | Device |
| 2024 | Material Fragmentation | 2 | Device |
| 2024 | High impedance | 6 | Device |
| 2024 | Fracture | 3 | Device |
| 2023 | Undesired Nerve Stimulation | 1 | Patient |
| 2023 | Insufficient Information | 1 | Patient |
| 2023 | Inadequate Pain Relief | 34 | Patient |
| 2023 | Foreign Body In Patient | 2 | Patient |
| 2023 | Failure of Implant | 4 | Patient |
| 2023 | Use of Device Problem | 2 | Device |
| 2023 | Therapeutic or Diagnostic Output Failure | 3 | Device |
| 2023 | Migration | 10 | Device |
| 2023 | Material Fragmentation | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | Impedance Problem | 1 | Device |
| 2023 | High impedance | 14 | Device |
| 2023 | Fracture | 6 | Device |
| 2023 | Failure to Deliver Energy | 1 | Device |
| 2022 | Inadequate Pain Relief | 9 | Patient |
| 2022 | Use of Device Problem | 2 | Device |
| 2022 | Therapeutic or Diagnostic Output Failure | 8 | Device |
| 2022 | Migration | 14 | Device |
| 2022 | Material Fragmentation | 2 | Device |
| 2022 | Impedance Problem | 2 | Device |
| 2022 | High impedance | 7 | Device |
| 2022 | Fracture | 13 | Device |
| 2021 | Migration | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | High impedance | 2 | Device |
| 2019 | Therapeutic or Diagnostic Output Failure | 20 | Device |
| 2019 | Patient-Device Incompatibility | 1 | Device |
| 2019 | Migration or Expulsion of Device | 1 | Device |
| 2019 | Migration | 16 | Device |
| 2019 | Impedance Problem | 5 | Device |
| 2019 | High impedance | 29 | Device |
| 2019 | Fracture | 39 | Device |
| 2019 | Disconnection | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 123 | Device |
| 2018 | Material Split, Cut or Torn | 2 | Device |
| 2018 | Material Fragmentation | 1 | Device |
| 2018 | Low impedance | 2 | Device |
| 2018 | Impedance Problem | 2 | Device |
| 2018 | High impedance | 42 | Device |
| 2018 | Fracture | 27 | Device |
| 2018 | Disconnection | 2 | Device |
| 2018 | Detachment of Device or Device Component | 2 | Device |
| 2018 | Cut In Material | 1 | Device |
| 2018 | Adverse Event Without Identified Device or Use Problem | 270 | Device |
| 2017 | Kinked | 1 | Device |
| 2017 | Impedance Problem | 18 | Device |
| 2017 | High impedance | 7 | Device |
| 2017 | Fracture | 10 | Device |
| 2017 | Device Damaged by Another Device | 4 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 118 | Device |
| 2016 | Naturally Worn | 1 | Device |
| 2016 | Fracture | 3 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 36 | Device |