STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
This device is manufactured by MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC NEUROMODULATION, MEDTRONIC PUERTO RICO OPERATIONS CO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Undesired Nerve Stimulation | 1 | Patient |
| 2024 | Swelling/ Edema | 2 | Patient |
| 2024 | Skin Discoloration | 1 | Patient |
| 2024 | Pain | 1 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Burning Sensation | 2 | Patient |
| 2024 | Unintended Collision | 1 | Device |
| 2024 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2024 | Overheating of Device | 1 | Device |
| 2024 | Migration or Expulsion of Device | 1 | Device |
| 2024 | Malposition of Device | 1 | Device |
| 2024 | Insufficient Information | 1 | Device |
| 2024 | High impedance | 1 | Device |
| 2024 | Disconnection | 1 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Pain | 3 | Patient |
| 2023 | Muscular Rigidity | 1 | Patient |
| 2023 | Inadequate Pain Relief | 2 | Patient |
| 2023 | Electric Shock | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Unintended Collision | 1 | Device |
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | No Device Output | 1 | Device |
| 2023 | Migration or Expulsion of Device | 2 | Device |
| 2023 | Malposition of Device | 1 | Device |
| 2023 | Low impedance | 1 | Device |
| 2023 | Insufficient Information | 8 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2023 | High impedance | 1 | Device |
| 2023 | Failure to Deliver Energy | 1 | Device |
| 2023 | Energy Output Problem | 2 | Device |
| 2023 | Connection Problem | 1 | Device |
| 2023 | Battery Problem | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2022 | Weight Changes | 1 | Patient |
| 2022 | Insufficient Information | 1 | Patient |
| 2022 | Electric Shock | 1 | Patient |
| 2022 | Discomfort | 2 | Patient |
| 2022 | Unstable | 1 | Device |
| 2022 | Unintended Collision | 1 | Device |
| 2022 | Patient Device Interaction Problem | 1 | Device |
| 2022 | Operating System Becomes Nonfunctional | 2 | Device |
| 2022 | No Device Output | 1 | Device |
| 2022 | Migration or Expulsion of Device | 3 | Device |
| 2022 | Malposition of Device | 1 | Device |
| 2022 | Insufficient Information | 2 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 1 | Device |
| 2022 | Failure to Power Up | 5 | Device |
| 2022 | Failure to Interrogate | 2 | Device |
| 2022 | Failure to Deliver Energy | 1 | Device |
| 2022 | Energy Output Problem | 1 | Device |
| 2022 | Electromagnetic Compatibility Problem | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Communication or Transmission Problem | 2 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Battery Problem | 1 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2021 | Sleep Dysfunction | 1 | Patient |
| 2021 | Shaking/Tremors | 1 | Patient |
| 2021 | Pain | 2 | Patient |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Electric Shock | 1 | Patient |
| 2021 | Device Overstimulation of Tissue | 1 | Patient |
| 2021 | Migration or Expulsion of Device | 1 | Device |
| 2021 | High impedance | 1 | Device |
| 2021 | Failure to Deliver Energy | 1 | Device |
| 2021 | Break | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2020 | Intermittent Continuity | 1 | Device |
| 2020 | Insufficient Information | 1 | Device |
| 2020 | Failure to Deliver Energy | 1 | Device |
| 2020 | Energy Output Problem | 3 | Device |
| 2020 | Device Operates Differently Than Expected | 2 | Device |
| 2020 | Communication or Transmission Problem | 1 | Device |
| 2020 | Break | 1 | Device |
| 2020 | Battery Problem | 3 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |