STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
This device is manufactured by MEDTRONIC, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC NEUROMODULATION, MEDTRONIC PUERTO RICO OPERATIONS CO, RICE CREEK MFG.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 1 | Patient |
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Undesired Nerve Stimulation | 2 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Skin Discoloration | 1 | Patient |
| 2024 | Scar Tissue | 1 | Patient |
| 2024 | Pocket Erosion | 1 | Patient |
| 2024 | Pain | 28 | Patient |
| 2024 | Muscular Rigidity | 1 | Patient |
| 2024 | Meningitis | 1 | Patient |
| 2024 | Itching Sensation | 1 | Patient |
| 2024 | Insufficient Information | 20 | Patient |
| 2024 | Inadequate Pain Relief | 2 | Patient |
| 2024 | Electric Shock | 7 | Patient |
| 2024 | Discomfort | 4 | Patient |
| 2024 | Device Overstimulation of Tissue | 1 | Patient |
| 2024 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2024 | Cramp(s) /Muscle Spasm(s) | 2 | Patient |
| 2024 | Burning Sensation | 2 | Patient |
| 2024 | Bacterial Infection | 1 | Patient |
| 2024 | Anxiety | 2 | Patient |
| 2024 | Use of Incorrect Control/Treatment Settings | 1 | Device |
| 2024 | Unintended Collision | 4 | Device |
| 2024 | Unable to Obtain Readings | 1 | Device |
| 2024 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2024 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2024 | Shipping Damage or Problem | 1 | Device |
| 2024 | Patient Device Interaction Problem | 3 | Device |
| 2024 | Overheating of Device | 3 | Device |
| 2024 | Operating System Becomes Nonfunctional | 3 | Device |
| 2024 | No Device Output | 2 | Device |
| 2024 | Migration or Expulsion of Device | 6 | Device |
| 2024 | Material Integrity Problem | 27 | Device |
| 2024 | Material Frayed | 3 | Device |
| 2024 | Material Deformation | 4 | Device |
| 2024 | Malposition of Device | 2 | Device |
| 2024 | Low impedance | 1 | Device |
| 2024 | Low Battery | 1 | Device |
| 2024 | Loss of Data | 1 | Device |
| 2024 | Intermittent Continuity | 3 | Device |
| 2024 | Insufficient Information | 41 | Device |
| 2024 | Inappropriate/Inadequate Shock/Stimulation | 7 | Device |
| 2024 | Improper or Incorrect Procedure or Method | 18 | Device |
| 2024 | Impedance Problem | 5 | Device |
| 2024 | High impedance | 33 | Device |
| 2024 | Failure to Power Up | 17 | Device |
| 2024 | Failure to Interrogate | 14 | Device |
| 2024 | Failure to Deliver Energy | 10 | Device |
| 2024 | Energy Output Problem | 9 | Device |
| 2024 | Electromagnetic Interference | 1 | Device |
| 2024 | Electromagnetic Compatibility Problem | 6 | Device |
| 2024 | Display or Visual Feedback Problem | 10 | Device |
| 2024 | Difficult to Remove | 2 | Device |
| 2024 | Device Operates Differently Than Expected | 2 | Device |
| 2024 | Device Dislodged or Dislocated | 1 | Device |
| 2024 | Device Contamination with Chemical or Other Material | 2 | Device |
| 2024 | Delayed Charge Time | 6 | Device |
| 2024 | Degraded | 3 | Device |
| 2024 | Connection Problem | 35 | Device |
| 2024 | Communication or Transmission Problem | 15 | Device |
| 2024 | Charging Problem | 36 | Device |
| 2024 | Break | 15 | Device |
| 2024 | Battery Problem | 52 | Device |
| 2024 | Audible Prompt/Feedback Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 15 | Device |
| 2023 | Weight Changes | 1 | Patient |
| 2023 | Unspecified Infection | 2 | Patient |
| 2023 | Undesired Nerve Stimulation | 4 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Sleep Dysfunction | 3 | Patient |
| 2023 | Scar Tissue | 3 | Patient |
| 2023 | Paresthesia | 3 | Patient |
| 2023 | Pain | 51 | Patient |
| 2023 | Nausea | 1 | Patient |
| 2023 | Itching Sensation | 1 | Patient |
| 2023 | Insufficient Information | 24 | Patient |
| 2023 | Inadequate Pain Relief | 7 | Patient |
| 2023 | Foreign Body Reaction | 1 | Patient |
| 2023 | Fall | 1 | Patient |
| 2023 | Erosion | 1 | Patient |
| 2023 | Electric Shock | 11 | Patient |
| 2023 | Distress | 1 | Patient |
| 2023 | Discomfort | 3 | Patient |
| 2023 | Device Overstimulation of Tissue | 3 | Patient |
| 2023 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2023 | Depression | 1 | Patient |
| 2023 | Burning Sensation | 11 | Patient |
| 2023 | Burn(s) | 1 | Patient |
| 2023 | Appropriate Term / Code Not Available | 1 | Patient |
| 2023 | Ambulation Difficulties | 2 | Patient |
| 2023 | Abdominal Pain | 1 | Patient |
| 2023 | Use of Device Problem | 3 | Device |
| 2023 | Unstable | 1 | Device |
| 2023 | Unintended Collision | 5 | Device |
| 2023 | Unexpected Therapeutic Results | 1 | Device |
| 2023 | Unable to Obtain Readings | 1 | Device |
| 2023 | Therapy Delivered to Incorrect Body Area | 4 | Device |
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | Positioning Problem | 2 | Device |
| 2023 | Pocket Stimulation | 2 | Device |
| 2023 | Patient Device Interaction Problem | 9 | Device |
| 2023 | Overheating of Device | 12 | Device |
| 2023 | Operating System Becomes Nonfunctional | 7 | Device |
| 2023 | No Device Output | 2 | Device |
| 2023 | Migration or Expulsion of Device | 11 | Device |
| 2023 | Material Integrity Problem | 89 | Device |
| 2023 | Material Frayed | 6 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Malposition of Device | 2 | Device |
| 2023 | Low impedance | 2 | Device |
| 2023 | Lack of Effect | 1 | Device |
| 2023 | Intermittent Continuity | 7 | Device |
| 2023 | Insufficient Information | 71 | Device |
| 2023 | Inappropriate/Inadequate Shock/Stimulation | 11 | Device |
| 2023 | Improper or Incorrect Procedure or Method | 37 | Device |
| 2023 | Impedance Problem | 5 | Device |
| 2023 | Human-Device Interface Problem | 2 | Device |
| 2023 | High impedance | 37 | Device |
| 2023 | Failure to Power Up | 22 | Device |
| 2023 | Failure to Interrogate | 14 | Device |
| 2023 | Failure to Deliver Energy | 29 | Device |
| 2023 | Environmental Compatibility Problem | 1 | Device |
| 2023 | Energy Output Problem | 17 | Device |
| 2023 | Electromagnetic Interference | 4 | Device |
| 2023 | Electromagnetic Compatibility Problem | 3 | Device |
| 2023 | Display or Visual Feedback Problem | 10 | Device |
| 2023 | Difficult to Remove | 2 | Device |
| 2023 | Difficult to Insert | 1 | Device |
| 2023 | Device Operates Differently Than Expected | 5 | Device |
| 2023 | Device Difficult to Program or Calibrate | 3 | Device |
| 2023 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2023 | Delayed Charge Time | 20 | Device |
| 2023 | Data Problem | 2 | Device |
| 2023 | Connection Problem | 99 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Communication or Transmission Problem | 25 | Device |
| 2023 | Charging Problem | 75 | Device |
| 2023 | Break | 11 | Device |
| 2023 | Battery Problem | 97 | Device |
| 2023 | Audible Prompt/Feedback Problem | 1 | Device |
| 2023 | Application Program Problem | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 27 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Undesired Nerve Stimulation | 1 | Patient |
| 2022 | Stenosis | 1 | Patient |
| 2022 | Sleep Dysfunction | 1 | Patient |
| 2022 | Paresthesia | 1 | Patient |
| 2022 | Pain | 20 | Patient |
| 2022 | Numbness | 1 | Patient |
| 2022 | Insufficient Information | 10 | Patient |
| 2022 | Inadequate Pain Relief | 2 | Patient |
| 2022 | Electric Shock | 2 | Patient |
| 2022 | Discomfort | 3 | Patient |
| 2022 | Device Overstimulation of Tissue | 4 | Patient |
| 2022 | Burning Sensation | 2 | Patient |
| 2022 | Ambulation Difficulties | 1 | Patient |
| 2022 | Use of Device Problem | 1 | Device |
| 2022 | Unstable | 1 | Device |
| 2022 | Unintended Collision | 25 | Device |
| 2022 | Unexpected Therapeutic Results | 1 | Device |
| 2022 | Unauthorized Access to Computer System | 1 | Device |
| 2022 | Therapy Delivered to Incorrect Body Area | 4 | Device |
| 2022 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2022 | Positioning Problem | 3 | Device |
| 2022 | Patient Device Interaction Problem | 8 | Device |
| 2022 | Overheating of Device | 12 | Device |
| 2022 | Operating System Becomes Nonfunctional | 8 | Device |
| 2022 | No Device Output | 4 | Device |
| 2022 | Migration or Expulsion of Device | 16 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Integrity Problem | 183 | Device |
| 2022 | Material Frayed | 7 | Device |
| 2022 | Malposition of Device | 5 | Device |
| 2022 | Low Battery | 1 | Device |
| 2022 | Loss of Data | 2 | Device |
| 2022 | Intermittent Continuity | 15 | Device |
| 2022 | Insufficient Information | 67 | Device |
| 2022 | Inappropriate/Inadequate Shock/Stimulation | 13 | Device |
| 2022 | Improper or Incorrect Procedure or Method | 32 | Device |
| 2022 | Impedance Problem | 3 | Device |
| 2022 | Human-Device Interface Problem | 1 | Device |
| 2022 | High impedance | 28 | Device |
| 2022 | Failure to Power Up | 62 | Device |
| 2022 | Failure to Interrogate | 18 | Device |
| 2022 | Failure to Deliver Energy | 34 | Device |
| 2022 | Energy Output To Patient Tissue Incorrect | 1 | Device |
| 2022 | Energy Output Problem | 15 | Device |
| 2022 | Electromagnetic Interference | 1 | Device |
| 2022 | Electromagnetic Compatibility Problem | 5 | Device |
| 2022 | Display or Visual Feedback Problem | 23 | Device |
| 2022 | Difficult to Remove | 2 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Operates Differently Than Expected | 2 | Device |
| 2022 | Device Displays Incorrect Message | 1 | Device |
| 2022 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2022 | Delayed Charge Time | 9 | Device |
| 2022 | Degraded | 1 | Device |
| 2022 | Data Problem | 4 | Device |
| 2022 | Corroded | 1 | Device |
| 2022 | Connection Problem | 187 | Device |
| 2022 | Communication or Transmission Problem | 33 | Device |
| 2022 | Charging Problem | 116 | Device |
| 2022 | Break | 13 | Device |
| 2022 | Battery Problem | 117 | Device |
| 2022 | Audible Prompt/Feedback Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 37 | Device |
| 2021 | Undesired Nerve Stimulation | 1 | Patient |
| 2021 | Pain | 8 | Patient |
| 2021 | Insufficient Information | 4 | Patient |
| 2021 | Inadequate Pain Relief | 2 | Patient |
| 2021 | Headache | 1 | Patient |
| 2021 | Electric Shock | 2 | Patient |
| 2021 | Discomfort | 1 | Patient |
| 2021 | Device Embedded In Tissue or Plaque | 1 | Patient |
| 2021 | Burning Sensation | 1 | Patient |
| 2021 | Ambulation Difficulties | 1 | Patient |
| 2021 | Vibration | 1 | Device |
| 2021 | Unstable | 1 | Device |
| 2021 | Unintended Collision | 5 | Device |
| 2021 | Unable to Obtain Readings | 1 | Device |
| 2021 | Therapy Delivered to Incorrect Body Area | 2 | Device |
| 2021 | Power Problem | 4 | Device |
| 2021 | Pocket Stimulation | 1 | Device |
| 2021 | Patient Device Interaction Problem | 1 | Device |
| 2021 | Overheating of Device | 4 | Device |
| 2021 | Operating System Becomes Nonfunctional | 9 | Device |
| 2021 | No Device Output | 4 | Device |
| 2021 | Migration or Expulsion of Device | 5 | Device |
| 2021 | Material Integrity Problem | 143 | Device |
| 2021 | Material Frayed | 4 | Device |
| 2021 | Material Deformation | 1 | Device |
| 2021 | Low Battery | 2 | Device |
| 2021 | Intermittent Continuity | 2 | Device |
| 2021 | Insufficient Information | 34 | Device |
| 2021 | Inappropriate/Inadequate Shock/Stimulation | 3 | Device |
| 2021 | Improper or Incorrect Procedure or Method | 11 | Device |
| 2021 | Impedance Problem | 1 | Device |
| 2021 | High impedance | 17 | Device |
| 2021 | Failure to Power Up | 31 | Device |
| 2021 | Failure to Interrogate | 9 | Device |
| 2021 | Failure to Deliver Energy | 8 | Device |
| 2021 | Energy Output Problem | 6 | Device |
| 2021 | Electromagnetic Interference | 3 | Device |
| 2021 | Electromagnetic Compatibility Problem | 2 | Device |
| 2021 | Display or Visual Feedback Problem | 23 | Device |
| 2021 | Difficult to Remove | 1 | Device |
| 2021 | Difficult to Insert | 2 | Device |
| 2021 | Device Or Device Fragments Location Unknown | 1 | Device |
| 2021 | Device Operates Differently Than Expected | 4 | Device |
| 2021 | Delayed Charge Time | 5 | Device |
| 2021 | Data Problem | 1 | Device |
| 2021 | Corroded | 1 | Device |
| 2021 | Connection Problem | 165 | Device |
| 2021 | Communication or Transmission Problem | 15 | Device |
| 2021 | Charging Problem | 77 | Device |
| 2021 | Break | 4 | Device |
| 2021 | Battery Problem | 36 | Device |
| 2021 | Audible Prompt/Feedback Problem | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 10 | Device |
| 2020 | Undesired Nerve Stimulation | 1 | Patient |
| 2020 | Pain | 3 | Patient |
| 2020 | Insufficient Information | 1 | Patient |
| 2020 | Inadequate Pain Relief | 1 | Patient |
| 2020 | Electric Shock | 1 | Patient |
| 2020 | Discomfort | 2 | Patient |
| 2020 | Unstable | 5 | Device |
| 2020 | Unintended Collision | 8 | Device |
| 2020 | Unauthorized Access to Computer System | 1 | Device |
| 2020 | Therapy Delivered to Incorrect Body Area | 4 | Device |
| 2020 | Positioning Problem | 1 | Device |
| 2020 | Patient Device Interaction Problem | 5 | Device |
| 2020 | Overheating of Device | 5 | Device |
| 2020 | No Device Output | 2 | Device |
| 2020 | Migration or Expulsion of Device | 10 | Device |
| 2020 | Material Protrusion/Extrusion | 1 | Device |
| 2020 | Malposition of Device | 2 | Device |
| 2020 | Low Battery | 2 | Device |
| 2020 | Intermittent Continuity | 5 | Device |
| 2020 | Insufficient Information | 33 | Device |
| 2020 | Inappropriate/Inadequate Shock/Stimulation | 4 | Device |
| 2020 | Improper or Incorrect Procedure or Method | 12 | Device |
| 2020 | Impedance Problem | 2 | Device |
| 2020 | Human-Device Interface Problem | 1 | Device |
| 2020 | High impedance | 10 | Device |
| 2020 | Failure to Interrogate | 7 | Device |
| 2020 | Failure to Deliver Energy | 14 | Device |
| 2020 | Failure to Charge | 1 | Device |
| 2020 | Energy Output Problem | 9 | Device |
| 2020 | Electromagnetic Interference | 3 | Device |
| 2020 | Electromagnetic Compatibility Problem | 1 | Device |
| 2020 | Display or Visual Feedback Problem | 1 | Device |
| 2020 | Device Operates Differently Than Expected | 8 | Device |
| 2020 | Device Displays Incorrect Message | 3 | Device |
| 2020 | Delayed Charge Time | 8 | Device |
| 2020 | Connection Problem | 2 | Device |
| 2020 | Communication or Transmission Problem | 8 | Device |
| 2020 | Charging Problem | 22 | Device |
| 2020 | Break | 3 | Device |
| 2020 | Battery Problem | 27 | Device |
| 2020 | Adverse Event Without Identified Device or Use Problem | 7 | Device |