RESTORE ADVANCED

STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

This device is manufactured by MDT PUERTO RICO OPERATIONS, MEDTRONIC, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC NEUROMODULATION and others.

The following problems were reported about this device:

Year Description Events/year Type
2024 Insufficient Information 1 Patient
2024 Hypersensitivity/Allergic reaction 1 Patient
2024 Migration or Expulsion of Device 1 Device
2024 Insufficient Information 2 Device
2024 Charging Problem 2 Device
2024 Adverse Event Without Identified Device or Use Problem 1 Device
2023 Pain 1 Patient
2023 Insufficient Information 1 Patient
2023 Discomfort 1 Patient
2023 Device Embedded In Tissue or Plaque 1 Patient
2023 Burning Sensation 1 Patient
2023 Overheating of Device 2 Device
2023 Material Integrity Problem 1 Device
2023 Insufficient Information 3 Device
2023 Inappropriate/Inadequate Shock/Stimulation 2 Device
2023 Energy Output Problem 1 Device
2023 Difficult to Remove 2 Device
2023 Device Operates Differently Than Expected 1 Device
2023 Connection Problem 1 Device
2023 Charging Problem 1 Device
2023 Break 1 Device
2023 Battery Problem 2 Device
2022 Migration or Expulsion of Device 1 Device
2022 Insufficient Information 3 Device
2022 Entrapment of Device 1 Device
2022 Break 1 Device
2022 Battery Problem 2 Device
2022 Adverse Event Without Identified Device or Use Problem 1 Device
2020 Loss of Data 1 Device
2020 Insufficient Information 3 Device
2020 High impedance 1 Device
2020 Energy Output Problem 1 Device
2020 Data Problem 1 Device
2020 Charging Problem 1 Device
2020 Break 1 Device
2020 Battery Problem 1 Device