A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

A Post-Market Study Evaluating the Prodigy MRI and Proclaim Elite MR Conditional SCS Systems

A post market study evaluating the safety of the Prodigy MRI and Proclaim Elite MR conditional Spinal Cord Stimulator (SCS) systems.

The study will be performed as an international, multicenter, prospective and single-arm design. The study will be conducted as a Post Market Clinical Follow Up (PMCF) study and the results will be submitted to the Notified Body: BSI Group (BSI).

Inclusion Criteria:

• Patient has been implanted with a Prodigy MRI or Proclaim Elite MR conditional SCS system
• Patient will receive an MRI scan in compliance with the Instructions For Use (IFU) for the implanted MR conditional SCS system
• Patient is ≥ 18 years of age
• Patient must be willing and able to comply with study requirements
• Patient must indicate his/her understanding of the study and willingness to participate by signing an appropriate Informed Consent Form

Exclusion Criteria:

• Patient has another implanted device (active or passive) that prohibits safe scanning
• Patient has previously experienced an MRI scan-related adverse event
• Patient is currently enrolled in another Abbott study that collects MRI safety data
• Patient is incapacitated, is unable to read or write, or is pregnant or breastfeeding