500
Participants
Start Date
September 15, 2015
Primary Completion Date
September 14, 2025
Study Completion Date
September 14, 2025
Enterra HDE
"Instructions for use Implanting physicians should have experience in the surgical and/or implantation techniques for the Enterra II system, operational and functional characteristics of the Enterra II system, 12 English 37800 2014-03 and experience in the continued management of patients by stimulation parameter adjustment. Physicians may contact Medtronic before prescribing or implanting an Enterra II system for the first time, and request a referral to a physician experienced in the use of the Enterra II system. Implanting physicians should be thoroughly familiar with all product labeling.~Cautions:~* When using sharp instruments near the neurostimulator, be extremely careful to avoid nicking or damaging the case, the insulation, or the connector block. Damaging the neurostimulator may require surgical replacement.~* Do not use saline or other ionic fluids at connections, which could result in a short circuit"
Methodist Richardson Medical Center, Richardson
Methodist Health System
OTHER