In the Lupe, Episode 13 

Description on PodBean 

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1.  Patel, Kiran V. "Dorsal Root Ganglion Stimulation for Chronic Pelvic Pain [39T]." Obstetrics & Gynecology 133 (2019): 223S. 

1. Abbott Proclaim Implantable Pulse Generator Clinician’s Manual. Plano, TX. 2019. 

*These are the experiences of these patients. Individual experiences, symptoms, situations and results may vary 

Rx Only 

Brief Summary:  

Prior to using these devices, please review the User’s Guide for a complete listing of indications, contraindications, warnings, precautions, potential adverse events, and directions for use. The system is intended to be used with leads and associated extensions that are compatible with the system. 

DRG 

Indications for Use:  

US: Spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with Complex Regional Pain Syndrome (CRPS) types I and II.** 

*Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least 2 prior pharmacologic treatments from at least 2 different drug classes and continued their pharmacologic therapy during the clinical study. 

**Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Nerve damage may result from traumatic or surgical nerve injury. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 

International: Management of chronic intractable pain.  

Contraindications:  

US: Patients who are unable to operate the system, who are poor surgical risks. Patients who have failed to receive effective pain relief during trial stimulation. 

International: Patients who are unable to operate the system, are poor surgical risks, are pregnant, or under the age of 18.  

Warnings/Precautions: Diathermy therapy, implanted cardiac systems or other active implantable devices, magnetic resonance imaging (MRI), computed tomography (CT), electrosurgery devices, ultrasonic scanning equipment, therapeutic radiation, explosive and flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery, equipment and vehicles, pediatric use, pregnancy, and case damage.  

Adverse Effects: Unpleasant sensations, changes in stimulation, stimulation in unwanted places, lead or implant migration, epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, cerebrospinal fluid leakage, tissue damage or nerve damage, paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, pain where needle was inserted or at the electrode site or at IPG site, seroma at implant site, headache, allergic or rejection response, battery failure and/or leakage. Clinician’s Manual must be reviewed for detailed disclosure. 

Abbott 

One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000 

Neuromodulation.Abbott 

™ Indicates a trademark of the Abbott group of companies. 

‡ Indicates a third party trademark, which is property of its respective owner. 

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MAT-2104565 v1.0 | Item is approved for global use.