PRODUCT CATALOG

Chronic Pain Therapies | Spinal Cord Stimulation | External Pulse Generators (EPGs)

St. Jude Medical™ Invisible Trial System Patient Controller App with BurstDR™ Stimulation

3875,3873

Description

Model 3875 Patient Controller App Model 3873 Apple™ iPod touch™ Mobile Digital Device

Product Highlights

Compatibility

St. Jude Medical™ Invisible Trial System External Pulse Generator (EPG)

Patient Controller


Ordering Information

Reorder Number Device Dimensions (H x W x T, cm) Weight (g) Battery
3873ANS Apple™ iPod touch™ mobile digital device, 6th generation 12.34 x 5.86 x 0.61 88 Built in rechargeable lithium ion
Reorder Number Description
3875 Enables patient-controlled therapy adjustment of the Proclaim™ Elite Neurostimulation System with BurstDR™ Stimulation and tonic stimulation modes
1916ANS Patient Controller Case
1223ANS Charger

*BurstDR™ stimulation, patented technology exclusively from St. Jude Medical, is also referred to as Burst stimulation in clinical literature.

 

CE marking does not necessarily indicate regulatory approval status for all markets. Please refer to the instructions for use for a full listing of indications, contraindications, warnings and precautions.

 

Rx Only

 

Brief Summary: Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.

 

Indications for Use: Spinal cord stimulation as an aid in the management of chronic, intractable pain of the trunk and limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome and intractable low back and leg pain.

 

Contraindications: Patients who are unable to operate the system or who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted.

 

Warnings/Precautions: Diathermy therapy, implanted cardiac systems, magnetic resonance imaging (MRI), explosive or flammable gases, theft detectors and metal screening devices, lead movement, operation of machinery and equipment, postural changes, pediatric use, pregnancy, and case damage. Patients should not be dependent on drugs and should be able to operate the neurostimulation system.

 

Adverse Effects: Painful stimulation, loss of pain relief, surgical risks (e.g., paralysis). Clinician’s Manual must be reviewed for detailed disclosure.

 

Apple and iPod touch are trademarks of Apple Inc. Bluetooth is a registered trademark of Bluetooth SIG, Inc. iOS is a trademark of Cisco Technology, Inc.

Unless otherwise noted, ™ indicates that the name is a trademark of, or licensed to, St. Jude Medical or one of its subsidiaries. ST. JUDE MEDICAL and the nine-squares symbol are trademarks and service marks of St. Jude Medical, Inc. and its related companies.

©2018 St. Jude Medical, Inc. All rights reserved.

SJM-WIT-1114-0002(2)

Last Updated: October 4, 2016