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                                            Safety Information Article
                      Information on this page is limited by the terms of our Disclaimer.  Please Read!

       Spinal Cord Stimulation Systems: St. Jude Medical 

Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew

The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimulation are indicated as aids in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with any of the following: failed back surgery syndrome, intractable low back and leg pain, as well as for the treatment of other conditions.

MRI Information. The labeling information for these afore-mentioned products states: “Warnings/Precautions: Diathermy therapy, cardioverter defibrillators, 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 who are poor surgical risks, with multiple illnesses, or with active general infections should not be implanted.”

In addition, the following has been stated: “Magnetic resonance imaging (MRI). Patients with implanted neurostimulation systems should not be subjected to MRI. The electromagnetic field generated by an MRI may forcefully dislodge implanted components, damage the device electronics, and induce voltage through the lead that could jolt or shock the patient.”

Therefore, these devices are currently contraindicated for patients referred for MR procedures. 

REFERENCE

http://sjmneuropro.com



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