Safety Information
Additional Device Information for Implantable Defibrillators
An implantable defibrillator system delivers therapies to treat patients with heart rhythm disorders or who are at significant risk of developing heart rhythm disorders. An implantable defibrillator is placed inside your body and works automatically.
Risks associated with an implantable defibrillator system implant include, but are not limited to, infection at the surgical site and/or sensitivity to the device material, failure to deliver therapy when it is needed, or receiving extra therapy when it is not needed. After receiving an implantable defibrillator, you will have limitations with magnetic and electromagnetic radiation, electric or gas powered appliances, and tools with which you are allowed to be in contact.
Treatment with an implantable defibrillator system is prescribed by your physician. This treatment is not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this treatment, results may vary.
Additional Device Information for AEDs
Automated External Defibrillators (AEDs) are prescription devices; please contact your physician. AEDs are intended for use on adults and children of all ages. For infants and children less than 8 years of age or 55 lbs (25 kg), use Infant/Child Reduced Energy Electrodes (available separately). AED users should be trained in CPR and use of the AED.
Although not everyone can be saved from sudden cardiac arrest, studies show that early defibrillation can dramatically improve survival rates.
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