Safety Alert | For Patients

Medtronic’s medical device registration indicates that you have an implanted neurostimulation device. The purpose of this letter is to inform you that you should not have shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) if you have an implanted neurostimulation device. Diathermy provides optional treatments for the following purposes:

reduce joint contractures

reduce swelling and pain after surgery

promote wound healing

When the energy from diathermy therapy interacts with neurostimulation devices, it can cause permanent nerve or tissue damage and result in severe injury or death. Therefore, DO NOT RECEIVE ANY DIATHERMY.

This contraindication applies to use of diathermy anywhere on your body, not just where your neurostimulation device is located.

This contraindication applies regardless of whether the diathermy is used to deliver heat or no heat.

This contraindication applies regardless of whether your Medtronic neurostimulation device is turned “on” or “off” during diathermy treatment.

This contraindication applies if any part (lead, extension, neurostimulator) of your neurostimulation device remains in your body.

Please note that the permanent nerve or tissue injury is not caused by a device malfunction. Rather, it is caused by the interaction of two devices (neurostimulation system and diathermy machine) when they are working properly.

There have been two known cases where patients with implanted deep brain stimulation systems received shortwave therapy (diathermy). In both cases, the therapy interacted with the implanted neurostimulation system and caused severe and permanent brain damage. Both patients are still in comas.

What are shortwave diathermy, microwave diathermy and therapeutic ultrasound diathermy treatments?
Diathermy, pronounced (d_´-a-thur-m_) are treatments that deliver energy to treat specific areas of the body. These treatments are typically used for the following purposes:

relieve pain, stiffness and muscle spasms

reduce joint contractures

reduce swelling and pain after surgery

promote wound healing

Your physician can answer any questions you may have about diathermy therapy or alternative treatments.

Diathermy is used by a variety of health care professionals, including physical therapists, nurses, chiropractors, dentists, sports therapists, ophthalmologists, and others. Health care professionals may refer to diathermy using the term “deep heat” or similar terms. Diathermy means deep heat, but these devices may also be used in a way that causes little or no heating.

What Should You Do?
First and foremost, do not receive any shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy, just as you would avoid a medicine to which you are seriously allergic. Before receiving any treatment, you should inform every health care professional (such as doctors, dentists, chiropractors, sports therapists, or physical therapists) that you have an implanted neurostimulation device. Follow these steps whenever you see any health care professional:

Show your device identification card if you have one.

Describe where your device and any of its parts are located.

Provide them with Medtronic’s customer service telephone number at 1-800-328-0810, to call if they have any questions.

For more detailed information, show them a copy of this letter.

Please place this letter with your manual so that it will be with the other important information regarding your implanted device. If you have any questions about this communication or your therapy, please contact the physician who manages your neurostimulation treatment or contact Medtronic directly at 1-800-328-0810.

To ensure that you continue to receive important information from Medtronic regarding your device, please inform us of any changes in your contact information by calling the number above, or on the Internet at http://www.medtronic.com/patients/patients.html. Please be assured we will not sell, exchange, or publish the contact information that you send us.

Glossary

Contraindication:	Absolutely not allowed under any circumstances because the risk outweighs any benefits.
Diathermy:	Medical device therapy that is applied externally to deliver energy into the patient’s body. The three types of energy that can be used are shortwave, microwave, and ultrasound. Depending on the power level used, diathermy devices may or may not produce heat within the patient’s body.