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http://www.medtronic.com/neuro/diathermy_alert/alert_patients.html

Safety Alert For Patients

CONTRAINDICATION: Inform anyone treating you that you CANNOT have any
shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy
(all now referred to as diathermy) anywhere on your body because you have an
implanted neurostimulation system. Energy from diathermy can be transferred
through your implanted system, can cause tissue damage and can result in
severe injury or death.

Diathermy can also damage parts of your neurostimulation system. This can
result in loss of therapy from your neurostimulation system, and may require
additional surgery to remove or replace parts of your implanted device.
Injury or damage can occur during diathermy treatment whether your
neurostimulation system is turned “on” or “off.”

May 18, 2001

Dear Patient:

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:

relieve pain, stiffness and muscle spasms
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.

Sincerely,

Cliff Owens
Vice President and General Manager
Medtronic Neurostimulation

Martha Goldberg Aronson
Vice President and General Manager
Medtronic Functional Stimulation

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.

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