SAFETY ALERT

In consultation with the Australian Therapeutic Goods Administration and the New Zealand Ministry of Health, Medtronic is issuing this Safety Alert to all health care professionals that may use diathermy, and may treat patients with implanted neurostimulation systems, which include: Deep Brain Stimulation, Spinal Cord and Peripheral Nerve Stimulation Systems, Sacral Nerve Stimulation, Dynamic Graciloplasty.

DO NOT use or prescribe shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy (all now referred to as diathermy) for patients implanted with any type of Medtronic neurostimulation system. Diathermy does not include ultrasonic imaging or electrocautery devices.

Health care professionals may refer to diathermy using the term “deep heat” or similar terms. Diathermy is treatment that delivers 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.

Use of diathermy on patients with any implanted neurostimulation device can cause heating at the tissue/stimulation electrode interface, which under certain circumstances can result in permanent tissue or nerve damage.

This alert is not on a device malfunction; rather, damage may be caused by the interaction of two devices (neurostimulation system and diathermy machine) when they are working properly.

This contraindication applies: regardless of where the diathermy treatment is targeted on the patient’s body in relation to the implanted stimulation system; regardless of whether it is used to deliver heat or no heat; regardless of whether the neurostimulation system is turned “on” or “off”; and regardless of how many individual components of the neurostimulation system remain implanted in the body.

Medtronic recommends that all health care professionals should ask their patients if they have an implanted neurostimulation system prior to providing any form of diathermy treatment. If they have an implanted neurostimulation system, then diathermy should not be performed.

If you have any questions please contact Medtronic Neurological Division on 02 9879 5999.