Medtronic Safety Alert:
Diathermy and Neurostimulation Systems
The attached Medtronic Safety Alert Diathermy and Neurostimulation Systems dated 15th June, 2001 has been received by several departments at Royal Perth Hospital. This alert warns not to prescribe shortwave diathermy, microwave diathermy or therapeutic ultrasound diathermy for patients implanted with any type of Medtronic neurostimulation system.
Since electrosurgical generators (typically ValleyLab or Britcher equipment at RPH) are sometimes referred to as diathermy equipment the alert has lead to confusion as to whether electrosurgical equipment can be used on patients with these implanted neurostimulation systems.
Following discussions with Mr Garry Fennell, Medtronics Regulatory Affairs Manager I can confirm that the information in this Safety Alert does not relate to the use of electrosurgical generators. At Royal Perth the shortwave, microwave and therapeutic diathermy equipment identified is typically that used by our Physiotherapy Department.
Medtronics response to what precautions should be observed when using electrosurgical equipment (alternatively referred to as electrocautery) on patients fitted with Medtronic neurostimulation system is as follows. I am told the same precautions apply to the whole range of Medtronic neurostimulation systems.
Note: 3888 PISCES-Quad Plus® Quadripolar lead with larger electrodes and spacing for increased coverage/area.
implantable pulse generator (IPG) - A small device that sends mild levels of electrical pulses for use in spinal cord stimulation. The IPG contains a special battery and electronic circuitry to create these tiny electrical pulses. The IPG is placed under the skin, usually below the collarbone or in the abdomen.
Turning off the programmable neurostimulation system is recommended to avoid the possibility of it being re-programmed or re-set to the default conditions. Turning off the implanted device will require use of the external Medtronic programmer. Im informed that the local Medtronic office will respond to a request to attending a surgical procedure to turn off the system for the required period.
Information on Medtronics products can be obtained on their web site http://www.medtronic.com/
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|Last update: 03/09/2001|
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