Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men over the age of 50 with prostate sizes between 20 and 50 cm3.

Medtronic has found through device testing that if the optional footswitch is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equi

Medtronic sent a "Urgent Medical Device Correction" letter dated January 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Medtronic has found through device testing that if the optional footswitch (Model 60883) is not connected to the Model 8930 RF generator during use, an electrostatic discharge (i.e. static electricity) to the footswitch connector port may toggle the RF output on or off. If this were to occur, it could result in unintentionally starting or stopping the lesion process, depending on the current status of the equipment. The status messages on the display screen and associated audible alarms operate as intended, and would notify the clinician of any change in status as described in chapter 2 of the system manual. Enclosed you will find an insulating cap that should be placed over the footswitch connector port when the Model 8930 RF Generator is used without the footswitch. The footswitch connector port is located on the rear panel of the Model 8930 RF Generator as shown below. For further questions In the United States, contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 or your local product representative. Outside of the United States, contact your local product representative.