Medtronic Prostiva RF Therapy Generator. The Prostiva RF system is indicated for the treatment of symptoms due to urinar

FDA device recall Z-1031-2013 · posted 2013-04-02 · Terminated

Recall details

Recalling firm

Medtronic Neuromodulation

Reason for recall

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

Action taken

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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

848 (696 US, 152 OUS)

Distribution

Nationwide Distribution including Puerto Rico and all States in continental USA except ID, MT, and NH.

Date initiated

2013-02-27

Date posted

2013-04-02

Date terminated

2013-11-21

Location

Minneapolis, MN

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