The Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom posted a field safety notice concerning MICRO-PACE 4580, manufactured by Pace Medical, Inc.

Pace Medical has observed in the REF 4580 that in a specific use of the device the defibrillation protection circuitry may not function as well as intended. If the device is used on a patient, with heart wires and the patient's heart is defibrillated directly on the heart, there may be a chance that the device will be damaged from the defibrillation output current.

The manufacturer has designed and validated a new defibrillation protection circuit which will eliminate the potential for this to occur. Furthermore, it advised that:

• users should return the affected device for a complimentary upgrade.
• the device should not be used in cardiac surgical theaters where heart wires are used and defibrillation is applied directly to the heart tissue.
• REF 4580 can be used in other procedures while scheduling product return, but patients should be monitored while the device is in use and a backup device should be on hand.

For details, please refer to the following MHRA website:
http://www.mhra.gov.uk/Safetyinformation/Safetywarningsalertsandrecalls/fieldsafetynotices/CON185136

If you are in possession of the product, please contact your supplier for necessary actions.

Posted on 25 September 2012