Medical device manufacturer, Medtronic, has issued a medical device safety alert concerning its Model 53912 Reusable External Pulse Generator (EPG) Extension Cable and Model 53912A EPG Extension Cable, packaged with Model 5391 EPG. The affected devices are identified as follows:

• Product names: 1) Cable EPG 53912 Reusable; 2) EPG 5391(only 53912A cables packaged with 5391 EPG are affected)
• Product numbers: 1) 53912; 2) 5391
• Universal Product Number: 1) 00643169306035, 00643169382985; 2) 00643169306028, 00643169382978
• Lot or serial numbers: All

Medtronic sells the Oscor ATAR extension cables individually as the model 53912 Reusable EPG Extension Cable, and with 5391 EPGs as the model 53912A Reusable EPG Extension Cable. According to Oscor, its reusable ATAR extension cables could separate from the connector during use when the instructions for reuse are not being followed. The separated connector from the cable could result in the interruption of stimulation during the exchange of cable.

Through 20 April 2017, Medtronic has identified 34 confirmed complaints with 4 reports of malfunctions during use requiring intervention to restore patient health, and no reports of death related to this issue.

To minimize the potential for a connector to cable separation, or any other failure with the cables, Oscor requests the users to follow the instructions defined within the current Instruction for use (IFU), which indicates the number of times for reuse and requirement for re-steriliczation of the product to be conducted by the manufacturer. In addition, Medtronic requests the users to carry out the following actions:

• Limit use of these extension cables to first use + 2 re-uses
• After each use of the 53912 or 53912A extension cables, the cables should be sent to Oscor for inspection and sterilization per the IFU.

According to the local supplier, the affected products are distributed in Hong Kong.

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

Posted on 15 June 2017