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Type of Product Medical Device
TGA Recall Reference RC-2014-RN-00495-1
Product Name/Description Model 5348 Single-Chamber External Pulse Generator

Serial number ranges : PEP001001P to PEP050019P and PEP001001K to PEP001714K

ARTG number: 128599
Recall Action Level Hospital
Recall Action Classification Class I
Recall Action Commencement Date 8/05/2014
Responsible Entity Medtronic Australasia Pty Ltd
Reason/Issue Medtronic has identified the development of high resistance on internal electrical connector contacts due to oxidation over time. Due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following:
• Pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm.
• Output amplitude or sensitivity outside of intended setting.
• Pace, Sense, or Low Battery LED indicators not lighting during power on or reset functions.
• Rapid Atrial Pacing (RAP) display with intermittent functionality.
• Intermittent functionality of the On/Off and RAP control buttons.
Recall Action Recall for Product Correction
Recall Action Instructions Medtronic recommends that the following actions be taken when using a potentially affected Model 5348 EPG:
• Monitor the EPG function and patient’s heart rhythm continuously while the EPG is in use to ensure it is operating properly and delivering appropriate therapy to the patient.
• If any malfunction is observed with a 5348 EPG, ensure the patient’s condition is stabilized, discontinue use of the Model 5348 device and contact your Medtronic representative.

During the design and development of new models, Medtronic identified that a service life of five years is most appropriate for an External Pulse Generator. Therfore, Medtronic is advising customers that they will no longer provide standard servicing of EPGs (calibration, physical inspection or repair) that are more than five years old including these potentially affected 5348 EPGs. Continued use of the device will require end users to perform the relevant maintenance procedures to ensure safe and effective operation of the devices.
Contact Information 02 9857 9000 - Medtronic Australasia Pty Ltd