China NMPA Product Recall - Model 5388 External Temporary Cardiac Pacemaker

Medtronic Inc. initiated a voluntary recall of its Model 5388 External Temporary Pacemaker, as announced by the National Medical Products Administration (NMPA) on December 7, 2010. The recall stems from a manufacturing defect: approximately 6,000 of 36,000 units globally contain a high-impedance contact on the electronic circuit board. This defect poses a risk of the device failing to power on or unexpectedly shutting down during use.

As of October 4, 2010, Medtronic had received 114 reports of devices shutting down shortly after startup and 2 reports of devices powering off during operation. Crucially, no patient injuries related to this issue have been reported. Medtronic has since developed a design upgrade to resolve the identified problem.

Under the guidance of the NMPA (formerly SFDA), Medtronic's required actions involve contacting affected customers to facilitate the return of devices for repair. While awaiting repair, which is estimated to take 2-4 weeks, customers may continue to use their devices if they are functioning normally. This proactive measure ensures product quality and patient safety, demonstrating Medtronic's commitment to addressing identified product deficiencies.