International safety notice

Due to an inappropriate inspection method for the inspection (polarization test) conducted during the manufacturing process of the product (XFine lead), regulations were not met. There is a possibility that leads exhibiting polarization voltage exceeding the standard (highly polarized leads) may be shipped without being properly detected and eliminated. has been confirmed. The highly polarized lead is sold under the name “Alizea” (common name: implantable cardiac pacemaker, approval number: 30400BZX00001000) When connected to the MV (Minute Ventilation) sensor function, a highly polarized state at the lead tip can be detected by the pacemaker. Depending on settings such as sensitivity, oversensing may occur. Improvements have already been made to address the inappropriateness of the testing method, and no products with problems due to the current testing method have been shipped. However, since the contamination of highly polarized leads cannot be ruled out in the product before improvement, we Voluntary recall of products and regular follow-up with medical institutions regarding patients implanted with the affected products We have decided to implement this. As mentioned above, improvements to the testing method have already been made, so it is unlikely that this phenomenon will occur in future products that will be newly implanted. There is no possibility of this happening. In addition, there is no possibility that this event will occur except with specific settings for specific products.

Japan / PMDA Recalls · JPN · Aug 31, 2022