Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its LATITUDE Programming Systems Model 3300 (Model 3300 Programmer) installed with Model 3892 v1.04 Altrua/ Insignia I/ Nexus I Support Application. Details of the serial numbers of the affected product are as follows:
On the affected product installed with the software, a user may not promptly detect loss of capture during a Manual Threshold test if the real-time electrogram (EGM) trace channels are repeatedly changed and Pause/Continue commands are pressed. If the test is not halted promptly after loss of capture, a pacemaker dependent patient may experience syncope.
The manufacturer has received one report of anomalous manual threshold test behavior with no patient syncope or injury. Manual Threshold tests are performed in-clinic and are not available in an ambulatory setting, thus the test can only be performed by a trained healthcare provider in a clinical setting.
Product recall is on-going. The manufacturer is developing an update to the Model 3892 Altrua/ Insignia I/ Nexus I Support App to address this unintended behavior.
According to the local supplier, the affected products are not distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 6 October 2020