Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its INGEVITY MRI endocardial pacing leads [Model (Serial) numbers: 7732 (488740); 7736 (631322, 632188); 7740 (610662, 633464); 7741 (563539, 628198, 636545, 641593, 656713, 656904, 657588); 7742 (572200, 631202)].
The manufacturer is implementing a voluntary Field Safety Corrective Action regarding a population of fifteen Boston Scientific INGEVITY MRI endocardial pacing leads. There is a possibility that the polyurethane boot at the terminal end of the lead was not securely connected to the lead body. Investigation determined that manufacturing equipment may not have applied adequate adhesive between the terminal boot and lead body.
When the terminal of an affected lead is successfully connected to the pulse generator, normal chronic lead performance is expected. However, damage may occur to the terminal boot during lead or pulse generator replacement.
According to the manufacturer, these leads were sold in Belgium, Germany, Italy, Netherlands, the United Kingdom, and the United States.
According to the local supplier, the affected products are NOT distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 December 2016