Medical device manufacturer, Medtronic, has issued a medical device alert concerning its INTELLIS MODEL 97755 RECHARGER.
The manufacturer has become aware of an issue that may cause unintended increased heating, specifically due to damage at the location where the cable enters the recharger antenna. Due to this damage, it causes unintended increased heating. Patients have reported experiencing temporary discomfort (e.g. heating, burning, or shocking sensations) from the recharger or signs of heating on the skin, such as redness, blistering, or a burn resulting from prolonged exposure to heat.
The medical device is designed to charge the following rechargeable neurostimulators:
The manufacturer is working to improve the design of the recharger, which should be available over the next few months pending regulatory clearances.
According to the local supplier, the products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary action.
Posted on 26 March 2021