Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning its neuromodulation devices.
The manufacturer has become aware that some neuromodulation devices have been distributed to customers in Turkey, India, and Mexico without the related Patient & Physicians Directions For Use (DFUs).
The absence of DFUs can increase the possibility that a patient with a spinal cord stimulator or deep brain stimulation system will experience difficulties using their remote control and/ or charger which can result in transient harms related to inadequate stimulation and difficulties with charging. There is a remote risk of a life-threatening due to a contraindicated procedure. The training and education that patients receive regarding the use of their devices and the continuous support available to them from a field representative can help lessen the likelihood of these harms.
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 30 August 2016