Medical device manufacturer, Boston Scientific, has issued a medical device safety alert concerning a subset of/certain recently released RESONATE, VIGILANT X4, PERCIVA, and MOMENTUM CRT-D/ICD from the United States (US) because the devices have an incorrect firmware configuration. The affected devices are identified as follows:-
1) VIGILANT X4 CRT-D IS1 DF4 IS4 US G247;
2) RESONATE EL ICD VR DF4 US D432;
3) RESONATE EL ICD DR IS1 DF4 US D433;
4) MOMENTUM X4 CRT-D IS1 DF1 IS4 US G138;
5) RESONATE X4 CRT-D IS1 DF4 IS4 US G447.
The manufacturer has received reports that when a device is interrogated by a programmer, a message presents stating"this device may contain features that are not approved and/or are investigational in some markets. Do not continue without contacting Boston Scientific."
According to the manufacturer, the affected products were only distributed in the US. Devices distributed to other countries have the correct firmware configuration.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 10 October 2017