Medical device manufacturer, Boston Scientific, has issued a field safety notice concerning its AUTOGEN DR ICDs and CRT-Ds. The affected model numbers for AUTOGEN CRT-D are G172, G173, G175, G177 and G179. The affected model numbers for AUTOGEN DR ICD D046, D047, D176 and D177.
According to the manufacturer, the concerned devices include the option of enabling a Right Ventricular Automatic Threshold (RVAT) test to determine the RV pacing threshold and adjust amplitude in an ambulatory setting. If the RVAT test feature is enabled and noise signals are continuously sensed within a brief RV noise window following an Atrial pace, a patient may not receive effective pacing support until the RVAT test ends (i.e., up to 20 cardiac cycles). Although no patients have been harmed in the cases reported to date, brief periods of dizziness were reported in one case. There is no additional risk for patients in whom the RVAT feature is disabled.
The manufacturer is developing a software solution that will prevent this device behaviour from occurring when the RVAT test feature is enabled. The software solution will be implemented via a non-invasive download from the programmer.
Until a software solution can be implemented, the manufacturer recommends the following:
According to the local supplier, Boston Scientific Hong Kong Limited, the affected products were distributed in Hong Kong.
If you are in possession of the products, please contact your supplier for necessary actions.
Posted on 18 November 2014