Medical device manufacturer, Medtronic, Inc., has issued a Medical Device Correction notice concerning InterStim, InterStim II, Itrel 3 and Enterra devices.
The manufacturer is updating the labeling related to the cycling feature in the above neurostimulation devices used for sacral nerve stimulation, gastric electrical stimulation and spinal cord stimulation.
Current labeling indicates the use of cycling improves device longevity under every programming scenario; however, enabling cycling at certain parameter settings may decrease the device battery longevity. Furthermore, when cycling is enabled, longevity estimation displayed on the N'Vision Clinician Programmer (Model 8840) may not be accurate. The potential hazard would be premature battery depletion requiring an earlier than anticipated device replacement. There is no impact from this issue to therapy delivered or battery level notifications.
According to the local supplier, the affected products are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 13 January 2015