Medical device manufacturer, Boston Scientific, has issued a letter to physician to explain changes in lead configuration preferences and new test methodology in COGNIS®, TELIGEN®, INCEPTA™, PUNCTUA™, and ENERGEN™ defibrillator families, and clarifies how to interpret test result differences from prior defibrillator-lead combinations.
Current Boston Scientific defibrillator systems measure shock lead impedances up to 200 ohms, and export results to the programmer and LATITUDE monitoring system via the Daily Measurements feature. A measured shock lead impedance that is greater than 125 ohms or less than 20 ohms will generate an alert message on programmer screens and a "Red Alert" within LATITUDE (if activated). However, the measured value that prompted the alert is not displayed. Similarly, out-of-range impedance measurements are not plotted on programmer or LATITUDE trending graphs. Boston Scientific has received reports that, in some instances, this has made it more difficult for physicians to troubleshoot the system and determine whether the out-of-range impedance value truly reflected an underlying lead/system issue.
If you are in possession of the affected products, please contact Boston Scientific Technical Services for instructions on how to obtain more detailed shock lead impedance information when needed.