Company:Boston Scientific CRM Corp.
Date of Enforcement Report 12/27/11
Class ll:
PRODUCT
LATITUDE Patient Management System, Models 6441*, 6442*, 6465*, 6488 (USA). There are two software applications: the programmer software and the LATITUDE remote monitoring system software. The Model 2868 Software Application is loaded onto the Model 3120 programmers. These programmers are used during in-office follow-ups. The software version affected domestically is version 1.05 for COGNIS and TELIGEN and internationally is version 2.04 for COGNIS, TELIGEN, and PUNCTUA, ENERGEN, and INCEPTA. The PUNCTUA, ENERGEN, and INCEPTA are not currently approved in the US. The LATITUDE Patient Management system is intended for use to remotely communicate with a compatible Guidant or Boston Scientific pulse generator and transfer data to a central database. The LATITUDE Patient Management System software is web-based and therefore at any point in time, there is only one (1) released version for each model number. The current version is 7.1. Both the programmer software and the LATITUDE remote monitoring system software similarly display the shock lead impedance measurements. Recall # Z-0333-2012
REASON
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.
RECALLING FIRM/MANUFACTURER
Boston Scientific CRM Corp., Saint Paul, MN, by letter dated October 2011. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
25,300 (14,700 Nationwide, 10,600 Internationally)
DISTRIBUTION
Nationwide and Internationally
