Class 2 Device Recall LATITUDE Patient Management System

• Date Initiated by Firm: October 12, 2011
• Date Posted: December 01, 2011
• Recall Status: Terminated on December 04, 2012
• Recall Number: Z-0333-2012
• Recall Event ID: 60244
• PMA Number: P910077
• Product Classification: Implantable cardioverter defibrillator (non-crt) - Product Code LWS
• 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.
• Code Information: Models 6441*, 6442*, 6465*, 6488 (USA).
• Recalling Firm/ Manufacturer: Boston Scientific CRM Corp; 4100 Hamline Ave N; Saint Paul MN 55112-5700
• For Additional Information Contact: 651-582-4000
• Manufacturer Reason for Recall: 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 mea
• FDA Determined Cause: Software design
• Action: Boston Scientific sent an "IMPORTANT DIAGNOSTIC INFORMATION" letter dated October 2011 to all affected customers. The letter described the product, problem and actions to be taken by the customers.
• Quantity in Commerce: 25,300 (14,700 US; 10,600 OUS)
• Distribution: Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the countries of AUSTRIA, BELGIUM, DENMARK, FINLAND, FRANCE, GERMANY, IRELAND, ITALY, NETHERLANDS, NORWAY, PORTUGAL, SPAIN, SWEDEN, SWITZERLAND, UNITED KINGDOM, CANADA, AUSTRALIA, NEW ZEALAND, CYPRUS, CZECH REPUBLIC, GREECE, GUADELOUPE, HUNGARY, BANGLADESH, CHINA, COCOS ISLAND, HONG KONG, INDIA, INDONESIA, KOREA, MALAYSIA, PHILIPPINES, SINGAPORE, SOUTH KOREA, SRI LANKA, THAILAND, RUSSIA, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, NEW CALEDONIA, POLAND, PORTUGAL, QATAR, REUNION,IRAN, ISRAEL, JORDAN, KUWAIT, LATVIA, LEBANON, LUXEMBOURG, MONACO, MOROCCO, JAPAN, ARGENTINA, ARUBA, BAHAMAS, BARBADOS, BELIZE, BERMUDA, BRAZIL, CAYMAN ISLANDS, CHILE, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EL SALVADOR, FALKLAND ISLANDS, HAITI, HONDURAS, JAMAICA, MEXICO, PANAMA, PERU, TRINIDAD & Tobago, URUGUAY, VENEZUELA, AND NETHERLANDS ANTILLES.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = LWS and Original Applicant = BOSTON SCIENTIFIC