Merlin PCS 3650 Software Upgrade Kit, REF 3330 St. Jude Medical The MerlinTM Patient Care System (MerlinTM PCS) Model 3650 is a portable, dedicated programming system designed to interrogate, program, display data, and test St. Jude MedicalTM implantable devices and leads.

Reason: Internal testing of software identified software anomaly scenarios where if non-applicable shock energy value is selected, the device will continue to use the previously programmed energy level and the user will not be alerted that the selected value was not retained.

Code information: Software Version: 24.6.1 Model: 3650, GTIN: 05414734500661 Model: 3330, GTIN: 05414734509725 For affected serial number of programmers see Attachment B.1 Programmers For models of ICDs interrogated by affected programmers see Attachment B.2 Devices.

Distribution pattern: U.S. AK, Al, AR, AZ, CA, CO, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NH, NJ, NY, OH, OK, PA, RI, SC, TN, TX, UT, VA, WA, WI, and WV. OUS: None - the firm stated that there are no OUS consignees associated to ICDs that were interrogated from January 22, 2020 to February 6, 2020.