Class 2 Device Recall BIOTRONIK ILESTO 7 DRT

• Date Initiated by Firm: March 08, 2021
• Create Date: April 21, 2021
• Recall Status: Terminated on April 25, 2023
• Recall Number: Z-1441-2021
• Recall Event ID: 87549
• PMA Number: P050023S058
• Product Classification: Defibrillator, implantable, dual-chamber - Product Code MRM
• Product: BIOTRONIK Ilestro 7 DR-T, DF-1, REF383562, UDI: 04035479125189 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: serial numbers: 60705317 60707977 60708912 60709157 60709393 60709408 60709992 60710002 60710004 60710006 60710009 60710010 60710202 60710203 60711081 60711093 60711108 60711123 60711124 60711130 60711285 60711293 60711297 60711301 60711624 60711628 60711633 60711641 60711653 60711655 60711656 60711658 60711659 60711660 60711661 60712136 60712137 60712142 60712164 60712165 60712171 60712212 60712362 60712364 60712366 60712381 60712433 60712434 60712440 60712453 60712454 60712455 60712456 60712632 60712635 60712662 60712667 60712668 60712677 60712678 60712679 60712680 60712681 60712683 60712688 60712690 60713619 60713623 60713624 60713625 60713626 60713628 60713629 60713630 60713631 60713877 60713878 60713879 60713881 60713882 60713883 60713887 60713891 60713894 60713899 60713906 60713907 60713908 60713910 60713911 60713913 60713917 60713922 60713928 60713929 60713935 60713939 60713940 60713941 60713945 60713947 60713949 60713956 60713957 60713958 60713960 60713961 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• Recalling Firm/ Manufacturer: BIOTRONIK Inc; 6024 Jean Rd; Lake Oswego OR 97035-5571
• For Additional Information Contact: BIOTRONIK Technical Services; 1800-547-0394
• Manufacturer Reason for Recall: There is a potential for premature battery depletion in Implantable Cardioverter Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT'Ds)
• FDA Determined Cause: Device Design
• Action: On 3/8/21, BIOTRONIK issued a "Urgent Field Safety" recall notification to all affected consignees via UPS. In addition to informing consignees about the recall, the firm asked consignees to take the following actions: 1. To determine if a specific device is affected by this corrective action you can lookup the device at the following web address: www.biotronik.com/devicelookup. 2. Devices in stock: Do not implant any potentially affected devices. Local BIOTRONIK representatives will replace affected devices in hospital inventory. 3. Continue with the standard patient follow-up schedule. -During follow-ups: Verify the status of the device and battery during in-office or Home Monitoring follow-ups. Please note that unresponsive devicesor those that are not transmitting data may be experiencing this issue and your BIOTRONIK representative should be informed if you observe any unusual device behavior. -Home Monitoring should be utilized whenever possible as it provides timely ERI warnings to reduce the risk of sudden loss of therapy. If you do not yet use Home Monitoring, please consider if this option is appropriate for you and your patients. BIOTRONIK will provide Cardio Messenger devices to monitor implants affected by this advisory. If you would like to register for Home Monitoring, please contact your local BIOTRONIK representative. 4. If there is an unexpected ERI notification for a device that is subject to this advisory, a timely replacement should be considered based on the patients underlying conditions: - For patients that are not pacemaker dependent, or patients with a primary prevention ICD, device replacement within one week after ERI notification is recommended. - For pacemaker dependent patients, replacement of the device is recommended immediately after ERI notification. 5. In consultation with our medical advisory board, BIOTRONIK does not recommend prophylactic replacement. The risk of complications for ICD exchange1-3 outweighs
• Distribution: US: Nationwide OUS: Worldwide
• 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 = MRM and Original Applicant = BIOTRONIK, INC.