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-1442-2021
• Recall Event ID: 87549
• PMA Number: P050023S076
• Product Classification: Defibrillator, implantable, dual-chamber - Product Code MRM
• Product: BIOTRONIK Ilestro 7 DR-T, DF-4, REF383564, UDI: 04035479125202 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: Affected Serial Number: 60744585 60744586 60744588 60744589 60744590 60744591 60744592 60744593 60744594 60744595 60744596 60744597 60744598 60744599 60744600 60744602 60744603 60744605 60744606 60744607 60744609 60744610 60744611 60744612 60744613 60744614 60744735 60744736 60744739 60744740 60744741 60744742 60744744 60744746 60744747 60744748 60744749 60744751 60744752 60744753 60745675 60745676 60745678 60745679 60745680 60745681 60745682 60745895 60745896 60745897 60745898 60745899 60745900 60745901 60745902 60745903 60745905 60745906 60745907 60745912 60745913 60745914 60746065 60746066 60746069 60746070 60746071 60746072 60746073 60746075 60746077 60746079 60746082 60746083 60746084 60747525 60747526 60747529 60747530 60747531 60747532 60747533 60747534 60747535 60747536 60747537 60747538 60747539 60747541 60747542 60747543 60747625 60747628 60747629 60747630 60747631 60747632 60747633 60747634 60747637 60747638 60747639 60747640 60747642 60747644 60747805 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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.