Class 2 Device Recall BIOTRONIK ILIVIA

• Date Initiated by Firm: March 08, 2021
• Create Date: April 21, 2021
• Recall Status: Terminated on April 25, 2023
• Recall Number: Z-1464-2021
• Recall Event ID: 87549
• PMA Number: P980023S093
• Product Classification: Implantable cardioverter defibrillator (non-CRT) - Product Code LWS
• Product: BIOTRONIK ILIVIA NEO 7 DR-T DF-1 ProMRI, REF 429529, UDI: 04035479156749 - Product Usage: intended to provide ventricular tachycardia pacing and ventricular defibrillation for automatic treatment of life-threatening ventricular arrhythmias.
• Code Information: Serial Number 61089430 84703220 84724608 84724622 84724623 84724625 84724786 84724793 84724809 84725291 84725310 84725318 84725332 84725340 84725641 84725655 84725745 84725773 84725774 84725784 84725790 84728481 84729774 84729990 84730000 84730092 84730133 84730723 84730740 84730741 84731227 84731461 84731469 84731838 84731848 84731849 84732339 84732353 84732359 84732360 84732587 84732885 84733496 84733757 84734018 84734027 84734047 84734065 84734106 84735588 84735595 84735608 84736377 84736703 84736705 84736732 84736952 84737029 84737035 84737561 84737864 84737892 84738265 84739242 84739719 84739727 84739735 84740051 84740058 84740061 84740065 84740069 84740083 84740093 84740481 84740482 84740484 84740489 84740721 84740735 84740741 84740746 84740759 84741676 84741696 84742209 84742220 84742525 84742533 84742538 84742544 84742550 84742828 84743250 84743516 84743517 84744326 84744871
• 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
• Quantity in Commerce: 98 UNITS
• 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 = LWS