MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number	404621
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	10/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Mdt affera ablation tool caused an adverse event to the patient.The patient was externally defibrillated and is stable.Device remains implanted.Should additional information be received this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24344867
• Report Number: 1028232-2026-00791
• Device Sequence Number: 9523688
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: (01)04035479142087(17)200430
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2020
• Device Model Number: 404621
• Device Catalogue Number: 404621
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male