MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA NEO 7 DR-T DF-1 PROMRI; ICD

Model Number	429529
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Death
Event or Problem Description
Patient deceased (b)(6) 2026 after (b)(6) 2026 generator changeout.Patients family believes death is related to this new device, implanting physician does not.No events were recorded for date of death.There has been an autopsy and the results are unknown.Should additional information be received, this file will be updated.

• Brand Name: ILIVIA NEO 7 DR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 24278442
• Report Number: 1028232-2026-00621
• Device Sequence Number: 8318906
• Product Code: MRM
• UDI-Device Identifier: 04035479156749
• UDI-Public: (01)04035479156749(17)270630
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/06/2026

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 Model Number: 429529
• Device Catalogue Number: 429529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Date Device Manufactured: 06/12/2025
• 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: Death
• Patient Age: 78 YR
• Patient Sex: Male