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

Model Number	404622
Medical Device Problem Codes	High impedance (1291); Failure to Interrogate (1332)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
This device stopped reporting shock impedance measurements in (b)(6) 2023 and remains implanted.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Additional report of unable to connect to device following dft attempt.The device was explanted on (b)(6) 2025 the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.Therefore, the icd was opened and the inner assembly was inspected.The inspection revealed that several components of the electronic module had been damaged, which resulted to the reported observations.As a result of the damaged electronic module, the device is not capable of delivering therapy.Based on the device analysis, it is reasonable to assume that excessive energy coupling occurred in the icd caused by the strong electromagnetic fields present during the reported ablation procedure when applied in close proximity to the implanted system.In a next step, the manufacturing process for this device was reviewed and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the device functions to be as specified.There was no indication of a material or manufacturing problem.

• Brand Name: ILIVIA 7 DR-T DF-1 PROMRI
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 21632807
• Report Number: 1028232-2025-01352
• Device Sequence Number: 7424797
• Product Code: MRM
• UDI-Device Identifier: 04035479142094
• UDI-Public: (01)04035479142094(17)210930
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 404622
• Device Catalogue Number: 404622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2025
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2020
• 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: Hospitalization
• Patient Age: 47 YR
• Patient Sex: Unknown