MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 DR-T DF4 PROMRI; ICD

Model Number	404623
Medical Device Problem Codes	Over-Sensing (1438); Premature End-of-Life Indicator (1480); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The patient had presented to the hospital after receiving shock therapy.Noise had been detected, and inappropriate therapy due to oversensing.Multiple shocks had been delivered, and the device had reached eos.A revision is scheduled for february 27th to check the lead and replace the icd.

• Brand Name: ILIVIA 7 DR-T DF4 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: 24495765
• Report Number: 1028232-2026-01070
• Device Sequence Number: 13431012
• Product Code: MRM
• UDI-Device Identifier: 04035479142100
• UDI-Public: (01)04035479142100(17)191031
• Combination Product (Y/N): N
• Initial Reporter Country: JP
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: 404623
• Device Catalogue Number: 404623
• 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: 03/02/2026
• Initial Report FDA Received Date: 03/03/2026
• Date Device Manufactured: 04/26/2018
• 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: Hospitalization
• Patient Sex: Male