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	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Device went from eri to eos after 68 shocks.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for 74 months and 118 charging cycles were recorded in the icds memory.The memory content of the device was inspected.The inspection revealed multiple episodes of regular vt detection on july 04, 2024 due to intrinsic signals.As a result of that fast-successive charging the eos battery status had occurred.In conclusion, the activation of the eos status resulted from that fast successive charging.A thorough analysis of the icd, however, proved the device to be fully functional.There was no indication of a device malfunction.
Event or Problem Description
Device went from eri to eos after 68 shocks.Should additional information become available, this file will be updated.

• 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 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 20631225
• Report Number: 1028232-2024-05818
• Device Sequence Number: 18152385
• Product Code: NIK
• UDI-Device Identifier: 04035479142087
• UDI-Public: (01)04035479142087(17)190430
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2025

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: 04/30/2019
• Device Model Number: 404621
• Device Catalogue Number: 404621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2024
• Supplement Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2017
• 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: 71 YR
• Patient Sex: Male