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

Model Number	404622
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Codes	Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was checked in emergency department (b)(6) 2024 after reported vt storm and multiple shocks delivered by the device.Today, (b)(6), during interrogation device reported eos.Recommendation to change device asap given.Device currently 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.
Additional Manufacturer Narrative
Device was explanted on (b)(6) 2024.Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for 56 months and 94 charging cycles were recorded in the devices memory.The memory content of the device was inspected.The inspection revealed 119 episodes of regular vf detection within eight hours on (b)(6) 2024 due to intrinsic signals that largely led to full energy therapy delivery.The analysis of the shock holter data showed that an amount of 78 charging cycles were performed by the device within 80 minutes on (b)(6) 2024.As a result of that fast-successive charging the eos battery status had occurred.In conclusion, the analysis of the memory content revealed a high number of regular vf episodes on (b)(6) 2024.Within 80 minutes 78 charging cycles were performed by the device.The activation of the eos status resulted from that fast-successive charging.However, there was no indication of a device malfunction.

• 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: 19996188
• Report Number: 1028232-2024-04359
• Device Sequence Number: 20978772
• Product Code: MRM
• UDI-Device Identifier: 04035479142094
• UDI-Public: (01)04035479142094(17)201231
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2025

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: 12/31/2020
• Device Model Number: 404622
• Device Catalogue Number: 404622
• 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: 08/08/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 01/08/2025
• Initial Report FDA Received Date: 08/15/2024
• Supplement Report FDA Received Date: 08/21/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/19/2019
• 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: 76 YR
• Patient Sex: Male