MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILIVIA 7 HF-T QP DF4 IS4 PROMRI; CRT-D

Model Number 404621

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/30/2023

Event Type  malfunction  

Event Description

It was reported that the eos status occurred approx.60 months after the implantation without previous eri status.Device currently remains implanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was received for analysis.Explant date is currently unknown prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The device interrogation revealed the eos battery status, detected on may 30, 2023.19 charging cycles were recorded in the devices memory.The current consumption of the icd was analyzed and found to be normal and as expected.However, an inconsistency between current consumption and battery voltage was noted.Therefore the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage confirmed a depleted battery.In a next step, the electronic module was attached to an external power supply and the eos status was removed with a technical programmer to check the functionality of the electronic module.There was no indication of a malfunction, particularly all therapy functions were available and worked as expected.Therefore, the battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The visual inspection of the battery did not reveal any external signs of damage.The voltage measurement confirmed the battery depletion.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified a short circuit, which led to an elevated internal self-depletion.In conclusion, analysis revealed an elevated internal self-depletion within the battery that contributed to the clinical observation.The therapeutic functionality of the device was tested with an attached external power supply and proved to be fully functional.

• Brand Name: ILIVIA 7 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 17079125
• MDR Text Key: 316707259
• Report Number: 1028232-2023-02869
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 404621
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/06/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization