MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 HF-T; CRT-D

Model Number 365608

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

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

This device shows eos on home monitoring.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.The clinical observation was confirmed, the device activated the eos battery status.The root cause of the eos activation could not be determined.However, based on the available data, a defective component cannot be excluded.For a root cause investigation an analysis of the icd would be necessary.Should the icd become available for analysis, this report will be updated.

Manufacturer Narrative

On (b)(6) 2022 device explanted.The device was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the icd functions to be as specified.The returned device data have been analyzed.The clinical observation was confirmed, the device activated the eos battery status.The root cause of the eos activation could not be determined.However, based on the available data, a defective component cannot be excluded.For a root cause investigation an analysis of the icd would be necessary.Should the icd become available for analysis, this report will be updated.

Manufacturer Narrative

On (b)(6) 2022, device explanted.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 icd interrogation revealed the eos battery status, detected on (b)(6) 2022, confirming the clinical observation.The memory content of the icd was inspected, revealing a normal current consumption of this device.However, the amount of charge taken from the battery was verified and the battery condition was not as expected.Therefore, the icd was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.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.The overall measured current consumption was normal and as expected.Analysis of the electronic module revealed no indication of a malfunction.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.In a next step, the battery was opened for destructive analysis.During the analysis of the inner assembly an elevated internal battery impedance was identified.It is reasonable to assume that the increased impedance has led to a voltage drop and therefore to the clinical observation.In conclusion, the electronic module of the icd was proven to be fully functional.Further analysis revealed an elevated battery impedance as the root cause of the clinical observation.

• Brand Name: LUMAX 740 HF-T
• 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: 14830659
• MDR Text Key: 294794108
• Report Number: 1028232-2022-03259
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 04035479110277
• UDI-Public: 04035479110277
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 365608
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2013
• 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 Age: 72 YR
• Patient Sex: Female