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 07/11/2021

Event Type  malfunction  

Event Description

Device remains implanted.Battery went from 8 percent to eos in one day.Nurse practitioner said that device will be explanted and sent back for analysis.No adverse patient events reported.Should additional information become available, it will be added to this file.

Manufacturer Narrative

We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.

Manufacturer Narrative

(b)(6) 2021 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) 2021.The device was implanted for approximately 93 months.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 measured current consumption was normal and as expected.There was no indication of a malfunction.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 device was implanted for approximately 93 months.Further investigations 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: 12177551
• MDR Text Key: 261949923
• Report Number: 1028232-2021-04019
• 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
• Report Date: 07/14/2021

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 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
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 07/15/2021
• Supplement Dates Manufacturer Received: 07/18/2021; 03/22/2022
• Supplement Dates FDA Received: 07/22/2021; 03/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2013
• 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: 61 YR
• Patient Sex: Male