MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG LUMAX 740 DR-T; ICD

Model Number	365606
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device remains implanted.Eos on home monitoring (b)(6) 2021, and had 29 percent with 2.94v battery on remote (b)(6) 2021.No adverse patient events reported.Should additional information become available, it will be added to this file.
Additional Manufacturer Narrative
Device was explanted on (b)(6) 2021 due to eos.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.
Additional Manufacturer Narrative
Device was explanted on (b)(6) 2021 due to eos.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 july 06, 2021.The device was implanted for about 106 months and 37 charging cycles were recorded in the devices memory.Subsequently, 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 showed a depleted battery.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.Thereby, the electrical parameters, particularly the current consumption of the electronic module were found to be normal and as expected.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 battery was subjected to a visual and an electrical inspection as well as a microcalorimetry analysis.The visual inspection of the battery did not reveal any external signs of damage.The voltage measurement confirmed a depleted battery.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified damaged insulation, which led to an increased internal self-depletion within the battery and therefore contributed to the clinical observation.In conclusion, the device was implanted for 106 months.Further investigations revealed an increased internal self-depletion within the battery that contributed to the clinical observation.

• Brand Name: LUMAX 740 DR-T
• 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: 12125292
• Report Number: 1028232-2021-03815
• Device Sequence Number: 19824887
• Product Code: MRM
• UDI-Device Identifier: 04035479110253
• UDI-Public: 04035479110253
• 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: 2012
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2021

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
• Operator of Device: Health Professional
• Device Model Number: 365606
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/06/2021
• Supplement Date Received by Manufacturer: 07/11/2021; 03/21/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 07/13/2021; 03/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2012
• 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
• Patient Age: 85 YR
• Patient Sex: Male