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	08/22/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Eri was reported in (b)(6) 2018.The patient came in for a change out and it was found that there was 76 percent battery left so the patient was sent home.This device was explanted and replaced due to eos on (b)(6) 2020.
Additional Manufacturer Narrative
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 (b)(6) 2020.The device was implanted for about 90 months and 33 charging cycles were recorded in the devices memory.In a next step, the amount of charge taken from the battery was verified.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 consequence.In conclusion, the device was implanted for 90 months.The analysis revealed an elevated battery impedance as the root cause of 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: 11088203
• Report Number: 1028232-2020-05688
• Device Sequence Number: 19503437
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2018

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: 04/30/2014
• Device Model Number: 365606
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2020
• Supplement Date Received by Manufacturer: 12/06/2021
• Initial Report FDA Received Date: 12/29/2020
• Supplement Report FDA Received Date: 12/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2013
• 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: 62 YR
• Patient Sex: Male