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

Model Number	365608
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device is at eos indication and was explanted and replaced.No adverse patient events were reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
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 icd interrogation revealed the eos battery status, detected on (b)(6) 2022.The device was implanted for about 106 months.An amount of 47 charging cycles were documented.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.Next, the icd was subjected to an electrical analysis.The eos status was removed with a technical programmer and the ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device detected the fibrillation signal as specified and started the charging of a defibrillation shock.However, within 20 s charging time the specified energy level could not be reached, caused by the depleted battery.In order to obtain further insights, the icd was opened, and the inner assembly was inspected.The visual inspection 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.Analysis of the module showed 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 approximately 106 months.Analysis of the devices electronic module showed no indication of a malfunction.Further investigations revealed an elevated battery impedance as the root cause of the clinical observation.

• Brand Name: LUMAX 740 HF-T
• Common Device Name: 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: 13251297
• Report Number: 1028232-2022-00216
• Device Sequence Number: 4269887
• Product Code: NIK
• UDI-Device Identifier: 04035479110277
• UDI-Public: 04035479110277
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2022

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: 365608
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2022
• Supplement Date Received by Manufacturer: 01/13/2022; 06/13/2022
• Initial Report FDA Received Date: 01/13/2022
• Supplement Report FDA Received Date: 01/14/2022; 06/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2012
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 76 YR
• Patient Sex: Male