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 01/18/2022

Event Type  malfunction  

Event 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.

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.

Manufacturer Narrative

Upon receipt, the device interrogation revealed the eri battery status.The device was implanted for approximately 104 months and a number of 42 charging cycles were documented to the devices memory.The bench test of the icd revealed that all therapy functions were available.The charge consumption of the device as well as the battery depletion were normal and as expected.Further, the manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process which may be related to the clinical observation.In conclusion the device was fully functional, there was no indication of a device malfunction.Analysis of the device revealed a normal battery depletion.

• 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: 13307145
• MDR Text Key: 284123948
• Report Number: 1028232-2022-00357
• 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: 01/19/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2014
• 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: 01/19/2022
• Initial Date FDA Received: 01/20/2022
• Supplement Dates Manufacturer Received: 01/21/2022; 09/13/2022
• Supplement Dates FDA Received: 01/21/2022; 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2013
• 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 Outcome(s): Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female