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

Model Number 381462

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/28/2022

Event Type  malfunction  

Event Description

After an implantation period of approx.115 months, it was observed via homemonitoring that the device shows the eos status.The icd was explanted.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The device was not returned for analysis.The analysis is therefore only based on the returned device data as well as the inspection of the quality documents associated with the manufacture of this particular device.The manufacturing process for this device was re-investigated.All production steps had been performed accordingly.There was no sign of any inconsistency during the manufacturing.In a next step, the returned device data was inspected.During the inspection the clinical observation could be confirmed.Analysis revealed an unexpected battery behavior, which led to the clinical observation.Based on the data available for analysis the root cause for that behavior was not determinable and could only be clarified by an analysis of the device itself.

• Brand Name: LUMAX 740 HF-T PROMRI
• 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: 15214513
• MDR Text Key: 297823005
• Report Number: 1028232-2022-04052
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2013
• Device Model Number: 381462
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2012
• 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