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

Model Number	372419
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approx.95 months, it was reported that the device shows the eos status.
Additional Manufacturer Narrative
The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the returned device data.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 process which might be related to the clinical observation.The returned device data have been analyzed.The analysis confirmed that the eos status of the icd was triggered on (b)(6) 2021.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.Biotronik has informed the health care professional about this analysis result, who decides, based on the patients individual circumstances and medical judgment, if the device will be exchanged.Should further relevant information or the device itself become available, this investigation will be updated and you will be informed accordingly.

• Brand Name: LUMAX 740 VR-T DX
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11980203
• Report Number: 1028232-2021-03160
• Device Sequence Number: 4268874
• Product Code: LWS
• UDI-Device Identifier: 04035479116057
• UDI-Public: 04035479116057
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2021

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 Expiration Date: 10/31/2013
• Device Model Number: 372419
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 06/10/2021
• Supplement Report FDA Received Date: 07/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1