MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 7 VR-T DX; ICD

Model Number	393037
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to eri with unusual battery behavior.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 based on available information at the moment.The file is closed.The investigation will be re-opened should additional data become available.
Event or Problem Description
This device was explanted due to eri with unusual battery behavior.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were reviewed.All production steps were performed accordingly, and the final acceptance test proved the device functions to be as specified.The device interrogation revealed the eri battery status.The device was implanted for 105 months.The icd was subjected to an electrical analysis.The current consumption of the icd was found to be normal and as expected.However, an inconsistency between the amount of charge taken from the battery and the battery voltage was noted.In order to obtain further insights, the icd was opened and the inner assembly was inspected.The visual inspection showed no anomalies.Subsequently the current consumption of the electronic module was verified by direct measurement and proved to be as expected and consistent with the interrogated icd data.There was no indication of a malfunction of the electronic module.The battery was sent to the manufacturer for a thorough 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 battery was subjected to a visual inspection which did not reveal any signs of damage.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified lithium plating, which led to an elevated internal self-depletion and, as a result, to the clinical observation.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ITREVIA 7 VR-T DX
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 19747094
• Report Number: 1028232-2024-03716
• Device Sequence Number: 9145041
• Product Code: LWS
• UDI-Device Identifier: 04035479129521
• UDI-Public: (01)04035479129521(17)161130
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/20/2025

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: 11/30/2016
• Device Model Number: 393037
• Device Catalogue Number: 393037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 05/20/2025
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 07/17/2024; 05/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2015
• 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: 67 YR
• Patient Sex: Male