MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 5 VR-T DF4

Model Number	383584
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The hm data showed early eri.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in (b)(6) 2021.
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.As a first step in the analysis, the device was interrogated.The device interrogation revealed the eos battery status, detected on may 29, 2021.The device was implanted for about 87 months and 30 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.The current consumption of the icd was found to be elevated.In addition, 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.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.There was no indication of a malfunction.The overall current consumption of the module was directly measured and proved to be normal.Therefore, the battery was disconnected from the electronic module and sent to the manufacturer for further analysis.The analysis confirmed a depleted battery that can be attributed to an increased internal self-depletion within the battery as a result of lithium plating.This icd is part of the population affected by the field safety notification regarding potential premature battery depletion due to lithium plating from march 2021.

• Brand Name: ILESTO 5 VR-T DF4
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 11848928
• Report Number: 1028232-2021-02710
• Device Sequence Number: 19097886
• Product Code: LWS
• UDI-Device Identifier: 04035479125400
• UDI-Public: 04035479125400
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2021
• 2 Devices were Involved in the Event: 1 2

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: 02/28/2015
• Device Model Number: 383584
• 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: 05/18/2021
• Supplement Date Received by Manufacturer: 03/21/2022
• Initial Report FDA Received Date: 05/19/2021
• Supplement Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2013
• 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
• Patient Sex: Unknown