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	10/05/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this device was explanted due to eri.
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 interrogation could be properly performed, and it revealed the battery status mos2.Battery trend data showed a temporary voltage drop followed by recovery of the battery voltage.Further analysis of the icd memory content showed a normal current consumption.However, the amount of charge taken from the battery was verified and the battery condition was not as expected.In order to obtain further insights, the icd was opened, and the inner assembly was inspected.The visual inspection showed no anomalies.The overall current consumption of the electronic module was verified by direct measurement and proved to be normal and as expected.There was no indication of a malfunction of the electronic module.Battery trend data and voltage measurement confirmed an unexpected battery behavior 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: 12656279
• Report Number: 1028232-2021-05770
• Device Sequence Number: 14572617
• 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: 2013
• 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): 10/15/2021

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: 11/30/2014
• 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: 10/18/2021
• Supplement Date Received by Manufacturer: 06/08/2022
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 06/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2013
• 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
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown