MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 VR-T DF-1; ICD

Model Number	383578
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Device at eri with unexpected battery behavior.The device remains implanted at this time.No adverse patient events have been reported.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
We received your event description for the above mentioned device and would like to thank you for supporting our post-market surveillance.As of today, the medical device is not available for analysis, therefore the device itself could not be investigated.The information you provided has been entered into our quality system as a complaint.These types of complaints are used to evaluate systems and device performance throughout our organization and help to maintain and improve the performance of our devices.Should additional relevant information or the device itself become available, the investigation will be updated.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 reviewed.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.Next, the icd was subjected to an electrical analysis, revealing that the device could not be interrogated.Therefore, the device was opened and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The measurement of the battery voltage showed a depleted battery.The electronic module was attached to an external power supply to test the functionality of the module.Thereby, the electrical parameters, particularly the current consumption of the electronic module were found to be normal and as expected.The ability of the electronic module to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.Next, the battery was sent to the manufacturer for a thorough analysis.During analysis of the battery lithium plating was identified, 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.
Event or Problem Description
Device at eri with unexpected battery behavior.The device remains implanted at this time.No adverse patient events have been reported.Should additional information be received, this file will be updated.

• Brand Name: ILESTO 7 VR-T DF-1
• 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: 11946445
• Report Number: 1028232-2021-03118
• Device Sequence Number: 1060855
• Product Code: LWS
• UDI-Device Identifier: 04035479125349
• UDI-Public: (01)04035479125349(17)160831
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 08/31/2016
• Device Model Number: 383578
• Device Catalogue Number: 383578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 06/07/2021; 03/28/2025
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/15/2021; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/27/2015
• 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
• Patient Age: 87 YR
• Patient Sex: Unknown