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

Model Number	383594
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2023
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted due to eos.No adverse patient events were reported.Should additional information become available, 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.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status.The device was implanted for 99 months and 94 charging cycles were recorded in the devices memory.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in shock delivery as mentioned in the complaint description.The analysis of the shock holter data showed that an amount of 55 charging cycles was performed by the device within 15 minutes on december 16, 2023.As a result of that fast successive charging the eos battery status had occurred.In conclusion, in the available iegms the occurrence of noise was observed in the right ventricular channel, confirming the clinical observation.This led to fast successive charging cycles that partially resulted in shock deliveries.The activation of the eos status resulted from that fast successive charging.However, a thorough analysis of the icd proved the device to be fully functional.There was no indication of a device malfunction.

• Brand Name: ILESTO 7 VR-T DX DF-1
• Common Device Name: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 18641915
• Report Number: 1028232-2024-00637
• Device Sequence Number: 8002659
• Product Code: LWS
• UDI-Device Identifier: 04035479125509
• UDI-Public: (01)04035479125509(17)170930
• 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
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: 09/30/2017
• Device Model Number: 383594
• 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: 02/01/2024
• Supplement Date Received by Manufacturer: 02/08/2024; 08/12/2024
• Initial Report FDA Received Date: 02/05/2024
• Supplement Report FDA Received Date: 02/08/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2015
• 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: 71 YR
• Patient Sex: Female