MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 HF-T DF-1; CRT-D

Model Number 383547

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2023

Event Type  malfunction  

Event Description

This device was explanted due to eos.No adverse patient events were reported.Should additional information become available, this file will be updated.

Manufacturer Narrative

The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.

Manufacturer Narrative

Upon receipt, the icd was interrogated, revealing the eos battery status, 176 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.Therefore, a sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.The analysis of the shock holter data showed that an amount of 43 charging cycles were performed by the device within 15 minutes on march 20, 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 HF-T DF-1
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16588390
• MDR Text Key: 311737446
• Report Number: 1028232-2023-01439
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2023

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
• Device Operator: Health Professional
• Device Model Number: 383547
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 03/21/2023
• Supplement Dates Manufacturer Received: 03/23/2023; 09/20/2023
• Supplement Dates FDA Received: 03/24/2023; 09/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female