MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 7 DR-T DF4; ICD

Model Number	383564
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Device explanted due to eol from multiple shocks.Should additional information be received, this file will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the battery status eos, detected on (b)(6) 2023.The icd was implanted for 85 months and 123 charging cycles were recorded to 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 resulted in several shock deliveries, confirming the clinical observation.All electrical parameters were verified and showed a normal device behavior.Especially, the current consumption and the battery state of discharge were found normal and as expected.There was no indication of a device malfunction.In conclusion, in the available iegms the occurrence of noise was observed in the right ventricular channel, confirming the clinical observation.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 DR-T DF4
• 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: 17203959
• Report Number: 1028232-2023-03195
• Device Sequence Number: 6667227
• Product Code: MRM
• UDI-Device Identifier: 04035479125202
• UDI-Public: (01)04035479125202(17)170331
• 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: 2022
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2017
• Device Model Number: 383564
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2023
• Supplement Date Received by Manufacturer: 11/06/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2014
• 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: 79 YR
• Patient Sex: Male