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

Model Number	383562
Medical Device Problem Codes	Failure to Interrogate (1332); Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
This device would not interrogate and is eos.Device remains implanted.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
On (b)(6) 2022 - device was explanted.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.
Additional 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.
Additional Manufacturer Narrative
15-sep-2022 - device explanted.The device was returned for analysis.A device interrogation using a clinical programmer was properly feasible and the clinical observation was not reproducible.Device interrogation revealed the battery status eri.An amount of 41 charging cycles was documented.The icd memory content was inspected, demonstrating a normal device function while the device was implanted and in service.The bench test of the icd revealed that all therapy functions were available.The charge consumption of the device as well as the battery status eri were normal and as expected.The device never activated the battery status eos.In conclusion, the device was fully functional.The battery status eri was anticipated.There was no indication of a device malfunction.In particular, the eos battery status was not activated and the icd could be interrogated without any problem.The clinical observation was not reproducible.

• Brand Name: ILESTO 7 DR-T 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: 14026857
• Report Number: 1028232-2022-01731
• Device Sequence Number: 11405876
• Product Code: MRM
• UDI-Device Identifier: 04035479125189
• UDI-Public: 04035479125189
• 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: 2014
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2022

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: 04/30/2015
• Device Model Number: 383562
• 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: 04/01/2022
• Supplement Date Received by Manufacturer: 04/08/2022; 09/15/2022; 03/23/2023
• Initial Report FDA Received Date: 04/06/2022
• Supplement Report FDA Received Date: 04/11/2022; 09/20/2022; 03/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/22/2013
• 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 Age: 80 YR
• Patient Sex: Male