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

Model Number	383547
Medical Device Problem Code	Premature End-of-Life Indicator (1480)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The device reached eos and was explanted.Should additional information become available, this report will be updated.
Additional Manufacturer Narrative
Upon receipt, the icd was interrogated, revealing the eos battery status, 31 charging cycles were recorded in the devices memory.The memory content of the device was inspected.The inspection revealed that the eos status was activated on november 02, 2020.Based on the data, the eos activation occurred after explantation, most likely resulting from an automatic capacitor reformation in a cold temperature environment.Besides that, the inspection showed no anomalies.There was no indication of a device malfunction.The device was subjected to an electrical analysis.The eos status was removed with a technical programmer and subsequent interrogation revealed the eri battery status.The amount of charge taken from the battery was verified.The battery condition was found to be normal and as expected.In conclusion, the device proved to be fully functional.There was no indication of a device malfunction.The eos status was triggered 13 days after the explantation of the device, most likely due to influences of a cold temperature environment.

• Brand Name: ILESTO 7 HF-T DF-1
• Common Device Name: 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: 10891919
• Report Number: 1028232-2020-05103
• Device Sequence Number: 16965266
• Product Code: NIK
• UDI-Device Identifier: 04035479125035
• UDI-Public: 04035479125035
• 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: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2020

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: 01/31/2015
• Device Model Number: 383547
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 12/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2013
• 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: 88 YR
• Patient Sex: Unknown