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

Model Number	383547
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
This device was explanted and replaced due to eri.No adverse patient events were reported.Should additional information become available, this file will be updated.
Additional Manufacturer Narrative
The device was returned and analyzed.The device memory demonstrated a normal device function while implanted and in service.The bench test of the icd revealed that all therapy functions were available.The archive data and the programmed parameters were inspected.High left ventricular pacing thresholds, up to 6.0v and 1.0ms, were documented in the archive data.Therefore it is reasonable to assume that the pacing outputs were programmed accordingly, which is confirmed by the last programmed left ventricular pacing output of 7.5v and 1.0ms.This represents a high current program, which results in a faster discharge of the battery.In conclusion, the device was fully functional.There was no indication of a device malfunction.Analysis of the device revealed a normal battery depletion.

• Brand Name: ILESTO 7 HF-T DF-1
• Common Device Name: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 8633769
• Report Number: 1028232-2019-02063
• Device Sequence Number: 11266968
• 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: 2015
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2019

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: 05/31/2018
• Device Model Number: 383547
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 87 YR