MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 5 HF-T DF-1

Model Number	393066
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
After an implantation period of approximately 64 months, it was reported that the device was explanted due to eri status.
Additional Manufacturer Narrative
The icd was received for analysis.Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated and all production steps were performed accordingly.Particularly the final acceptance test proved the device functions to be as specified.The ability of the device to deliver therapies was verified.The anti-bradycardia pacing pulses proved to be normal and in amplitude and frequency as programmed.A fibrillation signal was applied, and the device delivered a defibrillation shock as specified, documenting a normal and expected sensing and shock delivery.In particular, the specified energy level was reached.At a next step the memory content of the device was inspected.The data showed an inconsistency between the amount of charge taken from the battery and the battery voltage, which led to the automatic activation of the eri battery status.The data analysis confirmed an unexpectedly low battery voltage.Therefore, the device was opened, and the inner assembly was inspected.The visual inspection of the inner assembly showed no anomalies.The overall current consumption of the electrical module was directly measured and proved to be normal and as expected.The battery was sent to the manufacturer for further analysis.The manufacturing records of the battery were inspected, documenting that the battery parameters were within specification during the battery manufacturing.No anomalies were documented during the production process, associated with this battery.The battery was subjected to a visual inspection which did not reveal any signs of damage.In a next step, the battery was opened for destructive analysis.The inspection of the inner assembly identified a short circuit, which led to the elevated internal self-depletion.In conclusion, the analysis revealed an elevated internal self-depletion within the battery.Based on the analysis all therapy functions of the device were entirely available while the device was implanted and in service.

• Brand Name: ITREVIA 5 HF-T DF-1
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 12391602
• Report Number: 1028232-2021-04874
• Device Sequence Number: 11857595
• Product Code: NIK
• UDI-Device Identifier: 04035479129781
• UDI-Public: 04035479129781
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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: 09/30/2017
• Device Model Number: 393066
• 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: 08/30/2021
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2016
• 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 Sex: Unknown