MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ITREVIA 5 HF-T QP DF4 IS4; CRT-D

Model Number	402659
Medical Device Problem Code	Premature Elective Replacement Indicator (1483)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/28/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device reached eri status approx.44 months after the implantation.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in (b)(6) 2021 and the awareness date of the event was before the fsca started.
Additional Manufacturer Narrative
The icd was received for analysis and inspected.Upon receipt the device was interrogated.The interrogation could be properly performed and revealed the eri battery status.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.

• Brand Name: ITREVIA 5 HF-T QP DF4 IS4
• 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: 12129986
• Report Number: 1028232-2021-03794
• Device Sequence Number: 11522308
• Product Code: NIK
• UDI-Device Identifier: 04035479140144
• UDI-Public: 04035479140144
• Combination Product (Y/N): N
• PMA/510(K) Number: P050023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2021

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: 04/30/2018
• Device Model Number: 402659
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2016
• 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
• Patient Sex: Unknown