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

Model Number 402657

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

It was reported that the device was explanted due to eos status approx.71 months after the implantation.Please note this icd is affected by a field safety corrective action, bio-lqc, initiated in march 2021.

Manufacturer Narrative

Prior to the analysis of the device, the quality documents accompanying the manufacturing process for this icd were re-investigated.All production steps were performed accordingly, and in particular the final acceptance test proved the device functions to be as specified.The device interrogation revealed the eos battery status, detected on (b)(6), 2021.The device was implanted for 70 months and 23 charging cycles were recorded in the devices memory.The icd was subjected to an electrical analysis.The current consumption of the icd was found to be normal and as expected.However, an inconsistency between the amount of charge taken from the battery and the battery voltage was noted.In order to obtain further insights, the icd was opened and the inner assembly was inspected.The visual inspection showed no anomalies.Subsequently the current consumption of the electronic module was verified by direct measurement and proved to be as expected and consistent with the interrogated icd data.There was no indication of a malfunction of the electronic module.Therefore, the battery was disconnected from the electronic module and sent to the manufacturer for further analysis.During analysis of the battery lithium plating was identified, which led to an elevated internal self-depletion and, as a result, to the clinical observation.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in march 2021.

• Brand Name: ITREVIA 5 HF-T QP DF4 IS4 PROMRI
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• MDR Report Key: 11920369
• MDR Text Key: 254584185
• Report Number: 1028232-2021-03031
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P050023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/19/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 402657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/02/2021
• Supplement Dates Manufacturer Received: 10/06/2021
• Supplement Dates FDA Received: 10/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization