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 02/28/2023

Event Type  malfunction  

Event Description

It was reported that the device was explanted due to eos status approximately 74 months after the implantation.No adverse patient events were reported.Should additional information be received, this file will be updated.

Manufacturer Narrative

The icd was not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of this particular device as well as on the home monitoring data.The manufacturing process for this device was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance test proved the device functions to be as specified.The available data have been analyzed.The analysis revealed the eos battery status.The battery status was not as expected.Based on the data available for analysis the root cause for that behavior was not determinable and can only be clarified by an analysis of the device itself.However, it cannot be excluded that this occurrence resulted from a defective component, which may compromise the ability of the device to deliver therapy.It was reported that the device was replaced.Should the device itself become available this investigation will be updated.Please note, this icd is affected by the field safety corrective action, bio-lqc, initiated in (b)(6),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
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16492397
• MDR Text Key: 310778497
• Report Number: 1028232-2023-01141
• 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: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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: 11/30/2017
• Device Model Number: 402657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/06/2023
• Supplement Dates Manufacturer Received: 06/15/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization