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

Model Number 402659

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

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

Event Date 07/06/2022

Event Type  malfunction  

Manufacturer Narrative

The icd and the lead under complaint were not returned for analysis.The analysis is therefore based on the inspection of the quality documents associated with the manufacture of these particular devices as well as on the returned data.The manufacturing processes for these devices was re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.The final acceptance tests proved the devices functions to be as specified.The returned data have been analyzed.Analysis showed that the icd activated the battery status eos on (b)(6) 2022.Analysis of the shock holter data showed that an amount of 106 charging cycles, with 59 shock deliveries, was performed by the device on (b)(6) 2022.As a result of that successive charging the eos battery status had occurred.The analysis of the available iegms revealed noise in the rv channel, which led to the multiple charging cycles and shock deliveries.Based on the available data, the root cause of the noise could not be determined.However, a damage of the rv lead cannot be excluded.There was no indication of an icd malfunction.In conclusion, the devices were not returned for analysis.The review of the quality documents confirmed a regular manufacturing of the lead and the icd.In the available iegms the occurrence of noise was observed in the rv channel, which led to the clinical observation.Based on the available data the integrity of the lead cannot be assured.

Event Description

It was reported that this icd was explanted due to eri.Reportedly the patient received inappropriate shocks causing the battery depletion.The analysis showed that the device was in eos before explant.Should additional information be received, this file will be updated.

• Brand Name: ITREVIA 5 HF-T QP DF4 IS4
• Type of Device: CRT-D
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359 ; DE 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 15584899
• MDR Text Key: 301674886
• Report Number: 1028232-2022-05223
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: DE
• 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
• Type of Report: Initial
• Report Date: 07/29/2022

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: 07/31/2018
• Device Model Number: 402659
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/17/2017
• 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