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 09/22/2022

Event Type  malfunction  

Event Description

It was reported that the rv lead was replaced by a new one due to oversensing with artifacts and shock delivery.The lead was abandoned in patient.The associated icd was explanted due to battery depletion (eos).The device is affected by the field safety corrective action, bio-lqc, initiated in march 2021.Both products were implanted and active for approx.64 months.Should additional information be received, this file will be updated.

Manufacturer Narrative

The lead under complaint was not returned for analysis.This report is therefore only based on the analysis of the icd itself as well as the inspection of the quality documents associated with the manufacture of the lead and the icd.The manufacturing process for the devices was re-investigated, revealing that all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing process.Particularly the final acceptance test proved the devices functions to be as specified.Upon receipt, the icd was interrogated, revealing the eos battery status.The icd was implanted for 64 months and 76 charging cycles were recorded in the devices memory.The amount of charge taken from the battery was verified and the eos battery status was found to be normal and as expected.The memory content of the device was inspected.During the analysis of the available iegms, noise was observed in the right ventricular channel, leading to multiple charging cycles that partially resulted in several shock deliveries.Therefore, a sensing test was performed and the device sensed the attached heart signals free of noise, proving the sensing function of the icd to be normal and as expected.The analysis of the shock holter data showed that an amount of at least 52 charging cycles were performed by the device within 25 minutes on september 22, 2022.During the last charging cycle the device regularly activated the eos battery status.In conclusion, analysis of the icd revealed normal battery depletion.There was no indication of a malfunction of the icd.In the available iegms the occurrence of noise was observed in the ventricular channel, leading to multiple charging cycles draining the battery.Based on the icd analysis, the root cause of the observed noise signals was not determinable, however, possible damage to the lead cannot be excluded.

• 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: 15620931
• MDR Text Key: 301926891
• Report Number: 1028232-2022-05333
• 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: 10/10/2022

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: 04/30/2018
• Device Model Number: 402657
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 10/18/2022
• Supplement Dates Manufacturer Received: 01/06/2023
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2016
• 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