MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG IFORIA 3 HF-T DF4; CRT-D

Model Number 383556

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

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

Event Date 11/30/2022

Event Type  malfunction  

Event Description

It was reported that the icd was in eos status after shock delivery.A lead failure has been suspected.The lead was capped and replaced and the device explanted.Should additional information be received, this file will be updated.

Manufacturer Narrative

The lead under complaint was not received for analysis.This report is thus based on the analysis of the icd itself as well as on the inspection of the quality documents associated with the manufacture of these particular devices.The manufacturing processes for the lead and the icd were re-investigated and all production steps were performed accordingly.There was no sign of any inconsistency during the manufacturing.The final acceptance tests proved the devices functions to be as specified.The icd was received and analyzed.The memory content of the icd was inspected, showing a normal device function while implanted and in service.The battery status was eos and 171 charging cycles were documented.The amount of charge taken from the battery was verified and the battery condition was anticipated.The inspection of the available iegms confirmed the clinical observation.Noise was present in the rv channel, which led to charging cycles with shock deliveries.However, there was no indication of an icd malfunction.In conclusion, analysis of the icd showed a normal device behavior.The battery status was anticipated.

• Brand Name: IFORIA 3 HF-T DF4
• 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: 16009682
• MDR Text Key: 305905008
• Report Number: 1028232-2022-06499
• 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: 12/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 383556
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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