MAUDE Adverse Event Report: BIOTRONIK SE & CO. KG ILESTO 5 DR-T PROMRI DF4; ICD

Model Number 390116

Device Problem Low impedance (2285)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

It was reported that this device was explanted and replaced.Oversensing was noted on the associated right ventricular lead approx.85 months after the implantation.The pacing impedance was low (<200 ohm).The associated lead remains active.Should additional information be received, this file will be updated.

Manufacturer Narrative

As of today, the medical devices are not available for analysis, therefore the devices themselves could not be investigated.The analysis is thus based on the inspection of the manufacturing documents of the devices as well as on the provided data.The quality documents accompanying the manufacturing process for these devices were re-investigated.All production steps were performed accordingly, and in particular the final acceptance tests proved the devices functions to be as specified.The analysis of the provided trend data, acquired between (b)(6) 2022 and (b)(6) 2023 recorded 8 measurements of the pacing impedance <200 ohms.The provided iegm episodes were inspected showing artifacts on the rv channel on (b)(6) 2023 which led to the reported oversensing as well as an icd charging cycle with aborted shock.In spite of the available information, no conclusion can be drawn regarding the root cause of the clinical observation.However, the integrity of the lead cannot be assured.Should additional relevant information or the devices themselves become available for analysis, the investigation will be updated.

• Brand Name: ILESTO 5 DR-T PROMRI DF4
• Type of Device: ICD
• Manufacturer (Section D): BIOTRONIK SE & CO. KG; woermannkehre 1; berlin 12359
• Manufacturer Contact: 6024 jean road; lake oswego, OR 97035 ; 8772459800
• MDR Report Key: 16763095
• MDR Text Key: 313519233
• Report Number: 1028232-2023-01972
• Device Sequence Number: 1
• Product Code: MRM
• 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: 07/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2017
• Device Model Number: 390116
• Device Catalogue Number: SEE MODEL NO.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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