MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number MI1200 SYNCHRONY

Device Problems Improper or Incorrect Procedure or Method (2017); Migration (4003)

Patient Problem Failure of Implant (1924)

Event Date 11/22/2023

Event Type  malfunction  

Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

It was reported that the device was explanted due to the migration of the electrode.The user has been re-implanted.

Manufacturer Narrative

Conclsuion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report the device was explanted due to the electrode being pulled out of cochlea during an ear cleaning procedure.Mechanical damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

The user did not have any speech understanding anymore.It was initially reported that the device was explanted due to the migration of the electrode.As per additional information, the electrode array was pulled out of the cochlear during an ear cleaning procedure.During the explantation surgery it was confirmed that the electrode array was completely out of the cochlea.A complete insertion during the initial surgery were confirmed.The user has been re-implanted.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 18236802
• MDR Text Key: 329358744
• Report Number: 9710014-2023-01077
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

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: Lay User/Patient
• Device Expiration Date: 01/18/2021
• Device Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 11/30/2023
• Supplement Dates Manufacturer Received: 11/24/2023
• Supplement Dates FDA Received: 02/20/2024
• Date Device Manufactured: 01/18/2018
• 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): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male