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 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.

Event Description

The clinic has mentioned a reimplantation case where the electrode is reportedly not inside the cochlea anymore.The revision surgery has been scheduled for (b)(6) 2023.

Manufacturer Narrative

Device investigation did not reveal any device defect or damage, which has been present whilst implanted.According to the information received from the field the recipient pulled the electrode out of cochlea during an ear cleaning and damaged it.This damage could be confirmed during device investigation.Other mechanical damages found during investigation are attributable to the removal surgery.This is a final report.

Event Description

The clinic has mentioned a reimplantation case where the electrode is reportedly not inside the cochlea anymore.According to reports, the electrode array was pulled out of the cochlea, causing approximately 75% of the array to break off, resulting in a complete loss of sound perception.The user was 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: 17996157
• MDR Text Key: 326388451
• Report Number: 9710014-2023-00951
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737310936
• UDI-Public: (01)09008737310936
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/10/2017
• 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: 10/17/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 10/17/2023
• Supplement Dates FDA Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2015
• 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): Required Intervention
• Patient Age: 86 YR
• Patient Sex: Female