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

Model Number MI1250 SYNCHRONY 2

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 04/19/2022

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 user was seen for a routine follow-up and reported good use with her device.However, the in situ measurements indicated an increase of impedance on the most basal channels and objective hearing scores were reduced.The user was revised on the (b)(6) 2023.At the surgery 3 channels were found extra-cochlear.There was some scar tissue which had adhered to the electrode lead in the mastoid cavity.The electrode array was not explanted and instead fully reinserted into the cochlea.

Manufacturer Narrative

Additional information: based on the received information from the field, the experienced non-auditory sensation i.E.Extracochlear stimulation, was very likely due to a partial migration of the active electrode out of cochlea.As per implant registration card 1 channel was left extra-cochlear at implantation, and a further migration of the electrode array occurred, which was confirmed during revision surgery.The electrode array was successfully re-inserted and the device remains implanted and in use.This is a final report.

Event Description

The user was seen for a routine follow-up and reported good use with her device.However, the in situ measurements indicated an increase on the most basal channels (ch.10-12) and objective hearing scores were reduced.The user was revised on the 24th of march 2023.At the surgery 3-4 channels were found extra-cochlear.There was some scar tissue which had adhered to the electrode lead in the mastoid cavity which looked to have partially pulled the array out of the cochlea.Therefore, the electrode array was not explanted and instead fully reinserted into the cochlea.

• 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: 16680969
• MDR Text Key: 312759421
• Report Number: 9710014-2023-00276
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737395452
• UDI-Public: (01)09008737395452
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/29/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39573
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2023
• Date Device Manufactured: 10/29/2020
• 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: 19 YR
• Patient Sex: Female