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

Model Number MI1200 SYNCHRONY

Device Problem Impedance Problem (2950)

Patient Problem Failure of Implant (1924)

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

A decrease in the hearing performance with the device was reported.Further medical intervention is considered.

Manufacturer Narrative

Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is not planned at the moment.

Event Description

A decrease in the hearing performance with the device was reported.The user, who previously showed good responses, experienced a sudden drop in hearing benefits, as reported by his parents.

• 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: 18415749
• MDR Text Key: 331691329
• Report Number: 9710014-2023-01153
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (y/n): N
• Reporter Country Code: TC
• 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: 02/02/2024

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 Model Number: MI1200 SYNCHRONY
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 12/16/2023
• Supplement Dates FDA Received: 02/02/2024
• Date Device Manufactured: 02/26/2023
• 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 Age: 3 YR
• Patient Sex: Male