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

Model Number MI1200 SYNCHRONY PIN

Device Problems Impedance Problem (2950); Insufficient Information (3190)

Patient Problem Failure of Implant (1924)

Event Date 12/12/2023

Event Type  malfunction  

Event Description

The user's hearing performance with the device is affected after a trauma to the head.The user was reimplanted on (b)(6) 2023.

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.

Manufacturer Narrative

Conclusion: the investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.

Event Description

The user's hearing performance with the device is affected after a trauma to the head.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: 18398071
• MDR Text Key: 331385503
• Report Number: 9710014-2023-01149
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737094010
• UDI-Public: (01)09008737094010
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/20/2024

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: 03/08/2021
• Device Model Number: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2018
• 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: 55 YR
• Patient Sex: Female