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 Insufficient Information (4580)

Event Date 09/02/2022

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

Implant migration (displaced implant body which has slipped forwards against the pinna).At least 2 electrode contacts have emerged from the inner ear.Consecutive skin defect and defect in the external auditory canal as well as chronic mastoiditis.Electrode remains in place.

Manufacturer Narrative

Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the device was explanted due to a migration of the implant housing from its intended position.Further, the electrode array partially migrated out of cochlea.Reportedly one channel was left extra-cochlear already at implantation surgery.This is a final report.

Event Description

Implant migration (displaced implant body which has slipped forwards against the pinna).At least 2 electrode contacts have emerged from the inner ear.Consecutive skin defect and defect in the external auditory canal as well as chronic mastoiditis.The device was explanted.Electrode remains in place.

• 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: 18424283
• MDR Text Key: 331908475
• Report Number: 9710014-2024-00003
• 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: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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: 77 YR
• Patient Sex: Male