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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2023
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The field was informed that the implant housing rotated in the pocket anteriorly such that the magnet is above the ear.There was no trauma or incident that the family can determine caused this movement.Repositioning scheduled for (b)(6) 2023.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the implant housing had migrated and rotated from its intended position.A re-positioning surgery was performed successfully.The device remains implanted and in use.This is a final report.
Event or Problem Description
The field was informed that the implant housing rotated in the pocket anteriorly such that the magnet is above the ear.The issue started july 01, 2023.There was no trauma or incident that the family can determine caused this movement.Repositioning took place on (b)(6) 2023.The surgeon was able to successfully reposition the device.Upon opening, the package of the device had migrated and rotated anteriorly and had pulled the lead causing the electrode to migrate fully outside of the cochlea.The surgeon created a 1 mm well and channel and fixated the device with screws and sutures.Additionally, he fixated the lead with an incus buttress bridge.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: 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: 17304595
• Report Number: 9710014-2023-00593
• Device Sequence Number: 6684498
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2023

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/11/2025
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/24/2023
• Date Device Manufactured: 12/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 9 MO
• Patient Sex: Male