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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to 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
Affected channels were observed during in situ testing.User reported hearing 'muffled' sound.The electrode array has likely migrated out of the cochlea.
Event or Problem Description
Initially affected channels were observed during in situ testing.Recipient reported hearing 'muffled' sound.Programming changes were made to accommodate the affected channels.Recipient's hearing performance after programming was reportedly good.Objective speech testing scores were approximately 80%, consistent with previous test results and it was decided at that time that the recipient will be further monitored.As per additional information received in october 2020 the recipient requested a revision surgery due to decrease in hearing performance.
Additional Manufacturer Narrative
Additional information: based on the available information from the field, the recipient's hearing performance decreased.A partial migration of the active electrode out of cochlea has been observed.Further medical intervention is considered, but no date has been scheduled yet.
Event or Problem Description
Initially affected channels were observed during in situ testing.Recipient reported hearing 'muffled' sound.Programming changes were made to accommodate the affected channels.Recipient's hearing performance after programming was reportedly good.Objective speech testing scores were approximately 80%, consistent with previous test results and it was decided at that time that the recipient will be further monitored.As per additional information received in october 2020 the recipient requested a revision surgery due to decrease in hearing performance.The scheduled surgery was cancelled due to insurance reason.No new date for re-implantation has been scheduled yet.
Additional Manufacturer Narrative
Additional information: based on the available information from the field, the recipient's hearing performance decreased.A partial migration of the active electrode out of cochlea has been observed.Re-implantation is considered, but no date has been scheduled yet.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10724664
• Report Number: 9710014-2020-00607
• Device Sequence Number: 3483474
• Product Code: MCM
• UDI-Device Identifier: 09008737062743
• UDI-Public: (01)09008737062743
• 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: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/12/2021

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 Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2020
• Supplement Date Received by Manufacturer: 10/16/2020; 10/16/2020
• Initial Report FDA Received Date: 10/23/2020
• Supplement Report FDA Received Date: 11/18/2020; 02/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR