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	Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/05/2020
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
The user attended a fitting appointment and affected channels were observed.The mother said that she noticed that the child was listening less or not listening from the right side and reported that this occurred suddenly.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode, as might be caused by an external mechanical impact appears likely.However to determine an exact root cause a device investigation of the explanted device is necessary.Further tests are considered by the clinic but no date has been scheduled yet.
Event or Problem Description
The user attended a fitting appointment and affected channels were observed.The mother said that she noticed that the child was listening less or not listening from the right side and reported that this occurred suddenly.

• 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: 9686851
• Report Number: 9710014-2020-00092
• Device Sequence Number: 3341662
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 04/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR