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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Impedance Problem (2950); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
The user's family perceived in april 2022 that the user was not presenting auditory perception with the device.No trauma has been reported.
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.
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.
Event or Problem Description
The users family perceived on (b)(6) 2022 that the user was suddenly not presenting auditory perception with the device.Reimplantation is considered, however, no date has been scheduled yet.
Event or Problem Description
The user_s family perceived in april 2022 that the user was suddenly not presenting auditory perception with the device.No trauma has been reported.Reimplantation is considered, however, no date has been scheduled yet.
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.The device was explanted but has not been received for investigational purposes yet.
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.The device was explanted but has not been received for investigational purposes yet.
Event or Problem Description
The user_s family perceived in april 2022 that the user was suddenly not presenting auditory perception with the device.No trauma has been reported.Correction: the user has been reimplanted.The concerned device has not been recieved for investigation.

• 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: 15362781
• Report Number: 9710014-2022-00651
• Device Sequence Number: 5165154
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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,Followup
• Report Date (Section B): 10/02/2023

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 Expiration Date: 03/04/2024
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 09/05/2022; 09/05/2022; 09/05/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 11/17/2022; 10/02/2023; 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/04/2021
• 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: 28 MO
• Patient Sex: Male