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

Model Number	SONATA
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The child was brought by the parents for regular follow-up with the audiologist.Parents reported that the child responded to most of the sounds and common words (also observed during the session), but did not talk apart from vocalizing /aa/.No other technical checks have been scheduled.Diagnostic image report is awaited.
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 likely caused by minute device mobility is suspected.However, to determine an exact root cause a device investigation of the explanted device is necessary.No information on possible further steps has been received.
Event or Problem Description
The child was brought by the parents for regular follow-up with the audiologist.Parents reported that the child responded to most of the sounds and common words (also observed during the session), but did not talk apart from vocalizing /aa/.No other technical checks have been scheduled.Diagnostic image report is awaited.

• 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: 18029696
• Report Number: 9710014-2023-00974
• Device Sequence Number: 20348771
• Product Code: MCM
• UDI-Device Identifier: 09008737049133
• UDI-Public: (01)09008737049133
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 12/07/2023

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: 01/23/2025
• Device Model Number: SONATA
• 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: 10/27/2023
• Supplement Date Received by Manufacturer: 10/27/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 12/07/2023
• Date Device Manufactured: 01/23/2022
• 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
• Patient Age: 5 YR
• Patient Sex: Female