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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
While playing a stone fell on the user's head.The user's hearing performance is affected and channels with abnormal impedance were found.There was redness at the implant site observed.
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: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.However, to confirm an exact root cause device investigation would be necessary.No information on possible further steps has been received.
Event or Problem Description
While playing a stone fell on the user's head on (b)(6) 2023.The user's hearing performance is affected and channels with abnormal impedance were found.Revision surgery was recommended.
Additional Manufacturer Narrative
The investigation results revealed overload fractures in the active electrode confirming that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
Event or Problem Description
While playing a stone fell on the user's head on (b)(6) 2023.The user's hearing performance is affected and channels with abnormal impedance were found.The user was re-implanted.

• 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: 17317417
• Report Number: 9710014-2023-00608
• Device Sequence Number: 11761390
• Product Code: MCM
• UDI-Device Identifier: 09008737331863
• UDI-Public: (01)09008737331863
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/08/2024

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: 03/09/2023
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33337
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 07/12/2023; 07/12/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 09/08/2023; 02/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2020
• 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: 5 YR
• Patient Sex: Female