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	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Per the parents a decline in the hearing performance of the user was observed starting in (b)(6) 2021.The user has been re-implanted on (b)(6) 2023.
Additional Manufacturer Narrative
The device has been explanted and 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
Conclusion: the device investigation revealed a technical failure of the reference electrode, which explains the reported problems.In addition, the device investigation revealed mechanical damage to the coil pin, which is typical of severe external effects on the implant site.Even though no such event, such as an accident, is mentioned in the recipient report.The investigation results seem to be consistent with the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
Per the parents a decline in the hearing performance of the user was observed starting in (b)(6) 2021.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by an external impact, was determined to be the root cause of the reported problem.In addition, the device investigation revealed mechanical damage to the coil pin, which is also typical for an external impact on the implant site, even though no such event is reported in the recipient report.The investigation results seem to be consistent with the problems mentioned in the recipient report.This is a final report.This is a correction of the conclusion.
Event or Problem Description
Per the parents a decline in the hearing performance of the user was observed starting in (b)(6) 2021.The user has been re-implanted on (b)(6) 2023.

• 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: 17206888
• Report Number: 9710014-2023-00544
• Device Sequence Number: 6592172
• Product Code: MCM
• UDI-Device Identifier: 09008737062767
• UDI-Public: (01)09008737062767
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2023
• 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): 04/14/2025

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: 10/01/2015
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07674
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023; 06/26/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/31/2023; 04/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2013
• 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: 9 YR
• Patient Sex: Male