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)
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 cannot hear anymore using the device, the hearing perception changed overtime.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the reference electrode, as it might be caused by an external mechanical impact appears likely.In addition one channel showed hi status due to undetermined reasons.However to confirm an exact root cause of failure a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The recipient cannot hear anymore using the device, the hearing perception changed overtime.Re-implantation is considered.However, no date has been set yet.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the reference electrode, as it might be caused by an external mechanical impact appears likely.In addition one channel showed hi status due to undetermined reasons.However, to confirm an exact root cause of failure a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.If the device is received in the future, the case will be re-opened and the device investigated.
Event or Problem Description
The recipient cannot hear anymore using the device, the hearing perception changed overtime.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 device failure.In addition one channel showed high impedance status due to undetermined reasons.The investigation results appear to match the high gpi and decreased performance mentioned in the patient report.This is a final report.
Event or Problem Description
The recipient could not hear anymore using the device, the hearing perception changed overtime.The user has been reimplanted on (b)(6) 2021.

• 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: 12040404
• Report Number: 9710014-2021-00458
• Device Sequence Number: 17125117
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted 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): 05/27/2022

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021; 06/10/2021; 06/10/2021
• Initial Report FDA Received Date: 06/22/2021
• Supplement Report FDA Received Date: 09/23/2021; 12/21/2021; 05/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 29 MO
• Patient Sex: Male