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 Code	Failure of Implant (1924)
Date of Event	03/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the user attended a fitting session and during the in-situ measurements affected channels have been seen.Furthermore, the hearing performance with the device is affected.
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.
Event or Problem Description
On (b)(6) 2023 the user attended a fitting session and during the in situ measurements, affected channels have been seen.Furthermore, the hearing performance with the device was affected.The user has been re-implanted.
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.Explantation was carried out, but the concerned device has not been received for investigational purposes.
Event or Problem Description
On february 22nd, 2023 the user attended a fitting session and during the in situ measurements, affected channels have been seen.Furthermore, the hearing performance with the device was affected.The user has been re-implanted.
Additional Manufacturer Narrative
Conclusions: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.

• 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: 16626279
• Report Number: 9710014-2023-00256
• Device Sequence Number: 11880717
• Product Code: MCM
• UDI-Device Identifier: 09008737062729
• UDI-Public: (01)09008737062729
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• 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): 08/30/2023

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: 06/27/2019
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07672
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 03/23/2023; 03/23/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 06/23/2023; 08/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/27/2016
• 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: 10 YR
• Patient Sex: Female