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

Model Number	MI1000 MED-EL CONCERT PIN
Medical Device Problem Codes	Impedance Problem (2950); Output Problem (3005)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
Event or Problem Description
The user reported having no hearing sensation with the device.
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 as might be caused by an external mechanical impact appears likely.In addition the reference electrode seems to be damaged as well by the suspected impact.However, to determine an exact root cause 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 user reported having no hearing sensation with the device.The external parts were checked and no problems were reported.In situ testing from (b)(6) 2022 showed high impedance on 5 channels (ch1 - ch4 and ch6) and a gpi (ground path impedance) of 11.68 kohm.Re-implantation considered but is not sched.
Event or Problem Description
The user reported having no hearing sensation with the device.The user has been reimplanted.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely.In addition, the reference electrode seems to be damaged as well by the suspected impact.However, to determine an exact root cause 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.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure.The active electrode also showed some additional damage to the electrode wires, as being caused by minute device mobility.An accident or impact might have weakened the fixation of the implant, consequently leading to electrode mobility.This is a final report.
Event or Problem Description
The user reported having no hearing sensation with the device.The user has been 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: 14617865
• Report Number: 9710014-2022-00389
• Device Sequence Number: 19931132
• Product Code: MCM
• UDI-Device Identifier: 09008737062750
• UDI-Public: (01)09008737062750
• 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: 2019
• Device Explanted 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,Followup,Followup
• Report Date (Section B): 08/08/2023

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: 04/18/2022
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 07680
• 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: 06/03/2022
• Supplement Date Received by Manufacturer: 06/03/2022; 06/03/2022; 06/03/2022
• Initial Report FDA Received Date: 06/07/2022
• Supplement Report FDA Received Date: 07/26/2022; 01/19/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2019
• 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: Male