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)
Date of Event	05/24/2022
Type of Reportable Event	Malfunction
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
The user's mother had notice that the child is not hearing with the device.
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.Further in situ measurements show one channel with high impedance status already in january 2022 and beginning of may 2022 due to undetermined reasons.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's mother had notice that the child is not hearing with the device.Before the decrease the user had good hearing benefit with the device.Re-implantation has been recommended.However, no date for surgery has been communicated.
Additional Manufacturer Narrative
Conclusion: overload fractures in the active electrode which are consistent with an external mechanical impact were determined to be the root cause of device failure.Further, in situ measurements showed one channel with high impedance status already in (b)(6) 2022 and beginning of (b)(6) 2022 due to undetermined reasons.The problems given in the recipient report appear to match the damage found.Other damages found during device investigation are most likely related to the explantation surgery.This is a final report.
Event or Problem Description
The user's mother had notice that the child is not hearing with the device.Before the decrease the user had good hearing benefit with the device.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: 14546755
• Report Number: 9710014-2022-00379
• Device Sequence Number: 17767813
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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
• Report Date (Section B): 01/04/2023

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: 11/02/2023
• Device Model Number: MI1000 MED-EL CONCERT PIN
• Device Catalogue Number: 08841
• 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: 05/27/2022
• Supplement Date Received by Manufacturer: 05/27/2022; 05/27/2022
• Initial Report FDA Received Date: 05/31/2022
• Supplement Report FDA Received Date: 07/26/2022; 01/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2020
• 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: 35 MO
• Patient Sex: Male