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
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 came for a follow-up fitting and the parents reported that the child is not reacting to sounds.The child didn't react reliably since activation; therefore, it is not clear if she ever had any benefit from the device.The parents reported she reacted to voice of her brother in the beginning, but they couldn't replicate it.It is considered to proceed with a reimplantation.
Event or Problem Description
The user came for a follow-up fitting and the parents reported that the child is not reacting to sounds.The child didn't react reliably since activation; therefore, it is not clear if she ever had any benefit from the device.The parents reported she reacted to voice of her brother in the beginning, but they couldn't replicate it.Re-implantation is being considered.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.In addition the electrode array partially migrated out of cochlea.However, to determine an exact root cause a device investigation is necessary.Re-implantation is considered but no date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: 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.In addition, the electrode array partially migrated out of cochlea.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user came for a follow-up fitting and the parents reported that the child is not reacting to sounds.The child didn_t react reliably since activation; therefore, it is not clear if she ever had any benefit from the device.The parents reported she reacted to voice of her brother in the beginning, but they couldn_t replicate it.The user has been explanted.

• 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: 12637997
• Report Number: 9710014-2021-00782
• Device Sequence Number: 3292258
• Product Code: MCM
• UDI-Device Identifier: 09008737083625
• UDI-Public: (01)09008737083625
• 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: 2024
• 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): 08/07/2024

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: 03/08/2020
• 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: 10/14/2021
• Supplement Date Received by Manufacturer: 10/14/2021; 10/14/2021
• Initial Report FDA Received Date: 10/15/2021
• Supplement Report FDA Received Date: 02/16/2022; 08/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2017
• 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: 3 YR
• Patient Sex: Female