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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	No Device Output (1435); 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 was recently implanted with the device but due to severe malformations in the cochlea 9 electrodes were left extra-cochlea of the compressed array.At a recent follow-up session affected channels were seen.The parents reported a head trauma over the implant.A ct scan has been requested.
Additional Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to the reported trauma appears very likely.In addition only a small portion of the electrode array could be inserted at implantation surgery, likely because of cochlear malformation.However, the recipient reported sound perception with the device.To confirm an exact root cause device investigation would be necessary.Imaging is pending and no information about further steps has been made available yet.
Event or Problem Description
The user was implanted with the device but due to severe malformations in the cochlea 9 electrodes were left extra-cochlea.At a later follow-up session affected channels were seen.The parents reported a head trauma over the implant which occurred 2 months prior ((b)(6) 2022).Prior to this the user started to hear sounds and also noticed music with the device.A ct scan has been requested but no date has been set yet.
Additional Manufacturer Narrative
Additional information: according to the information received from the field only three channels could be inserted during initial implantation surgery because of cochlear malformation.The recipient underwent a re-insertion surgery during which 8 channels could be eventually inserted.In addition, a head trauma is reported which likely led to a minor damage to the active electrode.No information about reactivation has been received.
Event or Problem Description
The user was implanted with the device but due to severe malformations in the cochlea 9 electrodes were left extra-cochlea.At a later follow-up session affected channels were seen.The parents reported a head trauma over the implant which occurred 2 months prior ((b)(6) 2022).Prior to this the user started to hear sounds and also noticed music with the device.The user underwent a revision surgery on the (b)(6) 2022 to re-insert the array into the cochlea, 8 channels were inserted.The user is still to be re-activated following re-insertion but they have lost their audio processor.

• 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: 14927743
• Report Number: 9710014-2022-00474
• Device Sequence Number: 12334761
• Product Code: MCM
• UDI-Device Identifier: 09008737366766
• UDI-Public: (01)09008737366766
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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): 03/15/2023

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: 01/28/2024
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36705
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 07/04/2022; 07/04/2022
• Initial Report FDA Received Date: 07/06/2022
• Supplement Report FDA Received Date: 09/22/2022; 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/28/2021
• 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: 4 YR
• Patient Sex: Female