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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	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 implanted on the (b)(6) 2021 and activated on the 30th november.However, at the activation maximum mcl levels were reached without inducing any auditory stimulation.Trouble shooting attempts were made but still no auditory sensation could be achieved.Imaging from the (b)(6) 2021 would show all channels outside the cochlea.The user will most likely be re-implanted.
Additional Manufacturer Narrative
Additional information: according to the information received, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging.Re-implantation is planned in (b)(6) 2022.
Event or Problem Description
The user was implanted on the (b)(6) 2021 and activated on the (b)(6).However, at the activation maximum mcl levels were reached without inducing any auditory stimulation.Trouble shooting attempts were made but still no auditory sensation could be achieved.Imaging from the (b)(6) 2021 would show all channels outside the cochlea.The user will be re-implanted in (b)(6).
Additional Manufacturer Narrative
Additional information: according to the information received, the device was not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea, as confirmed by post-operative diagnostic imaging.A revision surgery was carried out and the implant housing was found dislocated from its intended position, which reportedly likely led to the active electrode migration i.E.The electrode was pulled by the migrated housing.The device was repositioned and the active electrode array has been re-inserted successfully.The device remains implanted and in use.
Event or Problem Description
The user was implanted on the (b)(6) 2021 and activated on the 30th november.However, at the activation maximum mcl levels were reached without inducing any auditory stimulation.Trouble shooting attempts were made but still no auditory sensation could be achieved.Imaging from the 7th december 2021 would show all channels outside the cochlea.The user underwent a revision surgery on the 4th may 2022.At the revision surgery the device was found migrated from its orginal position, which was indicated as explanation also for the migrated electrode array i.E.Due to traction.A new bed was drilled closer to the edge of mastoidectomy (20mm).

• 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: 13008287
• Report Number: 9710014-2021-01026
• Device Sequence Number: 4769132
• Product Code: MCM
• UDI-Device Identifier: 09008737366803
• UDI-Public: (01)09008737366803
• 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: 2021
• 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): 06/23/2022

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: 10/17/2022
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36709
• 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: 12/07/2021
• Supplement Date Received by Manufacturer: 12/07/2021; 12/07/2021
• Initial Report FDA Received Date: 12/15/2021
• Supplement Report FDA Received Date: 03/02/2022; 06/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/17/2019
• 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: 63 YR
• Patient Sex: Male