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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Dizziness (2194); Insufficient Information (4580)
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 hears a clicking, high and low pitched sound when pressing on the tragus or putting the audio processor on.Ct imaging will be performed.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient had poor hearing benefit since implantation surgery, because of surgical and clinical reasons, namely four channels were reportedly left extra-cochlea due to cochlear malformation.Imaging confirmed that those channels are extra-cochlear, with the rest of the active electrode array still within the cochlea.No information on possible further steps has been received.
Event or Problem Description
The user hears a clicking, high- and low-pitched sound, when pressing on the tragus or putting the audio processor on.Reportedly, per internal surgical report, there were 4 contacts left outside the cochlea at implantation due to the very small and malformed cochlea.The user has had a poor hearing performance with the device since activation.The user has not been seen for follow-up therefore no new information is available.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.The device is working within specification.According to the information received from the field the recipient had poor hearing benefit since implantation surgery, likely because of surgical and clinical reasons, namely four channels were reportedly left extra-cochlea due to cochlear malformation ans size.Imaging confirmed that those channels were extra-cochlear; additionally one further channel migrated out of cochlea as confirmed during explantation surgery.According to the device explant report, an inadequate electrode might have been chosen upon implantation.This is a final report.
Event or Problem Description
The user hears a clicking, high- and low-pitched sound, when pressing on the tragus or putting the audio processor on.The user has had a poor hearing performance with the device since activation and reported feeling dizzy.Ct imaging was performed and showed 4 extra-cochlear channels, with the rest of the electrode still within the cochlea.The user was re-implanted.According to the device explantation form there were 5 electrodes extra-cochlear at explantation.The device could be slightly rotated prior to explantation.

• 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: 12850748
• Report Number: 9710014-2021-00910
• Device Sequence Number: 4788175
• Product Code: MCM
• UDI-Device Identifier: 09008737371753
• UDI-Public: (01)09008737371753
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/05/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 37181
• 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: 11/17/2021
• Supplement Date Received by Manufacturer: 11/17/2021; 11/17/2021
• Initial Report FDA Received Date: 11/22/2021
• Supplement Report FDA Received Date: 03/04/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2020
• 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: 38 YR
• Patient Sex: Male