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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Nervous System Problem (4426)
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 (b)(6) 2021.After the first fitting the audiologist felt the user's hearing should be better and they informed the clinical engineer.On (b)(6) 2022 the user reported that he is able to hear well when he is holding the audio processor (ap) at a specific angle.Additional testing will be conducted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the hearing performance with the device is not satisfactory likely because of device unrelated medical issues.The described auditory disturbances might be consistent with a possible central hearing impairment, as also suspected by the clinic even if not yet confirmed.Echo perceived by the user seems to indicate that the cochlear implant is working properly, possibly resulting in the implanted ear hearing a sound at a different pitch and speed than the other ear.In addition, the user_s perception changes with the position of the coil are subjective and not supported by any objective testing.In situ measurements show the the device is working within specifications.
Event or Problem Description
The user was implanted on the (b)(6) 2021 and after the first fitting the audiologist felt the user's hearing should be better with the device.The user had difficulty with speech understanding and was afraid of loud noises and this situation never really improved.During an appointment on the (b)(6)2022 the user was able to hear well when holding the audio processor (ap) at a specific angle so he had been holding the ap throughout the day in order to hear well.It appeared that distance was needed between the head and a specific angle then the sound was fine.The user also heard a massive echo when the coil was directly over the implant.The device remains implanted and supposedly in use at this time with further monitoring.

• 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: 13281079
• Report Number: 9710014-2022-00039
• Device Sequence Number: 4968989
• Product Code: MCM
• UDI-Device Identifier: 09008737366711
• UDI-Public: (01)09008737366711
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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: 10/03/2022
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36700
• 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: 01/13/2022
• Supplement Date Received by Manufacturer: 01/13/2022
• Initial Report FDA Received Date: 01/18/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2019
• 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
• Patient Age: 27 YR
• Patient Sex: Male