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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); Device Overstimulation of Tissue (1991); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user presented sudden deafness in the left ear in 2020.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field, the recipient never had satisfactory benefit with the device.According to the clinic report, the recipient experienced sudden sensorineural hearing loss (ssnhl) and tinnitus prior to cochlear implantation.Further, diagnostic images indicate a possible slight electrode migration, which might have been facilitated by the reported postoperative, device unrelated otitis with effusion.However, the number of channels available for stimulation should be sufficient to provide good sound discrimination and in situ measurements are indicative of a functional device.Therefore, the reported hearing difficulties might be explained by a combination of factors, in the presence of a functional device, including partial migration, coexistence of pre-existing tinnitus, and the reported unrealistic expectations combined with inconsistent device use.The device remains implanted and no information on possible further steps has been received.
Event or Problem Description
The user presented sudden deafness associated with tinnitus in the left ear in 2020.Since the activation, the user only hears noise with the audio processor and cannot use it and therefore, she did not use the audio processor continuously since activation.The user perceives tinnitus with and without the audio processor.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field, the recipient never had satisfactory benefit with the device.According to the clinic report, the recipient experienced sudden sensorineural hearing loss (ssnhl) and tinnitus prior to cochlear implantation.Further, diagnostic images indicate a possible slight electrode migration, which might have been facilitated by the reported postoperative, device unrelated otitis with effusion.However, the number of channels available for stimulation should be sufficient to provide good sound discrimination and in situ measurements are indicative of a functional device.Therefore, the reported hearing difficulties might be explained by a combination of factors, in the presence of a functional device, including partial migration, coexistence of pre-existing tinnitus, and the reported unrealistic expectations combined with inconsistent device use.This is a final report.
Event or Problem Description
Since the activation, the user only heard noise with the audio processor and could not use it and therefore, she did not use the audio processor continuously since activation.Reportedly, the user may had unrealistic expectations.The user has been explanted of the device.

• 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: 15362130
• Report Number: 9710014-2022-00648
• Device Sequence Number: 20334196
• Product Code: MCM
• UDI-Device Identifier: 09008737062729
• UDI-Public: (01)09008737062729
• Combination Product (Y/N): N
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2024

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: 10/05/2023
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07672
• 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: 08/26/2022
• Supplement Date Received by Manufacturer: 08/26/2022; 08/26/2022
• Initial Report FDA Received Date: 09/06/2022
• Supplement Report FDA Received Date: 10/12/2022; 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2020
• 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
• Patient Age: 56 YR
• Patient Sex: Female