MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; COCHLEAR IMPLANT

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Impedance Problem (2950)
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 has always had high impedance in the three apical electrodes of her implant, but recently electrodes 1 and 3 showed even higher impedance levels.Her performance has been declining over the years, with a significant drop since august, accompanied by balance loss, tinnitus, and worsening listening quality.If necessary, a ct scan will be performed to further investigate the situation and provide additional insights into the user's condition.According to information from (b)(6) 2024 another channel was deactivated and the clinic wants to proceed with revision surgery.
Event or Problem Description
The user_s hearing performance with the device has been declining over the years, with a significant drop since (b)(6) 2023.In (b)(6) 2023 there was also an event where the user lost balance and since then she experienced tinnitus and worsening listening quality.The user's instance of balance loss reportedly did not correlate with any known medical conditions.Tinnitus was present prior to the implant and persists even after the processor replacement, with no specific medical explanations given for its occurrence.The clinic is considering re-implantation, but to date no decision has been made.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected.Further, the recipient experienced balance issues and tinnitus.Reportedly the tinnitus was already present before implantation surgery.Imbalance might be an undesired side effect of ci implantation.However, to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation surgery is considered, but no date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.Further, the recipient experienced balance issues and tinnitus.Reportedly the tinnitus was already present before implantation surgery.Imbalance might be an undesired side effect of ci implantation.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
The user_s hearing performance with the device has been declining over the years, with a significant drop since august 2023.The user was re-implanted.

• Brand Name: SYNCHRONY
• 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: 18475596
• Report Number: 9710014-2024-00019
• Device Sequence Number: 17873572
• Product Code: MCM
• UDI-Device Identifier: 09008737093983
• UDI-Public: (01)09008737093983
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2024
• 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): 03/11/2025

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: 10/11/2020
• Device Model Number: MI1200 SYNCHRONY
• 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: 01/03/2024
• Supplement Date Received by Manufacturer: 01/03/2024; 01/03/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 04/09/2024; 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2017
• 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: 73 YR
• Patient Sex: Female