MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; Cochlear Implant

Model Number	Mi1200 SYNCHRONY
Medical Device Problem Codes	Circuit Failure (1089); Impedance Problem (2950)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	07/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion: based on the received information, a damage to the active electrode due to excessive mechanical stress seems very likely.However, to determine an exact root cause device investigation would be necessary.The concerned device was explanted but has not been received for investigation yet.This is a combined initial and final report.
Event or Problem Description
Sudden hearing loss with device following head impact on (b)(6) 2026.The user was re-implanted.
Event or Problem Description
Sudden hearing loss with device ollowing head impact on (b)(6) 2026.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator electronics that is typical of a severe external impact to the housing.The active electrode also showed additional damage to the electrode wires, as would be expected from the reported impact.The problems described in the recipient report and the reported accident are consistent with the damage found during the device investigation.This is a final report.

• 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 ; +43()577885626
• MDR Report Key: 25834838
• Report Number: 9710014-2026-00657
• Device Sequence Number: 13121487
• Product Code: MCM
• UDI-Device Identifier: 09008737094041
• UDI-Public: (01)09008737094041
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• 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): 09/16/2026

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 Model Number: Mi1200 SYNCHRONY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/18/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Supplement Date Received by Manufacturer: 07/13/2026; 07/13/2026
• Initial Report FDA Received Date: 07/16/2026
• Supplement Report FDA Received Date: 07/16/2026; 09/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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: 9 YR
• Patient Sex: Male