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

Model Number	Mi1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User has no speech understanding with the implanted device on the left side (bilaterally implanted).
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
User has no speech understanding with the implanted device on the left side.Reimplantation will be scheduled.
Additional Manufacturer Narrative
Additional information: according to the information received from the field a damage to the reference electrode seems likely.However, to determine an exact root cause device investigation would be necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
User has no speech understanding with the implanted device on the left side.The user was reimplanted.
Additional Manufacturer Narrative
Conclusion: damage to the reference electrode, likely caused by an external impact, was determined to be the root cause of device failure.Other mechanical damages found are attributable to the removal surgery.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-(577)88
• MDR Report Key: 24427399
• Report Number: 9710014-2026-00178
• Device Sequence Number: 20872760
• Product Code: MCM
• UDI-Device Identifier: 09008737395483
• UDI-Public: (01)09008737395483
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2026

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 Expiration Date: 01/30/2025
• Device Model Number: Mi1250 SYNCHRONY 2 PIN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: 02/17/2026; 02/17/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 04/10/2026; 07/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2022
• 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: 4 YR
• Patient Sex: Female