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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Codes	Impedance Problem (2950); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Head Injury (1879); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been explanted and 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's hearing performance with the device was affected.The user underwent a revision surgery on (b)(6) 2025.
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 breakages.The investigation results appear to match the problems mentioned in the recipient report.This is a final report.
Event or Problem Description
The user's hearing performance with the device was affected.The user was reimplanted on (b)(6) 2025.

• 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: 23552182
• Report Number: 9710014-2025-01059
• Device Sequence Number: 18585840
• Product Code: MCM
• UDI-Device Identifier: 09008737094010
• UDI-Public: (01)09008737094010
• 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: 2017
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2026

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 PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 10/29/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 11/14/2025
• Supplement Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 36 YR
• Patient Sex: Female