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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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 reported intermittent function with the implant a few days ago.Although the sound processor was replaced, the complaint persisted.Prior to this, the user had benefited from the implant.Reportedly, there had been no issues before.The user's mother did not report any trauma, but mentioned other health comorbidities, including hernia surgery, asthma, and pneumonia attacks last year, requiring hospitalization for a few days.According to clinical support re-implantation might be considered.
Additional Manufacturer Narrative
Additional information: 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.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user reported intermittent function with the implant a few days ago.According to clinical support re-implantation might be considered.

• 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: 21823342
• Report Number: 9710014-2025-00327
• Device Sequence Number: 19905581
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• 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: 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): 06/17/2026

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: 11/23/2023
• Device Model Number: MI1210 SYNCHRONY ST
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 04/07/2025; 04/07/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 05/21/2025; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Male