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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Device Handling Problem (3265)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
After electrode insertion in situ measurements revealed high impedances.It was tried to massage stimulator, add saline onto ground electrode, ensure strong coupling, change testing coil, reduce layers between testing device and implant, but it still showed high impedances on all 12 contacts.The device was removed and the back-up implant was used without issue.
Event or Problem Description
After electrode insertion in situ measurements revealed high impedances.It was tried to massage stimulator, add saline onto ground electrode, ensure strong coupling, change testing coil, reduce layers between testing device and implant, but it still showed high impedances on all 12 contacts.The device was removed and the back-up implant was used without issue.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field in situ measurements during implantation surgery showed all channels with hi status.Device investigation revealed damage to the active electrode likely caused by mechanical stress during surgical handling of the device.A back-up device was implanted successfully.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 ; 57788
• MDR Report Key: 24190033
• Report Number: 9710014-2026-00062
• Device Sequence Number: 7975966
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 03/26/2026

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: MI1250 SYNCHRONY 2
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/14/2025
• 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: 79 YR
• Patient Sex: Female