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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The implant housing had shifted and the patient's understanding had deteriorated.The implant was damaged during the reposition surgery, therefore the user was reimplanted with a new device.
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 implant housing had shifted and the patient's understanding had deteriorated.The implant was damaged during the reposition surgery, therefore the user was reimplanted with a new device.Additionally, some electrodes migrated out of the cochlea.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the revision surgery.According to the information received from the field the recipient underwent a re-positioning surgery due to a migration of the implant housing from its intended position.During the revision surgery the device was damaged and explanted.Further the electrode was found partially migrated out of cochlea.In addition, in situ measurements before the revision surgery showed two channels with hi status due to undetermined reasons.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: 24679049
• Report Number: 9710014-2026-00285
• Device Sequence Number: 9653206
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Report Date (Section B): 04/21/2026

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: 07/21/2024
• 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: 03/18/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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: 81 YR
• Patient Sex: Female