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	Failure of Implant (1924)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user has no auditory impression in single-channel stimulation <40 qu in the initial fitting.The user has been re-implanted.According to the explantation report the device was dislocated.
Additional Manufacturer Narrative
The device has been explanted and has been returned to med-el hq where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received the device was not providing benefit due to a movement from the implant housing from its intended position causing a migration of the electrode out of cochlea.This is a final report.
Event or Problem Description
The user has no auditory impression in single-channel stimulation <40 qu in the initial fitting.The user has been re-implanted.According to the explantation report the device was dislocated.It is assumed that the displacement of the implant housing has caused the electrode to move out of the cochlear implant.

• 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: 19078625
• Report Number: 9710014-2024-00333
• Device Sequence Number: 6752374
• Product Code: MCM
• UDI-Device Identifier: 09008737395476
• UDI-Public: (01)09008737395476
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2024

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: 09/19/2026
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/19/2026
• 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: 11 YR
• Patient Sex: Female