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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/05/2024
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
It is currently unknown whether the user's hearing performance has been affected.
Additional Manufacturer Narrative
Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is plausible.However to determine an exact root cause a device investigation of the explanted device is necessary.Further technical checks are planned.
Event or Problem Description
It is currently unknown whether the user's hearing performance has been affected.An integrity test will be performed in (b)(6) 2024.No further information has been received.

• 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: 19947712
• Report Number: 9710014-2024-00717
• Device Sequence Number: 17923833
• Product Code: MCM
• UDI-Device Identifier: 09008737369026
• UDI-Public: (01)09008737369026
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 11/04/2024

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: 12/17/2023
• Device Model Number: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2024
• Supplement Date Received by Manufacturer: 08/07/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 11/04/2024
• Date Device Manufactured: 12/17/2020
• 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: 4 YR
• Patient Sex: Unknown