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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user was fitted with 8 active channels during her first fitting.Over time, the number of channels used decreased.Currently she is using 4 active channels.Reportedly, there are several extra-cochlear channels.The surgeon plans to perform a revision surgery, but also a back-up device has been requested.
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.
Additional Manufacturer Narrative
Additional information: according to the information received from the field, the device is not providing benefit to the recipient due to a post-operative active electrode migration out of the cochlea.A re-insertion surgery is considered but no date has been scheduled yet.
Event or Problem Description
The user was fitted with 8 active channels during her first fitting.Over time, the number of channels used decreased.Currently she is using 4 active channels.Reportedly, there are several extra-cochlear channels.The surgeon plans to perform a revision surgery, but also a back-up device has been requested.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage.According to the information received from the field the device was explanted due to a migration of the active electrode out of cochlea.In addition, the in situ measurements support a partial insertion at the time of implantation, although the implant registration card (irc) states a full insertion.This is a final report.
Event or Problem Description
The user was fitted with 8 active channels during her first fitting.Over time, the number of channels used decreased.Currently she is using 4 active channels.Reportedly, there are several extra-cochlear channels.The user has been re-implanted.

• 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: 19947584
• Report Number: 9710014-2024-00716
• Device Sequence Number: 17923825
• Product Code: MCM
• UDI-Device Identifier: 09008737331832
• UDI-Public: (01)09008737331832
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/20/2025

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: 12/05/2021
• Device Model Number: MI1210 SYNCHRONY ST
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• 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; 08/07/2024
• Initial Report FDA Received Date: 08/09/2024
• Supplement Report FDA Received Date: 09/16/2024; 02/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2018
• 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: 6 YR
• Patient Sex: Female