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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Improper or Incorrect Procedure or Method (2017); Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Discomfort (2330)
Date of Event	02/06/2025
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
The user's hearing performance with the device is affected.Due to the implant position the coil touched the processor.In order to fix this issue, the clinic performed a reposition of the implant two weeks ago.During/after the surgery the electrode migrated and channels 11 and 12 are now outside of the cochlea as confirmed by x-ray).An implant check is scheduled for (b)(6) 2025.
Event or Problem Description
The coil and the processor had an overlap which at first did not bother the user but over time it did.In order to fix this issue, the clinic performed a reposition of the implant on (b)(6) 2025.During/after the surgery the electrode migrated.The user's hearing performance with the device is affected after the reposition surgery.The patients would like another surgery to get a new implant so she can hear again with both ears.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery due to an inadequate position of the implant since implantation surgery.During revision surgery the electrode array was likely damaged.Further, two channels migrated out of cochlea after the re-positioning.Reportedly the recipient no longer has hearing benefit with the device.Re-implantation is planned, but no date has been scheduled yet.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery due to an inadequate position of the implant since implantation surgery.During revision surgery the electrode array was likely damaged.Further, two channels migrated out of cochlea after the re-positioning.Reportedly the recipient no longer has hearing benefit with the device.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The coil and the processor had an overlap which at first did not bother the user but over time it did.In order to fix this issue, the clinic performed a reposition of the implant on (b)(6) 2025.The user's hearing performance with the device is affected after the reposition surgery.The user has been reimplanted.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient underwent a revision surgery due to an inadequate position of the implant since implantation surgery.During revision surgery the electrode array was likely damaged.Further, two channels migrated out of cochlea after the re-positioning.Reportedly the recipient no longer had hearing benefit with the device.Device investigation confirmed a damage to the active electrode due to a cut into the silicone body and wires, which was likely caused during the revision surgery.Other mechanical damages found are related to the explantation surgery.This is a final report.
Event or Problem Description
The coil and the processor had an overlap which at first did not bother the user but over time it did.In order to fix this issue, the clinic performed a reposition of the implant on (b)(6) 2025.The user's hearing performance with the device is affected after the reposition surgery.The user has been reimplanted.

• 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: 21504597
• Report Number: 9710014-2025-00209
• Device Sequence Number: 19933584
• Product Code: MCM
• UDI-Device Identifier: 09008737395414
• UDI-Public: (01)09008737395414
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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,Followup,Followup
• Report Date (Section B): 08/18/2025

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: 07/18/2025
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 02/18/2025; 02/18/2025; 02/18/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 03/12/2025; 07/21/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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: 78 YR
• Patient Sex: Female