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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2025
Type of Reportable Event	Malfunction
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
A revision surgery to reposition the implant housing was performed on (b)(6) 2025.It seems that the electrode array was pulled out of cochlea during this surgery.On (b)(6) 2025 a second revision surgery was done to re-insert the electrode array, however, 1 channel was damaged and the surgeon decided to re-implant the user with a new device.The user will be reactivated as soon as possible.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient underwent a revision surgery to re-position the stimulator housing.During the surgery the electrode array was accidentally pulled out of cochlea.A second surgery to re-insert the electrode was performed, however the device was inadvertently damaged and the user was re-implanted within this surgery.The concerned device has not been received for investigation yet.
Event or Problem Description
A revision surgery to reposition the implant housing was performed on (b)(6) 2025.It seems that the electrode array was pulled out of cochlea during this surgery.On (b)(6) 2025 a second revision surgery was done to re-insert the electrode array, however, 1 channel was damaged and the surgeon decided to re-implant the user with a new device.
Event or Problem Description
A revision surgery to reposition the implant housing was performed on (b)(6) 2025.It seems that the electrode array was pulled out of cochlea during this surgery.On (b)(6) 2025 a second revision surgery was done to re-insert the electrode array, however, 1 channel was damaged and the surgeon decided to re-implant the user with a new device.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient underwent a revision surgery to re-position the stimulator housing.During the surgery the electrode array was accidentally pulled out of cochlea.A second surgery to re-insert the electrode was performed, however the device was inadvertently damaged and the user was re-implanted within this surgery.The damage was confirmed during device investigation.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: 21947825
• Report Number: 9710014-2025-00393
• Device Sequence Number: 9056079
• Product Code: MCM
• UDI-Device Identifier: 09008737331870
• UDI-Public: (01)09008737331870
• 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: 2020
• 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
• 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: 02/18/2023
• Device Model Number: MI1210 SYNCHRONY ST
• 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: 04/23/2025
• Supplement Date Received by Manufacturer: 04/23/2025; 04/23/2025
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/18/2020
• 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: 55 YR
• Patient Sex: Male