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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2025
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
Reimplantation with new device is considered.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was likely damaged during a revision surgery.Reportedly the revision surgery was done due to a dehiscence of the blind sac through which the electrode lead had extruded.Additionally, the electrode array migrated out of the cochlea.Further the electrode array was no longer inside the cochlea.The electrode was re-inserted, however post-operative in situ measurements point to an electrode damage.Re-implantation is planned but no date has been scheduled yet.
Event or Problem Description
Reimplantation with new device is considered.
Additional Manufacturer Narrative
Conclusion: reportedly the revision surgery was done due to a dehiscence of the blind sac through which the electrode lead had extruded.Additionally, the electrode array migrated out of the cochlea.The electrode was re-inserted, however post-operative in situ measurements point to an electrode damage.The device investigation could confirm that the device was likely inadvertently surgically damaged during the revision surgery.Other mechanical damages are attributable to the removal surgery.This is a final report.
Event or Problem Description
The user has been reimplanted.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the device was likely damaged during a revision surgery.Reportedly the revision surgery was done due to a dehiscence of the blind sac through which the electrode lead had extruded.Additionally, the electrode array migrated out of the cochlea.The electrode was re-inserted, however post-operative in situ measurements point to an electrode damage.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user has bene 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: 23167266
• Report Number: 9710014-2025-00908
• Device Sequence Number: 15701172
• Product Code: MCM
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/04/2026

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 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: 09/23/2025
• Supplement Date Received by Manufacturer: 09/23/2025; 09/23/2025; 09/23/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 10/09/2025; 12/09/2025; 03/04/2026
• Date Device Manufactured: 10/23/2023
• 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: 33 YR
• Patient Sex: Male