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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	Head Injury (1879); Failure of Implant (1924)
Date of Event	03/07/2025
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 suffered from a temporal bone fracture and has since then had no hearing perception.Re-implantation is being considered, but no decision has been made yet.
Additional Manufacturer Narrative
Additional information: based on the information and measurements received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
Event or Problem Description
The user suffered from a temporal bone fracture and has since then had no hearing perception.Re-implantation is being considered and was scheduled for (b)(6) 2025, however due to a heart condition had to be postponed.No new date has been set yet.
Additional Manufacturer Narrative
Additional information: based on the information and measurements received, a mechanical damage of the stimulator electronics, which is typical for a severe external impact to the housing, appears likely.However, to determine and confirm an exact root cause of failure cause a device investigation of the explanted device is necessary.The concerned device was explanted but has not been received for investigation yet.
Event or Problem Description
The user suffered from a temporal bone fracture and has since then had no hearing perception.The user has been reimplanted.
Event or Problem Description
The user suffered from a temporal bone fracture and has since then had no hearing perception.The user has been reimplanted.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator housing and electronics that is typical for the reported severe external impact to the housing.The problems described in the recipient report and the reported accident appears to match the damage found.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: 21573312
• Report Number: 9710014-2025-00236
• Device Sequence Number: 8751452
• Product Code: MCM
• UDI-Device Identifier: 09008737366827
• UDI-Public: (01)09008737366827
• 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: 2019
• 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): 02/19/2026

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 Expiration Date: 05/20/2022
• 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: 03/10/2025
• Supplement Date Received by Manufacturer: 03/10/2025; 03/10/2025; 03/10/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/09/2025; 11/13/2025; 02/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2019
• 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: 61 YR
• Patient Sex: Male