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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Codes	Head Injury (1879); Failure of Implant (1924)
Date of Event	06/10/2024
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
No hearing sensation with the device after severe trauma to the head was reported.
Event or Problem Description
It was reported that the user had no hearing sensation with the device after a severe trauma to the head.The user was re-implanted.
Additional Manufacturer Narrative
Additional information: based on the received information, a mechanical damage of the stimulator housing, which is typical for an external impact to the housing, appears likely.However, an investigation of the explanted device is necessary to determine an exact root cause of failure.The concerned device was explanted but has not been received for investigation yet.
Additional Manufacturer Narrative
Conclusion: the device investigation revealed mechanical damage to the stimulator electronics substrate that is typical for severe external impact to the housing.The investigation results appear to match the problems mentioned in the patient report.Other mechanical damages are attributable to the removal surgery.This is a final report.
Event or Problem Description
It was reported that the user had no hearing sensation with the device after a severe trauma to the head.The user was 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: 20167256
• Report Number: 9710014-2024-00818
• Device Sequence Number: 20531246
• Product Code: MCM
• UDI-Device Identifier: 09008737093952
• UDI-Public: (01)09008737093952
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 07/01/2025

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 Model Number: MI1200 SYNCHRONY
• 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: 09/04/2024
• Supplement Date Received by Manufacturer: 09/04/2024; 09/04/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 04/01/2025; 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/30/2023
• 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: 3 YR
• Patient Sex: Female