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

Model Number	MI1200 SYNCHRONY
Medical Device Problem Codes	Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	02/02/2025
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
On the (b)(6) 2025 the recipient had a fall and hit the right side of her head over the implant.She sustained an injury to right side of her head resulting in a large haematoma.The user is scheduled for reimplantation surgery on (b)(6) 2025.
Event or Problem Description
On (b)(6) 2025 the recipient hit the right side of her head over the implant.The user reported poor sound quality which has worsened over time since the initial injury.The user was reimplanted on (b)(6) 2025.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found are attributable to the removal surgery.According to the information received from the field the implant housing migrated from its intended position due to a head trauma.It seems likely that the electrode array migrated out of the cochlea, causing the decrease in hearing performance, however, this could not be assessed during explantation due to soft tissue growth.Additionally, according to the implant registration card a complete insertion was not achieved at implantation surgery and one channel was left extra-cochlear.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: 21750919
• Report Number: 9710014-2025-00306
• Device Sequence Number: 12784160
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• UDI-Public: (01)09008737094003
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: 02/15/2019
• 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: 03/19/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 04/02/2025
• Supplement Report FDA Received Date: 07/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2016
• 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: 70 YR
• Patient Sex: Female