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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Mechanical Jam (2983); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
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
In (b)(6) 2025 the user noticed a weakening of the magnet strength of his processor (rondo 3) holding over his implant.The clinic has scheduled a surgery to change the implant magnet on (b)(6) 2025.
Event or Problem Description
In (b)(6) 2025 the user noticed a weakening of the magnet strength of his processor (rondo 3) holding over his implant.The rondo 3 only seems to hold on the upper side of the coil and on the lower side retention is weak.The internal magnet was surgically exchanged.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the recipient used the device without any problems for almost 3 years and then noticed a decreased magnet strength and a misalignment of the audio processor over the coil.A revision surgery to exchange the implant magnet was performed successfully.The implant stays implanted and in use.Device investigation of the magnet revealed that two snap rings instead of one were placed inside the magnet assembly due to human error during manufacturing.Normally, this described misassembly of the magnet is detected during implemented tests in manufacturing.However, in this single occurrence, review of the device history record shows that all tests have been performed and passed during manufacturing.

• 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: 22382855
• Report Number: 9710014-2025-00595
• Device Sequence Number: 6979572
• Product Code: MCM
• UDI-Device Identifier: 09008737395353
• UDI-Public: (01)09008737395353
• 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: 2022
• 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
• Report Date (Section B): 04/07/2026

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: 09/30/2021
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2024
• 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: 48 YR
• Patient Sex: Unknown