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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user was implanted on (b)(6) 2024.Magnet retention force is insufficient despite skin flap <5mm, s-vector internal magnet and 5s rondo3 external magnet.The problem remains since activation.Relative orientation of internal and external magnet has been verified - magnet poles are aligned.Internal magnet is also rotatable.Different external magnets have been tested.The user was implanted on (b)(6) 2024.Magnet retention force is insufficient despite skin flap <5mm, s-vector internal magnet and 5s rondo3 external magnet.The problem remains since activation.Relative orientation of internal and external magnet has been verified - magnet poles are aligned.Internal magnet is also rotatable.Different external magnets have been tested.
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
Magnet retention force is insufficient despite skin flap <5mm, s-vector internal magnet and 5s rondo3 external magnet.The problem remains since activation.Different external magnets have been tested.Dl coil was tried and holds well, but also relatively weak.Currently the user is trying a sonnet 3, in the hopes to convince the user of a bte, to avoid a magnet exchange.The user is still using rondo and refuses to change to sonnet.The clinic considers a surgical exchange of the internal magnet despite internal recommendation to go for bte as a primary measure.However, no further information was received.
Additional Manufacturer Narrative
Additional information: reportedly, the recipient experienced retention issues with rondo 3 magnet strength #5s.It is assumed that the lack of retention may be the result of an unfavorable combination of different circumstances including physiology and activity profile of the respective user as well as the own weight of the rondo 3 processor.Hence, the currently strongest available rondo 3 magnet might not be sufficient.With the use of a sonnet 3 system, no more retention issues were observed.However, the recipient prefers to use the rondo 3.

• 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: 22738861
• Report Number: 9710014-2025-00724
• Device Sequence Number: 9240266
• Product Code: MCM
• UDI-Device Identifier: 09008737395353
• UDI-Public: (01)09008737395353
• 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
• 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): 11/03/2025

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: MI1250 SYNCHRONY 2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/03/2025
• Date Device Manufactured: 03/14/2024
• 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: 47 YR
• Patient Sex: Male