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	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2025
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's hearing performance with the device is affected.The clinic is planning to exchange the implant magnet.No surgery date has been scheduled yet.
Additional Manufacturer Narrative
Conclusion: according to the received information from the field, the implant magnet got de-magnetized after a 1,5t mri examination.The de-magnetization most likely occurred, due to the implant magnet being in an unfortunate orientation.In the rare event that the magnet is weakened, the magnet can regain full strength when exposed to a magnetic field above 2.0 tesla.In the present case, the magnet could be fully re-magnetized by being exposed to the static magnetic field of a 3t mri device, without imaging procedure.The device will remain implanted and in use.This is a final report.
Event or Problem Description
After undergoing an 1,5 t mri scan to the spine, the processor no longer stays in place, even with the strongest magnet (dl coil #6).There was a successfull remagnetization of the weakened implant magnet.

• 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: 21194780
• Report Number: 9710014-2025-00057
• Device Sequence Number: 7578417
• Product Code: MCM
• UDI-Device Identifier: 09008737366728
• UDI-Public: (01)09008737366728
• 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: 2020
• 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): 07/22/2025

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: 02/24/2023
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 01/21/2025
• Supplement Report FDA Received Date: 07/23/2025
• Date Device Manufactured: 02/24/2020
• 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
• Patient Age: 61 YR
• Patient Sex: Male