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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2024
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
The user's hearing with the device is affected.Since approximately 2-3 months he has intermittencies and volume decreases when moving the jaw.The user also reported pain in the ear and around the ear when laying on that side.Revision surgery is considered.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient experiences loudness fluctuations and sound intermittencies with jaw movement, which is likely caused by an air bubble above the reference electrode.Wearing a tight head band was suggested, however no information on the possible further steps has been received despite requested.
Event or Problem Description
The user's hearing with the device is affected.Since approximately 2-3 months, he has intermittencies and volume decreases when moving the jaw.The user also reported pain in the ear and around the ear when laying on that side.Per clinical support, further troubleshooting should be applied, like wearing a tight headband or recommending the user to press/massage the stimulator area in case intermittency is recognized.
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 recipient experiences loudness fluctuations and sound intermittencies with jaw movement, which is likely caused by an air bubble above the reference electrode.This is a final report.
Event or Problem Description
The user's hearing with the device is affected.Since approximately 2-3 months he has intermittencies and volume decreases when moving the jaw.The user also reported pain in the ear and around the ear when laying on that side.Per clinical support, further troubleshooting should be applied, like wearing a tight headband or recommending the user to press/massage the stimulator area in case intermittency is recognized.The user has bene reimplanted.

• 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: 20999221
• Report Number: 9710014-2024-01154
• Device Sequence Number: 13228427
• Product Code: MCM
• UDI-Device Identifier: 09008737395476
• UDI-Public: (01)09008737395476
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• 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): 02/26/2026

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: 12/14/2024
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 12/18/2024; 12/18/2024
• Initial Report FDA Received Date: 12/23/2024
• Supplement Report FDA Received Date: 05/06/2025; 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2021
• 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: 66 YR
• Patient Sex: Male