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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Impedance Problem (2950); Migration (4003)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
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
Before surgeon closed, he verified full insertion of electrode.Post-op ct scan indicated that electrode had migrated out of cochlea, with 5 electrodes extra cochlear.
Additional Manufacturer Narrative
Additional information: based on the received information from the field, the active electrode array partially migrated post-operatively out of cochlea, leaving five channels outside.However, reportedly the recipient was activated successfully.The device remains implanted and in use.
Event or Problem Description
Surgeon was able to get a full insertion, however when electrode was released it would migrate out, repositioned it several times.Fascia and tisseel sealant were used to seal opening of cochleostomy.Before surgeon closed he verified full insertion of electrode.Post-op ct scan indicated that electrode had migrated out of cochlea, with 5 electrodes extra cochlear.The user was activated successfully on (b)(6) 2024.The user has good behavioral responses when wearing ci.
Additional Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.Additionally, the electrode array partially migrated out of the cochlea post-implantation as confirmed by imaging.However, later ct scans show that the electrode array advanced back into the cochlea again.The problems given in the recipient report appear to match the damage found.This is a final report.
Event or Problem Description
Surgeon was able to get a full insertion, however when electrode was released it would migrate out, repositioned it several times.Before surgeon closed he verified full insertion of electrode.The user was activated successfully on (b)(6) 2024.Overtime affected channels were seen.The user has been 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: 18900617
• Report Number: 9710014-2024-00233
• Device Sequence Number: 20793324
• Product Code: PGQ
• UDI-Device Identifier: 09008737395438
• UDI-Public: (01)09008737395438
• 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: 2024
• 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): 08/21/2025

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?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2024
• Supplement Date Received by Manufacturer: 03/05/2024; 03/05/2024
• Initial Report FDA Received Date: 03/14/2024
• Supplement Report FDA Received Date: 06/12/2024; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 18 MO
• Patient Sex: Male