MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH SYNCHRONY; Cochlear Implant

Model Number	Mi1200 SYNCHRONY
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Tinnitus (2103)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been explanted and 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 began experiencing a high-pitched tinnitus, a high pitched "chirp" sound, taste disturbance (metallic taste), pain and speech degradation.The user was reimplanted with a longer electrode variant.Per explanation report, two channels were found extra-cochlear at explantation.A full insertion was achieved at implantation.
Event or Problem Description
In (b)(6) 2025, the user began experiencing a high-pitched tinnitus, a high pitched "chirp" sound, taste disturbance (metallic taste), pain and speech degradation.The user was reimplanted.Per explanation report, two channels were found extra-cochlear at explantation.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received, the recipient suffered from pain, tinnitus and taste disturbances, all of which are known undesired side effects of otologic surgery.In addition, two channels migrated out of cochlea, which could have contributed to the observed symptoms and the reported speech degradation.This is a final report.

• 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 ; +43()577885626
• MDR Report Key: 24566613
• Report Number: 9710014-2026-00245
• Device Sequence Number: 9561222
• Product Code: MCM
• UDI-Device Identifier: 09008737094003
• 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: 2015
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2026

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: 04/27/2017
• Device Model Number: Mi1200 SYNCHRONY
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/17/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 09/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/27/2015
• 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: 64 YR
• Patient Sex: Female