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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	11/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the information received from the field the device did not provide sufficient hearing benefit due to a incomplete insertion at implantation surgery.Reportedly only four electrode channels could be inserted.In addition, during device investigation damage to the active electrode caused by device minute mobility was found.Other mechanical damages found during device investigation are attributable to the removal surgery.This is a combined initial and final report.
Event or Problem Description
During the initial surgical procedure, the active electrode array couldn't be fully inserted into the user's cochlea due to anatomical issues.The clinic was only able to insert 4 channels which was confirmed by imaging.The clinic noticed multiple cholesteatomas and other ear diseases.The user did not follow the recommended clinical aftercare, recently presented at the clinic for explantation, having relied on hearing from the contralateral side and having never experienced any hearing perception post-surgery with the device.

• 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: 18966825
• Report Number: 9710014-2024-00278
• Device Sequence Number: 14961290
• Product Code: MCM
• UDI-Device Identifier: 09008737093976
• UDI-Public: (01)09008737093976
• 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: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/25/2024

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: MI1200 SYNCHRONY PIN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2024
• Initial Report FDA Received Date: 03/25/2024
• 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: 50 YR
• Patient Sex: Male