MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERÄTE GESELLSCHAFT M.B.H. SYNCHRONY 2; IMPLANT, COCHLEAR

Model Number	36681
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
Event or Problem Description
During a bilateral cochlear implantation, the doctor could not confirm that the synchrony 2 cochlear implant had successfully coiled, even after several x-ray where taken.It was decided to use a smaller cochlear implant which successfully coiled as confirmed by x-ray imaging.The defective synchrony 2 cochlear implant was returned to the manufacturer on july 23rd.The company informed uf that, according to fda regulations, the implant that was not used during the surgical procedure must be returned to the company.Company sent an over-night shipping package to obtain the device.Once the defective product is returned, the company will investigate the problem with the device and consider if uf must be reimbursed due to its malfunctioning.

• Brand Name: SYNCHRONY 2
• Common Device Name: IMPLANT, COCHLEAR
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERÄTE GESELLSCHAFT M.B.H.; 2645 meridian parkway, suite 100; durham NC 27713
• MDR Report Key: 10355414
• Report Number: 10355414
• Device Sequence Number: 11485054
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2020
• Report Date (Section F): 07/27/2020

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: Health Professional
• Device Model Number: 36681
• Device Catalogue Number: 36710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2020
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 91
• Date Report Sent to FDA: 07/27/2020