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

Model Number 36681

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2020

Event Type  malfunction  

Event 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
• Type of Device: 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
• MDR Text Key: 201340926
• Report Number: 10355414
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/27/2020
• Event Location: Hospital
• Date Report to Manufacturer: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 17155 DA
• Patient Weight: 91