MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

Model Number	MI1200 SYNCHRONY
Medical Device Problem Code	Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	Skin Tears (2516)
Date of Event	09/10/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
The recipient was planned to be explanted due to electrode lead extrusion through the tympanic membrane and non-use.The recipient never had benefit from the device due to cystic cochlea deformity and cochlear nerve deficiency.Expectations at implantation were minimal because of these conditions.The clinic had been planning explantation for a while.No new device will be implanted.The device was explanted (b)(6) 2020.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10676268
• Report Number: 1066702-2020-00069
• Device Sequence Number: 14197094
• Product Code: MCM
• UDI-Device Identifier: 09008737094089
• UDI-Public: (01)09008737094089
• 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: 2018
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/14/2020
• Report Date (Section F): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: MI1200 SYNCHRONY
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2020
• Event Location: Other
• Date Report to Manufacturer: 09/30/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 3 YR