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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Type of Reportable Event	Serious Injury
Event or Problem Description
Recipient reported swelling at the implant site since the device was implanted on (b)(6) 2019.The user was examined by physician about oozing of pus from the incision area on (b)(6) 2019.It was suspected that there was an infection.Recipient has been unable to use the device since the appointment on (b)(6) 2019.According to information received on the (b)(6) 2019, the infection was under control.It is believed that the user experienced a contact dermatitis from the external equipment that spread internally.As of information received in march 2020 the infection did flare up again and therefore the user was explanted on the (b)(6) 2020.This report refers to 9710014-2020-00170.For further information please refer to this report.

• 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: 11160309
• Report Number: 1066702-2021-00002
• Device Sequence Number: 14320731
• Product Code: MCM
• UDI-Device Identifier: 09008737094034
• UDI-Public: (01)09008737094034(11)180308(17)210308
• 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: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/13/2021
• Report Date (Section F): 01/11/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31092
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/08/2020
• Event Location: Other
• Date Report to Manufacturer: 01/11/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/13/2021
• 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: 61 YR