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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
Event or Problem Description
The user has a persistent, re-occurring infection over the left implant which limits the use of the audio processor.
Additional Manufacturer Narrative
Additional information: according to the information received from the field the recipient suffered from an infection and swelling at the implant site.Reportedly the recipient had an otitis media in the peri-operative period, which could be solved by conservative treatment.However, it is likely that the infection could not be completely eradicated and possibly spread to the implant site, since the culture taken on the fluid drained from the infection site showed sinus pathogens, typically responsible for otitis media.Due to a broad drug allergy, optimal treatment was not readily available.This could have contributed to persistence and spread of the initial middle ear infection.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No available information points to the implant being the source of infection.The recipient is doing fine.The device remains implantand in use.
Event or Problem Description
The recipient has had a persistent, re-occurring infection over the left implant which limited the use of the audio processor.The recipient has continued on medical management and has had no further swelling and no further surgery.He has been wearing the device consistently since (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: 11145201
• Report Number: 9710014-2021-00007
• Device Sequence Number: 11664602
• Product Code: MCM
• UDI-Device Identifier: 09008737366773
• UDI-Public: (01)09008737366773
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

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: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 36706
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/31/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/25/2021
• 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: Hospitalization; Required Intervention
• Patient Age: 15 MO