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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Microbial Contamination of Device (2303)
Health Effect - Clinical Code	Bacterial Infection (1735)
Date of Event	03/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user has been explanted.Further information stated this was due to medical reasons.The reason for explantation was an infection in the implant area with an exposed coil.In addition there was a biofilm on the implant.Staphylococcus aureus was verified.During explantation, the active electrode was cut off and left inside the cochlea.Re-implantation occurred at a later point in time.
Additional Manufacturer Narrative
The device has been explanted and should 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 reason for explantation was an infection in the implant area with an exposed coil.In addition staphylococcus aureus was verified.During explantation, the active electrode was cut off and left inside the cochlea.Re-implantation occurred at a later point in time.
Additional Manufacturer Narrative
Additional information: according to received information, the recipient had a post-operative infection in the area of the implant with an exposed coil.Microbiology results showed staphylococcus aureus, which is the most common pathogen found in surgical implant infections and represents a common skin contaminant at the time of surgery.A review of the devices sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.However, a device contribution to the subsequent development of the extrusion cannot be ruled out.The explanted device has not been received for investigation yet.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Common Device Name: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 17265324
• Report Number: 9710014-2023-00567
• Device Sequence Number: 6058963
• Product Code: MCM
• UDI-Device Identifier: 09008737395353
• UDI-Public: (01)09008737395353
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/11/2023

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: Lay User/Patient
• Device Expiration Date: 01/25/2025
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 39563
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2023
• Supplement Date Received by Manufacturer: 07/03/2023
• Initial Report FDA Received Date: 07/06/2023
• Supplement Report FDA Received Date: 09/11/2023
• Date Device Manufactured: 01/25/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male