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 Codes	Bacterial Infection (1735); Insufficient Information (4580)
Date of Event	04/28/2021
Type of Reportable Event	Serious Injury
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
There was a staphylococcus infection which caused skin breakdown.The device was explanted.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which is assumed to have been present whilst implanted.Mechanical damages found are attributable to the removal surgery.This finding was expected, since the recipient was explanted because of an infection in the area of the skin incision and implant pocket, as confirmed by cultures showing methicillin sensitive staphylococcus aureus.This bacteria is part of the skin flora and represents a common pathogen found in surgical implant infections.Also, review of the device device_s sterilization records shows that the device has been subjected to a valid sterilization process.Considering the available information, the observed infection was most likely due to inoculation of bacteria through the skin at the time of surgery.This is a final report.
Event or Problem Description
An infection started 3 weeks after implantation.The recipient developed an mssa (methicillin_sensitive staphylococcus aureus) infection post-operatively.The device was explanted on (b)(6) 2021.The recipient was not re-implanted with a new device, and will be re-implanted at a later date.

• 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: 11782673
• Report Number: 9710014-2021-00337
• Device Sequence Number: 11692802
• Product Code: MCM
• UDI-Device Identifier: 09008737366810
• UDI-Public: (01)09008737366810
• 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: 2021
• Device Explanted Year: 2021
• 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): 06/29/2021

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: 36710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/29/2021
• 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: 4 YR