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 Codes	Unspecified Infection (1930); Skin Tears (2516)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been explanted.If it should be explanted, it 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 user underwent a revision surgery to repair the skin flap on the (b)(6) 2021 due to exposure of the device.The implant housing had partially extruded through the skin.
Additional Manufacturer Narrative
Conclusion: device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.This finding was expected, because according to the recipient report the device was explanted for medical reasons, namely infection leading to fistula at the implant site.A history of previous device extrusion and revision surgery is known.Further the two most basal channels most likely migrated out of cochlea.A review of the device_s sterilization records show that the device has been subject to a valid sterilization process.No information available points to the implant being the source of the infection.This is a final report.
Event or Problem Description
The user underwent a revision surgery to repair the skin flap on (b)(6) 2021 due to exposure of the device.The implant housing had partially extruded through the skin.There was no known event that could have contributed to the exposure of the device; however the user has a particularly thin skin.The user was wearing magnet strength 3.The user was explanted on (b)(6) 2021 due to a fistula on the head that was thought to be the result of an infection.Results of the infection are pending.The electrode array was found not fully inserted at explantation.

• 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: 12451978
• Report Number: 9710014-2021-00688
• Device Sequence Number: 13748206
• Product Code: MCM
• UDI-Device Identifier: 09008737093983
• UDI-Public: (01)09008737093983
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2022

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 09/10/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 6 YR
• Patient Sex: Female