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

Model Number	MI1200 SYNCHRONY PIN
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Skin Tears (2516)
Type of Reportable Event	Serious Injury
Event or Problem Description
The implant housing is exposed behind the user's right ear.The user was reimplanted on (b)(6) 2023.
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.
Additional Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage 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 received information from the field, the device was explanted due to clinical/surgical reasons i.E.Infection leading to exposure of the implant on the skull one month post-operatively.A review of the device_s 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.In addition, the implant housing moved from its intended position.This is a final report.
Event or Problem Description
The implant housing is exposed behind the user's right ear.There are reportedly signs of infection, which was there before the exposure of the device.There is no allegation that the device caused or contributed to the exposure.The surgical wound healed completely after implantation, and the problems started within one month, without any reported trauma.The reason for the exposure of the device is unclear, but the clinic does not believe the device itself is the issue.There is no breakdown of the skin or extrusion of the device through the skin.The magnet strength of the external device is unknown, but exposure part isn_t located at the coil.The user was re-implanted.

• 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: 16945429
• Report Number: 9710014-2023-00421
• Device Sequence Number: 2161613
• Product Code: MCM
• UDI-Device Identifier: 09008737094034
• UDI-Public: (01)09008737094034
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• 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): 09/07/2023

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/05/2025
• Device Model Number: MI1200 SYNCHRONY PIN
• Device Catalogue Number: 31092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 09/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2022
• 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: 79 YR
• Patient Sex: Female