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

Model Number	MI1250 SYNCHRONY 2 PIN
Medical Device Problem Codes	Device Appears to Trigger Rejection (1524); Migration (4003)
Health Effect - Clinical Codes	Unspecified Infection (1930); Tissue Breakdown (2681)
Date of Event	02/15/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The device was explanted as it migrated and broke through the skin.The electrode was cut off and left in the cochlea for later reimplantation.
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
Conclusions: device investigations of the received parts did not reveal any device defect or problem which is expected to have been present whilst implanted.Mechanical damages found are attributable to the removal surgery.This finding was expected, because according to the recipient report the device was explanted following infection and extrusion i.E.The device broke through the skin.Reportedly, the implant had migrated from its position, which might have contributed to the observed symptoms.Furthermore, the recipient has a history of multiple retro-auricular skin infections, which is possibly a contributory factor for the current event, although this correlation has not been confirmed.A review of the device device_s sterilization records shows that the device has been subjected to a valid sterilization process.This is a final report.
Event or Problem Description
The device was explanted as it migrated and broke through the skin.The electrode was cut off and left in the cochlea for later re-implantation.No further information regarding the circumstances of this explantation has been received, although repeatedly requested.

• 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: 13617436
• Report Number: 9710014-2022-00147
• Device Sequence Number: 5201149
• Product Code: MCM
• UDI-Device Identifier: 09008737395469
• UDI-Public: (01)09008737395469
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2022
• 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): 06/24/2022

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 Expiration Date: 01/27/2024
• Device Model Number: MI1250 SYNCHRONY 2 PIN
• Device Catalogue Number: 39574
• 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: 02/18/2022
• Supplement Date Received by Manufacturer: 02/18/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: 57 YR
• Patient Sex: Female