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

Model Number	MI1210 SYNCHRONY ST
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Failure of Implant (1924)
Type of Reportable Event	Malfunction
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 reported that recently the implant housing has moved down towards the pinna.A revision surgery for an implant bed is considered.
Event or Problem Description
In (b)(6) 2022 the user had some swelling around the implant site, which was resolved with antibiotic treatment.The user also reported that the implant housing has moved down towards the pinna and when he eats, laughs or touches his pinna he hears a disturbing whistling sound.The user was re-implanted.
Additional Manufacturer Narrative
Conclusion: according to the information received from the field the implant housing migrated from its intended position.Further the recipient suffered from a swelling above the implant site, which was resolved with antibiotics.During explantation mastoidectomy cavity was found totally closed with new grown bone.In addition device investigation revealed damage to the active electrode caused by device minute mobility.Reported events might have contributed to the device migration.The reported housing migration likely led to movement of the electrode causing fatigue wire breakages.Other mechanical damages found are attributable to the removal surgery.This is a final report.

• 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: 15388783
• Report Number: 9710014-2022-00662
• Device Sequence Number: 5810426
• Product Code: MCM
• UDI-Device Identifier: 09008737331832
• UDI-Public: (01)09008737331832
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: P000025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2023

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: 09/17/2021
• Device Model Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 03/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2018
• 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: 28 YR
• Patient Sex: Male