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

Model Number	MI1250 SYNCHRONY 2
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Implant Pain (4561)
Type of Reportable Event	Serious Injury
Event or Problem Description
The user saw the surgeon on (b)(6) 2021 for significant pain overlying the implant site both with and without external device on her head.The pain was first reported on 19-jan-2021 as the user was not able to wear the device due to pain for one week prior to this.The pain is worse with use of the device.The performance with the device has been poor but the reason for the revision surgery is the pain and inability to wear the device.Reportedly, the housing likely shifted lower in the pocket post-operatively.Re-implantation was performed on the (b)(6) 2021 and the concerned device was found with 3 extra-cochlear channels.At explantation the device housing was found stable.

• 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: 11441536
• Report Number: 1066702-2021-00018
• Device Sequence Number: 11765822
• Product Code: MCM
• UDI-Device Identifier: 09008737366803
• UDI-Public: (01)09008737366803
• 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: 2019
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2021
• Report Date (Section F): 03/03/2021

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: Health Professional
• Device Model Number: MI1250 SYNCHRONY 2
• Device Catalogue Number: 36709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/03/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2021
• 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: 73 YR