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

Model Number	MI1000 MED-EL CONCERT
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/12/2015
Type of Reportable Event	Serious Injury
Event or Problem Description
In 2015, user underwent a contralateral side implantation of a cochlear device.Since this time the user has had no access to sound from the med-el device.Previous hearing level unknown as the patient is difficult to test.Reportedly, in situ measurements from 2015 were within normal limits and external equipment has been replaced.The appointment on (b)(6) 2015 revealed no further progress of the child's speech or signs.Information received on (b)(6) 2015 states that the clinic continued to monitor the patient.The last integrity test was performed on (b)(6) 2019 due to poor performances with the device.The user has been explanted and reimplanted with a device from another manufacturer.This report refers to 9710014-2015-00416.For further information please refer to this report.

• 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: 10565782
• Report Number: 1066702-2020-00063
• Device Sequence Number: 19484314
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• 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: 2014
• Device Explanted Year: 2020
• 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): 09/22/2020
• Report Date (Section F): 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Event Location: Other
• Date Report to Manufacturer: 09/18/2020
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/22/2020
• 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: 3 YR