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

Model Number MI1000 MED-EL CONCERT

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/12/2015

Event Type  Injury  

Event 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
• Type of Device: COCHLEAR IMPLANT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10565782
• MDR Text Key: 207896536
• Report Number: 1066702-2020-00063
• Device Sequence Number: 1
• Product Code: MCM
• UDI-Device Identifier: 09008737062705
• UDI-Public: (01)09008737062705
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/18/2020,09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MI1000 MED-EL CONCERT
• Device Catalogue Number: 07671
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/16/2020
• Event Location: Other
• Date Report to Manufacturer: 09/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR