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

Model Number MI1210 SYNCHRONY ST

Device Problem Output Problem (3005)

Patient Problem Failure of Implant (1924)

Event Date 09/15/2020

Event Type  Malfunction  

Manufacturer Narrative

The device has not been explanted. If it should be explanted, it is to be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.

Event Description

The parents noticed that the child had not been responding to sound for a few days. There is no report of an accident, or trauma.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: 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: 10624946
• MDR Text Key: 209763985
• Report Number: 9710014-2020-00566
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (Y/N): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 12/17/2020

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 10/05/2020
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: LAY USER/PATIENT
• Device MODEL Number: MI1210 SYNCHRONY ST
• Device Catalogue Number: 33333
• Was Device Available For Evaluation?: No

Is The Reporter A Health Professional?

• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 09/30/2020
• Was Device Evaluated By Manufacturer?: No
• Date Device Manufactured: 09/05/2019
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial