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U.S. Department of Health and Human Services

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

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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number MI1210 SYNCHRONY ST
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 09/30/2020
Event Type  Injury  
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 user's mom and speech and language pathologist reported that during a speech session on (b)(6) 2020 the user was not responding to her name being called. They thought the child was either ignoring the calls or the audio processor was faulty. There was no report of any trauma.

 
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Brand NameMED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck 6020
AU   6020
57788
MDR Report Key10625487
MDR Text Key209773058
Report Number9710014-2020-00567
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/11/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/05/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMI1210 SYNCHRONY ST
Device Catalogue Number33338
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/07/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/30/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/07/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/05/2020 Patient Sequence Number: 1
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