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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 SONATA
Device Problems Device Operates Differently Than Expected (2913); Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 12/25/2017
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

Decrease in the patients hearing performance with the device. An accident/trauma was reported.

 
Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode as might be caused by an external mechanical impact appears likely. However to determine an exact root cause a device investigation of the explanted device is necessary. Currently no information was made available on further steps.

 
Event Description

There was a decrease in the recipient's hearing performance with the device. No trauma was reported. No further information has been made available.

 
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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 Key7153784
MDR Text Key96022730
Report Number9710014-2017-01120
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeEG
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/04/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/29/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberSONATA
OTHER Device ID Number(01) 09008737049119
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/25/2017
Was Device Evaluated By Manufacturer? Yes
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: 12/29/2017 Patient Sequence Number: 1
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