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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 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

Patient's hearing with the device is affected. Parents reported that a head trauma had occurred. Re-implantation is considered.

 
Manufacturer Narrative

According to the currently available information, damage to the active electrode, as it might be caused by an external mechanical impact appears likely. An impact is mentioned in the patient report, however to confirm an exact root cause of failure a device investigation of the explanted device is necessary. Additionally, two electrode channels were already in status hi prior to the reported impact. Re-implantation is being considered but no date has been scheduled.

 
Event Description

Recipients_ hearing with the device is affected after a head trauma. Re-implantation is considered.

 
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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 Key7141523
MDR Text Key95797584
Report Number9710014-2017-001094
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 HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 12/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
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 Manufacturer11/14/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/19/2017
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: 12/22/2017 Patient Sequence Number: 1
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