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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

The patient no longer has hearing perception with the device after a reported trauma at school.

 
Manufacturer Narrative

Additional information: 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 recipient's report. Additionally, diagnostic imaging shows the active electrode to have migrated partially out of the cochlea most likely due to the reported impact. However to confirm an exact root cause of failure a device investigation of the explanted device is necessary. Re-implantation is being considered, but no surgery date has been communicated.

 
Event Description

The recipient no longer has any hearing perception with the device after a reported trauma. Re-implantation is considered, but no date has been scheduled yet.

 
Manufacturer Narrative

Damage to the active electrode, as might be caused by an external mechanical impact, was determined to be the root cause of device failure. The problems given in the recipient report appear to match the damage found. Additionally, diagnostic imaging shows the active electrode to have migrated partially out of the cochlea most likely due to the reported impact. This is a final report.

 
Event Description

The recipient no longer has any hearing perception with the device after a reported trauma. The user has been explanted.

 
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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 Key7141514
MDR Text Key95665713
Report Number9710014-2017-01088
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeIN
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 03/15/2018
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 Manufacturer10/03/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/16/2017
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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