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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 MI1000 MED-EL CONCERT
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Date 12/15/2017
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

The hearing performance with the device is affected. It is unknown if an accident or a trauma has happened. Re-implantation is considered.

 
Manufacturer Narrative

Additional information: according to the currently available information, damage to the active electrode likely caused by minute device mobility is suspected. However to determine an exact root cause a device investigation of the explanted device is necessary. Re-implantation is being considered, but no surgery date has been communicated.

 
Event Description

The hearing performance with the device is affected. It is unknown if an accident or a trauma has occurred. Re-implantation is considered but no date has been scheduled.

 
Manufacturer Narrative

Damage to the active electrode likely caused by minute device mobility was determined to have led to device failure over time. Other damages found during investigation are most likely related to explantation surgery. The investigation results appear to match the symptoms mentioned in the patient report. This is a final report.

 
Event Description

The hearing performance with the device is affected. It is unknown if an accident or a trauma has occurred. Re-implantation took place. On this same day the user was also implanted (initial implantation) on the contralateral side. The patient was seen for the first fitting on (b)(6) 2018. On the concerned right side all 12 channels were enabled. Channels 11-12 will be evaluated again as response to sound was unclear and patient was too tired to continue with testing. When the processor was activated, the patient understood speech and she replied to some simple questions.

 
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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 Key7141531
MDR Text Key95665295
Report Number9710014-2017-001097
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeSP
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 05/04/2018
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 NumberMI1000 MED-EL CONCERT
OTHER Device ID Number(01) 09008737062682
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/20/2018
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/20/2017
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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