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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
Date of Event 07/16/2019
Type of Reportable Event Serious Injury
Additional 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 or Problem Description
The user's hearing performance is affected; the user was responding to speech and sounds prior to this time.Further intervention is considered.
 
Additional Manufacturer Narrative
Conclusion: 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.Re-implantation is considered but no date has been scheduled yet.
 
Event or Problem Description
The recipient's hearing performance with the device was affected; the recipient was responding to speech and sounds before.No trauma was reported.The recipient will be re-implanted, however no date for surgery has been set yet.
 
Event or Problem Description
The recipient's hearing performance with the device was affected; the recipient was no longer responding to speech and sounds as before.No trauma was reported.
 
Additional Manufacturer Narrative
Conclusion: 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.This is a final report.
 
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Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Common Device Name
COCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key8811139
Report Number9710014-2019-00554
Device Sequence Number19382363
Product Code MCM
UDI-Device Identifier09008737062705
UDI-Public(01)09008737062705
Combination Product (Y/N)N
Initial Reporter CountryEG
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2020
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date (Section B) 10/08/2020
1 Device was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMI1000 MED-EL CONCERT
Device Catalogue Number07671
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/28/2020
Was the Report Sent to FDA? No
Initial Date Received by Manufacturer 07/17/2019
Supplement Date Received by Manufacturer07/17/2019
07/17/2019
Initial Report FDA Received Date07/22/2019
Supplement Report FDA Received Date10/09/2019
10/08/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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