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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 MI1200 SYNCHRONY PIN
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
Sounds being too soft was reported on (b)(6) 2019 and re-mapping was performed.Parent recognized that recipient wasn't responding as well as before.No trauma / accident was reported or changes in medical condition.In situ measurements showed affected channels and hearing performance with the device is affected.The user was successfully re-implanted on (b)(6) 2019.This report refers to 9710014-2019-00741.For further information please refer to this 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 Key9393475
Report Number1066702-2019-00034
Device Sequence Number2708685
Product Code MCM
UDI-Device Identifier09008737094010
UDI-Public(01)09008737094010
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 12/02/2019
Report Date (Section F) 11/13/2019
1 Device was Involved in the Event
1 Patient 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 NumberMI1200 SYNCHRONY PIN
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/13/2019
Event Location Other
Date Report to Manufacturer11/13/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/02/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age9 YR
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