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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
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
The user's performance with the device is affected.In situ testing showed affected channels.Reimplantation was performed on (b)(6) 2021.This report refers to 9710014-2021-0051.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 Key12292406
Report Number1066702-2021-00060
Device Sequence Number14620882
Product Code MCM
UDI-Device Identifier09008737078805
UDI-Public(01)09008737078805
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Serviced by Third Party (Y/N)Unknown
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/09/2021
Report Date (Section F) 08/05/2021
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 Lay User/Patient
Device Model NumberMI1200 SYNCHRONY
Device Catalogue Number31113
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/03/2021
Event Location Other
Date Report to Manufacturer08/05/2021
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date08/09/2021
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 Age20 YR
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