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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 PIN
Medical Device Problem Code Output Problem (3005)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 08/28/2019
Type of Reportable Event Serious Injury
Event or Problem Description
Recipient reported no sound from his processor while watching tv.There were no additional strange sounds or unusual auditory perceptions.There is no report of an accident or trauma, no changes in health or swelling at the implant site reported.The user was re-implanted on the (b)(6) 2019.This report refers to 9710014-2019-00655.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 Key9195646
Report Number1066702-2019-00017
Device Sequence Number11520804
Product Code MCM
UDI-Device Identifier09008737062699
UDI-Public(01)09008737062699
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2014
Device Explanted Year2019
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 10/16/2019
Report Date (Section F) 10/11/2019
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 NumberMI1000 MED-EL CONCERT PIN
Device Catalogue Number07677
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date10/11/2019
Event Location Other
Date Report to Manufacturer10/11/2019
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/16/2019
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 Age6 YR
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