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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 Migration (4003)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
The right implant has reportedly slipped down.Movement was first documented on the (b)(6) 2019.The coil touched the processor and therefore the user could only use the single unit processor.However, also that touched the pinna and got pushed off.Therefore, the user had to use the sonnet with it overlapping the coil.The user had the device re-positioned on (b)(6) 2020.The device remains implanted.
 
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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 Key10238285
Report Number1066702-2020-00042
Device Sequence Number2603504
Product Code MCM
UDI-Device Identifier09008737094034
UDI-Public(01)09008737094034
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) 07/07/2020
Report Date (Section F) 06/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberMI1200 SYNCHRONY PIN
Device Catalogue Number31092
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date06/25/2020
Event Location Hospital
Date Report to Manufacturer06/26/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date07/07/2020
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 Age70 YR
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