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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 MI1250 SYNCHRONY 2
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code Meningitis (2389)
Date of Event 03/05/2020
Type of Reportable Event Serious Injury
Event or Problem Description
Around one month after implantation surgery the recipient developed fever and was feeling sick, was tested for the flu but then recovered.On the (b)(6) 2020 the same symptoms occurred, sickness and high fever.The user was admitted to hospital and diagnosed with meningitis, then recovered and was released on (b)(6).The device has not been worn since being admitted to hospital.Due to the re-occurrence of meningitis, the user was explanted on the (b)(6) 2020.This report refers to 9710014-2020-00192.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 Key9887442
Report Number1066702-2020-00025
Device Sequence Number3183273
Product Code MCM
UDI-Device Identifier09008737366766
UDI-Public(01)09008737366766
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
P000025
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 03/27/2020
Report Date (Section F) 03/20/2020
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 NumberMI1250 SYNCHRONY 2
Device Catalogue Number36705
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/19/2020
Event Location Other
Date Report to Manufacturer03/20/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date03/27/2020
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 Age4 YR
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