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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
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
Event Description
Hearing performance using the device was affected and sound field audiogram has decreased to 40-45 db.The recipient does not have spoken language, so speech performance is difficult to assess.No specific report of injury or trauma.The user was re-implanted on (b)(6) 2020 (after the user has had adenoids and tonsils removed).
 
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Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of Device
COCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU 
MDR Report Key10565781
MDR Text Key207895719
Report Number1066702-2020-00062
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737310936
UDI-Public(01)09008737310936
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/17/2020,09/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMI1200 SYNCHRONY
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/16/2020
Event Location Hospital
Date Report to Manufacturer09/17/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age4 YR
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