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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 Output Problem (3005)
Health Effect - Clinical Code Failure of Implant (1924)
Type of Reportable Event Serious Injury
Event or Problem Description
Affected channels have been observed during in situ testing.At a visit on the 18th february the user reported an off-sensation of head feeling soft and dizziness when wearing the device.However, on the (b)(6) 2020 the user reported that the hearing was improving and the soft feeling and dizziness had gone.However, loud voices were uncomfortable when near the implanted side.The user was re-implanted on the (b)(6) 2020.
 
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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 Key10883206
Report Number1066702-2020-00079
Device Sequence Number14260388
Product Code MCM
UDI-Device Identifier09008737366728
UDI-Public(01)09008737366728
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
Device Explanted Year2020
Serviced by Third Party (Y/N)N
Reporter Type Importer
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 11/23/2020
Report Date (Section F) 11/19/2020
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 NumberMI1250 SYNCHRONY 2
Device Catalogue Number36701
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/17/2020
Event Location Hospital
Date Report to Manufacturer11/19/2020
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date11/23/2020
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 Age9 YR
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