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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 SONATA
Device Problem Output Problem (3005)
Patient Problem Head Injury (1879)
Event Date 06/25/2020
Event Type  Injury  
Manufacturer Narrative
The device has been explanted and should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Event Description
The parents reported that the user's hearing performance with the device declined after a head trauma occurred.After 2 months of observation there was no improvement.The user was re-implanted on (b)(6) 2020.
 
Manufacturer Narrative
Conclusion: the investigation results confirmed that the device has failed due to an external impact to the active electrode.All the problems given in the recipient report appear to match well with this finding.This is a final report.
 
Event Description
The parents reported that the user's hearing performance with the device declined after a head trauma occurred.After 2 months of observation there was no improvement.The user was re-implanted on (b)(6) 2020.
 
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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 Key10598465
MDR Text Key208926980
Report Number9710014-2020-00547
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737049119
UDI-Public(01)09008737049119
Combination Product (y/n)N
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 11/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberSONATA
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/04/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age5 YR
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