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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 Migration (4003)
Patient Problems Ossification (1428); Failure of Implant (1924)
Event Date 02/20/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Event Description
Reportedly, the user's hearing performance with the device has been affected since switch-on of the audio processor back in 2013.There were complaints about speech intelligibility since the first fitting, however, sounds are heard well.The user was seen by several audiologists and in 2018 the audio processor was switched from an opus2 to a rondo, but there was no improvement.
 
Event Description
Reportedly, the user's hearing performance with the device has been affected since switch-on of the audio processor back in 2013.There were complaints about speech intelligibility since the first fitting, however, sounds are heard well.The user was seen by several audiologists and in 2018 the audio processor was switched from an opus2 to a rondo, but there was no improvement.
 
Manufacturer Narrative
Additional information: based on the received information from the field, during implantation surgery only an incomplete insertion of the active electrode was achieved due to an ossification which was pre-operatively diagnosed.The hearing performance was not optimal but dropped over time.It was determined by ct scan that the electrode migrated further out of the cochlea, which is likely the reason for the drop in performance.Further steps are considered but no date has been scheduled yet.
 
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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 Key11778001
MDR Text Key249217009
Report Number9710014-2021-00332
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 06/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/05/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/30/2014
Device Model NumberSONATA
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age39 YR
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