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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 Problems Insufficient Information (3190); Migration (4003)
Patient Problem Undesired Nerve Stimulation (1980)
Event Type  malfunction  
Event Description
The user's hearing performance with the device is affected.It was reported that the user experienced facial nerve stimulation and other non-auditory side-effects due to possibly 6 extra-cochlear channels.
 
Manufacturer Narrative
The device has not been explanted.If it should be explanted, it should be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
 
Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.Based on the received information from the field, the device did not provide sufficient benefit due to a partial migration of the active electrode out of cochlea, as confirmed by post-operative diagnostic imaging.Further, the recipient experienced facial nerve stimulation most likely due to electrical stimulation in the middle ear caused by the extra-cochlear channels.In addition, in situ measurements show three channels with hi and short circuit status due to undetermined reasons.This is a final report.
 
Event Description
The user's hearing performance with the device is affected.It was reported that the user experienced facial nerve stimulation and other non-auditory side-effects due to possibly 6 extra-cochlear channels.The user was re-implanted.
 
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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 
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck 6020
AU   6020
57788
MDR Report Key15094116
MDR Text Key296579249
Report Number9710014-2022-00525
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 11/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date09/01/2014
Device Model NumberSONATA
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Date Manufacturer Received07/19/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2012
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 Age17 YR
Patient SexMale
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