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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 Impedance Problem (2950); Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
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.
 
Event Description
One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding and sent the external parts to the clinic for troubleshooting.Further technical checks and medical intervention is scheduled but no date has been provided yet.
 
Manufacturer Narrative
Additional information: based on the received information, a damage to the active electrode due to excessive mechanical stress appears very likely.However, to determine an exact root cause device investigation would be necessary.The recipient has been re-implanted but the explanted device has not been received for investigation yet.
 
Event Description
One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding with the device.The user has been re-implanted.
 
Manufacturer Narrative
Conclusion: damage to the active electrode which is consistent with minute device mobility was determined to have led to device failure over time due to fatigue wire breakages.The problems given in the recipient report appear to match the damage found.This is a final report.
 
Event Description
One month ago (approximately (b)(6) 2022) the parents of the user noticed a reduced hearing and poor speech understanding with the device.The user has been 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 Key16041817
MDR Text Key306077981
Report Number9710014-2022-00986
Device Sequence Number1
Product Code MCM
UDI-Device Identifier09008737049171
UDI-Public(01)09008737049171
Combination Product (y/n)N
Reporter Country CodeIN
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,Followup
Report Date 09/19/2023
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
Device Operator Lay User/Patient
Device Expiration Date07/03/2017
Device Model NumberSONATA
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/20/2022
Initial Date FDA Received12/23/2022
Supplement Dates Manufacturer Received12/20/2022
12/20/2022
Supplement Dates FDA Received03/10/2023
09/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/03/2015
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 Age12 YR
Patient SexMale
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