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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 MI1260 SONATA 2
Device Problems Circuit Failure (1089); No Device Output (1435)
Patient Problem Failure of Implant (1924)
Event Type  malfunction  
Event Description
Reportedly, the recipient was hearing very well with the device after using the rondo 2 in (b)(6) 2022.However, in (b)(6) 2023 the parents noticed that the cpu was always blinking red and no sound could be provided to the child.Re-implantation is considered but has not been scheduled yet.
 
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 investigations revealed the substrate of the device circuitry to be broken.The investigation results appear to match the problems mentioned in the recipient report.The exact reason for the crack in the substrate cannot be determined.However, a review of the dhr has been performed and it was confirmed that the device was released according to specifications.This is a final report.
 
Event Description
Reportedly, the recipient was hearing very well with the device after using the rondo 2 in (b)(6) 2022.However, in (b)(6) 2023 the parents noticed that the cpu was always blinking red and no sound could be provided to the child.The recipient 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 Key16535991
MDR Text Key311239768
Report Number9710014-2023-00222
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeTC
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 02/29/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberMI1260 SONATA 2
Device Catalogue Number38555
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Date Manufacturer Received03/12/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/18/2022
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 Age7 YR
Patient SexFemale
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