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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; MED-EL CONCERT
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MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; MED-EL CONCERT Back to Search Results
Device Problems Unintended Collision (1429); Communication or Transmission Problem (2896)
Patient Problem Hearing Loss (1882)
Event Date 11/26/2014
Event Type  malfunction  
Event Description
It was reported that the bilateral patient hit his head against a door several weeks ago,.Thereafter, the patient was not able to detect any sound with the left implant.Reimplantation has been scheduled.
 
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.
 
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Brand Name
MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of Device
MED-EL CONCERT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
innsbruck
AU 
Manufacturer Contact
laura simonotii
fuerstenweg 77a
innsbruck A-602-0
AU   A-6020
77885626
MDR Report Key4355602
MDR Text Key20362423
Report Number9710014-2014-00664
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Other Device ID Number(01)09008737083632(17)150700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received11/26/2014
Was Device Evaluated by Manufacturer? Yes
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 Age6 YR
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