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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 MI1000 MED-EL CONCERT
Device Problems Degraded (1153); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 09/02/2014
Event Type  Injury  
Event Description
It was reported that the concerned device was explanted.No further info is available at this time.
 
Manufacturer Narrative
(b)(4).The device has been explanted and should be returned to the manufacturer for eval.When available, a device failure analysis will be submitted as a f/u report.
 
Event Description
It was reported that the patient was reimplanted with an abi electrode.Additional information received stated that the patient is affected by goldenhar syndrome and diagnostic imaging performed before reimplantation revealed bilateral cochlear nerve aplasia.
 
Manufacturer Narrative
Additional information: since the device is not available to the manufacturer for examination, no device investigation was conducted.If the device is received in the future, the case will be re-opened and the device investigated.Based on information received with the pt report, the pt had no auditory sensation since implantation.As the patient was re-implanted with a different electrode type (i.E.Abi electrode) following diagnosis of bilateral cochlear nerve aplasia on post-operative imaging, obtaining hearing perception, it is assumed that an inadequate electrode selection was made during the initial implantation.
 
Manufacturer Narrative
Device investigations did not reveal any device defect or problem which is expected to have been present whilst implanted.This finding was expected, because according to the recipient report, the recipient had no auditory sensation since implantation.As the recipient was re-implanted with a different electrode type (i.E.Abi electrode) following diagnosis of bilateral cochlear nerve aplasia on post-operative imaging, obtaining hearing perception, it is assumed that an inadequate electrode selection was made during the initial implantation.During investigation the device operates within specification.This is a final report.
 
Event Description
It was reported that the patient was reimplanted with an abi electrode.Additional information received stated that the patient is affected by goldenhar syndrome and diagnostic imaging performed before reimplantation revealed bilateral cochlear nerve aplasia.
 
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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 Key4411583
MDR Text Key15910233
Report Number9710014-2014-00714
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 Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2015
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMI1000 MED-EL CONCERT
Other Device ID Number(01) 09008737062682
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/14/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2014
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 Outcome(s) Required Intervention;
Patient Age3 YR
Patient SexMale
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