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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number PULSAR
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 09/25/2020
Event Type  Malfunction  
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.

 
Event Description

Hearing performance with the device is affected. During fitting the user reported hearing noise at the same loudness level as speech when wearing the audio processor.

 
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Brand NameMED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck 6020
AU   6020
57788
MDR Report Key10605277
MDR Text Key209131522
Report Number9710014-2020-00558
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeSP
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 09/30/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberPULSAR
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/28/2020
Was Device Evaluated By Manufacturer? No
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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