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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 C40+
Device Problems Circuit Failure (1089); Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Type  Injury  
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

Patient describes a sudden loss of hearing. Surgery is scheduled for (b)(6) 2017.

 
Manufacturer Narrative

The device investigation found that the implant was not working according to specification due to a malfunction of the electronic circuitry caused by a malfunction of an electronic element. The investigation results appear to match the problems mentioned in the patient report. The observed mechanical damages are attributable to the explantation surgery. This is a final report.

 
Event Description

The user reported a sudden loss of hearing when using the device. There is no report of any accident or trauma to the implant site. The device was explanted in (b)(6) 2017.

 
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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 Key7141543
MDR Text Key95665897
Report Number9710014-2017-01089
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC40+
OTHER Device ID NumberN/A
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/04/2018
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/05/2017
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 TREATMENT DATA
Date Received: 12/22/2017 Patient Sequence Number: 1
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