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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 Problem Device Operates Differently Than Expected (2913)
Patient Problem Failure of Implant (1924)
Event Date 08/04/2017
Event Type  Malfunction  
Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.

 
Event Description

The user reports decline in hearing performance with the device since (b)(6) 2017. No head trauma, no problems with external devices were reported. The recipient's performance was initially fine. As per surgeon, ossification was already present before the first implantation, but not severe. Imaging was done before re-implantation to check the status of the ossification. A prognosis evaluation had been done before the re-implantation of the user. Due to the cochlear ossification it is known that the hearing performance with the device will still be poor if this user was re-implanted on the same side. Following up the suggestion of the surgeon, the previous implant wasn't removed, meanwhile re-implantation was done on the contralateral side on (b)(6) 2017.

 
Manufacturer Narrative

Conclusions: as per received in situ measurements, damage to the active electrode appears possible. However currently available information does not allow to identify a more specific root cause. Also, the observed growth of cochlea ossification may have contributed to the deterioration of hearing performance with the device and to the changes of impedance values. An investigation of the explanted device is necessary, but there are currently no plans to explant the concerned device. The recipient has been implanted on the contralateral side. This is a final report.

 
Event Description

The user reports decline in hearing performance with the device since (b)(6) 2017. No head trauma or problems with external devices were reported. The recipient's performance was initially fine. According to the surgeon, the impedance increase was in correspondence with growth of cochlear ossification, which was already present before first implantation but it was not severe. Following up the suggestion of the surgeon, the previous implant was not removed, meanwhile implantation was done on the contralateral side on (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 Key7141524
MDR Text Key95586002
Report Number9710014-2017-001093
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeCH
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 02/22/2018
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? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC40+
OTHER Device ID Number(01) 09008737015114
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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