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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 Device Operates Differently Than Expected (2913); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Failure of Implant (1924)
Event Date 09/27/2017
Event Type  Injury  
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

It was reported by the recipient's parents that there was a decrease in hearing performance with the device since (b)(6) 2017. No head trauma and no problems of external devices were reported. The patient was re-implanted on (b)(6) 2017.

 
Manufacturer Narrative

Based on measurements performed on the device whilst it was implanted and during explant investigation, it must be assumed that the explantation was not due to a technical problem. The recipient_s perception was unsatisfactory. During investigation minor damage to the active electrode was found, which does not explain for the reported lack of benefit. A ct scan was performed before the explantation but there was no indication that the electrode had migrated from it's original placement in the cochlea, however during initial implantation surgery one channel was reportedly left out of cochlea. Also this aspect does not explain for the reported symptoms. This is a final report.

 
Event Description

It was reported by the recipient's parents that there was a decrease in hearing performance with the device since (b)(4) 2017. No head trauma and no problems of external devices were reported. The user was re-programmed and monitored, but there was no improvement. The user was re-implanted.

 
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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 Key7141528
MDR Text Key95586532
Report Number9710014-2017-01090
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 05/02/2018
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? 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 Manufacturer12/28/2017
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? 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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