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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 Appears to Trigger Rejection (1524)
Patient Problem Skin Tears (2516)
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
The patient had an extrusion of the electrode lead, but the hearing performance was still good.The implant was not damaged, but the device was removed.The electrode has been partially cut, the remaining part has not been removed from the cochlea, because the surgeon would to re-implant a new device as soon as possible.
 
Manufacturer Narrative
Additional information: according to the information received from the field the electrode extruded through the skin almost 20 years after implantation.No medical or surgical cause has been named, which would account for the reported issue.The concerned device was reportedly explanted but has not been received for investigational purposes.
 
Event Description
The patient had an extrusion of the electrode lead, but the hearing performance was still good.The implant was not damaged, but the device was removed.The electrode has been cut, the remaining part has not been removed from the cochlea.
 
Manufacturer Narrative
Conclusion: device investigation did not reveal any device defect or damage, which has been present whilst implanted.Mechanical damages found during investigation are attributable to the removal surgery.According to the information received from the field the electrode extruded through the skin almost 20 years after implantation.No medical or surgical cause has been named, which would account for the reported issue.This is a final report.
 
Event Description
The patient had an extrusion of the electrode lead, but the hearing performance was still good.The implant was not damaged, but the device was removed.The electrode has been cut, the remaining part has not been removed from the cochlea.
 
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Brand Name
MED-EL COMBI 40+ 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 Key16049773
MDR Text Key306157482
Report Number9710014-2022-00988
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 11/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberC40+
Was Device Available for Evaluation? Device Returned to Manufacturer
Was the Report Sent to FDA? No
Date Manufacturer Received12/16/2022
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 Age23 YR
Patient SexFemale
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