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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 Circuit Failure (1089)
Patient Problem Failure of Implant (1924)
Event Date 09/17/2020
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
The user reported that she completely lost hearing benefit from the device a week ago.This was preceded by intermittencies in sound.
 
Manufacturer Narrative
Additional information: in accordance with the information in the recipient report and the manufacturers experience with this kind of device, it is assumed that it is likely in an early stage of failure due to humidity ingress at the housing braze joint through micro-leaks.However to determine an exact root cause a device investigation would be necessary.The concerned device was explanted but has not been received for investigation.
 
Event Description
The user reported that she completely lost hearing benefit from the device in (b)(6) 2020.This was preceded by intermittencies in sound.No redness or swelling or pain sensation has been reported.The user has been re-implanted on (b)(6) 2020.
 
Manufacturer Narrative
Conclusion: investigation results confirm that loss of hermeticity at the housing braze joint by micro-leaks most likely led to device electronics failure over time.It appears that the device is in an early stage of failure.Over a certain period of time, humidity will impinge on the electronics and cause damage, finally leading to complete failure of the circuitry.The investigation results seem to match the symptoms mentioned in the recipient report.This is a final report.
 
Event Description
The user reported that she completely lost hearing benefit from the device in (b)(6) 2020.This was preceded by intermittencies in sound.No redness or swelling or pain sensation has been reported.The user has been re-implanted on (b)(6) 2020.
 
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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 
MDR Report Key10598855
MDR Text Key208941299
Report Number9710014-2020-00545
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup,Followup
Report Date 02/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberC40+
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/22/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/23/2020
Initial Date FDA Received09/29/2020
Supplement Dates Manufacturer Received09/23/2020
09/23/2020
Supplement Dates FDA Received12/21/2020
02/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age22 YR
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