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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); Output Problem (3005)
Patient Problems Headache (1880); Failure of Implant (1924); Pain (1994)
Event Date 06/11/2020
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 was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.She also had some sensation of pain and headaches.The user did try the rondo 2 but could hear only a really low volume.An opus 2 was given to the user and she has hearing benefit with it, but she hears noise ("liquid or bubbles noises").She is currently using the opus 2 processor.
 
Event Description
The user was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.The user did try the rondo 2 audio processor but could hear only a really low volume.An opus 2 audio processor was given to the user and she had hearing benefit with it, but she hears noise ("liquid or bubbles noises").She is currently using the opus 2 audio processor.Re-implantation is considered, but no date has been scheduled yet.
 
Manufacturer Narrative
Additional information: as per the complaint information and the manufacturer_s experience with this kind of device, it is assumed that the device might have failed due to humidity ingress at the housing braze joint through micro-leaks.However to determine an exact root cause a device investigation of the explanted device is necessary.Re-implantation is considered but no date has been scheduled yet.
 
Manufacturer Narrative
Conclusion: device investigation confirmed that the stimulator electronics failed.The failure of the electronic circuitry was probably caused by humidity ingress at detected micro-leaks at the housing braze joint.Other damages found during investigation are most likely related to explantation surgery.The problems described in the recipient report appear to match the damage found.This is a final report.
 
Event Description
The user was to be fitted with a new rondo 2 audio processor on (b)(6) 2020, but the audiologist was not able perform in situ testing of the internal device.In the days leading up to the fitting the user reported she felt the volume was decreasing.The user did try the rondo 2 audio processor but could hear only a really low volume.An opus 2 audio processor was given to the user and she had hearing benefit with it, but she hears noise ("liquid or bubbles noises").She then used opus 2 audio processor.The user has been re-implanted.
 
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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 Key10199011
MDR Text Key196987940
Report Number9710014-2020-00344
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 company representative,health
Type of Report Initial,Followup,Followup
Report Date 10/28/2021
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 Manufacturer10/13/2021
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received06/26/2020
Supplement Dates Manufacturer Received06/17/2020
06/17/2020
Supplement Dates FDA Received09/15/2020
10/28/2021
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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