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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
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MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM Back to Search Results
Model Number MI1000 MED-EL CONCERT
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Cerebrospinal Fluid Leakage (1772); Seizures (2063); Meningitis (2389); No Known Impact Or Consequence To Patient (2692)
Event Type  Other  
Event Description
It was reported that the pt contracted bacterial meningitis (b)(6) 2015 with seizure, being discharged with successful infection resolution after 2 weeks hospitalization.Pt was re-admitted to the hosp (b)(6) 2015, with bacterial meningitis and discharged on (b)(6) 2015.The pt has vestibulocochlear abnormalities and a csf gusher was observed during the implantation surgery.Device explantation has been scheduled for (b)(6) 2015.
 
Manufacturer Narrative
The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for eval.When available, a device failure analysis will be submitted as a follow up report.
 
Manufacturer Narrative
(b)(4).Additional information: based on the received information, the patient experienced a post-operative meningitis.The surgeon determined that the patient had a cerbrospinal fluid (csf) leak from the cochleostomy which he was able to seal and decided to keep the implant in place.In situ measurements are pointing to a fully functional device.A review of the device's sterilization records confirms that proper sterilization was applied at the time of manufacturing.No information available points to the implant being the source of infection.
 
Event Description
The patient contracted bacterial meningitis in (b)(6) 2015 with seizure, was discharged with successful infection resolution after 2 weeks hospitalization.Patient was re-admitted to the hospital on (b)(6) 2015, with bacterial meningitis and discharged on (b)(6) 2015.The patient has vestibulocochlear abnormalities and a csf gusher was observed during the implantation surgery.Device explantation has been scheduled for (b)(6) 2015.The patient was not explanted as planned.During surgery, the surgeon determined that the patient had cerebrospinal fluid (csf) leak from the cochleostomy which he was able to seal and decided to keep the implant in place.
 
Manufacturer Narrative
(b)(4).Additional information: information received on (b)(6) 2016, stated that the patient contracted meningitis again.A revision surgery is scheduled for (b)(6) 2016.A backup implant has been provided but the surgeon would like to keep implant in place if possible.
 
Event Description
The patient contracted bacterial meningitis in (b)(6) 2015 with seizure, was discharged with successful infection resolution after 2 weeks hospitalization.Patient was re-admitted to the hospital on (b)(6) 2015, with bacterial meningitis and discharged on (b)(6) 2015.The patient has vestibulocochlear abnormalities and a csf gusher was observed during the implantation surgery.Device explantation has been scheduled for (b)(6) 2015.The patient was not explanted as planned.During surgery, the surgeon determined that the patient had cerebrospinal fluid (csf) leak from the cochleostomy which he was able to seal and decided to keep the implant in place.
 
Manufacturer Narrative
(b)(4).Conclusion: device investigations on the received part did not reveal any device defect or problem which is expected to have been present whilst implanted.According to the patient report the patient underwent surgery for medical reasons, namely meningitis.During the surgery it was observed that the patient had a significant cerebrospinal fluid leakage through the cochleostomy site around the array.Therefore the surgeon decided to explant the device.A review of the device_s sterilization records shows that the device has been subject to a valid sterilization process.No information available points to the implant being the source of infection.The damaged foung during investiagtaion are most likely related to explantation surgery.This is a final report.
 
Event Description
The patient contracted bacterial meningitis in (b)(6) 2015 with seizure, was discharged with successful infection resolution after 2 weeks hospitalization.Patient was re-admitted to the hospital on (b)(6) 2015, with bacterial meningitis and discharged on (b)(6) 2015.The patient has vestibulocochlear abnormalities and a cerebrospinal fluid (csf) gusher was observed during the implantation surgery.Device explantation has been scheduled for (b)(6) 2015.The patient was not explanted as planned.During surgery, the surgeon determined that the patient had csf leak from the cochleostomy which he was able to seal and decided to keep the implant in place.As per the information from the (b)(6) 2016, the patient contracted the meningitis again.Patient underwent surgery on (b)(6) 2016.Initially it was planned to keep the implant in place if possible.However during the surgery it was observed that the patient had a significant csf leakage through the cochleostomy site around the array.Therefore the patient was re-implanted.
 
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Brand Name
MED-EL MAESTRO 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 Key4843827
MDR Text Key5934703
Report Number9710014-2015-00428
Device Sequence Number1
Product Code MCM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,health professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup,Followup
Report Date 08/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberMI1000 MED-EL CONCERT
Other Device ID Number(01) 09008737062729
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/01/2016
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 06/01/2015
Initial Date FDA Received06/11/2015
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Not provided
Supplement Dates FDA Received11/03/2015
01/29/2016
08/03/2016
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 Age3 YR
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