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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 08/27/2020
Event Type  Injury  
Event Description

The user reported that is no sound with the right device. The user reported that when she put on the processor last thursday ((b)(6) 2020) she heard a static sound and since then there has been no sound. No head trauma, illness, tinnitus or dizziness reported. Re-implantation took place on (b)(6). This report refers to 9710014-2020-00481. Please refer to this report for further information.

 
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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
MDR Report Key10605169
MDR Text Key209140187
Report Number1066702-2020-00065
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 09/28/2020,09/30/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberC40+
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/24/2020
Event Location Other
Date Report TO Manufacturer09/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 09/30/2020 Patient Sequence Number: 1
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