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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 MI1200 SYNCHRONY PIN
Device Problem Output Problem (3005)
Patient Problem Failure of Implant (1924)
Event Date 06/04/2020
Event Type  Injury  
Event Description

The user reported not hearing well out of the right implant. The user was re-implanted on (b)(6) 2020. Visual inspection of the intact device under the microspore at explantation did not reveal any device damages.

 
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Brand NameMED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
innsbruck
AU
MDR Report Key10605170
MDR Text Key209129711
Report Number1066702-2020-00066
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 09/23/2020,09/30/2020
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 NumberMI1200 SYNCHRONY PIN
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date09/23/2020
Event Location Hospital
Date Report TO Manufacturer09/23/2020
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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