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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 MI1250 SYNCHRONY 2
Device Problem Device Handling Problem (3265)
Patient Problem Failure of Implant (1924)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative

The device has been explanted and should be returned to the manufacturer for evaluation. When available, a device failure analysis will be submitted as a follow up report.

 
Event Description

At implantation on (b)(6) 2020 intra-op testing showed abnormal results. There was no reported difficulties at surgery and a full insertion of the array was achieved.

 
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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
Manufacturer Contact
laura simonotti
fuerstenweg 77a
innsbruck 6020
AU   6020
57788
MDR Report Key10599510
MDR Text Key208944269
Report Number9710014-2020-00555
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeGM
PMA/PMN NumberP000025
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 09/29/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/29/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMI1250 SYNCHRONY 2
Device Catalogue Number36711
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/18/2020
Was Device Evaluated By Manufacturer? No
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: 09/29/2020 Patient Sequence Number: 1
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