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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES¿ ULTRA IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1600-04
Device Problems Electrode (451); Defective Component (2292)
Patient Problem Swelling (2091)
Event Date 02/19/2019
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing open electrodes. The recipient is presenting with swelling. The recipient was recommended to cease device use. Revision surgery will be scheduled.

 
Manufacturer Narrative

The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
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Brand NameHIRES¿ ULTRA IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
delilah garcia
28515 westinghouse place
valencia, CA 91355
MDR Report Key8429102
MDR Text Key139300441
Report Number3006556115-2019-00099
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeFR
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 02/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date04/30/2020
Device MODEL NumberCI-1600-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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