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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES¿ ULTRA 3D IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1601-05
Device Problems Electrode (451); Product Quality Problem (1506); Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/18/2019
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing poor sound quality due to open electrodes. Programming adjustments were made, however, the issue did not resolve. Revision surgery is scheduled.

 
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Brand NameHIRES¿ ULTRA 3D IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
brooke lopez
28515 westinghouse place
valencia, CA 91355
MDR Report Key8875490
MDR Text Key153954330
Report Number3006556115-2019-00500
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup,Followup
Report Date 07/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberCI-1601-05
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/16/2019
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 Manufactured03/12/2019
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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