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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 Problem Output below Specifications (3004)
Patient Problem Therapeutic Response, Decreased (2271)
Event Type  Malfunction  
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. The recipient's device will reportedly not be explanted at this time. The recipient continues to use the device with good performance and will be managed with programming changes. This is the final report.

 
Event Description

The recipient reportedly experienced decreased performance. Programming adjustments were made.

 
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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 Key10860544
MDR Text Key216904878
Report Number3006556115-2020-01412
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
Reporter Country CodeDE
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/11/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/18/2020
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? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/05/2019
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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