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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 Inaudible or Unclear Audible Prompt/Feedback (2283); Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/06/2020
Event Type  Malfunction  
Event Description

The recipient reportedly experienced no perception of sound since activation. Programming adjustments were made, however, the issue did not resolve. The recipient's device was explanted. The recipient was reimplanted with another cochlear device.

 
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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 Key10215310
MDR Text Key197737381
Report Number3006556115-2020-00521
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
Report Date 06/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/30/2020
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? Device Returned To Manufacturer
Date Returned to Manufacturer06/09/2020
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 Manufactured09/12/2019
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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