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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT

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ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-01
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Code Available (3191)
Event Type  Malfunction  
Event Description

The recipient reportedly experienced facial nerve stimulation. Programming adjustments were made, the facial nerve stimulation improved, however, the recipient then experienced sound quality issues. Revision surgery will be scheduled.

 
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Brand NameHIRES 90K¿ ADVANTAGE IMPLANT
Type of DeviceCOCHLEAR IMPLANT
Manufacturer (Section D)
ADVANCED BIONICS, LLC
28515 westinghouse place
valencia CA 91355
Manufacturer Contact
lacey mcdonald
28515 westinghouse place
valencia, CA 91355
MDR Report Key9935102
MDR Text Key187518239
Report Number3006556115-2020-00281
Device Sequence Number1
Product Code MCM
Combination Product (Y/N)N
PMA/PMN NumberP960058
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/09/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/08/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device EXPIRATION Date08/31/2017
Device MODEL NumberCI-1500-01
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/14/2015
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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