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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 Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem Tinnitus (2103)
Event Type  Injury  
Event Description

The recipient is reportedly experiencing sound quality issues and tinnitus. External equipment was exchanged and programming adjustments were made, however, the issue did not resolve. The recipient ceased device use. Revision surgery will be scheduled.

 
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. Programming adjustments were made, which resolved the issue. The recipient continues to use the device and will not be explanted at this time. This is the final report.

 
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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 Key8592060
MDR Text Key144455550
Report Number3006556115-2019-00216
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 04/15/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberCI-1600-04
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 05/08/2019 Patient Sequence Number: 1
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