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U.S. Department of Health and Human Services

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

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ADVANCED BIONICS, LLC HIRES 90K IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1400-01
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/25/2020
Event Type  Malfunction  
Event Description

The recipient reportedly experienced poor performance and facial nerve stimulation. Programming adjustments were made, and the facial nerve stimulation improved, however, the recipient continued to experience sound quality issues. Revision surgery will be scheduled.

 
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Brand NameHIRES 90K 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 Key9995145
MDR Text Key190007437
Report Number3006556115-2019-00836
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 10/22/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/01/2012
Device MODEL NumberCI-1400-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/16/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/13/2010
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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