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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/04/2020
Event Type  Malfunction  
Event Description

The recipient is reportedly experiencing overly loud sound and non-auditory sensations due to a possible electrostatic discharge (esd) event. External equipment was exchanged and programming adjustments were made. The recipient was recommended to wear the device full time, however, the issues remain. The recipient's device was explanted. The recipient was reimplanted with another cochlear device.

 
Manufacturer Narrative

The recipient has reportedly not undergone revision surgery yet. 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
alexandra gonzalez
28515 westinghouse place
valencia, CA 91355
MDR Report Key9194444
MDR Text Key177646119
Report Number3006556115-2019-00627
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,Followup,Followup,Followup
Report Date 09/25/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/15/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2014
Device MODEL NumberCI-1500-01
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/06/2020
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 Manufactured09/28/2012
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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