• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ADVANCED BIONICS, LLC HIRES 90K¿ ADVANTAGE IMPLANT COCHLEAR IMPLANT Back to Search Results
Model Number CI-1500-04
Device Problem Inaudible or Unclear Audible Prompt/Feedback (2283)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/06/2018
Event Type  Malfunction  
Event Description

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

 
Manufacturer Narrative

Advanced bionics considers the investigation into this event as closed. The recipient will reportedly not pursue revision surgery at this time. Programming adjustments were made which improved sound quality. The recipient was counseled and agreed to wear the device consistently. This is the final report.

 
Manufacturer Narrative

The recipient's device was explanted. The recipient was reimplanted with another advanced bionics cochlear device.

 
Manufacturer Narrative

The recipient reportedly followed recommendation to wear the device consistently, however, sound quality issues did not improve. The recipient has ceased device use and is pursuing revision surgery. Revision surgery is scheduled.

 
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. This is the final report.

 
Manufacturer Narrative

Advanced bionics considers the investigation into this reportable event as closed. The external visual inspection revealed the electrode was severed near the fantail and the silicone was damaged on the bottom cover prior to receipt. These are believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock was verified. The electrode condition prevented some of the electrical tests from being performed. The device passed the electrical and mechanical tests performed. The reported complaints of sound quality and tolerance issues could not be verified during this analysis, which was limited in some respects due to the electrode being severed prior to receipt. This is the final report.

 
Manufacturer Narrative

The external visual inspection revealed the electrode was severed near the fantail and the silicone was damaged on the bottom cover prior to receipt. These are believed to have occurred during revision surgery. The device passed the photographic imaging inspection. System lock was verified. The electrode condition prevented some of the electrical tests performed. The device passed the electrical tests performed. This is an interim report.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHIRES 90K¿ ADVANTAGE 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 Key7684132
MDR Text Key114052082
Report Number3006556115-2018-00310
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 06/21/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/12/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2019
Device MODEL NumberCI-1500-04
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2018
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 Manufactured07/13/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-